United States
Environmental Protection
Agency
Prevention, Pesticides, EPA 735-R-99001
And Toxic Substances August 1999
(7506C)
Implementing the
Food Quality Protection Act
-------
Progress Report: Implementing FQPA
Executive Summary
This report details the U.S. Environmental Protection Agency's (EPA) progress in
implementing the requirements of the Food Quality Protection Act (FQPA). It reflects how
implementation furthers EPA's mission to protect human health and the environment and assures
all Americans access to safe and affordable foods.
President Clinton signed FQPA into law on August 3, 1996, representing a major step
forward in the regulation of pesticide use in the United States. Among other things, FQPA:
established a single, health-based standard for pesticide residues in raw and
processed food;
provided tools for enhancing the protection of all consumers, particularly infants
and children; and
created an environment favorable for the development and adoption of lower risk,
effective crop protection tools for U.S. agriculture.
Most importantly, the law presented a strong challenge to regulators and regulated alike to
move beyond traditional methods and ways of thinking. FQPA's authors appreciated the need to
maintain a strong agricultural sector, but recognized that greater protections for the public needed
to be provided, and newer technologies introduced, without jeopardizing that strength.
Principles of Implementation
EPA's activities have been guided by four principles outlined in an April 8, 1998, memo
from Vice President Gore to EPA Administrator Browner and U.S. Department of Agriculture
(USD A) Secretary Glickman. Specifically, the Vice President stated the importance of using
sound science in protecting public health, developing a sufficiently transparent implementation
process, providing a process for the reasonable transition of agriculture to new pest management
strategies, and maintaining open consultation with the public and other agencies. With these
principles as the foundation, EPA and USDA have made significant progress in:
using the regulatory process to lower the risks of pesticide use,
ensuring that all new and previously registered pesticides meet the FQPA standard,
promoting public participation and transparency in the process,
providing special protections for those who are most vulnerable, especially infants
and children,
developing the tools needed to implement FQPA's innovative scientific
approaches, and
working with our partners and diverse stakeholders.
-------
Executive Summary continued
Lowering the Risks
FQPA enhanced EPA's responsibility to promote the development of safer pest control
options. We also have a responsibility to provide registrants with reasonable review times for
applications for pesticide registrations. This became a much greater challenge with the signing of
FQPA and the immediate effectiveness of most of the law's provisions. Nevertheless, we have
been very successful in instituting the reduced risk provisions codified by FQPA and in
maintaining the registration process, including the review of emergency exemption requests from
states.
Since FQPA passed, we have continued to reach historically high numbers of new
registered active ingredients 77 during the last three years. Of these, more than half are
biologicals or reduced risk pesticides. In addition, we have improved the review time for
biological pesticides, which are generally regarded as posing less risk than traditional pesticides.
According to many pesticide manufacturers, the emphasis on reduced risk pesticides has
fundamentally altered their research and development processes, placing a premium on the
identification and development of these types of products.
Ensuring the Safety of Existing Pesticides
While we move forward to assure that all new pesticides meet the stringent FQPA safety
standard, we also must reassess existing pesticide uses to assure that they are protective of public
health. This comprehensive effort involves completion of the Reregi strati on Program, begun in
1988 for all chemicals registered before November 1984, as well as the reassessment of existing
pesticide tolerances (allowable residue limits) required by FQPA. The law sets a ten year
schedule for review of the 9721 tolerances in existence when the law was signed to bring them
into compliance with the new standard. The first milestone for this ten-year reassessment effort is
August 3, 1999, when 33% (approximately 3207) of the total must be done.
During the past three years since passage of FQPA, we have completed reevaluation of 48
pesticides (or groups of similar pesticides) and determined whether they can continue to be used
or whether they should be restricted or canceled. Of these 48 pesticides, 33 are for pesticides
with food uses. This brings the total count to 189 pesticides which, coupled with 231 voluntary
cancellations of potential reregi strati on candidates, leaves 192 pesticides to be reevaluated. For
tolerance reassessment, as of July 30, 1999, we have reassessed 3290 tolerances, thereby
surpassing the 33% requirement. We are continuing our focus first and aggressively on
organophosphates, carbamates, and others identified for priority review. Of the reassessments
completed, 66% are for pesticides the Agency identified for priority review because they appear
to pose the greatest risk to human health.
-------
Executive Summary continued
Transparency and Public Participation
The challenge of FQPA requires greater public participation and processes which lead to
an understanding of EPA's regulatory approach. As soon as the law passed, EPA established a
Food Safety Advisory Committee. This diverse group of stakeholders provided the Agency with
guidance on prioritizing implementation activities. We have also taken advantage of existing
advisory bodies such as the Pesticide Program Dialogue Committee (PPDC) and the Federal
Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) to help the Agency
sort through the multitude of issues resulting from FQPA. Since May 1998, the Tolerance
Reassessment Advisory Committee (TRAC), co-chaired by EPA and USD A, has provided a
forum for the exchange of ideas and opinions on implementation issues such as: key science
policies; ways to increase the transparency of and public participation in our regulatory process;
and transition strategies for agriculture.
In addition to advisory committees, EPA has sought to improve public participation in
other aspects of its regulatory program. The Agency is using a strong consultative process to
address risk concerns about the fumigants, aluminum and magnesium phosphide, and about
products used to control rodents. Through this process, EPA hopes to develop practical,
effective methods of risk mitigation. The Agency also relied heavily on the use of public focus
groups as well as consultation with the PPDC in developing the FQPA-required consumer
brochure on pesticide risks, which was distributed early in 1999.
Special Protection for Vulnerable Populations
We know that some people may be more vulnerable to pesticide exposures than others.
For example, we have strong evidence to indicate that some pesticides can pose greater risk to
children than adults because children's internal organs and bodily processes are still developing
and maturing, their eating patterns are different, and their behavior patterns may increase
exposure. Consequently, all tolerances established since FQPA have been set to be protective of
children. Likewise, because of the length of exposure and the possible exposure to stronger
formulations of pesticides used commercially, agricultural workers are particularly vulnerable.
We are reviewing our worker protection activities, including the methods for risk assessment, to
determine if agricultural workers are receiving adequate protection or if more stringent
requirements are necessary to assure their safety.
To further increase protections for infants and children, EPA is requiring registrants to
conduct acute, subchronic, and developmental neurotoxicity studies for at least 140 pesticides.
We have also issued an updated set of test guidelines for development of data on reproductive and
developmental effects. EPA's Office of Research and Development currently is conducting and
supporting research on the evaluation of age-related differences in sensitivity to pesticides and the
development of toxicity testing procedures for immature animals that will further our knowledge
of any differences between children and adults. Other EPA efforts include conducting research on
appropriate techniques to measure residential exposure to pesticides, increased research on
iii
-------
Executive Summary continued
exposure to children in farming areas, particularly the children of migrant workers, and working
with USDA on the collection of better data on the food consumption patterns of infants and
children and residues in foods children eat. Where risks to children or agricultural workers are of
concern, the Agency may take action on specific pesticides, such as the recent modification and
elimination of uses for azinphos methyl and methyl parathion.
On the Forefront of Sound Science
FQPA requires EPA to address a number of new scientific areas related to pesticide
regulation, such as aggregate exposure (from all non-occupational routes) and cumulative risk
(consideration of effects and exposures from pesticides and other substances that act by a
common mechanism of toxicity). This work is strengthening the U.S. regulatory system making it
one of the most scientifically advanced in the world. Proper development of this cutting edge
science requires consultation with independent, respected scientists both internal and external to
the government. For instance, the Endocrine Disrupters Screening and Testing Advisory
Committee (EDSTAC) was formed to help us develop a process for determining which chemicals
might potentially disrupt the hormone (endocrine) systems of humans and wildlife. EDSTAC
reached consensus on recommendations in August 1998 and those recommendations, considered
in combination with public comments, are helping EPA develop a final endocrine disrupter effects
screening program.
Key to implementing FQPA's science provisions is the development of science policies.
Immediately after passage of FQPA, we established interim policies to allow for the continuation
of regulatory activities while revised policies were developed. With the help of TRAC, the
Agency identified nine areas where revised science policies were needed: (1) applying FQPA's 10-
fold safety factor, (2) conducting dietary exposure risk assessment [Monte Carlo analyses], (3)
interpreting cases where no pesticide residues are detected, (4) conducting dietary (food)
exposure assessment, (5) conducting dietary (drinking water) exposure estimates, (6) assessing
non-occupational/non-dietary (residential) exposure, (7) aggregating exposure from all non-
occupational sources, (8) conducting cumulative risk assessments for pesticides with a common
mechanism of toxicity, and (9) selecting appropriate toxicity endpoints for risk assessments of
organophosphate pesticides. Papers have been, or are being, prepared in each of the nine areas
and are being released for public comment.
IV
-------
Executive Summary continued
Partners and Other Stakeholders
FQPA created momentum for fuller participation by all stakeholders in the regulation of
pesticides. The complexities of the law have led us to increase our efforts to coordinate with
other regulatory authorities, both in the U.S. and abroad. USDA is an important partner in
gathering data on pesticide use and residues, developing and evaluating alternative pest control
tools, and reaching out to the agricultural community and ensuring that their concerns are
adequately addressed. We are also working with USDA and groups such as the Inter-regional
Research Project #4 (IR-4) to coordinate efforts on minor use pesticides. EPA works with the
Department of Health and Human Services (DHHS) in an effort to develop broad policies on food
safety and to consult on public health pesticides. Under international agreements, such as the
North American Free Trade Agreement, we are harmonizing standards and data requirements.
This work allows greater regulatory coordination, improving health and environmental protection,
saving time and resources for governments and registrants, and helping to speed the availability of
newer pest control methods to users.
Improved coordination with partners helps assure that our decisions are scientifically
sound, protective, and practical: USDA has reviewed 14 organophosphate risk assessments;
based on the work of the IR-4 and others, we have approved over 1300 new minor uses, more
than 80% of which are for reduced risk pesticides; we have consulted DHHS on 5
organophosphates with public health uses; and, the U.S. and Canada have jointly reviewed and
registered 3 new reduced risk pesticides and 1 pheromone. These results are indicative of the
future impacts of these strengthened relationships.
Conclusion
The passage of FQPA brought comprehensive reform to our nation's pesticide and food
safety lawssetting in motion many fundamental changes in our approach to protecting human
health and the environment from risks associated with pesticide use. Meeting the law's immediate
and more stringent requirements for a single, health-based safety standard for new and existing
pesticides, while also maintaining momentum for bringing new biologicals and safer products to
market, has been an extraordinary challenge. We will continue to work closely with our federal,
state and tribal partners, as well as with our many public stakeholders to seek guidance and
meaningful public involvement in FQPA implementation activities and in the development and
refinement of science policies.
-------
Contents
I. FQPA - The Basics 1
II. Lowering the Risks 3
Safer Pesticides
New Tolerances since FQPA
Emergency Exemptions and FQPA
Tolerances for Other Ingredients in Pesticide Products
Promoting Safer Pesticides for Minor Uses
III. Ensuring the Safety of Existing Pesticides 9
Reregi strati on Accomplishments since FQPA
Reducing Risks through Post-FQPA REDS
Meeting FQPA Tolerance Reassessment Goals
IV. Public Participation and Transparency 13
The Tolerance Reassessment Advisory Committee
Risk Assessment/Risk Management Pilot Project
Aluminum and Magnesium Phosphide Stakeholder Process
Rodenticide Cluster Stakeholder Process
Right-to-Know Brochure and Website
V. Special Protection for Vulnerable Populations 18
Special Protection for Infants and Children
National Agenda to Protect Children's Health from Environmental Threats
Special Protection for Agricultural Workers
Applicator Certification and Training
Pesticides and National Strategies Health Care Providers
Pesticide Workers Website
VI. On the Forefront of Sound Science 23
Development of Science Policies
Pesticide Use Information
Endocrine Disrupters
VII. Partners and Other Stakeholders 27
Other Federal Agencies
International Partnership
States, Regional, and Tribal Coordination
Unique Stakeholders
-------
Contents
Appendices
1 The Scope of Pesticide Regulation/Statutory Framework
2 Status of FQPA Statutory Deadlines
3a Review Process for the Organophosphates
3b Examples of Risk Reduction through REDs
4 National Academy of Sciences' Recommendations
5 FQPA TRAC Science Policy Issues and Related Papers
6 EPA's Proposed Endocrine Disrupter Screening Program
7 PESP Partners
-------
I. FQPA - The Basics
In the three years since FQPA passed, EPA, the U.S. Department of Agriculture (USD A),
and our many stakeholders have done much to realize its potential and make its provisions standard
practice. We have prepared this report to showcase many of these accomplishments. Since these
accomplishments derive from this landmark legislation, its major provisions are outlined below for
reference For background on pesticide regulation in general, see Appendix 1. Appendix 2 outlines
the statutory deadlines for FQPA major provisions.
New Safety Standard for all Pesticide Residues in Food
"Reasonable Certainty of No Harm" from exposure to residues;
Aggregate assessment of all non-occupational sources of exposure, including drinking water,
residential, and dietary exposure;
Assessment of cumulative exposure to a pesticide and other substances with common
mechanisms of toxicity.
Reduced Risk Pesticides
Streamlined the registration process of reduced risk pesticides, including new active
ingredients, new uses of existing active ingredients already found to be reduced risk, and
amendments to all uses deemed to reduce risk;
Adoption of Integrated Pest Management (IPM) techniques through research, education, and
procurement and regulatory policies.
Tolerance Assessment and Reassessment
Application of the new safety standard to all tolerances issued after August 3, 1996;
Reassessment, within 10 years, of all tolerances issued prior to enactment of FQPA to ensure
they meet the new safety standard;
Establishment of tolerances for emergency exemptions issued under Section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA);
Authorization to charge fees for performance of tolerance functions.
-------
I. FQPA - The Basics continued
Pesticide Reregistration and Periodic Registration Review
Reauthorization and increase of maintenance fees to complete review of older pesticides first
registered prior to November 1984;
Authorization for a 15-year registration review program.
Right-to-Know
Development of a simple, understandable consumer brochure on pesticide residues to be
distributed to large, retail grocers for public display;
Publication of an informative statement about the data relating to a tolerance.
