NPO No. 023-004
PBO No. 930002175
3rd Floor Greenmarket Place • 54 Shortmarket Street • Cape Town 8001 • South Africa PO Box 5227 • Cape Town 8000 •
South Africa • Tel: (021) 481 3000 • Fax: (021) 423 0935 • Email: angela@lrc.org.za Docex 64
07 September 2009
Registrar Act No 356 of 1947
Private Bag X 343
Pretoria
OOO1
SUBMISSION TO THE DEPARTMENT OF AGRICULTURE,
THE REGISTRAR (ACT 36 OF 1947) ON CHLORPYRIFOS
PROPOSED RESTRICTIONS NOTICE REGARDING THE USE OF CERTAIN AGRICULTURAL
REMEDY (CHLORPYRIFOS)
IN TERMS OF THE FERTILIZERS, FARM FEEDS, AGRICULTURAL REMEDIES AND STOCK
REMEDIES ACT 36 OF 1947 : GNR 816 OF 7 AUGUST 2009
Submitted by LEGAL RESOURCES CENTRE ON BEHALF OF
Dr J Minaar, Ms L Minnar
National Office:
Cape Town:
Durban:
Grahamstown:
Johannesburg
Constitutional Litigation Unit:
J Love (National Director), K Reinecke (Director: Finance), A Reed (Director: Donor Liaison),
JW Pienaar (Director), A Andrews, CM Fortuin, S Kahanovitz, WR Kerfoot, L Kubukeli, C May, HJ Smith,
MR Chetty (Director), S Samuel
S Sephton (Director), K Govender
N Gobodo (Director), S Dhever, N Fakir
G Bizos SC, J Brickhill, A Friedman
2
EXECUTIVE SUMMARY
LEGAL BASIS OF SUBMISSION
Action has recently been taken by the Registrar of Act 36 of 1947 to restrict domestic and
residential exposure to chlorpyrifos. The Registrar has proposed a ban on domestic products
containing certain formulations of chlorpyrifos. Rather than impose a complete ban on the use of
chlorpyrifos in and around residential homes, the Registrar’s decision allows the continued use of
chlorpyrifos in the home, albeit in lesser concentrations than was previously allowed.
Apart from the World Health Organisation (WHO) Guidelines, it is not clear what information has
informed the Registrar’s decision. However, the Registrar appears not to have taken into account
medical information on the neuro-toxicity of chlorpyrifos to the developing foetus and young children
especially (see Section III for a summary of recent scientific findings). In making regulatory
decisions, the Registrar is obliged to take into account all relevant information, and failure to do so
renders the decision reviewable under the Promotion of Administrative Justice Act 3 of 2000
(PAJA).
Alternatively, if this scientific information has been taken it into account, it is submitted that the
Registrar has failed to take a precautionary approach as required by the National Environmental
Management Act 107 of 1998 (NEMA) and international law. The content of the precautionary
principle, and its basis in law, is set out in Section II (3) of the Submission.
Having regard to the scientific findings set out in Section III, it is submitted that the action taken by
government does not go far enough to protect vulnerable persons, especially children, pregnant
women and the developing foetus. The State has a constitutional duty to ‘respect, protect, promote
and fulfil’ the rights in the Bill of Rights, which include the right to life and the right of everyone to an
environment that is not harmful to their health or well-being. Furthermore, in all matters concerning
the care, protection and well-being of a child, the State has a legal duty to apply the standard that
the child’s best interest is of paramount importance. See Section II (2) for a discussion of the
relevant constitutional provisions.
It is submitted further that the State has a legal duty to take all reasonable, positive steps to prevent
foreseeable harm from chlorpyrifos exposure. This duty arises from the Constiution’s Bill of Rights,
section 24 which states that everyone has the right to an environment that is not harmful to their
health or well-being and to have the environment protected through reasonable legislative and other
measures which prevent pollution and ecological degradation. This duty arises particularly in light
of the fact that it is the State’s prior conduct – namely by registering chlorpyrifos as an agricultural
remedy for sale, distribution and use in South Africa - that has created a source of danger of
exposure to chlorpyrifos and consequent dangers to health, particularly for children. (see Section II
(4)),
SCIENTIFIC EVIDENCE SUPPORTING A COMPLETE BAN ON CHLORPYRIFOS
Like other organophosphate compounds, chlorpyrifos inhibits cholinesterase enzymes that play a
key role in the normal functioning of the nervous system. This inhibiting effect can lead to the
accumulation of acetylcholine and the over-activation of its targets, which include muscles, sweat
glands, the digestive system, and heart and brain cells. The clinical symptoms of chlorpyrifos
poisoning can include: headache, dizziness, nausea, vomiting, diarrhoea, shortness of breath and
chest wheezing, eye pupil contraction, blurred vision, excessive salivation, convulsions, involuntary
3
urination and defecation, muscle spasms that may lead to muscle paralysis, and in extreme cases,
death by suffocation resulting from loss of respiratory muscle control.
Recent research indicates that chlorpyrifos is a developmental neurotoxin, which can cause
permanent deficits in neurodevelopment by altering gene expression at levels that seem much
lower than that needed to inhibit acetylcholinesterase. In particular, research demonstrates that lowlevel exposure of children to chlorpyrifos at a pre-natal or early life stage is associated with adverse
cognitive and motor functioning, and behavioural and neuro-psychological problems including
attention-deficit hyperactivity disorder (ADHD), pervasive development disorders (PDD) and autism.
Recent studies also indicate that chlorpyrifos is able to cross the placenta in humans, and cause
foetal death by apoptosis (cell death). Furthermore, studies indicate that chlorpyrifos has an
endocrine disrupting effect by interfering with the thyroid hormone function. This affects both
reproduction and neurodevelopment. There is also data to suggest a causal relation between
exposure to chlorpyrifos and certain types of cancer, including colorectal cancer and lung cancer.
Another basis for serious concern is the level of child poisoning from organophosphate pesticides in
South Africa, which has increased in recent years, and the undocumented and widespread
exposure of children to domestic pesticides that contain chlorpyrifos, as well as the fact that it is
distributed in an unregulated fashion through informal trading in low income areas in unmarked
containers. Proper regard of the socio-economic, behavioural and biological factors that render
children particularly vulnerable to pesticide poisoning requires the State to afford children greater
regulatory protection.
REGULATION OF CHLORPYRIFOS IN FOREIGN JURISDICTIONS
An overview of the regulation of chlorpyrifos in the United States, Canada, the United Kingdom, the
European Union and Australia reveals significant trends in recent regulatory approaches. From
2000, following the emergence of scientific evidence showing that human exposure to chlorpyrifos
is harmful to health through cholinesterase inhibition, steps were taken in the US, Canada, the UK
and the EU to impose a complete ban on domestic uses of chlorpyrifos. Within these jurisdictions,
there remain limited exceptions, such as fully contained ant baits in child-resistance packaging;
limited public health uses (eg. for mosquito control and fire ant mounds); limited use in industrial
settings (eg. manufacturing plants and ship holds); and restricted use on golf courses.
Australia has adopted a less restrictive approach: limiting liquid formulations of chlorpyrifos sold for
domestic use to concentrations of 50g/L or less, banning the use of chlorpyrifos in indoor broadcast
applications involving spraying surface areas such as floors and walls, and strengthening the label
safety instructions and warning requirements. These regulatory measures are of an interim nature
however, and current permissible uses such as mosquito control and granular ant baits are the
subject of ongoing review in Australia.
In the agricultural sector, chlorpyrifos use remains under review, while incremental restrictions are
being enforced across jurisdictions. In the US, restrictions were introduced on the application of
chlorpyrifos on apples, grapes and tomatoes to limit children’s exposure to chlorpyrifos. The limited
extent of these protective measures has been contested in the US, particularly in light of recent
scientific research suggesting the neurotoxic effects of chlorpyrifos. Similar measures have been
taken in Canada, the UK, the European Union and Australia to reduce the maximum residue limits
of chlorpyrifos on foodstuffs. Additional preventive measures have been taken, including reducing
the number of permissible applications of chlorpyrifos per season per crop, reducing the maximum
amount of application per season per crop, and increasing the minimum intervals for retreatment.
4
To address the risks of environmental harm, buffer zones (eg. for groundboom, airblast and aerial
applications of chlorpyrifos) have been variously introduced in the US, Canada, the UK, the
European Union and Australia, as well as no or significantly-reduced pesticide application zones.
The protection of aquatic resources, drinking water supplies and sensitive environmental areas from
spray drift (especially from aerial applications) is an issue currently of primary concern across
jurisdictions.
Another major issue of concern receiving attention in foreign jurisdictions is the health and safety of
agricultural workers. Protective measures that have been introduced include: mandatory warning
statements on chlorpyrifos product labels; establishing re-entry intervals for post-application
workers for incorporation on product labels; the discontinuation of paintbrush applications and
applications with high-pressure handwand equipment; implementing engineering controls and the
addition of personal protective equipment (PPE) for handlers of chlorpyrifos products; mandatory
training programmes for professional pesticide users, distributors and advisors; and mandatory
inspections of pesticide application equipment.
RECOMMENDATIONS
The Department of Agriculture, is called upon to reconsider its proposed restrictions on the use of
Chlorpyrifos in the light of the submissions contained herein, to consider the evidence presented in
this submission on the toxicity and associated risks of chlorpyrifos, and to take the following
reasonable, precautionary steps in accordance with its legal duties:
Part 1
(i) Hold a public enquiry into the future regulation of chlorpyrifos in terms of section 4 of The
Promotion of Administrative Justice Actno 3 of 2000;
(ii) Decide whether the steps set out in the Part 2 hereunder should not be implemented as final
regulatory measures;
(iii) Pending such enquiry impose the limitations contained in Part 2 below, ie paragraphs a), d),
h), l), m) as an interim measure:
Part 2
For Non-Agricultural Uses:
a) Ban chlorpyrifos from any over-the-counter sales for home, garden or other domestic uses, and
ban all private domestic uses accordingly.
b) In the event of any exceptions to (i) above, strictly enforce the requirement of child-proof
containers;
c) Limit all uses of chlorpyrifos to registered Pest Control Operators (PCOs) under strict conditions
of application.
d) Prohibit commercial PCOs from spraying chlorpyrifos in homes, schools, creches,
laygrounds,children’s hospitals, and any other area where children may be exposed.
For Agricultural Uses:
e) Review MRLS in light of new scientific evidence with priority given to the following crops,
grapes, tomatoes, bananas, broccoli, cauliflower;
f) Strengthen label requirements, with mandatory warning statements on all chlorpyrifos product
labels;
5
g) Discontinue applications with high-pressure equipment;
h) Enforce mandatory Personal Protective Equipment – specifically, double layers, chemical
resistant gloves, chemical resistant shoes plus socks, chemical resistant headgear for overhead
exposure, chemical resistant apron when cleaning and mixing or loading and a dust/mist
respirator – for at least the following scenarios: mixing/loading liquids for groundboom and
airblast application, loading granulars for ground application, tractor drawn granular spreader,
and low pressure handwand;
i) Establish re-entry levels for post-application workers for incorporation on product labels;
j) Implement mandatory training for pesticide users, distributors and advisors;
k) Implement mandatory inspections of chlorpyrifos application equipment;
l)
Prohibit aerial spraying of chlorpyrifos; and
m) Establish buffer zones around residential areas; aquatic resources and areas of biodiversity.
n) Prohibit the sale of chlorpyrifos in bulk1 quantities except to registered and authorised buyers.
Should the Department of Agriculture fail to implement these steps our clients reserve the right to
take further legal action in order to protect the public interest.
1
To be determined
6
I.
INTRODUCTION
This submission responds to the decision by the Registrar (Act No. 36 of 1947) to propose restrictions on
agricultural remedies containing chlorpyrifos for household, home garden and domestic use, as published in
Government Notice R816 dated 7 August 2009. Our clients, welcome the restriction of chlorpyrifos use in
South Africa. However, it is submitted that the proposed restrictions do not extend far enough, and must be
made more stringent for the reasons set out in this submission.
This submission petitions the Registrar of Fertilizers, Farm Feeds, Agricultural Remedies and Stock
Remedies to cancel the registration of all agricultural remedies containing chlorpyrifos for
household, home garden, and domestic use in terms of section 4(1)(e) of the Fertilizers, Farm
Feeds, Agricultural Remedies and Stock Remedies Act 36 of 1947 and, in the alternative, the
Minister of the Department of Agriculture (‘the Minister’) to prohibit the acquisition, disposal, sale or
use of chlorpyrifos in all products for household, home garden and domestic use in terms of section
7bis(1) of the Act. The proposed restrictions should, accordingly, constitute only an interim measure
pending the ultimate cancellation of the registration of chlorpyrifos for domestic use, and the
submission petitions the Registrar to effect such cancellation.
The submission further petitions the responsible functionaries to effect certain immediate
restrictions on the agricultural use of chlorpyrifos. The submission requests the Department of
Agriculture to undertake a comprehensive evaluation of the use of chlorpyrifos in the agricultural
sector, and to take all reasonable measures, where necessary in conjunction with other
Departments, to protect human health and the environment. Specific recommended measures are
set out in Section VI.
Chlorpyrifos is an organophosphate pesticide that is registered for agricultural and household use in
South Africa. In agriculture, chlorpyrifos is used to control a broad range of pests on food and feed
crops. In domestic and commercial settings it is used for the control of pests such as cockroaches,
termites, fleas, and mosquitoes. Following the WHO toxicity classification of pesticides, chlorpyrifos
is currently registered by the Department of Agriculture as a Class II ‘moderately hazardous’
pesticide. This classification does not, however, take account of the full spectrum of toxicity
evidenced in recent scientific studies.
7
Like other organophosphate compounds, chlorpyrifos inhibits cholinesterase enzymes that play a
key role in the normal functioning of the nervous system. Chlorpyrifos blocks the ability of
cholinesterase enzymes to deactivate the nerve signalling protein (or ‘neurotransmitter’)
acetylcholine, which carries the signal from a nerve cell to its targets. This can lead to the
accumulation of acetylcholine and the over-activation of its targets, which include muscles, sweat
glands, the digestive system, and heart and brain cells. The clinical symptoms of chlorpyrifos
poisoning are consistent, and can include: headache, dizziness, nausea, vomiting, diarrhoea,
shortness of breath and chest wheezing, eye pupil contraction, blurred vision, excessive salivation,
convulsions, involuntary urination and defecation, muscle spasms that may lead to muscle
paralysis, and in extreme cases, death by suffocation resulting from loss of respiratory muscle
control.2
Recent studies investigating pre-natal and early-life stage exposure to chlorpyrifos suggest that
chlorpyrifos is also a neurodevelopment toxin, which is associated with poor birth outcomes (lower
birth weight and length), adverse cognitive and motor functioning, and behavioural and neuropsychological problems including attention problems, ADHD, PDD and autism.3 Scientific studies
have reported that, at sub-clinical levels, chlorpyrifos may also have endocrine disrupting effects,
which is linked to infertility and adverse neurological development of a foetus or newborn, and that
exposure to chlorpyrifos is associated with certain cancer risks. Section III of this submission
summarises recent scientific evidence supporting a total ban on domestic uses of chlorpyrifos in
South Africa, and stricter regulation of agricultural uses. Section III includes a discussion on the
increasing problem of childhood pesticide poisoning in South Africa, often by ingestion of
organophosphates including chlorpyrifos.
