I-140 Petition Full PDF

Dramappydedelgado@yahoo.
com 24 May 2023
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About this file

This is a real example of an I-140 Petition for EB2 National Interest Waiver (NIW) Green Card. The last
name of the petitioner has been replaced by the fake last name “Apelido” and some personal
information has been redacted. In some instances, the yellow highlight points out changes made to
redact certain names or things that may change over time (for example the government fee amount).
Dramappydedelgado@yahoo.com 24 May 2023
Petitioner/Beneficiary: Dr. Oscar Apelido
Petition: I-140, EB-2 National Interest Waiver - INA §203(b)(2)(B)

List of Documents
A. Forms and Fee

A.1 Filing Fee per Form I-140 - $700
A.2 Form I-140
A.3 Form ETA-9089 (in duplicate)
B. Petition Cover Letter

1. Advanced Degree Professional
2. Substantial Merit and National Importance
3. I am well positioned to advance the proposed endeavor
4. It would be beneficial to the USA to waive the Labor Certification
5. My nonimmigrant status
6. Conclusion
List of Exhibits
Exhibit 1: Letter of Recommendation – Name of Recommender 1, Title/Position, Institution

(Independent Advisory Opinion)
Exhibit 1.1: Recommender 1’s Curriculum Vitae



Exhibit 4.1: Recommender 4’s Bioscketch


Exhibit 7: Advanced Degree – Ph.D.

Exhibit 7.1: Copy of Diploma of Ph.D. in Biosystems Engineering from the Oklahoma State
University
Exhibit 7.2: Copy of Transcripts of Ph.D. in Biosystems Engineering from the Oklahoma State
University
Exhibit 8: Curriculum Vitae
Exhibit 9: Relevance of research for the U.S. National Interest

Exhibit 9A: Bioeconomy Blueprint WH Press Release
EB-2 NIW - Dr. Oscar Pardo Planas – List of Documents

Exhibit 9B: Screenshot of BETO website

Exhibit 9C: Biomass Energy Program Fact Sheet
Exhibit 9D: Biopesticide Oversight and Registration at the US EPA
Exhibit 9E: The Role of Biopesticides in Sustainability Feeding the 9 Billion Global Populations
Exhibit 10: Three most recent Paychecks from GreenLight Biosciences, Inc.
Exhibit 11: Letter of Support for NIW from GreenLight Biosciences’ Position/Title of HR
Exhibit 12: Median salary of peers

Exhibit 12.1: Screenshot from CareerOneStop portal
Exhibit 12.2: Screenshot from GlassDoor.com
Exhibit 13: 2018 W-2
Exhibit 14: GreenLight Biosciences initial Offer Letter and latest Promotion Letter
Exhibit 15: Citation Record by Google Scholar
Exhibit 16: Copies of peer-reviewed publications co-authored
Exhibit 17: Evidence of Serving as Reviewer in Journals
Exhibit 18: Ranking information of peer-reviewed journals
Exhibit 19: Key Contributor Award Letter and Check
Exhibit 20: Documents regarding Current Nonimmigrant status F-1

Exhibit 20.1: Passport
Exhibit 20.2: Current I-20 and I-94
Exhibit 20.3: F-1 visa stamp
Exhibit 20.4: Travel History
Exhibit 20.5: Current EAD card (STEM OPT)
Exhibit 20.6: Copy of form I-797C, Notice of Action for H—1B application
Exhibit 21: Documents Regarding Past Nonimmigrant status

Exhibit 25.1: Copy of past J-1 visa
Exhibit 25.2: Copy of past H-1B visa (Oklahoma State University)
EB-2 NIW - Dr. Oscar Pardo Planas – List of Documents

A. Forms and Fee

A.2 Form I-140
EB-2 NIW – Dr. Oscar Apelido – Forms and Fee

EB-2 NIW - Dr. Oscar Apelido – Filing Fee per Form I-140
A.2 Form I-140
EB-2 NIW - Dr. Oscar Apelido – Form I-140

ENGINEER, PROCESS DEVELOPMENT
1 9 1 0 2 9
DESIGN AND EXECUTE EXPERIMENTS FOR

DEVELOPMENT OF PROCESSES IN THE
BIOTECHNOLOGICAL INDUSTRY, INCLUDING
RNA FOR BIOPESTICIDE USE IN AGRICULTURE
110,000
EB-2 NIW - Dr. Oscar Apelido – Form ETA-9089

B. Petition Cover Letter

1. Advanced Degree Professional
2. Substantial merit and national importance
3. I am well positioned to advance the proposed endeavor
4. It would be beneficial to the USA to waive the Labor Certification
5. My nonimmigrant status
6. Conclusion
EB-2 NIW - Dr. Oscar Apelido – Petition Cover Letter

June 25, 2019
USCIS
Attn: I-140
P.O. Box 660128
Dallas, TX 75266
Re: EB-2 Immigrant Petition for Permanent Residency with request for a National Interest
Waiver

Nature of submission: ORIGINAL SUBMISSION
Type of Petition: I-140, EB-2 National Interest Waiver
Classification Sought: Immigration and Nationality Act 203(b)(2)(B)
Dear USCIS Officer:
This letter is respectfully submitted in support of my Immigrant Petition for Alien Worker (I-
140) sent by me, Dr. Oscar Apelido, as a self-petitioner/beneficiary. I would like to demonstrate
my fulfillment of the following EB-2 National Interest Waiver requirements and provide
supporting evidence for it.
I am eligible for EB-2 classification as a member of the professions holding an advanced degree
pursuant to section 203(b)(2) of the Immigration and Nationality Act, 8 U.S.C. §1153(b)(2)
because I hold a Ph.D. in Biosystems Engineering and I am currently employed as a researcher
by GreenLight Biosciences, Inc. See Chapter 1 (page 4).
I further submit evidence and documentation to demonstrate that a waiver of the labor
certification in my specific case is in the national interest pursuant to In re Matter of Dhanasar,
26 I&N Dec. 884 (AAO 2016), Int. Dec. 3882.
1. My proposed endeavor has both substantial merit and national importance.

Bioprocessing is needed to generate a range of fuels and chemicals that are sustainable
and in occasions not available through traditional manufacturing, including liquid fuels,
biopesticides. Their availability enhances Food, Energy and National Security. Through
my research I have developed such bioprocesses. My research achievements are
beneficial for the whole U.S. nation and satisfy national goals set by government
agencies. See Chapter 2 (page 4).
1|Page EB-2 NIW - Dr. Oscar Apelido – Petition Cover Letter

2. I am well positioned to advance the proposed endeavor. I have developed bioprocesses

that generate liquid fuels, enzymes, and biopesticides using novel biocatalysis routes. My
research has been recognized by peers in the field through frequent citations and through
requests from top journals to serve as judge of the work of other scientists. As a result of
my achievements, I currently hold a critical role in a US company that will disrupt the
agrochemical industry in a very positive manner. See Chapter 3 (page 9).
3. On balance, it would be beneficial to the United States to waive the job offer and labor
certification requirements. GreenLight Biosciences, Inc requires my expertise for a long
time period because their long-term projects would be seriously impaired without my
contribution. A requirement for labor certification would also adversely affect the
national interest. See Chapter 4 (page 22).
This letter serves as a guide through all submitted evidence - I will provide references directly
from the content of the letter. Evidence is placed beneath this letter in the following order:
• Recommendation letters written by outstanding experts (together with resumes of the

authors) from well recognized US institutions such as Institution 1, Institution 2,
Institution 3, Institution 4 and top institutions abroad such as the Institution 5, and
Institution 6. See Exhibits 1 – 6.
• My Advanced Degree including Diploma and Transcripts. See Exhibit 7.
• My Curriculum Vitae. See Exhibit 8.
• My current employment – Offer letter (2017) and latest promotion letter (2019) from
GreenLight Biosciences, Inc. See Exhibit 14.
• Evidence supporting my past track of achievements and impact on the field, including
citations, publications, reviews in journals, evidence of higher salary, awards. See
Exhibits 15-19.
• Current and past nonimmigrant status– passports, approval notices, I-94, visas. See
Exhibits 20 – 21.

The content of this petition letter is divided into chapters to clearly address all required criteria.
1 Advanced Degree Professional ............................................................................................................. 4
2 Substantial Merit and National Importance .......................................................................................... 4
2.1 Introduction to Bioprocessing to generate biofuels and bioproducts such as biopesticides ......... 4
2.2 Development of biofuels increases Energy and National Security ............................................... 5
2.3 Development of biopesticides increases Food Safety and Security .............................................. 7
2.4 Summary of Benefits to U.S. Nation ............................................................................................ 9
3 I am well positioned to advance the proposed endeavor....................................................................... 9
3.1 My background and achievements ................................................................................................ 9
3.2 Summary of Qualifications ......................................................................................................... 11
3.3 Specific extraordinary contributions to Bioprocess Engineering ................................................ 13
3.4 Evidence of the influence of my research ................................................................................... 21
3.5 I review work from peers in international journals ..................................................................... 21
3.6 I command a higher salary .......................................................................................................... 21
4 It would be beneficial to the USA to waive the Labor Certification................................................... 22
5 My nonimmigrant status ..................................................................................................................... 25
6 Conclusion .......................................................................................................................................... 25

1 Advanced Degree Professional
I earned my Ph.D. degree in Biosystems Engineering from Oklahoma State University, in

Stillwater, OK, in 2016 (Exhibit 7: Copy of PhD Diploma and Transcripts). Through this and
previous educational experiences, I have gained the knowledge and skills required to fill my
current position as Engineer III, Process Development at GreenLight Biosciences, Inc (Exhibit
14: GreenLight’s initial Offer Letter and latest Letter of Promotion). In this position, I focus on
developing a commercially relevant bioprocess for a novel biopesticide: an RNA molecule that
targets specific pests without affecting other species (such as endangered bees), and does not
pose any risk for humans who consume the crops.
Significant original research achievements obtained during my PhD studies are further described
in details in Chapter 3.
Based on the facts demonstrated above, I qualify for the EB-2 classification as a member of
the professions holding an advanced degree.
2 Substantial Merit and National Importance
My research is focused on process development and scale-up of microbial cell cultures and
bioprocessing to generate novel products, such as biofuels, proteins (enzymes), or nucleic
acids (like RNA for use as biopesticide). These are key areas of US development and have a
positive impact on Food, Energy, and National Security. To develop those novel bioprocesses, I
focus on bioreactor design and characterization of key operating parameters, such as dilution rate
or aeration; and through optimization of media components using statistical tools to
systematically improve cell biomass, productivity, and yields.
2.1 Introduction to Bioprocessing to generate biofuels and bioproducts such as

biopesticides
Bioprocessing, or bioprocess engineering refers to a specific process that uses complete

living cells (for example, bacteria, or fungi) or their components (such as enzymes, DNA, RNA)
to obtained desired products. The term bioeconomy refers to all processing, marketing,
transportation, and consumption of biologically derived products.
The interest for fostering a biobased economy was consolidated in the National
Bioeconomy Blueprint released by the United States White House on April, 2012. In that
document, a number of federal departments and agencies announced initiatives aimed at helping
to attain the strategic objectives, among them “Expanding the biobased products purchasing

program”, “building support for biofuel production facilities to create jobs and expand the use of
alternative energy”, “collaborating to reduce the need for nitrogen fertilizer inputs”, “improving
homeland security through biological research”. (Exhibit 9A: Relevance of research for the U.S.
National Interest – Bioeconomy Blueprint WH Press Release)
In the following sections I will describe how my research has substantial merit and it aligns
with the National Interest of the United States in key areas.
2.2 Development of biofuels increases Energy and National Security

The U.S. Department of Energy has a specific federal office dedicated to alternative
energy: the Bioenergy Technologies Office (BETO). Its mission is to “develop technologies for
production cost-competitive advanced biofuels from non-food biomass resources, including
cellulosic biomass, algae, and wet waste (e.g. biosolids).” (Exhibit 9B: Relevance of research for
the U.S. National Interest – Screenshot of BETO website).
Depletion of non-renewable resources has raised concerns about issues such as

environmental pollution, climate change, and national security. Discussion about oil and gas
availability, among other resources, has dominated the conversation because of their critical role
as energy sources. According to the US Energy Information Administration, 63% of the energy
consumed in the country in 2013 was produced from petroleum and natural gas. According to
BETO’s website, this federal office aims to “work with a broad spectrum of government,
industrial, academic, agricultural, and nonprofit partners across the United States to develop
commercially viable, high-performance biofuels, bioproducts, and biopower made from
renewable U.S. biomass resources that reduce our dependence on imported oil while
enhancing energy security.”.
The Bioenergy Technologies Office goes on to specifically describe how biofuel

production will create a more “secure, sustainable, and economically sound future”. In its
website the federal office outlines four key areas of action: “Promoting national security by
developing domestic sources of energy”, “Growing a sustainable future with renewable biomass
resources”, “Generating green jobs by stimulating the U.S. bioenergy economy”, and “Leading
global technology innovation”. (Exhibit 9B: Relevance of research for the U.S. National Interest
– Screenshot of BETO website). It is evident that the field of bioprocess engineering, specifically
bioenergy and biofuels, is a top priority for the U.S. government.
As another piece of evidence to illustrate how biofuels is a topic of National Interest is

the specific “Biomass program” by the US Department of Energy. According to its own Fact
Sheet “The emerging U.S. bioenergy industry provides a secure and growing supply of
transportation fuels, biopower, and bioproducts from a range of biomass resources. Abundant,
renewable bioenergy can help secure America’s energy future, reducing our dependence on
foreign oil and ensuring American prosperity while protecting the environment.”. “The

Renewable Fuel Standard (RFS) mandates biofuel use to improve our nation’s energy security.
The standard requires 36 billion gallons of renewable fuels production by 2022, of which 21
billion gallons will be advanced biofuels. Meeting the RFS will require technological
innovation, private investment, and clear government support in the U.S. biofuels industry
over the next decade.” (Exhibit 9C: Relevance of research for the U.S. National Interest –
Biomass Energy Program Fact Sheet).
My research at Oklahoma State University focused on development of bioprocesses for

generation of liquid fuels such as ethanol, and butanol, which are compatible with the existing
infrastructure. Moreover, I investigated and successfully designed methodologies to convert non-
edible biomass into these valuable products. While at Oklahoma State University I focused on
conversion of switchgrass and eastern redcedar to liquid fuels. Switchgrass is considered a
renewable feedstock due to its high productivity, suitability for marginal land use, and low water
requirements. Eastern redcedar is a plant considered a pest in Oklahoma and other states, because
it is invasive, moderate allergenic, and it increases wildfires ($100 million lost every year in
Oklahoma alone in wildfires caused by this plant). My research established bioconversion
methods so 300 million gallons of butanol, a biofuel that can easily replace gasoline, can be
produced from eastern redcedar. These projects are absolutely aligned with the objectives
and mission of BETO and the US Department of Energy and address the areas of National
Importance described by the United States Government. As an example of the outcomes of
my work at Oklahoma State University, the following peer-reviewed articles were published
(Exhibit 15: Citation Record by Google Scholar, and Exhibit 16: Copies of peer-reviewed
publications):
• “Simultaneous saccharification and fermentation of Eastern redcedar heartwood and

sapwood using a novel size reduction technique”. Bioresource Technology, 2014. 8
citations.
• “Butanol production from hydrothermolysis-pretreated switchgrass: quantification of
inhibitors and detoxification of hydrolyzate”. Bioresource Technology, 2015. 49
citations.
• “Process development for biological production of butanol from Eastern redcedar”.
Bioresource Technology, 2015. 15 citations.
• “Process simulation of ethanol production from biomass gasification and syngas
fermentation”. Bioresource Technology, 2017. 9 citations.
In addition to these outcomes of my contributions to areas of national importance, my PhD

work focused on design and operation of a novel bioreactor system to produce an enzyme (aryl
alcohol oxidase) with potential application in the biofuel industry:
• High-yield production of aryl alcohol oxidase under limited growth conditions in small-
scale systems using a mutant Aspergillus nidulans strain”. Journal of Industrial
Microbiology and Biotechnology, 2017. 4 citations.

• “Prevention of melanin formation during aryl alcohol oxidase production under growth-
limited conditions using an Aspergillus nidulans cell factory”. Bioresource Technology,
2017. 5 citations.
• “Continuous aryl alcohol oxidase production under growth-limited conditions using a
trickle bed reactor”. Bioresource Technology, 2018.
More information about their significance and impact and impact will be provided later in
Chapter 3.
Experts in the field commented on my contributions to areas of National Importance:
• “Considering the need for replacing fossil fuels and the biofuel production objectives
mandated by the Energy Independence and Security Act, Dr. Apelido’ work is of
extreme importance to advance the biofuel research field towards commercial
implementation at scale.” (Exhibit 2. Name of Recommender 2, Ph.D., Position/Title,
Institution) (Independent Advisory Opinion)
• “I know that Dr. Apelido’ skills in the field of bioprocessing will deeply benefit the
United States and the development of new technologies to produce fuels and chemicals in
a renewable and sustainable manner.” (Exhibit 5. Name of Recommender 5, Ph.D.,
Position/Title, Institution)
• “Obtaining sustainable sources for fuels and products is a major challenge for the USA
and several countries around the world. Biotechnology and bioprocessing are emerging
technologies that can be explored to replace many production processes t based in non-
renewable sources that are costly and non-environment friendly. Therefore, scientists
like Dr. Apelido, are crucial to contribute in the development of more efficient
technologies applied in the transition to a bio-based economy.” (Exhibit 3. Name of
Reccomender 3, Ph.D., Position/Title, Institution) (Independent Advisory Opinion)
2.3 Development of biopesticides increases Food Safety and Security

Biopesticides are derived from natural materials such as animals, plants, bacteria, certain
minerals, with unique modes of actions and reduced risk compared to traditional chemical-based
pesticides. The US Government established the Biopesticides and Pollution Prevention Division
(BPPD) in the Environmental Protection Agency’s (EPA) Office of Pesticide Program (OPP) to
“promote the use of safer pesticides, including biopesticides”.(Exhibit 9D: Relevance of
research for the U.S. National Interest –Biopesticide Oversight and Registration at the US EPA).
As this official document denotes, the US Government considers biopesticides safer than other
conventional pest-control products.

The official document goes further in highlighting the benefits of biopesticides to the US
nation: “Decreased risk without affecting yield”, “Often less toxic than conventional pesticides”,
“Often effective in very small quantities”, “Targeting of specific pests” in contrast to
conventional pesticides that may affect non-target organisms such birds, insects, and mammals,
“When used in rotation with conventional products, biopesticides can help prevent the
development of pest resistance problems”, “improved residue management”.
In an article published in the Journal of Biofertilizers and Biopesticides, Dr. Suresh

Kumar, an expert in the field of Agriculture, highlights the role of biopesticides in a world
expected to reach 9 billion inhabitants by 2050:
• “Biological pesticides are expected to provide predictable performance, and they

must do so in an economically viable manner for their better acceptability and
adaptability. Deployed appropriately, biopesticides have potential to bring
sustainability to global agriculture for food security to the 9 billion people by the
year 2050” (Exhibit 9E – Relevance of research for the U.S. National Interest - The
Role of Biopesticides in Sustainability Feeding the Nine Billion Global
Populations)
It can be concluded that biopesticides pose an enormous potential to enhance the United
States’ (and the World’s) Food Safety and Security. In economic terms, the biopesticide market
in North America alone exceeded 1.2 billion dollars in 2017, and it is expected to surpass $2.3
billion by 2023.
My current work at GreenLight Biosciences, Inc is aligned with the objectives set by the
EPA in developing biopesticides. I am a key contributor developing a commercial process for
production of a dsRNA molecule that is highly specific to the target pest, therefore does not
affect other species that are endangered (e.g. bees), and is nontoxic to humans. For example, I
used my knowledge on fermentation and bioprocessing to optimize the microbial growth of the
Escherichia coli strains we use to produce a range of enyzmes that enable our Cell Free Reaction
platform to produce RNA. Specifically, I investigated the effect of temperature, pH, aeration and
bioreactor mode of operation on fermentation performance indicators such as cell mass
concentration, enzyme titers, or productivity. I also optimized the media composition to
maximize cell growth and production of desired enzymes.
Name of Recommender 4, Position/Title at Institution, summarizes the goals of our

organization and my level of contribution to them:
• “Our scalable technology will be used to generate RNA products to control

agricultural pests that have become resistant to traditional chemical pesticides. We
are proud to be near commercialization of biopesticides that are highly specific,
sustainable, and environmentally friendly. Oscar is a member of the team I lead

which is responsible for the research and development of a commercial process for
the proprietary production methods invented by GreenLight Biosciences, Inc.” (…)
“ I can say with confidence he is a top contributor and a highly valued member of
my team” (Exhibit 4. Name of Recommender 4, Title/position, Institution)
2.4 Summary of Benefits to U.S. Nation
Bioprocessing generates products, including fuels, enzymes, and biopesticides, that

enhance energy security, food security and safety, national security, and therefore should be
considered efforts of National Importance. For example, production of ethanol and butanol as
fuels reduces the need for foreign oil therefore increasing energy independence of the U.S. In
addition, the use of RNA biopesticides reduce the toxic chemicals sprayed onto crop fields and
can control pests in a highly specific manner without hurting beneficial organisms such as bees.
My work developing production processes to obtain liquid fuels from non-edible biomass
sources, and production of enzymes, as well as production of RNA pesticides, have been
recognized by experts in the field and have advanced these areas of bioprocess engineering.
Hence, my research has both substantial merit and national importance.
3 I am well positioned to advance the proposed endeavor
This chapter:
• Shows my overall background and achievements.

• Describes specific extraordinary contributions I made to the field of Bioprocessing, both
at Oklahoma State University and currently at GreenLight Biosciences, Inc.
• Explains how my research has impacted and influenced the field of endeavor and
benefits the nation.
• Provides further evidence of outstanding merits such as serving as reviewer for peer-
reviewed publications and commanding a higher salary.
3.1 My background and achievements
In this section I will defend how I have made substantial contributions to the field of
bioprocess engineering. My work has focused on process development and scale-up of microbial
cell cultures and biocatalysis processes to generate novel products, such as biofuels, proteins
(enzymes), or nucleic acids (to be used as biopesticides, like RNA). I focus on bioreactor design
and characterization of key operating parameters, such as dilution rate or aeration; and through
optimization of media components using statistical tools to systematically improve cell biomass,
productivity, and yields.
Successful research in my field addresses the design, development, and operation of

equipment and processes involved in the manufacturing of biological materials, including fuels,
pharmaceuticals, chemicals, polymers, biopesticides, and food products. Therefore, my research
results have directly contributed to improving processes in the energy, agricultural, and food
industries. Additionally, my research concerning the development of fermentation processes for
production of alcohols from biomass are contributing to the United States’ energy independence,
and my current research at GreenLight Biosciences, Inc. concerning the development of a
commercial process for production of dsRNA as a biopesticide is contributing to the United
States’ food security and independence.
In order to conduct this cutting-edge research, I have developed an extensive background

in fermentation process development, and bioreactor design and operation (Exhibit 8:
Curriculum Vitae). Dr. Recommender 5 and Ms. Recommender 4 summarize my background
and achievements:
• “Because Dr. Apelido was involved in a wide range of projects, he has obtained a unique
set of skills and expertise in several bioprocessing areas, such as biomass conversion,
sugar fermentation, bioreactor design and operation, enzymatic hydrolysis, and gas-liquid
fermentation.” (Exhibit 5. Name of Recommender 5, Title/position, Institution)
• “We hired Dr. Apelido as a Post-Doctoral Process Development Engineer in January,

2017. He came from Oklahoma State University with remarkable recommendations
because of his work developing an enzyme production bioreactor system in collaboration
with a German company.” (…) “His contributions to GreenLight Biosiences have been
outstanding and have been recognized with several promotions: from Post-Doctoral
Engineer to Fermentation Supervisor, then to Engineer II and more recently to Engineer
III, with the corresponding pay increases. All this in only 2.5 years of employment with the
organization”. (Exhibit 4. Name of Recommender 4, Title/position, Institution)
Therefore, based on my achievements in my research field (bioprocess engineering) and

substantial educational and experiential backgrounds, as explained in the attached
recommendation letters and evidenced with supporting materials, my substitution with another
minimally qualified researcher would adversely affect the national interest of the United States
of America.
10 | P a g e EB-2 NIW - Dr. Oscar Apelido – Petition Cover Letter

3.2 Summary of Qualifications

Beyond my advanced degree (Ph.D. in Biosystems Engineering from Oklahoma State
University, Exhibit 7), I have made and continue to make significant contributions to the field of
bioprocessing, all of which place me among the top scientists working in my field of endeavor
(Exhibits 1-6, Letters of recommendation). I hold an impressive record of authorship and the
field of bioprocessing. As evidence of this success, my work has resulted in 7 peer-reviewed
journal articles, 4 of them first-authored) (Exhibits 15 and 16), and 16 conference
presentations including international professional meetings (Exhibit 8: Curriculum Vitae). Dr.
Recommender 5, my former PhD advisor, highlights how extraordinary this accomplishment is
in his letter:
• “Most of the graduate students I worked with in the past years publish 1 or 2 papers
based on their research work. Dr. Apelido published 7 articles in top international
peer-reviewed journals based on his work done while at OSU. This is an impressive
and unusual achievement, especially if we consider the short span of time (4 years) for
this high-quality work to be designed, executed, and disseminated.” (Exhibit 5. Name
of Recommender 5, Title/position, Institution)
This productive and laudable record compared to others in the bioprocessing engineering
field was also recognized by independent experts, such as Dr. Recommender 2:
• “Dr. Apelido has been a prolific author in the field of Bioprocessing and
Biotechnology. He has published repeatedly in top ranking journals such as
Bioresource Technology and the Journal of Industrial Microbiology and
Biotechnology, which are two of the most prestigious journals that focus on topics such
as biofuels, biomass conversion, bioreactor design, and fermentation. The fact that Dr.
Apelido was able to publish his work so frequently in journals that are highly
selective shows that his research work deserved the attention of his peers in the
bioengineering and scientific community” (Exhibit 2. Recommender 2, Ph.D.,
Title/Position, Institution) (Independent Advisory Opinion)
As these experts state in their recommendation letters quoted above, these peer-reviewed
journals are prestigious and highly impactful in the field (Exhibit 18. Ranking information of
peer-reviewed journals). Their metrics are summarized below:
• Bioresource Technology: The Impact Factor of this journal is 6.669. Ranked #2 in