Special Protections for Infants and Children
Consideration of children's special sensitivity and exposure to pesticides;
Use of an extra 10-fold safety factor in addition to the traditional 100-fold safety factor,
unless, on the basis of reliable data, a different factor is determined to be safe for children;
Explicit determination that a tolerance is safe for children.
Endocrine Disrupters Screening and Testing Program
Development and application of a screening and testing program for chemicals with the
potential to disrupt the endocrine process;
Progress report to Congress by August 2000.
Antimicrobial Pesticides
Reform of the antimicrobial registration process to meet shortened review period goals while
still ensuring efficacy and safety;
Annual report to two Congressional Committees on progress in meeting the reform goals.
Minor Use Pesticides
Incentives to maintain existing minor uses and to develop new ones;Establishment of minor
use offices within EPA and the U.S. Department of Agriculture.
-------
II. Lowering the Risks
With the introduction of a new, single health-based
standard, FQPA significantly advanced the protection of
human health and the environment from the risks posed by
pesticides. This landmark legislation introduced several
more protective factors that we must take into account in
registering pesticides and setting tolerances.
FQPA formalized the expedited review for reduced
risk pesticides, which are considered to pose even less risk
than conventional pesticides registered under the FQPA
safety standard. (EPA began this program in 1993.)
The reduced risk program, together with a streamlined
registration process for biopesticides, has resulted in
dozens of new "safer" products being introduced into the
marketplace, providing greater protections to human health
and the environment, and clear benefits to growers and
homeowners.
Since 1996, every new tolerance established for new
uses and products has met the new safety standard. We have reviewed other ingredients used in
pesticide formulations (formerly known as inert ingredients) against the FQPA safety standard,
and registered new products for important minor crop and public health uses.
Safer Pesticides
REDUCING RISK: An
Alternative to Using Some of the
Organophosphates
In a recent action, EPA set new
tolerances for the reduced-risk insecticide
tebufenozide for use on pome fruit and
cotton. Tebufenozide has been identified
as a potential alternative to some of the
more toxic organophosphate pesticides--
azinphos-methyl, phosmet, chlorpyrifos,
and chlorpyrifos and dimilin in cotton.
(See Section III for details on the
organophosphates.)
FQPA mandates expedited registration of reduced risk pesticides, which can be expected to
pose even less risk to human health and the environment than other pesticides that meet the FQPA
safety standard. These pesticides typically have one or more of the following advantages over
existing products:
lower impact on human health,
lower toxicity to non-target organisms (e.g., birds, fish, and plants),
lower potential for groundwater contamination,
lower use rates, low pest resistance potential, and
compatibility with Integrated Pest Management.
There are two types of safer pesticides: conventional reduced risk pesticides (which we screen in
our reduced risk program) and biopesticides, which are generally distinguished from conventional
chemical pesticides by their unique modes of action, low use volume, lower toxicity, target species
specificity or natural occurrence. Two ways to measure the success of the expedited registration
program for safer pesticides is by (1) the number of registrations for new safer active ingredients and
(2) by the number of new uses of pesticides considered safer.
-------
II. Lowering the Risks continued
(1) Safer active ingredients
Active ingredients are the substances
in a pesticide that prevent, destroy,
repel or mitigate a pest. Since FQPA
was enacted, we have registered 48
active ingredients which are
considered "safer" than conventional
pesticides, representing 62% of the
total number of active ingredients
registered.
Active Ingredients Registered Since FQPA
as of June 3D, 1999
Safer (Conventional Reduced Risk and Biopestitides)
Conventional
Antimicrobial
(2) Safer New Uses
"Uses" are the specific crop(s) or
other site(s) where a pesticide
product can be used. One active
ingredient can have many different
uses. Since FQPA was enacted, EPA
has approved 774 new uses that are
considered "safer," representing 77%
of the total new uses approved.
New Uses Registered Since FQPA
as of July 23,1999
Safer (Conventional Reduced Risk and Biopeiticides.)
Conventional
Antimicrobial
-------
II. Lowering the Risks continued
In addition to providing risk reduction through the registration of safer pesticides, EPA has also
registered six new active ingredients that provide for lower-risk alternatives to several
organophosphates. The organophosphates are among the first group of pesticides for which EPA is
reassessing tolerances (see Section III for details).
Organophosphate Alternatives
Chemical
bifenazate
diflubenzuron
hexaflumeron
pyriproxyfen
spinosad
tebufenozide
Alternative for...
chlorpyrifos
chlorpyrifos
chlorpyrifos, isofenfos
azinphos methyl, chlorpyrifos, phosmet, methidathion,
acephate
acephate
profenfos
chlorpyrifos
diazinon, chlorpyrifos, methidathion, naled, phosmet,
azinphos methyl
diazinon, chlorpyrifos, naled, phosmet, azinphos methyl
malathion, methamidophos, dibrom, diazinon,
dimethoate, chlorpyrifos, naled
malathion, methamidophos, dibrom, diazinon, acephate,
methyl parathion
azinphos methyl, malathion, dibrom, diazinon, acephate
chlorpyrifos
acephate, chlorpyrifos, diazinon
azinphos methyl, chlorpyrifos, phosment
azinphos methyl, chlorpyrifos
acephate, diazinon, azinphos methyl, chlorpyrifos
diazinon, azinphos methyl, malathion
acephate
On...
ornamentals
homes (below ground bait stations)
homes (below and above ground bait
stations)
apples, pears, walnuts
cotton
cotton
sweet com
almonds
apples
brassica (cole) leafy vegetable
citrus
fruiting vegetable (except cucurbits)
leafy vegetables (except brassica)
cotton, leafy and cole vegetables, pecans,
forestry
pome fruit
walnut
cranberry
berry crop group
mint
-------
II. Lowering the Risks continued
New Tolerances Since FQPA
Since FQPA, we have set 701 tolerances in conjunction with registrations under Section 3 of
FIFRA. Every new tolerance has met the new safety standard.
Number of Tolerances Approved Since FQPA
as of June 30, 1999
| | Section 3 Tolerances
Section 18 Tolerances
Tolerances for Other Ingredients in Pesticide Products
EPA is required to set tolerances or grant exemptions based on the new FQPA safety standard
for all ingredients in a pesticide product for use on food, both the active and the other ingredients used
to make the product formulation. Generally, these other ingredients are not "pesticidally" active
themselves and are exempted from the need for a tolerance so long as they do not present a hazard to
the public health.
For these other ingredients, EPA has set one tolerance and exempted 17 from the requirements
of a tolerance based on the FQPA standard. EPA is developing a new risk assessment methodology for
the other ingredients that will help streamline the Agency's assessment of aggregate exposure.
Aggregate exposures for these ingredients can include exposure from food, drinking water and
residences as a result of pesticide use as well as other consumer exposures resulting from their
nonpesticidal uses as components of laundry detergents and food additives, for example.
-------
II. Lowering the Risks continued
Emergency Exemptions and FQPA
FQPA requires EPA to establish pesticide tolerances for all food and feed uses, including for uses
of pesticides under emergency conditions, based on the new safety standard. Before FQPA, we did not
establish tolerances for pesticides used under emergency exemptions. We moved quickly to implement
the new FQPA provisions, recognizing the time-
sensitive nature and economic importance of these
decisions. The Agency has worked with states,
growers, and other interested stakeholders to
develop new policies and procedures for considering
emergency exemption requests according to the new
statutory provisions.
Since August 1996, 1154 emergency
exemptions were authorized, with 195 tolerances
set, each meeting the FQPA safety standard. The
average turn-around time for emergency exemptions
is under 60 days. In June of this year, we proposed a
rule that provides criteria and procedures for
tolerance-setting for emergency exemptions. We
also solicited comments on several measures to
further improve the emergency exemption program.
EMERGENCY EXEMPTIONS AND FQPA
Section 18 of FIFRA authorizes EPA to
allow state and federal agencies to permit
the unregistered use of a pesticide for a
limited time if EPA determines that
emergency pest conditions exist and there is
no registered pesticide available that would
be effective. When this occurs, a state or
federal agency applies to EPA on behalf of
growers for an "emergency exemption."
Reducing the Risks of Medfly Control Pesticides
Medfly quarantine programs are vitally important to the citrus industry in Florida and California. In the past, when
emergencies arise, the states have used the organophosphate malathion. Recently, EPA and USDA have worked with
the states, local authorities, and concerned citizens to find creative solutions. As a result:
Florida will be using the reduced risk pesticide spinosad to address medfly infestation under this year's
quarantine program;
EPA and California are working together to integrate spinosad into its approach as well, and the state has
initiated the internal process to analyze spinosad in the hopes of moving to its use next season;
Both California and Florida have extensive prevention and monitoring programs which should greatly diminish
the need for a large-scale eradication program;
Both states are also using sterile medfly releases as a non-chemical control mechanism.
-------
III. Ensuring the Safety of Existing Pesticides
Promoting Safer Pesticides for Minor Uses
EPA is working closely with USDA's research
program (IR-4) that generates residue data needed for
tolerances to streamline the data development and
review process for reduced risk pesticides used on
minor use crops. Measures taken include:
Issued Pesticide Registration Notice 97-2 in
April 1997, defining minor crops and providing
guidance on submission of minor use, and
emphasized that the Agency would give priority
review for minor uses;
Improved the petition format, reducing the
review time by 2-3 months;
Streamlined the reduced risk justification form,
making it less resource intensive for IR-4 to
request reduced risk consideration;
Identified with USDA potential vulnerable crop
and pest combinations to facilitate development
and approval of alternative controls.
Nearly 84 percent of uses approved in 1998 and
1999 were for minor use. These efforts are
particularly important because many of the fruits and
vegetables children eat daily are considered minor use
crops.
What are Minor Uses?
A "minor use" of a pesticide can be any use on a
commercial agricultural crop or site, livestock, or for the
protection of public health where: 1) the total U.S.
acreage for the crop is less than 300,000 acres or 2) the
use does not provide sufficient economic incentive to
registrants to provide data for supporting initial or
continuing registration. Minor use pesticides are of major
significance in agricultural production, to farmers as well
as to consumers. Without these small scale but vital
pesticide uses, farmers would not grow many of the fruits,
vegetables, and ornamentals that we enjoy in the U.S.,
worth billions of dollars. Minor uses are also important
in protecting public health from disease vectors such as
mosquitoes, ticks, cockroaches, and rats, and disease-
causing microorganisms.
Minor Uses Approved, 1998-1999
as of July 23.1999
Conventional
Safer
Registration of Pesticide for Potentially Vulnerable Crops
Recently, EPA set a permanent tolerance for the synthetic pyrethroid, cyfluthrin, on potatoes (a
potentially vulnerable crop) and removed the time limitations for tolerances on sweet corn, field
corn, and pop corn (including forage and fodder). Potentially vulnerable crop/pest combinations
are those for which producers have only one or a limited number of effective alternatives, where
pest resistance limits effective pest management, or where regulatory action would result in pest
management problems.
-------
III. Ensuring the Safety of Existing Pesticides continued
EPA has been reviewing older pesticides during the past 10 years to
make sure that they meet current scientific and regulatory standards.
FQPA mandates completion of this review, called reregi strati on, by 2002.
In completing each review of a registered pesticide's human health and
environmental effects, the Agency makes changes to the pesticide's
registration where necessary to reduce risks. Our evaluation and
regulatory changes are summarized in a Reregistration Eligibility Decision
(RED). Of the 612 pesticide cases (or groups of related active
ingredients) subject to reregi strati on, EPA has issued a total of 189 REDs
to date. In addition, all the pesticide products in 231 cases were
voluntarily canceled; 192 more REDs must be completed by 2002. (To
obtain REDs and fact sheets, see www.epa.gov/REDs)
Reregistration Accomplishments Since FQPA
Progress in Completing RED)
D 192REDstoComplete(31%)
G 189 REDs Com pleted (31 %)
| 231 Cancellations
Universe = 612 Cases
Since FQPA was enacted, we have completed 48 post-FQPA REDs, 33 for pesticides with
food uses. Seven of these were voluntary cancellations, and all include measures to reduce risks
and improve the safety of the uses that were allowed to continue. With some required
modifications, the tolerances for the chemicals that are eligible for reregi strati on have been found to
meet the FQPA safety standard.
48 Post-FQPA REDs
FY 96 REDs (71
+ Bromacil
+ Colletotrichum gloeosporioides
+ Mepiquat Chloride
+ Paraquat Bichloride
+ Polyhedral Inclusion Bodies
S-Kinoprene
+ Virelure
FY 97 REDs, Rodenticide Cluster (6)
Brodifacoum
Bromethalin
Bromadiolone
Chlorophacinone
Diphacinone
Pival
Other FY 97 REDs (171
+ Bt
Butralin
+ Dichlobenil
+ Diflubenzuron
+ Diphenylamine
IPBC
Methylene bis-thiocyanate
(MET)
+ Metribuzin
* Paranitrophenol (PNP)
+ Pendimethalin
+ Propoxur
+*Sulprofos
+ Terbacil
+ Thiobencarb
+ Triclopyr
Triethylhexahydro-s-triazine
+ Zinc Phosphide
FY 98 REDs (131
+ Alachlor
+ Aluminum Phosphide
+ Magnesium Phosphide
+ Bromoxynil
+ Chlorothalonil
DEET
1,3-Dichloropropene
+ Dicofol
+ Hydramethylnon
+ Iprodione
+ Methomyl
+ Propachlor
+ Thiodicarb
FY 99 REDs
(thru July'991 (5)
+*Fonofos
+*Isofenphos
* Oxythioquinox
+*Ryanodine
+*Vemolate
+ Includes Food Uses
* Voluntary Cancellation
-------
III. Ensuring the Safety of Existing Pesticides continued
Reducing Risks through Post-FQPA REDs
During the reregi strati on process, EPA may identify risks that must be reduced to ensure safety
before a pesticide can be eligible for reregi strati on. A wide range of remedies are available to
reduce those risks. EPA works with registrants and others to develop voluntary measures or
regulatory controls that are both practical and effective to reduce risks of concern. The table below
shows the types of risk mitigation measures EPA has required for the 48 post-FQPA REDS. Three
examples of risk reduction through REDs are provided in Appendix 3b.