Risks of exposure to chlorpyrifos can arise as a result of dietary exposure, residential exposure to
the chemical post application, for example when the chemical is used as a termiticide and
occupational exposure, for example during mixing/loading liquids for aerial/chemigation and ground
boom application, mixing wettable powder for ground boom application, aerial application and
application by backpack sprayer, high-pressure hand wand and hand-held spray or duster.
US EPA, ‘Revised Human Health Risk Assessment for Chlorpyrifos’ (8 June 2000), available at
http://www.epa.gov/scipoly/sap/meetings/2008/september/hed_ra.pdf.; Australia NRA, ‘Chlorpyrifos: Public
Health Fact Sheet’ (March 2002), available at http://www.health.qld.gov.au/ph/Documents/ehu/8196.pdf.
3 See Section III below.
2
8
Applications of chlorpyrifos also pose risks to small mammals, birds, fish and aquatic invertebrate
species.4
Cancellation of the registration of all household, home garden and domestic-use products
containing chlorpyrifos, coupled with stricter regulation of agricultural uses, would bring South Africa
in line with the regulatory approach adopted in the US, Canada and the European Union (including
the United Kingdom). An overview of the regulatory developments concerning chlorpyrifos in foreign
jurisdictions is contained in Section IV of the submission.
II
LEGAL ANALYSIS
The use of chlorpyrifos in South Africa is regulated under the Fertilizers, Farm Feeds, Agricultural
Remedies and Stock Remedies Act 36 of 1947 (‘the 1947 Act’), and under the auspices of the
Department of Agriculture. In terms of the 1947 Act, chlorpyrifos constitutes an ‘agricultural
remedy’, which is defined in section 1 as ‘any chemical substance or biological remedy, or any
mixture or combination of any substance or remedy intended or offered to be used –
(a) for the destruction, control, repelling, attraction or prevention of any
undesired microbe, alga, nematode, fungus, insect, plant, vertebrate,
invertebrate, or any product thereof, but excluding any chemical
substance, biological remedy or other remedy in so far as it is controlled
under the Medicines and Related Substances Control Act, 1965 (Act 101
of 1965), or the Hazardous Substances Act, 1973 (Act 15 of 1973); or
(b)
as plantgrowth regulator, defoliant, desiccant or legume inoculant,
and anything else which the Minister has by notice in the Gazette declared an agricultural
remedy for the purposes of this Act’
The provisions of the Act upon which this submission is based are sections 4(1)(e) and 7bis(1).
Section 4(1)(e) provides that the Registrar of Fertilizers, Farm Feeds, Agricultural Remedies and
Stock Remedies (‘the Registrar’) may, inter alia, cancel the registration of any agricultural remedy at
US EPA, ‘Interim Reregistration Eligibility Decision for Chlorpyrifos, (February 2002), available at
http://www.epa.gov/oppsrrd1/REDs/chlorpyrifos_ired.pdf, at page 2
4
9
any time ‘if he is satisfied that it is contrary to the public interest’ that such agricultural remedy shall
remain registered.5 Section 7bis(1) empowers the Minister to by notice in the Gazette to –
‘(a)
prohibit the acquisition, disposal, sale or use of fertilizers, farm feeds,
agricultural remedies or stock remedies; or
(b)
prohibit such acquisition, disposal, sale or use, except in accordance with
such conditions as may be specified in the notice or except under the
authority of and in accordance with such conditions as may be specified in
a permit issued by the registrar, and may in like manner repeal or amend any such notice.’
It is submitted the Registrar and the Minister have a legal duty to take further measures to restrict the use of
chlorpyrifos through the exercise of their legislative powers under the 1947 Act. This duty has at least four legal
grounds, which are discussed in turn below.
(1) Duty to take all relevant information into account
In making regulatory decisions on chlorpyrifos, the decision-maker is required in terms of the
Promotion of Administration of Justice Act 3 of 2000 (PAJA) to take into account all relevant
information. Under section 6(2)(e)(iii) of PAJA, administrative action is reviewable ‘because
irrelevant considerations were taken into account or relevant considerations were not considered’. It
is submitted that ‘relevant considerations’ necessarily includes the growing body of scientific
evidence identifying the harmful effects of chlorpyrifos on human health and the environment.
The above principle of administrative law applies equally, if not more stringently, when the decisionmaker exercises a legislative power to act ‘in the public interest’ (as under section 4(1)(e) of the
1947 Act). The implications of the legislative power of a functionary to act in ‘the public interest’
were considered by the Supreme Court of Appeal in the Pepcor case.6 Cloete JA held that, to be
lawful, such a power must be exercised properly, and on the basis of true facts. Moreover, where
an initial decision was made in ignorance of the material facts, the functionary should (depending
on the legislation involved and the nature and functions of the public body) be entitled to seek
judicial review of the decision in light of the true facts. Cloete JA stated as follows:
5
Emphasis added.
Retirement Fund and Another v Financial Services Board and Another 2003 (6) SA 38 (SCA).
6 Pepcor
10
If legislation has empowered a functionary to make a decision, in the public interest, the
decision should be made on the material facts which should have been available for the
decision properly to be made. And if a decision has been made in ignorance of facts material to
the decision and which therefore should have been before the functionary, the decision
should…be reviewable at the suit of, inter alios, the functionary who made it – even although
the functionary may have been guilty of negligence and even where a person who is not guilty
of fraudulent conduct has benefited by the decision. The doctrine of legality which was the
basis of the decisions in Fedsure, Sarfu and Pharmaceutical Manufacturers requires that the
power conferred on a functionary to make decisions in the public interest, should be exercised
properly, i.e. on the basis of the true facts; it should not be confined to cases where the
common law would categorise the decision as ultra vires.7
(2) Duty to protect and promote the rights in the Bill of Rights
In exercising public power, functionaries must have regard to the fundamental rights in the
Constitution, and the paramount duty on the State to respect, protect, promote and fulfil the rights in
the Bill of Rights.8 The advancement of human rights and freedoms, and adherence to
constitutional imperatives, is foundational to our democracy. Section 2 of the Constitution provides
that the Constitution is ‘the supreme law of the Republic’, such that ‘law or conduct inconsistent with
it is invalid, and the obligations imposed by it must be fulfilled’.
The centrality of the Bill of Rights is expressed in section 7(1) of the Constitution, which provides:
‘This Bill of Rights is the cornerstone of democracy in South Africa. It enshrines the rights of all
people in our country and affirms the democratic values of human dignity, equality and freedom’.
Under section 7(2), the State has a constitutional duty to ‘respect, protect, promote and fulfil the
rights in the Bill of Rights’.
The provisions of the Bill of Rights bind the State as well as natural and juristic persons, as
expressed in section 8:
7
Pepcor Retirement Fund and Another v Financial Services Board and Another 2003 (6) SA 38 (SCA)
para 47.
8 Section 7(2) of the Constitution of the Republic of South Africa, 1996.
11
‘8(1) The Bill of Rights applies to all law, and binds the legislature, the executive, the
judiciary and all organs of state.
(2) A provision of the Bill of Rights binds a natural or a juristic person, if, and to the extent
that, it is applicable, taking into account the nature of the right and the nature of any duty
imposed by the right.’
The Constitutional Court has repeatedly emphasised that constitutional rights must be generously
interpreted.9 The Constitution also lays down certain principles of interpretation. These are
embodied in s 39 of the Constitution, which provides:
‘39(1) When interpreting the Bill of Rights, a court, tribunal or forum –
(a)
must promote the values that underlie an open and democratic society
based on human dignity, equality and freedom;
(b)
must consider international law; and
(c)
may consider foreign law;
(2) When interpreting any legislation, and when developing the common law or
customary law, every court, tribunal or forum must promote the spirit, purport and
objects of the Bill of Rights.
(3) …’
The meaning and import of the injunction contained in s 39(2) has been stated by the Constitutional
Court as follows:
This means that all statutes must be interpreted through the prism of the Bill of Rights. All
law-making authority must be exercised in accordance with the Constitution.10
The relevant provisions in the Bill of Rights, which must inform the exercise of regulatory power by
the Department with regard to the registration of harmful agricultural remedies, include:
9
S v Zuma and Others 1995 (2) SA 642 (CC). See especially para 14 where the Constitutional Court
approved the following passage from a judgment of Lord Wilberforce in Minister of Home Affairs (Bermuda v
Fisher [1980] AC 319 (PC 328-9: ‘[A supreme constitution requires] a generous interpretation…suitable to
give to individuals the full measure of the fundamental rights and freedoms referred to….’ See also S v
Mhlungu 1995 (3) SA 391 (CC).
10 Investigating Directorate: Serious Offences v Hyundai Motor Distributors (Pty) Ltd: In re Hyundai Motor
Distributors (Pty) Ltd v Smit NO 2001 (1) SA 545 (CC), para 21.
12
(i)
The right to life
The entrenchment of an unqualified right to life in the Constitution requires the state to take a
leading role in affirming respect for human life and dignity. This obligation was articulated by the
Constitutional Court in the case of S v Makwanyane, where Langa CJ held that the state should be
‘a role model’ for our society by demonstrating society’s regard for human life.11 Importantly, the
right to life imposes a positive duty on the state to protect the lives of its citizens. 12 Moreover, the
right to life incorporates a right to an existence consonant with human dignity, which the State must
protect. As O’Regan J stated in S v Makwanyane:
The right to life is, in one sense, antecedent to all the other rights in the Constitution.
Without life in the sense of existence, it would not be possible to exercise rights or to be
the bearer of them. But the right to life was included in the Constitution not simply to
enshrine the right to existence. It is not life as mere organic matter that the Constitution
cherishes, but the right to human life: the right to share in the experience of humanity. This
concept of human life is at the centre of our constitutional values. The Constitution seeks
to establish a society where the individual value of each member of the community is
recognised and treasured…The right to life, thus understood, incorporates the right to
dignity. So the rights to human dignity and life are entwined….13
(ii) Children’s rights
Section 28(2) of the Constitution provides that ‘A child’s best interests are of paramount importance
in every matter concerning the child’. Section 9 of the Children’s Act 38 of 2005 similarly states: ‘In
all matters concerning the care, protection and well-being of a child the standard that the child’s
best interest is of paramount importance, must be applied.’ The ‘best interests of the child’ principle
is affirmed in international instruments, including Article 3 of the 1989 UN Convention on the Rights
11
S v Makwanyane 1995 (3) 391 (CC), per Langa J at paras 83-5.
See Carmichele v Minister of Safety and Security 2001 (4) SA 938 (CC), para 45 especially; Minister of
Safety and Security v Hamilton 2001 (3) SA 50 (SCA); Minister of Safety and Security v Van Duivenboden
2002 (6) SA 431 (SCA); Mohamed v President of the Republic of South Africa 2001 (3) SA 893 (CC).
13 S v Makwanyane (n 10), per O’Regan J at paras 326-7. See also para 271 (Mahomed J); para 311
(Mokgoro J). The statement was approved by the majority of the court in Soobramoney v Minister of Health
(Kwazulu-Natal) 1998 (1) SA 765 (CC) para 31.
12
13
of the Child (ratified by South Africa in 1995),14 and Article 4 of the 1990 African Charter on the
Rights and Welfare of the Child (ratified by South Africa in 2000).15 Article 4 of the African Charter
imposes a broad duty on officials, as it provides that ‘In all actions concerning the child undertaken
by any person or authority the best interests of the child shall be the primary consideration.’
In the specific context of the regulation of pesticides and other agricultural remedies containing
chlorpyrifos, consideration of the well-being of children is particularly important. As discussed
more fully in Section III of this submission, children are especially vulnerable to certain
detrimental effects of organophosphates such as chlorpyrifos. Moreover, children are often at
greater risk of exposure to pesticides used in and around the home, both by absorption through
the skin of floor and carpet residues, as well as through inhalation of higher pesticide
concentrations in the less ventilated, infant breathing zone nearest the floor. The level of child
poisoning from pesticide ingestion in South Africa is also of serious concern, as is discussed in
Section III (5).
(iii) Environmental rights
The environmental rights under section 24 of the Constitution provide:
‘Everyone has the right (a) to an environment that is not harmful to their health or well-being; and
(b) to have the environment protected, for the benefit of present and future generations,
through reasonable legislative and other measures that (i)
prevent pollution and ecological degradation;
(ii)
promote conservation; and
(iii) secure ecologically sustainable development and use of natural resources while
promoting justifiable economic and social development.’
By virtue of s 24, environmental considerations, often ignored in the past, have now been given
rightful prominence by their inclusion in the Constitution. Describing this elevation to prominence, it
was stated in Director: Mineral Development, Gauteng Region and Another v Save the Vaal
Environment and Others16 that:
14
Adopted and opened for signature, ratification and accession by General Assembly resolution 44/25 of 20
November 1989, entered into force 2 September 1990.
15 OAU Doc. CAB/LEG/24.9/49 (1990), entered into force 29 November 1999.
16 1999 (2) SA 709 (SCA) at 719C – D.
14
Our Constitution, by including environmental rights as fundamental, justiciable human rights,
by necessary implication requires that environmental considerations be accorded
appropriate recognition and respect in the administrative processes in our country. Together
with the change in the ideological climate must also come a change in our legal and
administrative approach to environmental concerns.
In overseeing the registration of chlorpyrifos, the Department of Agriculture, and particularly the
Registrar of Act 36 of 1947, is at the centre of an administrative process which fundamentally
concerns the right of every person to an environment that is not harmful to their health or wellbeing. Regard must be had to the importance of the environmental rights guaranteed in the
constitution, which was articulated by Claassen J in BP Southern Africa (Pty) Ltd v MEC for
Agriculture, Conservation, Environment and Land Affairs:17
[T]he constitutional right to environment is on a par with the rights to freedom of trade,
occupation, profession and property entrenched in ss 22 and 25 of the Constitution. In any
dealings with the physical expressions of property, land and freedom to trade, the
environmental rights requirements should be part and parcel of the factors to be considered
without any a priori grading of the rights…The balancing of environmental interests with
justifiable economic and social development is to be conceptualised well beyond the interests
of the present living generation. This must be correct since s 24(b) requires the environment to
be protected for the benefit of 'present and future generations.
