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A review of the global pesticide legislation and


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Integrated Environmental Assessment and Management — Volume 9999, Number 9999—pp. 1–12
© 2015 SETAC 1

A Review of the Global Pesticide Legislation and the Scale


of Challenge in Reaching the Global Harmonization of Food
Safety Standards
Caroline E Handford,y Christopher T Elliott,y and Katrina Campbell*y
yInstitute for Global Food Security, School of Biological Sciences, Queen's University, Belfast, Northern Ireland, United Kingdom

(Submitted 20 October 2014; Returned for Revision 20 January 2015; Accepted 23 February 2015)

ABSTRACT
Pesticide use is important in agriculture to protect crops and improve productivity. However, pesticides have the potential

Critical Review
to cause adverse human health or environmental effects, depending on exposure levels. This review examines existing
pesticide legislation worldwide, focusing on the level of harmonization and impacts of differing legislation on food safety
and trade. Pesticide legislation varies greatly worldwide, because countries have different requirements, guidelines, and legal
limits for plant protection. Developed nations have more stringent regulations than developing countries, which lack the
resources and expertise to adequately implement and enforce legislation. Global differences in pesticide legislation act as a
technical barrier to trade. International parties such as the European Union (EU), Codex Alimentarius Commission (Codex),
and North American Free Trade Agreement (NAFTA) have attempted to harmonize pesticide legislation by providing
maximum residue limits (MRLs), but globally these limits remain variable. Globally harmonized pesticide standards would
serve to increase productivity, profits, and trade and also enhance the ability to protect public health and the environment.
Integr Environ Assess Manag 2015;9999:1–12. © 2015 SETAC

Keywords: Food safety Global harmonization Legislation Maximum residue limits Pesticides

INTRODUCTION workers are particularly vulnerable to pesticide poisoning. This


Pesticides have a longstanding and particularly important risk is further heightened in developing countries because a
role in agriculture by protecting crops and improving larger percentage of the population work in agriculture and are
productivity. “First generation” pesticides such as S, As, and exposed to more toxic pesticides that are banned or restricted in
nicotine were predominantly applied to crops before the developed countries. Additional means of increased exposure
chemical age, when their use was mostly discontinued because are incorrect application techniques, poorly maintained or
of toxicity or ineffectiveness because of pest resistance. After inappropriate spraying equipment, and insufficient storage
World War II, a more effective group of synthetic pesticides, practices (Damalas and Eleftherohorinos 2011). Pesticides,
known as “second generation” pesticides, emerged. These selected for their biological activity, therefore have the ability to
included organochlorine pesticides such as DDT and dieldrin. cause adverse health effects in humans, ranging from acute
Organochlorines were popular because of their low cost, easy impacts, such as nausea, headaches, and skin and eye irritation,
application, and efficacy. The introduction of other synthetic to chronic impacts, such as cancer, neurological and develop-
pesticides such as organophosphates and phenoxy acids shortly ment defects, diabetes, reproductive disorders, birth defects,
followed (Fishel 2009a). and cardiovascular disease (Mostafalou and Abdollahi 2013).
Improper pesticide application, including incorrect selection, Pesticide application also may cause harm to other nontarget
overuse of pesticides on agricultural commodities, or harvesting organisms, including birds, bees, and fish, environmental
crops before the residues have washed off after application, can damage through contaminating soil, water, turf, and other
lead to a high amount of residues on produce that consumers are plants, and increased resistance in the target pest organisms
eating (Chen et al. 2011). Human exposure to pesticides can (K€ohler and Triebskorn 2013). Recent studies have implicated
occur through ingestion of contaminated foods, drinking water, pesticides in changes in bee behavior and declines in colony
and animal products because of bioaccumulation, inhalation, or queen production (Gill et al. 2012).
skin contact (Bakirci et al. 2014). The Pesticide Action Network Pesticides must be regulated to ensure that they do not
UK (PAN UK) (2013) reported that nearly two thirds (63%) of present unacceptable risks to humans, animals, or the
supermarket own-brand loaves and top brand-name loaves environment. This article reviews current global pesticide
analyzed in 2013 contained traces of 1 or more pesticides. legislation and focuses on the level of harmonization in
Individuals in high exposure risk occupations such as farm regulations and policies employed worldwide, as well as the
implications of differing legislation on food safety and
* Address correspondence to: katrina.campbell@qub.ac.uk trade.
Published online 12 March 2015 in Wiley Online Library
(wileyonlinelibrary.com).
DEVELOPMENT OF PESTICIDE LEGISLATION
The development of pesticide legislation in 8 key regions—
DOI: 10.1002/ieam.1635
the US, Europe, China, India, Australia, Japan, Brazil, and
2 Integr Environ Assess Manag 9999, 2015—CE Handford et al.

Figure 1. Parallel timelines of the development of pesticide legislation worldwide.