Risk Reduction Through Post-FQPA REDs
# of REDs
Canceled, deleted, or declared not eligible for reregistration in 21 REDs
Restricted to use only by trained & certified applicators in 14 REDs
Limited the amount, frequency, or timing of use in 14 REDs
Other application restrictions in 38 REDs
Personal Protective Equipment (PPE) or in 32 REDs
Restricted Entry Intervals (REI)
User safety measures in 35 REDs
Engineering controls/special packaging in 14 REDs
Ground water or surface water safeguards in 13 REDs
Spray drift labeling in 19 REDs
Other environmental safeguards in 17 REDs
Other significant measures in 13 REDs
Reduction of residential/children's risks in 17 REDs
10
-------
III. Ensuring the Safety of Existing Pesticides continued
Meeting FQPA Tolerance Reassessment Goals
FQPA requires EPA to reassess
all 9721 tolerances and tolerance
exemptions that were in effect when
the law was passed in August 1996.
EPA must complete reassessment of
33% of these tolerances by August
1999, 66% by August 2002, and the
remaining tolerances by August 2006.
As required by FQPA, we
reassessed 3290 tolerances by July 30,
1999, surpassing the 33% goal for
August 1999. Of the reassessments
completed, 66% (2178) are in our first
priority group. These reassessments
represent over 39% of the 5546
tolerances in this highest
priority group. (See box below
detailing the three priority
groups.) We have reassessed
28% of the organophosphate
tolerances, 31% of the
carbamate tolerances, and 20%
of the organochlorine
tolerances, as well as 29% of
the tolerances for pesticides
classified as "probable" human
carcinogens.
OP Replacement Registered for 1999 Growing Season
EPA registered new uses for the insecticide, bifenthrin, an
organophosphate alternative for cabbage, the cucurbit vegetable crop
group, edible-podded legume vegetable subgroup, eggplant, globe
artichoke, head and stem Brassica subgroup (except cabbage),
rapeseed (canola), succulent shelled pea and bean subgroup (includes
green, wax, lima and snap beans); and sweet com. Tolerances for the
last two crop groupings were jointly requested by the Interregional
Research Project (IR-4) and FMC Corporation, the manufacturer of
bifenthrin. The registration of bifenthrin was expedited to meet
targeted organophosphate reduction efforts by the food processing
industry for the 1999 crop season. EPA understands that this action
occurred in time for Del Monte Foods and other processors of peas,
beans and sweet corn to begin replacing methyl parathion, dimethoate
and acephate with bifenthrin. Del Monte expects that, if commercial
control is as successful as their trials have suggested, bifenthrin will
Priority Groups for Tolerance Reassessment
In August 1997, EPA published a Federal Register notice dividing the pesticides with
tolerances that must be reassessed into three priority groups. FQPA requires EPA to give
highest priority to pesticides that appear to pose the greatest risk.
Group 1 (228 pesticides/5546 tolerances ) includes
-Organophosphates
-Carbamates
-Organochlorines
-Probable carcinogens
-Reference dose exceeders*
-High-hazard inerts
Group 2 (93 pesticides/1928 tolerances)
-Possible carcinogens
-All remaining reregistration chemicals (those that were first registered before
1984)
Group 3 (148pesticides/2247 tolerances)
-Remaining pre-FQPA pesticides with reregistration eligibility decisions
-Remaining post-1984 pesticides
-Biological pesticides
-Remaining inerts
* Dietary exposure at levels above the amount that is believed to be safe for life-long,
daily consumption
11
-------
III. Ensuring the Safety of Existing Pesticides continued
Among the reassessed tolerances are 1493
tolerance revocations, of which 1258 are for
pesticides in priority Group 1, and 796 are for
organophosphates, carbamates, organochlorines,
and carcinogens. Revoking tolerances for these
pesticides helps ensure that foods exported to the
U.S. do not have residues of these pesticides.
Reassessments Completed by Priority Group
Group 1
Group 3
Group 2
Reassessments Completed &. Pending by Priority Group
Group 3
Group 2
Group 1
D 1DDD 2DDD 3DDD 4DDD 5DDD 6DDD
Completed
Pending
Tolerance Fees
FQPA requires EPA to collect fees that
will be sufficient to cover the costs of evaluating
tolerances for pesticide products. It expanded the
number of regulatory actions that fall under the
heading of tolerance processing. The largest
category of new actions is tolerance reassessment.
Factors such as more comprehensive data
requirements, scientific advancements in risk
assessment, improvements in data base
management and tracking systems, and the
increasing complexity of scientific review of
petitions have resulted in costs substantially
exceeding the fees currently charged.
On June 9, 1999, EPA published a
proposed rule regarding the collection of fees for
establishing and reassessing pesticide tolerances
and exemptions. The proposed fees for tolerances
are based on the actual resources needed for each
type of tolerance action and are designed to fully
recover costs. The rule proposes several
exemptions from fees for tolerance actions that in
the public interest, as well as a continuation of
current practice of granting fee waivers on a case-
by-case basis, according to criteria and procedures
in the proposed rule. The proposed automatic
waiver categories are:
Petitions submitted by IR-4 (a research
program sponsored by the U.S.
Department of Agriculture to help
establish tolerances for pesticide uses on
minor crops)
Minor use tolerances, unless the minor
use is the first or only food use of a
pesticide
Tolerances for emergency exemptions
Tolerance revocations
Biopesticide tolerance actions, except
plant-pesticides
Other ingredients generally regarded as
safe (List 4A inerts)
Tolerance exemptions for chemicals
exempted from FIFRA regulations under
section 25(b)
The fees in the rule, when final and
implemented, will be the first major increase in
tolerance fees in almost 15 years.
12
-------
IV. Public Participation and Transparency
Public consultation improves the quality of decisions. Sharing information and involving the
pubic are important commitments for EPA. Sharing information and involving the public are
important commitments for us. It is essential that the public play a major role in environmental
decision making today, and pesticide decisions are no exception. By including stakeholders and
other members of the public to an unprecedented extent, we hope to arrive at the fairest, most
realistic and informed decisions possible for these pesticides. Our expanded stakeholder
involvement is reflected in the examples below.
The Tolerance Reassessment Advisory Committee (TRAC)
Meetings and the OP Tolerance Reassessment Process
In April 1998, in response to a request from
Vice President Gore to enhance stakeholder input
on FQPA implementation, EPA and USDA formed
the Tolerance Reassessment Advisory Committee
(TRAC) to help the two agencies establish a
framework for making tolerance reassessment
decisions. TRAC has been co-chaired by the
Deputy Administrator of EPA and the Deputy
Secretary of Agriculture and was established as a
subcommittee under EPA's National Advisory
Council for Environmental Policy and Technology.
The TRAC provides a forum for a diverse group of
individuals representing a broad range of interests
and backgrounds from across the country to consult
with and make recommendations to EPA and
USDA on how best to reassess tolerances,
particularly those for organophosphate pesticides
(see box).
TRAC has met six times, with one additional
meeting planned for later in 1999. The group has
helped EPA and USDA make significant progress
in several areas critical to the successful
implementation of FQPA. For example, with the
assistance of TRAC, EPA and USDA have:
Organophosphate Pesticides
Acephate
Azinphos-methyl
Bensulide
Cadusafos*
Chlorethoxyfos
Chlorpyrifos
Chlorpyrifos methyl
Chlorthiophos**
Coumaphos
Dialiflor**
Diazinon
Dichlorvos (DDVP)
Dicrotophos
Dimethoate
Dioxathion**
Disulfoton
Ethion
Ethoprop
Ethyl parathion
Fenamiphos
Fenitrothion
Fenthion
Fonofos**
Isazophos **
Isofenphos**
Malathion
Methamidophos
Methidathion
Methyl parathion
Mevinphos**
Monocrotophos* *
Naled
Oxydemeton methyl
Phorate
Phosalone**
Phosmet
Phosphamidon* *
Phostebupirim
Pirimiphos methyl
Profenofos
Propetamphos
Sulfotepp
Sulprofos**
Temephos
Terbufos
Tetrachlorvinphos
Tribufos (DBF)
Trichlorfon
* Import tolerances only; no U.S.
registrations for use
** These chemicals have been
canceled or proposed for
cancellation. They will be
included in the organophosphate
risk assessment if import
tolerances remain after other
tolerances are revoked.
13
-------
IV. Public Participation and Transparency continued
Initiated a pilot approach for obtaining public comment on preliminary risk
assessments for the organophosphate pesticides improving transparency of
decisionmaking; and
Increased focus on transition issues to prepare growers for possible changes in
pesticide use patterns.
Risk Assessment/Risk Management Pilot for the Organophosphate
Pesticides
In July 1998, in consultation with TRAC, EPA and USD A started a process that allows all
stakeholders to review preliminary risk assessments and contribute to their improvement, as well as
to provide risk management ideas later in the process. In the first step of the process, EPA
releases preliminary risk assessments for the organophosphate pesticides for public comment. EPA
placed the first nine preliminary risk assessments in the docket and on the internet
(http://www.epa.gov/pesticides/op/) in August 1998. In September 1998, EPA released seven
more preliminary risk assessments. As of July 1999, EPA has released a total of 29
preliminary risk assessments for public comment with 11 preliminary risk assessments remaining to
be released.
Following completion of the public comment period on each preliminary risk assessment, EPA
reviews the comments and revises the risk assessment, as appropriate. USDA then reviews the
revised risk assessment to identify opportunities for risk management and the potential need for
transition strategies. In many cases, EPA and USDA present a technical briefing on the revised risk
assessment to provide an opportunity for the public to learn about the data, information, and
methods used to develop and revise the risk assessments. EPA then publishes the revised risk
assessment and a comment period on risk management follows during which the public is invited to
submit risk management ideas and proposals. Five organophosphates have entered the risk
management consultation phase and two are in the risk management strategy stage. Appendix 3
briefly describes the risk assessment/risk management pilot phases.
Aluminum and Magnesium Phosphide Stakeholder Process
EPA initiated an extensive public and stakeholder process to obtain input and ideas about ways
to reduce the risks associated with aluminum and magnesium phosphide, two fumigants used to
control insects and rodents where agricultural commodities are stored. In issuing the Reregi strati on
Eligibility Decision for these two pesticides in December 1998, EPA identified risks of concern to
bystanders and pesticide applicators from exposure to phosphine, a highly toxic gas created when
these fumigants are used.
The Agency proposed 15 risk reduction measures to increase the level of protection to
bystanders and pesticide applicators from exposure to phosphine. We received many comments
questioning the feasibility of the proposed measures. Since few, if any, viable alternatives exist for
fumigation to control pests in stored products, we are continuing to seek extensive stakeholder and
public involvement in developing workable ways to reduce risks.
14
-------
IV. Public Participation and Transparency continued
EPA has extended its schedule for completing the ongoing reregi strati on review of aluminum
and magnesium phosphide. This extension will allow more time for stakeholder involvement, public
input, and complete consideration of alternative ways to reduce risks from these important
pesticides. We are considering all comments received so far and attended fumigant demonstrations
from May to July. According to the recently revised schedule, the Agency plans to:
issue a revised set of proposed risk mitigation measures in September 1999;
hold stakeholder meetings in several U.S. cities in October, November, and December 1999;
and
issue final risk mitigation measures needed for reregi strati on, in late 1999 or early 2000.
To identify feasible risk mitigation measures before releasing a new proposal, EPA is working
with the U.S. Department of Agriculture, the National Institute of Occupational Safety and Health,
the Occupational Safety and Health Administration, and a coalition of industry groups and user
organizations. In addition, EPA is consulting with the Phosphine Task Force, a group of experts
from Land Grant Universities and USDA Agricultural Research Service scientists with expertise in
commodity storage pest management systems who are investigating possible alternative risk
mitigation measures. EPA recognizes the importance of phosphine to agriculture, the lack of viable
alternatives, and the potential impacts of the initial set of risk mitigation measures on the continued
use of the chemicals. Final decisions will be based on sound science and a full understanding of
agricultural needs. With the full participation of stakeholders EPA will be able to develop improved
risk mitigation measures that are both protective and practical.
Rodenticide Cluster Stakeholder Process
In completing the Reregi strati on Eligibility Decision (RED) for a cluster of six rodenticide
pesticides in September 1998, EPA announced its plans to assemble a stakeholder workgroup to
explore and recommend ways to reduce the risk of exposure to rodent control products, especially
accidental exposures experienced by young children. Six months later, in March 1999, the
Rodenticide Stakeholder Workgroup, established under the Pesticide Program Dialogue
Committee, held its first open meeting. Members of the workgroup represent public health and
environmental organizations, industry groups, government agencies, and the general public.
Through an ongoing series of public meetings this spring and summer, the workgroup is discussing
and analyzing options and proposals for reducing risks. So far, the workgroup has developed an
initial recommendation on product labeling and a plan for continued progress, including a meeting
this fall to discuss additional options and consider ways to communicate with rodenticide product
users. EPA will use the workgroup's recommendations in developing a strategy to reduce the risks
of exposure to rodenticides while preserving their public health benefits. Meanwhile, EPA is
requiring rodenticide registrants to incorporate an indicator dye and a bittering agent into their
product formulations; the timing of these changes is under discussion.
(www.epa.gov/pesticides/ppdc/rodent)
Right-to-Know Brochure and Website
15
-------
IV. Public Participation and Transparency continued
With advice from the Pesticide Program Dialogue
Committee and consumers, and consultation with USDA and
FDA, EPA developed a brochure, Pesticides and Food, to
inform consumers about pesticide use on food, government
programs that protect them from pesticide risks, and ways they
can reduce their exposure to pesticides. The brochure also
explains how the Food Quality Protection Act (FQPA)
increases protection of infants and children from exposure to
pesticides.
EPA distributed copies to 30,000 grocery stores during
the Winter of 1999. Copies have also been distributed to
public health officials, libraries, and the medical community.
Over 4 million copies have been distributed to date. In addition
to the brochure, EPA designed a website, also called Pesticides
and Food. This website, which is referenced in the printed
brochure, provides consumers with more detailed information.
(www.epa.gov/pesticides/food)
16
-------
IV. Public Participation and Transparency continued
About the Pesticides and National Strategies for Health Care Providers
Last year, an EPA-led interagency initiative began that includes the support of the U.S.
Department of Agriculture, U.S. Department of Health and Human Services, and the U.S.