Biotechnology by Google Scholar. Ranked 1 out of 184 journals in Environmental
Engineering (top 0.5%) and ranked 13 out of 177 journals in Bioengineering (top
7.3%) by SCImago (https://www.scimagojr.com/).
• Journal of Industrial Microbiology and Biotechnology. The Impact Factor is 3.103.
The journal is listed as #20 in Biotechnology by Google Scholar.
Based on this evidence, it is clear that I am not only conducting important original
research, but that my work is considered majorly significant by the top journals in the field.
These highly selective journals have consistently accepted my research for publication, showing
that my work in considered to be among the best in the field.
It must be noted also that my work has been cited a total of 90 times according to Google
Scholar (Exhibit 15: Citation Record by Google Scholar), demonstrating that these publications
are widely recognized and relied upon in the field of bioprocess engineering. My peers in the
field comment on the impressive citation record of my work:
• “[Dr. Apelido’] research papers have been cited more than seventy times from
researchers based all over the world, which highlights the international acclaim
achieved by Dr. Apelido.” (Exhibit 3. Recommender 3, Ph.D., Title/Position,
• “According to Dr. Oscar Apelido’ Google Scholar profile, his articles have deserved
over 80 citations so far, and this number has grown exponentially since 2014. This
attention is a result of his contributions to advance the field of biofuels and
bioprocessing: Dr. Apelido has become a highly influential member of his field”
(Exhibit 2. Recommender 2, Ph.D., Title/Position, Institution) (Independent Advisory
Opinion)
• “In his [Apelido’] article “Butanol production from hydrothermolysis-pretreated

switchgrass: Quantification of inhibitors and detoxification of hydrolyzate”, he
carefully analyzed the inhibitors present in switchgrass hydrolyzates that prevented the
strain Clostridium acetobutylicum from converting sugars into butanol. Dr. Apelido
was able to reduce or eliminate these inhibitors (mainly furanic and phenolic
compounds) through detoxification with activated carbon” (…) “As further evidence of
its significance, this article has been cited more than 40 times in just four years,
which is well above the average number of citations per paper in the field”. (Exhibit
1. Recommender 1, Ph.D., Title/Position, Institution) (Independent Advisory
Opinion)
In line with Dr. Recommender 1´s testimony, the papers I co-authored have been cited at a
high rate compared to other papers in the same journals. For instance, the paper “Process
development for biological production of butanol from Eastern redcedar” published in
Bioresource Technology in 2015 received 15 citations so far. The average citation per paper for
this journal is only 6.96, according to SCImago. (Exhibit 18. Ranking information of peer-
reviewed journals)
• The paper entitled “Butanol production from hydrothermolysis-pretreated

switchgrass: quantification of inhibitors and detoxification of hydrolyzate”,

published in 2015 in Bioresource Technology received 49 citations to date, which is

seven times above the average number of citations for the papers in the same
journal (6.96, according to SCImago).
• The article “High-yield production of aryl alcohol oxidase under limited growth
conditions in small-scale systems using a mutant Aspergillus nidulans strain”,
published in 2017 in the Journal of Indsutrial Microbiology and Biotechnology
received 4 citations to date, which is above the average citations per paper in the
same journal (3.07, according to SCImago).
My work has therefore been among the most cited in the field in the past several years,
and I have been consistently cited more than one would expect from an average researcher in the
field (Exhibit 15: Citation Record by Google Scholar; Exhibit 18: Ranking information of peer-
reviewed journals). It can be concluded that I have made significant original contributions
through my publications, since my achievements have been widely recognized and relied upon in
the field of bioprocess engineering.
In addition, all of my recommenders are internationally acclaimed scholars in the

bioprocess engineering field, who belong to reputable organizations such as Institutions 1, 2, 3,
4, 5, 6. (Exhibits 1 to 6: Letters of recommendation).
3.3 Specific extraordinary contributions to Bioprocess Engineering

In this section I will describe my original contributions of major significance in the field of
bioprocessing engineering. Specifically, my research has focused on process development and
scale-up of microbial cell cultures and biocatalysis processes to generate novel products, such as
biofuels, proteins (enzymes), or nucleic acids (to be used as biopesticides, e.g. RNA).
3.3.1. Conversion of biomass feedstocks to bio-butanol: overcoming the challenge of

fermentation inhibitors
Conversion of herbaceous/woody materials that are considered waste into higher value
products, such as biofuels, has gained attention in the Bioprocessing field in the last decades due
to sustainability awareness and energy security needs. One of the main challenges is the structure
of biomass itself, which is difficult to access to by the enzymes that convert sugar polymers into
simple sugars that can be used by microorganisms to generate biofuels or others. Because of this
issue, it requires a pretreatment step at the beginning of the conversion process that uses high
temperature and/or pressure, and/or addition of chemicals, to open the structure and make the
wood material amenable to enzymes. These pretreatments generate a variety of compounds that
are toxic for the microorganisms used later in the process to convert sugars into products.
Because of this, detoxification step(s) may be required in order to achieve a commercially
relevant process. My work on process development of biomass to butanol conversion
demonstrated successful end-to-end production from two different feedstocks: switchgrass and

eastern redcedar, which are considered renewable sources of energy.

This project led to two peer-reviewed publications (Exhibit 16: Copies of peer-reviewed
publications):
• “Butanol production from hydrothermolysis-pretreated switchgrass: quantification

of inhibitors and detoxification of hydrolyzate”. Bioresource Technology, 2015.
49 citations.
• “Process development for biological production of butanol from Eastern
redcedar”. Bioresource Technology, 2015. 15 citations.
An expert on biomass-to-biofuel conversion describes the second paper in detail:
• “Dr. Apelido described a process that starts from grounding redcedar wood to the final
butanol production using two different Clostridia strains, and it includes pretreatment
of redcedar, enzymatic hydrolysis, detoxification of hydrolyzates, and anaerobic
fermentation. The process presented in this publication achieved similar butanol
production than that obtained by suing a model pure sugar: glucose, which is
remarkable. This peer-reviewed article is highly significant, as it establishes the
potential production of 315 million gallons of butanol from the 11.5 million dry metric
tons of above ground redcedar biomass just in Oklahoma. This is, to the best of my
knowledge, the first report of acetone-butanol-ethanol (ABE) fermentation using
Easter redcedar as a feedstock” (Exhibit 1. Recommender 1, Ph.D., Position/Title,
The two papers appear in a prominent source in the field, Bioresource Technology. The
journal’s relevant rankings are reproduced below:

7.3%) by SCImago (https://www.scimagojr.com/).(Exhibit 18. Ranking information
of peer-reviewed journals)
3.3.2. Reduction of cost of pretreatment of eastern redcedar for biofuel production
Conversion of herbaceous/woody materials that are considered waste into higher value
products, such as biofuels, has gained attention in the Bioprocessing field in the last decades due
to sustainability awareness and energy security needs. One of the main challenges is the structure
of biomass itself, which is difficult to access to by the enzymes that convert sugar polymers such
as cellulose and hemicellulose into simple sugars (like glucose) that can be used by
microorganisms to generate biofuels or other products. This issue requires a pretreatment step at
the beginning of the conversion process that uses high temperature and/or pressure, and/or
addition of chemicals, to open the structure and make the wood material amenable to enzymes.
This pretreatment process is specific to the feedstock and it is a major cost-contributor (about
35% of the processing price of ethanol according to the Department of Energy). This high
contribution of pretreatment to the total cost is one of the bottlenecks to the biomass conversion
to biofuels. One of the approaches I followed to tackle this issue was summarized in the peer-
reviewed publication listed below. It consisted on the use of a novel size reduction technique
prior to pretreatment of eastern redcedar wood. Usually, biomass is finely ground (to 0.5 mm)
before entering the conversion platform to facilitate the pretreatment process. In this project I
showed that we could obtain the same high yields of ethanol using 2.5 mm particles that were
generated with a proprietary size reduction process developed by Forest Concepts, LLC that
saved up to 93% energy compared to the traditional milling processes.
Another approach I followed to reduce the cost was to modify the pretreatment process
that uses high temperature, high pressure, and chemicals (sulfuric acid and sodium bisulfite). I
was able to reduce the amount of sulfuric acid, sodium bisulfite, and water used by 40% and the
temperature of the process by 18% and still produce a high yield of sugars in the process. These
reductions are important because of cost implications (lower temperature means lower energy
needs, and less chemicals used imply lower cost of wastewater treatment), and from a
sustainability point of view: less chemicals in the process make it more favorable when looking
at the environmental impact of producing ethanol. An expert that attended an international
conference where I presented these findings describe the significance of the work:
• “Dr. Apelido showed in his presentation how he reduced the amount of water and
chemicals by nearly half, and temperature by about 20%. Despite these reductions he
was able to maintain a high yield of sugars produced from the redcedar. This is a
remarkable contribution to the field, one that would enable the conversion of
redcedar to fuels and chemicals in a sustainable way”(Exhibit 1. Recommender 1,
Ph.D., Title/Position, Institution) (Independent Advisory Opinion)
This project resulted in one peer-reviewed publication (Exhibit 16: Copies of peer-
reviewed publications):
• “Simultaneous saccharification and fermentation of Eastern redcedar heartwood and

sapwood using a novel size reduction technique”. Bioresource Technology, 2014. 8
citations.
Bioresource Technology is an impressive journal, with an Impact Factor of 6.669. It is ranked

#2 in Biotechnology by Google Scholar. It is also ranked 1 out of 184 journals in
Environmental Engineering (top 0.5%) and ranked 13 out of 177 journals in Bioengineering

(top 7.3%) by SCImago (https://www.scimagojr.com/).(Exhibit 18. Ranking information of

peer-reviewed journals)
3.3.3. Process simulation of a syngas fermentation plant to produce ethanol from

switchgrass
There are two main routes for production of bioethanol: the traditional biochemical
platform and the novel hybrid gasification-fermentation technology. In the traditional platform,
the biomass is pretreated to disrupt its challenging structure and make it possible for enzymes to
convert cellulose to simple sugars that can be used by microbes. This process is energy intensive
and therefore, expensive. Also, about a third of the biomass is lignin, which cannot be converted
by the biochemical route. In contrast, the hybrid gasification-fermentation technology converts
the biomass into a gas called syngas (mainly carbon monoxide, carbon dioxide, and hydrogen)
and then this gas is fed to very specific microbes capable of consuming it while production
ethanol. This technology has gained much interest in the last decade, but there was a lack of tools
for modeling and process simulation required for techno-economic analysis toward designing
large scale syngas fermentation processes. This is a completely necessary step for the ultimate
goal of commercialization. In my work (which resulted in a peer-reviewed publication), I
described a comprehensive model of a biorefinery that consumes 1,200 tons of switchgrass per
day (switchgrass: herbaceous crop considered a renewable biomass source) to produce 36 million
gallons of ethanol per year. The model includes the gasification stage, the fermentation module,
and the product recovery units. In each of them we performed sensitivity analyses around the key
performance parameters to assess how different scenarios would affect the output of the plant.
This proved how this modeling work can help optimizing each module of the process or the
process as a whole. The overall conclusion of the study was that 97.7 gallons of ethanol can be
produced in this plant from each ton of switchgrass. This yield is higher than what had been
reported previously in experimental studies using the traditional biochemical platform.
An independent expert in the field of modelling and simulation gives a description of the
importance of this work:
• “The technology described in the paper involves gasification of biomass (conversion of

switchgrass into a gas called syngas; mainly CO, H2, and CO2), a bioreaction using
gas-fermenting bacteria, and a final stage where the ethanol produced by the
microorganism gets purified into the final product. To my knowledge, this is the first
peer-reviewed document that discusses the process simulation of such an industrial
process from end to end. None of the available studies have examined the effects of
critical syngas fermentation parameters such as ethanol titers, specific gas uptake
rate, or substrate conversion efficiencies. In that, Dr. Apelido’ work is unique and
novel.” (Exhibit 2. Recommender 2, Ph.D., Title/Position, Institution) (Independent
Advisory Opinion)

This work produced one peer-reviewed publication (Exhibit 16: Copies of peer-reviewed
publications):
• “Process simulation of ethanol production from biomass gasification and syngas

fermentation”. Bioresource Technology, 2017. 9 citations.
Bioresource Technology is an impressive journal, with an Impact Factor of 6.669. It is

ranked #2 in Biotechnology by Google Scholar. It is also ranked 1 out of 184 journals in
Environmental Engineering (top 0.5%) and ranked 13 out of 177 journals in Bioengineering
(top 7.3%) by SCImago (https://www.scimagojr.com/).(Exhibit 18. Ranking information of
peer-reviewed journals)
The words of the expert Dr. Recommender 1 illustrate the impact that this peer-reviewed article
had in the field of simulation:
• “Akhatar et al. discussed Dr. Apelido’ work in their review of combustion, pyrolysis
and gasification of biomass, and even included one of his figures in their review article
published in Energy & Fuels. Considering the need for replacing fossil fuels and the
biofuel production objectives mandated by the Energy Independence and Security Act,
Dr. Apelido’ work is of extreme importance to advance the biofuel research field
towards commercial implementation at scale” (Exhibit 2. Recommender 2, Ph.D.,
Position/Title, Institution) (Independent Advisory Opinion)
Indeed, the fact that a review article in an important journal such as Energy & Fuels not
only mentions but even reproduces a figure from one of my publications is another piece of
evidence to corroborate the significance of my research.
3.3.4. Production of aryl alcohol oxidase in growth-limited conditions in a trickle bed

reactor using an Aspergillus nidulans cell factory
My research focused on producing an enzyme, aryl alcohol oxidase, with potential

applications in the biomass to biofuel conversion field. To do that, we constructed a mutant
fungal strain (A. nidulans) that overexpressed the targeted enzyme, and at the same time was
unable to grow in absence of a vitamin: pyridoxine. The purpose of limiting the growth can be
understood after describing the reactor used for production. Typically, enzyme production is
done in agitated vessels where the microorganisms grow in liquid media. The energy cost of
these processes is intensive, and the main contributor is the energy cost invested in agitation of
the media to provide mixing and oxygen transfer to the microbes. In my project, I used a novel
trickle bed reactor: a column filled with an inert packing material where the fungal strain could
grow. Liquid media with nutrients was pumped to the top of the column and trickled down the

packing material where a biofilm of fungus grew in close contact with those nutrients and with
oxygen. The operating cost of this reactor is much lower than that of traditional agitated tanks.
One challenge prevented this technology from being a reality: the uncontrolled growth of the
fungus clogged the column and terminated production runs quickly. Thanks to the pyridoxine
limitation marker incorporated in the strain constructed, I could regulate the growth of the
fungus: when the vitamin was not provided the fungus would not grow.
An important issue was detected when growth was limited: production of melanin and
decrease of enzyme productivities. My research reduced or suppressed this melanin problem and
restored enzyme production while limiting the growth of the A. nidulans strain. I carefully
investigated the cause of the problem and modified the liquid media recipe, reducing certain
metals such as copper and zinc, and adding ascorbic acid (vitamin C). This enabled operation of
the trickle bed reactor in a continuous mode with low growth rate of the fungus and production
of aryl alcohol oxidase. During the reactor runs, I investigated the effect of key performance
parameters such as the type of packing material used for supporting the biofilm, or flow rate of
air and liquid media used, on enzyme yields and titers. The findings were published in three
peer-reviewed papers and in a Ph.D. dissertation at Oklahoma State University.
• “High-yield production of aryl alcohol oxidase under limited growth conditions in

small-scale systems using a mutant Aspergillus nidulans strain”. Journal of Industrial
Microbiology and Biotechnology, 2017. 4 citations.
• “Prevention of melanin formation during aryl alcohol oxidase production under growth-
limited conditions using an Aspergillus nidulans cell factory”. Bioresource Technology,
2017. 5 citations.
• “Continuous aryl alcohol oxidase production under growth-limited conditions using a
trickle bed reactor”. Bioresource Technology, 2018.
Dr. Recommender 6, an expert on Aspergillus nidulans, summarizes the work and outcomes in
his recommendation letter:
• “I know Dr. Apelido since 2014, when we started collaborating on a project that aimed
to produce an enzyme (aryl alcohol oxidase) using an Aspergillus nidulans cell factory
with growth limitation in a novel trickle bed reactor. This research was implemented as a
collaboration between two departments at OSU (Biosystems Engineering and
Microbiology) and a research institute in Germany (PFI-Pirmasens). Dr. Apelido was
responsible for leading the research at OSU and for providing tech transfer to our
German partners. This project resulted in 3 peer-reviewed publications in the high
impact factor journals Bioresource Technology and the Journal of Industrial
Microbiology and Biotechnology, as well as in one Ph.D. dissertation (Dr. Apelido’s
doctoral work), and 3 professional conference presentations in the US, Germany, and
India. The prolific dissemination of this work already speaks for the significance of its
findings”. (Exhibit 6. Dr. Recommender 6, Title/Position, Institution)

In his letter, the independent expert Recommender 3, describes each of the three peer-
reviewed articles in great detail. Below is an excerpt where he describes the third publication
listed above:
• “He [Dr. Apelido] evaluated the impact of key bioreactor conditions such as dilution rate
or air flow rate supplied on critical fermentation metrics, such as enzyme titers and
productivities achieved. As a researcher and enthusiastic person in this field there is no
other publication that investigates the effect of these bioreactor operation parameters
on enzyme production under growth limited conditions. This work clearly highlights
that Dr. Apelido is a very qualified researcher. I truly believe that the results showed in
the articles described in this recommendation letter are in agreement with expertise,
skills and impact of Dr. Apelido on bioprocessing field”. (Exhibit 3. Recommender 3,
Ph.D., Position/Title, Institution) (Independent Advisory Opinion)
These three papers were published in two top-tier journals of the field, and the metrics for
their impact are listed below (Exhibit 18. Ranking information of peer-reviewed journals).

7.3%) by SCImago (https://www.scimagojr.com/).
• Journal of Industrial Microbiology and Biotechnology. The Impact Factor is 3.103.
The journal is listed as #20 in Biotechnology by Google Scholar.
3.3.5. Development and scale-up of a bioprocess for production of RNA as a biopesticide using
the cell-free reaction platform
My recent work at GreenLight Biosciences, Inc. has been focused in two major areas:
development of commercially relevant fermentation processes, and scale-up of the Cell Free
Reaction (CFR) platform. During 2017, I designed and executed experiments with the goal of
developing fermentation processes that can support the needs of our production platform;
specifically, production of recombinant proteins and nucleic acids. Through bioreactor operation,
and media optimization, the team I supervised established a fermentation process that enables
low cost production of our final product in the Cell Free Reaction.
On the other hand, since January 2018 until now my work has focused on scaling up the
Cell Free Reaction process. This platform is unique and only a handful of organizations have
been exposed to it, mostly in the academic area. To the best of my knowledge GreenLight
Biosciences, Inc is the only near-commercial organization that not only has been exposed to the
technology but also is ready for implementation at scale thanks to my key contributions. In my
role, I was presented with a microliter scale process and in a few months and under my
leadership my team delivered a liter-scale process that is commercially relevant. The total scale-
up fold achieved to date is 3.6 million without decrease in performance. In order to
accomplish this significant milestone, I developed scale-down systems to predict with high
degree of confidence, and in a high throughput fashion, the effect of different conditions on the
process at the large scale without the need for the large scale equipment and costly resources
related to them. In addition to this research and development efforts, I lead the Operations team
during sample generation times. This is a crucial production effort to support all our Field Trials
to test our potential RNA biopesticide in the real world.
Due to confidentiality issues, no peer-reviewed publications have been generated based

on my efforts at GreenLight. However, Ms. Recommender 4’s testimony can attest to the
importance of my work at this organization:
• “Under Dr. Apelido leadership and technical direction, his team took the
process from the microliter scale and demonstrated it in the commercially
relevant liter scale (a 300,000-fold scale-up) without a decrease in performance
by any of the performance metrics used, such as titers or yields. In fact, he was
able to deliver this essential milestone two months before the deadline, which is
rare in these situations. This extraordinary achievement enabled the company to
expedite field trials by 1 year and to start the work towards obtaining the
pertinent regulatory approvals. Its importance is such that this is one of the
reasons why we were successful in raising additional capital from our group of
investors.” (Exhibit 4. Recommender 4, Position/Title, Company).
As a recognition for the excellence shown and key roles played at GreenLight
Biosciences, the Position/Title, Name and Last Name, wrote these words in a letter
communicating a Key Contributor Award to me:
• “Dear Oscar,
This letter and award are to recognize you for your key contribution to the
sample generation efforts that have transpired at GreenLight during the first half
of 2019.
Thanks to your hard work, we have materials out for testing in the field, in the
greenhouse, and as part of various technology evaluations, all of which will help
to enable the creation of a rich product pipeline” (Exhibit 19: Key Contributor
Award, Letter and Check”

3.4 Evidence of the influence of my research

According to the Google Scholar database my publications have been cited at least 90
times by researchers worldwide, the majority of whom are unaffiliated with me (Exhibit 15:
Citation record by Google Scholar). This is good evidence that with 90 citations, I have
significantly influenced my field of endeavor and thus am deserving of a National Interest
Waiver.
As evidence of the impact of my work in the international community, top researchers
from leading institutions and universities in the U.S. and abroad have submitted letters
supporting me as an Outstanding Researcher and a Person of Extraordinary Abilities in my
specialized field of endeavor (Exhibit 1 to 6: Letters of Recommendation). Please note that
included are 3 Independent Advisory Opinions from scientists who have not worked with me
or do not know me personally, but rather are familiar with my work through having read or relied
upon my publications (Exhibits 1, 2, and 3). The letters attached to this petition show that I will
serve the national interest to a substantially higher degree than a researcher having the same
minimum qualification, while also making a greater impact than other highly qualified,
experienced, and skilled researchers in the field.
3.5 I review work from peers in international journals

As an additional piece of evidence to support my international recognition in the field of
Bioprocess Engineering, I establish here how I serve as a reviewer for prestigious peer-review
journals in my field. Only very accomplished scientists are asked to serve as reviewer in
international journals that are top of the field. To date, I have reviewed at least 9 submissions to
4 different peer-reviewed journals, including:
• Biochemical Engineering Journal: 3 submissions reviewed. Impact Factor of the

journal: 3.371
• Bioresource Technology: 3 submissions reviewed. Impact factor of the journal:
6.669
• Biomass Conversion and Biorefinery: 1 submission reviewed. Impact Factor of
the journal: 1.310
• Enzyme and Microbial Technology: 2 submissions reviewed. Impact Factor of
the journal: 3.553
As proof of these claims, I have attached to this petition e-mails from the Editors of each of the
mentioned journals requesting my participation as reviewer and e-mails thanking me after the
review process was completed (Exhibit 17: Evidence of Serving as Reviewer in Journals).
3.6 I command a higher salary

In the previous sections I demonstrated my extraordinary contributions to the field of
Bioprocessing by describing the different projects I led as well as the multiple peer-reviewed
publications that resulted from them, together with expert opinions that confirmed that I should
be considered an Outstanding Researcher. In this section, I will demonstrate how my salary is
higher than others in the field, which is more evidence of my extraordinary abilities.

My current annual salary as Engineer III in GreenLight Biosciences, Inc is $110,000

excluding a 15% bonus. Considering the bonus, the real salary will be $126,000 per year.
According to the W-2 document, I received a total of $101,297.53 in 2018. (Exhibit 10: Latest
Paychecks; Exhibit 13: 2018 W-2; Exhibit 14: 2017 Offer Letter and Promotion Letter)
In order to compare my salary with peers of similar experience, education and position, I
used two sources of information available online (Exhibit 12: Median salary of peers)
1) CareerOneStop – portal sponsored by the US Department of Labor
This website is sponsored by the Federal Government and uses data from the Bureau of
Labor Statistics, Occupational Employment Statistics Program. According to them, the median
salary in Boston area for “Biological Scientists” is $60,950. My annual salary is well above
this figure (80% higher).
2) GlassDoor.com
A person with 6 years of experience with the job title “Process Development Engineer” in
a company of 51-200 employees in the Biotech & Pharmaceuticals space would make $77,923
per year. According to this website, my salary is in the top 10% of the field.
In this section I have demonstrated that I command a salary significantly above the
median salary of those with a similar title and educational level in the same geographical
area. This is further proof of my extraordinary ability.
Conclusion to Chapter 3:
Given the different pieces of evidence and the support provided by independent experts
of the field in the form of Letters of recommendation as described in this Chapter, I can say with
confidence that I am well positioned to advance the proposed endeavor.
4 It would be beneficial to the USA to waive the Labor Certification
The labor certification takes into account only minimum requirements but not exceptional
abilities or outstanding past track of individual. My professional skills, expertise and knowledge
are extraordinary and set me above level of ordinary peers in the field of bioprocess
engineering (refer to Chapter 3 for details). My prior achievements described earlier justify the
projected future benefits.
My combination of skills, knowledge, and background will serve the national interest. I have
demonstrated how my diverse background and experiences position me for current and future

work in the field of endeavor. My outstanding ability to solve complex problems pertinent to
bioprocessing, fermentation, cell free reaction, has been recognized by preeminent experts in the
field:
• “It is my honor to provide my strong support for Dr. Apelido’ application, and to attest to
my knowledge of his outstanding achievements and contributions to the field of
Bioprocessing as a researcher. Dr. Apelido’ research work has focused on sustainable
production of fuels and chemicals that are critical for the US and the global economy,
through fermentation and biocatalysis. He is an expert in bioreactor design and
operation, and has excelled at working with different microorganisms to produce a
range of bioproducts” (Exhibit 5. Recommender 5, Ph.D., Position/Title, Institution)
• “We need engineers like Oscar Apelido, who has demonstrated a deep understanding of
bioreactor design and microbial metabolism, to develop the technologies that help us
transition to a cleaner, efficient, green economy. The United States will benefit greatly
from Dr. Apelido’ continued presence and active role in the field of Bioprocessing.
Therefore, I strongly support his petition.” (Exhibit 6. Dr. Recommender 6,
Position/Title, Institution)
• “Obtaining sustainable sources for fuels and products is a major challenge for the USA
and several countries around the world. Biotechnology and bioprocessing are
emerging technologies that can be explored to replace many production processes t
based in non-renewable sources that are costly and non-environment friendly.
Therefore, scientists like Dr. Apelido, are crucial to contribute in the development of
more efficient technologies applied in the transition to a bio-based economy. Dr.
Apelido has risen to the very top of his technical field and has obtained sustained
international recognition. His expertise and many original contributions, some of
which were described in this letter, are central to the field of bioengineering” (Exhibit
3. Recommender 3, Ph.D., Position/Title, Institution) (Independent Advisory
Opinion)
The continuation of my work in GreenLight Biosciences and in the United States is needed.
The development of sustainable processes for novel products such as enzymes, fuels, or bio-
pesticides, are matters that are critical for the nation. Researchers who are highly skilled in this
area are therefore crucial to the United States’ national interest, and individuals who merely meet
the technical qualification of education and experience are not acceptable substitutes for those
with demonstrated accomplishments and special, unquantifiable abilities. I should be granted a
National Interest Waiver because it will be extremely difficult, if not impossible, to find another
researcher who can mirror my contributions to this nationally imperative area of research. It is
not because of a shortage of US workers, but because of the need to retain my unique profile that
is superior to most of my peers.