(3) Duty to exercise a precautionary approach
The Department is required to exercise a precautionary approach when making regulatory
decisions in terms of the environmental management principles set out in the National
Environmental Management Act 107 of 1998 (NEMA). NEMA came into operation on 29 January
1999, to give effect to the environmental rights in section 24 of the Constitution. The purpose of
NEMA is –
To provide for co-operative environmental governance by establishing principles for
decision-making on matters affecting the environment, institutions that will promote co17
2004 (5) SA 124 (W).
15
operative governance and procedures for co-ordinating environmental functions exercised
by organs of State; to provide for the prohibition, restriction or control of activities which are
likely to have a detrimental effect on the environment; and to provide for matters connected
therewith.
Section 1(1) of NEMA defines ‘environment’ in broad terms as ‘the surroundings within which
humans exist’ and that are made up, inter alia, of ‘chemical properties…that influence human health
and well-being’.18
Section 2 of NEMA sets out the environmental management principles that ‘apply throughout the
Republic to the actions of all organs of state that may significantly affect the environment’. The
umbrella-nature of the NEMA principles is emphasised in section 2(1)(c), which stipulates that the
principles must ‘serve as guidelines by reference to which any organ of state must exercise any
function when taking any decision in terms of this Act or any statutory provision concerning the
protection of the environment’.
Several NEMA principles are relevant to, and must therefore inform, the exercise of regulatory
powers under the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act. These
include –
–
Section 2(2): ‘Environmental management must place people and their needs at the
forefront of its concern, and serve their physical, psychological, developmental, cultural and
social interests equitably’;
–
Section 2(4)(a)(vii): ‘[T]hat a risk averse and cautious approach is applied, which takes into
account the limits of current knowledge about the consequences of decisions and actions’;
18
The full definition of ‘environment’ in section 1 of NEMA reads:
‘the surroundings within which humans exist and that are made up of (i) the land, water and atmosphere of the earth;
(ii) micro-organisms, plant and animal life;
(iii) any part or combination of (i) and (ii) and the interrelationships among and between them; and
(iv) the physical, chemical, aesthetic and cultural properties and conditions of the foregoing that
influence human health and well-being’.
16
–
Section 2(4)(a)(viii): ‘[T]hat negative impacts on the environment and on peoples’
environmental rights be anticipated and prevented, and where they cannot altogether be
prevented, are minimised and remedied’;
–
Section 2(4)(c): ‘Environmental justice must be pursued so that adverse environmental
impacts shall not be distributed in such a manner as to unfairly discriminate against any
person, particularly vulnerable and disadvantaged persons’;
–
Section 2(4)(e): ‘Responsibility for the environmental health and safety consequences of a
policy, programme, project, product, process, service or activity exists throughout its life
cycle’;
–
Section 2(4)(g): ‘Decisions must take into account the interests, needs and values of all
interested and affected parties, and this includes recognising all forms of knowledge,
including traditional and ordinary knowledge’;
–
Section 2(4)(i): ‘The social, economic and environmental impacts of activities, including
disadvantages and benefits, must be considered, assessed and evaluated, and decisions
must be appropriate in the light of such consideration and assessment’;
–
Section 2(4)(j): ‘The right of workers to refuse work that is harmful to human health or the
environment and to be informed of dangers must be respected and protected’;
Of these principles, the most important for the purposes of this submission are: the principle in
section 2(2), which recognises that environmental management fundamentally concerns the
protection of human rights; the ‘precautionary principle’ in section 2(4)(a)(vii) and the ‘preventive
principle’ in section 2(4)(a)(viii).
Both the precautionary principle and the preventive principle have acquired the status of
international law norms,19 and are thus also binding on the State as such. Under section 39(1) of
19
For a compilation of the international conventions incorporating the precautionary principle see Briefing
Paper of Pesticide Action Network (PAN) International on the Precautionary Principle at 3, available at
http://www.panap.net/uploads/media/PAN_Precaution_14_Sep_06.pdf (accessed 19 March 2009). See also
P. Sands Principles of International Environmental Law 2ed (Cambridge: Cambridge UP, 2003) at 246-279.
See, especially, the European Commission’s Communication on the precautionary principle, which
recognizes it to have been ‘progressively consolidated in international environmental law, and so it has since
17
the Constitution, international law must be considered when the rights in the Bill of Rights are
interpreted, in this case the right to a healthy environment (section 24 of the Constitution).
The preventive principle seeks to minimise environmental damage as an object in itself, and
requires action to be taken at an early stage, if possible before damage has actually occurred.20 The
precautionary principle aims to provide guidance in environmental management decision-making
where there is scientific uncertainty.21 Most important, the principle permits a lower level of proof of
harm to be used in policy making whenever the consequences of waiting for higher levels of proof
may be very costly and/or irreversible. The core of the precautionary principle was enunciated in
Principle 15 of the Rio Declaration from the 1992 UN Conference on Environment and
Development:
Where there are threats of serious or irreversible damage, lack of full scientific certainty shall
not be used as a reason for postponing cost-effective measures to prevent environmental
degradation.22
The 1998 Wingspread Conference on Implementing the Precautionary Principle included human
health in its definition of the precautionary principle:
When an activity raises threats of harm to human health or the environment,
precautionary measures should be taken even if some cause and effect relationships
are not fully established scientifically.23
The precautionary principle has been incorporated into many international instruments in
increasingly far-reaching terms. Many conventions now commit their parties to prevent harm to
human health and the environment, even if scientific evidence is inconclusive. For example,
become a full-fledged and general principle of international law’. COM 2000(1), 2 February 2000, available at
http://europa.eu.int/comm/dgs/health_consumer/library/pub/pub07_en.pdf).
20 Sands ibid at 246-247.
21
In 2000, the European Commission Communication on the Precautionary Principle stated:
The precautionary principle applies where scientific evidence is insufficient, inconclusive or uncertain and
preliminary scientific evaluation indicates that there are reasonable grounds for concern that the potentially
dangerous effects on the environment, human, animal or plant health may be inconsistent with the high level of
protection chosen by the EU.
22
UN General Assembly, Report of the United Nations Conference on Environment and Development (Rio de Janeiro,
3-14 June 1992) Annex I, A/CONF.151/26 (vol. I), available at http://www.un.org/documents/ga/conf151/aconf151261annex1.htm (accessed 19 March).
23
Wingspread Conference on the Precautionary Principle, 26 January 1998, available at
http://www.sehn.org/wing.html.
18
addressing the issue of hazardous substances, the parties to the 1992 Watercourses Convention
agreed to be guided by the precautionary principle
by virtue of which action to avoid the potential transboundary impact of the release of
hazardous substances shall not be postponed on the ground that scientific research has not
fully proved a causal link between those substances, on the one hand, and the potential
transboundary impact, on the other.
Similarly the 1992 OSPAR Convention provided for preventive measures to be taken when there
are ‘reasonable grounds for concern…even where there is no conclusive evidence of a causal
relationship between the inputs and the effects’; while the 1992 Baltic Sea Convention provided for
preventive measures ‘when there is reason to assume’ that harm might be caused ‘even when
there is no conclusive evidence of a causal relationship between inputs and their alleged effects’.
There is increasing support in state practice for an interpretation of the precautionary principle that
shifts the burden of proof onto the party who wishes to carry out an activity to prove that it will not
harm human health or the environment.24 In its most recently proposed Regulation on the placing of
pesticides in the European Union market (approved by the European Parliament on 23 October
2007),25 the European Commission invokes the precautionary principle to impose an onus on
industry to demonstrate the safety of their products, particularly in respect of vulnerable groups of
the population:
The purpose of this Regulation is to ensure a high level of protection of both human and
animal health and the environment. Particular attention should be paid to the protection
of vulnerable groups of the population, including pregnant women, infants and children.
The precautionary principle should be applied and ensure that industry demonstrates
that substances or products produced or placed on the market do not adversely affect
human health or the environment.26
See, for example, the European Community’s 1991 Urban Waste Water Directive, 91/271 article 6(2); and
the 1992 OSPAR Convention, Annex II, article 3(3)(c).
25
European Parliament legislative resolution of 23 October 2007 on the proposal for a regulation of
the European Parliament and of the Council concerning the placing of plant protection products on
the market (COM(2006)0388 — C6-0245/2006 — 2006/0136(COD)), available at http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2008:263E:0181:0182:EN:PDF (accessed 19 March
2009).
26 Commission of the European Communities, Proposal for a Regulation of the European Parliament and of the Council
concerning the placing of plant protection products on the market COM (2006) 388 final (Brussels, 2006) at 14
24
19
Similarly, the new European Community Regulation concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH), which came into force on 1 June 2007, is
based on the idea that industry itself is best placed to ensure that the chemicals it manufactures
and puts on the market in the EU do not adversely affect human health or the environment. The
Regulation requires that manufacturers and importers obtain relevant information on their
substances and use that data to manage potential risks; while authorities focus their resources on
ensuring that industry meet their obligations and taking action on substances of very high concern
or where there is a need for Community action.27
It is submitted that such an approach should be adopted by the Department in considering the
future registration of chlorpyrifos in South Africa, such that an onus is imposed on the registrationholders to show that chlorpyrifos-use is not harmful to human health or the environment. This
approach is congruent with the principle of responsibility in NEMA, section 2(4)(e) (cited in full
above), and is of particular importance where there is significant scientific evidence suggestive – as
in the case of chlorpyrifos – of harmful effects to humans and the environment. Moreover, this
approach takes necessary cognisance of the vulnerability and limited knowledge of the risks
associated with chlorpyrifos among persons directly affected by its use.
In addition, the precautionary approach, read with the preventive and protective principles and the
relevant constitutional provisions, imposes a responsibility on the regulatory body – that is the
Registrar (Act 36 of 1947) – to monitor the effects of chlorpyrifos and to ensure that its registered
uses do not cause harm to the environment or human health.
(emphasis added), available at http://ec.europa.eu/food/plant/protection/evaluation/com2006_0388en01.pdf (accessed 19
March 2009)
27 Regulation (EC) No.1907/2006 of the European Parliament and of the Council, 18 December 2006,
available at http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1907: EN:NOT (accessed
19 March 2009). See also European Commission, Environment Directorate General REACH in Brief (October
2007) 4, available at http://ec.europa.eu/environment/chemicals/
reach/pdf/2007_02_reach_in_brief.pdf (accessed 19 March 2009). It should be noted that REACH does not
apply to chlorpyrifos, as active substances and co-formulants for use in plant protection products (pesticides)
are regarded as registered (subject to specified conditions), as the plant protection products and their active
ingredients and co-formulants are covered by Directive 91/414/EEC (Directive on plant protection products)
and in principle undergo a thorough assessment, on the basis of already submitted substantial information,
before they can be placed on the market. Active substances for use in biocidal products are also regarded as
registered as biocidal active substances and biocidal products, and are covered by Directive 98/8/EC
(Biocidal Products Directive).
20
In assessing the risks of chlorpyrifos use in terms of the precautionary approach, it is
submitted that the following associated principles and considerations must be taken into
account:28
(i)
The substitution of harmful pesticides with suitable, less harmful alternatives, including
agro-ecological methods, and holistic approaches to control pests, weeds, and diseases
(viz the ‘substitution principle’);29
(ii)
Regulation on the basis of the most vulnerable groups affected, for example pregnant
women, the unborn foetus and the newly-born child;
(iii)
Reliance on a full data set including long-term, cumulative effects before pesticides are
released into the environment. This requirement acknowledges the problem of ongoing
low doses exposures to combinations of chemicals and cumulative effects of small
doses;
(iv)
Recognition of the experiences of workers and communities with regard to adverse
effects of pesticides;
(v)
The right of those using or exposed to pesticides to know what it is they are exposed to,
and the hazardous properties of the pesticide. Without such knowledge they cannot take
precautionary measures themselves to avoid potential harm; and
(vi)
The right of popular participation in decision-making regarding pesticide regulation,
including active participation in national pesticides committees.
(4) Duty to act positively to prevent reasonably foreseeable harm
The State’s legal duty to take positive steps to prevent reasonably foreseeable harm from
chlorpyrifos exposure arises too by virtue of the State’s prior conduct. By registering chlorpyrifos as
28
Adapted from Briefing Paper of Pesticide Action Network (PAN) International on the Precautionary Principle
at 6.
29 The substitution principle is included in the new European Community Regulation concerning the
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). All companies applying for
authorisation of chemical substances are required to provide an analysis of alternatives considering their risks
and the technical and economic feasibility of substitution.
21
an agricultural remedy for sale, distribution and use in South Africa, the State has created a source
of danger of harmful exposure to chlorpyrifos – a danger that the State is obliged to take steps to
guard against. The ‘prior conduct doctrine’ has long been part of South African law,30 although it has
been incorporated into the broader ‘legal convictions of the community’ test for a legal duty
articulated in the Ewels case.31 In Minister of Safety and Security v Van Duivenboden,32 the
Supreme Court of Appeal held that the Ewels test for a legal duty ‘must necessarily now be
informed by the norms and values of our society as they have been embodied in the 1996
Constitution’.33 It is submitted that the legal convictions of the community require the State
functionaries concerned to take all reasonable steps to prevent harm from exposure to chlorpyrifos
(as specified in Section V). This ‘legal conviction’ is informed by, and indeed reflected in, the
provisions and norms of the Constitution, the environmental management principles contained in
NEMA and international law, and the particular responsibility of the Registrar to act ‘in the public
interest’. This duty arises particularly in light of the fact that it is the State’s prior conduct – namely
by registering chlorpyrifos as an agricultural remedy for sale, distribution and use in South Africa that has created a source of danger of exposure to chlorpyrifos and consequent dangers to health,
particularly for children. (see Section III below),
III.
SCIENTIFIC FINDINGS SUPPORTING A COMPLETE BAN ON
CHLORPYRIFOS
Recent research indicates that chlorpyrifos is a developmental neurotoxin and exposure to children
and pregnant women should be strictly limited. The regulation of chlorpyrifos must take into
consideration the full spectrum of its toxicity, having proper regard to recent scientific findings. The
findings summarised below trigger the precautionary approach, and require the State to take
protective measures where preliminary scientific evaluation – albeit insufficient, inconclusive or
uncertain – indicates reasonable grounds for concern.
In 2000, when the United States Environmental Protection Agency (EPA) compelled the
manufacturers of chlorpyrifos to ‘voluntarily’ cancel registrations for all residential uses of
30
Halliwell v JMC 1912 AD 659; Municipality of Bulawayo v Stewart 1916 AD 357; CTM v Clohessy 1922 AD 4; De
Villiers v JHB Municipality 1926 AD; Moulang v PE Municipality 1958 (2) SA 518 (A); Administrator, Cape v Preston
1961 (3) SA 562 (A).