Department of Labor. The interagency group sponsored a workshop to identify strategies to
improve the ability of health care providers to recognize, diagnose, manage and prevent adverse
health effects due to pesticide exposure. Based on the proceeding of the workshop, EPA
published a report, "Pesticides and National Strategies for Health Care Providers", which outlines a
series of recommendations for improving the training that health care providers receive on health
concerns related to pesticide exposures. Among the recommendations included are the need to:
specify competencies that providers should demonstrate upon completion of their
education and other specially training;
develop educational tools and training materials that will motivate students and
health care providers to acquire an understanding and knowledge of possible health
effects resulting from pesticide exposure; and
raise awareness and make more information available to providers on health
complaints and illnesses that may be related to pesticide exposure through materials
and resource development, professional meetings, marketing and outreach programs,
and other activities.
To carry forward this initiative and further develop the 4 broad strategies, workgroups were
created in three core areas: Formal Education of Health Care Providers, Health Care Provider
Practice and Resources for Health Care Providers.
In May 1999, EPA and several other federal agencies convened the Education and Practice
workgroups to further develop components of an implementation plan for raising knowledge and
awareness of pesticide issues in the educational and practice settings of primary care providers.
Workgroup members came from academic faculty; professional associations for physicians, nurses
and physician assistants; farmworker and community interest groups, federal and state agencies, and
pesticide experts. A third workgroup on resources will convene in August 1999. A draft national
implementation plan will be published which will serve as working document for the next year of
activity on this initiative, culminating in a National Forum in 2000.
17
-------
V. Special Protection for Vulnerable Populations
FQPA includes several provisions that increase protection for vulnerable populations. EPA has
vigorously implemented these provisions when making regulatory decisions based on the safety
standard of "reasonable certainty of no harm" and in considering the appropriate FQPA safety
factor for each pesticide.
Special Protection for Infants and Children
FQPA emphasizes the potential for
infants and children to be especially sensitive
to pesticides and the need to ensure that they
are afforded adequate protection. This issue
received significant attention in the 1993
National Academy of Sciences (NAS) report,
Pesticides in the Diets of Infants and
Children. Many of FQPA's provisions are
based on that report's recommendations
(which are discussed in more detail in
Appendix 4).
New Data will Help Ensure Protection of
Children
In an effort to further increase protections for infants and
children, EPA is requiring registrants of many food use
pesticides to conduct acute, subchronic, and
developmental neurotoxicity studies and submit the
results to EPA This program to call in data will apply to
at least 140 pesticides and will be completed in phases
over the next several months. EPA expects to receive the
first studies within two years. This data call-in program
was developed in part following advice from the FIFRA
Scientific Advisory Panel.
Among the NAS recommendations
codified by FQPA are the need to specifically
determine that tolerances are protective of
infants and children and the use of a safety
factor during risk assessment to account for
special sensitivities. In keeping with FQPA, each tolerance decision issued after August 3, 1996,
contains a specific finding that the tolerance levels are appropriately protective of children. FQPA
requires EPA to apply an additional safety factor of 10 during its risk assessment to account for the
potential for pre- and post-natal toxicity, as well as for the completeness of the toxicology and
exposure database, unless the Agency determines that another factor is adequately protective. EPA
uses available, reliable data when considering the need to raise, retain, modify, or remove the 10-
fold additional safety factor.
EPA, recognizing the importance of the 10-fold safety factor, began developing policy and
implementation procedures soon after passage of FQPA to ensure consistent and defensible
decisions. Within three months, we sought advice from the FIFRA Scientific Advisory Panel (SAP)
regarding the Agency's approach to this issue. In January 1997, we issued guidance in Pesticide
Registration Notice 97-1, which describes generally the types of information needed to determine
whether infants and children are especially sensitive to a chemical and whether an additional safety
factor is needed for their protection. More recently, an EPA task force has considered policy issues
18
-------
V. Special Protection for Vulnerable Populations continued
related to the FQPA safety factor, and we submitted our revised draft policy and operational
practices for making decisions on the 10-fold FQPA safety factor to the SAP for review in May
1999. These documents also have been released (in July 1999) for public review and comment,
based on a process established in conjunction with the TRAC.
We have also updated our pesticide toxicity testing guidelines to enable the Agency to better
assess risks to infants and children. The proposed revisions to guidelines for animal studies on
prenatal development and reproduction and new guidelines on effects to the immune system were
reviewed by the SAP. EPA incorporated recommendations from the SAP and published the
guidelines for use by registrants in conducting such studies in July 1998.
Reducing Organophosphate Risks to Children and Workers - Two Case Studies
Methyl Parathion Uses Eliminated
Methyl parathion is a very acutely toxic organophosphate insecticide and is widely used on crops. Like
azinphos methyl, it is one of the early organophosphates in the public review process.
EPA is canceling the use of the pesticide methyl parathion on all fruits and many vegetables (including
apples, peaches, pears, grapes, nectarines, cherries, plums, carrots, certain peas and beans, and tomatoes), eaten
frequently by children. These actions will help protect children as well as adults. In addition, worker risks are
unreasonable for many use scenarios, and EPA is modifying product labels to increase worker protection. This
decision protects two of our most vulnerable populations, children and workers. It is based on a thorough, sound,
and refined analysis of all the available data. In particular, it will help ensure that our food is safe by providing a
greater margin of protection to the foods we and our children eat. A diet rich in fruits and vegetables is important
for children and adults.
Azinphos Methyl Uses Modified and Reduced
Azinphos methyl is an organophosphate pesticide used on many fruits eaten by children and is one of the
first pesticides to enter the final stage of the pilot review process.
EPA is requiring changes to the use patterns for the pesticide to reduce dietary risks that exceed the
margins of safety deemed acceptable under FQPA. These use changes (for example, lengthening the pre-harvest
interval to reduce residues on foods) are important to ensure adequate protections for both children and workers.
EPA is canceling use of azinphos methyl on sugarcane nationwide and cotton in areas of surface water
vulnerability to prevent unreasonable risks to wildlife and contamination of water. EPA is also imposing a cap on
sales of azinphos methyl.
19
-------
V. Special Protection for Vulnerable Populations continued
National Agenda to Protect Children's Health from Environmental
Threats
EPA has initiated a "National Agenda to Protect Children's Health from Environmental
Threats." This agenda is helping to focus additional attention on this important sub-population in
all of our regulatory actions. The Children's Health Protection Advisory Committee published
several recommendations related to the pesticide program:
Reevaluate the atrazine pesticide tolerances;
Reevaluate pesticide tolerances for methyl parathion, dimethoate, and chlorpyrifos;
and
Reevaluate the Worker Protection Standard.
We have included atrazine, methyl parathion, dimethoate, and chlorpyrifos in the first priority
group of tolerances for reassessment. All of these tolerances will be reviewed in the coming
months. The preliminary risk assessments for methyl parathion and dimethoate have been
completed. The preliminary risk assessment has been revised for methyl parathion. We announced
risk management actions for methyl parathion on August 2 and held a technical briefing on the
revised risk assessment the same day. The preliminary risk assessment for dimethoate is currently
being revised based on comments received during the public comment period. The review of
atrazine will be completed by next summer. Future efforts also will increase protection of children
of workers based on reexamination of risk assessment methods and research that will identify areas
of vulnerability.
Special Protection for Agricultural Workers
We place a strong emphasis on assuring the health of agricultural workers whose jobs require
mixing, loading, or applying pesticides and are committed to strengthening national efforts to
safeguard upwards of 3.5 million farm workers and their families. EPA's Worker Protection
Standard, first implemented in 1992, has resulted in pesticide safety education and training efforts
across the country.
Since the passage of FQPA, our Worker Protection Program to implement the standard has
devoted significant resources to producing and distributing bilingual or multi-lingual and
educational materials. Our communication efforts include a new Pesticide Workers Website,
publication of over 1 million grower compliance manuals, over 2.7 million safety training manuals,
over 680,000 safety posters, and more than 11,000 safety training videos.
20
-------
V. Special Protection for Vulnerable Populations continued
Finally, the EPA is conducting a review of its worker protection activities, including the
methods for risk assessment, to determine if workers are receiving adequate protection. Last year,
the EPA initiated a national assessment of implementation and enforcement of the worker
protection regulation. This effort includes a worker protection assessment group composed of the
EPA, the USD A, the Department of Labor, the Department of Health and Human Services, state
regulators, state extension service safety educators, farm worker advocacy groups, farm worker
service/training associations, agricultural employer associations, farm worker clinicians networks,
and others. The goals of the group are to:
assess the current program's status;
generate stakeholder interest that can effect change in the programs;
provide a means to foster the partnerships essential to make the program work;
and most importantly, provide a continuing forum to focus and resolve worker
protection issues.
The worker protection assessment group will develop a strategic plan for the national worker
protection program and issue annual reports detailing accomplishments and progress towards
achieving its goals.
Applicator Certification and Training
Over one million applicators are currently
certified nationwide, including over 900,000 private
applicators and about 350,000 commercial
applicators. For the past three years,
approximately 243,000 private and 198,000
commercial applicators received their initial
certification. EPA has recertified approximately
129,000 private and 121,000 commercial
applicators each year for the past three years.
Several hundred thousand applicators attended
training sessions to learn or review the appropriate
methods for applying pesticides.
As noted above, the Agency is currently
conducting a national assessment of the applicator
certification and training program. A certification
and training assessment group of representatives
from EPA, USD A, state pesticide agencies, tribes
and pesticide safety educators was formed to draft
About Pesticide Certification and
Training Programs
EPA may designate some or all uses
of a pesticide as "restricted." Restricted use
pesticides may only be used by or under the
direct supervision of specially trained and
certified applicators. Certification programs
are conducted by states, territories, and
tribes in accordance with national standards
set by the EPA. All states require
commercial applicators to be recertified,
generally every three to five years, to
maintain their certification.
21
-------
V. Special Protection for Vulnerable Populations continued
proposals to guide the program's future. The proposals for review by the nation's program
partners are grouped under five program goals:
Reduce the risks to the public from pesticide use;
Provide high quality pesticide education and safety training programs;
Maintain the consistency, integrity and validity of the certification and recertification
programs and processes;
Ensure that adequate and equitable funding is available to education and training
programs,
Improve the efficiency of program organization and operations and;
Response from the program partners and the program stakeholders will help frame a national
strategy for the future of the applicator certification and training program.
Pesticide Workers Website
Just recently, the EPA began a new pesticide safely programs website
(www.epa.gov/pesticides/safety) to inform farm
workers, certified applicators, and health care
providers about the Agency's pesticide safety
programs. This site, which provides easy access to
information in both English and Spanish, marks an
important step in the Agency's pesticide worker
safety outreach efforts. It provides specific
information on applicator certification and training
requirements and the EPA's Worker Protection
Standard, including pesticide safety training,
notification of pesticide application, use of personal
protective equipment, and emergency medical
assistance.
The site also provides information on the EPA's
Pesticides and National Strategies for Health Care
Providers initiative aimed at helping health care
providers become better aware and trained in
diagnosing and preventing pesticide related illnesses.
EPA's new publication, the 5th Edition of
Recognition and Management of Pesticide
Poisonings, a manual that assists health care providers in the diagnoses and management pesticide
poisonings, is also available at this site.
22
-------
VI. On the Forefront of Sound Science
Implementing the new FQPA safety standard is driving changes in risk assessment methods and the
science policies that support regulatory decisions. FQPA requires EPA to consider the combined or
aggregate effects of pesticide exposure from food, drinking water, and other non-occupational uses (such
as in the home), as well as the cumulative effects of pesticides that act in the same way. EPA is
developing new aggregate and cumulative exposure and risk assessment methods. In addition, FQPA
directs EPA to explore the potential of chemicals to disrupt the functioning of the human hormonal or
endocrine system, by developing an extensive new screening and testing program. In leading these
changes, EPA is consulting with a wide array of outside experts in many scientific disciplines.
EPA also has worked to increase the transparency of its scientific work both during the development
of methods and policies and by inviting review of draft documents such as risk assessments on various
chemicals. Public comment is informing our science policies as well as providing access to data that can
be used in refining chemical-specific risk assessments.
Development of Science Policies
Shortly after passage of FQPA, EPA began using a
set of interim guidance (developed with input from the
Food Safety Advisory Committee) in making various
pesticide-related decisions. In response to subsequent
advice from the Tolerance Reassessment Advisory
Committee, EPA identified nine science policy issues that
needed to be resolved in updating the interim guidance.
On October 29, 1998, EPA published a Federal Register
notice summarizing the science issues and outlining a
schedule for publication of the related documents. Since
then, EPA has issued several of the documents for public
comment and is revising them and reissuing them based
on comments received. The documents are posted on the
Internet as they are completed.
(http://www.epa.gov/pesticides/trac/science/)
What are the nine science policies?
1. Applying the FQPA 10-Fold Safety Factor
2. Dietary Exposure Assessment - Whether and
How to Use "Monte Carlo" Analyses
3. Exposure Assessment - Interpreting "No
Residues Detected"
4. Dietary (Food) Exposure Estimates
5. Dietary (Drinking Water) Exposure
Estimates
6. Assessing Residential Exposure
7. Aggregating Exposures from all Non-
occupational Sources
8. How to Conduct a Cumulative Risk
Assessment for Organophosphate
Insecticides or Other Pesticides With a
Common Mechanism of Toxiciry
9. Selection of Appropriate Toxiciry Endpoints
for Risk Assessments of Organophosphates
23
-------
VI. On the Forefront of Sound Science continued
Among the issues included in this science policy discussion are application of the FQPA 10-fold
safety factor ("10X"), how to conduct a cumulative risk assessment, several exposure assessment issues
(dietary, drinking water, residential, aggregate), selection of toxicity endpoints, and use of probabilistic
exposure assessment techniques. In addition, we have released for public comment several other policy
documents that were not part of the original discussion, such as The Role of Use-Related Information in
Pesticide Risk Assessment and Risk Management (published July 14 1999). There are 19 planned science
policy papers associated with the nine policy areas; of the 19, 14 have been published. Appendix 5
includes a list of the planned papers and current status. These science policies represent a major advance
in the methodology of risk assessment, and will ensure that the Agency is using the most appropriate and
protective standards in its pesticide regulatory program.