Global Harmonization of Pesticide Legislation—Integr Environ Assess Manag 9999, 2015 3

South Africa—is presented in Figure 1. These regions were general population and sensitive subpopulations, including
selected to illustrate the advancements in pesticide legislation in infants and children (USEPA 2014a).
both developed and developing regions. Pesticide regulation was In the EU, previously fragmented legislation was replaced
given little attention until the 1940s, when the use of synthetic with harmonized pesticide standards for all member states
pesticides such as DDT became more widespread in agriculture, (Figure 1). National maximum residue limits (MRLs),
with application on major field crops (Figure 1). In 1962, the otherwise known as tolerances in the US, are no longer in
publication of Silent Spring substantially heightened public use, and only European limits apply. A major focus of current
concern regarding the environmental damage caused by EU legislation, along with harmonizing the pesticide registra-
synthetic pesticides (Carson 1962). DDT was banned for all tion process in Europe, is the future sustainable use of
agriculture uses in developed nations by the 1980s, and the need pesticides and adoption of IPM techniques. The use of
for improved pesticide legislation was recognized. The United pesticides is reviewed in new scientific findings exemplified
Nations Environment Programme also was established to by the European Commission (EC) imposing a restriction on
protect the global environment for present and future certain nicotinamides for use in 2013, because of uncertainties
generations. In association with the World Health Organisation in the link to pollinator population declines. The EC have
(WHO) and the Food and Agriculture Organisation (FAO), committed to initiate a review of the conditions of approval,
the United Nations Environment Programme works to within 2 years at the latest, to take into account new scientific
encourage integrated pest management (IPM), techniques to and technical developments (Gill et al. 2012; Regulation [EU]
hinder pest population development, promoting safer sustain- No 485/2013).
able alternative strategies to the use of persistent organic Numerous developed and developing nations have progressed
pollutants. in the same direction, thus resulting in different national
Significant changes have been made to US pesticide pesticide standards worldwide (Figure 1). In Australia, pesticide
legislation in recent years (Figure 1), with the US Environmental legislation has also moved toward national harmonization
Protection Agency (USEPA) establishing the tolerance reassess- (Figure 1), although further work is required to apply
ment and reregistration review program. This has allowed for modifications that improve consistency in pesticide regulatory
the implementation of new standards for dietary pesticide approaches across jurisdictions. In developing countries, such as
safety, changing the standard for tolerance for pesticide residues China and India, which have implemented their own pesticide
to “reasonable certainty of no harm,” and making considerations regulatory systems, highly toxic pesticides are still used because
for aggregate and cumulative risk assessment and safety for the of legislation being inadequate or poorly enforced.

Table 1. Apple maximum residue limits as parts per million (ppm) for selected pesticides in different global regions
(values from the USDA MRL Database)

Type of Codex EU US Canada China Japan India Australia South Africa


pesticide MRL MRL MRL MRL MRL MRL MRL MRL MRL

Acetamiprid 0.8 0.8 1 1 0.8 2 0.8a — 0.8a

Captan 15 3 25 5 15 5 15 10 15a

Chlorantraniliprole 0.4 0.5 1.2 0.4 — 1 0.4a 0.3 0.5b

Deltamethrin 0.2 0.2 0.2 — 0.1 0.5 0.2a — 0.2a

Fenbutatin-oxide 5 2 15 3 5 5 5a 3 5ab

Fludioxonil 5 5 5 5 — 5 5a 5 5a

Hexythiazox 0.4 1 0.4 — 0.5 1 0.4a 1 1b

Malathion 0.5 0.02 8 2 2 0.5 4 2 0.5b

Oxamyl — 0.01 2 — — 2 — — 0.01b

Permethrin 2 0.05 0.05 1 2 2 2a — 2a

Pyrethrins — 1 1 1 — 1 1 1 1b

Spinosad 0.1 1 0.2 0.1 — 0.5 0.1a 0.5 1b

Thiacloprid 0.7 0.3 0.3 0.3 — 2 0.7a 1 0.7a

Thiram 5 5 7 7 5 5 5a 3 5a

Ziram 5 0.1 7 7 — 5 5a 3 5a

MRL ¼ maximum residue limit.


—Means no MRL was established.
a
Codex MRLs are applied.
b
EU MRLs are applied.
4 Integr Environ Assess Manag 9999, 2015—CE Handford et al.

Table 2. Grain corn maximum residue limits as parts per million (ppm) for selected pesticides in different global regions
(values from the USDA MRL Database)

Type of Codex EU US Canada China Japan India Australia South Africa


pesticide MRL MRL MRL MRL MRL MRL MRL MRL MRL

2,4-D 0.05 0.05 0.05 0.05 — 0.05 0.01 0.2 0.05a

Atrazine — — 0.2 0.2 0.05 0.2 0 0.1 0.05

Carboxin — 0.01 0.2 — 0.2 0.2 — 0.1 0.01b

Chlorpyrifos 0.05 0.05 0.05 0.05 0.05 0.1 0.05 0.1 0.05a

Deltamethrin 2 2 1 — 0.5 1 0.5 2 2a

EPTC — 0.01 0.08 0.1 — 0.1 — 0.04 0.01b

Fluoride — 2 10 — — — — — 2b

Glyphosate 5 1 5 3 1 1 5a 5 5a

Malathion 0.05 8 8 8 8 2 4 8 8b

Piperonyl Butoxide 30 — 20 20 — 24 30a 20 30a

Prothioconazole — 0.02 0.35 0.35 — — — 0.3 0.02b

Spinosad 1 1 1.5 1.5 — 2 1a 1 1a

Sulfuryl fluoride 0.05 0.05 0.05 0.03 — 0.05 0.05a 0.05 0.05a

Tefluthrin — 0.05 0.06 0.06 — 0.1 — — 0.05b

Zeta-Cypermethrin 0.3 0.3 0.05 — — 0.2 0.3a 1 0.3a

MRL ¼ maximum residue limit.


