Dr. Schierow discusses the effects of a recent statute on food safety

Schierow, Linda-Jo

English

The Food Quality Protection Act of 1996 (FQPA) amended the Federal Insecticide, Fungicide, and Rodenticide Act, governing U.S. registration, sale, and use of pesticide products, and the Federal Food, Drug, and Cosmetic Act, under which the Environmental Protection Agency (EPA) sets allowable pesticide residue levels for food (tolerances). The FQPA directs EPA to ensure a "reasonable certainty of no harm" due to pesticide exposure and requires reevaluation of 33% of existing tolerances against this new safety standard by August 1999, 66% by August 2002, and 100% by August 2006. The Act direc

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Pesticide Residue Regulation: Analysis of Food Quality Protection Act Implementation

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RISK: Health, Safety & Environment (1990-2002)Volume 10 | Number 4 Article 3September 1999Pesticide Residue Regulation: Analysis of FoodQuality Protection Act ImplementationLinda-Jo SchierowFollow this and additional works at: https://scholars.unh.edu/riskPart of the Agricultural Science Commons, Agriculture Commons, Agriculture Law Commons,Bioresource and Agricultural Engineering Commons, Consumer Protection Law Commons, Foodand Drug Law Commons, and the Food Security CommonsThis Article is brought to you for free and open access by the University of New Hampshire – School of Law at University of New Hampshire Scholars'Repository. It has been accepted for inclusion in RISK: Health, Safety & Environment (1990-2002) by an authorized editor of University of NewHampshire Scholars' Repository. For more information, please contact ellen.phillips@law.unh.edu.Repository CitationLinda-Jo Schierow, Pesticide Residue Regulation: Analysis of Food Quality Protection Act Implementation , 10 RISK 281 (1999).Pesticide Residue Regulation: Analysis of FoodQuality Protection Act Implementation*Linda-Jo Schierow**IntroductionThe 104th Congress enacted significant changes to two statutes thataffect the use of pesticides: the Federal Insecticide, Fungicide, andRodenticide Act (FIFRA), and the Federal Food, Drug and CosmeticAct (FFDCA). FIFRA governs U.S. registration, sale and use ofpesticide products. The FFDCA establishes standards under which theU.S. Environmental Protection Agency (EPA) sets pesticide residuelevels (tolerances) in food and animal feed. The vehicle for thesechanges was the Food Quality Protection Act (FQPA) of 19961 thatestablished a new food safety standard. It requires a "reasonablecertainty of no harm" from any legally permissible pesticide residue,while recognizing the benefits of pesticide use on food crops. Since theFQPA was enacted, EPA implementation of the new standard has beencarefully observed and often criticized by farmers, chemicalmanufacturers, environmentalists, other stakeholders and theAdministration. This article evaluates the status of the FQPAimplementation and related issues; particularly its potential effects oncertain popular pesticides used in food production and processing.Food Quality Protection Act MandatesA key purpose of the FQPA was to coordinate pesticide registrationunder the FIFRA with FFDCA tolerances to ensure that any pesticideused on food would leave only a "safe" residue. The FFDCA, asamended, defines "safe" to mean that EPA "has determined that there* The views expressed here are the author's and do not necessarily represent thoseof the Congressional Research Service.** Dr. Schierow is a Specialist in Environmental Policy, Environment and NaturalResources Div., Congressional Research Services. She received her B.S. (Education),M.S. and Ph.D. (Land Resources) from the University of Wisconsin-Madison. Email:Lschierow@crs.loc.gov.1 Pub. L. 104-170.10 Risk. Health, Safety & Environment 281 [Fall 1999]is a reasonable certainty that no harm will result from aggregateexposure... including all anticipated dietary exposures and all otherexposures for which there is reliable information."2To ensure the safety of pesticide tolerances established prior toAugust 1996, EPA must reevaluate the tolerances against the new safetystandard. The Act requires reevaluation of 33% of existing residuelimits for food-use pesticides by August 1999, 66% by August 2002and 100% by August 2006. It also directs EPA to reevaluate the riskiestpesticides first.If EPA finds that food pesticide residues may pose a risk greaterthan allowed under the FQPA, the FFDCA tolerance level and theFIFRA registration (that is, product labels) to restrict the number ormanner of approved