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Pesticide Registration (PR) Notice 97-1: Agency Actions under the Requirements of the Food Quality Protection Act
Resources
January 31, 1997
Notice To: Manufacturers, Producers, Formulators, and Registrants of Pesticide Products
Attention: Persons Responsible for the Registration and Reregistration of Pesticides
Subject: Agency Actions under the Requirements of the Food Quality Protection Act
I. INTRODUCTION
The Food Quality Protection Act of 1996 (FQPA) requires the
Environmental Protection Agency (EPA) to consider new factors when
making pesticide regulatory decisions. Registrants, applicants, or
petitioners for pesticide product registrations or reregistrations, or
for tolerances or tolerance exemptions, whether pending or future, are
advised to consider comprehensively the provisions contained in the
Food Quality Protection Act (FQPA), specifically the factors relevant
to aggregate exposure assessment, children's exposure, and other
issues raised by the new statutory standard. This PR Notice explains
to registrants how EPA will, on an interim basis, implement the new
statutory provisions.
Although this PR Notice does not require registrants to submit
any additional information, the Agency recognizes that because the
Agency is required to consider additional information in order to make
the necessary decisions, many registrants, applicants and petitioners
may wish to provide the supplemental information to the Agency even
without a requirement to do so. The Agency has already received a
number of requests for information about the type of information that
the Agency will need to consider under the new statutory provisions,
as well as instructions for ensuring that the proper requests are
updated with any supplemental information the registrant, applicant or
petitioner wishes the Agency to consider. For those registrants,
applicants or petitioners who wish to supplement their original
submissions with additional information, the Appendices to this Notice
describe what information the Agency would consider helpful, when and
how material may be submitted to allow for the most efficient
processing and review(*1).
(*1) The collection of information related to the
registration, reregistration, and tolerance programs has
been approved by the Office of Management and Budget (OMB)
pursuant to the Paperwork Reduction Act under OMB Control
Numbers 2070-0024; 2070-0032; 2070-0040; 2070-0060; 2070-
0122; 2070-0107. These approvals cover the original
submissions by the registrant, applicant or petitioner. In
addition, EPA believes that the discussions within these
existing Information Collection Requests also serve to cover
any registrant's voluntary submission of information
intended to supplement their original submissions.
II. APPLICABILITY
This Notice applies to most applicants with registration
applications, non-crop-destruct experimental use permit applications,
tolerance or tolerance exemption petitions, or reregistration
eligibility decisions pending within the Agency. It also applies to
most future applicants seeking new or amended pesticide registrations.
This Notice includes all actions for synthetic chemicals,
antimicrobials, biochemical and microbial pesticides. Those who may
be affected are pesticide manufacturing companies, Interregional
Research Project No. 4 (IR-4) petitioners, and other third party
registrants. This Notice, however, does not apply to applicants
seeking fast track "me-too" registrations or amendments not involving
new uses.
Although the new standard in FQPA is clearly applicable to food
use pesticides and chemicals related to such pesticides, EPA intends
to apply a similar standard to actions involving non-food use
pesticides that may pose significant non-dietary risks to infants and
children.
III. EFFECTIVE DATE
This PR Notice is effective immediately.
IV. BACKGROUND
On August 3, 1996, the Food Quality Protection Act was signed
into law. Effective upon signature, the new statute significantly
amended the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA). It was
designed, among other things, to provide increased protection for
infants and children from pesticide risks.
FQPA
Title IV of the statute amends the Federal Food, Drug and
Cosmetic Act. The most important aspect of this title is the
establishment of a single, health-based standard for setting pesticide
residue tolerances. This eliminates the longstanding problems posed
by different standards for pesticides in raw and processed foods. The
provision removes the requirement of food additive tolerances for
processed foods and instead regulates them all under the same
tolerance provision. A tolerance (or exemption from tolerance) for a
pesticide residue on a raw agricultural commodity (RAC) also applies
to residues in a processed food derived from the RAC that are not
higher than the RAC tolerance. If the levels in the processed food
are higher, a separate tolerance must be set for that processed food.
Residue levels in both the RAC and the processed food must be
determined by EPA to be "safe."
The new safety standard, provided in section 408(b)(2)(A)(ii) of
the statute, is a "reasonable certainty of no harm" standard for
aggregate exposure using dietary residues and all other reliable
exposure information. When setting new or reassessing existing
tolerances or tolerance exemptions under the new standard, EPA must
now focus explicitly on exposures and risks to children and infants.