—Means no MRL was established.
a
Codex MRLs are applied.
b
EU MRLs are applied.

Maximum residue limits Codex, although variations in standards still cause disruptions
Most countries use MRLs to regulate pesticides. Maximum in trade.
residue limits are defined as “the upper legal levels of a
concentration for pesticide residues (expressed in mg/kg) in or International position on pesticide standards
on food or feed based on good agricultural practices (GAP) and International parties have attempted to harmonize pesticide
to ensure the lowest possible consumer exposure” (European standards worldwide to facilitate trade. In 1985, FAO adopted
Food Safety Authority [EFSA] 2011). These must be safe for an International Code of Conduct on the Distribution and Use
all consumers and protect vulnerable groups such as children. of Pesticides; this was updated in 2014. The code is a set of
The MRLs are derivatives of statistical calculations from field voluntary standards that are especially useful where national
trials. An acute reference dose and acceptable daily intake are pesticide legislation is inadequate or absent. The standards
determined from the toxicological data (EFSA 2011). These encourage responsible and generally accepted trade practices,
are compared with food consumption patterns, obtained from ensure effective and efficient use of pesticides, and promote
dietary intake surveys and residue data from rotational crop risk reduction in handling pesticides (FAO 2014). Several
studies, supervised field trials, and, if available, monitoring other international instruments, which any country can adopt,
data, to ensure that exposure does not exceed specified safety have come into force to aid with pesticide management,
limits (FAO 2009). Tables 1 and 2 provide illustrative including the Basel Convention on the Control of Trans-
examples of global commodities and the set MRLs for boundary Movements of Hazardous Wastes and Their
randomly selected pesticides, to show how these differ Disposals, the Rotterdam Convention on the Prior Informed
between countries. Consent (PIC) Procedure for Certain Hazardous Chemicals
In some cases, these differences can be minor, as shown for and Pesticides in International Trade, and the Stockholm
acetamiprid on apple or spinosad on corn. Although for other Convention on Persistent Organic Pollutants.
pesticides, MRLs can vary enormously; the US limits for captan The General Agreement on Tariffs and Trade (GATT) was
and fenbutatin-oxide on apple are approximately 8 times created in 1947 to provide rules for international trade; this was
higher than the European limits. The EU has the strongest a provisional agreement and organization. The Uruguay round
standards (the lowest MRL) for most of the pesticides of the GATT negotiations took place between 1986 and 1994
examined, and the United States has the weakest standards and led to the establishment of the World Trade Organisation
(highest MRL) in several cases. Internationally, many (WTO) in 1995. The WTO has superseded GATT and deals
exporters defer to pesticide MRLs devised by the EU or with regulations of trade between participating nations. The
Global Harmonization of Pesticide Legislation—Integr Environ Assess Manag 9999, 2015 5