pesticide uses, must be changed to reduce humanexposure to a "safe" level. In assessing a pesticide residue tolerance, theFQPA requires EPA to consider:* the susceptibility of children to exposure and/or toadverse health effects;* potential disruptive effects on endocrine systems;* potential effects of in utero exposure;* cumulative risk from all sources and through all routesof exposure; and* aggregate risks due to exposure to the pesticide and toother pesticides that may have similar toxic effects (i.e., a"common mechanism of toxicity").FQPA ImplementationGenerally, EPA is on schedule. It expects to reach or surpass theAugust 1999 milestone for reevaluating and, if necessary, modifying33% of tolerances for pesticide residue levels in food to ensure thesafety of children and other consumers. EPA continues to work withstakeholders to implement the new law. Pesticide producers and usersare working to secure assurances that the risks of popularorganophosphates and other pesticides will be fairly evaluated by EPA,based on real data, not worst-case assumptions. At the same time,environmental and consumer groups are trying to ensure promptregulation of pesticides that are not "safe." The FQPA implementationis complicated by several particularly contentious issues.2 FFDCA § 408(b)(2)(A)(ii), 21 U.S.C. 346a(b)(2)(A)(ii) (1999).Schierow: Pesticide Residue Regulation 283Progress Towards MilestonesOn the date of the FQPA enactment, there were 9,728 residuetolerance levels and exemptions, in effect for active and inert pesticideingredients. EPA divided these into groups based largely on relative riskto public health, and published a schedule for reevaluation oftolerances. 3 The first group of pesticides subject to tolerancereassessment includes:* organophosphates, carbamates, and organochlorines;* probable and some possible human carcinogens;* high-hazard inert ingredients;* pesticides that exceed their reference dose - RfD, anestimate of a safe daily exposure levels likely to be safe overa lifetime;; pesticides subject to reregistration requirements4 andfor which EPA would be issuing Reregistration EligibilityDecisions after the FQPA enactment; and* pesticides whose tolerances and exemptions are in theprocess of being revoked.An itemized list of pesticides and request for public comments appearswith the schedule. 5 EPA expected to complete reevaluation of morethan 3,000 tolerances before the August 1999 deadline. In FY1998, itreevaluated more than 1,400 tolerances and revoked 874, according toa fact sheet.6 About 415 tolerances were evaluated in FY1997.Stakeholder InvolvementAccording to EPA, pesticide regulations directly affectapproximately 30 major pesticide producers, 100 smaller producers,2,500 formulators, 29,000 distributors and retailers, 40,000 commercialpest control firms, 1 million farms, 3.5 million farm workers, severalmillion industry and government users, and all households. 7 Withineach of these groups, distinct subgroups have different views on thefederal role in pesticide regulation. Some politically active stakeholder3 62 F. R. 42019 (1997).4 EPA has a deadline of 2002 for completing the reregistration of pesticidesregistered prior to 1984. Amendments to the FIFRA in 1972 directed the EPA to"reregister" approximately 35,000 older products, thereby, assessing their safety inlight of current standards.5 Supra note 3.6 EPA, Pesticide Program Highlights from Fiscal Year 1998 (1998).7 EPA, Office of Prevention, Pesticides and Toxic Substances, 1996 Food QualityProtection Act Implementation Plan, Mar. 1997, at 4.10 Risk. Health, Safety & Environment 281 [Fall 1999]groups include multinational pesticide producers (i.e., Monsanto),specialty chemical manufacturers, agribusinesses, organic farmers, dairyfarmers, fruit and nut growers, landscape gardeners, environmentalists,and consumer groups.A handful of contentious issues has potentially far-reaching impactson the availability of pesticides for particular uses, the cost of food andother consumer products, and international competitiveness of U.S.agricultural products. EPA is seeking to resolve these issues throughcooperative decisions involving the major stakeholders. Theses issues aresummarized below.EPA has been working with several committees since the law'senactment to ensure an open decision-making process. A Food SafetyAdvisory Committee (FSAC), consisting of growers, pesticidecompanies, environmental groups, and state officials, was establishedimmediately after the FQPA passage and they developed interimdecision policies, which still are being employed. This committeefinished its work in December 1996. A permanent, broadlyrepresentative advisory committee, the Pesticide Program DialogueCommittee, has had ongoing discussions about the FQPAimplementation. EPA has also involved its FIFRA Science AdvisoryPanel of independent scientists in developing approaches forimplementing several of the more technically challenging FQPAprovisions. Another standing committee advising EPA is the StateFIFRA Research and Evaluation Group. Several task forces and ad hocworking groups have worked on specific issues. For example, EPAcreated a task force to identify data and methods needed to apply the10-times safety factor to protect the health of children. 