My extraordinary skills and impressive past track record of achievements cannot be

articulated in a labor certification process. Considering only minimum qualifications given by
labor certification it would lead to choosing a person with weaker skills and experience than I
have. GreenLight Biosciences would be probably able to find some ordinary peer with a PhD in
Engineering but certainly not someone who has scaled-up a Cell Free Reaction process because
there are a handful of them in the United States. Such skill is beyond the scope of a labor
certification process.
Recommender 4, Position/Title at GreenLight Biosiences, Inc, specifically states in her Letter of

recommendation that requiring a Labor Certification for my case would have a negative impact on
the organization she leads:
• “I fully expect Dr. Apelido to continue playing a critical role in GreenLight Biosciences
in the coming years. By doing so, he will also serve the United States of America in
transitioning to the green, sustainable agricultural practices very much needed by our
farmers. Given his highly specialized profile in the field of bioprocessing and especially cell
free reaction, requiring a Labor Certification will definitely not articulate his skills and
experience, and would definitely adversely impact GreenLight Biosciences progress.
Similarly, losing a scientist like Dr. Apelido would be detrimental to the U.S. as whole
considering his contributions in areas of national interest”. (Exhibit 4. Recommender 4,
Position/Title, Institution).
Similarly, Mr. Name and Last Name, Position/Title of Human Resources at GreenLight
Biosciences, Inc comments on the need for a waiver in my case:
“Please note that the need for Dr. Apelido’ continued participation is not the result of a
labor shortage of U.S. researchers. Instead, this need for retaining Dr. Oscar Apelido in
GreenLight Biosciences, Inc in the long term, stems from his unique combination of
remarkable skills and the fact that his contributions are superior to those of the majority of
his peers. As Director of Human Resources at GreenLight Biosicences, I know first-hand
how losing Dr. Apelido would impair our operations and would affect the United States
negatively. Therefore, I ask you to consider and approve Dr. Apelido’s petition for EB-2
with National Interest Waiver” (Exhibit 11: Letter of Support for NIW from GreenLight
Biosciences’ Position/Title of Human Resources)
It is clear from these two testimonies that there is a need from GreenLight Biosciences to
retain me in the long term as a researcher to avoid disruption of their plans and progresses.
GreenLight Biosicences is working on a field of National Importance. My work in the organization
is key to develop a new line of RNA biopesticides that are highly specific to the targeted pest, and
will not damage beneficial species such as honeybees, or humans who consume the crops treated
with the RNA product. As discussed in Chapter 1, GreenLight’s mission aligns with the efforts of
improving the United States’ food security.
My outstanding knowledge and skills are crucial for the future success of research projects in
bioprocessing engineering but they would not be considered if labor certification is required and
thus many of these projects which are in a national interest would be seriously impaired without
my contribution. Therefore the labor certification process should not be used in my special
case. On balance, it would be beneficial to the United States to waive the job offer and labor
certification requirements.
5 My nonimmigrant status
I currently hold an F-1 visa and an EAD card tied to the OPT STEM program. In addition, I
have applied for an H-1B visa with consular processing (I was selected in the lottery system in
April, 2019). My passport, the copy of my visa, the I-20, I-94, EAD card, and the receipt notice
for the recently applied H-1B are attached to this petition. (Exhibit 20: Documents regarding
current nonimmigrant status)
Prior to my current F-1 status, I held a J-1 visa (exchange student at the University of Utah,
2011-2012), and a cap-exempt H1-B visa while working at the Oklahoma State University
(2013-2016). (Exhibit 21: Documents regarding last nonimmigrant status).
6 Conclusion
I provided evidence to demonstrate my extraordinary skills and unique experience in the field
of bioprocess engineering, specifically in the production of fuels, proteins (enzymes), or nucleic
acids (biopesticides like RNA). This research field brings valuable benefits to the U.S. nation in
the form of improved energy security (renewable fuels reduce the need for foreign sources of
energy), increased national security (many diplomatic and war conflicts are related to energy
disputes), improved food security (safer food products as a result of the development of bio-
pesticides), and increased sustainability (due to more specific pesticides that do not pose a risk to
humans or beneficial species such as bees).
My track of achievements includes my work in Government funded institutions such as

Oklahoma State University, and privately held organizations such as GreenLight Biosciences,
Inc. In both of these enterprises, I made significant contributions to the field, such as
development of processes to produce liquid fuels (ethanol and butanol) from renewable sources
such as switchgrass, redcedar, or other renewable and waste streams; production of enzymes
using a novel bioreactor design, or production of RNA as a sustainable and highly specific
biopesticide. All these successful projects have direct impact on U.S. competitiveness and
national interest.
My impressive past track of research achievements justifies projected future benefits in the
national interest. My exceptional abilities are significantly above ordinary peers and cannot be
articulated in a labor cortication process which considers only minimum requirements.
Therefore, in conclusion, it would be beneficial to the United States of America to waive the job
offer and labor certification requirements. Without my contribution, GreenLight Biosciences and
future projects on Cell Free Technology and bioprocessing would be significantly impaired and
GreenLight Biosciences strongly indicated its intention to retain me so I can lead those projects
on long-term basis.
I respectfully request that you consider this petition and the evidence submitted herewith. I
greatly appreciate your time and attention to my case. Thank you for your consideration of my
request.
With my sincere respect,
Oscar Apelido, Ph.D.

Engineer III, Process Development
GreenLight Biosciences, Inc.

Exhibit 1: Letter of Recommendation – Dr. Recommender 1

Exhibit 1.1: Dr. Recommender 1’s Curriculum Vitae
EB-2 NIW - Dr. Oscar Apelido – Letters of Recommendation

Official Letterhead
[Date]
U.S. Department of Homeland Security

Citizenship and Immigration Services
RE: Independent Assessment / Recommendation Letter for Dr. Oscar Apelido
Dear Immigration Officer,

I am writing this letter of support of Dr. Oscar Apelido’ petition regarding his immigration status. I
never worked or collaborated with him, but I know of him though his participation in the American
Society of Agricultural and Biological Engineers and through his published research in the field of
biomass conversion and biofuel production. Based on an independent and critical assessment I can
say that Dr. Apelido has made outstanding contributions to the field of Bioprocessing, which I will
describe in this letter. I also believe that given his extraordinary abilities he will continue to create
value and make a significant impact on this research field.
My name is [Name of Recommender and a few sentences about their background and
achievements so it is clear they are a reference in the field] My research focuses on biomass
conversion, specifically on cellulosic and algal biofuels and bioproducts, processing of biobased
feedstocks into fuels and chemicals, and systems analysis process modeling and simulation. Since
my research and Dr. Apelido work are both in these areas I believe I can provide an independent
and well-informed assessment of his work.
I first learned from Dr. Oscar Apelido’ research through one of his presentations at the Annual
International Meeting of the American Society of Agricultural and Biological Engineers (ASABE).
Specifically, I attended an oral presentation he gave at the meeting that took place in July of 2015 in
New Orleans, Louisiana. In that presentation, he described his work on pretreatment of Eastern
redcedar to fermentable sugars for production of biofuels and bioproducts. Eastern redcedar is a
rapidly spreading invasive species that increases the risk of wildfires, is moderately allergenic, and
presents a high water consumption, which leaves less water for endemic plants to grow on and in
turn affects the habitats of wildlife in the region. Conversion of redcedar to biofuels would help
mitigate these issues and create value at the same time. The available technology to convert this
pest into profit through bioconversion used high amounts of water, chemicals, and temperature. Dr.
Apelido showed in his presentation how he reduced the amount of water and chemicals used by
nearly half, and temperature by about 20%. Despite these reductions he was able to maintain a high
yield of sugars produced from the redcedar. This is a remarkable contribution to the field, one that
would enable the conversion of redcedar to fuels and chemicals in a sustainable way.
1
Another essential contribution by Dr. Apelido in the redcedar conversion field is reflected in his
peer-reviewed publication “Simultaneous saccharification and fermentation of Eastern redcedar
heartwood and sapwood using a novel size reduction technique”. Particle size reduction of biomass
is an extremely energy intensive process which requires a high capital cost, and is one of the main
barriers for the growth of biofuel technologies. Woody biomass, such as Eastern redcedar, needs a
size reduction step before it is converted to sugars (the intermediate chemical for conversion to
fuels or bioproducts). In this work, Dr. Apelido demonstrated that ethanol production from Eastern
redcedar logs crumbled to a particle size of 2.5 mm was as good as finely ground wood (0.5 mm
particle size). The energy savings associated to the use of crumbled biomass was between 68 and
93% compared to traditional particle size reduction methods. This finding is of extreme significance
and will help reduce the capital costs of this bioprocess and yield higher returns of investment.
Another critical contribution that Dr. Oscar Apelido brought to the table was the development of a
process for biological production of butanol from Eastern redcedar. Butanol has higher energy
content than ethanol and has the potential to replace liquid fuels, including jet and diesel fuels. The
findings of this project were summarized in the high impact factor journal Bioresource Technology,
through an article entitled “Process development for biological production of butanol from Eastern
redcedar”. Dr. Apelido described a process that starts from grounding redcedar wood to the final
butanol production using two different Clostridia strains, and it includes pretreatment of redcedar,
enzymatic hydrolysis, detoxification of hydrolyzates, and anaerobic fermentation. The process
presented in this publication achieved similar butanol production than that obtained by using a
model pure sugar: glucose, which is remarkable. This peer-reviewed article is highly significant, as
it establishes the potential production of 315 million gallons of butanol from the 11.5 million dry
metric tons of above ground redcedar biomass just in Oklahoma. This is, to the best of my
knowledge, the first report of acetone-butanol-ethanol (ABE) fermentation using Eastern redcedar
as a feedstock.
In addition to the contributions mentioned, Dr. Apelido applied his exceptional skills to overcome
the barrier imposed by inhibitors when producing biobutanol from switchgrass. In his article
“Butanol production from hydrothermolysis-pretreated switchgrass: Quantification of inhibitors and
detoxification of hydrolyzate”, he carefully analyzed the inhibitors present in switchgrass
hydrolyzates that prevented the strain Clostridium acetobutylicum from converting sugars into
butanol. Dr. Apelido was able to reduce or eliminate these inhibitors (mainly furanic and phenolic
compounds) through detoxification with activated carbon. This resulted in the production of 11 g/L
butanol, which showed the potential of butanol production from hydrothermolysis pretreated
switchgrass. The pretreatment of switchgrass by hydrothermolysis (high pressure and high
temperature treatment with water) offers advantages over other pretreatment methods, such as
absence of catalysis and lower cost of reactor due to low corrosion potential. This is an excellent
example of Dr. Apelido’ outstanding abilities to develop a novel process with the potential of
lowering the cost of production of chemicals. As further evidence of its significance, this article has
been cited more than 40 times in just four years, which is well above the average number of
citations per paper in the field.
Given the examples I described in this letter, I am pleased to offer my decided support for Dr. Oscar
Apelido’ petition to USCIS. Through his published and verifiable outstanding contributions to the
field of Bioprocessing, he has established himself as a reputable researcher and as a person that will
continue to advance the field, which will have an enormous and positive impact on the US
technology and economy.
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Sincerely,
Name and Last name

Signature
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Reccomender’s Name
Contact information
EDUCATION
Type of degree and field 1 Date

Institution

Institution
EXPERIENCE
Position 1 Date
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Position 2 Date
Company 2
Position 3 Date
Company 3


Official Letterhead
[Date]

U.S. Citizenship and Immigration Services
RE: Independent Recommendation Letter for Oscar Apelido
Dear USCIS officer:

I write this letter in support of Dr. Oscar Apelido’ application. I have never
collaborated or worked with him, so please consider this an independent reference for his
case. I met Dr. Apelido during a professional trip to the United States. As part of my
itinerary, I visited Oklahoma State University in April, 2015 and I gave a lecture about
process modeling and simulation of a bioethanol production process using EMSO
(Environment for Modeling, Simulation, and Optimization). Dr. Apelido attended that
seminar and he also participated in a professional lunch that took place on the same day.
During both of these events and through his questions and discussion, I was impressed
with his knowledge on process simulation in the biotechnology field. Then, I came to know
his research on biomass conversion and fermentation through his multiple publications
and I can decisively say that he is an outstanding researcher. I will make my case in this
letter.
Before elaborating on Dr. Apelido’ achievements, let me introduce myself. My
name is [Name of Recommender and a few sentences about their background and
achievements so it is clear they are a reference in the field] My research focuses on the
following areas: computational intelligence, modelling, simulation, optimization and
strategies of control applied to bioprocesses, and fermentation. There is a very significant
overlay between these areas and Dr. Apelido’ areas of expertise, which allows me to
examine and assess his work.
The first of Dr. Apelido’s contributions that caught my eye as an expert on process
simulation was his publication “Process simulation of ethanol production from biomass
gasification and syngas fermentation”. In this article published in 2017 Dr. Apelido
presents his careful work on modeling and simulation of a biorefinery that uses a hybrid
conversion technology for production of ethanol. The technology described in the paper
involves gasification of biomass (conversion of switchgrass into a gas called syngas;
mainly CO, H2, and CO2), a bioreaction using gas-fermenting bacteria, and a final stage
where the ethanol produced by the microorganism gets purified into the final product. To
my knowledge, this is the first peer-reviewed document that discusses the process
simulation of such an industrial process from end to end. None of the available studies
1
have examined the effects of critical syngas fermentation parameters such as ethanol
titers, specific gas uptake rate, or substrate conversion efficiencies. In that, Dr. Apelido’
work is unique and novel. His work presented a detailed material balance, and sensitivity
analyses around the three main stages of the process: gasification, fermentation, and
recovery. He concluded that such a biorefinery could produce 36.5 million gallons of
ethanol from 1,200 tons of switchgrass per day, yielding 97.7 gallons of ethanol per dry ton
of switchgrass. This yield is higher than those achieved by the traditional biochemical
ethanol platform.
This study I described was published in one of the top journals, Bioresource
Technology, which Google Scholar classifies as #2 of the field of Biotechnology. In
addition, it has been cited by others due to its significance. For example, Akhtar et al.
discussed Dr. Apelido’ work in their review of combustion, pyrolysis and gasification of
biomass, and even included one of his figures in their review article published in Energy &
Fuels. Considering the need for replacing fossil fuels and the biofuel production objectives
mandated by the Energy Independence and Security Act, Dr. Apelido’ work is of extreme
importance to advance the biofuel research field towards commercial implementation at
scale.
Beyond his process simulation work, Dr. Apelido has been a prolific author in the
field of Bioprocessing and Biotechnology. He has published repeatedly in top ranking
journals such as Bioresource Technology or the Journal of Industrial Microbiology and
Biotechnology, which are two of the most prestigious journals that focus on topics such as
biofuels, biomass conversion, bioreactor design, and fermentation. The fact that Dr. Apelido
was able to publish his work so frequently in journals that are highly selective shows that his
research work has deserved the attention of his peers in the bioengineering and scientific
community. According to Dr. Oscar Apelido’ Google Scholar profile, his articles have
deserved over 80 citations so far, and this number has grown exponentially. This attention
is a result of his contributions to advance the field of biofuels and bioprocessing: Dr. Apelido
has become a highly influential member of his field.
For these reasons, I consider Dr. Oscar Apelido a vital member of the bioengineering
research community. He has contributed enormously to the field and will continue to create
value in the United States of America and internationally. It is my pleasure to extend this
letter of support for him. Please feel free to contact me in case you have questions.
Best Regards,
Name and Last name

Signature
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2
Contact information
EDUCATION

Institution

Institution
EXPERIENCE
Position 1 Date
Company 1
Position 2 Date
Company 2
Position 3 Date
Company 3


Official Letterhead
[Date]
RE: Independent Recommendation Letter for Dr. Oscar APELIDO
Dear Madam/Sir:
My name is Name of Recommender and position]. I am writing this letter in support of

Dr. Oscar Apelido’ petition to the United States Citizenship and Immigration Services (USCIS). I do
not know Dr. Apelido personally and have never met or collaborated with him, but I know of him
through his published research work on bioprocessing, and more specifically, on enzyme production
using the filamentous fungus Aspergillus nidulans in a novel bioreactor system. Based on his
outstanding contributions, I believe he will continue to make a significant and positive impact on
this research field.
[Few sentences on Recommender’s achievements]. My expertise is in molecular genetics

in microorganisms, and it includes topics such as filamentous fungi, heterologous expression of
proteins with industrial interest, and lignocellulosic material degradation. Therefore, my research
overlaps with Dr. Apelido’, so I am confident I am well qualified to provide an independent
assessment of his work solely based on his original contributions.
I became aware of Dr. Apelido’ work during the preparation of a chapter for the book
entitled “Advances in Sugarcane Biorefinery”. Said chapter (“The Use of Synthethic Biology Tools in
Biorefineries to Increase the Building Blocks Diversification”) discusses the development of
microorganisms with desirable industrial characteristics and the expectations and future of
synthetic biology applications in biorefineries. I cited one of Dr. Apelido’ peer-reviewed publications
while discussing the fitness of filamentous fungi as chassis strains for the production of fuels and
other products in biorefineries.
In his paper, “High-yield production of aryl alcohol oxidase under limited growth conditions
in small-scale systems using a mutant Aspergillus nidulans strain” published in the Journal of
Industrial Microbiology and Biotechnology, Dr. Apelido describes a mutant A. nidulans strain capable
of overexpressing an enzyme with potential industrial interest (aryl alcohol oxidase) but unable to
synthesize its own pyridoxine. Pyridoxine is a vitamin absolutely required for growth of this
filamentous fungus, so using this feature, Dr. Apelido was able to control its growth by limiting the
supply of this nutrient. This is of extreme importance, since he aimed to use this microorganism in
a novel bioreactor system in which uncontrolled growth of the fungus would cause clogging and
1
eventually, failure of the production process. However, limitation of growth in A. nidulans caused a
phenomenon called melanization, which can be detrimental for enzyme expression. Through careful
experimental designs using scale-down systems, Dr. Apelido screened a range of extremely low
pyridoxine concentrations that reduced the growth rate of the strain by 95% without halting enzyme
production. This research is unique in the field of Aspergillus nidulans cell factories and
demonstrates the creativity and outstanding ability of Dr. Apelido as a researcher.
A second article published by Dr. Apelido on “Prevention of melanin formation during aryl
alcohol oxidase production under growth-limited conditions using an Aspergillus nidulans cell
factory” expanded even more on the design of media for enzyme production in a novel reactor
system, a trickle bed reactor (TBR) under growth-limited conditions. Dr. Apelido observed that
melanization was more marked in his TBR benchtop reactor compared to small scale systems, and
designed a series of experiments to develop the right media to support enzyme production while
controlling growth of the strain. Dr. Apelido identified certain metals in the media (zinc and copper)
that promoted melanization, and was able to reduce them; he also included ascorbic acid (vitamin
C) in the media recipe, eliminating the melanin problem and increasing enzyme production two-
fold. His results are of significance when compared to other publications: he obtained higher aryl
alcohol oxidase titers than most of the recent studies (up to 300 times higher) but in addition he
restrained the growth of the microorganism.
In a third study on “Continuous aryl alcohol oxidase production under growth-limited

conditions using a trickle bed reactor” published in the journal Bioresource Technology, Dr. Apelido
used the media developed in his previous research in a 1.1L trickle bed reactor. He tested different
packing materials inside the bioreactor to support the establishment of a fungus biofilm. In addition
to these different packing materials, he evaluated the impact of key bioreactor conditions such as
dilution rate or air flow rate supplied on critical fermentation metrics, such as enzyme titers and
productivities achieved. To the best of my knowledge, there is no other publication that investigates
the effect of these bioreactor operation parameters on enzyme production under growth limited
conditions. This work clearly highlights that Dr. Apelido is an outstanding researcher and a person
of extraordinary ability. I truly believe that the expertise and skills showed in the papers described
in this letter will have similar impact on the area of bioprocessing.
In this letter I have focused on three of Dr. Apelido´ publications, the ones that are more
closely related to my own research focus. However, his other four peer-reviewed publications on
topics such as butanol and ethanol fermentation are further evidence of Dr. Apelido’ excellence. His
research papers have been cited more than seventy times from researchers based all over the world
(Scotland, US, Iran, Poland, Tunisia, to name a few), which highlights the international acclaim
achieved by Dr. Apelido.
Obtaining sustainable sources for fuels and products is a major challenge for the United
States of America and the rest of the world. By using biotechnology and bioprocessing, we can
replace production processes that are costly and pollute the environment, establishing
environmentally friendly and cost effective ones instead. Scientists like Dr. Oscar Apelido, who have
a deep understanding of bioprocessing, are crucial for the development of more efficient
technologies in the transition to a much needed bio-based economy. Dr. Apelido has risen to the
very top of his technical field and has obtained sustained international recognition. His expertise
2
and many original contributions, some of which were described in this letter, are central to the field
of bioengineering. Hence, I strongly support his petition while I reiterate my consideration of him as
a person of extraordinary ability and as an outstanding researcher.
Sincerely yours,
Name and Last name

Signature
Position
Company/Institution
3
Contact information
EDUCATION

Institution

Institution
EXPERIENCE
Position 1 Date
Company 1
Position 2 Date
Company 2
Position 3 Date
Company 3
Exhibit 4: Letter of Recommendation – Ms. Recommender 4

Exhibit 4.1: Ms. Recommender 4’s Curriculum Vitae

Official Letterhead
[Date]

United States Citizenship and Immigration Services (USCIS)
RE: Oscar Apelido
Dear Sir/Madam,
The present letter is to demonstrate my support for Oscar Apelido’ application. Dr. Apelido is an
employee of our organization and has made tremendous contributions towards the achievement of
our goals. His technical abilities, his insight in the fields of fermentation and biocatalysis, and his
capacity to apply his technical knowledge to solve complex challenges are outstanding. I can say
with confidence he is a top contributor.
My name is [Name of Recommender and a few sentences about their background

and achievements so it is clear they are a reference in the field]
Given my current role at GreenLight Biosciences, Inc, I am in an appropriate position to evaluate

Dr. Apelido’ research contributions to our organization and to the field of bioprocessing and
biotechnology. We hired Dr. Apelido as a Post-Doctoral Process Development Engineer in
January, 2017. He came from Oklahoma State University with remarkable recommendations
because of his work developing an enzyme production bioreactor system in collaboration with a
German company. In just couple of months and given his excellent performance, I offered Dr.
Apelido the role of Fermentation Laboratory Supervisor reporting directly to me. In this role, he
supervised and led the work of a group of 6 Research Associates with the goal of establishing a
commercially relevant fermentation process in collaboration with multiple departments in the
organization. By the end of the year, the Fermentation Team had reached and exceeded the
annual targets set by Management and had defined fermentation processes that enabled
inexpensive production of recombinant proteins for our production platform.
Since then Dr. Apelido has led the scale-up efforts of our proprietary production platform. With
this novel technology, GreenLight Biosciences, Inc, can produce a complex biological molecule
(RNA) that traditional synthesis methods cannot produce at a competitive cost or at commercial
quantities. Under Dr. Apelido leadership and technical direction, his team took the process from
the microliter scale and demonstrated it in the commercially relevant liter scale (a 300,000-fold
scale-up) without a decrease in performance by any of the performance metrics used, such as
titers or yields. In fact, he was able to deliver this essential milestone two months before the
deadline, which is rare in these situations. This extraordinary achievement enabled the company
to expedite field trials by 1 year and to start the work towards obtaining the pertinent regulatory
approvals. Its importance is such that this is one of the reasons we were successful in raising
additional funding from our group of investors.
Furthermore, Dr. Apelido leads the Operations team during sample generation and is currently in
charge of overseeing RNA production efforts of the active ingredient and management of
inventories. In addition to this, during the first three months of 2019 Dr. Apelido led the
technology transfer of our Cell Free Reaction technology to a third-party Contract Manufacturing
Organization (CMO) and demonstrated in their pilot scale a 170 liter reaction with equivalent
performance than that at lab scale. This is a required step towards turning research and
development into manufacturing to create revenue.
All these achievements I described in the previous paragraphs are just a few relevant examples of
Dr. Oscar Apelido’ merits and his outstanding abilities as a researcher. He is a skilled engineer
who is capable of solving complex and novel problems and deliver practical, realistic solutions in
a rapidly changing environment. His interpersonal skills make him also an excellent team player
and a leader. His contributions to GreenLight Biosciences have been outstanding and have been
recognized with several promotions: from Post-Doctoral Engineer to Fermentation Supervisor,
then to Engineer II and more recently to Engineer III, with the corresponding pay increases. All
this in only 2.5 years of employment with the organization. I fully expect Dr. Apelido to continue
playing a critical role in GreenLight Biosciences in the coming years. By doing so, he will also
serve the United States of America in transitioning to a green, sustainable agricultural practices
very much needed by our farmers. Given his highly specialized profile in the field of
bioprocessing and cell free reaction, requiring a labor certification will definitely not articulate his
skills and experience, and would adversely impact GreenLight Biosciences plans. Similarly,
losing a scientist like Dr. Apelido would be detrimental to the U.S. as whole considering his
contributions in areas of national interest.
At GreenLight Biosciences we are confident that we will revolutionize the agricultural industry
by providing inexpensive, sustainable, and healthy solutions for controlling agricultural pests here
and around the world. Dr. Oscar Apelido is and will continue to be playing an essential part in
this mission. For these reasons, I ask you to consider and approve Dr. Oscar Apelido’ application
for permanent residency under the category of EB-2 with a National Interest Waiver (NIW).
Respectfully,
2
Name and Last name

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EXPERIENCE
Position 1 Date
Company 1
Position 2 Date
Company 2
Position 3 Date
Company 3


Official Letterhead
[Date]