EPA must, 1) explicitly determine that the tolerance, or exemption
from tolerance, is safe for children; 2) consider the need for an
additional safety factor of up to ten-fold to account for uncertainty
in the data base relative to children unless there is evidence that a
different factor should be used; and 3) consider children's special
sensitivities and often unique exposure patterns to pesticides.
In addition, when making a determination as to whether or not
there is a reasonable certainty that a pesticide chemical will cause
"no harm," EPA must now consider other non-occupational sources of
pesticide exposure when performing risk assessments and setting
tolerances. This includes dietary exposure from drinking water,
non-occupational exposure, exposure from like pesticides that share a
common mechanism of toxicity as well as other exposure scenarios.
When setting new or reassessing existing tolerances and tolerance
exemptions, EPA must also evaluate the potential for endocrine
disruption. The new law directs the Agency to use its authority to
require specific tests and information on estrogenic effects for all
pesticide chemical residues.
Initial Communication to Registrants
EPA began the task of implementing the requirements of the FQPA
by explaining its goals and immediate plans in a letter sent August
21, 1996, to all current pesticide manufacturers, grower and other
pesticide user groups, industry, environmental, consumer, and public
interest groups. A second letter, containing more detailed
information, was sent on September 6, to all holders of pesticide
registrations. In its September 6 letter, the Agency stressed that
work was continuing on many registration and reregistration activities
and that interim decisions were being made. However, to ensure
compliance with the new law's provisions to protect against pesticide
uses which may pose unacceptable risks to children, additional time
was needed to adequately review certain applications, especially food
use applications. A letter has been sent to the States outlining the
additional materials and information needed to make section 18
emergency exemption tolerance decisions.
Program Implementation - Status of Food Use Phase-in Process
To deal with day-to-day decisions and procedural changes that
must occur, EPA has identified key implementation processes on which
to focus for all of the food and tolerance provisions of the Act. One
area of immediate concern is phasing-in and applying the new
requirements to currently pending registration, reregistration, and
tolerance decisions. The Agency is inventorying all pending actions,
and sorting them according to the applicable requirements of FQPA.
The Agency estimates that there are more than a thousand actions
pending at various stages of review. The inventory of all the
registration priority actions, biopesticide actions, and scheduled
reregistration actions is almost complete. Criteria for ranking the
inventory are being developed and, once actions are ranked, a process
for handling each category will be devised and put into place.
V. INTERIM APPROACH TO RISK MANAGEMENT
The Food Quality Protection Act does not provide an explicit
transition or phase-in period for many of the new requirements in the
law. Some of the new requirements call for scientific analyses which
have not been part of EPA's current risk assessment procedures. For
example, traditionally EPA has assessed pesticide exposures separately
by source and has not combined risks. Developing methodologies to
address these issues requires a new way of approaching risk assessment
and risk management.
While FQPA did not specify time frames for phasing in most of
these provisions (with the exceptions of the 3-year time frame for
developing a plan to assess endocrine effects, 1 year to develop an
antimicrobial program, and a few others), the law contains sufficient
flexibility to allow for a transition period while EPA develops new,
long-term assessment practices. Congress, in discussions regarding
the law, has confirmed this flexibility. EPA's goal even during this
interim period is to fulfill the intent of the new law to increase the
protectiveness of its regulatory process. While it is necessary to
develop new assessment procedures and policies to implement the new
requirements to the fullest, the Agency also needs to make timely
decisions about the use of pesticide products. Delaying decisions
does not achieve greater health protection and, in some instances, can
cause harm. An interim decision logic allows decisions to be made now
which are protective, more economic of resources, and which can be
revisited as knowledge increases. EPA has designed an interim
strategy to meet the new FQPA reasonable certainty of no harm standard
in the absence of full data and fully developed exposure and risk
assessment methodologies.
Interim Decision Logic for Aggregate Exposure
The Agency's interim decision logic is a screening process for
making regulatory decisions that are protective of public health and
are workable within the current risk assessment practices with
available data and methodologies. It also is designed to be flexible
so that when actual data are submitted, earlier assumptions can be
easily replaced with new information. Outcomes, at least initially,
will be conservative and any approvals will most likely result in time
limited or conditional decisions. As additional exposure data and
improved methods and models are developed, decisions based on the
interim logic will be revisited and modified as appropriate.