8Despite these consultative efforts, growers and chemicalmanufacturers continued to express concerns, and Vice President Goresent a memorandum on April 8, 1998 to EPA directing the Agency towork more closely with the U.S. Department of Agriculture and thestakeholders in implementing the FQPA. 9 In response, EPAestablished a new advisory group and committed itself to apply sound8 Regarding the EPA implementation process and advisory committees, seegenerally <http://www.epa.gov/oppfeadl> and <www.epa.gov/pesticides>.9 See EPA Tolerance Reassessment Advisory Committee, Meeting Summary,May 28, 1998 at <http://www.epa.gov/oppfeadl/trac/summaryl.htm>.Schierow: Pesticide Residue Regulation 285science, employ an open process of decision making, and ease anynecessary transition to new rules to not jeopardize the agriculture andfarm communities. The Tolerance Reassessment Advisory Committee(TRAC) was established jointly by EPA and USDA as a subcommitteeof EPA's National Advisory Council for Environmental Policy andTechnology. 10 The 45 members represent environmental and publicinterest groups; pesticide industry and trade associations; users,growers, and commodity organizations; pediatric and public healthorganizations; federal agencies, tribal, state, and local governments;academia and consumers. However, the Environmental Working Groupresigned claiming that the Clinton Administration had failed to takeaction to protect children from pesticide risks.Implementation IssuesThe TRAC has identified nine science policy issue areas affectingimplementation of the FQPA with regard to tolerances: 11* applying the FQPA 10-fold safety factor for children;* dietary exposure assessment (the role of Monte Carlo[probability] methods and the percentile of foodconsumption included);* exposure assessment (how to interpret a result of "nodetectable residue");* dietary exposure estimates (need for better data);* dietary (drinking water) exposure estimates;* assessing residential exposure;• aggregating all non-occupational exposures;* cumulative risk assessments for pesticides with acommon mechanism of toxicity (e.g., organophosphates);and0 appropriate toxicity endpoints for risk assessments oforganophosphates.10 See <http://www.epa.gov/pesticides/trac> for an overview of TRAC.11 63 F. R. 58038 (1998). Arguments surrounding statistical issues are technical butthe impact may be substantial. For example, EPA currently uses a 99.9th percentile togenerate risk estimates. According to a summary of a meeting, the FIFRA ScientificAdvisory Panel "differed on whether setting criteria at the 99.9th percentile is aconservative approach. However, if the 99.9th percentile is utilized... 23,000children[] will still be exposed to acute effects" (<http://www.epa.gov/pesticides/SAP>). Some want EPA to use a 95th percentile, which would leave a greaterpercentage of the population exposed to potential acute effects but would allow thepesticide to be used more.10 Risk. Health, Safety & Environment 281 [Fall 1999]EPA is developing policy guidance documents on each of theseissues. 12 Draft policies are getting published in the Federal Registerand, although it is under no obligation to do so, public comments arewelcomed. EPA will evaluate the policies after considering publiccomments. The remaining two TRAC meetings will consider means ofreducing adverse impacts of any new pesticide regulations on growersand others who use those pesticides.A particularly contentious implementation issue revolves around theFQPA directives to use "available data" and "reliable data," as well asthe FQPA mandate to order testing if EPA determines that the dataare "reasonably required to support the continuation of a tolerance orexemption that is in effect . . . for a pesticide chemical residue on afood." 