WTO’s Sanitary and Phytosanitary Agreement aims “to of these products on their territory and abide by EU rules. In
harmonise sanitary and phytosanitary measures on as wide a brief, manufacturers of an active substance must submit an
basis as possible; members shall base their sanitary or application to the rapporteur member state in which they
phytosanitary measures on international standards, guidelines intend to place the new product on the market. Applications
or recommendations” (WTO 2013). This agreement encour- must include a complete safety dossier, which is a highly
ages compliance with the Codex standards on pesticide residues. extensive, costly procedure, with the provision of scientific
Codex sets nonbinding consensus-based MRLs, which are data regarding mainly physical and chemical properties of the
particularly useful for countries without or having a limited level substance, and toxicology and exposure information based on
of pesticide residue standards for international trade. laboratory experiments and epidemiological studies. Evalua-
Since 1992, the Organisation for Economic Co-operation tion by the rapporteur member state leads to their recom-
and Development (OECD) pesticide program has enabled mendation on the active substance.
wider international harmonization of pesticide registration Authorized substances are included in a positive list; Table 3
procedures. The OECD pesticide and testing projects work to summarizes and compares EU legislation on selected pesticides
harmonize the test methods and, as a result, the mutual with that of India to illustrate differences between developed
acceptance of data among member countries. The process and developing nations. Those included are illustrative
includes developing test guidelines for the tests used to fulfill examples of substances that are authorized, restricted for
the pesticide registration data requirements and harmonizing use, or banned in the EU. To date 459 active substances have
exposure, hazard, and risk assessment methods to interpret the been approved, 781 substances were not approved, and 52
test results and to assess a pesticide’s risk. This harmonization substances are pending approval. Due to the nature of plant
enables a producer to register a pesticide in a number of protection required in Europe, herbicides tend to be more
countries with the same safety dossier, which will save a predominantly used for weed control.
considerable amount of time and expenses. The OECD has Pesticide MRLs for agricultural commodities are applicable
also developed an MRL calculator to harmonize pesticide in all member states. The EU laws set a default lowest limit of
MRLs across OECD countries (OECD 2014). analytical determination value of 0.01 mg/kg for when a
The Globally Harmonised System of Classification and pesticide is not specifically mentioned or for crops on which
Labelling of Chemicals (GHS) was created to promote the the pesticide has not been used, or when its use has not left
sound management of chemicals worldwide through the detectable residues. Methods of sampling for the determi-
provision of an internationally comprehensible system for nation of pesticide residues for compliance with MRLs are
hazard communication on labels and safety data sheets, outlined in SANCO/12571/2013. Foods imported to EU
creating classification processes that use available data on countries are sampled to ensure that they do not contain any
chemicals for comparison with hazard criteria, and to facilitate illegal substances or pesticides above the set MRLs.
international trade in chemicals whose hazards have been The EFSA is also working with regulatory bodies, scientists,
identified and properly assessed on an international basis and policy makers worldwide to refine methodologies and
(United Nations 2011). provide risk assessors with new tools to determine possible
In 1994, the North American Free Trade Agreement combined effects derived from exposure to multiple chemicals
(NAFTA) came into force, which led to cooperative efforts through consumers’ diets (EFSA 2013).
to harmonize pesticide regulatory requirements between
Canada, the US, and Mexico. In 1997, a Technical Working United States
Group on pesticides was established to develop more In recent years, tougher legislation has been implemented to
effective and less expensive pesticide regulation and trade ensure better control of pesticides (Figure 1). The USEPA is
among the 3 nations. The NAFTA MRL/Tolerance Harmo- charged with pesticide registration, which involves the
nisation Workgroup developed a spreadsheet to calculate submission of a comprehensive application by manufacturers
pesticide MRLs to coordinate the pesticide regulatory of new substances and new uses for currently registered
framework among NAFTA countries. However, the US pesticides. Registration specifies the crops and sites on which
and Canada joined the OECD in their use of the OECD the pesticide may be applied and is supported by extensive
MRL calculator in 2011, which has since replaced the data, comprising environmental, health, and safety documents
NAFTA MRL calculator (USEPA 2014b). regarding physical and chemical properties of the substance,
toxic hazards, residue chemistry, and product performance.
CURRENT GLOBAL PESTICIDE LEGISLATION The USEPA routinely requires efficacy data to be submitted for
Although a vast increase has been seen in the enactment of review for those pesticide applications in which public health
pesticide legislation worldwide, it remains absent in approx- claims are being made; however, efficacy data can be requested
imately a quarter of countries in Africa and the Southeast Asian for all pesticides. Approximately 2 years are needed to obtain
region (Matthews et al. 2011). Where present, regulations registration approval from the USEPA. After a pesticide has
often lack comprehensiveness and the capacity to enforce these been licensed, states can register pesticides for use under
effectively; developed nations, conversely, are increasingly specific state pesticide registration laws. Pesticides that are not
implementing more stringent legislation. approved or registered in the US may still be manufactured in
the US and exported.
Europe The USEPA also establishes tolerance limits; child health
The EU pesticide legislative framework has evolved consid- and the risks of pesticide exposure in numerous products must
erably over the years (Figure 1), with the current “thematic be considered (USC 2014c). Tolerance exemptions are
strategy for pesticides” comprising 4 elements (Stark 2011). occasionally granted for a pesticide ingredient where the
The EC is responsible for the approval of active substances exemption is found to be safe. The US Department of
(SANCO/10181/2013), and member states authorize the use Agriculture enforces tolerances for meat and certain egg
6
Table 3. Comparison of EU and Indian legislation for selected pesticides (Data from EU Pesticides Database and CIBRC)

European Union India


Current
status
Current (Section 9
status (Reg. (3)
Active (EC) No Date of Insecticides
substance 1107/2009) approval Expiry date Legislation Notes MRL Act, 1968) Notes MRL

2,4-D Approved 01/10/2002 31/12/2015 01/103/EC Reg. (EU) Extension of Yes Approved — Yes
No 540/2011 expiry date for
inclusion (2010/77)

2,4,5-T Not — — 2002/2076 — — Not Refused —


Approved approved registration

Aldrin Not — — 850/2004 Banned — Not Banned for —


Approved approved manufacture,
import, and use

Atrazine Not — — 2004/248/EC — — Approved — Yes


Approved

Captan Approved 01/10/2007 30/09/2017 07/5/ECReg. — Yes Approved — Yes


(EU) No 540/2011

DDT Not — — 850/2004 Banned — Approved Restricted for Yes


Approved use in India

Deltamethrin Approved 01/11/2003 31/10/2016 03/5/ECReg. — Yes Approved — Yes


(EU) No 540/2011
Reg. (EU)
No 823/2012

Ethoxysulfuron Approved 01/07/2003 31/03/2014 03/23/ECReg. — Yes Approved —


(EU) No 186/2014
Reg. (EU)
No 540/2011
(Reg. [EU] No 823/2012)

Heptachlor Not — — 850/2004 Banned — Not Banned for —


approved approved manufacture,
import and use

Lindane Not — — 00/801/EC — — Approved Banned for —


approved manufacture,
import and use
Integr Environ Assess Manag 9999, 2015—CE Handford et al.
European Union India
Current
status
Current (Section 9
status (Reg. (3)
Active (EC) No Date of Insecticides
substance 1107/2009) approval Expiry date Legislation Notes MRL Act, 1968) Notes MRL