Pesticide Use Information
In 1998, EPA began collecting available information about current pesticide usage (starting with the
organophosphates) and organized it into tables or Crop Matrices to improve accessibility and ease of use
by analysts, decision-makers, and stakeholders. Crop matrices present, on a crop basis, best available
information on actual use of organophosphates. The information, largely quantitative, describes the
percent of crop treated, average and maximum rates of pesticide use, and number of applications. They
also identify target pests, alternatives to the organophosphates (OPs), and their constraints. We use data
from the matrices to assess risks and to make decisions about regulatory actions. Draft OP matrices for
10 crops were posted on the Internet at (http://www.epa.gov/oppbeadl/matrices). Matrices for other
crops will be posted as they are complete.
Sources of Pesticide Use Information
Most of the available data about pesticide usage is on agricultural crops, but some limited data are
available for non-agricultural uses. The use data are obtained through various sources:
Agreements with other government agencies for data that are generally publicaly available
(e.g., USDA National Agricultural Statistics Service, USDA National Agricultural
Pesticide Impact Assessment Program, and the California Department of Pesticide
Regulation);
Purchases from firms who are in the business of collecting and selling pesticide use data.
Such data must be bought under proprietary agreements, and data are not available to
those who have not entered into agreements with the provider;
State recommendations for pest control and crop and livestock management for farmers
and ranchers generated by each state's agricultural extension office. These publications
present the views of the agricultural science community in each state about which
pesticide products are most likely to work in their area;
24
-------
VI. On the Forefront of Sound Science continued
USD A crop profiles generated by USDA's State Liaison Representatives and other
entities. They capture information in narrative format about crop production, cultural
practices, and pesticide use. (ipmwww.ncsu.edu/opmppiap); and
The Label Use Information System (LUIS), an EPA database of use patterns found on the
labels of currently registered pesticide productsin other words, the legal limits on how
the product may be used. It contains detailed information on registered sites, application
methods (type, timing, and equipment), application rates, and limitations on the use of
pesticides (e.g., preharvest intervals, reentry intervals). LUIS captures only information
specified on the approved label for a pesticide product.
Another category of pesticide use information is the Quantitative Usage Analysis (QUA) and the
Quantitative Usage Analysis Plus (QUA+). The QUA summarizes from the sources listed above
estimates of use of individual pesticides on both crop and non-crop sites. The QUA+ contains
supplementary data received from growers and registrants on typical usage rates, descriptions of
alternatives and their limitations, as well as expanded information about application methods and pest
pressures. For those crops where this information is available, it has been included in the matrices
described above.
Endocrine Disrupters
In recent years, evidence has arisen to suggest that chemicals may disrupt the hormone (endocrine)
systems of humans and wildlife and cause reproductive disorders, birth defects, immune dysfunction, and
other harmful effects. A variety of chemicals, including pesticides, have been found to disrupt the
endocrine systems of animals in laboratory and field studies, and compelling evidence has accumulated
that endocrine systems offish and other wildlife have been altered by chemicals that contaminate their
habitats. With few exceptions, however, such effects have not been conclusively demonstrated in human
beings to date.
Because of the potentially serious consequences of human exposure to endocrine disrupting
chemicals, Congress included a mandate to EPA in the FQPA and the 1996 amendments to the Safe
Drinking Water Act (SDWA) to develop an endocrine disrupter screening program. FQPA requires EPA
to:
develop a screening program for pesticides that may have estrogenic or other endocrine effects
within two years of enactment;
implement the program within three years of enactment; and
report progress to Congress within four years of enactment.
Since receiving the statutory authority, EPA has moved quickly to set up a screening program that
can be used to gather data on the endocrine disrupting potential of pesticides and other chemicals.
25
-------
VI. On the Forefront of Sound Science continued
To help inform the implementation of the screening program provisions of FQPA, EPA formed an
advisory committee, the Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC).
This committee provided recommendations on how to develop the screening program. EDSTAC reached
consensus on its recommendations and presented them to EPA in August 1998.
EPA used the EDSTAC recommendations as the primary basis of a proposal for an Endocrine
Disrupter Screening Program (EDSP). This proposal was published in the Federal Register on December
28, 1998. EPA's proposed screening program has the following characteristics:
A two-tiered screening program for chemicals, pesticides, and environmental contaminants to
detect effects on the estrogen, androgen, and thyroid hormone systems;
Inclusion of evaluation of potential for effects on human health and wildlife;
Potential use of high-volume, automated technology to screen large numbers of chemicals to
help set priorities (under research and development);
Development of a relational database to help set priorities and track data; and
Standardization and validation of all assays before regulatory use.
EPA is beginning to implement the Endocrine Disrupter Screening Program using a tiered approach.
This approach appears to be the most effective way to use available resources to detect endocrine
disrupting chemicals and quantify their effects. The core elements of the approach include initial sorting,
priority setting, tier one screening, and tier two testing. The final step is hazard assessment.
The Agency is establishing the priority setting process for selecting the initial chemicals for the
screening program, developing methods for endocrine disrupter screening and testing, and standardizing
and validating the screening and testing methods for regulatory programs. For more details on the
endocrine disrupter screening program, see Appendix 6.
In order to improve its regulation of pesticides, EPA has created partnerships with other federal
agencies, international organizations, states, tribes, and directly with stakeholders. These partnerships
generate consortia of interest that can effect change to reduce pesticide risk.
26
-------
VII. Partners and Other Stakeholders
Other Federal Agencies
Pesticide regulatory authority resides with several U.S. government agencies, making coordination at
the federal level essential. FQPA contains specific provisions for cooperative activities between EPA,
USD A, and the Department of Health and Human Services (DHHS).
U.S. Department of Agriculture
USD A, a particularly important partner given its relationship with the grower community, has:
served as co-chair of the TRAC;
created an Office of Pest Management Policy to serve as liaison to EPA and the agricultural
community on FQPA issues;
provided data through food consumption surveys and the Pesticide Data Program which help
refine risk estimates and ensure that they reflect actual pesticide use;
reviewed EPA's preliminary and revised organophosphate risk assessments to determine how
pesticide use and food consumption data are considered, to validate assumptions, and to consult
on risk management strategies where necessary;
worked with growers and registrants to identify crop/pesticide combinations where limited crop
protection alternatives exist, and supported minor use registrations through its IR-4 program.
through the extension service, conducted certification and training for pesticide applicators.
Health and Human Services
EPA is actively consulting with USDA and DHHS on pesticides with public health uses, such as
mosquito or cockroach control. For food use pesticides which also have public health uses, FQPA
requires EPA to factor exposure from the public health use into its aggregate exposure assessments.
There is concern by some public health professionals that this provision may lead to limits on some public
health pesticide uses because registrants may choose to support more profitable food uses at the expense
of the public health uses. When evaluating tolerances, consideration of the benefits of public health uses
are limited to special circumstances, subject to the same restrictions in FQPA as all other pesticide uses.
The important benefits of public health pesticides, however, would be considered by the Agency in
determining how best to mitigate any unacceptable risks in order to bring aggregate exposures within safe
levels.
27
-------
VII. Partners and Other Stakeholders continued
For example, if the aggregate risk of a pesticide were found to be unacceptable, EPA would
consider the benefits associated with all the uses, and the availability of alternatives, when determining
how to bring the risk down to an acceptable level. FQPA requires that EPA consult with DFIHS and
USD A if the Agency were to conclude that a non-food public health use may need to be limited or
eliminated. Rather than relying solely on this requirement to ensure that public health uses are given
appropriate consideration, EPA is sharing with DHHS all risk assessments for pesticides with public
health uses at a stage well before any regulatory decisions are to be made. To date, EPA has requested
DHHS comment on risk assessments for five organophosphates with public health uses.
Food and Drug Administration
EPA also is coordinating with HHS' Food and Drug Administration (FDA) on improved pesticide
residue detection. While EPA sets tolerances, it is the responsibility of FDA to monitor domestic and
imported fruits and vegetable for residue levels. In order to improve the quality of monitoring data, the
Agency has begun to purchase analytical instruments for FDA laboratories which will allow for detection
of pesticides at levels far below what is currently possible. EPA is developing methodologies for
laboratory use and will provide FDA with a list of pesticides and crops which should be a monitoring
priority. The pesticides will be mainly organophosphates and the crops will consist of many children's
foods. This improved monitoring will serve two purposes. First, it will allow detection of low levels of
pesticides for which there are no tolerances. Second, where there are tolerances, it will provide better
information on actual organophosphate residue levels for use during EPA's risk assessments.
President's Council on Food Safety
EPA is an active participant in the President's Council on Food Safety. This council, co-chaired by
the Secretary of Agriculture, the Secretary of Health and Human Services, and the Chairman of the White
House's Office of Science Technology and Policy, is examining the current structure for regulating food
safety at the federal level. While the Council's initial focus was bacterial and microbial contamination of
food, it has expanded its work to include pesticides. The Council is holding a series of public meetings to
allow interested parties to provide their suggestions for improving food safety regulation in the U.S.
Member agencies have established a website (http://www.foodsafety.gov) containing information on the
Council's activities and are developing a comprehensive Federal food safety plan which will guide
cooperative efforts at the national level and between the U.S. government and state and local regulatory
authorities.
28
-------
VII. Partners and Other Stakeholders continued
International: The NAFTA Technical Working Group on Pesticides
EPA, under statutory requirements and international agreements, works with other countries and
international organizations on a wide array of pesticide issues. For example, in 1996 the U.S., Canada,
and Mexico established a Technical Working Group on Pesticides (TWG) under the North American Free
Trade Agreement (NAFTA). Many TWG activities build on work previously being conducted by the
U.S. and Canada, with Mexico continually becoming more active.
The TWG's primary objective is to facilitate cost effective pesticide regulation and trade among the
three countries through harmonization and work sharing. These activities will improve food safety, help
ensure environmental protection, assist in the resolution of trade problems, and streamline regulatory
processes.
Through the TWG, EPA and its Canadian
counterpart, the Pesticide Management
Regulatory Agency (PMRA), have already jointly
reviewed and registered three reduced-risk
chemical pesticides and one pheromone. The
next step in the joint review process is for
Canada, Mexico, and the U.S. to conduct tri-
national review of a new chemical pesticide. This
review will also give all three countries
experience with the new submission format
developed by the Pesticide Working Group of the
Organization for Economic Cooperation and
Development (OECD). The TWG is considering
potential organophosphate alternatives as
candidates for joint review, since reevaluation of
organophosphates under FQPA may result in
changes in the uses and associated tolerances of
these chemicals, potentially affecting trade with NAFTA partners.
(http://www.epa.gov/oppfead 1 /international/).
PMRA has been working closely with EPA to ensure that Canada fully understands the scientific
issues raised by FQPA. Canada supports the new safety standard and is incorporating these new
approaches into its review processes and methodologies. EPA and PMRA are also coordinating their
efforts to reevaluate older pesticides, focusing on the priority chemicals under FQPA. In June 1999,
PMRA announced their intent to conduct a re-evaluation of the uses of all organophosphates, similar to
the reregi strati on process in the U.S. PMRA will be using EPA reviews as much as possible and will
assess risk from food, occupational, and bystander exposure, plus drinking water exposure relevant to
Canadian conditions. PMRA anticipates completing its review in December 2000 and will not accept
submissions for major new uses of organophosphates until the review is finished.
Joint U.S./Canadian Reviews
Cyprodinil (Vangard ) - Reduced risk fungicide for
field and nut crops. Registered by Novartis.
Fenhexamid (Elevate) - Reduced risk fungicide to
control grey mold on grapes, strawberries, and
ornamentals. Registered by Tomen Agro.
Diflufenzopyr (Distinct) - Reduced risk herbicide for
use on field corn. Registered by BASF.
Eastern Pine Shoot Borer (9-dodecenyl acetate) -
Pheromone for use in forests and wood lands.
Registered by 3M.
29
-------
VII. Partners and Other Stakeholders continued
EPA and Canada have recently taken a critical step towards practical implementation of
harmonization goals. In June 1999, EPA and PMRA agreed upon a formal memorandum of
understanding (MOU) on good laboratory practices (GLP) providing a framework for mutual acceptance
of reviews of pesticide studies that are used to support pesticide registration in both countries. GLP is an
internationally-recognized quality system which covers the organizational processes and conditions under
which non-clinical human health and environmental safety studies are conducted. In keeping with
international standards for mutual acceptance of data and GLP compliance monitoring, the MOU
establishes mutual recognition of each country's GLP requirements and associated compliance program.
The agreement will be fully implemented after the joint inspection and program evaluation activities are
completed to confirm the compatibility of U.S. and Canadian programs.
States, Tribes, and Regional Coordination
Since EPA delegates authority to enforce pesticide regulations to states and some tribes, they are
very much our regulatory partners and have an integral role in FQPA implementation. State and tribal
regulators interact directly with pesticide dealers and commercial applicators, as well as farmers and
others who use pesticide products. Thus, they are in a unique position to help collect information on pest
control needs, current pesticide use practices, and the potential impacts of changes in pesticide availability
that may result from decisions taken to meet FQPA mandates. State and tribal agencies also have the role
of communicating regulatory decisions to the user community, and in providing information and training
in the use of alternative pest control methods to replace highly toxic products that may not meet the new
safety standards of FQPA. Much of the routine exchange of information and coordination between
states, tribes and EPA occurs within the Agency's 10 regional offices.
Dialogue with states is important for providing feedback on the field impact of pesticide regulations,
policies, and product registration and labeling decisions. EPA interacts with states in a number of
different forums. Regular meetings are held with organizations consisting solely of state representatives,
such as the State FIFRA Issues Research and Evaluation Group, and states are represented on the
Agency's broad stakeholder advisory groups, such as the Tolerance Reassessment Advisory Committee
and the Pesticide Program Dialogue Committee.
EPA headquarters and regional offices work closely with states on pesticide field programs such as
groundwater and endangered species protection, worker protection, and certification and training of
pesticide applicators. EPA and States also work together on special efforts such as the emergency
response to the misuse of methyl parathion, which began in 1994. EPA is investigating ways states can
play a more active role in supporting minor use pesticides and facilitating the emergency exemption
process under Section 18 of FIFRA. Since FQPA amended FIFRA to require tolerances for uses granted
an emergency exemption, EPA issued guidance to states and increased efforts to discuss potential
applications with states prior to submission. This allows the Agency to provide a preliminary indication
as to the likelihood that a tolerance can be established, possibly avoiding situations where crops treated
under an emergency exemption are not allowed to be marketed.
