Assignment

Dhruv Desai 23BT356

A] Write Up on Laboratory requirements for Recombinant DNA

Technology

Preface

The mandated list of laboratory requirements for recombinant DNA

technology consists of a set list of guidelines set by the national and
state wise governing bodies in conjunction with the institutional findings
and precautions based on previous experiences and other experimental
findings, the end goal of these requirements aim to make the
experiments conducted safer, reduce workplace exposure to harmful
chemicals and/or radiation and obtaining concise and accurate results.
The sources used for the following writeup are the NIH website, WHO
website and other reputed outlets.

Requirements

1. Biosafety Levels and Containment

 The first and most basic requirement is Biosafety level and

containment measures. Laboratories will be inspected by
Environmental Health and Safety (EHS) prior to the start of any
rDNA research at BSL2, and research requiring BSL2 containment
may necessitate additional biosafety practices.

 The IBC review includes an assessment of animal housing

containment for laboratory work involving rDNA, and all work with
vertebrate animals must also be assessed to make sure there is
no harm to the animals or malpractices.

2. Compliance with NIH Guidelines

 All rDNA research must adhere to the National Institutes of Health

guidelines, and a copy of the current NIH guidelines should be
available for reference.
 General practices include following the NIH guidelines for research
involving rDNA, completing biological safety training, and providing
annual lab-specific safety training in order to prevent mishaps.
 3. Institutional Biosafety Committee (IBC) Approval

 Laboratories conducting rDNA work must receive approval from

the Institutional Biosafety Committee before initiating any
experiment involving rDNA molecules
 The IBC reviews and approves research protocols involving the
use of rDNA techniques and determines the appropriate biosafety
level based on a risk assessment

4. Registration and Certification

 Newly registered laboratories must undergo inspection and

certification by the IBC for rDNA experiments, particularly those
performed at biosafety level 3.
 Principal investigators intending to use rDNA molecules are
required to notify the IBC and prepare a registration document
according to the nature of the research, regardless of the source of
funding.

B] Safety Guidelines for rDNA in India

The safety guidelines for recombinant DNA (rDNA) technology in India

are established to regulate research, use, and applications of rDNA. The
Department of Biotechnology, Ministry of Science and Technology,
Government of India, has issued comprehensive guidelines and
regulations to ensure the safe handling of genetically modified
organisms and products derived from rDNA technology. Some of the key
aspects covered in these guidelines include:

1. Institutional Oversight: The guidelines emphasize the need for

institutional oversight through the Recombinant DNA Advisory
Committee (RDAC) and the Genetic Engineering Approval
Committee (GEAC) to ensure compliance with safety regulations

2. Containment and Biocontainment: They provide detailed

requirements for containment measures, including laboratory and
glasshouse containment conditions for plant experiments, to
prevent the release of genetically modified organisms into the
environment
 3. Research and Development Activities: The guidelines focus on
regulating research and development activities involving
genetically modified organisms, genetic transformation of green
plants, and large-scale production using rDNA technology

4. Regulatory Authorities and Competent Bodies: The regulations are

implemented by the Ministry of Environment, Forest and Climate
Change and the Department of Biotechnology through six
competent authorities to ensure compliance with the Rules for use,
import, export, and storage of genetically engineered organisms

5. Exclusions and Ethical Considerations: The guidelines exclude

certain areas such as genetic engineering of human embryos, use
of embryos and foetuses in research, and human germ line gene
therapy from the scope of regulation

These safety guidelines and regulations are updated regularly to stay up

to date with the advancements in biotechnology and to address
emerging gene technologies, ensuring the safe and responsible use of
rDNA in India.