31
Minister van Polisie v Ewels 1975 (3) SA 590 (A).
32
2002 (6) SA 431 (SCA).
33
At para 17.
22
chlorpyrifos, the EPA did so on the basis of the scientific evidence showing that human exposure to
chlorpyrifos causes adverse health effects, many of which are suspected of being the result of the
substance’s well-know capacity to inhibit acetylcholinesterase (AChE), a key enzyme required for
normal neurotransmission. Similar concerns motivated the restriction of chlorpyrifos in Canada,
Europe and Australia. The inhibition of AChE can lead to the accumulation of acetylcholine and the
over-activation of its targets, which include muscles, sweat glands, the digestive system, and heart
and brain cells. The clinical symptoms of chlorpyrifos poisoning can include: headache, dizziness,
nausea, vomiting, diarrhoea, shortness of breath and chest wheezing, eye pupil contraction, blurred
vision, excessive salivation, convulsions, involuntary urination and defecation, muscle spasms that
may lead to muscle paralysis, and in extreme cases, death by suffocation resulting from loss of
respiratory muscle control. 34
New scientific information has emerged since 2000, which indicates that chlorpyrifos toxicity is not
limited to cholinesterase inhibition alone but can cause harm by other mechanisms. This evidence
is extremely significant to future efforts to regulate chlorpyrifos. In 2009, we know much more about
the dangers of exposure to chlorpyrifos: it can cause permanent deficits in neurodevelopment by
altering gene expression at levels that seem much lower than that needed to inhibit
acetylcholinesterase (AChE) by interfering with neural cell replication and differentiation, and with
synapse development and function. In particular, research demonstrates that low-level exposure of
children to chlorpyrifos at a pre-natal or early life stage is associated with adverse cognitive and
motor functioning, and behavioural and neuro-psychological problems including attention-deficit
hyperactivity disorder (ADHD), pervasive development disorders (PDD) and autism. Recent studies
also indicate that chlorpyrifos is able to cross the placenta in humans, and cause foetal death by
apoptosis (cell death). The significance of the new scientific evidence pertaining to chlorpyrifos
(CPF) is described by Colborn:35
It would be difficult to find another pesticide in use today that has been as systematically
studied as CPF [chlorpyrifos]. The amazing litany of diverse mechanisms discovered in the
series of CPF studies raises serious questions about the safety of not only CPF and the other
Ops [organophosphates] but all pesticides in use today. Most astounding is the fact that a large
part of CPF’s toxicity is not the result of cholinesterase inhibition, but of other newly discovered
US EPA, ‘Revised Human Health Risk Assessment for Chlorpyrifos’ (8 June 2000), available at
http://www.epa.gov/scipoly/sap/meetings/2008/september/hed_ra.pdf.; Australia NRA, ‘Chlorpyrifos: Public Health Fact
Sheet’ (March 2002), available at http://www.health.qld.gov.au/ph/Documents/ehu/8196.pdf.
35
T Colborn (2006) ‘A Case for Revisiting the Safety of Pesticides: A Closer Look at
Neurodevelopment’, Environmental Health Perspectives 114(1):10-17.
34
23
mechanisms that alter the development and function of a number of regions of the brain and
CNS. These findings send a warning that even though an OP pesticide like CPF may have a
very high EC50 (concentration that produces 50% of the maximum possible effective response)
for acute toxicity as a result of cholinesterase inhibition, it may have other toxic strategies that
are far more egregious than cholinesterase inhibition.
Furthermore, studies indicate that chlorpyrifos has an endocrine disrupting effect by interfering with
the thyroid hormone function. This affects both reproduction and neurodevelopment. There is also
data to suggest a causal relation between exposure to chlorpyrifos and certain types of cancer,
including colorectal cancer and lung cancer.
Another basis for serious concern is the level of child poisoning from organophosphate pesticides in
South Africa, which has increased in recent years, and the undocumented and widespread
exposure of children to domestic pesticides containing chlorpyrifos.36 Proper regard of the socioeconomic, behavioural and biological factors that render children particularly vulnerable to pesticide
poisoning, requires the State to afford children greater regulatory protection against pesticide
poisoning.
If there was good cause to prohibit consumer use of chlorpyrifos in 2000, then there is now
compelling cause to prohibit consumer use and restrict agricultural use of chlorpyrifos in 2009.
(1) Neurotoxicity of chlorpyrifos: Long-Lasting Effects from Early Exposure in Children
Below is a summary of the most recent data on chlorpyrifos (CPF) outlining the results of in vitro
and in vivo laboratory studies37 as well as epidemiological studies in humans showing that CPF may
affect the foetus and young at lower levels than previously thought and that the effects of exposure
during the prenatal and early postnatal period could result in permanent harmful effects. Much of
the recent research on the effects of CPF has focused on the effects of exposure to low
concentrations of CPF during early development. The in vitro and in vivo work in animal models has
revealed new evidence about the effects of what are considered to be subtoxic levels of this
organophosphate on the placenta as well as the developing brain and the consequent effects in
36
For example, the South African Medical Journal of March 2009 contains a research report indicating that 73% of
urban children are exposed to pesticide usage in the home, and 6% are exposed to chlorpyrifos containing pesticides.
37
In science, in vivo refers to experimentation done in or on the living tissue of a whole, living organism as opposed to a
partial or dead one or a controlled environment. Animal testing and clinical trials are forms of in vivo research. In vitro
refers to the technique of performing a given procedure in a controlled environment outside of a living organism.
24
later life. Epidemiological work looking at in utero (or foetus) exposure to CPF indicates that the
effects of CPF observed in the laboratory may also occur in humans.
(i)
Laboratory Research on Animals
Data emerging from cell culture and animal models provides evidence that CPF is harmful to cells
of the nervous system. In the last few years, research has shown that the developing brain is more
susceptible to neurotoxic injury than the adult brain and developmental neurotoxicity can have longterm and permanent consequences such as attention deficit disorder, learning or cognitive
problems and autism spectrum disorders. 38
CPF was found to be toxic to cultured glial cells of the nervous system, in vitro triggering cell death
by inducing oxidative stress.39 Glial cells are essential for neuronal functioning, serving to provide
nourishment, physical support, and protection for the cells which transmit nerve impulse. Damage
to glial cells in the nervous system is a major component of chemically-induced neurotoxicity. 40
Glial cells also play an important role during development, guiding the migration of newborn
neurons during early development, and promoting the maturation and modification of neural cells.
Hence, damage to glial cells due to exposure to CPF during early development could result in
abnormal neurodevelopment.
The results from studies using in vivo animal models also suggest that exposure to CPF even at
levels that are currently considered to be safe during early development may have long term
effects. Eaton et al reviewed several studies investigating the developmental neurotoxicity of CPFs
using in vivo animal models.41 Using different methodologies, these studies detected neurochemical
and /or behavioural effects of CPF at levels that caused inhibition of brain and/or plasma AChE
activity. Significantly, some studies also showed effects of CPF at levels which did not inhibit AChE
activity indicating that other mechanism/s may account for the consequences of CPF exposure. For
SL Connors, P Levitt, SG Matthews et al. (2008) ‘Fetal Mechanisms in Neurodevelopmental Disorders’, Paediatric
Neurology 38: 163-176.
39
MD Saulsbury, SO Heylinger, K Wang & DJ Johnson (2009) ‘Chlorpyrifos induces oxidative stress in
oligodendrocyte progenitor cells’, Toxicology (E-pub).
40
L Overstreet (2005) ‘Quantal transmission: not just for neurons’, Trends Neurosc. 28(2): 59-62.
41
DL Eaton, RB Daroff, H Autrup et al (2008) ‘Review of Chlorpyrifos with an emphasis on human exposure and
neurodevelopment’, Critical Reviews in Toxicology Supplement 2: 1-125.
38
25
example, Slotkin and Seidler42 found that rats exposed prenatally to CPF at doses which did not
inhibit AChE activity in the foetal brain elicited changes in dopamine and serotonin presynaptic
activity at adolescence. They found that the effects of CPF were dependent on the stage of
development at which exposure occurred, indicating longer lasting effects of CPF exposure in utero.
(ii)
Human Studies
Several epidemiological studies have been carried out to ascertain if there is any association
between organophosphates and neurological development in humans. In 2008, Eaton et al
reviewed the work of groups which looked specifically at the effects of CFP and its metabolites. 4
These studies were carried out at three American institutions namely, Columbia University, the
University of California, and the Mount Sinai School of Medicine. The principal findings of each
study are summarised below.
The Columbia University group looked at a cohort of minority inner-city mothers and their infants
who had been exposed to high levels of chlorpyrifos through domestic pesticide use in New York
City. Using maternal and umbilical cord plasma CPF levels as a measure of CPF exposure, this
investigation indicated that CPF exposure was associated with decreased birth weight and length43.
The results of further work by this group supported this conclusion. 44 In addition, it was observed
after 2001, when the Environmental Protection Agency in the USA revised and limited the use of
CPF, that CPF exposure was lower and the associated adverse effects on birth weight and length
were diminished.
Subsequent work on the New York cohort by Rauh et al showed that at 3 years of age, children
who had been exposed pre-natally to higher levels of chlorpyrifos were significantly more likely to
score in the clinical range for attention problems, ADHD problems, and PDD problems than were
children with lower levels of foetal exposure to chlorpyrifos. Children with prenatal chlorpyrifos
exposure also had greater mental and motor delays by the age of 3, and over time they
experienced adverse cognitive and psychomotor effects. The study concludes that while it is not
TA Slotkin and FJ Seideler (2007) ‘Prenatal chlorpyrifos exposure elicits presynaptic serotonergic and dopaminergic
hyperactivity at adolescence: Critical periods for regional and sex-selective effects’, Reproductive Toxicology 23: 421427.
43
FP Perera, VA Rauh, WY Tsai et al (2003) ‘Effects of transplacental exposure to environmental pollutants on
birthoutcomes in a multiethnic population’, Environ. Health Perspect 111:201-205.
44
RM Whyatt, VA Rauh, DB Barr et al (2004) ‘Prenatal insecticide exposure and birth weight and length among an
urban minority cohort’, Environ. Health Perspect.112:1125-32.
42
26
clear, on the basis of the present report, exactly how prenatal chlorpyrifos exposure might affect the
onset of clinically diagnosed ADHD, or whether there is a dose-response relationship with the
severity of ADHD symptoms, the finding of significant associations between chlorpyrifos exposure
and behavioural problems deserves additional study. 45 The results of the study were summarised
as follows:
Three substantive findings emerged from the study. First, by 3 years of age, significantly
greater proportions of highly exposed children scored in the range of mental and motor delays,
compared with those with lower exposures. After adjustment for the effects of covariates, highly
exposed children scored, on average, 6.5 points lower on the test of motor development (P
_.003) and 3.3 points lower on the test of mental development (P _.06) at 3 years of age than
did those with lower levels of exposure. Second, the developmental trajectories for PDI and
MDI scores confirmed that adverse cognitive and psychomotor effects increased over time and
these effects were present in both Dominican and black subjects, which supported the main
conclusion of the study. Third, at 3 years of age, children who were exposed prenatally to high
levels of pesticides were significantly more likely to score in the clinical range for attention
problems, ADHD problems, and PDD problems than were children with lower levels of
chlorpyrifos exposure.
The study conducted by the group at the University of California examined a group of pregnant
mothers and their children from a chiefly agricultural area who were chronically exposed to
organophosphates including chlorpyrifos but found no relationship between organophosphate
exposure and foetal growth46. However, subsequent work showed that foetal organophosphate
exposure adversely affected neurological function in the neonate suggesting that some aspects of
neurological development were adversely affected. 47 The infants were followed up until the age of
24 months, during which period exposure to organophosphate was found to be associated with
unfavourable cognitive and behavioural outcomes.48
VA Rauh, R Garfinkel, FP Perera et al (2006) ‘Impact of prenatal chlorpyrifos exposure on neurodevelopment in the
first three years of life among inner-city children’, Paediatrics (electronic publication) 118: 1845-1859.
46
B Eskenazi, K Harley, A Bradman et al (2004) ‘Association of in utero organophosphate exposure and fetal growth
and length of gestation in an agricultural population’, Environ. Health Perspect.112:1116-1124.
47
JG Young, B Eskenazi, EA Glastone et al (2005) ‘Association of in utero organophosphate exposure and abnormal
reflexes in neonates’, Neurotoxicology 26: 199-209.
48
B Eskenazi, AR Marks, A Bradman, et al (2007) ‘Association of in utero organophosphate exposure and
neurodevelopment in young Mexican-American children’, Environ. Health Perspect.115:792-798.
45
27
The Mount Sinai group looked at a cohort of mothers and infants born in New York City. This group
looked for the involvement of the different genetic variants or polymorphisms of the enzyme,
paraxonase (PON1) and adverse effects of prenatal CPF exposure. PON1 breaks down the toxic
by-products of CPF in the body thus preventing their accumulation in the body. The different
polymorphisms result in differences in the levels of PON1 activity. Berkowitz et al found that CPF
could have an adverse effect on foetal development if the mothers had low levels of PON1
activity.49 This was confirmed by later work which found that PON1 genetic variation and activity
were significantly associated with head circumference. 50 It was also found that the reflexes of
infants exposed to higher levels of organophosphates prenatally had an increased risk of abnormal
reflexes suggesting longer lasting effects of pesticide exposure on neural development.
The mechanisms for the developmental neurotoxicity of CPF have not yet been determined, but the
ever-widely accepted hypothesis is that CPF and its metabolites, chlorpyrifo-oxon and trichloro-2pyrindinol (TCPy) may interact with other targets and exert effects at lower concentrations, and
have biological effects other than AChE inhibition4. Consequently, more work is required to clarify
the way in which CPF acts on the human foetus and to determine the consequences of exposure to
this pesticide.
To summarise, recent research indicates that CPF and its metabolites can have harmful effects
which are manifested at low levels of CPU exposure, and which are not associated with
acetylcholinesterase (AChE) inhibition. The studies indicate that prenatal exposure to CPF can
result in adverse effects at birth as well as poor neuro-developmental and behavioural outcomes. In
addition, genetic variability can predispose foetuses to CPF toxicity due to lower maternal PON1
activity.
(2) Fetotoxicity
In recent research (2008) using an in vitro model, CPF was found to be toxic to human placental
cells, specifically by triggering programmed cell death (apoptosis). Furthermore, the work indicated
that CPF acts via a pathway independent of acetylcholinesterase (AChE) inhibition.51 This suggests
GS Berkowitz, JG Wetmur, E Birman-Deych et al (2004) ‘In utero pesticide exposure, maternal paraoxonase activity,
and head circumference’, Environ. Health Perspect.11:388-391.