30
-------
VII. Partners and Other Stakeholders continued
EPA maintains an active partnership with over 25
tribes that have pesticide programs. Like states, tribes
have primary responsibility for enforcing federal pesticide
laws on tribal lands. With help from states, EPA provides
support to tribes wishing to identify and monitor pesticide
use and develop programs to educate pesticide users on
proper techniques and available pest control methods.
EPA and tribes are developing a national Tribal Pesticide
Program Council that will work to address tribal pesticide
program needs and technical issues. The agency also
assists tribes with specific issues through activities such as
workshops on the Pesticide Management Plan rule, which
is scheduled to be promulgated in 2000.
A new approach, being used in EPA's Region 10
(San Francisco) office, involves a "circuit rider" staff
position. The circuit rider travels among reservations in
the region and provides technical assistance on pesticide
regulatory issues. The circuit rider concept is one that
EPA is considering expanding and is a possible mechanism
to ensure that tribes are familiar with, and will properly
implement, FQPA requirements.
EPA's regional offices serve as a link between the
Agency, states, and tribes. They establish and manage
cooperative agreements, participate in enforcement
activities, and promote community based programs and
pollution prevention activities. Regions also play an active
role in tracking pesticide imports and assisting with
international technical assistance activities. Regional
offices help connect EPA with activities undertaken at the
state and local level which might be beneficial if conducted
on a broader basis. Through grants, regional offices are
allowed to reward these activities by providing support
and attention not always available on the national program
level. In addition, particularly for FQPA and other
agricultural issues, EPA regions can help determine the
unique effects of a national regulation in an individual
state or group of states within the same geographical
region.
In Fiscal Year 1998, EPA initiated funding for the
Regional Agricultural Initiative. Under this initiative,
Regional Agricultural Initiative
There are currently four pilot projects being
conducted by EPA regional offices with the
support of headquarters. The objective of
the Regional Agricultural Initiative is to
increase communication between EPA and
stakeholders related to implementation of
FQPA. Highlights of the four pilots
include:
Region 4 (Atlanta) - enrollment of more
than 163 thousand acres of farmland in the
Delta F.A.R.M. project (Mississippi),
designed to increase the acceptance of best
environmental practices, and development
of crop profiles in Florida, which will
provide better data on current pesticide use.
Region 5 (Chicago) - a pesticide residue
study conducted by Michigan State
University and the Michigan Department of
Agriculture, which will result in more
accurate risk assessments for minor use
crops.
Region 9 (San Francisco) - a joint project
between the California grape industry, the
University of California, USDA, and others
to develop a comprehensive overview and
analysis of the problems faced by grape
growers, current pesticide use, and
available alternatives.
Region 10 (Seattle) - a cooperative
agreement with Washington State
University to study biological controls,
alternative cropping systems, precision
pesticide application, and other mechanical
and cultural practices which might mitigate
pesticide risk.
31
-------
VII. Partners and Other Stakeholders continued
regions are provided with money to be used to work with and support state projects specific to FQPA
implementation. Four pilot projects were undertaken in 1998 and EPA hopes to expand the effort in the
year 2000.
Unique Stakeholders
FQPA contains specific provisions recognizing the uniqueness, and importance, of two segments of
the regulated community. Antimicrobial pesticides are used in a variety of settings such as hospitals,
around the home, and recreational areas. These pesticides may have important public health uses and
generally pose less risk than agricultural chemicals. Some agricultural uses of pesticides are termed
"minor use" because they are used on limited acreage or they do not provide the registrant with as much
economic return as other pesticides. These uses, while termed minor, are often of major significance to
consumers and growers. Without these small scale but vital pesticide uses, many of the fruits, vegetables,
and ornamentals that we enjoy in the U.S. could not be grown successfully.
Antimicrobial Pesticides
Antimicrobial pesticides are used to control
harmful microorganisms including bacteria, viruses
or fungi in/on inanimate objects and hard surfaces.
Antimicrobial products include sterilants,
disinfectants, and sanitizers, as well as swimming
pool chemicals, wood preservatives, and
antifoulant paints. Antimicrobial products also
include public health pesticides. To obtain
registration for antimicrobial products,
manufacturers are required to meet general
standards of FIFRA. For public health pesticides,
registrants must also submit detailed efficacy data
to document their claims against specific
microorganisms. Prior to FQPA, FIFRA contained
no separate provisions for regulating antimicrobial
products. EPA shared regulatory responsibilities
with FDA for some products, and gave no
particular review priority to antimicrobial products
over other types of pesticide products.
Antimicrobial Review Timeframes
540 days for a new antimicrobial active
ingredient
270 days for a new antimicrobial use of a
registered active ingredient
120 days for any other new antimicrobial
product
90 days for a product that is substantially
similar or identical to a previously registered
product (a "me-too" product)
90 days for an amendment to an antimicrobial
product registration requiring no scientific
review
90 to 180 days for any other antimicrobial
product amendment requiring scientific review.
FQPA required that EPA revise the antimicrobial registration processes to reduce review times for
antimicrobial products to less than that of other types of pesticide products. Specific review-time goals
for different regulatory actions on antimicrobials are detailed in the law (see Appendix 5). To help
32
-------
VII. Partners and Other Stakeholders continued
implement FQPA's requirements, an Antimicrobial Division was formed within EPA's Office of Pesticide
Programs. This Division has made significant progress towards meeting the FQPA requirements for
antimicrobials, including:
Streamlining the regulatory review process, enabling the Agency to meet all registration deadlines
for submissions filed since November 1996;
Reducing the backlog of registration actions by 98% since the beginning of 1997;
Clarifying the roles of EPA and the Food and Drug Administration concerning regulation of
antimicrobial pesticides that come in contact with food, and the use of liquid chemical sterilants;
Issuing draft guidance to help prevent the public from being misled that certain products (e.g., paint
treated with a pesticide to protect the paint coating) actually protect consumers from germs and
bacteria.
Minor Use Pesticides
In response to FQPA, and the needs of the minor use growers, EPA established a Minor Use Team
which is drawn from throughout the Pesticide Program and is headed by a Minor Use Officer. The Minor
Use Team has three primary goals:
obtaining and using the best available data to support minor use tolerances;
working more closely with the minor use grower community early in the regulatory process;
and;
promoting the use of safer pesticides for minor uses by urging manufacturers to research and
expedite registrations for lower risk pesticides.
With the help of the Minor Use Officer, EPA has strengthened its communication with minor use
growers and has helped bring growers and registrants together earlier in the registration process. In
addition, by including minor use representatives on the TRAC, the Agency has helped bring the issues
surrounding these important uses to the attention of other stakeholders.
33
-------
Pesticide Environmental Stewardship Program
Although the Pesticide Environmental Stewardship Program (PESP) was initiated in 1994 before
FQPA was enacted, the goals of program are consistent with those of FQPA. The PESP is a partnership
between EPA and pesticide user groups to reduce pesticide risk in agricultural and nonagricultural
settings. The guiding principle for PESP is reduction of pesticide risk through various means.
Organizations who elect to become PESP members develop strategies for their organization that use
Integrated Pest Management (IPM), grower education, use reduction, improved application techniques,
and other methods to reduce risks from the use of pesticides. PESP Partners (pesticide user groups) and
Supporters (organizations who work with pesticide user groups) number over 100 at this time (see
Appendix 7). Each organization has an EPA Liaison who works with the Partner or Supporter to
enhance communication between the user community and EPA.
EPA has small incentives grant programs to assist Partners and Supporters in implementing their risk
reduction strategies. These grants, for example, may help a Partner learn to use a new alternative
pesticide which would replace a more toxic pest control. These grants support both laboratory and field
research as well as a number of training programs. PESP is committed to helping its members protect
public health, the environment, and the food supply in the US through the use of efficient, cost effective
pest control practices.
34
-------
FQPA Progress Report Appendices
Appendix 1
The Scope of Pesticide Regulation
Pesticides subject to EPA regulation include insecticides, herbicides, fungicides, rodenticides,
disinfectants, plant growth regulators and other substances intended to control pests. Pesticides have
many uses: in agriculture, greenhouses, and on lawns; in swimming pools, industrial buildings and
households; and in hospitals and food service establishments. Overall, there are about 20,000 registered
pesticide product formulations, containing over 900 active ingredients and 1,835 inert ingredients. About
470 pesticide active ingredients are used in agriculture, and EPA has established more than 9,000 residue
limits (tolerances) for pesticides in food.
EPA's pesticide regulations directly affect approximately 30 major pesticide producers, another 100
smaller producers, 2,500 formulators, 29,000 distributors and other retail establishments, 40,000
commercial pest control firms, one million farms, three and a half million farm workers, several million
industry and government users, and all households. Within EPA's Office of Pesticide Programs (EPA),
over 800 people in nine divisions carry out activities relating to pesticide regulation and management. In
addition, a large number of people in other EPA offices, including regional offices, provide
administrative, legal, enforcement, and research support to the pesticide program.
Statutory Framework: EPA's Role in Food Safety
EPA regulates pesticides under two major statutes: the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). FIFRA requires that
pesticides be registered (licensed) by EPA before they may be sold or distributed for use in the United
States, and that they perform their intended functions without causing unreasonable adverse effects on
people or the environment when used according to EPA-approved label directions.
FFDCA authorizes EPA to set tolerances, or maximum legal limits, for pesticide residues in food.
Tolerance requirements apply equally to domestically-produced and imported food, and any food with
residues not covered by a tolerance (or in amounts that exceed an established tolerance) may not be
legally marketed in the United States. Due in no small measure to EPA's work under these two laws,
Americans enjoy one of the safest, most abundant, and most affordable food supplies in the world.
EPA requires extensive data as part of its pesticide review and approval process, requiring more than
120 studies before granting a registration for most pesticides used in food production. Study
requirements are tiered to the intended use and certain properties of the pesticide. These studies allow
EPA to assess risks to human health, domestic animals, wildlife, plants, groundwater, beneficial insects
and other environmental effects. When new evidence arises to challenge the safety of a registered
pesticide, the Agency may take action to suspend or cancel its registration and revoke the associated
tolerances. EPA may also undertake an extensive special review of a pesticide's risks and benefits or work
with manufacturers and users to implement changes in a pesticide's use (such as eliminating use on some
crops, reducing application rates, or cancellation of a pesticide's uses). As part of its ongoing
35
-------
reregi strati on program, EPA is systematically reviewing all older pesticides registered before November
1984, to ensure that they meet current testing and safety standards.
While EPA is responsible for making registration and tolerance decisions, the Agency relies on
others to carry out enforcement activities. Registration-related requirements under FIFRA are enforced
by the states. Tolerances are enforced by the Department of Health and Human Services/Food and Drug
Administration for most foods, and by the U.S. Department of Agriculture/Food Safety and Inspection
Service for meat, poultry, and some egg products.
36
-------
Appendix 2
Status ofFQPA Statutory Deadlines
Endocrine Disrupters Screening and Testing Program
Develop an Endocrine Disrupter
screening program [FFDCA 408(p)(l)]
Implement program to screen and test
endocrine disrupters [FFDCA
408(p)(2)]
Report to Congress on screening and
testing program [FFDCA 408(p)(7)]
Augusts, 1998
Augusts, 1999
August 3, 2000
Endocrine Disrupters Screening and Testing
Advisory Committee final recommendations
submitted August 1998. EPA used these as the
basis for its proposed program, beginning in
1998.
Validation program underway
EPA will meet this deadline
FIFRA Section 18 (Emergency Exemption) Tolerances
Publish final regulation outlining
process for establishing Section 18
tolerances [FFDCA 408(1)(6)]
Augusts, 1998
Proposal published on June 3, 1999; comment
period runs through August 2, 1999. Final
rule in 2000.
Tolerance Reassessment
Publish general schedule for tolerance
reassessment [FFDCA 408(q)(3)]
Complete 33% of reassessments
[FFDCA 408(q)(l)(A)]
Complete 66% of reassessments
[FFDCA 408(q)(l)(B)]
Complete 100% of reassessments
[FFDCA 408(q)(l)(C)]
August 1997
August 1999
August 2002
August 2006
Completed August 1997
Agency has met this deadline; 3290 tolerances
reassessed by August 2, 1999.
Agency will meet this deadline
Agency will meet this deadline
37
-------
Tolerance Fees
Require fees sufficient to cover costs of
processing tolerance petitions [FFDCA
408(m)(l)]
No set time
Proposed rule published on June 9, 1999;
comment period runs through September 9,
1999. Final rule in 2000.
Consumer Right-to-Know
Publish Consumer Brochure [FFDCA
408(o)]
August 1998
Final Brochure published and distributed in
February 1999
Minor Uses
Publish progress report on the
registration of minor uses in Federal
Register [FIFRA 3 l(b)]
August 1999
EPA is working with USDA, IR-4, and minor
use stakeholders to prepare the report
Reduced Risk Pesticides
Develop procedures/ guidelines for
implementing expedited
processing/review of reduced risk and
biological pesticides [FIFRA
August 1997
Published as Pesticide Registration Notice 97-
3 on September 4, 1997
Antimicrobial Pesticides
Submit first annual report on
antimicrobial regulatory reform
progress to Congress [FIFRA
3(h)(4)(A)]
No later than
March 1 of each
year, beginning in
1997
First report submitted in October 1997. The
second report will be submitted October 1999.
Publish proposed Antimicrobial Reform
Regulation [FIFRA 3(h)(3)(A)]
May 1997 (not
later than 270 days
after enactment of
the law)
Publication of Proposal expected September
1999
Final Antimicrobial Reform
Regulation [FIFRA 3(h)(3)(B)]
Not later than
240 days after
close of comment
period for the
proposed rule
Final rule planned within eight months of
the proposed regulation.
38
-------
Reregistration
Adopt accounting rules, approved by
GAO and the IG, to ensure that fee
money is allocated to reregi strati on
and fast track actions [FIFRA
Effective October
1, 1997
Cost accounting standards have been
adopted. Procedures are reviewed in detail
by the IG each year as part of the formal
audit mandated by the CFO Act of 1990.
Publish report on progress of
reregi strati on and projected
completion for remaining cases
[FIFRA 4(1)]
No set time -
language calls for
EPA to
"...establish and
publish annually"
Report for FY '97 was published in the
Federal Register on October 7, 1998;
report for FY " 98 is under review and is
expected to be published in September
1999.