13 Stakeholders disagree regarding an appropriate course ofaction for EPA to pursue when there is insufficient "reliable" data toestimate risk. Pesticide producers ideally would like EPA to delayestimating risk until reliable data can be collected; environmentalistswould like EPA to estimate risk based on "available" data and, ifunacceptable risk is found, to reduce the potential for human exposurethrough regulations. Alternatively, EPA may impose a time-limitedtemporary tolerance for pesticide residues on certain crops (a procedureallowed by FQPA and in current use for emergency exemptions). 14This may prove to be an acceptable compromise between environmentalgroups and pesticide producers.Members of the pesticide industry also want EPA to "call in" data,particularly on exposure levels. Although it is the pesticide producerswho conduct toxicity testing without needing to wait for an EPA orderto produce the data, such an order provides certain legal and financialprotections, and probably would delay revocation of a tolerancepending data development.Food Tolerances for Organophosphate Pesticide ResiduesOrganic phosphates, or organophosphates, are complex syntheticcompounds. Two well-known organophosphates are methyl parathionand malathion. In agriculture, organophosphates are used as broadly12 Id.13 FFDCA § 408(0(1), 21 U.S.C. § 346a(0(1) (1999).14 Id. § 408(b)(2)(B), 21 U.S.C. § 346a(b)(2)(B) (1999).Schierow: Pesticide Residue Regulation 287effective insecticides; for example, to kill boll weevils, spider mites, fruitflies, or aphids. Various organophosphates are used on fruit trees,vegetables, ornamental plants, cotton, corn, soybeans, rice, and wheat.EPA determined that organophosphates are among the pesticidesposing the greatest risks to human health and the environment, and,therefore, the safety of these products must be evaluated during thefirst three-year period following enactment of the FQPA in 1996.15Organophosphates have a highly variable, toxic effect on the nervoussystems of people and other animals. Some are highly acutely toxic,others much less so; but, because they share a common mechanism forexerting this effect, they are the first pesticides that EPA is consideringas a group. 16 There are 1,800 tolerances established for variousorganophosphate pesticide residues on crops.Growers and pesticide manufacturers are concerned about theimpact of the FQPA implementation on these widely used pesticides.Although rumors that EPA might cancel registrations for the entireclass of organophosphates seem to be alarmist, concern about the futureavailability of some of these pesticides for certain uses is justifiedbecause evidence suggests that cumulative risk probably is greater thanallowed under the new law. EPA conducted preliminary riskassessments for 28 organophosphates and made the results available forpublic comment. 17 These assessments indicate that the risks of someindividual organophosphates (e.g., methyl parathion) exceed acceptablelevels, even if non-food sources of exposure to the pesticide are notconsidered. However, most of the preliminary risk assessments reliedon numerous assumptions about exposure, because the data were eitherunavailable or unreliable. EPA is currently collecting data on rates of useof the organophosphates on various commodities. As more data arecollected, assessments might narrow the range of probable exposuresand risks to levels that are reasonably certain to be safe, as farm groupsand pesticide producers contend. On the other hand, the data mightsupport conclusions of the Environmental Working Group, a consumersafety advocacy group, which claims that children are exposed to unsafe15 62 F.R. 42019 (1997).16 Organophosphates inhibit cholinesterase, an enzyme necessary for the properfunctioning of the nervous system.17 Risk assessments can be downloaded from <http://www.epa.gov/oppsrrdl/op/>.10 Risk- Health, Safety & Environment 281 [Fall 1999]levels of organophosphates on pears, apples, grapes, and peaches, andthat the exposure can damage developing brains and nervoussystems. 18ConclusionWhen Congress passed the FQPA by unanimous votes in bothChambers, many hailed it as one of two "risk-based" laws enacted in1996. It established a new standard for food safety that recognized thebenefits of pesticide use on food crops, but also guaranteed that therewould be a reasonable certainty of safety from pesticide residues. Twoand one-half years after its enactment, EPA appears to be makingprogress at an acceptable rate relative to statutory deadlines. However,it is not clear whether the promise of the FQPA will be filly realized,since contentious implementation issues remain unresolved.18 Richard Wiles et al., How 'Bout Them Apples? Pesticides in Children's FoodTen Years after Alar, (Environmental Working Group 1999).