RE: Oscar APELIDO

Dear Sir or Madam,
It is my honor to provide my strong support for Dr. Apelido’ application, and to

attest to my knowledge of his outstanding achievements and contributions to the
field of Bioprocessing as a researcher. Dr. Apelido’ research work has focused on
sustainable production of fuels and chemicals that are critical for the US and the
global economy, through fermentation and biocatalysis. He is an expert in
bioreactor design and operation, and has excelled at working with different
microorganisms to produce a range of bioproducts. His accomplishments in this
field are reflected in his authorship of 7 peer reviewed research articles in
international research journals, and 15 presentations at national and international
research professional meetings.
[One paragraph discussing background of Recommender, professional trajerctory, and
accomplishments that make it clear he is an important figure in the same field]
I have known Dr. Oscar Apelido for over 6 years. I was his supervisor while he was
a full time Research Engineer at Oklahoma State University and also his academic
advisor for his PhD degree. He was also my student in one of the graduate courses
I taught: Food Engineering. It is from this extensive experience that I can describe
Dr. Apelido’ abilities.
Dr. Apelido is, without a doubt, one of the top students I have ever worked with. He
stands out as a creative, independent, and dedicated researcher. I will describe
these qualities further this letter. Most of the graduate students I worked with in the
past years publish 1 or 2 papers based on their research work. Dr. Apelido
published 7 articles in top international peer-reviewed journals based on his work
done while at OSU. This is an impressive and unusual achievement, especially if
we consider the short span of time (4 years) for this high quality work to be
designed, executed, and disseminated. Dr. Apelido achieved this level of
excellence because of several factors.
First, he is creative in finding ideas and solutions for research problems. This is a
critical skill that an excellent researcher must possess. An example of this is his
PhD work. Dr. Apelido research targeted the production of enzymes in a novel
bioreactor system by a mutant fungus. Because of clogging issues that would
cause operational problems in the bioreactor, the fungal strain was constructed so
its growth could be limited and production of the enzyme maximized. However,
during the first phase of the project, Dr. Apelido observed that this growth limitation
caused a phenomenon called melanization, in which melanin was produced while
the targeted enzyme decreased significantly. Because of his deep understanding
of bioprocessing and the strain metabolism, Dr. Apelido was able to overcome this
issue by carefully modifying the media composition that supported the growth and
maintenance of the microorganism. This problem could have resulted in the failure
of this important project that was done in collaboration with both national and
German partners, but Dr. Apelido’ dedication and creativity kept the project on
target.
The second factor that I consider critical in making Dr. Apelido an outstanding
researcher is his ability to collaborate with others, and particularly with international
partners. As I mentioned earlier, his PhD research was a project that counted with
the collaboration on a German research institute, the Prüf- und Forschungsinstitut
Pirmasens e.V. (PFI). The research developed by Dr. Apelido was used by PFI to
scale-up the process from the liter scale to the 300L scale in a pilot plant facility
located in their German headquarters. Dr. Apelido did an outstanding job not only
on his part of the project, but also making sure that the technology transfer
between US and German researchers happened smoothly and successfully, both
by drafting the appropriate protocols and by establishing the right communication
channels and professional relationships with the counterparts. His work on this
project enabled the continuation of my research work on this field at the University
of Nebraska-Lincoln. His collaboration skills also shined when it came to partner
with Dr. Rolf Prade, a professor in Microbiology at OSU. Despite the difference in
disciplines, Dr. Apelido (an engineer) and Dr. Prade (a molecular biologist) worked
closely to construct the mutant fungus used in his project and I only heard excellent
feedback from Dr. Prade’s in relation with Dr. Apelido’ ability to quickly learn new
concepts in molecular genetics and to explain bioreactor and engineering ideas to
Dr. Prade and his research team.
Third, Dr. Apelido is known by his hard work. His work ethic is exceptional, and he
is always willing to work long hours when this is critical to meet deadlines and
successfully reach milestones. This trait, combined to his creativity and ability to
collaborate efficiently, resulted in successful outcomes in every project he was
involved in. For example, beyond his PhD research, Dr. Apelido also researched
topics related to conversion of Eastern redcedar to fermentable sugars and
production of enzymes. My lab at OSU did many experiments on using Eastern
redcedar to produce ethanol, which resulted in 5 peer-reviewed journal articles.
However, these experiments used a process to treat the redcedar that included
high amounts of chemicals and water as well as high temperatures, which is
expensive. Dr. Apelido designed a set of experiments to reduce the amount of
water and chemicals used in the redcedar treatment by 40%. He also reduced the
temperature by 18%. Despite these reductions, he was able to maintain a high
yield of sugars produced from the redcedar. His work served as the basis for my
sabbatical research in the fall of 2015 in Germany where I used his treatment
conditions to prepare redcedar as a feedstock for production of PHB, a bioplastic
produced from sugars by a bacterial strain.
Because Dr. Apelido was involved in a wide range of projects, he has obtained a
unique set of skills and expertise in several bioprocessing areas, such as biomass
conversion, sugar fermentation, bioreactor design and operation, enzymatic
hydrolysis, and gas-liquid fermentation. With this background and high level of
competency, I expect Dr. Apelido to continue playing a key role in the development
of new technologies and solutions for sustainable production of fuels and
chemicals through bioprocessing.
It is not only his research ability what makes Dr. Apelido outstanding. He was also
an excellent mentor for other students while at OSU. He played a pivotal role in
training students working for different professors on laboratory techniques,
bioprocessing concepts, and safety protocols. His ability to lead was also
demonstrated by his involvement in the University community. For example, his
peers elected him President of the Biosystems and Agricultural Engineering
Graduate Student Association. During his term he led a project that raised
awareness about environment and sustainability in the University family housing,
and he expanded this project to other areas of campus. The success of the project
was recognized by the University through the awarding of funding to the student
organization in the amount of thousands of dollars. He also served as
representative of the University-wide Graduate and Professional Student
Government Association. This was not only noticed by me, but also by my peers at
the faculty.
In summary, I strongly support Dr. Oscar Apelido’ petition before the United States
Citizenship and Immigration Services. His combination of research excellence,
creativity, work ethic, mentoring and leadership makes him the perfect example of
an “Outstanding Researcher” and a person of “Extraordinary ability”. Dr. Apelido’
skills in the field of bioprocessing will deeply benefit the United States and the
development of new technologies to produce fuels and chemicals in a renewable
and sustainable manner.
Sincerely,
Name and Last name

Signature
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Official Letterhead
[Date]

RE: Recommendation for Oscar APELIDO

Dear USCIS,
It a privilege provide this recommendation for Dr. Oscar Apelido. Based on his
scientific contributions and his unique combination of skills, I consider Dr. Apelido a
person of extraordinary abilities and an outstanding researcher.
My name is is [Name of Recommender and a few sentences about their background and
achievements so it is clear they are a reference in the field]. My research work focuses
on the development of bioinformatics and molecular genetic tools of sensory
mechanisms in Aspergillus nidulans, a type of filamentous fungus. Specifically, I
investigate and develop protein expression/secretion systems that enable protein
production employing a gene silencing sequencing. I have special interest on
identification and production of biomass degrading enzymes that operate at high
temperature (up to 95°C), which can have an enormous impact on the
development of sustainable bioprocesses that utilize residues such as agricultural
wastes, and turn them into biofuels or other bioproducts.
I know Dr. Apelido since 2014, when we started collaborating on a project that
aimed to produce an enzyme (aryl alcohol oxidase) using an Aspergillus nidulans
cell factory with growth limitation in a novel trickle bed reactor. This research was
implement as a collaboration between two departments at OSU (Biosystems
Engineering and Microbiology) and a research institute in Germany (PFI-
Pirmasens). Dr. Apelido was responsible for leading the research at OSU and for
providing tech transfer to our German partners. This project resulted in 3 peer-
reviewed publications in the high impact factor journals Bioresource Technology
and the Journal of Industrial Microbiology and Biotechnology, as well as in one
Ph.D. dissertation (Dr. Apelido’s doctoral work), and 3 professional conference
presentations in the US, Germany, and India. The prolific dissemination of this
work already speaks for the significance of its findings, which I will comment on
next.
In the first part of his project, Dr. Apelido and I worked closely to transfer to him the
protocols and procedures on fungal genetics needed to construct an Aspergillus
mutant. Even when his formal training was on Chemical Engineering, Dr. Apelido
showed an exceptional ability in acquiring new skills on topics he was not an expert
in. In a few weeks he was fully trained and he was executing his work in our fungal
genetic labs as one member more of the team. This learning ability and the
capacity to work in multidisciplinary teams and projects is a much needed and
sought one for development of biotechnological solutions. Dr. Apelido quickly
finished the construction and screening of a fungal strain that overexpressed the
target enzyme, aryl alcohol oxidase. This enzyme has the potential to be applied to
the pretreatment of lignocellulosic biomass for conversion of waste from agriculture
to biofuels or other products. The strain also had a “pyridoxine marker”, which
means that without the supply of pyridoxine this microorganism could not grow. Dr.
Apelido did this in order to use this fungus in a trickle bed bioreactor. In this type of
reactor, the fungus grows on the surface of a packing material that is placed inside
a column. Liquid media is pumped to the top and moves down the packing material
by gravity. Without limitation of cell growth, the column eventually clogs; hence the
importance of the pyridoxine marker.
Dr. Apelido used small scale fermentation systems to screen the effect of
pyridoxine limitation on enzyme production and cell growth. He encountered an
important challenge: pyridoxine limitation caused melanization (production of
melanin), increased acid production, and decrease enzyme secreted. This issue
was even more marked in the larger scale of the trickle bed reactor. He carefully
studied the metabolic pathway of the melanization phenomenon and, based on his
findings, made modifications on the recipe of nutrients provided to the strain. In a
span of weeks, Dr. Apelido had fixed the issue and was ready to scale-up the
process to his in-house made trickle bed reactor. On the reactor scale, Dr. Apelido
tested different bioreactor operating parameters such as dilution rate (related to the
rate at which nutrients are provided), aeration, and type of packing material used
as a support for fungal biofilm attachment. While there are other reports of aryl
alcohol oxidase production, this is the first report of continuous production of this
enzyme at a relevant liter-scale under growth-limited conditions. The significance
of this is remarkable: traditional enzyme production uses large agitated tanks were
the fungus grows in liquid media. The agitation is needed for mixing and to provide
enough oxygen to the microbes. This is an expensive requirement, since agitation
consumes large amounts of energy especially as the cell concentration in the tank
goes up and with it, the viscosity of the fluid. Dr. Apelido demonstrated a novel
bioreactor system (trickle bed reactor) combined with a strain genetic solution
(growth limitation based on a pyridoxine marker) that can provide a cheaper
operating cost because no agitation is required in the reactor: oxygen transfer
happens naturally as the liquid trickles down the column where the fungus is
established. As mentioned earlier, this is a creative and interdisciplinary solution
that combines engineering and biology, and it certifies the outstanding ability of Dr.
Apelido as a researcher. Moreover, this demonstration of aryl alcohol oxidase
production is easily transferable to production of other targeted proteins, so the
impact of his findings is really extraordinary.
In addition to his successful research, Dr. Apelido was also essential in maintaining
a fruitful relationship with our German counterparts at the PFI institute in
Pirmasens. Dr. Apelido developed a mutual relation of trust and respect when he
conducted weekly research updates, and when he transferred protocols over to
PFI for execution of assays and production runs at their pilot facilities. This type of
relationship is beneficial for the University and ensures continued funding
opportunities, which in turn affect the society at large. Not to mention that these
international collaborations affect the reputation of our institutions in a very positive
manner.
Beyond the work described in this letter, Dr. Apelido has made multiple other
contributions to the field of Bioprocessing, including his published research on
biomass conversion to ethanol and butanol, and process simulation of
biorefineries. His current position at GreenLight Biosciences, Inc, as Engineer III of
Process Development is further evidence of his continued growth and contributions
to the field. This company can disrupt the agricultural space by generating
inexpensive and highly specific biopesticides that do not pose risks for humans or
other species. We need engineers like Oscar Apelido, who has demonstrated a
deep understanding of bioreactor design and microbial metabolism, to develop the
technologies that help us transition to a cleaner, efficient, green economy. The
United States will benefit greatly from Dr. Apelido’ continued presence and active
role in the field of Bioprocessing. Therefore, I strongly support his petition.
Sincerely,
Name and Last name
Signature
Position
Company/Institution
Contact information
EDUCATION

Institution

Institution
EXPERIENCE
Position 1 Date
Company 1
Position 2 Date
Company 2
Position 3 Date
Company 3
Exhibit 7: Advanced Degrees

Exhibit 7.1: PhD Degree in Biosystems Engineering from Oklahoma State
University – Copy of Diploma
Exhibit 7.2: Transcripts from PhD Degree in Biosystems Engineering from
Oklahoma State University
EB-2 NIW - Dr. Oscar Apelido – Advanced Degrees

Exhibit 7.1: PhD Degree in Biosystems Engineering from Oklahoma State

University - Diploma
EB-2 NIW - Dr. Oscar Apelido – PhD Degree from Oklahoma State University
Exhibit 9.2: PhD Degree Transcripts from Oklahoma State University
EB-2 NIW - Dr. Oscar Apelido – PhD Degree from Oklahoma State University
redacted
Exhibit 8: Curriculum Vitae
EB-2 NIW - Dr. Oscar Apelido – Relevance of research for the U.S. National Interest
Oscar Apelido
Address line 1 Phone number
Address line 2 emailaddress@gmail.com
United States of America https://www.linkedin.com/in/pardoplanas
EDUCATION
Postdoctoral Engineer in Bioprocessing December 2017

GreenLight Biosciences, Inc, Medford, MA, US
Doctor of Philosophy in Biosystems Engineering 2013-2016

Oklahoma State University, Stillwater, Oklahoma, US GPA: 4.0
Chemical Engineering (equivalent to BS + MSc level) 2006-2012

University of Santiago de Compostela, Galicia, Spain, EU Final grade: 7.06/10
►2011-12. University of Utah – Awarded scholarship for a one-year exchange research experience.
►2009-10. Technical University of Denmark – Awarded Erasmus scholarship for a one-year exchange.
EXPERIENCE
Engineer III, Process Development January 2019 – present

GreenLight Biosciences, Inc, Medford, MA
▪ Led technology transfer of Cell Free Reaction dsRNA production process at contract
manufacturing facility.
▪ Achieved an additional 17-fold scale-up (compared to 2018) of the Cell Free Reaction
bioprocess, which resulted in a 3.4 million-fold scale-up from the initial reaction volumes.
▪ Led product generation in the gram scale to support company´s R&D plans for agricultural
dsRNA platform.
▪ Managed a database of intermediate and finished product inventory.
▪ Supervised quality control (QC) and quality assurance (QA) of the finished product inventory, as
well as traceability of each material and process.
▪ Supervised three Process Development Research Associates.
Engineer II, Process Development January 2018 – December 2018

GreenLight Biosciences, Inc, Medford, MA
▪ Co-led scale-up of GreenLight’s dsRNA Cell Free Reaction bioprocessing.

▪ Successful 200,000-fold scale-up achieved in 3 months, enabling expedited trials of product and
advanced company’s objectives for the year.
▪ The team I led accomplished the scale-up goals in 25% less time than projected, and with an
extra 10-fold scale-up factor over the milestone requirements.
▪ Designed and executed scale-down experiments in high throughput systems to predict
performance of Cell Free Reaction bioprocess at scale, saving time and resources in the process
development work. Validated the results in the large scale CFR.
Curriculum vitae of Oscar Apelido Page 1

▪ Designed and executed scale-down experiments in high throughput systems to develop a High
Temperature Short Time (HTST) protocol for process streams. Validated the results and drafted
SOP for operation of the commercially relevant HTST scale equipment.
▪ Performed quality control of different input materials to the process, and maintained proper
documentation to ensure traceability.
▪ Performed data analysis to develop understanding of tradeoffs between process parameters and
key performance metrics, such as rates, titers, and yields.
▪ Led the sample generation efforts to produce the required amounts of product to be tested in-
house or through collaborations.
▪ Supervised the operations of routine downstream processing of the product to be added to the
inventories.
▪ Drafted Standard Operating Procedures for the Cell Free Reaction bioprocessing platform as
well as for other parts of the process.
▪ Managed and couched two Process Development Research Associates.
Post-Doctoral Process Development Engineer / Fermentation Laboratory Supervisor

GreenLight Biosciences, Inc, Medford, MA January 2017 – December 2017
▪ Designed and executed experiments in the field of fermentation, from the milliliter scale up to
10L reactors.
▪ Supervised the fermentation team (5-6 research associates and interns) as part of the dsRNA
program.
▪ Led the operations group in fermentation of E. coli. Streamlined laboratory procedures to
increase efficiency and experiment success.
▪ Guided the team towards implementation of multiple different modes of fermentation operation
(continuous, fill and draw, batch, high cell density) for protein and nucleic acid production.
▪ Established protocols and procedures to culture a novel fast-growing microorganism. After media
development, obtained a 7-fold increase in cell density in high cell density fermentations; higher
than what was reported in the literature.
▪ The supervised team reached all the end-of-year goals in 2017 and exceed many of these goals.
▪ Presented data to the team and in company-wide meetings.
▪ Developed or improved analytical methods to support the fermentation group efforts, including:
o Total protein quantification: screened three methods and recommended best option.
o Recombinant protein quantification. Reduced variability of analysis by 90% from initial
results.
o Determination of soluble and insoluble recombinant protein.
o Nucleic acid quantification.
▪ Transferred methods to Research Associate in Analytical Chemistry group.
▪ Updated and streamlined laboratory documentation for increased efficiency.
▪ Created and maintained an inventory of samples.
o Managed more than 200 boxes of samples in different freezers
o Ended mistaken disposal of samples
o Increased efficiency during sampling analysis (about half an hour of three researchers
saved daily)
o Presented the new inventory system across research groups as a workshop
▪ Actively participated in the hiring process of two new employees, including job description
drafting and interview process.

▪ Successfully transitioned the team from hourly technicians to salaried Research Associates,
including job description updates, calculations of salary updates based on extensive audits of
timecards. Resulted in simplified management system and increased expectations for team
members.
▪ Managed all the purchases for the team, including more than 200 Purchase Orders.
▪ Led the technology transfer and supervision of a contract research facility for a joint project
between the strain engineering and fermentation teams.
Graduate Research Associate in Bioprocessing January 2016 – December 2016

Oklahoma State University, Stillwater, OK
▪ Constructed a mutant fungal strain to overexpress aryl alcohol oxidase protein under limited
growth conditions.
▪ Developed cross-discipline collaboration with Dr. Rolf Prade’s laboratory in the Microbiology and
Molecular Genetics department.
▪ Investigated and improved culture media for the mutant strain. Achieved 48% increase in
enzyme production titers after media development.
▪ Used statistical tools, such as SAS, to analyze data and reach conclusions.
▪ Operated trickle bed reactor (TBR) using mutant strain to produce the targeted protein in a
continuous mode.
▪ Obtained an increase of 20 to 140% in enzyme productivities when melanization phenomenon
was reduced or suppressed.
▪ Investigated the effect of operational parameters such as recycle rate, dilution rate, air flow rate,
and type of bed packing material on enzyme production.
▪ Collaborated with a German research institute (PFI-Pirmasens) to enable scale-up of findings at
lab bench scale to pilot scale (300L).
▪ Generated reports and presented findings in meetings with the German partners.
▪ Maintained and performed quality control on stock cultures of the mutant Aspergillus nidulans
used.
▪ Produced 3 peer-reviewed publications in international journals from the PhD dissertation work.
▪ Presented findings in 2 international professional meetings.
Research Engineer in Bioprocessing January 2013 – December 2015

Oklahoma State University, Stillwater, OK
▪ Staff position to support 2 research groups focused on biomass conversion on biochemical and
hybrid gasification-syngas fermentation technologies.
▪ Co-designed and demonstrated bio-butanol production from switchgrass and redcedar.
▪ Improved redcedar to ethanol process by reducing the chemical and water loads by 40% during
pretreatment.
▪ Obtained 95% wood glucan-to-ethanol yield with simultaneous saccharification and fermentation
of redcedar sapwood crumbles®.
▪ Initiated process development work for a novel thermophilic hydrogen-producer bacterial strain
using biomass as a raw material. Obtained similar results than when using glucose as carbon
source.
▪ Modeled and simulated syngas fermentation process using Aspen Plus.

▪ Supervised and/or mentored 12 students and researchers.

▪ Prepared Standard Operating Procedures (SOPs) and Procedure Hazard Analysis (PHAs) for
instruments and methods.
▪ Routinely maintained cultures of strains used by two groups, including C. carboxidivorans, C.
ragsdalei, C. acetobutylicum, K. marxianus IMB, S. cervisae D5A.
▪ Performed periodic assays on enzyme activity of Accelerase 1500® and maintained quality
assurance (QA) records.
▪ Assisted in drafting a research project proposal that was awarded $136,000 from the SunGrant
Initiative (US DOT).
▪ Contacted suppliers, requested quotes, compared products and purchased materials and
specialized instruments for the entire research group (summing up to a total of $100,000).
▪ Created and maintained an inventory of compressed gas cylinders in two laboratory locations to
ensure availability of gas and minimize operating costs.
▪ Design wall mounted panel for custom made bioreactor.
▪ Worked in coordination with Environmental Health and Safety (EHS) to improve safety conditions
in laboratories.
▪ Summarized research methods and outcomes in formal reports and research meetings.
▪ Prepared and co-authored peer-reviewed publications and presentations in international
professional meetings.
Graduate Research Assistant in Bioprocessing August 2011 – May 2012

University of Utah, Salt Lake City, UT
▪ Developed a novel immobilization technology for bacteria for production of biofuels via syngas
fermentation.
▪ Designed and performed experiments at the lab bench scale to demonstrate feasibility of the
novel immobilization technology using the enzymatic complex glucose oxidase-catalase.
▪ Drafted first Standard Operating Procedures (SOPs) for media preparation, culture maintenance,
and culture growth and development of syngas fermenting strains.
▪ Created a model using the finite elements software COMSOL Multiphysics to predict mass
transfer of gas into novel immobilization biobeads.
▪ Presented findings in internal research group meetings.
▪ Summarized results in master´s thesis entitled “Immobilized enzymes and bacteria in gas-
enhanced biobeads”, deposited in the University of Santiago de Compostela.
▪ Supervised 5 undergraduate students.
Laboratory Technician Intern Summer 2011

Agbar-Aquagest, Santiago de Compostela, Galicia, EU
▪ Performed routine analyses of wastewater and tap water, including:

o Total and insoluble solids
o Determination of microbial bioburden
o Total nitrogen and phosphate
o Determination of turbidity and pH
o Analysis of biochemical and chemical oxygen demand
▪ Documentation of results to comply with regulatory policies

CORE COMPETENCIES
Bioprocessing ■ Cell Free Reaction ■ Bioreactor design and operation ■ Fermentation ■ Pasteurization
(High Temperature Short Time, HTST) ■ Filtration ■ Statistics ■ Optimization ■ Process Development ■
Six Sigma ■ Strain and metabolic engineering ■ Aseptic microbial techniques ■ 1st, 2nd, and 3rd
generation of ethanol production ■ Butanol production ■ Chromatography ■ Sustainability ■ Project
management ■ Inventory management ■ Grant writing ■ Hazard analysis ■ Leadership ■ Team building
■ International collaboration
PEER REVIEWED PUBLICATIONS
1. Oscar Apelido, Hasan Atiyeh, Rolf Prade, Michael Müller, Mark Wilkins. Continuous aryl alcohol
oxidase production under growth-limited conditions using a trickle bed reactor. 2018.
Bioresource Technology. 255, 149-155.
2. Oscar Apelido, Hasan Atiyeh, John Phillips, Clint Aichele, Sayeed Mohammad. 2017. Process
simulation of ethanol production from biomass gasification and syngas fermentation. Bioresource
Technology. 245, 925-932.
3. Oscar Apelido, Rolf Prade, Michael Müller, Hasan Atiyeh, Mark Wilkins. Prevention of melanin
formation during aryl alcohol oxidase production under growth-limited conditions using an
Aspergillus nidulans cell factory. 2017. Bioresource technology, 243, 874-882.
4. Oscar Apelido, Rolf Prade, Mark Wilkins. High-yield production of aryl alcohol oxidase under
limited growth conditions in small-scale systems using a mutant Aspergillus nidulans strain.
2017. Journal of industrial microbiology and biotechnology, 44 (2), 247-257.
5. Kan Liu, Hasan K Atiyeh, Oscar Apelido, Thaddeus C Ezeji, Victor Ujor, Jonathan C Overton,
Kalli Berning, Mark R Wilkins, Ralph S Tanner. 2015. Butanol production from hydrothermolysis-
pretreated switchgrass: Quantification of inhibitors and detoxification of hydrolysate. Bioresource
Technology. 189, 292-301.
6. Kan Liu, Hasan K. Atiyeh, Oscar Apelido, Karthikeyan D. Ramachandriya, Mark R. Wilkins,
Thaddeus C. Ezeji, Victor Ujor, Ralp S. Tanner.2015. Process Development for Biological
Production of Butanol from Eastern Redcedar. Bioresource Technology, 176, 88-97.
7. Karthikeyan D. Ramachandriya, Mark R. Wilkins, Oscar Apelido, Hasan K. Atiyeh, Nurhan T.
Dunford and Salim Hiziroglu. 2014. Simultaneous saccharification and fermentation of Eastern
redcedar heartwood and sapwood using a novel size reduction technique. Bioresource
Technology, 161, 1-9.
ORAL AND POSTER PRESENTATIONS

1. Oscar Apelido, Karthikeyan Ramachandriya, Himanshu Dhamankar, Ify Iwuchukwu, Ray
Farmer, Elisha Fielding, Nicholas Skizim, James Abshire, Drew Cunningham, Thais Rodrigues,
Suresh Desai, Douglas Boyes. Developing a low-cost and scalable bio-catalytic process for
targeted and effective insect control. 2019 ASABE Annual International Meeting, Boston, MA.
July, 2019. Oral Presentation. Accepted.