Data Coordination
Develop process to address
disparities between state and federal
data requirements [FIFRA
August 1997
Workgroup was formed with SFIREG and
registrants; severity of problem was
evaluated and all agreed that no formal
action was needed; if future problems
arise, workgroup will act as mechanism for
addressing them.
Periodic Registration Review
Establish a process for the periodic
review of pesticide registrations,
with a goal of review every 15 years
[FIFRA 3(g)(l)(A)]
No specific
deadline for
development
Advanced Notice of Proposed
Rulemaking, covering procedural issues, is
under development; We have begun pilot
projects using current authority to
determine if construct of review process is
practical.
39
-------
Appendix 3 a
Review Process for the Organophosphates
Phase 1 (30 days) - Registrant "Error Only" Review: EPA sends its preliminary human health and
ecological risk assessments to registrant(s) of the pesticide and the U.S. Department of Agriculture
(USDA) for a 30-day review. They are asked to identify any computational or other errors that EPA
may have made in developing its preliminary assessment of the pesticide's risks.
Phase 2 (up to 30 days) - EPA Considers Registrants' and USDA's Comments: EPA
summarizes and considers comments from registrants and USDA. If necessary, EPA incorporates
comments or makes changes in the preliminary risk assessment to correct any errors identified. By
the end of this phase, EPA opens a Public Docket for the pesticide.
Phase 3 (60 days) - Public Comment on Preliminary Risk Assessment: EPA publishes a
Federal Register (FR) Notice of Availability announcing its preliminary risk assessment, opening a
60-day public review and comment period. Registrants, grower groups, other stakeholders, and the
public are encouraged to submit data and other information to revise EPA's preliminary risk
assessment. They also may begin submitting proposals to address any risk concerns identified in the
document. EPA may meet with registrants and other stakeholders to discuss risk related data, use
information, and risk assessment/ risk mitigation alternatives.
Phase 4 (90 days + USDA review and public meetings/briefings) - EPA Revises Risk
Assessments, Holds Public Meetings/Technical Briefings: EPA summarizes and considers
comments, data and risk mitigation proposals received during Phase 3, develops a revised risk
assessment, and sends it to USDA for review. EPA and USDA host public meetings or technical
briefings to share the revised risk assessment with stakeholders and the public and to discuss risk
management ideas.
Phase 5 (60 days) - EPA Solicits Risk Management Ideas: EPA releases the revised risk
assessment to the public for viewing via the OP Public Docket. EPA publishes an FR Notice of
Availability opening a 60-day public consultation period during which risk management proposals are
solicited. Registrants, grower groups, other stakeholders and the public are encouraged to participate
and submit their risk management proposals. EPA and USDA may meet with registrants and other
stakeholders to discuss risk management alternatives and strategies. Meeting minutes are included
in the Public Docket.
Phase 6 (up to 60 days) - EPA Develops Risk Management Strategies: EPA considers all risk
management proposals received. With input from USDA, EPA develops risk management strategies
that ultimately will contribute to the Agency's risk management decisions for the OPs.
40
-------
Appendix 3b
Examples of Risk Reduction through REDs
The following examples illustrate the ways in which risks, especially risks to children, are being
reduced through post-FQPA REDs (Reregi strati on Eligibility Decisions).
Chlorothalonil - Used to control foliar diseases of vegetable, field, and ornamental crops and to
control mildew in paint. Homeowner uses include paint additive, ornamental plant, and turf uses.
Cholorothalonil poses a cancer risk to occupational and residential handlers, and to toddlers exposed
through home lawns. To protect toddlers and residential handlers, the home lawn use was deleted
through the RED; all chlorothalonil products are prohibited for use on home lawns. In addition, paint
additive products containing chlorothalonil must be labeled to prohibit over-the-counter and retail sale,
and in-container preservative products are prohibited. An impurity limit for technical and manufacturing
use products must be met by January 2003 or registrations will be canceled. To protect workers,
engineering controls (water soluble bags or closed systems), increased Personal Protective Equipment
(PPE) and Reentry intervals (REIs), and application restrictions are imposed. To protect wildlife, many
application rates are reduced and buffers are required, as are surface water, ground water, and aerial drift
reduction advisories.
DEET - Widely used among the U.S. population, including children, DEET is one of the few
residential-use pesticides applied directly to the skin. It is an insect repellent used in households, on the
human body and on clothes being worn, and on cats, dogs, horses, and pet living and sleeping quarters.
DEET has been implicated with seizures in children but data are insufficient to establish DEET as the
cause. DEET does not appear to pose a significant health risk to the general U.S. population. To protect
children and others vulnerable populations, however, EPA believes it is prudent to require improved label
warnings and use restrictions, including 14 statements informing users/consumers about safe methods of
application, special precautions for children, and directions for medical attention. Products that contain
DEET and sunscreen together are not eligible for reregi strati on pending consultation with outside
agencies and groups.
Iprodione - A fungicide used on a variety of field, fruit and vegetable crops, ornamentals, lawns and
golf courses, iprodione is a Group B2 carcinogen and causes developmental and reproductive effects. All
residential uses were voluntarily canceled through the reregi strati on process due to cancer risk concerns.
Acute dietary risk and aggregate cancer risk from dietary, residential, and water exposure are acceptable
with risk mitigation measures identified in the RED, including increased pre-harvest intervals and reduced
tolerances for strawberries and stone fruit. The belly grinder application method is prohibited to protect
handlers. Other handler risks are acceptable with engineering controls, enhanced PPE, extended REIs,
limiting the number of applications per season, and other application restrictions. The herbaceous
ornamental seed treatment use was voluntarily canceled to mitigate risks to birds. With risk mitigation,
including a vegetative buffer strip requirement, other ecological risks are acceptable.
41
-------
Appendix 4
National Academy of Sciences Recommendations
In 1988, the U.S. Congress requested that the National Academy of Sciences establish a committee
within the National Research Council to study scientific and policy issues concerning pesticides in the
diets of infants and children. The committee on Pesticide Residues in the Diets of Infants and Children
was charged with examining what is known about exposures to pesticide residues in the diets of infants
and children, the adequacy of current risk assessment methods and policies, and toxicological issues of
greatest concern.
In 1993, the National Academy of Sciences published the committee's report entitled, "Pesticides in
the Diets of Infants and Children." The committee concluded that estimates of expected total exposure
to pesticide residues should reflect the unique characteristics of the diets of infants and children and
should account also for all non-dietary intake of pesticides. A progress report on the committee's
specific recommendations follows.
NAS Recommendation #1: Tolerances
EPA should modify its decision-making process for setting tolerances so that it is based more on health
considerations than on agricultural practices. These changes should incorporate the use of improved
estimates of exposure and more relevant toxicology, along with continued consideration of the
requirements of agricultural production. As a result, human health considerations would be more fully
reflected in tolerance levels. Children should be able to eat a healthful diet containing legal residues
without encroaching on safety margins. This goal should be kept clear.
EPA Implementation: Beginning in 1994 and increasingly since the enactment of the Food Quality
Protection Act of 1996 (FQPA), EPA has made numerous changes to its tolerance setting process
that strengthen the protections for infants and children. FQPA amended the food safety laws to
establish a single, health-based safety standard for all pesticide residues in food. Under FQPA, EPA
must specifically determine that each newly established tolerance is safe for infants and children. In
addition, FQPA requires the Agency to reexamine all existing tolerances against its new safety
standard, and bring them into compliance if they are not safe. EPA has changed many aspects of its
risk assessment process to improve its ability to assess exposure more accurately and to strengthen
its capacity for understanding the potential for chemicals to pose greater toxicity to children. As a
result of these new approaches, EPA is confident that its decisions fully protect infants and children
from risks due to pesticide use on food.
NAS Recommendation #2: Toxicity Testing
Toxicity testing procedures must be developed that specifically evaluate the vulnerability of infants and
children. Testing must be performed during the developmental period in appropriate animal models, and
the adverse effects that may become evident must be monitored over a lifetime. Of particular importance
are tests for neurotoxicity and toxicity to the developing immune and reproductive systems. Careful
attention to interspecies differences in pharmacokinetics and metabolism of pesticides and the relative
ages at which organ systems mature is essential. It is also important to enhance understanding of
42
-------
developmental toxicity, especially in humans, during critical periods of postnatal development, including
infancy and puberty.
EPA Implementation: EPA has developed and published new guidelines for conducting studies to
evaluate the potential of pesticides to cause neurotoxicity (effects on the nervous system),
immunotoxictiy (effects on the immune system), and developmental neurotoxicity (effects on the
nervous system of newborns and the young). EPA has begun a data call-in program to require acute,
subchronic and developmental neurotoxicity data for at least 140 pesticides. We wil aslo revise our
current rule on data requirements to reflect these test guidelines. In addition, EPA is making greater
use of information on the pharmacokinetics and metabolism of pesticides in its risk assessments.
NAS Recommendation #3: Uncertainty Factors
Because there exist specific periods of vulnerability during postnatal development, an uncertainly factor
up to the 10-fold factor traditionally used by EPA and FDA for fetal developmental toxicity should also
be considered when there is evidence of postnatal developmental toxicity and when data from toxicity
testing relative to children are incomplete.
EPA Implementation: FQPA requires EPA to apply an additional safely factor of 10 in its risk
assessments to account for potential for pre- and post-natal toxicity, as well as for the completeness
of the toxicity and exposure databases, unless based on reliable, available data EPA determines that
a different factor would be safe for infants and children. EPA's approach to implementing this
provision, which became effective on enactment, is described in a series of science policy documents
that have undergone peer review by the FIFRA Scientific Advisory Panel and that have been recently
been made available for comment by the general public.
NAS Recommendation #4: Food Consumption Data
Additional data on the food consumption patterns of infants and children should be collected within
narrow age groups because available data indicate that infants and children consume much more of
certain foods on a body weight basis than do adults.
EPA Implementation: EPA's risk assessments have long taken into account that infants and
children typically consume a different blend of foods and more food per body weight than adults do.
The food consumption data EPA uses in risk assessment come primarily from surveys conducted by
the USD A. Since the 1993 NAS Report, USD A has updated the food consumption data with new
studies, and EPA is using the updated information. In addition, USDA is actively working on
completion of a survey that provides a significantly larger amount of information on the eating habits
of infants and children. The most recent survey data on food consumption will be incorporated into
EPA's risk assessments beginning this fall.
43
-------
NAS Recommendation #5: Pesticide Residue Data
To maximize the utility of pesticide residue data collected by various laboratories, comparable analytical
methods and standardized reporting procedures should be used, and a computerized data base should be
established to collate data on pesticide residues generated by different laboratories.
-FDA should increase the frequence of sampling of the commodities most likely to be consumed by
infants and children, including metabolites and degradates.
-Food residue monitoring should target a special "market basket survey" focused toward the diets of
infants and children.
-Pesticide field trial data should be consulted to provide a basis for estimating potential maximum
residue levels.
-More information should be gathered on the effects of food processing on levels of pesticides in
specific food-chemical combinations potentially present in the diets of infants and children.
EPA Implementation: EPA, working with USD A, FDA, food processors, and chemical companies,
have agreed to establish a comprehensive National Pesticide Residue Database. This Database will
include information from a variety of sources and will be available for use in pesticide risk
assessments.
-Most of the pesticide residue data used in risk assessment come either from field trials
performed by chemical companies or from the Pesticide Data Program administered by USDA.
In recent years, EPA and USDA have agreed that PDF sampling will focus on commodities that
are most likely to be consumed by infants and children. The resulting PDF data have been used
extensively in risk assessments for a number of organophosphate insecticides.
-In addition to PDF monitoring, which resembles a "market basket survey" in many respects,
EPA is working with individual chemical companies on the design of specialized market basket
surveys for specific pesticides or groups of pesticides.
-For over twenty-five years EPA has used pesticide field trial data to estimate the maximum
residues likely to remain in treated commodities when they enter commerce. EPA has issued
guidelines for collecting, reporting, and analyzing such data; these guidelines are widely
followed by chemical companies and others, not only in the United States but also around the
world.
-EPA routinely requires studies to determine whether various types of processing will increase
or decrease the concentration of pesticides, compared to levels in the raw commodities.
Recently, chemical companies, grower organizations, and food processors have been providing
additional studies on the impacts of processing on residues. The Agency uses this information
in its risk assessments for pesticides.
44
-------
NAS Recommendation #6: Risk Assessment
All exposures to pesticides - dietary and non-dietary - should be considered when evaluating the
potential risks to infants and children. Non-dietary environmental sources of exposure include air, dirt,
indoor surfaces, and pets.
-Estimates of total dietary exposure should be refined to consider intake of multiple pesticides with a
common toxic effect.
-Risk assessment should include estimates of exposure to pesticides in drinking water and in water as
a component of processed foods.
-Given adequate data on food consumption and residues, exposure distributions should be used,
rather than single point data to characterize the likelihood of exposure to different concentrations of
pesticide residues.
EPA Implementation: FQPA requires EPA to consider both dietary and non-dietary and non-
occupational sources of exposure in making decisions regarding the safely of pesticide residues in
food. To this end, EPA has expanded the scope of its risk assessments to take into account not only
the exposures that occur from residues in food, but also residues in drinking water. Further, EPA
aggregates these exposures with exposure that occurs when pesticides are used in and around
homes, offices, schools, parks, or other similar sites. In evaluating the risks from these different
uses, EPA examines each pathway and route by which people may be exposed: for example, by
inhalation of vapor or mist; absorption through the skin following contact with pets, dirt, or treated
surfaces; and ingestion of drinking water or treated food.
-In addition, FQPA requires that EPA consider the cumulative effects of pesticides which have a
"common mechanism of toxicity," since such chemicals may have a combined impact greater
than the risks from exposure to only one compound. EPA expects to have guidance on
cumulative risk assessment during the summer of 2000.
-The new food consumption data from USDA which EPA will begin to use this fall, provides
information on individual consumption of water, both as drinking water and as a result of use in
processing. EPA will be able to combine this information with data on pesticide residues in
water to produce more realistic exposure estimates.
- EPA has implemented new risk assessment techniques which provide a description of the
distribution of exposure to pesticide residues in food. These "probabilistic" techniques take into
account the variability in both food consumption from individual to individual and the variation
in the levels of pesticide residues found in food.