Malathion Approved 01/05/2010 30/04/2020 2010/17/EUReg. Included after Yes Approved — Yes
(EU) No 540/2011 resubmission for
inclusion according
to Reg. 33/2008

Methyl Parathion Not — — 03/166/EC — — Approved Restricted for Yes


approved use in India

Phorate Not — — 2002/2076 — — Approved — Yes


approved

Pyrethrins Approved 01/09/2009 31/08/2019 2008/127Reg. Substance Yes Approved — Yes


(EU) No 540/2011 satisfying criteria
Reg. (EU) Annex VI
No 798/2013 Reg. 2229/2004

Simazine Not — — 04/247/EC Essential — Not Pesticide —


approved use 835/2004 approved withdrawn

Triazophos Not — — 2002/2076 Essential use — Approved — Yes


approved

EU ¼ European Union; CIBRC ¼ Central Insecticide Board and Registration Committee; MRL ¼ maximum residue limit.
Global Harmonization of Pesticide Legislation—Integr Environ Assess Manag 9999, 2015
7
8 Integr Environ Assess Manag 9999, 2015—CE Handford et al.

products, and the US Food and Drug Administration imple- 2009b). Because China is currently one of the largest
ments tolerances specified for other foods. manufacturers of pesticides worldwide (Sola et al. 2014),
stricter legislation has since been implemented (Figure 1). In
Australia 2009, the MOA became responsible for specifying residue limits
Pesticide regulation (Figure 1) is the shared responsibility of for pesticides in China; these standards are jointly published by
the Commonwealth and the States and Territories through the the MOA and the Ministry of Health. The national pesticide
National Registration Scheme. Manufacturers seeking regis- residue standard committee was created to aid with setting
tration for a pesticide are required to go through the Australian MRLs. As a result, existing MRLs have been re-evaluated and
Pesticides and Veterinary Medicines Authority (APVMA) and new MRLs issued; Codex MRLs have also been adopted.
provide a dossier with information on toxicology, environment
fate and effects, residue data, occupational health and safety, India
and chemistry (including production methods). Applications Pesticide registration in India is through the Central
must be accompanied by a prescribed fee. The APVMA Insecticides Board and Registration Committee, who evaluate
collaborates with other Commonwealth agencies during the the data concerning the product’s chemistry, bio-efficacy, and
registration process of pesticides. The APVMA also establishes toxicity. Authorized pesticides are listed on a schedule of
pesticide MRLs during the evaluation process before their approved substances; the board sporadically reviews all
registration. Evaluators consider submissions on the use of the pesticides and can ban or consign any pesticide to restricted
pesticide and other information, including recommendations use (Table 3). Insecticides, such as DDT, which are highly
made by other governments and internationally recognized effective against various pests, are restricted for use in India,
organizations. The MRLs set by the APVMA for human foods because they have been banned in many other countries due to
are advanced to the Food Standards Australia New Zealand for their acute toxicity (Abhilash and Singh 2009). There are 248
incorporation into Standard 1.4.2 of the Food Standards Code. approved pesticides; 28 pesticides banned from manufacture,
For MRLs in animal feeds, the entries in the MRL are usually import and use; 2 pesticides banned for use but their
adopted into the appropriate state legislation. The MRLs are manufacture allowed for export; 4 pesticide formulations
monitored by national programs such as the Food Standards banned for import, manufacture, and use; 7 pesticides
Australia New Zealand’s Australian Total Diet Survey withdrawn; 18 pesticides refused registration; and 13 pesti-
(APVMA 2014). cides restricted for use in India.
In previous years, India’s pesticide legislation (Figure 1)
Japan exposed loopholes and lacked adequate enforcement, thus
Pesticides are primarily regulated by the Ministry of resulting in persisting problems relating to the environment
Agriculture, Forestry and Fisheries, who specifies standards and public health. Consequently, new legislation was intro-
for the required amount of active ingredients, the maximum duced in 2008 (Figure 1) in a bid to control pests, ensure
permitted amount of hazardous chemical ingredients, and availability of quality pesticides, improve training of pesticide
other requirements specific to each type of pesticide (Figure 1). application, and minimize contamination of agricultural
Applicants seeking registration must provide scientific data commodities with pesticide residues. However, this legislation
regarding the physical and chemical properties, types of active has also been greatly scrutinized and has yet to be passed by
ingredients, phytotoxicity, toxicity, and efficacy of the parliament (Sola et al. 2014).
substance along with the provision of samples.
The Ministry of Health, Labour, and Welfare is authorized Africa
to establish pesticide MRLs. Because Japan is one of the Pesticide use in Africa is mostly targeted at high-value cash
world’s largest users of pesticides (Zhang et al. 2011), a crops for export (Sola et al. 2014). Although many African
positive list system was introduced in 2006 (Figure 1). At that states have developed pesticide laws to a greater or lesser
time the Ministry of Health, Labour, and Welfare established extent, member states present various challenges to sound
new MRLs for some food commodities and comprehensively pesticide management, because national regulatory agencies
reviewed existing MRLs. Codex MRLs have been adopted as are often underfunded and lack resources to enforce regu-
Japanese MRLs, where in existence. Since its introduction, all lations, and some countries do not have a pesticide registry
Japanese agricultural products and imports have had to comply system. Further problems include a lack of guidelines for
with the positive list. For substances with no established MRL, pesticide control, insufficient knowledge about pesticides,
a uniform default level of 0.01 ppm is set as the maximum limit poorly equipped laboratories, and inadequate storage of
(Hayashi et al. 2009). pesticides (Matthews et al. 2011; WHO 2011).
South Africa is one of the largest consumers of pesticides in
China Africa (Sola et al. 2014), making adequate legislation funda-
The Institute for the Control of Agrochemicals, Ministry of mental. Even so, the country (Figure 1) has been criticized for
Agriculture, established under the Ministry of Agriculture lacking in key areas, including the establishment of pesticide-use
(MOA), regulates pesticides in China (Figure 1). Registration surveillance and monitoring systems; the necessary education,
of a new pesticide involves the submission of a dossier training, and certification to apply pesticides; and research into
containing a summary of the product, production process, alternative nonchemical approaches to pesticides (Joemat-
chemical data, safety data, labeling, an illustration manual, a Pettersson 2010). Furthermore, of the thousands of pesticide
business license, and study reports. products authorized in South Africa, several may not have been
Before 2009, scientific data to support MRL setting was re-evaluated for many years and so may not meet the current
lacking, and standards were based on unsound risk assessment. stricter criteria of risk assessment. The approval of pesticide
Consequently, approximately 30% of China’s pesticide market MRLs for agricultural products is the responsibility of the
comprised acutely toxic, fake, and illegal pesticides (Fishel Department of Health (DOH), though this list is limited. Codex
Global Harmonization of Pesticide Legislation—Integr Environ Assess Manag 9999, 2015 9