2. Mark Wilkins, Oscar Apelido, Rolf Prade, Hasan Atiyeh, Michael Mueller. Production of aryl
alcohol oxidase by an Aspergillus nidulans mutant in a trickle bed reactor. 14th Convention of
The Biotech Research Society, India, and International Conference on Emerging Trends in
Biotechnology for Waste Conversion (ICETBWC – 2017), Nagpur, India, October 8-10, 2017.
Oral Presentation.
3. Michael Mueller, Oscar Apelido, P. Ballmann, Mark Wilkins, Rolf Prade, S. Droge. Enzyme
production with Aspergillus nidulans under growth limited conditions in a trickle bed reactor. 5th
Joint Conference of the DGHM & VAAM / VAAM Annual Meeting 2017 / 69th Annual Meeting of
the DGHM. Würzburg, Germany (EU). March 8, 2017. Oral Presentation.
4. Oscar Apelido, Rolf Prade, Michael Mueller, Mark Wilkins. Aryl alcohol oxidase production
under growth-limited conditions using a mutant Aspergillus nidulans strain. 2016 ASABE Annual
International Meeting, Orlando, FL, Jul 18, 2016. Oral Presentation.
5. Oscar Apelido, Mengxing Li, Mark R. Wilkins. High solids acid sulfite pretreatment of Eastern
redcedar for ethanol production via SSF. 2015 ASABE Annual International Meeting, New
Orleans, LA, Jul 26-29, 2015. Oral Presentation.
6. Kan Liu., Hasan K. Atiyeh, Oscar Apelido, Thaddeus C. Ezeji, Victor Ujor, Jonathan Overton,
Kalli Berning, Mark R. Wilkins and Ralp S. Tanner. Production of Butanol from Switchgrass with
and without Detoxification. 2015 ASABE Annual International Meeting, New Orleans, LA, Jul 26-
29, 2015. Oral Presentation.
7. Irum Khan, Jonathan C. Overton, Oscar Apelido, Hasan Atiyeh. Production of biohydrogen from
switchgrass hydrolyzate by Anaerobaculum hydrogeniformans. 2015 NSF-REU Mini
Symposium. Oklahoma State University, Stillwater, OK. July 24, 2015. Poster presentation.
8. Irum Khan, Jonathan C. Overton, Oscar Apelido, Hasan Atiyeh. Production of biohydrogen from
switchgrass hydrolyzate by Anaerobaculum hydrogeniformans. 2015 NSF-REU Mini
Symposium. Oklahoma State University, Stillwater, OK. July 24, 2015. Oral presentation.
9. Jonathan Overton, Oscar Apelido, Hasan K. Atiyeh, Ralph S. Tanner. Production of hydrogen
from renewable feedstocks by a novel thermophilic bacterium. Wentz Resarch Symposyum.
Oklahoma State University, Stillwater, OK, April 24, 2015. Poster presentation.
10. Jonathan Overton, Kan Liu, Oscar Apelido, Hasan K. Atiyeh. Production of Jet Fuel
Intermediates from Biomass. Research Day at the State Capitol, Oklahoma City, OK. March 31,
2015. Poster presentation.
11. Oscar Apelido, Hasan K. Atiyeh, John R. Phillips, Clint P. Aichele. Process Simulation of a
Hybrid Gasification-Syngas Fermentation Plant for Production of Ethanol from Switchgrass. 2014
AIChE Annual Meeting. Atlanta, GA. November 16-21. Oral presentation.
12. Kan Liu, Hasan K. Atiyeh, Oscar Apelido, Karthikeyan D. Ramachandriya, Mark R. Wilkins,
Thaddeus C. Ezeji, Victor Ujor, Ralp S. Tanner. Butanol Production from Eastern Redcedar.
2014 AIChE Annual Meeting. Atlanta, GA. November 16-21. Poster presentation.
Intermediates from Biomass. 2014 NCEES Midwest Section Meeting. Fort Smith, Arkansas.
September 24, 2014. Poster presentation.

14. Kan Liu, Hasan K. Atiyeh, Oscar Apelido, Mark R. Wilkins, Karthikeyan D. Ramachandriya,
Thaddeus Ezeji, Ralph Tanner. Production of butanol from eastern redcedar. 2014 ASABE
International Meeting. Montreal, Quebec, Canada. July 14, 2014. Oral presentation.
Intermediates from Switchgrass. 2014 ASABE International Meeting. Montreal, Quebec, Canada.
July 15, 2014. Poster presentation.
16. Mark R. Wilkins, Karthikeyan D. Ramachandriya, Oscar Apelido, Hasan K. Atiyeh, Nurhan T.
Dunford and Salim Hiziroglu. The use of a novel biomass size reduction technique to prepare
Eastern red cedar for ethanol production. 2014 Institute of Biological Engineering (IBE) 2014
Annual Meeting. Lexington, Kentucky. March 6-8, 2014.Oral presentation.
INVITED PRESENTATIONS
▪ Oscar Apelido. Biofuels for the future: the complexity of an ethical analysis. BAE Professional
Practice course. Oklahoma State University, Stillwater, OK. September 2, 2015.
▪ Oscar Apelido. Annual Update on Oklahoma State University Biosystems and Agricultural
Graduate Student Association.Oklahoma Section ASABE Annual Meeting. OSU, Stillwater, OK.
Februrary 24, 2014.
▪ Ilda Hershey, Oscar Apelido, Sauyer Lay. Sustainability at the Family and Graduate Student
Housing of OSU. Family Resource Center Resident Training Series. Oklahoma State University,
Stillwater, Oklahoma. November 5th and 9th, 2013.
▪ Oscar Apelido. Saccharification-fermentation and syngas fermentation routes. Challenges and
Opportunities. Biosystems and Agricultural Engineering Department. Oklahoma State
University, Stillwater, Oklahoma. August, 2012.
HONORS AND AWARDS
▪ Finalist in Three Minute Thesis (3MT) Competition at College Level. Oklahoma State
University, Stillwater, OK. February, 2016.
▪ Finalist in Ag & Bio Ethics Essay Competition held at the 2015 International Meeting of
ASABE. New Orleans, LA. July, 2015.
▪ Awarded Love of Learning Award by The Honor Society of Phi Kappa Phi in November, 2015.
These awards help fund post-baccalaureate studies and/or career development for active Phi
Kappa Phi members to include (but not be limited to): Graduate or professional studies, doctoral
dissertations, continuing education, career development, travel related to teaching/studies, etc.
▪ Mentored student Jonathan Overton won 2nd place/honorable mention in the Wentz
Research Symposium. Title of poster: Production of Hydrogen from renewable feedstocks by a
novel thermophilic bacterium. Oscar Apelido is a co-author of the poster.
▪ Mentored student Jonathan Overton won Best poster at ASEE Midwest Section
Conference. Title of poster: Production of Jet-Fuel Intermediates from Biomass. Oscar Apelido
is a co-author for the poster. Fort Smith, AR. September 25, 2014.

▪ Awarded scholarship funded by the Galician Government (Spain) to participate in

International Student Exchange Program (ISEP). This exclusive scholarship covered all
expenses (flights, tuition, fees, meals, and accommodation) during one year at the University of
Utah, where I did research towards my Master’s thesis. Academic year 2011-2012.
▪ Awarded Erasmus scholarship to attend the Technical University of Denmark (DTU)
during one academic year while studying Chemical Engineering at the University of Santiago
de Compostela, Spain. The Erasmus scholarship is funded by the European and State
governments and covers fees/tuitions and a monthly stipend. Academic year 2009-2010.
▪ Best Poster “Women and Engineering”. School of Engineering. University of Santiago de
Compostela, Galicia, Spain. June 2010.
PROJECT PROPOSALS WITH FUNDING STATUS
▪ John McMaine, Holly Enlow, Michelle Melone, Alex McLemore, Oscar Apelido, Kate Klavon,
Whitney Lisenbee. A Focus on Sustainable Water Resources in OSU campus and the City of
Stillwater. Submitted: March, 2016. OSU Green Student Initiative. (Funding status: Accepted and
awarded $2,875)
▪ Oscar Apelido, Sagar Neupane, Saroj Kandel, Mengxing Li, Collin Craige, Antoni Llongarriu,
Elena Lopez Zozaya, Alex McLemore, Anish Khanal, Ram Kumar Isakki, Mikayla Wanger.
Fostering sustainability awareness in OSU campus City of Stillwater - Phase IV. Submitted:
March 31, 2014. OSU Green Student Initiative. (Funding status: Accepted and awarded $5,153)
▪ Hasan K. Atiyeh, Ajay Kumar, Mark Wilkins. Development of Sustainable Hybrid Gasification-
Syngas Fermentation Process for Alcohol Production. Submitted: October, 2013. SunGrant
Initiative South Central Region, Department of Transportation. (Funding status: Accepted and
awarded $130,000 for implementation. Start Date: 1/1/2014. End Date: 12/31/2015). Oscar
Apelido participated in drafting the proposal documents but is not listed in the Principal
Investigators (PIs) list because students cannot be a PI on a project.
▪ Karthikeyan Ramachandriya, Neha Bhadbhade, Oscar Apelido, Jasreen Sekhon, Yeyin Shi,
Halle Maley, Madhura Sarkar, Mamatha Devarapalli and Yongbo Wan. Fostering sustainability
awareness in OSU campus City of Stillwater - Phase III. Submitted: February 22, 2013. OSU
Green Student Initiative. (Funding status: Accepted and awarded $7,991)
TEACHING EXPERIENCE
TEACHING PRACTICUM

• Assisted in teaching the course BAE 3113 “Microbial Technology” in Fall 2016 at
Oklahoma State University, in the Biosystems and Agricultural Engineering: under the direction
of Dr. Danielle Bellmer.
o The topics covered were:
▪ “Enzymes: basic concepts and kinetics”
▪ “Biomass conversion”
▪ 2 sets of homework were prepared and graded
o The students returned feedback in the form of grades for the instructor:
▪ Knowledge demonstrate of the subject matter: 4.83/5.00
▪ Level of preparation for class: 4.65/5.00
▪ Ability to explain concepts to students: 3.96/5.00
▪ Attitude towards students: 4.57/5.00
▪ Overall teaching ability: 4.13/5.00
TEACHING IN THE LABORATORY
• Process simulation of bioprocessing plants using Aspen Plus
o Trained professor on how to use process simulators to perform mass and energy
balances around a bioprocessing plant.
o The training included use of the software, interaction of Aspen Plus with Microsoft Excel
for better customization of the simulation, and performing sensitivity analyses to measure
the impact of process parameters on relevant output metrics.
o The work resulted in a peer-reviewed publication describing a simulation of a switchgrass
to ethanol plant.
• Ethanol production using Saccharomyces cerevisiae under separate hydrolysis and
fermentation and simultaneous saccharification and fermentation.
o Trained two graduate students on how to conduct compositional analysis of biomass, use
of high pressure reactors, and design and execution of shake flask experiments for
hydrolysis/fermentation.
o Trained the two students in operation of a mill, sieving of biomass, gravimetric analysis,
drying, acid hydrolysis, mass balances of components, and spectrophotometric
techniques.
• Acetone-butanol-ethanol (ABE) production from switchgrass and redcedar.
o Trained two post-doctoral fellows, two graduate students, and three undergraduate
students.
o The work included how to use a high pressure reactor for pretreatment of biomass,
compositional analysis using NREL protocols, enzymatic hydrolysis, anaerobic
fermentations, and sample analysis using chromatography.
o The training involved data analysis and performing component mass balances around the
unit operations.
• Use of gas chromatography (GC) and high pressure liquid chromatography (HPLC):
o Trained two post-doctoral associates, two graduate students, and one professor, on how
to operate, maintain, and troubleshoot the chromatographs and their software.
o Supervised the use of these analytical instruments and their proper maintenance.
• Mentored/couched three undergraduate students while working as Research Engineer at
Oklahoma State University (2013-2016).

o Irum Khan, undergraduate student of Chemical Engineering at Oklahoma State

University participant of the National Science Foundation (NSF) Research Experiences
for Undergraduates (REU) program.
▪ Trained Ms. Khan on enzymatic hydrolysis of switchgrass and anaerobic sugar
fermentation using a thermophilic hydrogen producer strain.
▪ Introduced Ms. Khan to the statistical analysis using the software SAS.
▪ The work involved training on data analysis and interpretation, as well as
preparation of technical reports and presentations of findings to external
audience.
o Kalli Berning, undergraduate student of Agricultural and Biological Engineering at North
Dakota State University participant of the National Science Foundation (NSF) Research
Experiences for Undergraduates (REU) program.
▪ Trained Ms. Berning on Acetone-Butanol-Ethanol (ABE) fermentation as well as
biomass conversion techniques.
▪ The work involved training on data interpretation and presentation in form of
internal reports, external presentations, and peer-reviewed manuscript
preparation.
o Jonas Overton, undergraduate student of Biosystems and Agricultural Engineering at
Oklahoma State University.
▪ Trained him on anaerobic microbial fermentation techniques, such as Acetone-
Butanol-Ethanol (ABE) fermentation, and culturing thermophilic hydrogen
producing strains, as well as biomass conversion techniques such as enzymatic
hydrolysis and high pressure pretreatments.
▪ The work involved training on data interpretation and presentation in form of
internal reports, external presentations, and peer-reviewed manuscript
preparation.
▪ The mentored student was awarded a number of national and regional
recognitions as the result of his work under my guidance (see Awards section).
LANGUAGES
▪ Spanish: native level

▪ Galician: native level
▪ English: proficient level
▪ Portuguese: intermediate level
▪ Catalan: intermediate level
SOFTWARE SKILLS:
▪ Statistical Data Analysis: SAS, JMP, SPSS.

▪ Process Design, Modeling, and Simulation: Aspen Plus, Aspen Hysis, SimSci Pro/II, Matlab,
National Instruments Labview, COMSOL Multiphysics.
▪ Laboratory software packages: Agilent Chemstation (chromatography), Eppendorf
Biocommand.
▪ Others: Microsoft Word, Excel, Project, Access.

PROFESSIONAL AND DEVELOPMENT ACTIVITIES
Professional Organizations
▪ Biosystems and Agricultural Engineering Graduate Student Association (BAEGSA)
o Green Student Initiative officer. February 2013 – August 2013.
o President. September 2013 – September 2014
o GPSGA representative for BAE. September 2015 – September 2016.
o Member. February 2013 – December 2016.
▪ Graduate and Professional Student Government Association. September 2015-September 2016.
o Research Symposium Committee Member, 2016.
▪ The Honor Society of Phi Kappa Phi.
o Member. March 2015 – December 2016.
o Recipient of Love of Learning award (2015).
▪ Golden Key Honour Society.
o Member. March 2015 – December 2016.
▪ American Society of Biological and Agricultural Engineers (ASABE)
o Member. May 2013 – present.
▪ American Institute of Chemical Engineers (AIChE)
o Member. January 2014 – December 2015.
▪ The International Society of Automation (ISA).
o Member of University of Santiago de Compostela’s student branch. 2010-2011.
Professional Meetings attended

▪ 2019 ASABE Annual International Meeting. July 7-10, 2019. Boston, MA (Expected).
▪ 2016 ASABE Annual International Meeting. July 17-20, 2016. Orlando, FL.
▪ 2015 ASABE Annual International Meeting. July 26-29, 2015. New Orleans, LA.
▪ 2014 Annual ASABE Oklahoma Section Meeting. February 2014. Stillwater, OK.
▪ 2013 ASABE International Meeting. June 2013, Kansas City, Missouri.
▪ Oklahoma EPSCoR 2013 Annual State Conference. May 2013, Stillwater, OK.
Courses/Seminars/Webinars attended
▪ ACS Reviewer Lab. American Chemical Society Publications. February 14, 2019.
▪ Basic Skills for First Time Supervisors. ADP Learning solutions. January 29, 2019.
Marlborough, MA.
▪ Emotional Intelligence and Leadership. ADP Learning solutions. January 29, 2019.
Marlborough, MA.
▪ QPLS1x: Six Sigma: Define and Measure. TUMx (Technical University of Munich through
EdX). October, 2018.
▪ JMP® Software: ANOVA and Regression. SAS. GreenLight Biosciences, Medford, MA.
December 5-7, 2017.
▪ 2017 Metabolic Engineering Workshop. University of California San Diego. August 14-15,
2017.
▪ Agilent Gas Chromatography seminar day. Stillwater, Oklahoma. April, 2014.
▪ LabVIEW and Computer-Based Measurements Hands-On Seminar. National Instruments.
Tulsa, Oklahoma. 6 hours course. May 7th, 2013.

▪ Systems for environmental management. Galician Professional Association of Chemical

Engineers. Online. 60 hours online course. 2011
▪ Instrumented Safety Systems (ISS) and Hazard and Operability study (HAZOP) analysis.
The International Society of Automation. 12 hours course. 2011.
▪ Control systems in Process Engineering. The International Society of Automation. 12 hours
course. 2010
PEER-REVIEW ACTIVITY
▪ Reviewer in peer-reviewed journal, Biochemical Engineering Journal (3 papers reviewed,

2018/19). Impact factor of journal (2017): 3.226
▪ Reviewer in peer-reviewed journal, Bioresource Technology (3 papers reviewed, 2019).
Impact factor of journal (2017): 5.807
▪ Reviewer in peer-reviewed journal, Biomass Conversion and Biorefinery (1 paper reviewed,
2019). Impact factor of journal (2017): 1.310
▪ Reviewer in peer-reviewed journal, Enzyme and Microbial Technology (2 paper reviewed,
2019). Impact factor of journal (2017): 2.932
▪ Judge for oral presentations in the 2016 Graduate College Research Symposium.
Oklahoma State University, Stillwater, OK. February, 2016.
SERVICE ACTIVITIES / VOLUNTEERING
▪ Held leadership positions in departmental graduate student association (2013-2016).
▪ Created sustainability awareness in the family and graduate student housing (FGSH),
2013-2016.
o Awarded more than $10,000 for graduate student association in three years, to
implement sustainability awareness campaigns.
o Developed workshops for children to promote recycling in the Family and Graduate
Student Housing area (FGSH).
o Drafted educational material about composting and carried out a composting workshop
for residents.
o Promoted awareness on sustainability and recycling, distributing recycling bins to 200
apartments, hundreds of reusable grocery bags, and monthly newsletters in the FGSH
area.
o As a result of our educational efforts, the amount of recycling in the FGSH area
increased 3-fold in three months (October 2013: 2 tonnes, January 2014: 6 tonnes).
o Edited and authored five green leaflets with sustainability related information, such as
water management, food waste, electricity usage, and composting.
o Organization of events promoting sustainability at OSU campus, such as documentary
nights, or special events (invited speaker: 2013 CNN’s Hero of the Year Chad
Pregracke).
o Organized field trips for the University community, including

▪ Tour to the Cowboy Wind Farm. May, 2015.

▪ Tour to Highland Park High School (energy efficient building). October, 2015.
▪ Tour to OSU Water Plant. February, 2014.
▪ Participated in organization of social events at the Biosystems and Agricultural

Engineering department (2013-2016).
o Movie nights featuring documentaries on sustainability.
o Ice cream social events to promote social interactions in the department.
o Pot-lucks to promote social interactions among graduate students.
o Co-organized the World Water Day events at OSU, March 2014 and 2015.

6/23/2019 About the Bioenergy Technologies Office: Growing America's Energy Future | Department of Energy
Office of BIOENERGY
ENERGY EFFICIENCY & RENEWABLE ENERGY
About the Bioenergy Technologies Office: Growing

America's Energy Future
Home » About the Bioenergy Technologies Office: Growing America's Energy Future
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The U.S. Department of Energy's (DOE’s) Bioenergy Technologies Office (BETO) establishes partnerships with
key public and private stakeholders to develop technologies for producing cost-competitive advanced
biofuels from non-food biomass resources, including cellulosic biomass, algae, and wet waste (e.g., biosolids).
What We Do
BETO works with a broad spectrum of government, industrial, academic, agricultural, and nonprofit partners
across the United States to develop commercially viable, high-performance biofuels, bioproducts, and
biopower made from renewable U.S. biomass resources that reduce our dependence on imported oil while
enhancing energy security.
https://www.energy.gov/eere/bioenergy/about-bioenergy-technologies-office-growing-americas-energy-future 1/4
BETO’s web pages on Key Activities, Accomplishments, and User Facilities provide more information about the
BIOENERGY
Office's vision, mission, and activities.
Why It Matters
The creation of a robust, next-generation domestic bioenergy industry is one of the important pathways for
providing Americans with sustainable, renewable energy alternatives. Imagine, for example, a transportation
fuel made from an energy crop that can grow on marginal lands unsuitable for producing food, or even from
municipal waste or algae. Such fuels are compatible with existing infrastructure and could directly fill your
car's gas tank, warm your house, or help power an airplane. With research and development dedicated to
producing these fuels sustainably and affordably, we can provide home-grown supplements for a
transportation sector that is heavily dependent on foreign oil. In addition, we’re supporting the development
of bioproducts, which enable biofuels, since the production of bioproducts relies on much of the same
feedstocks, infrastructure, and technologies that are central to biofuel production. This support is moving the
United States toward a more secure, sustainable, and economically sound future.
• Promoting national security by developing domestic sources of energy—In 2015, the United States imported more
than 3.4 billion barrels of petroleum from about 88 countries, amounting to approximately one-quarter of all
petroleum used in the United States. U.S. biofuels can improve this balance by displacing imported oil. Reducing
dependence on foreign oil requires developing technologies to replace gasoline, diesel, jet fuel, heavy distillates, and
a range of biobased chemicals and products. In partnership with the U.S. Navy and the U.S. Department of
Agriculture, under the Defense Protection Act, DOE is co-funding the construction of three integrated biorefineries
that will have the capacity to produce hydrocarbon fuels that meet military specifications. Federal investment in
these commercial-scale biorefinery projects will help meet the transportation needs of the U.S. military and private
sector.
• Growing a sustainable future with renewable biomass resources—An expanding bioenergy industry must be
sustainable, and we are addressing environmental, social, and economic aspects of sustainability along the entire
bioenergy supply chain. DOE focuses solely on non-food feedstocks, which do not affect food supply or prices, and
often have ancillary benefits. For example, producing energy from waste sources is a double win because it helps
address the growing problem of what to do with this waste. And grasses planted specially to produce fuels could be
grown with minimal land-use change and could actually prove beneficial by reducing erosion and nutrient runoff,
thus protecting water sources. Biomass resources can also be managed sustainably by following such practices as
ensuring that sufficient nutrients are returned to the soil when harvesting agricultural residues and allowing
adequate time for plant regeneration between harvests. Using forest management best practices to collect and
remove dead trees can even help to improve forest health and mitigate fire risk. Through field- and laboratory-based
research, computer modeling, and advanced analysis, the Office investigates the life-cycle contributions of
bioenergy production to cleaner air, improved soil quality, enhanced water quality, lower harmful emissions, greater
biodiversity, and increased use of marginal croplands. The 2016 Billion-Ton Report documented the magnitude of the
biomass resource potential across the contiguous United States, and concluded that the United States could
sustainably triple its annual biomass production by 2030.
• Generating green jobs by stimulating the U.S. bioenergy economy—Biofuels are truly home-grown fuels. Biofuel
feedstocks are produced by U.S. farmers and other landowners, generating jobs and economic activity across rural
America. The money that the United States spends on the research, development, and use of biofuels recirculates in
our economy, providing further indirect economic and trade benefits. Estimates based on a recent study led by DOE
BIOENERGY
and the U.S. Department of Agriculture suggest that that if the United States were to triple its biomass production,
we could potentially generate 1.1 million direct jobs and $260 billion in direct revenue. A resilient bioenergy industry
will provide a variety of jobs across several sectors, including scientific research, agriculture, engineering,
construction, plant operations, and sales. Also, since the bioeconomy would draw on a variety of biomass sources,
the United States would have greater flexibility to accommodate market fluctuations.
• Leading global technology innovation—Breakthroughs in bioconversion technologies and successes in scaling up
technologies for commercial operations promote U.S. leadership in global clean energy innovation. Advances can
provide benefits in such related areas as agricultural production and food processing. Investments in bioprocessing
will also help to reduce production costs, improve process and product reliability, and increase profitability. U.S.
leadership in this growing sector will improve competitiveness in global markets.
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Chapter 1
Biopesticide Oversight and Registration at the

U.S. Environmental Protection Agency
John Leahy, Mike Mendelsohn,* John Kough, Russell Jones, and
Nicole Berckes
Publication Date (Web): October 23, 2014 | doi: 10.1021/bk-2014-1172.ch001
Downloaded by 172.28.244.186 on October 28, 2014 | http://pubs.acs.org
Environmental Protection Agency, Biopesticides and Pollution Prevention

Division (7511P), 1200 Pennsylvania Avenue, Washington, DC 20460
*E-mail: mendelsohn mike@epa.gov.
The Environmental Protection Agency (EPA) is committed

to encouraging the development and use of biopesticides
and considers them inherently reduced-risk pesticides.
Biopesticides (microbial pesticides, biochemical pesticides,
and plant-incorporated protectants) are required to be evaluated
by EPA. The Agency must make findings of “no unreasonable
adverse effects” to man and the environment to support its
registration decision to permit sale and distribution under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),
as well as a “reasonable certainty of no harm” under the Federal
Food, Drug, and Cosmetic Act (FFDCA) to permit residues
in food and/or feed. This chapter will review areas including
how EPA views the benefits of biopesticides, related laws and
legal requirements, biopesticide registration, and biopesticide
data requirements. EPA’s commitment to low risk biological
pesticides as alternatives to conventional chemical pesticides
will also be emphasized.
What are Biopesticides?
Biopesticides, also known as biological pesticides, are pesticides derived

from natural materials such as animals, plants, bacteria, and certain minerals.
Typically, biopesticides have unique modes of action and are considered reduced
risk pesticides. Biopesticides fall into three major classes:
Not subject to U.S. Copyright. Published 2014 by American Chemical Society

In Biopesticides: State of the Art and Future Opportunities; Coats, et al.;
ACS Symposium Series; American Chemical Society: Washington, DC, 2014.
• Biochemical pesticides;
• Microbial pesticides; and
• Plant-incorporated protectants.
Biochemical Pesticides
Biochemical pesticides are naturally occurring substances or are synthetically

derived equivalents that have a non-toxic mode of action to the target pest(s), and
have a history of exposure to humans and the environment demonstrating minimal
toxicity. Synthetically derived biochemical pesticides are equivalent to a naturally
occurring chemical with such a history. Biochemical pesticides include, but are not
limited to: semiochemicals (insect pheromones and kairomones), natural plant and
insect regulators, naturally occurring repellents and attractants, induced resistance

promoters, and enzymes. Biochemical pesticides typically degrade rapidly and are
not persistent in the environment.
Biochemical pesticides, with the exception of pheromones, tend to have much
less species-specificity and are broader spectrum pesticides than the microbials.
They also may have lethal effects upon the target pest. Lethal but non-toxic
biochemical pesticides include suffocating agents (e.g., soybean oil), dessicants
(e.g., acetic acid), and abrasives (e.g., diatomaceous earth).
Microbial Pesticides
Microbial pesticides are microorganisms that produce a pesticidal effect.