University of New Hampshire

RISK: Health, Safety & Environment (1990-2002)
Volume 10 | Number 4 Article 3
September 1999
Pesticide Residue Regulation: Analysis of Food
Quality Protection Act Implementation
Linda-Jo Schierow
Follow this and additional works at: https://scholars.unh.edu/risk
Part of the Agricultural Science Commons, Agriculture Commons, Agriculture Law Commons,
Bioresource and Agricultural Engineering Commons, Consumer Protection Law Commons, Food
and Drug Law Commons, and the Food Security Commons
This Article is brought to you for free and open access by the University of New Hampshire – School of Law at University of New Hampshire Scholars'
Repository. It has been accepted for inclusion in RISK: Health, Safety & Environment (1990-2002) by an authorized editor of University of New
Hampshire Scholars' Repository. For more information, please contact ellen.phillips@law.unh.edu.
Repository Citation
Linda-Jo Schierow, Pesticide Residue Regulation: Analysis of Food Quality Protection Act Implementation , 10 RISK 281 (1999).
Pesticide Residue Regulation: Analysis of Food
Quality Protection Act Implementation*
Linda-Jo Schierow**
Introduction
The 104th Congress enacted significant changes to two statutes that
affect the use of pesticides: the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), and the Federal Food, Drug and Cosmetic
Act (FFDCA). FIFRA governs U.S. registration, sale and use of
pesticide products. The FFDCA establishes standards under which the
U.S. Environmental Protection Agency (EPA) sets pesticide residue
levels (tolerances) in food and animal feed. The vehicle for these
changes was the Food Quality Protection Act (FQPA) of 19961 that
established a new food safety standard. It requires a "reasonable
certainty of no harm" from any legally permissible pesticide residue,
while recognizing the benefits of pesticide use on food crops. Since the
FQPA was enacted, EPA implementation of the new standard has been
carefully observed and often criticized by farmers, chemical
manufacturers, environmentalists, other stakeholders and the
Administration. This article evaluates the status of the FQPA
implementation and related issues; particularly its potential effects on
certain popular pesticides used in food production and processing.
Food Quality Protection Act Mandates
A key purpose of the FQPA was to coordinate pesticide registration
under the FIFRA with FFDCA tolerances to ensure that any pesticide
used on food would leave only a "safe" residue. The FFDCA, as
amended, defines "safe" to mean that EPA "has determined that there
* The views expressed here are the author's and do not necessarily represent those
of the Congressional Research Service.
** Dr. Schierow is a Specialist in Environmental Policy, Environment and Natural
Resources Div., Congressional Research Services. She received her B.S. (Education),
M.S. and Ph.D. (Land Resources) from the University of Wisconsin-Madison. Email:
Lschierow@crs.loc.gov.
1 Pub. L. 104-170.
10 Risk. Health, Safety & Environment 281 [Fall 1999]
is a reasonable certainty that no harm will result from aggregate
exposure... including all anticipated dietary exposures and all other
exposures for which there is reliable information."2
To ensure the safety of pesticide tolerances established prior to
August 1996, EPA must reevaluate the tolerances against the new safety
standard. The Act requires reevaluation of 33% of existing residue
limits for food-use pesticides by August 1999, 66% by August 2002
and 100% by August 2006. It also directs EPA to reevaluate the riskiest
pesticides first.
If EPA finds that food pesticide residues may pose a risk greater
than allowed under the FQPA, the FFDCA tolerance level and the
FIFRA registration (that is, product labels) to restrict the number or
manner of approved pesticide uses, must be changed to reduce human
exposure to a "safe" level. In assessing a pesticide residue tolerance, the
FQPA requires EPA to consider:
* the susceptibility of children to exposure and/or to
adverse health effects;
* potential disruptive effects on endocrine systems;
* potential effects of in utero exposure;
* cumulative risk from all sources and through all routes
of exposure; and
* aggregate risks due to exposure to the pesticide and to
other pesticides that may have similar toxic effects (i.e., a
"common mechanism of toxicity").