values are the principal default values when no South African crop loss caused by climate changes. The highest losses in global
MRL has been established. The DOH inspection services monitor food production are in arid and subhumid tropics in Africa and
pesticide residues to ensure compliance with the set MRLs. South Asia (Hanjra and Qureshi 2010). With food security
Other parts of Africa have shown similar problems with vulnerability already rife among these nations, this is expected to
poorly implemented pesticide legislation, leading to a high use increase further, which could result in lower standards for food
of highly toxic, illegal pesticides. In Ghana, an estimated 10% safety and quality being applied.
to 15% of imported pesticides are illegal (Northern Global differences in pesticide regulations act as a technical
Presbyterian Agricultural Services and Partners 2012). In barrier to trade, impeding trade of both pesticides and
2011, the FAO Regional Office in Ghana held a workshop to agricultural commodities. Legislation affects trade competive-
harmonize pesticide legislation across West and Central Africa, ness, because nontariff measures can constitute entry barriers
and it has since developed tools to aid these countries with in the form of additional compliance costs for producers, which
regional schemes and pesticide registration. Likewise, in East in turn increases food prices. Furthermore, those exporting
Africa the Treaty for the establishment of the East African their produce to numerous foreign markets are faced with even
Community was signed in November 1999 by Kenya, Uganda, greater costs, because they have to abide by several standards
and Tanzania. Article 108 on Plant and Animal Disease according to the export destination. Importing countries with
Control specifies that member states shall harmonize policies stricter regulations can cause significant losses in trade for
and legislation for enforcement of pest and disease control, exporting countries. A nation that already enforces stringent
harmonize and strengthen regulatory initiatives, and adopt a pesticide residue standards is therefore likely to encounter
common mechanism to ensure safety, efficacy, and potency of fewer difficulties in complying with the provisions of the
agricultural chemicals. importing nation, considering its producers have already
satisfied the costs associated with maintaining low residue
South America levels (Drogue and DeMaria 2012). Developing countries are
Brazil is the third leading agricultural exporter in the world, particularly affected by the more stringent food safety stand-
after the EU and the US (EC 2014). Agricultural activities ards of developed nations.
within this country have therefore required an increasing Global differences in regulated pesticides (Table 3) cause
reliance on pesticides and the subsequent need for pesticide further problems in the course of international trade, especially
legislation (Figure 1). Pesticide registration is the shared for countries in the developing world, which still may use
responsibility of 3 agencies: The Ministry of Agriculture hazardous pesticides that are not authorized in developed
evaluates the product’s effectiveness and issues the certificate nations. The PIC is used to control the export of certain
of registration; the Ministry of Health is in charge of hazardous pesticides through notifying and providing adequate
toxicological assessments, classification of pesticides, and data to the importing nation. Nevertheless, the system fails to
specifying MRLs; and the Ministry of Environment deals support developing countries in the establishment of a
with the environmental assessment. Currently in place are 2 regulatory framework to help them assess pesticides for
monitoring programs for pesticide residues in food in Brazil, import. Furthermore, no obligatory mechanism exists for
which seek to ensure compliance with national MRLs: the compliance with the PIC; therefore, producers may regularly
Programme on Pesticide Residue Analysis, which is coordi- violate the PIC provisions in the channel of pesticide trade,
nated by the Ministry of Health, and the National Residue and thus potentially affecting the safety of food.
Contaminant Control Programme, coordinated by the Minis- Countries routinely reject crops containing pesticide residue
try of Agriculture (Jardim and Caldas 2012). levels above their national MRL values or when MRLs are
Other South American countries have developed standards absent, even if Codex MRLs have been established. Accord-
similar to those implemented in Brazil. Nevertheless, as in ingly, monitoring is generally intensified for agricultural
other developing regions, many countries have struggled to products from the country where the original violation
enforce their pesticide legislation. To assist in the management happened, and if the problem perseveres, a ban may be
of pesticides, many countries have become members of permanently implemented on imports from that country. For
international bodies such as GHS. Uruguay became the first example, in the EU, a 2010 survey found 8 samples of okra
country in South America to adopt GHS in 2009, followed by from India that contained pesticide residues exceeding
Brazil. Other countries in South America are expected to also specified MRLs. An import restriction was therefore placed
adopt the GHS. on okra from India, meaning that it can only enter the EU
through certain listed ports and airports, where a proportion of
IMPACTS OF DIFFERING LEGISLATION ON FOOD the consignments are to be tested for pesticide residues. The
SAFETY AND TRADE consignment is not permitted to enter the EU if it is
International trade in foodstuffs has grown rapidly and noncompliant with MRLs (Expert Committee on Pesticide
changed profoundly over recent decades, in response to a Residues in Food 2012).
growing global population with changing diets. The EU is by far Many countries may comply with standards in the countries
the leading importer of agricultural commodities, with imports they predominantly export to and apply lower standards
reaching an all-time high of s102 billion in 2013 (EC 2014). elsewhere. Violative shipments with foods containing banned
This indicates why it has the most advanced regulatory system or restricted substances, or with residues exceeding legal limits,
worldwide, because the setting of high food safety standards is may be exported to countries with an inadequate sampling
paramount in the protection of human health. However, that program and lower inspection rates, therefore increasing risks
standards are implemented to protect domestic consumers from to food safety (Neff et al. 2012). Bakirci et al. (2014)
harmful residues in food from their own country, and for investigated the presence of pesticide residues in a total of 1423
domestic trade, is equally important. Developing countries are samples of different fresh fruit and vegetables collected from a
becoming increasingly dependent on food imports, because of market in the Aegean region of Turkey from 2010 to 2012.
10 Integr Environ Assess Manag 9999, 2015—CE Handford et al.