They have pesticidal modes of action that often include competition or inhibition,
toxicity and even use of the target pest as a growth substrate. They may be:
• Eukaryotic microorganisms including, but not limited to, protozoa, algae,

and fungi;
• Prokaryotic microorganisms, including, but not limited to, bacteria;
• Autonomous replicating microscopic elements, including, but not limited
to, viruses.
Microbial pesticides can control many different kinds of pests, although each
separate active ingredient is relatively specific for its target pest(s). For example,
there are fungi that control certain weeds and other fungi that kill specific insects.
The most widely used microbial pesticides are subspecies and strains of
Bacillus thuringiensis, or Bt. Each strain of this bacterium produces a different
mix of proteins, and specifically kills one or a few related species of insect larvae.
While some Bt strains control moth larvae feeding on plants, others are specific
for larvae of flies and mosquitoes. The target insect species are determined by
whether the particular Bt produces a protein that can bind to a larval gut receptor,
thereby causing the insect larvae to starve.
4
Plant-Incorporated-Protectants (PIPs)
Consistent with the Coordinated Framework for Regulation of Biotechnology
issued by the U.S. Office of Science and Technology Policy in 1986 (51 FR
23302) genetically modified (GM) crops with pesticidal traits fall under the
oversight of EPA, the U.S. Department of Agriculture, and the U.S. Food and Drug
Administration. EPA’s oversight focuses on the pesticidal substance produced
(e.g., Bt Cry proteins) and the genetic material necessary for its production in
the plant (e.g., Cry genes). EPA calls this unique class of biotechnology-based
pesticides plant-incorporated protectants (PIPs).
PIPs are pesticidal substances that plants produce and the genetic material
that has been added to the plant. For example, scientists can take the gene for the
Bt pesticidal protein and introduce the gene into the plant’s own genetic material.
Then the plant, instead of the Bt bacterium, manufactures the substance that
destroys the pest. EPA regulates the protein and its genetic material, but not the
plant itself.
How EPA Views Benefits of Biopesticides

In 1994, the Biopesticides and Pollution Prevention Division (BPPD)
was established in EPA’s Office of Pesticide Programs (OPP) to facilitate the
registration of biopesticides. BPPD promotes the use of safer pesticides, including
biopesticides, as components of integrated pest mangement (IPM) programs.
EPA is committed to encouraging the development and use of low risk
biological pesticides as alternatives to conventional chemical pesticides (1). The
Agency recognizes that these pesticides are often different in their mode of action
and has employed numerous measures to facilitate the application process. These
include distinct data requirements for microbial and biochemical biopesticides,
consolidation of biological pesticide application processing to a single group
within OPP, and regulatory relief activities (2) . EPA is committed to the efficient,
effective approval of safer pesticides as well as a transparent, predictable process
in decision making.
Since biopesticides tend to pose fewer risks than conventional pesticides,
EPA generally requires much less data to register a biopesticide than to register a
conventional pesticide, and EPA’s review times are shorter for biopesticides.
While biopesticides require less data and are registered in less time than
conventional pesticides, EPA always conducts rigorous reviews to ensure that
pesticides will not cause unreasonable adverse effects on human health or the
environment. For EPA to be sure that a pesticide is safe, the Agency requires that
registrants submit a variety of data about the composition, toxicity, degradation,
and other characteristics of the pesticide. These data requirements are described
in more detail later in this paper.
There are several benefits to using biopesticides, including:
• Decreased risk without affecting yield. Biopesticides—when used

as a component of an IPM program—can greatly decrease the use of
conventional pesticides, without affecting crop yield.
5
• Often less toxic. Generally, biopesticides are inherently less toxic than
conventional pesticides and are safer to those using them.
• Often effective in very small quantities and decompose quickly. This can
result in lower exposures and avoid pesticide pollution problems.
• Targeting of specific pests. Biopesticides generally affect only the
target pest and closely related organisms, in contrast to broad spectrum,
conventional pesticides that may affect non-target organisms such birds,
insects, and mammals.
• When used in rotation with conventional products, biopesticides can help
prevent development of pest resistance problems.
• Improved residue management. Buyers and consumers are becoming
increasingly selective in their purchasing habits. Illegal pesticide residues
left on produce can result in loss of markets, fines, and other consumer
avoidance. Biopesticides often contain natural products that are normally

consumed and do not have residue concerns.
Many microbial and biochemical biopesticides are not intended to function as

"stand-alone" pest control products to completely replace conventional pesticides.
Instead, these biopesticides are most effective when used as a component of an
IPM program because they generally affect only the target pest and closely related
organisms.
Additionally, for agricultural use products, biopesticides typically qualify for
a reduced restricted entry interval and have no pre-harvest interval. Restricted
entry intervals are requirements that limit the time that workers can return to a
field once it has been treated with a pesticide. Restricted entry intervals can delay
or obstruct time-sensitive cultural practices. Many biopesticides also do not have
harvest restrictions. A harvest restriction is a waiting period between when a
pesticide is applied and when the treated crop can be harvested and marketed. The
waiting period after treatment can often be several days. Biopesticides without
harvest restrictions give a grower much greater flexibility during harvest.
Microbial and biochemical biopesticides are generally labeled for use on a
wide range of crops. As a result, for some minor crops or obscure pest problems,
a biopesticide may be available when no conventional product is registered for
the use. In addition, for larger crops such as corn, soybean, and cotton, PIP
biopesticides have reduced the use of more toxic conventional insecticides.
Overview of OPP and BPPD’s Role

EPA’s Office of Pesticide Programs (OPP), along with the Office of Chemical
Safety and Pollution Prevention (OCSPP), works with 10 Regional Offices and
other EPA program offices on a wide range of pesticide issues and topics, such as:
• Evaluating potential new pesticides and uses;

• Providing for Special Local Needs and emergency situations;
• Reviewing safety of older pesticides;
• Registering pesticide producing establishments;
6
• Enforcing pesticide requirements; and

• Pesticide field programs, such as the frontline implementation activities
carried out by states, tribes, and EPA Regional pesticide experts.
OPP is comprised of nine divisions, three of which are divisions responsible

for the registration of pesticides. The Biopesticides and Pollution Prevention
Division (BPPD) is responsible for all regulatory activities associated with
biologically-based pesticides. Within BPPD, the Biochemical Pesticides Branch
and Microbial Pesticides branch are responsible for registering biochemical and
microbial pesticides, respectively. Additionally, the Microbial Pesticides Branch
registers PIPs and other biotechnology-related products.
BPPD also is working to reduce pesticide risk by promoting Integrated Pest
Management (IPM) initiatives and coordinating the Pesticide Environmental
Stewardship Program (PESP). BPPD’s vision is to be a world leader in biopesticide

regulation and pollution prevention. The mission of BPPD is to protect human

health and the environment by reducing the risks of pesticides through registering
biopesticides and through encouraging pollution prevention practices.
Main Statutes and Legal Requirements

EPA regulates the use of pesticides under the authority of two federal statutes:
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug, and Cosmetic Act (FFDCA) (3)(4). Additionally, the Food Quality
Protection Act of 1996 (FQPA) amended FIFRA and FFDCA setting tougher
safety standards for new and old pesticides and to make uniform requirements
regarding processed and unprocessed foods (5). Finally, the Pesticide Registration
Improvement Act (PRIA) establishes pesticide registration service fees for
registration actions in the three registering divisions of EPA’s Office of Pesticide
Programs (6).
Other statutes that play roles in the regulation of biopesticides include:
• Endangered Species Act;

• Migratory Bird Treaty Act; and
• Clean Water Act
The following descriptions give brief overviews of the main statutes, though
such descriptions are not intended to be comprehensive.
FIFRA
FIFRA provides the basis for regulation, sale, distribution and use of
pesticides in the U.S. FIFRA authorizes EPA to review and register pesticides for
specified uses. EPA also has the authority to suspend or cancel the registration
of a pesticide if subsequent information shows that continued use would pose
unreasonable risks. Some key elements of FIFRA include:
7
• Is a product licensing statute; pesticide products must obtain an EPA

registration before manufacture, transport, and sale
• Registration based on a risk/benefit standard
• Strong authority to require data--authority to issue Data Call-ins
• Ability to regulate pesticide use through labeling, packaging,
composition, and disposal
• Emergency exemption authority--permits approval of unregistered uses
of registered products on a time limited basis
• Ability to suspend or cancel a product’s registration: appeals process,
adjudicatory functions, etc.
Microbial, biochemical, and plant-incorporated protectant biopesticides are

considered pesticides under FIFRA, and generally are required to be evaluated
and registered by EPA under Section 3 of FIFRA. EPA must make a finding of no
unreasonable adverse effects to man and the environment from use of the pesticide
in order to support its registration decision.
FFDCA and FQPA
The Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes EPA to
set maximum residue levels, or tolerances, for pesticides used in or on foods or
animal feed. Under FFDCA and amendments to both FFDCA and FIFRA under
the FQPA, EPA must make a similar finding of a reasonable certainty of no harm
if the use of such agents results in residues in food or feed. If the submitted
information supports this safety finding, EPA may establish a numerical tolerance
or an exemption from the requirement of a tolerance regarding those residues.
As of this writing, no microbial pesticides or plant-incorporated protectants
registered for food use have been required to obtain a numerical tolerance. Rather,
exemptions from the requirement of a tolerance have been granted based on the
finding of no significant adverse effects in the supporting data.
PRIA
In 2004, Congress passed the Pesticide Registration Improvement Act

(PRIA) and established a registration fee-for-service system with specific fees
and decision times by type of action. PRIA 3 is the second five-year extension
of the original Act and was the result of support and collaboration from a
coalition of industry, grower, environmental groups, and farm worker advocates.
As biopesticides are usually inherently less toxic than conventional pesticides,
biopesticide registrations require a significantly reduced data set compared to
conventional registrations. Additionally, biopesticides can follow truncated
decision review timelines as well as reduced registration fees.
8
Experimental Use Permits, Emergency Exemptions, and State and Local

Need Registrations
In the process of pesticide development, field testing is often necessary to

evaluate the efficacy of a pesticide. Title 40 CFR Part 172 describes when it is
necessary to obtain an Experimental Use Permit (EUP) under Section 5 of FIFRA
for testing unregistered pesticides. Briefly, the size of the outdoor test acreage is
greater than a cumulative 10 acres of land or 1 surface acre of water, an EUP
is required. Any food or feed crops involved in or affected by the tests must
be destroyed or consumed only by experimental animals unless a tolerance or
exemption from a tolerance has been established. These acreage limitations are
applicable only for outdoor terrestrial and aquatic uses. For those pesticides being
tested on sites for which acreage is not relevant (e.g., tree stumps, rodent control,
structural treatments or bird repellents), the determination of the need for an EUP
is made on a case-by-case basis.

Other criteria to determine when an EUP must be obtained are set forth in
40 CFR Part 172.3. An EUP is of limited duration and requires that the test be
carried out under controlled conditions. For small-scale field tests of genetically
modified microbial pesticides or non-indigenous microbial pesticides that USDA
has not previously acted upon, applicants must submit a notification to EPA for
determination of whether an experimental use permit is necessary, even if the
testing is on less than 10 acres
In addition to registration under Section 3 of FIFRA, there are two additional
means under FIFRA whereby a pesticide product may be distributed in the absence
of a Section 3 registration or an experimental use permit. One is pursuant to an
emergency exemption under Section 18 of FIFRA. Under this section, Federal or
State agencies may request limited approval for an unregistered use of a currently
registered pesticide product or the use of an unregistered pesticide product. Such a
request can only be granted when there is a potentially severe economic or human
health impact and no other alternatives are available for pest control. A Section
18 exemption usually allows use of the particular pesticide product for a year;
however, the duration of the exemption may be limited or expanded depending on
the situation (7).
Cases also exist where a particular pesticide product may be registered for one
or more uses, but not for a particular use which is determined by the State as being
a special local need. In these cases, the State may register that use or formulation
needed for the special local need under Section 24(c) of FIFRA provided that
appropriate tolerances or exemptions from tolerance exist if food or feed uses are
involved. The EPA has 90 days to disapprove of such State registrations.
Biopesticide Registration
Before a pesticide can be marketed and used in the United States, FIFRA
requires that EPA evaluate the proposed pesticide to assure that its use will not pose
unreasonable risks of harm to human health and the environment, including non-
target species. This involves an extensive review of health and safety information.
9
Pesticide registration is also the process through which EPA examines the
ingredients of a pesticide; the site or crop on which it is to be used; the amount,
frequency, and timing of its use; and storage and disposal instructions. A pesticide
cannot legally be used, sold, or distributed if it has not been registered with EPA’s
Office of Pesticide Programs. FIFRA Section 2 (u), defines the term “pesticide”
as:
(1) any substance or mixture of substances intended for preventing,

destroying, repelling, or mitigating any pest;
(2) any substance or mixture of substances intended for use as a plant
regulator, defoliant, or desiccant; and
(3) any nitrogen stabilizer.
EPA makes online resources, such as the Pesticide Registration Manual (also
known as the Blue Book), available to assist applicants through the registration
process (8).
As biopesticides are usually inherently less toxic than conventional pesticides,
biopesticide registrations may require a significantly reduced data set compared to
conventional registrations. Additionally, there are reduced associated timelines
and fees to help expedite registration processes. Timeframes to register pesticide
products vary dependent on the PRIA code assigned to the submission. Based on
PRIA 3 decision review timelines and fees for FY 14/15, biopesticide submissions
can range from 7 months and $6,079 USD for a new non-food use (PRIA 3 code:
B650) to 19 months and $48,621 USD for a new food use active ingredient with
a petition to establish a tolerance (PRIA 3 code: B580). This is compared to 12
months and $12,156 USD for a conventional new non-food indoor use (PRIA 3
code: R260) and 24 months and over $590,000 USD for a new food use active
ingredient (PRIA 3 code: R010).
Additionally, the Agency recommends that registrants request a pre-
submission meeting with the appropriate registering branch. The pre-submission
meeting is an excellent opportunity to discuss products in development and steps
to take to ensure a timely registration decision. All information exchanged at
these meetings is held confidential until a pesticide registration submission is
made.
Pheromone Regulatory Relief
The Agency acknowledges that use of certain types of pheromone products

presents lower risk than conventional pesticides, and also acknowledges the
unique properties of these niche-type products regarding their inherently narrow
host range (9). To promote the use of pheromone products, the Agency initiated a
regulatory relief program that allows flexible confidential statements of formula
for pheromone experimental use permits (EUPs) to allow for active ingredient
adjustments during the course of experimentation. The Agency has also published
generic tolerances and relaxed the acreage cut-off when an EUP is required for
pheromones.
10
EPA established the following exemptions from the requirement of a

tolerance as a result of the pheromone regulatory relief program: 1) for inert
materials in polymeric matrix dispensers (40 CFR 180.1122); 2) for pheromones
in retrievably-sized polymeric matrix dispensers (40 CFR 180.1124); 3) for
straight-chained lepidopteran pheromones (sprayables) (40 CFR 180.1153); and
4) for inert polymers in sprayable formulations, (40 CFR 180.1162). EPA further
set forth certain policies raising the acreage limit to 250 acres for experimental use
permit requirements for the testing of pheromones in polymeric matrix dispensers
(59 FR 3681), for testing of non-food use broadcast pheromones (59 FR 34182),
and for straight-chained pheromones (sprayables) (60 FR 168).
Products Exempt from Registration

EPA has determined that pest control organisms such as insect predators,
nematodes, and macroscopic parasites are exempt from the requirements of FIFRA
(40 CFR 152.20(a)). In addition, pheromones (and identical or substantially
similar compounds) labeled for use only in pheromone traps for monitoring and
pheromone traps in which those chemicals are the sole active ingredients are
not subject to regulation under FIFRA (40 CFR 152.25(b)). However, the use
of pheromones in traps in conjunction with conventional pesticides, in other
application methods (other than traps), or for purposes other than monitoring, is
subject to regulation under FIFRA.
Minimum risk pesticides that meet certain criteria are a special class of
pesticides that are not subject to federal registration requirements because their
ingredients, both active and inert, are demonstrably safe for the intended use.
They are exempt from federal registration under section 25(b) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA does not review
or register pesticides that satisfy the 25(b) criteria (40 CFR 152.25(f)), though
registration of these products is required by most states.
International Partnerships, Involvement, and Outreach

To streamline agency resources and promote international biopesticide
registration, EPA and Health Canada’s Pest Management Regulatory Agency
(PMRA) have established a process for the joint review of biopesticide products.
The procedure entails a joint pre-submission consultation to establish specific
data requirements.
Joint reviews increase the efficiency of the registration process, facilitate
simultaneous registration in Canada and the U.S., and increase access to new
pest management tools in both countries. Efficient work-sharing requires a
mutual understanding of the responsibilities of each agency, as well as common
procedures and time frames (10).
EPA has been an active member of the Organisation for Economic
Co-operation and Development’s (OECD) Biopesticide Steering Group (BPSG)
which meets annually to discuss harmonization of guidelines and principles of
11
risk assessment. Comparisons and modifications of guidelines for toxicity and

pathogenicity studies are vetted within the BPSG to reach consensus on risk
assessment procedures for a variety of microorganisms used in pest management.
In addition, specific organisms are reviewed to ensure that the latest scientific
information on their biology is considered when evaluating their safe use in
pest management. Production of toxins or secondary metabolites by some
microbial pest control agents (MPCA) are of concern and it is critical that risk
managers understand the prevalence of these compounds in products intended for
environmental release.
While the BPSG brings together a broad range of scientists from many
countries, not all aspects of dossier formating, concerns over aspects of study
guidelines and which studies are critical for risk assessment will be agreed
upon by all members. Despite this, the BPSG provides an important forum for
discussion on a wide range of topics and is the only such venue to reach such
a broad range of MPCA developers and regulators. The greater the degree of
harmonization of data requirements among member countries resulting from
these interactions, the more likely reduced-risk biopesticides will find widespread
use in agriculture.
Regarding international outreach, EPA’s Office of Pesticide Programs meets
periodically with representatives from several countries to discuss products of
biotechnology and their impact on trade of agricultural commodities. Updates
on regulatory approvals and assessment of novel traits are presented to U.S.
and foreign governmental representatives for consideration and discussion.
Asynchronous approval of biotechnology products by trading partners has led to
occasional rejections of shipments of commodities at great expense and disruption
of trade. These meetings provide a forum for direct interaction between regulators
and a greater understanding of the risk assessment process as the U.S. is often seen
as the lead country in the development and regulation of genetically engineered
crops. The ultimate goal of these exchanges is the acceptance of risk management
decisions (i.e., approvals) from one country by an importing country without the
need for a separate additional review process.
Biopesticide Data Requirements

Looking at the data that is required for biopesticide registration, biochemical
and microbial pesticides are subject to a different set of data requirements
for registration than conventional chemicals. These Data Requirements for
Registration, which are tiered, are listed in 40 CFR Part 158: Subpart U
Biochemical Pesticides 158.2000 and Subpart V: Microbial Pesticides 158.2100.
EPA has published guidance for developing these data in the Biochemical
Pesticides Test Guidelines, OSCPP Series 880 and the Microbial Pesticides Test
Guidelines, OSCPP Series 885.
The current regulations allow for flexibility in fulfilling the required data. This
can be accomplished through providing a rationale as to why a specific test is not
practical to perform, or by providing scientific rationale to address the particular
12
endpoint. In addition, the Agency has the authority to invoke additional testing
requirements if a potential risk has been identified and needs to be investigated.
This flexible approach ensures that potential risks presented by biopesticides will
be properly assessed.
Biochemical Data Requirements

Product Analysis and Mammalian Toxicology
In general, the product characterization information required for biochemical

pesticides is the same as required for conventional chemical pesticides. These
include:
• Data/information on product identity and composition;

• Information on manufacturing process; and

• Discussion of the formation of impurities, enforcement analytical
methods, analysis for certification of limits, and physical/chemical
properties.
The Agency has adopted a tiered testing scheme to assure the safety of
biochemical pest control agents toward mammalian species, similar to that used
for microbial pesticides, and is comprised of three tiers. Adverse effects in a
lower tier will trigger additional testing in the next higher tier (11) (12).
The mammalian toxicology studies generally required for registration in or
on a terrestrial food crop include, in Tier I, acute toxicity tests (oral, dermal, and
inhalation exposures, & primary dermal and primary eye irritation studies).
In addition, a battery of genotoxicity studies, 90- day oral, dermal, and
inhalation studies (depending upon likely routes of repeated exposure), an
immunotoxicity study, and a developmental toxicity study may be required.
Hypersensitivity incidents are to be reported, if they occur. The Agency has, on
a case by case basis, considered scientifically valid information or peer reviewed
literature in lieu of guideline studies. In many cases, lack of significant exposure
serves as a basis for not requiring active ingredient or product specific data.
Non-Target Organism Testing
The unique nature of biochemical pesticides has led to a reduction in the data
requirements for these products, as compared to synthetic chemical pesticides.
Maximum hazard or limit dose testing of the technical grade of the active
ingredient (TGAI) is used in assessing hazard to non-target wildlife. The TGAI
is the purest and highest concentration form of the biochemical pesticide active
ingredient.
There are three tiers of biochemical pesticide data requirements with regards
to non-target organism testing. If adverse effects are not observed in Tier I testing
(short term studies on non-target birds, aquatic organisms, plants, and insects),
no further testing will be required. Should adverse effects be observed in Tier
13
I studies, Tier II environmental fate studies will be triggered. If Tier II studies

indicate that the biochemical active ingredient will persist in the environment,
potentially resulting in longer exposure periods, longer term Tier III non-target
wildlife studies will be required. Rarely are biochemical pesticides subjected to
testing above Tier I.
Once the potential hazards to non-target wildlife have been determined via
the tiered testing scheme, risk to non-target wildlife can be assessed based on
expected exposure to a biochemical active ingredient via its application in an
end-use product (EP) according to its proposed product label use directions.
Product Performance
Product performance data must be developed for all biochemical pesticides.

However, such data is typically not required to be submitted unless it relates to a

public health pest or is requested by the agency.
Microbial Data Requirements

Product Analysis and Mammalian Toxicology
Crucial to any evaluation of the hazards presented by a microbial pest control

agent is correct identification. This identification allows the Agency to ascertain
possible hazards associated with the proposed microbial agent and any closely
related organisms, and to utilize published literature to facilitate the review. The
Agency expects a registrant to provide the most accurate, current taxonomic
information to verify the identity of their active microbial agent. For bacteria this
information can include genetic DNA homology, morphology, biochemical tests
and antibiotic sensitivity. Information for other types of microbes such as fungi,
viruses and protozoa is usually less extensive, and may therefore involve other
identification methodologies such as serotyping, DNA homology, restriction
mapping or isozyme analysis when available. Any adverse effects known to be
associated with the microbe, or closely related species, (such as toxin production
and pathogenicity in species other than the target pest) should also be reported.
Additionally, the method used to manufacture microbial products is examined
to determine whether adequate quality controls are in place to insure a pure
product. This quality control review includes an examination for methods to
verify purity and stability of the seed or stock cultures and to ensure that the final
product is not contaminated with mammalian pathogens. Consideration is also
given to final quality control measures for the microbial product that determine
potency to insure that these tests relate to bioactivity and label claims (13).
The purpose of reviewing mammalian toxicology data for microbial pesticides
is to ensure that the use of these products causes no unreasonable adverse effects
to human health or non-target mammals. In order to do this the Agency must
verify that the microbial product is correctly identified, presents little possibility
of pathogenicity or toxicity to humans or other mammals, and is manufactured in
a manner to prevent contamination with human pathogens.
14
To assure the safety of microbial pest control agents toward mammalian

species, the Agency has adopted a tiered testing scheme similar to the tiered
scheme used for biochemical pesticides. Tier I is designed to expose the test
animal, mice or rats, to a single acute, maximum hazard or limit dose of the live
microbial pesticide. Tests involving mammalian tissue cultures are required for
viral pest control agents to insure there is no possibility of mammalian infection
given optimal conditions for expression of viral pathogenesis.
The major endpoints for the toxicity/pathogenicity tests are to observe any
adverse effects on the test animals and to establish that the microbial test substance
is being cleared from the exposed animals. The animals are observed for any
unusual clinical signs during the test, and for gross abnormalities at necropsy.
Specific organs are isolated from sacrificed animals during the course of the test to
determine the level of microbial test substance present. This is done to assure that
a high dose was administered and track the normal mammalian response which
recognizes the test substance as foreign and clears it from the system. Unusual
persistence of the test microbe in an organ is also considered an adverse effect.
Replication of the test microbe in organs is also an adverse reaction, indicating
potential for infectivity.
If any adverse effects are noted in the Tier I of the toxicity/pathogenicity tests,
further testing is indicated using a tier progression to verify the observed effects
and clarify the source of the effects. These Tier II tests could involve a subchronic
toxicity/pathogenicity test or, if the adverse effect was believed to be due to a toxic
reaction rather than pathogenicity, an acute toxicity test to establish an LD50 value
for the toxin. Residue data are required if significant human health concerns arise
from the toxicology testing. The majority of biopesticide products screened to date
have not indicated any adverse effects to warrant testing further than Tier I.
In addition to testing the safety of the purified microbial agent, the safety of the
marketed pesticide product, including inert ingredients, is ascertained. Acute oral,
dermal, and inhalation toxicity as well as eye irritation, and dermal irritation testing
may be required. However, rationales for no further testing may be appropriate
depending on the nature of the inert ingredients and results of the initial toxicity/
pathogenicity tests with the microbial agent. Any incidents of hypersensitivity
in production workers, applicators or the general public must be reported to the
Agency.
Genetically Modified Microbial Pesticides
Genetically modified microbial pesticides may be subject to different

data or information requirements on a case-by-case basis, depending on the
particular microorganism, the parent microorganism, the proposed use pattern,
and the manner and extent to which the organism has been genetically modified.
Additional data requirements may include:
• Information on the genetic engineering techniques used;

• The identity of the inserted or deleted gene segment (base sequence data
or enzyme restriction map of the gene);
15
• Information on the region controlling expression of the gene in question;

• A description of the new traits or characteristics that are intended to be
expressed;
• Tests to evaluate genetic stability and exchange of the new traits; and/or
• Selected Tier II environmental expression and toxicology tests.
It is important for applicants to work closely with the Agency regarding data
requirements to ensure that the proper tests are done and any unique characteristics
of the microbial pesticide are taken into account in specific testing procedures.
Non-Target Organism Testing

The unique nature of microbial pesticides has led to changes in the data
requirements for these products as compared to synthetic chemical pesticides.

This is particularly evident in assessing risk to non-target wildlife (14). The testing
requirements have been set up to test not only toxicity but also pathogenicity.
This was accomplished by increasing the length of the tests (up to 30 days), and
looking for signs of infection during and after the testing period. Beneficial insect
testing was added in order to ensure that potential risks from insect pathogens
used as pesticides had been adequately assessed.
For microbial pesticides used to control post-harvest diseases, the non-target
organism data requirements to assess potential risks would also follow this case by
case procedure. For example, in many instances the use of these products would
be in enclosed areas (i.e., packing houses, storage buildings, etc.) and would be
considered an indoor use. If this were the case, then testing of non-target organisms
would probably not be required because of a lack of exposure. However, if the
proposed use was determined to be outdoor and to have potential exposure to
non-target organisms, then the ecological testing requirements would need to be
addressed.
Tier I short term testing utilizes maximum hazard or limit dosing of non-target
organisms. If no adverse results are observed in Tier I, then further testing is not
warranted and environmental fate data are not required. In the first tier of non-
target organism testing, avian oral, freshwater fish, freshwater aquatic invertebrate,
and honeybee testing are required. In addition, tests to evaluate microbial pesticide
effects on wild mammals, plants, and beneficial insects are required depending
on the proposed use site, target organism, and degree of anticipated exposure. If
adverse effects are observed in the first tier, then potential exposure to non-target
organisms is evaluated in Tier II studies.
Product Performance
Product performance data must be developed for all microbial pesticides.