50
MS Wolff, S Engel, G Berkowitz et al (2007) ‘Prenatal pesticide and PCB exposures and birth outcomes’, Pediatr.
Res. 61: 234-250.
51
MD Saulsbury, SO Heyliger, K Wang & D Round (2008) ‘Characterization of chlorpyrifos-induced apoptosis in
placental cell’, Toxicology 244: 98-110.
49
28
that CPF is fetotoxic and moreover that the use of AChE inhibition as a standard measure for CPF
exposure may be inadequate or incorrect.
Solomon and Moodley52 reported in 2008 the ingestion of CPF by woman in South Africa during her
29th week of pregnancy to commit suicide. The woman survived, but the baby was born prematurely
after the incident and died two days after birth. No laboratory tests or autopsy were carried out on
the baby. Sebe et al (2005) report a similar case in Turkey where a woman in her 19th week of
pregnancy used CPF in a suicide attempt. In this case the woman also survived, but the foetus
died. 53 The foetus appeared normal, but high levels of CPF were detected. These case reports
indicate that CPF is able to cross the placenta in humans, and can potentially cause foetal death.
(3) Endocrine Disrupting Effects
Both animal and human studies have indicated that chlorpyrifos exposure may interfere with the
functioning of the thyroid hormone. The thyroid hormone is essential for many functions in the body,
including reproduction and neurodevelopment. A 2006 study of sub-fertile men found that
chlorpyrifos exposure was associated with reduced levels of the thyroid stimulating hormone (TSH)
and thyroxine;54 while a 2005 study of rat pituitary cells, showed pituitary cell growth (which is
stimulated by exposure to the thyroid hormone) to be inhibited by chlorpyrifos exposure.55 In
addition to causing infertility, reduction in thyroid hormone concentrations, even at subclinical levels,
can cause permanent neurological effects on the developing nervous system of a foetus or
newborn.56
Studies have also indicated that chlorpyrifos can affect the reproductive hormones of estrogen and
testosterone. In human studies, exposure to chlorpyrifos has been shown to be associated with
GM Solomon & J Moodley (2007) ‘Acute chlorpyrifos poisoning in pregnancy: a case report’, Clinical Toxicology 45:
416-419.
53
A Sebe, S Satar, R Alpay et al (2005) ‘Organophosphate poisoning associated with fetal death: a case study’, The Mnt
SinaiJ. Med 72:354-356.
54
JD Meeker, DB Marr, R Hauser (2006) ‘Thyroid hormones in relation to urinary metabolites of non-persistent
insecticides in men of reproductive age’, Reprod. Toxicol. 22(3): 437-42.
55
M Ghisari, EC Bonefeld-Jorgensen (2005) ‘Impact of environmental chemicals on the thyroid hormone function in
pituitary rat GH3 cells’, Mol. Cell Endocrinol. 244 (1-2): 31-41.
56
NRDC Petition to Revoke All Tolerances and Cancel All Registrations for the Pesticide Chlorpyrifos (12 September
2007) at 9, citing VJ Pop, EP Brouwers, HL Vader et al (2003) ‘Maternal hypothyroxinaemia during early pregnancy
and subsequent child development: a 3-year follow-up study’, Clin Endocrinol 59(3): 282-8; and JE Haddow, GE
Palomaki, WC Allan et al (1999) ‘Maternal thyroid deficiency during pregnancy and subsequent neuropsychological
development of the child’, N Engl. J Med. 341(8): 549-55.
52
29
lower levels of testosterone, poor sperm quality and increased sperm DNA damage.57 Exposure to
chlorpyrifos has also been found to alter the biosynthesis of Gonadotropin-releasing Hormone
(GnRH), which affects androgen and estrogen levels.58
In a recent study on developmental exposure of chlorpyrifos to mice, published in January 2009,
Tait et al found that their data lends support to chlorpyrifos being considered an Endocrine
Disrupting Chemical, albeit with specific mechanisms and targets; and should be further
investigated at the hypothalamic–pituitary–adrenal axis level. The researchers conclude that
neuroendocrine effects, especially in susceptible developmental windows, deserve more attention
in the risk assessment of organophosphate insecticides.59
(4) Cancer Risks
Although not conclusive, there is data to suggest that exposure to chlorpyrifos is associated with
certain forms of cancer. In a 2007 study, Lee et al found a correlation between the incidence of
colorectal cancer and CPF, indicating at least that further study is required to verify that CPF is not
carcinogenic.60 The 2004 Agricultural Health Study of the National Institutes of Health, a robust
prospective epidemiological study of pesticide applicators in the North American Midwest, reported
statistically significant associations between chlorpyrifos exposure and the incidence of lung cancer.
The report found that ‘individuals in the highest quartile of chlorpyrifos lifetime exposure-days (> 56
days) had a relative risk of lung cancer of 2.18 (95% CI=1.31-3.64), significantly higher than those
with no chlorpyrifos exposure’.61 This data is relevant to the risk assessment of chlorpyrifos, and
should not be ignored in registration decisions.
(5) Childhood Pesticide Poisoning in South Africa
JD Meeker, L Ryan, DB Barr, R Hauser (2006) ‘Exposure to non-persistent insecticides and reproductive hormones in
adult men’, Epidemiology 17: 61-8; and Meeker et al (2004) ‘Urinary levels of insecticide metabolites and DNA damage
in human sperm’, Hum Reprod 19: 2573-80; cited in NRDC Petition supra 10.
58
AC Gore (2002) ‘Organochlorine pesticides directly regulate gonadotropin-releasing hormone gene expression and
biosynthesis in the GT1-7 hypothalamic cell line’, Moll Cell Endocrinol 192 (1-2): 157-70; cited in NRDC Petition
supra 10.
59
S Tait et al (January 2009) ‘Long-Term Effects on Hypothalamic Neuropeptides after Developmental Exposure to
Chlorpyrifos in Mice’, Environmental Health Perspectives 117(1):112-116.
60
WJ Lee, DP Sandler, A Blair et al. (2007) ‘Pesticide use and colorectal cancer risk in the Agricultural Health Study’,
Int.J.Cancer 121:339-346.
61
Lee et al (2004) ‘Cancer Incidence among Pesticide Applicators Exposed to Chlorpyrifos in the Agricultural Health
Study’, Journal of the National Cancer Institute 96(23): 1781-9.
57
30
Childhood poisoning from pesticides has been recognised by the World Health Organisation as a
significant public health problem. In its 2008 World Report on Child Injury Prevention, the WHO
estimated that in 2004, acute poisoning resulted in the death of some 45, 000 people under the age
of 20 years, with the highest rate of poisoning found to be among infants aged less than one year.
Significantly, the rates of death were four times higher in low-income and middle-income countries
such as South Africa.62
Pesticide poisoning is a notifiable condition in South Africa. In its 2005 Statistical Notes on pesticide
poisoning, the Department of Health reported that between 2001 and November 2005 a total of 1,
462 cases and 72 deaths were notified to the Department. The majority of these cases were from
the Free State province, followed by Northern Cape. The Department notes however, these figures
are a substantial underestimation of the true rates, as many of these cases go unreported. The age
specific incidence of pesticide poisoning for this period shows a distinct pattern which is indicative
of the vulnerability of children to pesticide poisoning, particularly in agricultural areas: a pronounced
peak in the 15-19 years age group and a dip in the older age groups.63
A 2005 South African study investigated the incidence of paediatric organophosphate poisoning at
a regional hospital of an agricultural community in the Western Cape.64 The study found that 23
cases of paediatric organophosphate poisoning were referred to the regional hospital over a 5 year
period between 1996 and 2001. Of these cases, 61% were the result of accidental ingestion of
pesticides, either as residues on unwashed fruit or from poorly marked storage containers, or from
dermal and respiratory absorption following organophosphate application for pest control in and
around homes. The study shows that most cases occurred at the time of peak spraying activities on
farms. This is a pattern similar to that found in other developing countries where high rates of
pesticide poisoning in rural populations have included high frequencies of childhood poisonings
linked to unsafe use of, and uncontrolled access to, hazardous chemicals used in agriculture.65 The
study noted the failure of regulatory measures to provide adequate protection against pesticide
poisoning, finding that the incidence of childhood organophosphate poisoning was increasing in
South Africa.
62
WHO World Report on Child Injury Prevention (2008) at 123; see also Statistical Annex Table A1 at 174. Available
online at http://www.who.int/violence_injury_prevention/child/en/ (last accessed 31 March 2009).
63
Department of Health, RSA (November 2005) ‘Statistical Notes: Pesticide Poisoning’; available at
http://www.doh.gov.za/facts/stats-notes/2005/pesticide.pdf (accessed 31 March 2009).
64
R Dippenaar & RJ Diedericks (2005) ‘Paediatric organophosphate poisoning – a rural hospital experience’, S Afr Med
J 95(9): 678-681.
65
L London (2005) ‘Childhood pesticide poisoning – a clarion call for action on children’s vulnerability’, SAMJ 95(9) at
673, and the references cited therein.
31
A recent investigation by Noseweek suggests that the level of child poisoning from pesticide
ingestion in South Africa’s urban areas is also of serious concern. The article reports that the vast
majority of child poisonings treated by the Red Cross Hospital are of children aged between one
and five – ‘when they are mobile and naturally curious, and don’t understand warnings or dangers
inherent in many substances’. The statistics of the Red Cross Hospital document that from 2003 to
the end of 2007, the total number of actual and suspected cases of child poisoning seen at this one
hospital was 2, 404 – of which 244 were attributed to household cleaning products and 233 to
pesticides. Of the pesticide victims, 63 were ‘severely poisoned’ and in danger of death, and five of
them died. It is notable further that the Hospital has seen a sharp increase in the number of
poisoning cases attributed specifically to pesticides, from 25 in 2003 to 70 in 2007, most of which
were likely due to organosphosphates or carbamates.66
The factors that render children vulnerable to pesticide poisoning can be grouped into three
categories: socio-economic factors, behavioral factors and biological factors. All of these factors
must inform the regulation of pesticides in South Africa.67 Firstly, with regard to socio-economic
factors, pest infestations associated with poor housing conditions can prompt adults, unaware of the
risks, to resort to chemical pest control in ways that are extremely hazardous to children. For
example, the practice of spraying children’s beds and bedding with pesticide to control fleas or
bedbugs is not an uncommon cause of severe childhood poisoning necessitating admission to
intensive care facilities.68 Data from a study of urban residents in South Africa in 2001 suggested
that 20% of urban households make regular use of pesticide sprays at home.69 Currently street
vendors can purchase chlorpyrifos in the agricultural co operatives, and it is commonly decanted
common drink bottles and resold at taxi ranks/markets for domestic pest control. This practice will
continue as long as chorpyrifos is available to be acquired in this way. 70
‘Bringing home the poison’ Noseweek (13 January 2009), available online at
http://www.noseweek.co.za/article.php?current_article=1919 (accessed 27 February 2009).
67
See L London (n 64).
68
L London, R Ehrlich, S Rafudien, F Krige & P Vurgarellis (1994) ‘Notification of pesticide poisoning in the Western
Cape 1987 – 1991’, S Afr Med J. 84: 269-272.
69
EP Thomas, JR Seager, E Vilgoen, et al (2001) ‘Household Environment and Health in Port Elizabeth, South
Africa. Executive Summary’, Tygerberg, W. Cape: Medical Research Council, South Africa; University of Port
Elizabeth, South Africa: Stockholm Environment Institute, Sweden.
70
Rother Dr H, Poverty Pests and Pesticides Sold on South Africa’s Streets: Implications for Women and Health,Women
and Environments , Fall/Winter 2008
66
32
In the rural context, agricultural pesticides are often readily available, and used by farm workers for
domestic pest control in and around their homes, particularly where controls over pesticide stores
are not enforced by farm owners. Contaminated overalls can be a source of pesticide exposure for
children at home (this is particularly problematic where there is a lack of ablution facilities for farm
workers), as well as the re-use of pesticide containers to store food, water or other household
items. The proximity of many farm workers’ homes to their working environment renders them
vulnerable to exposure from spray-drift.71 This has become of pressing concern in recent years,
with, on the one hand, the increased use of new pesticide spray technologies, including crop
dusting aircraft and tractor-borne sprayers, and on the other the steady encroachment of smaller
towns on the fringes of farmlands.72 Families lacking recreational spaces or childcare have little
choice but to allow children to play in and around vineyards and fields during or after pesticide
application, where they may be exposed either directly from spraying or from contact with foliar or
soil residues.
Secondly, the behavioural factors that increase children’s risks from pesticides (particularly in and
around the home) include: their limited cognitive capacity to take notice of or comprehend warning
signs or labels, and their play behaviours which frequently bring them into contact with pesticides in
ways that do not occur in adults. Young children spend large amounts of time on the ground, where
they may be exposed through dermal absorption of floor and carpet pesticide dust and residues, as
well as through inhalation of higher pesticide concentrations in the less ventilated, infant breathing
zone nearest the floor. Hand-to-mouth activity and the mouthing of objects, common in infanthood,
may also provide a route for ingestion of pesticide residues that accumulate on a range of
household items.73
Thirdly, certain biological factors increase children’s unique vulnerability to pesticides, and cause
children to suffer physiological and pathological consequences disproportionately greater than an
adult with the same exposure. Children’s higher surface area to body weight ratios increase the risk
posed by skin contact (the most common means of pesticide absorption). Pesticides absorbed
through respiratory routes are also more likely to present a hazard to children, who have breathing
rates higher than adults. Moreover, children are predisposed to disproportionately higher exposures
See L London (1998) ‘Occupational epidemiology in agriculture: A case study in the Southern African context’, Int J
Environ Occup Health 4: 245-256, and the references cited therein.
72
T Bell ‘Pesticide poisoning not just farm worker hazard’ Business Report (31 August 2007), available at
http://www.busrep.co.za/index.php?fSectionId=553&fArticleId=4010571 (accessed 7 April 2009).
73
See particularly on this point, S Gurunathan et al ‘Accumulation of chlorpyiros on residential surfaces and toys
accessible to children’ (1998) 1 Environmental Health Perspectives 9. See also London (n 64).
71
33
to environmental contaminants because they consume greater quantities of food and water for their
body weight, increasing the dose of pesticide, while foods common in children’s diet (e.g. fruit) may
be more likely to be contaminated with pesticides. Environmentally persistent pollutants, which
include a number of pesticides, may accumulate in the food chain and be concentrated in
breastmilk, thereby increasing risks to children. Children’s metabolism also differs significantly from
that of adults, as a result of which they will exhibit different capacity to metabolise, excrete, activate
or deactivate pesticides.74
Finally, a recent (2009) study has also shown that infants and children up to age seven are more
significantly more susceptible to the toxic effects of pesticides due to lower levels of the enzyme
paraoxanase 1, making them more vulnerable than adults to the effects of organophosphate
pesticides including chlorpyrifos.75 This study calls upon future policy makers addressing pesticide
exposure in children to take into account that the window of vulnerability to organophosphates in
young children may last beyond infancy.76
All these factors mean that children are particularly vulnerable to the effects of exposures to
pesticides. Critically however, cases of childhood pesticide poisoning are almost always eminently
preventable. Preventive interventions must address the practices and policies that foster
inappropriate and unsafe pesticide use.