FQPA Implementation
Generally, EPA is on schedule. It expects to reach or surpass the
August 1999 milestone for reevaluating and, if necessary, modifying
33% of tolerances for pesticide residue levels in food to ensure the
safety of children and other consumers. EPA continues to work with
stakeholders to implement the new law. Pesticide producers and users
are working to secure assurances that the risks of popular
organophosphates and other pesticides will be fairly evaluated by EPA,
based on real data, not worst-case assumptions. At the same time,
environmental and consumer groups are trying to ensure prompt
regulation of pesticides that are not "safe." The FQPA implementation
is complicated by several particularly contentious issues.
2 FFDCA § 408(b)(2)(A)(ii), 21 U.S.C. 346a(b)(2)(A)(ii) (1999).
Schierow: Pesticide Residue Regulation 283
Progress Towards Milestones
On the date of the FQPA enactment, there were 9,728 residue
tolerance levels and exemptions, in effect for active and inert pesticide
ingredients. EPA divided these into groups based largely on relative risk
to public health, and published a schedule for reevaluation of
tolerances. 3 The first group of pesticides subject to tolerance
reassessment includes:
* organophosphates, carbamates, and organochlorines;
* probable and some possible human carcinogens;
* high-hazard inert ingredients;
* pesticides that exceed their reference dose - RfD, an
estimate of a safe daily exposure levels likely to be safe over
a lifetime;
; pesticides subject to reregistration requirements4 and
for which EPA would be issuing Reregistration Eligibility
Decisions after the FQPA enactment; and
* pesticides whose tolerances and exemptions are in the
process of being revoked.
An itemized list of pesticides and request for public comments appears
with the schedule. 5 EPA expected to complete reevaluation of more
than 3,000 tolerances before the August 1999 deadline. In FY1998, it
reevaluated more than 1,400 tolerances and revoked 874, according to
a fact sheet.6 About 415 tolerances were evaluated in FY1997.
Stakeholder Involvement
According to EPA, pesticide regulations directly affect
approximately 30 major pesticide producers, 100 smaller producers,
2,500 formulators, 29,000 distributors and retailers, 40,000 commercial
pest control firms, 1 million farms, 3.5 million farm workers, several
million industry and government users, and all households. 7 Within
each of these groups, distinct subgroups have different views on the
federal role in pesticide regulation. Some politically active stakeholder
3 62 F. R. 42019 (1997).
4 EPA has a deadline of 2002 for completing the reregistration of pesticides
registered prior to 1984. Amendments to the FIFRA in 1972 directed the EPA to
"reregister" approximately 35,000 older products, thereby, assessing their safety in
light of current standards.
5 Supra note 3.
6 EPA, Pesticide Program Highlights from Fiscal Year 1998 (1998).
7 EPA, Office of Prevention, Pesticides and Toxic Substances, 1996 Food Quality
Protection Act Implementation Plan, Mar. 1997, at 4.
10 Risk. Health, Safety & Environment 281 [Fall 1999]
groups include multinational pesticide producers (i.e., Monsanto),
specialty chemical manufacturers, agribusinesses, organic farmers, dairy
farmers, fruit and nut growers, landscape gardeners, environmentalists,
and consumer groups.
A handful of contentious issues has potentially far-reaching impacts
on the availability of pesticides for particular uses, the cost of food and
other consumer products, and international competitiveness of U.S.
agricultural products. EPA is seeking to resolve these issues through
cooperative decisions involving the major stakeholders. Theses issues are
summarized below.
EPA has been working with several committees since the law's
enactment to ensure an open decision-making process. A Food Safety
Advisory Committee (FSAC), consisting of growers, pesticide
companies, environmental groups, and state officials, was established
immediately after the FQPA passage and they developed interim
decision policies, which still are being employed. This committee
finished its work in December 1996. A permanent, broadly
representative advisory committee, the Pesticide Program Dialogue
Committee, has had ongoing discussions about the FQPA
implementation. EPA has also involved its FIFRA Science Advisory
Panel of independent scientists in developing approaches for
implementing several of the more technically challenging FQPA
provisions. Another standing committee advising EPA is the State
FIFRA Research and Evaluation Group. Several task forces and ad hoc
working groups have worked on specific issues. For example, EPA
created a task force to identify data and methods needed to apply the
10-times safety factor to protect the health of children.