However, such data is typically not required to be submitted unless it relates to a
public health pest or is requested by the agency (15).
16
Plant-Incorporated Protectant Data Requirements
In general, the data requirements for PIPs are based on those for microbial
pesticides (16). The reason for this situation is that PIP traits registered to date have
been developed from genes found in microorganisms. The exact data requirements
for each product have been developed on a case by case basis. The majority
of products EPA has seen have been proteins, either related to plant viruses or
based on proteins from the common soil bacteria Bacillus thuringiensis (Bt). The
general data requirements include product characterization, mammalian toxicity,
allergenicity potential, effects on non-target organisms, and environmental fate.
For the Bt products, insect resistance management is included to prevent the loss
of benefits of both the microbial sprays and the Bt PIPs from overuse and selection
for resistant pest populations.
Conclusion
EPA is committed to encouraging the development and use of low risk

biological pesticides as alternatives to conventional chemical pesticides. This
commitment is shown by having a division dedicated to the registration of
biopesticides, as well as distinct review timelines, fees, and required data. The
efficient, effective approval of safer pesticides as well as a transparent, predictable
process in decision making are top priorities for EPA, OPP, and BPPD.
Every day, the management and staff of BPPD focus on protecting human
health and the environment by reducing the risks of pesticides through regulating
biopesticides and encouraging pollution prevention practices. These safer options
maximize the benefits of pesticides while helping to protect the air we breathe and
the water we drink for generations to come. EPA looks forward to a continued role
in helping to bring a broad array of safer pesticide options to market.
References
1. U.S. Environmental Protection Agency, Office of Pesticide Programs.
Biopesticides Fact Sheet, EPA 731-F-08-009, October 2008.
2. Mendelsohn, M.; Kough, J.; Rose, R. Biological Pesticides: How Reduced
Risk Applies. In Eighth IUPAC International Congress of Pesticide
Chemistry Book of Abstracts Volume 2; July 4−9, 1994.
3. U.S. Environmental Protection Agency, Office of Pesticide Programs, Web
Page FIFRA; http://www.epa.gov/pesticides/bluebook/FIFRA.pdf (accessed
June 26, 2014).
Page FFDCA; http://www.epa.gov/pesticides/regulating/laws htm#ffdca
(accessed June 26, 2014).
Page FQPA; http://www.epa.gov/pesticides/regulating/laws/fqpa/index.htm
17

Page PRIA; http://www.epa.gov/pesticides/fees/tool/category-table.html
Page Section 18s; http://www.epa.gov/opprd001/section18/ (accessed June
26, 2014).
Page The Pesticide Registration Manual; http://www.epa.gov/opprd001/
registrationmanual/ (accessed June 26, 2014).
9. U.S. Environmental Protection Agency, Office of Pesticide Programs.
Pesticide Registration Manual Chapter 3: Additional Considerations
for Biopesticide Products; http://www2.epa.gov/pesticide-registration/
pesticide-registration-manual-chapter-3-additional-considerations (accessed
June 26, 2014).


Page Joint Reviews; http://www.epa.gov/oppfead1/international/naftatwg/
biopest-jointre.html (accessed June 26, 2014).
11. Mendelsohn, M.; Ellwanger, T.; Rose, R.; Kough, J.; Hutton, P. Registration
of Biologicals I How Product Formulations Affect Data Requirements.
In Biorational Pest Control Agents/Formulation and Delivery; Hall, F.,
Barry, J., Eds.; ACS Symposium Series 595; American Chemical Society:
Washington, DC, 1995.
12. Mendelsohn, M.; Nelson, W.; Jamerson, H.; Beegle, C.; Sjoblad, R.
Regulatory Requirements for Biopesticide Registrations. In Proceedings
IR-4 Minor Use Registration and IPM: Registration of Biologically Based
Pesticides for Minor Crops; April 21, 1994.
13. Mendelsohn, M.; Hutton, P. Obtaining EPA Approval to Test or
Commercialize Microbial and/or Biochemical Pesticides. In Proceedings
U.S. Department of Agriculture Interagency Gypsy Moth Research Forum I
995 (United States Department of Agriculture Forest Service Northeastern
Forest Experiment Station General Technical Report NE-213).
14. Mendelsohn, M.; Delfosse, E.; Grable, C.; Kough, J.; Bays, D.; Hutton, P.
Commercialization, Facilitation and Implementation of Biological Control
Agents: A Government Perspective. In Biological Control of Postharvest
Diseases - Theory and Practice; Wilson, C.; Wisniewski, M., Ed.; CRC
Press: Boco Raton, FL, 1994.
Page Public Health Pests; http://www.epa.gov/PR_Notices/pr2002-1.pdf
16. Mendelsohn, M.; Kough, J.; Vaituzis, Z.; Matthews, K. Are Bt crops safe?
The U.S. EPA’s analysis of Bt crops finds they pose no significant risk to the
environment or to human health. Nat. Biotechnol. 2003, 21 (9), I 003–1009.
18
Exhibit 9: Relevance of research for the U.S. National Interest

Exhibit 9E: The Role of Biopesticides in Sustainability Feeding the 9 Billion Global
Populations
Executive Office of the President
Putting the Bioeconomy Blueprint to Work
April 26, 2012
Today, a number of departments and agencies announced initiatives aimed at helping to attain
the strategic objectives outlined in the National Bioeconomy Blueprint. Among them:
Expanding the biobased products purchasing program: Today the US Department of

Agriculture (USDA) announced that it will issue a rule that will expand upon a Presidential
Memorandum signed in February that called upon Federal agencies to more effectively execute
Federal procurement requirements for biobased products through the BioPreferred program. That
program was established by Congress to increase Federal procurement of biobased products to
promote rural economic development, create new jobs, and provide new markets for farm
commodities. The new rule will add a procedure for designating intermediate materials and
feedstocks—the chemical building blocks of biobased products—as acceptable for the
BioPreferred program. The change will make it easier for companies to choose raw materials that
will help ensure that their final products will qualify for the BioPreferred program. In addition,
the rule will provide a streamlined procedure for designating as biobased those products
composed in significant part from such intermediate materials and feedstocks, and it will create a
procedure for designating as biobased certain complex assembly products that cannot be tested
for biobased content in the laboratory due to their heterogeneous nature. The rule will also
broaden USDA’s efforts to provide information on the environmental and public health benefits
of biobased materials during the designation process. Together, these actions will provide
significant support for the goal of reducing our reliance on petroleum-based products, and will
drive the creation of new innovative new products, markets, and jobs in rural communities.
Building support for biofuel production facilities to create jobs and expand the use of
alternative energy: Earlier this month, foreshadowing key priorities in the Bioeconomy
Blueprint, Agriculture Secretary Tom Vilsack announced USDA approval of a $5 million
payment to Western Plains Energy, LLC, to support the construction of a biogas anaerobic
digester in Oakley, KS. The completed project will utilize waste energy resources from a local
cattle feedlot to replace the vast majority of the fossil fuels currently used by Western Plains
Energy. The funding of this project is expected to create 15 full-time positions and almost 100
additional construction opportunities. The digester, which will be fully operational by next year,
is expected to produce enough biogas to replace 89 percent of the fossil fuel that Western Plains
currently uses to provide process heat at its Oakley ethanol plant, which produces 50 million
gallons of ethanol annually. Animal waste from a local feedlot will be the primary feedstock that
Western Plains will use for the digester. It also will use grain dust as well as waste from a variety
of industrial food and municipal facilities. Western Plains expects to be able to produce more
than 100 million BTUs of renewable energy per hour daily.
Transforming the FDA archives into a driver of discovery and development: The Food and
Drug Administration (FDA) currently houses one of the largest known repositories of clinical
data, including safety, efficacy, and performance information, and an increasing amount of post-
market safety surveillance data. Integrating and analyzing these data, with appropriate patient
privacy protections, could revolutionize the development of new patient treatments and allow
researchers to address fundamental scientific questions about how different patients respond to a
therapy, but many of these data are today not organized in ways to allow them to be plumbed for
the full value they contain. In order to harness the power of these data, FDA is rebuilding its
information technology and data analytic capabilities and establishing “science enclaves”—
virtually networked IT environments where multi-disciplinary teams can work together to
analyze large sets of data extracted from the vast FDA data resource while complying with
applicable law concerning proprietary information and patient privacy. This approach promises
to not only speed the development of new therapies for patients but also result in significant
reductions in costs to drug and medical device developers.
Science enclaves are a response to the fact that in the emerging bioeconomy, data sharing, and
management will catalyze research and product development in unprecedented and unanticipated
ways. The ability to integrate big data sets and collaborate both internally and with external
partners—under non-disclosure agreements, for example—will generate new insights into
product development and use. The enclaves can also be used to design new software that should
enhance the quality, efficiency, and accuracy of FDA regulatory reviews.
Training the power of induced pluripotent cell technology on blood-related and

neurological diseases: The recent discovery that adult skin or blood cells can be reprogrammed
to produce induced pluripotent stem (iPS) cells—which have the ability to become nearly any
type of cell in the body—promises to revolutionize understanding of disease, spur progress in
drug discovery, and pave the way for new cell-based therapies. The National Institutes of Health
(NIH) recently launched its new Intramural Center for Regenerative Medicine (NIH CRM) to
support advancement of iPS cell technologies. Building on that foundation, NIH CRM and its
partners are exploring the development of iPS cell therapies to treat blood-related diseases, such
as leukemia and metabolic diseases, including the devastating lysosomal storage diseases that
affect children. In addition, researchers will investigate whether iPS cells can be used to develop
blood products that could help meet the demand for blood transfusions during medical
emergencies and surgeries. NIH also recently embarked on a major effort to use iPS technology
to advance research into neurodegenerative diseases. That effort already has developed and made
widely available neural cell lines for Parkinson’s disease, amyotrophic lateral sclerosis, and
Huntington’s disease. NIH CRM plans to expand its iPS cell efforts in the near future, with an
2
eye towards accelerating discovery of new candidate drugs to treat or prevent Parkinson’s
disease.
Growing the economy and rural jobs by supporting biomass production: Today, as a down
payment on fulfillment of the objectives outlined in the National Bioeconomy Blueprint, the
USDA is releasing a whitepaper describing progress to date and emerging opportunities for the
United States to transition from fossil- and petroleum-based sources of carbon to renewable
biomass from sustainable agricultural practices. The White Paper notes that rural America will
play a significant role in this transition since the raw materials needed to grow the biobased
products industry are largely produced on farms and forests. It also notes the importance of (1)
using USDA’s data and economic analysis capacities to guide decisions about workforce
development; (2) developing strategic partnerships with the private sector to enhance technology
and knowledge transfer; and (3) supporting financial and technical assistance programs to
identify the bioproducts that hold the most promise for expanded markets, rural economic
development, and solutions to societal grand challenges.
Forging new relationships to provide FDA device review staff with real-world knowledge:
This week, FDA launched its new Experiential Learning Program (ELP), a new educational
program within the agency’s Center for Devices and Radiological Health (CDRH), designed to
enhance medical device review staff’s real-world knowledge of existing and emerging
technologies. Because medical device technology continuously evolves, it is essential that
CDRH review staff stay abreast of new technology developments and improvements in how
devices are developed, clinically tested, manufactured, and utilized. The ELP will include visits
to academic institutions, device manufacturers, research organizations, and healthcare facilities.
The program will address knowledge gaps and help FDA better understand innovative devices,
with the goal of improving the quality and timeliness of product reviews. The ELP is just one of
the several innovative initiatives that FDA has recently implemented for medical devices this
year, including the Innovation Pathway 2.0—an evolving effort to test ways to shorten the
overall time for the development, assessment and review of medical devices by enhancing
premarket interactions between FDA and innovators—and the Entrepreneurs-in-Residence
program, which allowed CDRH to bring in vision leaders in business process innovation,
decision science, medical device innovation, venture partners, and information technology to
work alongside agency staff and leadership.
Expanding Medicare’s evidence development program to drive innovation: Medicare

payment for medical treatments is a powerful driver of industry investment. Under the Coverage
with Evidence Development (CED) program, Medicare pays for promising new technologies that
do not currently meet the evidence threshold for broader coverage. The CED program furnishes
payment while simultaneously requiring the collection of more evidence to determine the full
potential impact of a new health care technology. Although the CED authority has existed for
more than a decade, it has been applied sparingly. The Centers for Medicare & Medicaid
3
Services (CMS) is now poised to implement a new phase of CED by better defining the
parameters and guidance for CED so it can be used more widely and effectively as a driver of
innovation. Specifically, CMS will convene its Medicare Evidence Development and Coverage
Advisory Committee next month to consider input on how to update CED based on lessons
learned to date, with the goal of increasing this program’s use to create predictable incentives for
innovation while providing greater assurance that new technologies fulfill their initial claims of
benefit.
Creating a step-by-step guide to turning discoveries into treatments: The NIH’s newest
center, the National Center for Advancing Translational Sciences (NCATS), recently teamed up
with Eli Lilly to create a step-by-step playbook to help researchers from all sectors translate their
basic findings into potential treatments for patients. The Assay Guidance Manual, which will be
available as a free e-book in early May
(http://preview.ncbi.nlm.nih.gov/bookshelf/booktest/br.fcgi?book=assayguide), reflects the
wisdom of more than 100 authors from around the world who contributed content to this free
tool. The book will guide researchers through the complex process of turning basic research
findings into tests that can be applied to thousands of compounds to screen for and identify
potential new drug candidates. This collaborative project embodies the NCATS mission to
improve the process by which therapeutics are developed and make translational sciences more
efficient, and less expensive.
Collaborating to reduce the need for nitrogen fertilizer inputs: The National Science
Foundation (NSF) has developed an “Ideas Lab” collaboration with the United Kingdom’s
Biotechnology and Biological Sciences Research Council (BBSRC) to identify novel approaches
to design and engineer agricultural systems that will maintain or increase crop yields with
minimal input of nitrogen fertilizers. Ideas Labs are innovative approaches to devising potential
solutions to complex problems that have not been solved despite long periods of research. The
approach features an intensive interactive workshop involving up to 30 participants brought
together from around the world, with the aim of developing new and bold approaches to address
grand challenges—all with a promise made in advance to provide funding for research projects
that emerge from the process. In this case, NSF and the UK’s BBSRC have each committed to
contribute $8 million over three years.
The new Ideas Lab takes aim at the fact that nitrogen is critical to plant growth, but only a
limited number of plants have the capacity to obtain nitrogen from non-biological sources—a
process generally accomplished with the help of nitrogen-fixing bacteria. Farmers have
compensated for this deficit through increased application of nitrogen-based fertilizers, a costly
and often environmentally damaging approach since much of the applied nitrogen is lost as run-
off into water courses or as greenhouse gases. Because global food production needs to increase
significantly to feed a growing human population, the Ideas Lab collaboration will explore new
opportunities to decrease the inputs of nitrogen fertilizer while increasing the efficiency of its
4
use, and investigate exciting approaches to develop plants that can fix their own nitrogen in the
absence of helper bacteria. In addition to using synthetic biology to design plants with these
desired characteristics, NSF envisions that inspirations from marine and soil nitrogen fixation
mechanisms could also provide new ways to engineer plants.
Improving homeland security through biological research: Because a genome provides the
most definitive signature for an organism, it can be used to distinguish an organism from all
others. As a consequence of this, genome sequencing is a foundational technology for microbial
forensics. The Department of Homeland Security’s Science and Technology Directorate (DHS
S&T) is developing a genomics-based approach to microbial forensic analysis to allow
identification and characterization of any microbial organism, including “unknown” organisms
such as emerging, chimeric, or synthetic organisms. This new effort involves development and
refinement of several intersecting technologies, including bioinformatic analysis, metagenomic
analysis, and comparative genomics. The largest impediment to the success of this approach
remains the lack of an adequate comparative genomics database. To address this issue, DHS
S&T is working with the National Center for Biotechnology Information and others to establish a
comprehensive catalog of genomes that covers a diverse array of pathogens. To integrate
genomic information with additional information for successful identification of pathogens, DHS
plans to leverage other promising “omics” technologies (proteomics, metabolomics,
transcriptomics) to generate profiling methods for microbial organisms. The integration of
information gleaned from the multiple “omics” methodologies constitutes a systems-based
approach to microbial characterization that will be a first-of-its-kind capability and promises to
have important applications to the fields of public health, food safety, medical diagnostics, and
homeland security.
###
5
BIOMASS PROGRAM
Growing America’s Energy Future

The emerging U.S. bioenergy industry provides a secure
and growing supply of transportation fuels, biopower, and
bioproducts from a range of biomass resources. Abundant,
renewable bioenergy can help secure America’s energy
future, reducing our dependence on foreign oil and ensuring
American prosperity while protecting the environment.
DOE’s Biomass Program is accelerating development of a
Program Goal sustainable U.S. bioindustry to improve our nation’s energy
security, stimulate the economy, and reduce climate impacts.
Develop technologies to enable cost-competitive production of
biofuels, bioproducts, and biopower that will reduce Photo artwork by BCS Incorporated
dependence on imported oil and lower carbon emissions.
on greenhouse gas emissions, air quality, soil quality, water,

The Renewable Fuel Standard (RFS) mandates biofuel use to
biodiversity, and land use.
improve our nation’s energy security. The standard requires
36 billion gallons of renewable fuels production by 2022, of
which 21 billion gallons will be advanced biofuels. Meeting
Integrated Biorefineries
the RFS will require technological innovation, private Biofuels are produced in integrated biorefineries that
investment, and clear government support in the U.S. biofuels efficiently convert a broad range of biomass feedstocks into
industry over the next decade. affordable biofuels, bioproducts, and heat and power. The
Biomass Program focuses its efforts on key supply chain
Success will depend on the development of efficient new challenges. These include developing replicable feedstock
systems and networks to sustainably produce, harvest, and supply systems and innovative conversion technologies, both
transport large quantities of diverse feedstocks; advanced of which result in lower production costs. The program is
technologies to cost-effectively convert biomass to fuels; also overcoming key supply chain challenges by developing
and an expanded and improved distribution and end-use replicable feedstock supply systems and innovative
infrastructure to deliver these fuels to consumers across the conversion technologies with lower production costs.
United States.
The success of the U.S. bioenergy industry depends in
Strategic Approach part on the quantity and quality of biomass available,
as well as the industry’s ability to collect, store, and
The U.S. Department of Energy’s (DOE) Biomass Program
cost-effectively transport it. In cooperation with several
primarily works with industry, academic, and laboratory
partners, the program is identifying sustainable biomass
partners to develop advanced technologies and real-world
feedstock resources, developing economically viable and
solutions to reduce costs and spur market growth. Through
environmentally sound production methods, and designing
a multitude of research, development, and demonstration
feedstock logistics systems to ensure resource readiness.
(RD&D) projects, DOE is facilitating technology
While the program focuses on several types of herbaceous
advancements that accelerate the sustainable production
and woody feedstocks and residues, it also supports algal
of clean, affordable energy. Unlocking the potential of
feedstock R&D. Advances in algal research may lead to the
diverse, non-food biomass resources—such as switchgrass,
sustainable production of algae-derived biofuels, opening
agricultural and forest residues, municipal waste, and algae—
creating new abundant, cost-effective, and sustainable
will yield advanced biofuels including cellulosic ethanol and
domestic biomass supply.
renewable gasoline, aviation, and diesel fuels. These resources
will also produce biopower and bioproducts.
Integrated Biorefinery Demonstrations
Sustainability The Biomass Program provides cost-shared support for construction
DOE’s sustainability efforts address environmental, social, and start-up of pilot, demonstration, and commercial-scale
biorefineries that convert various feedstocks to advanced biofuels
and economic issues along the entire bioenergy supply
using multiple conversion pathways. These projects will validate new
chain. The Biomass Program is committed to maximizing technology integration to produce advanced biofuels, bioproducts,
environmental benefits while mitigating concerns. Through and heat and power, which will reduce technical and financial risks
field research, modeling, and advanced analysis, the program and encourage the private investment required for commercial
investigates the life-cycle impacts of bioenergy production replication.
S E ITIC N A E L C
BIOMASS PROGRAM
Biofuels will make efficient use of a broad range of biomass

feedstocks across the nation. Photo from INL
Conversion Processes
The Biomass Program is exploring new ways to convert
feedstocks into cost-competitive liquid renewable The program is currently supporting development of cellulosic
transportation fuels. The program conducts collaborative ethanol as well as renewable gasoline, diesel, and jet fuels.
R&D to primarily explore biochemical and thermochemical Photo from BCS Incorporated
conversion as well as processes that combine the two
methods.
Distribution and End Use
Biochemical Conversion entails breaking down biomass to
make carbohydrates available for conversion into sugars, The Biomass Program works with industry, academia, and
which can then be converted into biofuels and bioproducts other government agencies to help create market conditions
using microorganisms and other catalysts. Researchers amenable for biofuels to safely, cost-effectively, and
are working to drive down the cost of pretreatment and sustainably reach consumers while displacing petroleum.
enzymatic hydrolysis processes. They are also exploring Integrating increasing volumes of biofuels into the nation’s
robust new fermentation microorganisms. Future research fuel supply will require improved downstream infrastructure
will explore biological and chemical catalysis integration to capacity to transport, store, and distribute these fuels
produce a wider range of advanced fuels and products. to consumers. Work in this area includes economic
and geospatial evaluation of U.S. biofuels distribution
Thermochemical Conversion processes use heat and infrastructure needs. Recently funded projects include
chemistry to convert biomass into a liquid or gaseous research and testing on intermediate ethanol blends,
intermediate. The intermediates, such as synthetic gas and deployment of strategically located E85 retail pumps, and
bio-oil, subsequently go through customized processing development of geospatial tools designed to analyze biomass
to produce biopower resource locations and routing options while reducing
or biofuels, such as biofuels delivery costs.
gasoline, diesel, and
jet fuel. Researchers Bioenergy Industry Creates Green Jobs
are focusing on cost- A robust bioenergy industry will be the source of a variety
effective options of jobs across several sectors, from farming and trucking
for gas and bio-oil to biochemical engineering and microbiology. The sector is
cleanup, development projected to stimulate significant job growth.
of high-yield catalysts
Algae R&D focuses on genetics, for fuel synthesis, and
strain development, cultivation other thermochemical Learn More
strategies, and harvesting and routes to biofuels
dewatering, as well as sustainability that compatible with
and siting considerations. existing petroleum
Photo from iStock/5312772 infrastructure. biomass.energy.gov
eere.energy.gov
biomass.energy.gov
DOE/GO-102011-3279 • September 2011
Printed with a renewable-source ink on paper containing at least 50% wastepaper, including 10% post consumer waste.
Exhibit 9E: The Role of Biopesticides in Sustainability Feeding the 9 Billion Global
Populations
lizers &
erti
of
Bi
Kumar, J Biofertil Biopestici 2013, 4:2
urnal of Bi
op
Journal of Biofertilizers & Biopesticides
esticides
DOI: 10.4172/2155-6202.1000e114
Jo
ISSN: 2155-6202
Editorial Open Access
The Role of Biopesticides in Sustainably Feeding the Nine Billion Global