IV.
ENVIRONMENTAL IMPACTS OF CHLORPYRIFOS
Chlorpyrifos has been reported to be very toxic to freshwater fish, aquatic invertebrates and
estuarine organisms.77 The effects of chlorpyrifos to aquatic organisms are relatively well known
and risk assessment studies has shown that invertebrates, especially crustaceans and larval
insects, are the most affected.78 Direct application of chlorpyrifos to water bodies to control
mosquitoes or agricultural run-off treated areas can result in contamination of chlorpyrifos up to 4.3
mg/L in streams and lakes.79 In a report entitled REPORT: AN ASSESSMENT OF AGRICULTURAL
74
London (n 64).
K Huen et al (9 June 2009) “ Developmental Changes in PONI 1 Enzyme Activity in Young Children and Effects of
PONI 1 Polymorphisms Environmental Health Perspectives available on http://dx.doi.org
76
Id page 5
77
EXTOXNET Pesticide Information Profiles: Clorpyrifos
<http://www.extoxnet.orst.edu/cgiwebglimpse/mfs/services/data/info/extoxnet?link=http://ac>
78
Giesy, J P et al, 1999. Chlorpyrifos: ecological risk assessment in North American aquatic environments. Rev.
Environ.Contam.Toxicol.160, 1 -129.
Thomas, K and Nicholson., B C 1989. Pesticide losses in runoff from a horticultural catchment in South Australia and
their relevance to stream reservoir water quality. Environ. Technol. Lett. 20, 117 – 129; Richards, R.P., Baker, D. B.,
1993. Pesticide concentration patterns in agricultural drainage networks in theLake Erie basin. Environ. Toxicol. Chem.
75
34
PESTICIDES IN THE UPPER OLIFANTS RIVER CATCHMENT Final Draft Department of Water
Affairs and Forestry Resource Quality Services First Edition October 2008 chlorpyrifos levels in the
Upper Olifants River cathment were examined and the report concluded that: "The low tier model
and the high tier model (Predicts the Ecological Risk of Pesticides (PERPEST)) predicted the
highest hazard for the application of dichlorvos, followed by parathion and chlorpyrifos. Both models
also predicted a significantly higher hazard associated with aerial application compared to ground
application." The guideline values that the report uses for comparison are the 2000 version of the
Australian and New Zealand Environment and Conservation Council (ANZECC) water quality
guidelines.80 In six of the seven locations tested in the Upper Olifants River Catchment,levels of
chlorpyrifos exceeded the ANZECC water quality guideline for good waters
(0.01 ug/L). In the location with the lowest level of chlorpyrifos, the level of chlorpyrifos exceeded
the ANZECC water quality guidelines for natural waters (0.00004 ug/L). By way of comparison, in
California the water quality criteria for chlorpyrifos in freshwater is 0.014 ug/L81
V.
REGULATION OF CHLORPYRIFOS IN FOREIGN JURISDICTIONS
This section traces recent developments in the regulation of chlorpyrifos in the United States,
Canada, the United Kingdom and the European Union, and Australia. The overview reveals
significant trends in the regulatory approaches that have been adopted. From 2000, following the
emergence of scientific evidence showing that human exposure to chlorpyrifos is harmful to health
through cholinesterase inhibition, steps were taken in the US, Canada, the UK and the EU to
impose a complete ban on domestic uses of chlorpyrifos. Within these jurisdictions, there remain
limited exceptions, such as fully contained ant baits in child-resistance packaging; limited public
health uses (eg. for mosquito control and fire ant mounds); limited use in industrial settings (eg.
manufacturing plants and ship holds); and restricted use on golf courses.
Australia adopted a less restrictive approach: limiting liquid formulations of chlorpyrifos sold for
domestic use to concentrations of 50g/L or less, banning the use of chlorpyrifos in indoor broadcast
applications involving spraying surface areas such as floors and walls, and strengthening the label
12, 13 -26. Wood, B., Stark, J.D., 2002 Acute toxicity of drainage ditch water from a Washington state cranberry
growing region to Daphnia Pulex in laboratory bioassays Ecotoxicol. Environ. Safety 53, to 73-280
80
See: http://www.mfe.govt.nz/publications/water/anzecc-water-quality-guide-02/anzecc-water-quality-guide-02pdfs.html; For guideline values for pesticides, see: Chapter 3 - Aquatic ecosystems
(PDF 838 KB)http://www.mincos.gov.au/__data/assets/pdf_file/0019/316126/wqg-ch3.pdf
81See:http://www.waterboards.ca.gov/water_issues/programs/tmdl/records/state_board/2006/ref12.pdf
35
safety instructions and warning requirements. These regulatory measures are of an interim nature
however, and current permissible uses such as mosquito control and granular ant baits are the
subject of ongoing review in Australia.
In the agricultural sector, chlorpyrifos use remains under review, while incremental restrictions are
being enforced. In the US, restrictions were introduced on the application of chlorpyrifos on apples,
grapes and tomatoes to limit children’s exposure to chlorpyrifos. The limited extent of these
protective measures has been contested in the US, particularly in light of recent scientific research
suggesting the neurotoxic effects of chlorpyrifos. Similar measures have been taken in Canada, the
UK, the European Union and Australia to reduce the maximum residue limits of chlorpyrifos on
foodstuffs. Additional preventive measures have been taken in Canada, such as reducing the
number of permissible applications of chlorpyrifos per season per crop.
To address the risks of environmental harm, buffer zones (eg. for groundboom, airblast and aerial
applications of chlorpyrifos) have been variously introduced in the US, Canada, the UK, the
European Union and Australia, as well as no or significantly-reduced pesticide application zones.
The protection of aquatic resources, drinking water supplies and sensitive environmental areas from
spray drift (especially from aerial applications) is an issue currently of primary concern across
jurisdictions.
Another major issue of concern, which has received recent regulatory attention in foreign
jurisdictions is the health and safety of agricultural workers. Protective measures that have been
introduced include: mandatory warning statements on chlorpyrifos product labels; establishing reentry intervals for post-application workers for incorporation on product labels; the discontinuation of
paintbrush applications and applications with high-pressure handwand equipment; implementing
engineering controls and the addition of personal protective equipment (PPE) for handlers of
chlorpyrifos products; mandatory training programmes for professional pesticide users, distributors
and advisors; and mandatory inspections of pesticide application equipment.
What follows is a more detailed country-by-country overview of these regulatory developments.
(1)
United States
(i)
Non-Agricultural Use
36
With the enactment of the Food Quality Protection Act (FQPA) of 1996, the pesticide and food
safety laws in the United States underwent ‘the most comprehensive and historic overhaul’.82 The
FQPA amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food Drug, and Cosmetic Act (FFDCA) to introduce more stringent health-based and childprotective regulatory standards. The 1996 amendment required the US Environmental Protection
Agency (EPA) to reassess pesticide safety and tolerances (i.e. maximum pesticide residue limits on
food) according to a set schedule. The EPA released a revised risk assessment of chlorpyrifos in
June 200083 – after it was sued by the National Resources Defence Council (NRDC) for failing to
proceed timeously with the assessment. The Assessment evaluated the available hazard and
exposure databases for chlorpyrifos, and noted the need for ‘an overall higher degree of concern
regarding the potential consequences of chlorpyrifos exposure to infants and children than was
determined during the FQPA safety evaluation in March 1999’.84
On 8 June 2000, the EPA signed a Memorandum of Agreement with chlorpyrifos manufacturers to
eliminate and phase out nearly all indoor and outdoor non-agricultural uses of chlorpyrifos.85 The
agreement effectively eliminated the use of chlorpyrifos by home-owners by limiting its use to
certified, professional or agricultural applicators. In particular, the following residential and
recreational uses of chlorpyrifos were eliminated for non-termiticide use:
(i)
all indoor residential uses (except fully contained ant baits in child-resistance
packaging);
(ii)
all outdoor residential uses (except limited public health uses);
(iii)
all indoor and outdoor non-residential uses except: use on golf courses (with a reduced
maximum application rate from 4 to 1 lb/ai/A), limited public health uses (i.e. mosquito
control and fire ant mounds), and limited use in industrial settings (e.g. industrial and
manufacturing plants, shipholds and railroad boxcars).
See US EPA online resource: ‘Pesticides - Regulating Pesticides: Food Quality Protection Act (FQPA) of 1996’,
available at http://www.epa.gov/pesticides/regulating/laws/fqpa/.
83
US EPA, ‘Revised Human Health Risk Assessment for Chlorpyrifos’ (8 June 2000), available at
http://www.epa.gov/scipoly/sap/meetings/2008/september/hed_ra.pdf.
84
US EPA, ‘Overview of Chlorpyrifos Revised Risk Assessment’ at 3 (emphasis in original), accessed at
http://www.epa.gov/oppsrrd1/op/chlorpyrifos/overview.pdf, copy on file with author.
85
US EPA, ‘Memorandum of Agreement between the Environmental Protection Agency and Signatory Registrants
Regarding the Registration of Pesticide Products Containing Chlorpyrifos’ (8 June 2000), copy on file with author.
82
37
Residential risk concerns posed by the termiticide use of chlorpyrifos were mitigated by (i)
eliminating whole house “post-construction” termiticide use; (ii) phasing out limited post-construction
spot and local termiticide treatments by 2002; and (iii) phasing out pre-construction termiticide
treatments by 31 December 2005. Non-residential uses of chlorpyrifos were also cancelled in
schools, parks, day-care centres and other settings where children could be exposed.
The EPA formalised the cancellation of domestic products containing chlorpyrifos with the issue of a
Federal Register Notice in January 2001.86 Sale of cancelled chlorpyrifos products by formulators
was banned from 1 February 2001, with the last date of sale by retailers being 31 December
2001.87
(ii)
Agricultural Use
According to the EPA, chlorpyrifos is ‘one of the most widely used organophosphate insecticides’ in
the US.88 The crops with the most intense chlorpyrifos use are cotton, corn, almonds, and fruit trees
including oranges and apples. The Memorandum of Agreement of 8 June 2000 reduced food uses
of chlorpyrifos by limiting the application of chlorpyrifos on apples, grapes and tomatoes. These
measures were designed to limit children's exposure from fruit, juices and staples like tomato sauce
in order to reduce acute dietary exposure to chlorpyrifos by 75 percent.89 The EPA formalised these
provisions on 20 September 2000, with a Federal Register Notice that revoked the tolerance for
chlorpyrifos residues in or on tomatoes (ie no longer allowed residues of chlorpyrifos in tomatoes)
and lowered the tolerance for chlorpyrifos residues in or on apples and grapes to 0.01 part per
million (ppm).90
The failure of the EPA to go beyond these revisions, and to further curtail the use of chlorpyrifos on
food crops, has been controversial however. In September 2001, the EPA completed the
chlorpyrifos aggregate assessment (called an ‘Interim Re-registration Eligibility Decision’ (IRED))
86
Chlorpyrifos: End-Use Products Cancellation Order, 66 Fed. Reg. 7753 (25 January 2001), available at
http://www.epa.gov/EPA-PEST/2001/January/Day-25/p2184.htm.
87
US EPA, ‘Chlorpyrifos Revised Risk Assessment and Agreement with Registrants’ at 3, available at
http://www.healthyhousing.org/clearinghouse/docs/Article0294.pdf.
88
US EPA ‘Interim Re-registration Eligibility Decision for Chlorpyrifos’ at viii. Available at
http://www.epa.gov/oppsrrd1/REDs/chlorpyrifos_ired.pdf.
89
Ibid at 1.
90
Chlorpyrifos: Receipt of Requests for Amendments, Cancellations, and Notification of Tolerance Revocation and
Modifications, 65 Fed. Reg. 56886 (20 September 2000), available at http://www.epa.gov/fedrgstr/EPAPEST/2000/September/Day-20/p24211.htm.
38
which retained many of the pre-existing allowable residues on food.91 At the time, the IRED was
contested by, amongst others, the National Resources Defense Council (NRDC), the Pesticide
Action Network North America (PANNA), and the New York Attorney General.92 The particular
concerns articulated were inter alia the scientific limitations of the IRED, and the inadequacy of
evidence to establish a safe level at which infants and children will not suffer any developmental
harm due to chlorpyrifos exposure. The EPA failed to respond to these protestations.93
The following measures were, however, introduced at the IRED stage in 2001 to mitigate risks to
agricultural workers:94
(i)
Personal Protective Equipment, consisting of double layers, chemical resistant gloves,
chemical resistant shoes plus socks, chemical resistant headgear for overhead exposure,
chemical resistant apron when cleaning and mixing or loading and a dust/mist respirator,
was made mandatory for the following scenarios: mixing/loading liquids for groundboom
and airblast application, loading granulars for ground application, tractor drawn granular
spreader, and low pressure handwand.
(ii) Engineering controls were introduced for the following scenarions: mixing wettable powder
for groundboom application (water soluble packaging), mixing wettable powder for airblast
application (water soluble packaging), and aerial application of sprays (enclosed cockpit).
To mitigate ecological risks, and to protect water quality, fish and wildlife, technical registrants
agreed to the following measures:95
(i)
91
Amending labels to include the use of no-spray buffer zones around surface body waters;
66 Fed Reg 57073 (14 November 2001) Organophosphate Pesticide; Availability of Chlorpyrifos Interim Risk
Management Decision Document. IRED at 64-68, available at http://www.epa.gov/fedrgstr/EPAPEST/2001/November/Day-14/p28525.htm.
92
NRDC, Petition to Revoke All Tolerances and Cancel All Registrations for the Pesticide Chlorpyrifos (12 September
2007) at 3 [hereinafter: ‘Petition’]. Available as US EPA Document ID: EPA-HQ-OPP-2007-1005-0005 at
http://www.regulations.gov/fdmspublic/component/main?main=AdvancedDocket.
93
Ibid at 3.
94
For a summary, see US EPA ‘Pesticides: Re-registration – Chlorpyrifos facts’, available at
http://www.epa.gov/oppsrrd1/REDs/factsheets/chlorpyrifos_fs.htm. See also the full US EPA report ‘Interim Reregistration Eligibility Decision for Chlorpyrifos’ at 74-86. Available at
http://www.epa.gov/oppsrrd1/REDs/chlorpyrifos_ired.pdf.
95
US EPA ‘Pesticides: Re-registration – Chlorpyrifos facts’. See also ‘Interim Re-registration Eligibility Decision for
Chlorpyrifos’ at 87-93.