8
Despite these consultative efforts, growers and chemical
manufacturers continued to express concerns, and Vice President Gore
sent a memorandum on April 8, 1998 to EPA directing the Agency to
work more closely with the U.S. Department of Agriculture and the
stakeholders in implementing the FQPA. 9 In response, EPA
established a new advisory group and committed itself to apply sound
8 Regarding the EPA implementation process and advisory committees, see
generally <http://www.epa.gov/oppfeadl> and <www.epa.gov/pesticides>.
9 See EPA Tolerance Reassessment Advisory Committee, Meeting Summary,
May 28, 1998 at <http://www.epa.gov/oppfeadl/trac/summaryl.htm>.
Schierow: Pesticide Residue Regulation 285
science, employ an open process of decision making, and ease any
necessary transition to new rules to not jeopardize the agriculture and
farm communities. The Tolerance Reassessment Advisory Committee
(TRAC) was established jointly by EPA and USDA as a subcommittee
of EPA's National Advisory Council for Environmental Policy and
Technology. 10 The 45 members represent environmental and public
interest groups; pesticide industry and trade associations; users,
growers, and commodity organizations; pediatric and public health
organizations; federal agencies, tribal, state, and local governments;
academia and consumers. However, the Environmental Working Group
resigned claiming that the Clinton Administration had failed to take
action to protect children from pesticide risks.
Implementation Issues
The TRAC has identified nine science policy issue areas affecting
implementation of the FQPA with regard to tolerances:
11
* applying the FQPA 10-fold safety factor for children;
* dietary exposure assessment (the role of Monte Carlo
[probability] methods and the percentile of food
consumption included);
* exposure assessment (how to interpret a result of "no
detectable residue");
* dietary exposure estimates (need for better data);
* dietary (drinking water) exposure estimates;
* assessing residential exposure;
• aggregating all non-occupational exposures;
* cumulative risk assessments for pesticides with a
common mechanism of toxicity (e.g., organophosphates);
and
0 appropriate toxicity endpoints for risk assessments of
organophosphates.
10 See <http://www.epa.gov/pesticides/trac> for an overview of TRAC.
11 63 F. R. 58038 (1998). Arguments surrounding statistical issues are technical but
the impact may be substantial. For example, EPA currently uses a 99.9th percentile to
generate risk estimates. According to a summary of a meeting, the FIFRA Scientific
Advisory Panel "differed on whether setting criteria at the 99.9th percentile is a
conservative approach. However, if the 99.9th percentile is utilized... 23,000
children[] will still be exposed to acute effects" (<http://www.epa.gov/pesticides
/SAP>). Some want EPA to use a 95th percentile, which would leave a greater
percentage of the population exposed to potential acute effects but would allow the
pesticide to be used more.
10 Risk. Health, Safety & Environment 281 [Fall 1999]
EPA is developing policy guidance documents on each of these
issues. 12 Draft policies are getting published in the Federal Register
and, although it is under no obligation to do so, public comments are
welcomed. EPA will evaluate the policies after considering public
comments. The remaining two TRAC meetings will consider means of
reducing adverse impacts of any new pesticide regulations on growers
and others who use those pesticides.
A particularly contentious implementation issue revolves around the
FQPA directives to use "available data" and "reliable data," as well as
the FQPA mandate to order testing if EPA determines that the data
are "reasonably required to support the continuation of a tolerance or
exemption that is in effect . . . for a pesticide chemical residue on a
food." 13 Stakeholders disagree regarding an appropriate course of
action for EPA to pursue when there is insufficient "reliable" data to
estimate risk. Pesticide producers ideally would like EPA to delay
estimating risk until reliable data can be collected; environmentalists
would like EPA to estimate risk based on "available" data and, if
unacceptable risk is found, to reduce the potential for human exposure
through regulations. Alternatively, EPA may impose a time-limited
temporary tolerance for pesticide residues on certain crops (a procedure
allowed by FQPA and in current use for emergency exemptions).