Populations
Suresh Kumar*
Division of Biochemistry, Indian Agricultural Research Institute, New Delhi, India
The world population is expected to reach 9 billion by 2050. This Biopesticides, being natural products derived from materials such
global population growth of 2 to 3 billion people over the next 40 as plants, bacteria, viruses, minerals etc., are considered to be safer for
years, combined with the changing diets, would result in a predicted the environment. They are usually less toxic than synthetic chemical
increase in food demand of 70% by 2050 [1,2]. To feed the burgeoning pesticides, affect only the target pest and closely related organisms,
population, we need to produce more food and livelihood opportunities often effective in small quantities and decompose naturally and quickly.
from less per capita arable land and water. Providing ample food for the More importantly, they can help minimizing the use of chemical
ever-growing global population is only the first part of the challenge; pesticides and the associated environmental pollutions. When used in
the second and more important part is to produce this in a safe and combination with conventional crop protection measures, biopesticides
sustainable manner [3]. There are certain other challenges in sustainably have been shown to improve pest control efficacy, enhance crop yield
feeding the 9 billion global populations by the year 2050. Sustainability and become cost effective. When used as one of the components of
comprises of people, prosperity and the planet. For prosperity of an integrated pest management (IPM) program, biopesticides are
the people, sustainable farming in an eco-friendly manner is must. targeted to particular pests and have high impact on pests and lowest
While agriculture consumes about two-third of the fresh water, 11% impact on the environment. Typically, they do not persist longer in the
of the world’s land and 10% of the global petroleum, there would be environment after application, come from renewable sources and are
several challenges in bringing sustainability to agriculture. The major safe for other organisms, farm workers and consumers of the produces.
challenges of sustainable farming are productivity, food quality and Al-shannaf et al. [4] evaluated efficiency of bioinsecticides and insect
diminishing return of agricultural inputs. growth regulating chemicals against larvae of American bollworm
(Helicoverpa armigera) and their side effects on common predators
The conventional approaches may not prove adequate to meet
in Egyptian cotton field. Their results indicated that chemical insect
the projected food requirements, both in terms of quantity and
growth regulators, though more effective against H. armigera, adversely
quality of the food. Moreover, most of the cultivated crops/varieties
affect non-target insects in the field.
have reached the yield plateau. Hence, crop protection to harvest
maximum produce of the crops is one of the ways to meet the food As of early 2013 there were approximately 400 registered biopesticide
demand of the growing population and to attain global food security active ingredients, and more than 1250 registered biopesticide products
on sustainable basis. Farmers, who were basically organic farmers, [5]. Increasing demands for residue-free crop produce, growing
have adapted to green revolution technology characterized by the use organic food market and easier registration than chemical pesticides
of high yielding varieties (HYVs), chemical fertilizers and pesticides. are some of the key drivers of the biopesticide market [3]. The available
Although intensive agriculture has so far been able to provide sufficient biopesticides may be divided into three major categories: microbial,
food grains for the growing global population, it treads heavily in the biochemical (or botanical) and plant-incorporated protectants.
environment. Continuous use of HYVs without proper crop rotation Microbial pesticides consist of microorganism (bacteria, fungi, viruses,
has resulted in enhanced pest incidences. Insect-pest management in or protozoans) or their derivative as active-ingredient, and they have
HYVs by extensive use of all sort of chemical pesticides has certainly been successfully being used in controlling insect pests. One of the
provided protection to crops over the past decades; it has also raised most widely used microbial biopesticides is Bacillus thuringiensis,
concerns about pesticide residues in food and environmental pollutions. popularly known as Bt. The bacterium produces crystalline proteins
Therefore, the need of the day is to produce more and more food from and specifically kills one or a few related insect species. Biochemical or
decreasing availability of natural resources. botanical pesticides are naturally occurring substances that control pest
population by non-toxic mechanisms. Such examples are Azadirachtin
An integrated crop management approach needs to be deployed from Neem tree, insect sex-pheromones (that interfere with their
to counteract degradation of the agro-ecosystem due to the on-going mating and population build-up), various scented extracts (that attract
intensive agriculture. This would include the use of biofertilizers and insect pests to traps) and some vegetable oils [6,7]. Sometimes it
biopesticides, integrated pest management, soil and water conservation becomes difficult to determine whether a substance meets the criteria
practices, biodiversity conservation etc. The increasing public concerns for classification as a biochemical pesticide, hence US Environmental
and growing awareness about the potential adverse environmental
effects as well as health hazards associated with the use of synthetic
plant protection and other agrochemicals has prompted search for *Corresponding author: Suresh Kumar, Division of Biochemistry, Indian Agricultural
the technologies and products which are safer for the end users and Research Institute, New Delhi, India, E-mail: sureshkumar3_in@yahoo.co.uk
the environment. Due to the concerns of resistance development in Received August 12, 2013; Accepted August 13, 2013; Published August 16,
pests and withdrawal of some of the products for either regulatory or 2013
commercial reasons, a lesser number of chemical pesticides are now Citation: Kumar S (2013) The Role of Biopesticides in Sustainably Feeding the
available in the market. Natural pesticides are environment friendly Nine Billion Global Populations. J Biofertil Biopestici 4: e114. doi:10.4172/2155-
6202.1000e114
and safer than classical chemical pesticides. Hence in the recent
years considerable attention has been paid towards exploitation of Copyright: © 2013 Kumar S. This is an open-access article distributed under the
terms of the Creative Commons Attribution License, which permits unrestricted
biopesticides in protection of food crops/commodities from pest use, distribution, and reproduction in any medium, provided the original author and
infestations and the associated losses. source are credited.
J Biofertil Biopestici
ISSN:2155-6202 JBFBP, an open access journal Volume 4 • Issue 2 • 1000e114
Citation: Kumar S (2013) The Role of Biopesticides in Sustainably Feeding the Nine Billion Global Populations. J Biofertil Biopestici 4: e114.
doi:10.4172/2155-6202.1000e114
Page 2 of 3
Protection Agency has established a special committee to make such protein may be produced as a recombinant protein in microbial system,
decisions. Plant-incorporated protectants include substances that are which can be scaled up for industrial production and commercial
produced naturally on genetic modification of plants. Such examples formulations. Several other innovative approaches are being applied to
are incorporation of Bt gene, protease inhibitor, lectines, chitinase etc. develop biopesticides as effective, efficient and acceptable pest control
into the plant genome so that the transgenic plant synthesizes such measure among the farmers and common man.
biopesticide on its own. If transgenic technology is integrated into the
traditional system of crop husbandry, probably it holds great promise To be readily acceptable by the end users, biopesticides must be
in augmenting agricultural production, while conserving biodiversity, effective in controlling the pest(s) that they are targeting to control.
natural resources and the environment for future generations [8]. Many biopesticides target a single pest species, but it is always desirable
to have biopesticide that can control a range of pest species. It is also
Pests are one of the major problems in crop husbandry. A major believed that biological pesticides may be less vulnerable to genetic
portion of expenditure on pesticides is for protecting the crop in the variations in plant populations that cause problems related to pesticide
field. There has been an estimated 67,000 pest species that damage resistance. Biological pesticides are expected to provide predictable
agricultural crops [9], and pest management is one of the important performance, and they must do so in an economically viable manner
activities required to maximise crop production. In certain crops, for their better acceptability and adaptability. Deployed appropriately,
e.g. Cotton, Brinjal etc. pest management constitute a significant part biopesticides have potential to bring sustainability to global agriculture
of the cost of the crop production. This not only requires purchase for food security to the 9 billion people by the year 2050.
of chemicals, but considerable input is required on implements and
labour required for their repeated applications on the standing crop. The Journal of Biofertilizers and Biopesticides, an open access
The current pest management strategies adopted for the intensive international peer-reviewed journal, plays an important role towards
agriculture rely heavily on synthetic chemical pesticides which cause dissemination of the new information generated by the researchers all
adverse/harmful effects on beneficial organisms, leave toxic residues in over the world for the development and utilization of more effective
food and feed, and are considered to be harmful to the environment. biofertilizers and biopesticides, and creating awareness about these
among the researchers, farmers, environmentalists, policy makers and
Storage pests and post-harvest losses significantly affect the the general public.
availability of quality food. It has been estimated that approximately
one-third of the world’s food production (valued more than US$ 100 The views expressed here are those of the author only. It may not
billion annually) is destroyed under storage, which is highest (43% of necessarily be the views of the institution/organization, the author is
potential production) in the developing Asian and African countries associated with.
[10]. Loss of food grains during storage is a serious threat to food References
security, particularly in developing countries where poor sanitation and
1. Bruinsma J (2009) The resource outlook to 2050: By how much do land, water
inappropriate storage facilities encourage storage pests [11]. Tribolium
and crop yields need to increase by 2050? FAO Expert Meeting on ‘How to
castaneum is one of the important storage pests of cereals. Control of this Feed the World in 2050’, Rome.
insect relies mainly on the use of synthetic insecticides and fumigants
2. UNDESA (United Nations Department of Economic and Social Affairs) (2009)
which cause environmental pollution, pest resurgence, residual effects World population prospects: The 2008 revision, highlights, working Paper No.
on the health of the grain consumers and harmful effects on non-target ESA/P/WP.210. New York, UN.
organisms [12]. 3. Kumar S (2012) Biopesticides: A need for food and environmental safety. J
Biofertil Biopestici 3:e107.
Plant tissues from several species contain chemical compounds
that are considered as defensive substances against their enemies. These 4. Al-shannaf HM, Mead HM, Hassan Sabry AK (2012) Toxic and biochemical
include oils, alkaloids, organic acids and other compounds. Insecticidal effects of some bioinsecticides and IGRs on American Bollworm, Helicoverpa
armigera (hüb.) (noctuidae: lepidoptera) in Cotton Fields. J Biofertil Biopestici
and acaricidal properties of a number of plants have been well known, 3:118.
and some of these can compete with synthetic chemicals besides being
5. USEPA (United States Environmental Protection Agency) (2013) Regulating
environmentally safer [13]. Antifeedant, deterrent and repellents have biopesticides.
been tested for pest control in the recent years [14-16]. Abbasi et al. [17]
tested efficacy of Calotropis Procera and Datura alba extracts against the 6. Mazid S, Kalida JC, Rajkhowa RC (2011) A review on the use of biopesticides in
insect pest management. Int J Sci Advanced Technol 1: 169-178.
Tribolium castaneum in stored wheat grains and reported maximum
repellency, mortality at higher concentrations of C. sprocera and D. alba 7. Singh A, Khare A, Singh AP (2012) Use of vegetable oils as biopesticide in
grain protection -A review. J Biofertil Biopestici 3:114.
on 3 months storage of wheat with minimum infestation/spoilage loss
of the grain. Use of vegetable oils for protection of food grains in an 8. Kumar S, Chandra A, Pandey KC (2008) Bacillus thuringiensis (Bt) transgenic
environmentally safe manner has been recently reviewed by Singh et crop: an environment friendly insect-pest management strategy. J Environ Biol
29: 641-653.
al. [7].
9. Ross MA, Lembi CA (1985) Applied weed science. Burgess Publishing Co,
Recent Advances and Future Prospects Minneapolis.
In addition to the continuous search for new biomolecules and 10. Ahmed S, Grainge M (1986) Potential of the neem tree (Azadirachta indica) for
pest control and rural development. Eco Botany 40: 201-209.
improving efficiency of the known biopesticides, recombinant DNA
technology is being deployed for enhancing efficacy of biopesticides. 11. Talukhdar FA (2005) Insects and insecticide resistance problems in post-
harvest agriculture. Proceedings of international conference, post-harvest
Fusion protein is being designed to develop next-generation technology and quality management in arid tropics, Sultan Qaboos University.
biopesticides. The technology allows selected toxins (not toxic to higher
animals) to be combined with a carrier protein which makes them toxic 12. Okenkwo EV, Okoye WI (1996) The efficacy of four seed powders and
essential oils as protectants of cow pea and maize grains against infestation
to insect pests when consumed orally, while they were effective only by Collosobruchus maculantus and Sitophillus zeamais in Nigeria. Intl J Pest
when injected into a prey organism by a predator [18]. The fusion Manag 42: 143-146.
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doi:10.4172/2155-6202.1000e114
Page 3 of 3
13. Hedin PA, Hollingworth RM (1997) New Applications for Phytochemical R Br-in (Ait) on reproductive potential of Flat grain beetle Cryptolestespusillus.
Pest-Control Agents, In: Medin PA, Hollingworth RM, Maseler EP (Ed). Bangladesh J Sci lnd Res 42: 157-162.
Phytochemicals for pest control, American Chemical Society, Washington,
USA. 17. Abbasi AB, Khan AA, Bibi R, Iqbal MS, Sherani J, et al (2012) Assessment
of Calotropis Procera Aiton and Datura alba Nees leaves extracts as bio-
14. Govindachari TR, Suresh G, Gopalakrishnan G, Wesley SD (2000) IInsect Insecticides against Tribolium castaneum Herbst in stored wheat Triticum
antifeedant and growth regulating activities of neem seed oil – the role of major Aestivum L. J Biofertil Biopestici 3:126.
tetranortriterpenoids. J Appl Ent 124: 287-291.
18. Fitches E, Edwards MG, Mee C, Grishin E, Gatehouse AM, et al. (2004) Fusion
15. Ahmad S, Fiaz S, Riaz MA, Hussain A (2005) Comparative efficacy of crude
proteins containing insect-specific toxins as pest control agents: snowdrop
extracts of Calotropi sprocera, Datura alba and imidacloprid on termites in
lectin delivers fused insecticidal spider venom toxin to insect haemolymph
sugarcane at Faisalabad. Pak Entomol 27: 11-14.
following oral ingestion. J Insect Physiol 50: 61–71.
16. Rahman MM, Islam W (2007) Effect of acetonic extracts of Calatropi sprocera
Exhibit 10: Three Most Recent Paychecks from GreenLight Biosciences, Inc
EB-2 NIW - Dr. Oscar Apelido – Three Most Recent Paychecks from GreenLight Biosciences, Inc
Exhibit 11: Letter of Support for NIW from GreenLight Biosciences’

Title/Position of Human Resources
EB-2 NIW - Dr. Oscar Apelido – Letter of Support for NIW from GreenLight Biosciences’ Director of Human
Resources
Company’s LetterHead
Date

United States Citizenship and Immigration Services (USCIS)
RE: Oscar Apelido application for EB-2 with request for National Interest Waiver
Dear Immigration Officer:
My name is [NAME] and I am [Position] of Human Resources at GreenLight Biosciences, Inc. In

my position, I oversee all the activities related to Human Resources, including hiring processes. I
work with the hiring managers to attract the best candidates and successfully retain them so we
can advance our goals and move closer to commercialization of RNA-based products that will
revolutionize the U.S. agricultural and medical spaces.
GreenLight Biosciences leverages a unique Technology called Cell Free Reaction. There are only
a handful of experts in this bioprocessing field. In his work in the organization, and before that,
Dr. Apelido has positioned himself as a recognized expert in the field of bioprocessing, and
specifically in Cell Free Reaction.
I am writing this letter to support Dr. Apelido’ petition for a waiver of Labor Certification given
the National Interest of his research contributions. Please note that the need for Dr. Apelido’
continued participation is not the result of a labor shortage of U.S. researchers. Instead, this need
for retaining Dr. Oscar Apelido in GreenLight Biosciences, Inc in the long term, stems from his
unique combination of remarkable skills and the fact that his contributions are superior to those of
the majority of his peers. As [Position] of Human Resources at GreenLight Biosicences, I know
first-hand how losing Dr. Apelido would impair our operations and would affect the United States
negatively.
Therefore, I ask you to consider and approve Dr. Apelido’s petition for EB-2 with National
Interest Waiver. Sincerely,
Name
Position
Company
Company contact info

Exhibit 12: Median Salary of Peers

Exhibit 12.1: Screenshot from CareerOneStop portal
Exhibit 12.3: Screenshot from PayScale.com
EB-2 NIW - Dr. Oscar Apelido – Median Salary of Peers

Exhibit 12.1: Screenshot from CareerOneStop

Screenshot from CareerOneStop Portal


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Exhibit 13: 2018 W-2
EB-2 NIW - Dr. Oscar Apelido – 2018 W-2

Exhibit 14: GreenLight’s Initial Offer Letter and latest Promotion Letter
Exhibit 14.1: GreenLight’s Initial Offer Letter (2017)
Exhibit 14.2: GreenLight’s latest Promotion Letter (2019)
EB-2 NIW - Dr. Oscar Apelido – GreenLight’s Initial Offer Letter and latest Promotion Letter
Exhibit 14.1: GreenLight’s Initial Offer Letter
Initial Offer
Due to confidentiality, this document was completely redacted

Exhibit 14.2: GreenLight’s latest Promotion Letter
Exhibit 15: Citation Record by Google Scholar
EB-2 NIW - Dr. Oscar Apelido – Citation Record by Google Scholar

Exhibit 16: Copies of peer reviewed publications co-autored (7 articles)
EB-2 NIW - Dr. Oscar Apelido – Copies of peer reviewed publications co-autored
Journal Name
Scientific Article Title

Author 1, Author 2, Author 3
Authors’ affiliation
Abstract: An abstract is a brief summary of a research article, thesis, review, conference proceeding, or
any in-depth analysis of a particular subject and is often used to help the reader quickly ascertain the
paper's purpose. When used, an abstract always appears at the beginning of a manuscript or typescript,
acting as the point-of-entry for any given academic paper or patent application. Abstracting and
indexing services for various academic disciplines are aimed at compiling a body of literature for that
particular subject.
Introduction
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dolore magna aliqua. Eget felis eget nunc lobortis. Nunc vel risus commodo viverra maecenas. Diam
phasellus vestibulum lorem sed risus ultricies tristique nulla. Turpis egestas integer eget aliquet nibh
praesent tristique. Cras semper auctor neque vitae tempus quam pellentesque nec. Faucibus pulvinar
elementum integer enim neque volutpat ac tincidunt vitae. Aliquet sagittis id consectetur purus ut
faucibus pulvinar. Viverra mauris in aliquam sem fringilla ut. Commodo sed egestas egestas fringilla
phasellus faucibus scelerisque eleifend donec. Feugiat sed lectus vestibulum mattis ullamcorper velit.
Arcu cursus vitae congue mauris rhoncus aenean. Elementum curabitur vitae nunc sed velit dignissim
sodales ut. Enim sed faucibus turpis in eu mi bibendum neque. Neque laoreet suspendisse interdum
consectetur libero. Aliquet eget sit amet tellus cras adipiscing. Turpis egestas sed tempus urna et
pharetra pharetra massa.
At augue eget arcu dictum varius duis at. Elementum pulvinar etiam non quam lacus. Vulputate sapien
nec sagittis aliquam. In cursus turpis massa tincidunt dui ut ornare. Rhoncus aenean vel elit scelerisque
mauris. Maecenas pharetra convallis posuere morbi leo urna molestie at elementum. Morbi blandit
cursus risus at ultrices mi tempus imperdiet nulla. Orci sagittis eu volutpat odio facilisis mauris sit amet.
Sit amet nisl purus in mollis nunc sed id semper. Leo a diam sollicitudin tempor. Tellus id interdum velit
laoreet id donec ultrices. Nibh praesent tristique magna sit amet purus gravida quis blandit.
Pellentesque adipiscing commodo elit at imperdiet dui accumsan sit amet. Ut tortor pretium viverra
suspendisse potenti nullam ac tortor vitae. Blandit cursus risus at ultrices. Amet facilisis magna etiam
tempor orci. Lectus urna duis convallis convallis.
Donec pretium vulputate sapien nec sagittis aliquam malesuada. Ullamcorper velit sed ullamcorper
morbi. Eget est lorem ipsum dolor sit amet consectetur. Amet mattis vulputate enim nulla aliquet
porttitor. Imperdiet proin fermentum leo vel orci porta. Faucibus ornare suspendisse sed nisi lacus sed
Exhibit 17: Evidence of Serving as Reviewer in Journals
EB-2 NIW - Dr. Oscar Apelido – Evidence of Serving as Reviewer in Journals

Exhibit 18: Ranking information of journals

Exhibit 18.1. Rankings listed by SCImago
Exhibit 18.2. Ranking of “Biotechnology” journals by Google Scholar
Exhibit 18.2. Screenshots of journals with Impact Factor Listed
EB-2 NIW - Dr. Oscar Apelido – Ranking information of journals

also developed by scimago: SCIMAGO INSTITUTIONS RANKINGS
Scimago Journal & Country Rank Enter Journal Title, ISSN or Publisher Name
Home Journal Rankings Country Rankings Viz Tools Help About Us
Environmental
All subject areas Engineering All regions / countries All types 2018
Only Open Access Journals Only SciELO Journals Only WoS Journals Display journals with at least 0 Citable Docs. (3years)
Download data
1 - 50 of 184
Total Citable Ref. /

H Total Docs. Total Refs. Total Cites Cites / Doc.
Title Type SJR Docs. Docs. Doc.
index (3years) (2018) (3years) (2years)
(2018) (3years) (2018)
2.157
1 Bioresource Technology journal 251 1721 4766 74886 33591 4732 6.96 43.51
Q1
1.958
2 Journal of Hazardous Materials journal 235 914 2498 45652 19705 2460 8.00 49.95
Q1
Critical Reviews in Environmental 1.955

3 journal 88 34 173 5255 1287 164 6.39 154.56
Science and Technology Q1
1.879
4 Building and Environment journal 124 587 1295 29746 7212 1278 5.20 50.67
Q1
1.806
5 Agronomy for Sustainable Development journal 81 67 219 5441 1293 212 4.74 81.21
Q1
Reviews in Environmental Science and 1.793

6 journal 63 35 93 5098 687 92 5.36 145.66
Biotechnology Q1
1.732
7 Environmental Modelling and Software journal 112 234 786 14421 3925 763 4.87 61.63
Q1
1.727
8 Coastal Engineering journal 93 157 358 7642 1445 347 3.99 48.68
Q1
1.616
9 Indoor Air journal 88 88 266 4116 1193 240 4.92 46.77
Q1
1.536
10 Science of the Total Environment journal 205 4305 6766 268589 39894 6640 5.90 62.39
Q1
1.448
11 Chemosphere journal 212 2180 4820 113605 25650 4753 5.35 52.11
Q1
1.280
12 Ocean Engineering journal 80 913 1704 34979 6080 1685 3.25 38.31
Q1
1.218
13 Elementa journal 20 83 184 6882 585 184 3.33 82.92
Q1
also developed by scimago: SCIMAGO INSTITUTIONS RANKINGS
Scimago Journal & Country Rank Enter Journal Title, ISSN or Publisher Name
Home Journal Rankings Country Rankings Viz Tools Help About Us
Chemical Engineering Bioengineering All regions / countries All types 2018
Only Open Access Journals Only SciELO Journals Only WoS Journals Display journals with at least 0 Citable Docs. (3years)
Download data
1 - 50 of 177
Total Total Citable Cites / Ref. /

H Total Docs. Total Cites
Title Type SJR Docs. Refs. Docs. Doc. Doc.
index (3years) (3years)
(2018) (2018) (3years) (2years) (2018)
17.049
1 Nature Nanotechnology journal 286 260 722 7810 17095 550 28.28 30.04
Q1
14.568
2 Nature Biotechnology journal 399 365 1083 5858 12450 612 16.91 16.05
Q1
9.430
3 Annual Review of Biophysics journal 146 30 55 3821 719 55 12.05 127.37
Q1
6.236
4 Nano Today journal 119 52 164 8226 2421 137 16.19 158.19
Q1
6.211
5 Nano Letters journal 430 1131 3622 50604 45682 3536 12.34 44.74
Q1
4.974
6 Nature Biomedical Engineering journal 23 136 162 5369 1283 118 10.87 39.48
Q1
3.482
7 Trends in Biotechnology journal 195 150 335 8974 3393 273 11.41 59.83
Q1
3.179
8 Biotechnology Advances journal 161 151 290 26563 4022 281 13.22 175.91
Q1
3.165
9 Metabolic Engineering journal 101 153 387 10747 3403 385 7.88 70.24
Q1
3.005
10 Biomaterials journal 337 600 1969 39664 19345 1952 10.25 66.11
Q1
2.802
11 Current Opinion in Biotechnology journal 181 157 483 8861 4074 450 8.46 56.44
Q1
Lab on a Chip - Miniaturisation for 2.365

12 journal 181 356 1381 17994 8707 1338 6.75 50.54
Chemistry and Biology Q1
2.157
13 Bioresource Technology journal 251 1721 4766 74886 33591 4732 6.96 43.51
Q1
Publicaciones principales
Categorías Life Sciences & Earth Sciences Biotechnology
Mediana
Publicación Índice h5
h5
1. Nature Biotechnology 158 307
2. Bioresource Technology 106 133
3. Biotechnology Advances 85 140
4. Current Opinion in Biotechnology 79 105
5. Trends in Biotechnology 71 99
6. Applied Microbiology and Biotechnology 68 92
7. Biotechnology for Biofuels 64 82
8. Metabolic Engineering 62 80
9. Biomass and Bioenergy 59 78
10. Biotechnology and Bioengineering 58 76
11. ACS Synthetic Biology 50 71
12. Journal of Biotechnology 49 60
13. Microbial Cell Factories 48 64
14. Algal Research 45 66
15. Global Change Biology Bioenergy 44 60
16. Biotechnology Journal 43 63
17. Critical Reviews in Biotechnology 41 54
18. Process Biochemistry 41 54
19. Biochemical Engineering Journal 41 51
20. Journal of Industrial Microbiology & Biotechnology 40 53
Las fechas y los recuentos de citas son estimados y se determinan de forma automática mediante un programa informático.
Ayuda Privacidad Condiciones

Exhibit 18: Key Contributor Award Letter and Check
EB-2 NIW - Dr. Oscar Apelido – Key Contributor Award Letter and Check
Exhibit 20: Documents regarding Current immigration status F-1

Exhibit 20.1. Passport
Exhibit 20.2. Current I-20 and I-94
Exhibit 20.3. F-1 visa stamp
Exhibit 20.4. Travel History
Exhibit 20.5. Current EAD card (STEM OPT)
Exhibit 20.6. Copy of form I-797C, Notice of Action for H-1B application
EB-2 NIW - Dr. Oscar Apelido – Documents regarding Current Nonimmigrant Status
I-797C Notice of Action for H1b
I no longer have a copy of this document so this is a placeholder

Exhibit 21: Documents regarding Past immigration status

Exhibit 21.1. Copy of past J-1 visa
Exhibit 21.2. Copy of part H-1B visa (Oklahoma State University)
EB-2 NIW - Dr. Oscar Apelido – Documents regarding Past Nonimmigrant Status

I-140 Petition Full PDF

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Dramappydedelgado@yahoo.

com 24 May 2023

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About this file

Petitioner/Beneficiary: Dr. Oscar Apelido

Petition: I-140, EB-2 National Interest Waiver - INA §203(b)(2)(B)

A. Forms and Fee

B. Petition Cover Letter

Exhibit 1: Letter of Recommendation – Name of Recommender 1, Title/Position, Institution

Exhibit 2: Letter of Recommendation – Name of Recommender 2, Title/Position, Institution

Exhibit 3: Letter of Recommendation – Name of Recommender 3, Title/Position, Institution

Exhibit 4: Letter of Recommendation – Name of Recommender 4, Title/Position, Institution

Exhibit 5: Letter of Recommendation – Name of Recommender 5, Title/Position, Institution

Exhibit 6: Letter of Recommendation – Name of Recommender 6, Title/Position, Institution

Exhibit 7: Advanced Degree – Ph.D.

Exhibit 8: Curriculum Vitae

Exhibit 9: Relevance of research for the U.S. National Interest

EB-2 NIW - Dr. Oscar Pardo Planas – List of Documents

Exhibit 9B: Screenshot of BETO website

Exhibit 12: Median salary of peers

Exhibit 13: 2018 W-2

Exhibit 15: Citation Record by Google Scholar

Exhibit 16: Copies of peer-reviewed publications co-authored

Exhibit 17: Evidence of Serving as Reviewer in Journals

Exhibit 18: Ranking information of peer-reviewed journals

Exhibit 19: Key Contributor Award Letter and Check

Exhibit 20: Documents regarding Current Nonimmigrant status F-1

Exhibit 21: Documents Regarding Past Nonimmigrant status

EB-2 NIW - Dr. Oscar Pardo Planas – List of Documents

Petitioner/Beneficiary: Dr. Oscar Apelido

Petition: I-140, EB-2 National Interest Waiver - INA §203(b)(2)(B)

A. Forms and Fee

EB-2 NIW – Dr. Oscar Apelido – Forms and Fee

Petitioner/Beneficiary: Dr. Oscar Apelido

Petition: I-140, EB-2 National Interest Waiver - INA §203(b)(2)(B)

A.1 Filing Fee per Form I-140 - $700

Petitioner/Beneficiary: Dr. Oscar Apelido

Petition: I-140, EB-2 National Interest Waiver - INA §203(b)(2)(B)

A.2 Form I-140

EB-2 NIW - Dr. Oscar Apelido – Form I-140

ENGINEER, PROCESS DEVELOPMENT

DESIGN AND EXECUTE EXPERIMENTS FOR

Petitioner/Beneficiary: Dr. Oscar Apelido

Petition: I-140, EB-2 National Interest Waiver - INA §203(b)(2)(B)

A.3 Form ETA-9089 (in duplicate)

EB-2 NIW - Dr. Oscar Apelido – Form ETA-9089

Petitioner/Beneficiary: Dr. Oscar Apelido

Petition: I-140, EB-2 National Interest Waiver - INA §203(b)(2)(B)

B. Petition Cover Letter

EB-2 NIW - Dr. Oscar Apelido – Petition Cover Letter

June 25, 2019

Petitioner/Beneficiary: Dr. Oscar Apelido

Dear USCIS Officer:

1. My proposed endeavor has both substantial merit and national importance.

1|Page EB-2 NIW - Dr. Oscar Apelido – Petition Cover Letter

2. I am well positioned to advance the proposed endeavor. I have developed bioprocesses

• Recommendation letters written by outstanding experts (together with resumes of the

2|Page EB-2 NIW - Dr. Oscar Apelido – Petition Cover Letter

1 Advanced Degree Professional ............................................................................................................. 4

2 Substantial Merit and National Importance .......................................................................................... 4

2.2 Development of biofuels increases Energy and National Security ............................................... 5

2.3 Development of biopesticides increases Food Safety and Security .............................................. 7

2.4 Summary of Benefits to U.S. Nation ............................................................................................ 9

3 I am well positioned to advance the proposed endeavor....................................................................... 9