39
(ii) Reducing the number of applications per season and the maximum amounts applied per
season; and
(iii) Increasing the minimum intervals for retreatment.
In 2006, the EPA completed the cumulative risk assessment for all organophospates (including
chlorpyrifos), as required by the FQPA.96 The cumulative risk assessment concluded that
chlorpyrifos uses would be eligible for re-registration in accordance with the IRED, and that the
current pesticide tolerances met the legal safety standard.97 These findings were again challenged
by the NRDC and PANNA in a formal petition to the EPA to revoke all tolerances and cancel all
registrations for chlorpyrifos.98 The Petition drew attention to the EPA’s failure to consider scientific
evidence that had emerged since 2001 in the cumulative risk assessment, which linked chlorpyrifos
to adverse health effects (including a variety of behavioural and attention disorders in young
children).99 These complaints also form the basis of a law suit brought against the EPA in 2007 by
a coalition of farm worker and advocacy groups (including the NDRC), which seeks to end
agricultural use of the chlorpyrifos, on the basis that the continued use of chlorpyrifos poses an
unnecessary risk to farm workers and their families.100
The EPA responded in 2008 by releasing a ‘Science Issue Paper: Chlorpyrifos Hazard and Dose
Response Characterization’.101 The Issue Paper draws on a wide array of recent studies to evaluate
various aspects of chlorpyrifos toxicity, particularly the effects in animals and humans of gestational
and postnatal exposure. The preliminary conclusions drawn in the EPA report were reviewed in
September 2008 by the Scientific Advisory Panel (SAP) of the Federal Insecticide, Fungicide and
96
US EPA, Organophosphate Cumulative Risk Assessment; Notice of Availability, Federal Register Document,
available at http://www.epa.gov/EPA-PEST/2006/August/Day-02/p12343.htm.
97
US EPA, ‘Memorandum: Finalization of Interim Reregistration Eligibility Decisions (IREDs) and Interim Tolerance
Reassessment and Risk Management Decisions (TREDs) for the Organophosphate Pesticides, and Completion of the
Tolerance Reassessment and Reregistration Eligibility Process for the Organophosphate Pesticides’ (31 July 2006),
available at http://www.epa.gov/pesticides/cumulative/2006-op/op_ireds_reds_memo.pdf.
98
NRDC Petition (n 83).
99
The petition summarises the post-2001 scientific evidence upon which its claims are based. See also National
Resources Defense Council, Press Release, ‘Common Pesticide Poses Serious Threat, new Study Finds - Chemical
Linked to Nervous System Damage in Kids; NRDC Calls for Total Ban’, available at
http://www.nrdc.org/media/pressreleases/061204.asp.
100
United Farm Workers of America and others v Administrator, US EPA, United States District Court for the Northern
District of California, filed 31 July 2007, case no. CV 04-0099-RSM. See EarthJustice press release ‘Lawsuit Challenges
EPA on Deadly Pesticide’ (31 July 2007), available at http://www.earthjustice.org/news/press/007/lawsuit-challengesepa-on-deadly-pesticide.html.
101
US EPA (Health Effects Division, Office of Pesticides Programs), ‘Science Issue Paper: Chlorpyrifos Hazard and
Dose Response Characterization’ (Draft, 21 August 2008), available at
http://www.epa.gov/scipoly/sap/meetings/2008/september/chlorpyrifoscharacter.pdf.
40
Rodenticide Act (FIFRA), the primary scientific peer review mechanism of the EPA. While agreeing
with a number of the conclusions drawn by the EPA, the SAP emphasised the need for further
scientific study to support several of its claims.102 The EPA’s work to improve scientific support for
its risk assessment remains ongoing.103
The US EPA has also come under persistent pressure to extend buffer zones for chlorpyrifos and
other pesticides around waters holding threatened and endangered fish species, including salmon
species. In a lawsuit filed in 2001 by the Washington Toxics Coalition and others,104 the US District
Court of Seattle ruled that the EPA had violated the Endangered Species Act when it failed to
consult with National Marine Fisheries Service (NMFS) when approving the physical applications of
the pesticides. The Court required the EPA to complete its consultation by 1 December 2004, and
approved an injunction request that set buffer zones for 34 of the pesticides, including chlorpyrifos,
until the EPA had completed its review and establishes its own restrictions on the pesticides. The
injunction prohibited aerial spraying of the chemicals within 300 feet of salmon bearing streams and
it prohibited ground spraying within 60 feet of those streams.
In November 2008, the NMFS issued a biological opinion concluding that chlorpyrifos, and two
other pesticide chemicals (diazonin, malathion) are likely to jeopardize 27 West Coast salmon and
steelhead populations that are listed under the Endangered Species Act. The Fisheries Service
biologists proposed expanding the buffer zones for spraying near Salmon-holding waters to 500
feet for ground spraying and 1,000 feet for aerial spraying. The NMFS also recommended banning
spraying when winds exceed 10 mph and called for planting 20-foot non-crop barriers between
fields and streams. The EPA has one year to implement the NMFF’s findings.105
(2)
Canada
(i)
Non-Agricultural Use
FIFRA Scientific Advisory Panel, Minutes 2008-04. ‘A Set of Scientific Issues Being Considered by the
Environmental Protection Agency Regarding: the Agency’s Evaluation of the Toxicity Profile of Chlorpyrifos’ (16-18
September 2008, FIFRA Scientific Advisory Panel Meeting held at the Holiday Inn – Roslyn, Arlington, Virginia),
available at http://www.epa.gov/scipoly/sap/meetings/2008/091608_mtg.htm#transcripts.
103
Ibid at 8.
104
Washington Toxics Coalition and others v EPA and others, US District Court, Western District of Washington,
Seattle (2004), case no. C01-0132C. Available at http://www.watoxics.org/files/order-01-22-04.pdf.
105
J Barnard, ‘US Biologists: 3 Common Pesticides Harm Salmon’ Associated Press (19 November 2008). Available at
http://www.watoxics.org/pressroom.
102
41
Since 2000, Canada’s Pest Management Regulatory Agency (PMRA) has carried out a phased reevaluation of chlorpyrifos.106 In the first phase of the re-evaluation, the PMRA completed a risk
assessment of chlorpyrifos using its own reviews of data, as well as internationally available
evaluations including those of the United States’ EPA. Having regard to the identified risks of
chlorpyrifos to human health and the environment, and reflecting new approaches to riskmanagement adopted by the PMRA and the US EPA, an additional 10-fold safety factor was
applied to the existing 100-fold safety factor for chlorpyrifos. The additional (child-protective) safetyfactor necessitated the limiting of existing chlorpyrifos uses, including all residential uses.107 By 31
December 2001, the PMRA had implemented a phase-out of most residential uses of chlorpyrifos.
The specific mitigation measures, and the time frame for their implementation, were similar to those
being implemented in the United States:108
(i)
All indoor and outdoor domestic and commercial class products with residential uses
were cancelled from 31 December 2001, with the exception of containerised, lowconcentration baits;
The use of commercial class products in non-residential areas such as schools and
(ii)
playgrounds was discontinued, with additional labelling required to warn against use in
and around residences and other areas where children may be exposed.
Turf uses were limited to the treatment of golf courses, industrial sites, highway
(iii)
medians and sod farms only;
Structural pest control uses inside and outside commercial buildings were limited to
(iv)
scenarios where public access is restricted, as follows:
–
crack and crevice in ship holds, railroad boxcars, industrial plants, manufacturing
plants, warehouses, meat packing plants and food processing plants;
–
spot treatment in industrial plants, manufacturing plants, warehouses, meat packing
plants and food processing plants;
Canadian Pest Management Regulatory Agency, ‘Chlorpyrifos Re-evaluation Note’, Rev 2000-05, available at
http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_decisions/rev2000-05/index-eng.php.
107
Ibid.
108
Canadian Pest Management Regulatory Agency, ‘Update on the Re-evaluation of Chlorpyrifos’, Rev 2007-01,
available at http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_decisions/rev2000-01/index-eng.php (Hereinafter: ‘Update
2007’).
106
42
–
bait treatment in food processing plants, meat packing plants as well as warehouses;
and
–
perimeter soil treatment or localized areas on outside surfaces of industrial plants,
manufacturing plants, warehouses, meat packing plants and food processing plants;
Uses in farm and livestock buildings were limited to the treatment of farm buildings (in
(v)
and around dairy cattle, beef cattle, swine, sheep, poultry), feedlots, corrals, stockyards,
holding pens and other livestock holding areas;
Uses for treatment of ornamentals were limited to the following:
(vi)
–
treatment of ornamentals for commercial production only (greenhouses, nurseries and
industrial sites); and
–
treatment of elm for control of adult bark beetles (restricted use to be used only under a
provincial Dutch elm disease program); and
(vii)
Restricted uses for mosquito control (larvae and adults) were maintained, and its
application was limited to treatment of temporary pools to protect non-target aquatic
organisms (e.g. fish).
(ii)
Agricultural Use
The first phase of the re-evaluation of chlorpyrifos also addressed its use on agricultural food
products. The re-evaluation study revealed that, when age-related dietary preferences and daily
consumption patterns were taken into account, the expected residue levels of chlorpyrifos on
agricultural products were higher than the acceptable one-day intake for the most highly exposed
subgroup, children aged 1 to 6 years old. The major contributors to this acute dietary risk were
found to be tomatoes, imported apples, and imported grapes. Consequently, a regulation was
passed under the Food and Drugs Act, 1999 that banned the use in Canada of products containing
chlorpyrifos on tomatoes after 31 December 2000 (the same restriction already applied to locallygrown grapes and apples), while the Maximum Residue Limit for imported apples, grapes and
tomatoes was decreased to 0.01 ppm.109
Ibid. Food and Drug Regulations – Amendments, Schedule No. 1341 (Chlorpyrifos), published in Canada Gazette,
Part II of September 21, 2005.
109
43
Phase Two of the re-evaluation focused on the remaining agricultural and forestry uses of
chlorpyrifos, with the aim of further mitigating environmental and occupational risks.110 Announcing
a tiered approach to its environmental assessment, Phase Two introduced the following interim
measures for the protection of the environment:
(i)
The reduction of the maximum number of applications permitted per season per
crop; and
(ii)
The implementation of buffer zones for groundboom, airblast and aerial
applications of chlorpyrifos; and
(iii)
The addition of precautionary statements regarding hazards to bees to the labels
of all chlorpyrifos products with agricultural uses.111
The following worker safety measures were also implemented:
(i)
The discontinuation of paintbrush applications for indoor uses;
(ii)
The discontinuation of applications with high-pressure handwand equipment;
(iii)
Implementing engineering controls and/or the addition of personal protective
equipment (PPE) for handlers who mix, load and apply pest control products that
contain chlorpyrifos; and
(iv)
Establishing re-entry intervals for post-application workers.112
Phase 3 of the re-evaluation of chlorpyrifos was intended to entail a refined environmental risk
assessment, based on the identification of hazards to non-target organisms. It was also intended to
revisit the registration of particular uses of chlorpyrifos identified as problematic in the initial
environmental assessment (completed in March 2003). These included: the aerial application of
chlorpyrifos for agricultural commodities, air-blast application for peaches and nectarines, as well as
See PMRA ‘Proposed Acceptability for Continuing Registration document PACR2003-03, Phase 2 of the
Re-evaluation of Chlorpyrifos’ (18 March 2003).
110
111
112
‘Update 2007’ (n 99) 2-4.
Ibid at 2.
44
applications for mosquito larvae control.113 Phase Three of the reevaluation was due to be
completed in 2008, but has been deferred with no further changes expected in the near future.114
Instead, a future re-evaluation process will refine the PMRA’s environmental assessment and
address issues related to aerial uses.115
(3)
United Kingdom & European Union
(i)
Non-Agricultural Use
As a Member State of the European Union, non-agricultural pesticide (biocide) use in the United
Kingdom is governed by the ‘Biocidal Products Directive’ of the European Parliament and EU
Council, which was adopted in 1998.116 Member States were required to incorporate the provisions
of the Directive into national law before 14 May 2000. The three main objectives of the Directive
are:
(i)
To harmonise the European market for biocidal products and their active
substances such that product authorisation in one Member State can be
recognised in other Member States;
(ii)
To provide a high level of protection for people, animals and the environment from
the use of biocidal products through risk assessment. This requires the
submission and evaluation of data relating to substances’ chemistry, toxicity to
humans, and toxicity and fate in the environment; and
(iii)
To ensure products are sufficiently effective against the target species.117
Since 31 December 2007, chlorpyrifos has been banned from the EU market for non-agricultural
use, including storage for any purpose outside of agricultural use (except for disposal or export out
of the EU). This banning followed its exclusion from continuing review by the European
113
Ibid 1–5.
Personal correspondence from Robert Martin, the Regulatory Information Officer, Pest Management Regulatory
Agency, 27 February 2009.
115
Ibid.
116
‘Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of
biocidal products on the market’ Official Journal of the European Communities L 123/1.
117
Ibid. See also the following online resources: UK Health and Safety Executive, ‘Biocidal Products
Directives/Regulations (BPD/R)’ available at http://www.hse.gov.uk/biocides/bpd/index.htm; and ‘Biocides:
Introduction and Objectives’, available at: http://ec.europa.eu/environment/biocides/index.htm.
114
45
Commission, because all participating advocates for the substance either withdrew or submitted an
incomplete dossier that could not be considered by the Commission.118 EC Regulation 1849/2006
stipulated that after 1 September 2006 certain biocidal products, including chlorpyrifos, would no
longer be included in the review programme, and would be withdrawn from the market within 12
months of such exclusion.119
(ii)
Agricultural Use
With regard to the use of chlorpyrifos on British crops and foodstuffs, the Maximum Residue Levels
(MRLs) set by the EC were voluntarily enforced by the UK Pesticides Safety Directorate (PSU) in
December 2005.120 Since 1 September 2008, all statutory Maximum Residue Limits are set on an
EC–wide basis, and are binding on Member States.121
The European Union has recently brought its attention to improving the overall sustainability of
agricultural pesticide use. With the adoption of the 6th Environment Action Programme in July 2002,
the European Parliament and the EU Council recognised, as an environmental priority problem, the
need to reduce the impact of pesticides (particularly plant protection products) on human health and
the environment. A two-track approach was adopted, entailing (i) the full implementation and
appropriate revision of the relevant legal framework; and (ii) the development by the European
Commission of a Thematic Strategy on the Sustainable Use of Pesticides.122 In 2006, the European
Commission presented its Communication on ‘A Thematic Strategy on the Sustainable Use of
Pesticides’123 as well as a draft Directive to implement parts of the Thematic Strategy that require
new legislation.124 On 13 January 2009, the draft Directive was jointly adopted with amendments by
UK Health and Safety Executive, ‘31 December 2007 deadline under the Biocidal Products Directive (BPD) – List of
active substances in products approved under the Control of Pesticides Regulations (COPR), which are affected’,
accessed at http://www.hse.gov.uk/biocides/activesubundercopr.htm.