14
This may prove to be an acceptable compromise between environmental
groups and pesticide producers.
Members of the pesticide industry also want EPA to "call in" data,
particularly on exposure levels. Although it is the pesticide producers
who conduct toxicity testing without needing to wait for an EPA order
to produce the data, such an order provides certain legal and financial
protections, and probably would delay revocation of a tolerance
pending data development.
Food Tolerances for Organophosphate Pesticide Residues
Organic phosphates, or organophosphates, are complex synthetic
compounds. Two well-known organophosphates are methyl parathion
and malathion. In agriculture, organophosphates are used as broadly
12 Id.
13 FFDCA § 408(0(1), 21 U.S.C. § 346a(0(1) (1999).
14 Id. § 408(b)(2)(B), 21 U.S.C. § 346a(b)(2)(B) (1999).
Schierow: Pesticide Residue Regulation 287
effective insecticides; for example, to kill boll weevils, spider mites, fruit
flies, or aphids. Various organophosphates are used on fruit trees,
vegetables, ornamental plants, cotton, corn, soybeans, rice, and wheat.
EPA determined that organophosphates are among the pesticides
posing the greatest risks to human health and the environment, and,
therefore, the safety of these products must be evaluated during the
first three-year period following enactment of the FQPA in 1996.15
Organophosphates have a highly variable, toxic effect on the nervous
systems of people and other animals. Some are highly acutely toxic,
others much less so; but, because they share a common mechanism for
exerting this effect, they are the first pesticides that EPA is considering
as a group. 16 There are 1,800 tolerances established for various
organophosphate pesticide residues on crops.
Growers and pesticide manufacturers are concerned about the
impact of the FQPA implementation on these widely used pesticides.
Although rumors that EPA might cancel registrations for the entire
class of organophosphates seem to be alarmist, concern about the future
availability of some of these pesticides for certain uses is justified
because evidence suggests that cumulative risk probably is greater than
allowed under the new law. EPA conducted preliminary risk
assessments for 28 organophosphates and made the results available for
public comment. 17 These assessments indicate that the risks of some
individual organophosphates (e.g., methyl parathion) exceed acceptable
levels, even if non-food sources of exposure to the pesticide are not
considered. However, most of the preliminary risk assessments relied
on numerous assumptions about exposure, because the data were either
unavailable or unreliable. EPA is currently collecting data on rates of use
of the organophosphates on various commodities. As more data are
collected, assessments might narrow the range of probable exposures
and risks to levels that are reasonably certain to be safe, as farm groups
and pesticide producers contend. On the other hand, the data might
support conclusions of the Environmental Working Group, a consumer
safety advocacy group, which claims that children are exposed to unsafe
15 62 F.R. 42019 (1997).
16 Organophosphates inhibit cholinesterase, an enzyme necessary for the proper
functioning of the nervous system.
17 Risk assessments can be downloaded from <http://www.epa.gov/oppsrrdl/op/>.
10 Risk- Health, Safety & Environment 281 [Fall 1999]
levels of organophosphates on pears, apples, grapes, and peaches, and
that the exposure can damage developing brains and nervous
systems. 18
Conclusion
When Congress passed the FQPA by unanimous votes in both
Chambers, many hailed it as one of two "risk-based" laws enacted in
1996. It established a new standard for food safety that recognized the
benefits of pesticide use on food crops, but also guaranteed that there
would be a reasonable certainty of safety from pesticide residues. Two
and one-half years after its enactment, EPA appears to be making
progress at an acceptable rate relative to statutory deadlines. However,
it is not clear whether the promise of the FQPA will be filly realized,
since contentious implementation issues remain unresolved.
18 Richard Wiles et al., How 'Bout Them Apples? Pesticides in Children's Food
Ten Years after Alar, (Environmental Working Group 1999).


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Pesticide Residue Regulation: Analysis of Food Quality Protection Act Implementation

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