These samples were taken in accordance with the Turkish foods available at a lower price, and thus enhanced food
regulation. In 2010, 68 (14%) samples contained pesticide security. For farmers, the benefits would be new, safer
residues above MRLs, whereas in 2011, 42 (10%) samples technologies for crop protection and increased productivity,
exceeded the MRLs, and in 2012, only 21 (4%) of samples profits, and trade. For manufacturers, this would result in a
were above the MRLs. This study highlights the importance of simplified and more efficient risk assessment and registration
regularly monitoring pesticide residues on agricultural com- process, and prospects of quicker access to global markets with
modities to avoid risks to human health. However, a slight new pesticides and uses, with lower costs for new pesticide
decline has been seen in the percentage of samples exceeding development. For regulators, this would be a cost-effective
pesticide residue MRLs in recent years, which may be way of devising regulations for governments with limited
attributable to the implementation of more stringent legis- resources, improve global working relationships with shared
lation and IPM strategies. expert knowledge, enable additional expert support to address
key problems, and increase trust in regulatory decisions if
GLOBAL HARMONIZATION considerable differences do not exist between these countries.
Worldwide, each country has different pesticide standards, Of course, challenges to global harmonization must be
most of which are complex and multidimensional; these are considered, such as the high costs and time associated with
not easily harmonized. The key drivers of legislation identified changing regulatory systems that are already in place. In
include culture, politics, economy, science (i.e., differing test addition, pesticide regulations in a particular country are
standards and food consumption patterns), health, food specifically geared toward its own pesticide needs; global
sustainability and security, safety, trade, pest management, standards cannot address the individual needs of each country.
and the development of the country. For instance, the differing Finally, harmonization moves the decision making away from
needs for pesticides worldwide (Table 3) can cause discrep- easily accessed and accountable national regulatory bodies to
ancies in authorized products or uses in different countries, international bodies, which are largely unavailable and more
with a common example being DDT, which remains obscure to citizens. As local groups have more involvement in
important in India for malaria control (Abhilash and Singh the process of establishing national regulations, they may be
2009). The MRLs can vary because of different GAPs in more compliant with these as opposed to those set interna-
countries with differing application rates for control of various tionally (Badulescu and Baylis 2006).
pests (FAO 2009). Therefore, residue limits for commodities A number of attempts have been made to harmonize
will differ for different pesticides and markets, although these pesticide standards worldwide by international parties such as
MRLs are still safe (Tables 1 and 2), and pesticides or products the Codex, NAFTA, and the OECD. Although progress has
in the channel of trade must comply with pesticide regulations been made in some areas of regulatory harmonization, it has
from both importing and exporting countries. The EU is been slow. The main reasons for this are that the members
renowned for having one of the strictest regulatory systems in involved work within their own country and are in charge of
the world and is considered a key player internationally with its their nation and its concerns; scientists have different inter-
harmonized approach to pesticide standards among member pretations and opinions, which leads to disagreements and the
states, thus making it a good model for global harmonization need to compromise; the main developed countries (EU and the
(Erlacher and Wang 2011). Currently, in its efforts to compete US) have their own internal priorities, and developing countries
in the global markets, EFSA consults with the WTO before often lack the resources and expertise to manage the reviews on
establishing MRLs. However, since the establishment of the their own. Nonetheless, some progress has been made in the
EU’s harmonized MRL system, many countries (especially establishment of global pesticide MRLs to allow agricultural
developing countries) have struggled to meet the very low produce to move more freely across borders. However, the
MRLs that are specified (Froman 2014). By contrast, number of pesticides with Codex MRLs is limited. Updates to
important deficiencies exist in legislation, registration, and Codex procedures have been proposed and are outlined in
enforcement of pesticides in developing nations (Matthews Verger and Boobis (2013). The OECD has been successful in
et al. 2011; WHO 2011), because of a limited awareness and speeding up the process of harmonizing pesticide standards
understanding of the risks of pesticides (particularly public through their work share program (OECD 2011). The OECD
health pesticides), as well as limited resources (funding and MRL calculator, as discussed previously, harmonizes EU and
facilities) and expertise to develop and enforce legislation. NAFTA procedures as much as possible. The OECD is also
Legislation is often lacking basic elements such as labeling, currently working toward harmonizing pesticide registration
storage, transport, and the disposal of pesticides. Pesticide systems. By the end of 2014, the OECD also envisages all data
registration systems are often underdeveloped and lack submissions for pesticides to be prepared globally whenever
published guidelines of pesticide requirements, as well as the possible, and dossiers in the OECD format will be accepted by
necessary registration requirements such as the requirement to all member countries. Global reviews of new pesticides can help
reregister a pesticide periodically. Therefore, many hazardous greatly with the harmonization process and can also save
or substandard pesticides remain available for use in develop- countries considerable time and resources through work sharing
ing nations. Where legislation is sufficient, compliance (OECD 2011). In developing regions, a number of pesticide
monitoring and enforcement is often inadequate because of collaborations also have been established to help strengthen
a lack of pest control inspectors. regulatory programs, including the association of Southeast
Global harmonization of pesticide legislation and conform- Asian Nations, the African Union, the Community of Andean
ance tests is desirable for all 4 parties involved—pesticide Nations, and the Central American Customs Union.
manufacturers, consumers, farm workers, and regulators (Don While global harmonization is underway, the following key
Wauchope 2008). For consumers, this would result in recommendations are made for its success: Knowledge gaps
increased confidence in the regulatory system and the science regarding the risks of pesticides need to be addressed by
applied, safer pesticides being introduced, a greater variety of research programs; key drivers of pesticide legislation should
Global Harmonization of Pesticide Legislation—Integr Environ Assess Manag 9999, 2015 11