119
Article 1 of European Commission Regulation (EC) No 1849/2006, 14 December 14, available at: http://eurlex.europa.eu/LexUriServ/site/en/oj/2006/l_355/l_35520061215en00630071.pdf.
120
See the old MRL database of the UK Pesticides Safety Directorate online at
https://secure.pesticides.gov.uk/MRLs_EC_Original/search.asp.
121
This is in accordance with EC Regulation 396/2005(EC), which provides a harmonised system of MRLs setting, and
applies to all foods treated with pesticides after 1 September 2008. See https://secure.pesticides.gov.uk/MRLs/main.asp
for the EC Statutory MRLs.
122 See European Commission, ‘The Sixth Environment Action Programme of the European Community 2002-2012:
Thematic Strategies’ at http://ec.europa.eu/environment/newprg/strategies_en.htm.
123
European Commission, ‘Communication from the Commission to the Council, the European Parliament, the
European Economic and Social Committee and the Committee of the Regions: A Thematic Strategy on the Sustainable
Use of Pesticides’ [COM (2006) 372] (adopted on 12 July 2006) available at
http://ec.europa.eu/environment/ppps/pdf/com_2006_0372.pdf.
124
European Commission, ‘Proposal for a Directive of the European Parliament and of the Council establishing a
framework for Community action to achieve a sustainable use of pesticides’ (Brussels, 12 July 2006), 2006/0132 (COD)
available at http://ec.europa.eu/environment/ppps/pdf/com_2006_0373.pdf.
118
46
the European Parliament and the Council, and will come into force on its adoption as a legislative
text.125
The Framework Directive requires all Member States to develop National Action Plans for pesticide
sustainability within three years of the Directive coming into force. The plans must specify
quantitative targets, measures and timetables to reduce risks and impacts of pesticide use on
human health and the environment.126 Furthermore, the Framework Directive requires Member
States to create the necessary conditions for implementing Integrated Pest Management by 1
January 2014, with its promotion of low pesticide-input farming, low-risk products and reduced
dependency on the use of pesticides.127
Of primary concern in the Framework Directive is the protection of aquatic resources, drinking water
supplies and sensitive environmental areas. The Framework Directive accordingly introduces
mitigation measures that include the creation of buffer zones around waterways and the
establishment of no or significantly-reduced pesticide application zones.128 Aerial spraying is also
prohibited (with limited exceptions), with preference given to low-spray pesticide application
devices.129
Some member states, including the United Kingdom, have already established buffer zone
protection for water bodies.130 In the UK, chlorpyrifos sprayed from horizontal boom sprayers is not
allowed to fall within 5 metres of the top of the bank of a static or flowing water body. Additionally,
chlorpyrifos cannot be sprayed within 1 metre of the top of a ditch that is dry at the time of
application. When applied with a hand-held sprayer, the buffer zone around the top of a bank of
static of flowing water bodies is 1 metre.131
European Parliament, ‘European Parliament legislative resolution of 13 January 2009 on the Council common
position for adopting a directive of the European Parliament and of the Council establishing a framework for Community
action to achieve a sustainable use of pesticides (6124/2008 – C6-0323/2008 – 2006/0132(COD)), read with ‘Position of
the European Parliament adopted at second reading on 13 January 2009 with a view to the adoption of Directive
2009/…/EC of the European Parliament and of the Council establishing a framework for Community action to achieve
the sustainable use of pesticides’ [hereinafter: ‘Framework Directive’], available at http://www.europarl.europa.eu.
126
Ibid ‘Framework Directive’ article 4.
127
Ibid article 14.
128
Ibid article 11 & 12.
129
Ibid article 9 & 11.
130
UK Pesticide Safety Directorate, ‘LERAPs (Buffer Zone): Category A & B Active Ingredients Results’ available at
https://secure.pesticides.gov.uk/LerapsCatAB/catAB-ap.asp.
131
UK Pesticide Safety Directorate, ‘Local Environmental Risk Assessment for Pesticides (LERAP) Category A and B
Descriptions’ available http://www.pesticides.gov.uk/psd_databases.asp?id=912.
125
47
Lastly, the Framework Directive is to replace EC Directives 79/117/EEC and 91/414/EEC, which
currently regulate the placing of plant protection products on the market, including the labelling and
safety data required for agricultural pesticides.132 Under the Framework Directive, training
programmes will be mandatory for professional pesticide users, distributors and advisors,133 and
regular inspections of pesticide application equipment are to be mandatory.134 Moreover, Member
States will be required to promote and facilitate awareness programmes and the availability of
information relating to pesticides for the general public, in particular regarding their health, safety
instructions, environmental effects and non-chemical alternatives.135
(4)
Australia
(i)
Non-Agricultural Use
Chlorpyrifos has been available for use in Australia for more than 30 years. The majority of
chlorpyrifos usage (over 60%) is for agricultural purposes, with the remainder mostly used in termite
control. Chlorpyrifos products are registered for the control of a broad range of insects in agriculture
(mainly horticulture), for the control of pests such as cockroaches, termites and fleas in buildings,
and as domestic animal and garden pesticides.136
The Australian Pesticides and Veterinary Medicines Authority (APVMA) (formerly the National
Registration Authority (NRA) for Agricultural and Veterinary Chemicals) initiated a review of
chlorpyrifos in December 1996, as part of a broader Existing Chemical Review Program.
Chlorpyrifos was nominated for review because of concerns over its human toxicity; acute toxicity to
birds; water pollution potential and the imposition of US restrictions to reduce hazards to fish, birds
and other wildlife; the demonstrated potential for adverse effects in users; and the high potential
chronic and moderate potential acute toxicity risk.137
132
In the UK, these Directives apply together with a national Code of Practice for the use of plant protection
products. The Code of Practice requires competency certifications for commercial pesticide applicators. See
UK Pesticide Safety Directorate, ‘FAQ Agricultural Uses of Pesticides’, available at:
http://www.pesticides.gov.uk/safe_use.asp?id=2128#Q2.
133
EC Proposal (n 115) article 5 read with Annex I.
134
Ibid article 8 read with Annex II.
135
Ibid article 7.
136
APVMA, ‘Chlorpyrifos – Australian review outcomes and current regulatory status’ (20 January 2006), available at:
http://www.apvma.gov.au/media/chlorpyrifos_statement.shtml. (hereinafter: ‘Review outcomes’)
APVMA, ‘Chlorpyrifos review history and regulatory outcomes’, available at:
http://www.apvma.gov.au/chemrev/chlorpyrifosHistory.shtml.
137
48
In September 2000, after an extensive three-year period of consultation and review, the APVMA
released the Chlorpyrifos Interim Review Report.138 The review introduced interim measures
pending the collection and evaluation of further data (particularly regarding residue levels in
commodities). The final review is in the process of finalisation. The APMVA are expected to make
final regulatory decisions in May 2009, with the final report following within a month. The review is
only formally finalized, however, when registrants have submitted and achieved approval for reviewamended labels, at which point all prior labels are cancelled. This may be some months after the
final regulatory decisions are made.139
With regard to non-agricultural uses of chlorpyrifos, the Interim Review Report found that the use of
home and garden chlorpyrifos products with concentrations of greater than 50 g/L could no longer
be supported because of acute toxicity concerns.140 The APVMA made the following key regulatory
decisions as a result of the review findings:141
(i)
Restricting liquid formulations sold for domestic use to a concentration of no greater than 50
g/L.
(ii) Requiring a warning to appear on labels of chlorpyrifos products of concentration greater
than 5% to the effect that ‘This product is too hazardous for use by householders.
Householders must not use this product in or around the home’. This requirement is
intended to prevent concentrated chlorpyrifos products intended for PCO use, from being
used by householders.
(iii) Removing approval for the use of chlorpyrifos in indoor broadcast applications involving
spraying surface areas such as floors and walls; and strengthening the labels accordingly to
provide clear directions to users/applicators to prevent indoor broadcast applications of
chlorpyrifos.
(iv) Improving the safety instructions on many chlorpyrifos products.142
138
National Registration Authority for Agricultural & Veterinary Chemicals, The NRA Review of Chlorpyrifos: Interim
Report (September 2000) vol. 1, NRA Review Series 00.5. Available at http://www.apvma.gov.au/chemrev/
downloads/chlorpyrifos_summary.pdf. (hereinafter: Interim Review Report)
139
Personal correspondence from Ron Marks, Review Evaluator, APVMA, 20 March 2009.
140
Interim Review Report (n 129) at 68-69.
141
Ibid at 68-71.
142
See 'Chlorpyrifos Safety Directions’ Commonwealth of Australia Gazette, No. 9 (4 September 2001)
49
Chlorpyrifos products are still available in Australia for pre-construction use, but are Restricted
Chemical Products by proclamation, and are thus only available to authorised pest-control
operators. With regard to this particular use of chlorpyrifos, the September 2000 Review concluded
that exposure to chlorpyrifos vapour in the air of treated homes was low, and did not pose an
unacceptable health risk provided it was used according to directions. The APVMA is, however,
promoting alternative available technologies to protect buildings against termites. 143
(ii)
Agricultural Use
The Interim Review Report revealed deficiencies in chlorpyrifos residue data for certain agricultural
commodities, crops and processed crop commodities. Notwithstanding the limited data, the Report
suggests that the available data indicated very low residues in Australian produce, such that the
population with the highest estimated exposure had a dietary intake which was only 3% of the
Acceptable Daily Intake (ADI) for chlorpyrifos. Notably, the Australian ADI value is 0.003mg/kg/day,
which is lower than the international equivalent established by the World Health Organisation
(WHO) in 1999.144 Pending the collection and evaluation of new data, the APMVA amended certain
Maximum Residue Limits (MRLs) and accorded others temporary status (TMRLs).145 Further data
was submitted in 2005 and an assessment report written in 2006/7, with various recommendations
restricting of some use patterns; changing TMRLs to MRLs; changing associated witholding periods
(WHPs) for harvest and grazing; and amending harvest/grazing/ slaughter/fodder intervals for
export commodities.146
To address occupational health and safety risks to agricultural workers, the Interim Review Report
recommended the incorporation of specified re-entry periods on product labels.147 The APVMA also
recommended the incorporation of warning statements on product labels in order to reduce the
potential for environmental contamination. In particular, it recommended strengthened label
restraints designed to minimise spray drift, surface run-off to waterways, and releases to urban
34.
143
‘Review Outcomes’ (n 127).
144
‘Review Outcomes’ (n 127). The Australian ADI is based on the No Observed Effect Level (NOEL) for plasma
cholinesterase inhibition of 0.03 mg/kg/day in a 28-day human volunteer study (Coulston et al, 1972), and uses a 10-fold
safety factor for individual variability. See Interim Report (n 129) 22. A supplementary toxicology assessment was done
in 2006, which confirmed the toxological endpoints used in the 2000 Interim Review Report. The toxological endpoints
accordingly remain unchanged (Correspondence from Ron Marks (n 130)).
145
See Interim Review Report (n 129) 13-15.
146
Correspondence from Ron Marks (n 130).
147
Ibid 70.
50
drains. The Department of the Environment and Heritage was satisfied that, subject to these label
changes and accompanying changes in uses, harmful effects on the animals or the environment
were unlikely.148 Spray drift assessments were commenced by the APMVA in 2009 for
environmental safety and prevention of residues (on neighbouring land). These assessments
should be completed in April 2009, and will either amend or confirm the no-spray zones (i.e. spray
buffers) for aerial and ground application currently required on product labels.149
Finally, as indicated by the 2000 Interim Review Report, decisions remain to be taken on
chlorpyrifos use for mosquito control, agricultural soil baits (e.g. for crickets) and domestic granular
baits (e.g. for ants). These are to be addressed in the Final Review Report.
V1.
RECOMMENDATIONS
The Department of Agriculture, is called upon to reconsider its proposed restrictions on chlorpyrifos
in the light of the submissions contained herein, to consider the evidence presented in this
submission on the toxicity and associated risks of chlorpyrifos, and to take the following reasonable,
precautionary steps in accordance with its legal duties:
Part 1
(i)
Hold a public enquiry into the future regulation of chlorpyrifos in terms of section 4 of
The Promotion of Administrative Justice Act no 3 of 2000;
(ii)
Decide whether the steps set out in the Part 2 hereunder should not be implemented
as final regulatory measures;
(iii)
Pending such enquiry impose the limitations contained in Part 2 below, ie
paragraphs a), d), h), l), m) as an interim measure:
Part 2
For Non-Agricultural Uses:
a)
Ban chlorpyrifos from any over-the-counter sales for home, garden or other domestic uses,
and ban all private domestic uses accordingly.
148
149
Interim Review Report (n 129) 70-71
Correspondence with Ron Marks (n 130).
51
b)
In the event of any exceptions to (i) above, strictly enforce the requirement of child-proof
containers;
c)
Limit all uses of chlorpyrifos to registered Pest Control Operators (PCOs) under strict
conditions of application.
d)
Prohibit commercial PCOs from spraying chlorpyrifos in homes, schools, creches,
laygrounds,children’s hospitals, and any other area where children may be exposed.
For Agricultural Uses:
e)
Review MRLS in light of new scientific evidence with priority given to the following crops,
grapes, tomatoes, bananas, broccoli, cauliflower;
f)
Strengthen label requirements, with mandatory warning statements on all chlorpyrifos
product labels;
g)
Discontinue applications with high-pressure equipment;
h)
Enforce mandatory Personal Protective Equipment – specifically, double layers, chemical
resistant gloves, chemical resistant shoes plus socks, chemical resistant headgear for
overhead exposure, chemical resistant apron when cleaning and mixing or loading and a
dust/mist respirator – for at least the following scenarios: mixing/loading liquids for
groundboom and airblast application, loading granulars for ground application, tractor drawn
granular spreader, and low pressure handwand;
i)
Establish re-entry levels for post-application workers for incorporation on product labels;
j)
Implement mandatory training for pesticide users, distributors and advisors;
k)
Implement mandatory inspections of chlorpyrifos application equipment;
l)
Prohibit aerial spraying of chlorpyrifos;
m)
Prohibit the sale of chlorpyrifos in bulk150 quantities except to registered and authorised
buyers and
n)
Establish buffer zones around residential areas; aquatic resources and areas of biodiversity.
Should the Department of Agriculture fail to implement these steps our clients reserve the right to
take further legal action in order to protect the public interest.
150
To be determined.
52
LEGAL RESOURCES CENTRE
PER: ANGELA ANDREWS