45
-------
Appendix 5
FQPA TRAC SCIENCE POLICY ISSUES AND RELATED PAPERS
FQPA TRAC Science Policy Papers
1. Guidance for Identifying Pesticide Chemicals and Other
Substances that Have a Common Mechanism of Toxicity
2. Office of Pesticide Programs' Science Policy on the Use of
Data on Cholinesterase Inhibition for Risk Assessments
3. Guidance for the Submission of Probabilistic Human
Health Exposure Assessments to the Office of Pesticide
Programs
4. Proposed Threshold of Regulation Policy When a Food Use
Does Not Require a Tolerance
5. Assigning Values to Nondetected/ Nonqualified Pesticide
Residues in Human Health Dietary Exposure Assessments
6. A Statistical Method for Incorporating Nondetected
Pesticide Residues into Human Health Dietary Exposure
Assessments
7. A User's Guide to Available OPP Information on
Assessing Dietary (Food) Exposure to Pesticides
8. Dietary (Drinking Water) Exposure Estimates
9. Framework for Assessing Non-Occupational/Non-Dietary
(Residential) Exposure to Pesticides
10. Standard Operating Procedures (SOPs) for Residential
Exposure Assessment
11. Choosing a Percentile of Acute Dietary Exposure as a
Threshold of Regulatory Concern (99.9th percentile)
12. 10X Task Force and OPP Guidance Documents (three
draft documents; one final)
1 3 . Standard Operating Procedures (SOPs) for Use of the
FQPA Factor
14. Guidance for Performing Aggregate Exposure and Risk
Assessment
Status of Draft
for Public
Comment
Issued 8/6/98
Issued 11/5/98
Went to SAP
several times.
Issued 11/5/98
Went to SAP
3/98
Issued 12/4/98
Issued 12/4/98
Issued 12/4/98
Issued 1/4/99
Issued 1/4/99
Went to SAP 5/99
Issued 1/4/99
Issued 1/4/99
Issued 4/7/99
Went to SAP
as part of #3.
Issued 7/8/99
Went to SAP
5/99
Issued 7/8/99
Went to SAP 5/99
Expected 10/99
Status of Revision
after Public
Comment
Issued 2/5/99
Expected 10/99
Expected 6/00
Expected 8/99
Expected 3/00
Merged with #5
Expected 3/00
Expected 10/99
Expected 12/99
Expected 12/99
To SAP 9/99
Expected 12/99
Expected 3/00
Expected 3/00
Expected 5/00
46
-------
15. SOP: Interim Guidance for Conducting Aggregate
Exposure and Risk Assessment
16. Use of the Pesticide Data Program (PDF) in Acute Dietary
Assessment
17. Cumulative Risk Assessment Guidance
18. Drinking Water Screening Level Assessment
19. SOP for Drinking Water Assessments, including
Reservoir Model
Additional Related Papers
20. Data for Refining Anticipated Residue Estimates Used in
Dietary Risk Assessments for Organophosphate Pesticides
21. Interim Early Assessment Policy for Organosphosphate
Pesticides
22. The Role of Use-Related Data in Pesticide Risk
Assessment and Risk Management
23. Interim Human Studies Policy Guidance
24. Guidelines for the Conduct of Bridging Studies for Use in
Probabilistic Risk Assessment
25. Guidelines for the Conduct of Residue Decline Studies for
Use in Prob. Risk Assess.
26. Quantitative Assessment of Uses of Concern for Drinking
Water
27. Factoring Drinking Water Treatment into Drinking Water
Assessments for Pesticides
Merge with #14
Went to SAP
5/99
Expected 1/00.
Hazard part to SAP 9/99;
Exposure part to SAP
12/99
(Merge with
paper #8)
(Merge with
paper #8)
Issued 4/7/99
To Be Determined
Issued 7/14/99
To Be Determined
Expected 8/99
Expected 8/99
Expected 12/99
To SAP 5/00
Expected 2/00
To SAP 5/00
Merge with #14
Expected 1/00
Expected 8/00
N/A
N/A
Expected 3/00
To Be Determined
Expected 2/00
To Be Determined
Merge with #20
Merge with #20
Expected 7/00
Expected 9/00
(7/21/99)
47
-------
Appendix 6
EPA's Proposed Endocrine Disrupter Screening Program
EPA outlined its Endocrine Disrupter Screening Program (EDSP) on August 11,1998, and provided greater
detail in a proposed policy statement on December 28, 1998. The Agency's proposed EDSP closely follows
consensus recommendations provided by the Endocrine Disrupter Screening and Testing Advisory Committee
(EDSTAC). The EDSP involves four discrete stages: initial sorting of chemicals; establishment of screening
priorities; Tier 1 analysis; and Tier 2 analysis. The proposed EDSP is summarized below, followed by a status
report of implementation activities within the Agency.
Initial sorting
Chemicals to be sorted include approximately 900 pesticide active ingredients; 2,500 pesticide formulation
inert ingredients; 75,500 industrial chemicals; and 8,000 cosmetics, food additives, and nutritional supplements.
EPA may not have regulatory purview over the latter three chemical groups; it will focus its efforts on pesticides,
industrialchemicals, and environmental contaminants. In keeping with the EDSTAC recommendations, EPA will
continue to collaborate with other appropriate federal agencies (e.g., Food and Drug Administration, National
Institute of Environmental Health Sciences) to facilitate examination of the remaining groups of chemicals.
The initial sorting stage will separate chemicals into four categories based upon a review of all existing
relevant scientific information. Category 1 includes those chemicals that are unlikely to exhibit endocrine activity
and should not be screened (e.g., strong mineral acids and bases, amino acids, sugars, certain polymers, etc.).
Category 2 consists of chemicals with insufficient data to determine their potential for endocrine activity. Category
3 includes those chemicals that have sufficient data to bypass screening, but need testing. Finally, Category 4
consists of substances with adequate data which willbe referred to the appropriate agency for hazard assessment.
Priority setting
The Category 2 chemicals (those with insufficient information and data to determine if they are endocrine
active) may constitute the largest category, and are therefore of the greatest interest to EPA for priority setting.
EPA is presently developing a relational database to consolidate existing databases and information for chemicals.
The database will also be used to establish sets of chemicals to be ranked for priority setting.
Tier 1 Screening
No single assay system can presently be used to detect estrogenic and other closely related types of hormonal
activity. Therefore a battery of eight assays was proposed as necessary to evaluate endocrine disruption potential.
Chemicals that are negative in Tier 1 would be considered to have a low potential for estrogen, androgen, or thyroid
activity. Chemicals with positive Tier 1 results move to Tier 2 for a more comprehensive evaluation.
Tier 2 Testing
Tier 2 testing is intended to identify effects due to endocrine disruption and establish dose-response
relationships. The Tier 2 tests include the most sensitive developmental life stages and multi-generational effects
for mammals, birds, fish, amphibians, and invertebrates.
Implementation of the Endocrine Disruptor Screening Program
EPA has begun to implement its Endocrine Disruptor Screening Program (EDSP) under the deadlines
mandated by FQPA. The Agency is focusing its implementation priorities on the explicit statutory mandates of the
48
-------
FQPA, and will phase in broader discretionary aspects of the program as allowed by available resources. The
Agency has already accomplished key implementation steps for its EDSP:
Convened the Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC) under the
Federal Advisory Committee Act to obtain recommendations from federal and state governments, industry,
environmental groups, public health groups, worker protection groups and academic scientists concerning how
the Agency should proceed with endocrine disrupter screening and testing (August 1996 to August 1998).
Accepted ED STAC's final report of 71 recommendation regarding the development of an endocrine
disrupter screening program (October, 1998).
Consulted with a joint committee of the U.S. EPA Science Advisory Board and the FIFRA Scientific
Advisory Panel regarding the scientific merits of the EDSTAC draft recommendations (May, 1998).
Proposed the Endocrine Disrupter Screening Program (August, 1998)
Published a proposed statement of policy concerning the EDSP and requested public comments (December,
1998).
Held a workshop to provide public input into the development of the Endocrine Disrupter Priority Setting
Database and priority setting approach (January 1999).
Completed a high-throughput pre-screening (HTPS) feasibility demonstration study (March, 1999). The
study indicated that the technology requires additional development prior to regulatory use.
Convened a formal scientific peer review of the proposed statement of policy concerning the EDSP by a
joint committee of the U.S. EPA Science Advisory Board and the FIFRA Scientific Advisory Panel (April,
1999).
The Agency is engaged in numerous ongoing implementation activities. These include:
~ continuing to develop the Endocrine disrupter Priority Setting Database;
~ working with the international community to validate and harmonize endocrine screening tests;
~ convening an Endocrine Disrupter Standardization and Validation Task Force to accomplish
appropriate scientific validation of screening assays;
~ conducting demonstration studies of several screening assays proposed for use in the EDSP.
49
-------
Appendix 7
Pesticide Environmental Stewardship Program (PESP) Partners
All Service Pest Management, Inc. (FL)
Almond Board of California (CA)
American Electric Power Service Corporation (OH)
American Mosquito Control Association (FL)
American Nursery and Landscape Association (DC)
American Peanut Council (VA)
American Pest Management, Inc. (MD)
Arizona Public Service (AZ)
Artichoke Research Association (CA)
California Citrus Research Board (CA)
California Cling Peach Growers Advisory Board (CA)
California Floral Council (CA)
California Fresh Carrot Advisory Board (CA)
California Lettuce Research Board (CA)
California Pear Advisory Board (CA)
California Pear Growers (CA)
California Pistachio Commission (CA)
California Prune Board (CA)
California Tomato Commission (CA)
Carolina Power & Light (NC)
Central Maine Power Company (ME)
Chevy Chase Village (MD)
City of Davis (CA)
City/County of San Francisco Department of Agriculture
(CA)
Connectiv (DE)
Cranberry Institute (MA)
Creative Technology, Inc. (AL)
Daystar Termite Control Inc. (CA)
Delta Pest Control (FL)
Duke Power Company (NC)
Eastern Utilities (MA)
Eden Advanced Pest Technologies (WA)
Edison Electric Institute (DC)
Enviroguard Pest Control (TX)
Environ "Pest Elimination" Inc. (TN)
Fillmore Citrus Protective District (CA)
Florida Fruit & Vegetable Association (FL)
Florida Pest Control Association (FL)
Florida Turfgrass Association (FL)
Georgia Peach Council (GA)
Global Integrated Pest Management (MD)
Golf Course Superintendents Association of America (KS)
Griggs County, ND 319 Water Quality Project (ND)
Hawaii Agriculture Research Center (HI)
Hawaii Banana Industry Association (HI)
Hawaiian Electric Company (HI)
Hood River Grower-Shipper Association (OR)
Kansas Corn Growers Association (KS)
Kansas Grain Sorghum Producers Association (KS)
Lodi-Woodbridge Winegrape Commission (CA)
Massey Services, Inc. (FL)
Michigan Cherry Committee (MI)
Mint Industry Research Council (WA)
Monroe County School Corporation (IN)
National Pest Control Association (VA)
National Potato Council (CO)
Nature's Safeway Pest Control (FL)
New England Vegetable & Berry Growers Association (MA)
New Orleans Mosquito Control Board (LA)
New York Berry Growers Association (NY)
New York City Board of Education (NY)
New York State Gas & Electric (NY)
Northeast Utilities (CT)
Northern Indiana Public Service Corporation (IN)
Northwest Alfalfa Seed Grower Association (WA)
Oregon Wheat Growers League (OR)
Owen Specialty Services, Inc. (MI)
Pacific Coast Producers (CA)
Pear Pest Management Research Fund (CA)
Pebble Beach Company (CA)
Pennsylvania Electric (PA)
Pennsylvania Power & Light (PA)
Pennsylvania Rural Electric Association (PA)
Pest Birds, Inc. (OK)
Pest Police Pest Control (ME)
Pineapple Growers Association of Hawaii (HI)
Processed Tomato Foundation (CA)
Professional Lawn Care Association of America (GA)
Reliable Pest Control (WI)
Roses Inc. (MI)
Sanitary Pest Control Company (NV)
South Dakota Cattlemen's Association (SD)
South Texas Cotton and Grain Association, Inc. (TX)
Sprague Pest Solutions (WA)
Steritech Group, Inc. (MD)
Sunkist Growers (CA)
Sun-Maid Growers of California (CA)
Tennessee Valley Authority (TN)
Texas Association of Nurserymen, Inc. (TX)
Texas Pest Management Association (TX)
U.S. Apple Association (VA)
U.S. Canola Association (DC)
U.S. Department of Defense (DC)
U.S. Hop Industry Plant Protection Committee (WA)
U.S. Public Health Service - Centers for Disease Control and
Prevention (GA)
50
-------
University of Georgia-College of Agriculture &
Environmental Sciences (GA)
Utilicorp United (CO)
VA, MD & DE Association of Electric Cooperatives (VA)
Vegetation Managers, Inc. (PA)
Walnut Marketing Board (CA)
Washington State Department of Transportation (WA)
West Virginia Power (WV)
Winter Pear Control Committee (WA)
Wisconsin Ginseng Growers Association (WI)
Wisconsin Public Service Corporation (WI)
Pesticide Environmental Stewardship Program (PESP) Supporters
Agricultural Conservation Innovation Center (SC)
American Association of Pesticide Safety Educators (HI)
Aqumix, Inc. (VA)
Association of Applied Insect Ecologists (CA)
Audubon International (NY)
Bay Area Stormwater Management Agencies Assoc. (CA)
Bio-Integral Resource Center (CA)
Campbell Soup Company (CA)
Claymont Center for Continuous Education (WV)
Del Monte (CA)
Farm*A*Syst / Home*A*Syst (WI)
Gempler's Inc. (WI)
General Mills, Inc. (MN)
Gerber Products Company (MI)
Glades Crop Care, Inc. (FL)
Institute for Agriculture and Trade Policy (MN)
IPM Institute of North America, Inc. (WI)
Maryland Department of Agriculture (MD)
Miami Tribe of Oklahoma (OK)
National Council of Farmer Cooperatives (DC)
Northeast Research, Extension & Academic Program
Committee for IPM (NY)
Rainforest Alliance - ECO O.K. Program (NY)
United States Golf Association (NJ)
University of Wisconsin Center for Integrated
Agricultural Systems (WI)
51
------- |