be ranked in order of their importance by each country to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant
establish which to prioritize; the current regulatory systems in protection products on the market. OJEU, L230/1, 19/08/1991, Brussels (BE).
place should each be critically evaluated in terms of their p 1–32.
Damalas CA, Eleftherohorinos IG. 2011. Pesticide exposure, safety issues,
strengths and weaknesses to establish a system that fits all; the
and risk assessment indicators. Int J Environ Res Public Health 8:1402–
benefits and risks of a harmonized system for all parties
1419.
concerned should be examined; considerations should be made Directive 2009/127/EC of 21 October 2009 amending Directive 2006/42/EC with
regarding the individual needs of different countries to regard to machinery for pesticide application. OJEU, L310/29, 25/11/2009,
implement a harmonized system; and improvements should Brussels (BE). p 29–33.
be made to the knowledge base of concerned parties so that Directive 2009/128/EC of 21 October 2009 establishing a framework for
legislation is sufficiently implemented and enforced. community action to achieve the sustainable use of pesticides. OJEU, L309/
71, 24/11/2009, Brussels (BE). p 71–86.
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Pesticide legislation is mostly developed and enforced on a Regulation [Internet]. [Cited 2014 June 27]. Available from: http://www.daff.
gov.au/agriculture-food/ag-vet-chemicals/regulation
regional, as in the EU, or national basis, which causes major
[DOH] Department of Health. 2010. A guide to the use of pesticides in Western
complications in international trade. Developing countries are
Australia: Providing information on legislation, policies and best practice.
particularly affected by the stringency of pesticide legislation in [cited 2014 July 14]. Available from: http://www.health.wa.gov.au/publica-
developed nations. Pesticide MRLs are not harmonized on a tions/documents/11627_Pesticides.pdf
global scale, although international instruments such as Codex Don Wauchope R. 2008. Global harmonisation of pesticide regulation: Greater
have provided MRLs to assist in international trade. Further- transparency of the risk assessment process is a prerequisite. Outlooks on Pest
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additional high compliance costs to producers, which in turn
sanco_pesticides/public/?event=activesubstance.selection
increases food prices. Therefore, single, globally harmonized
[EC] European Commission. 2014. Agricultural trade in 2013: EU gains in
pesticide standards would be beneficial in increasing produc- commodity exports. [cited 20xx Month xx]. Available from: http://ec.europa.
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