The new law says the Agency must now consider aggregate exposures
from dietary and non-occupational sources when assessing the risks of
a chemical and setting tolerances. In addition to dietary exposure,
such sources as drinking water, residential and lawn care use need to
be considered. For most pesticides, EPA has insufficient information
on specific exposures through these routes. While new data are being
generated and new exposure models developed, EPA will estimate the
exposure components and risk, and allocate portions of that total
aggregate risk to drinking water, and residential and lawn use
exposures (provided the pesticide is to be used indoors or on lawns).
The remainder of the aggregate risk will be allocated to dietary
exposure.
"The Risk Cup"
EPA's interim decision logic is based on the concept that the
total level of acceptable risk to a pesticide is represented by the
pesticide's Reference Dose (RfD). This is the level of exposure to a
specific pesticide that a person could receive every day over a
seventy-year period without significant risk of a long-term or chronic
non-cancer health effect. The analogy of a "risk cup" is being used
to describe aggregate exposure estimates. The full cup represents the
total RfD and each use of the pesticide contributes a specific amount
of exposure that adds a finite amount of risk to the cup. As long as
the cup is not full, meaning that the combined total of all estimated
sources of exposure to the pesticide has not reached 100% of the RfD,
EPA can consider registering additional uses and setting new
tolerances. If it is shown that the risk cup is full, no new uses
could be approved until the risk level is lowered. This can be done
by the registrant providing new data which more accurately represent
the risk or by implementing risk mitigation measures. While this
explanation is focused on chronic non-cancer risk, the Agency will use
a similar logic to assess acute risk and cancer risk.
The important issue for making interim decisions which take
aggregate exposure into account is how much of the "risk cup" should
be set aside or reserved for sources of possible exposure for which
the Agency has limited or no actual data. Unless actual exposure data
are available for these non-dietary pathways, the size of the
"reserve" portion will be based on various characteristics of the
pesticide, such as toxicity, mobility and persistence in soils, and
use pattern. It has been decided that, in general, between 5% and 20%
of the risk cup will be set aside for non-dietary exposures. The
remainder of the risk cup will be left for dietary risk for which
reliable data are available.
Interim Decision Logic for Common Mechanism of Toxicity
Similar to the decision logic for aggregate exposure, the Agency
has developed a conservative approach for assessing a common mechanism
of toxicity for pesticides, ensuring that it is protective of public
health, workable, and flexible for making timely regulatory decisions.
If a pesticide shares a common toxicological endpoint and structural
similarity with other substances, EPA will assume that a common
mechanism of toxicity may exist. For such pesticides, any approvals
will be time limited or conditional. As the Agency's understanding of
common mechanism of toxicity increases, it will revisit such time
limited or conditional decisions.
Making Interim Regulatory Decisions
The decision logic for aggregate and cumulative risk, as
described above, applies when EPA lacks data to estimate specific
exposures from the various routes. If data were submitted which
permitted a more precise estimate of exposure from a particular
source, that information would be used to assign the appropriate
portion of the risk cup for that source, rather than the more general
default assumption. Further, if a registration or reregistration
action did not pass the decision logic screen, additional data could
be used to reassess the risk or risk mitigation measures could be
adopted which could lower the risk sufficiently to grant the action.
Using this interim decision logic, EPA is making regulatory
decisions on pending actions, and registrants can now submit
applications as instructed in the Appendices of this PR Notice. Over
time, the decision logic will be revised and updated as new exposure
data are generated. The interim decisions made will also be
revisited, as necessary, based on new information and/or new
methodologies.
VI. NEXT PR NOTICES
EPA places a very high priority on the development of new
policies and procedures to implement the new law quickly and
efficiently and to achieve its pre-enactment pace of regulatory
activities. Even while activities resulting from this PR Notice are
being put in place, work is continuing on many registration and
reregistration activities, and interim decisions are being made.
Biopesticide registration activities have continued although all
pending tolerance actions have to be reannounced to meet the new FQPA
requirements. For chemical pesticides, the Agency intends to issue a
PR Notice requesting that registrants submit their next round of five
priorities within several months. These priorities will include those
required under the new law for minor use pesticides. The Agency also
will be issuing a Notice similar to this one specifically directed to
the minor use registrant community.
As the Agency works on a number of fronts to implement the new
law fully and resume processing of all actions, it will provide
registrants and applicants early and continuous information relating
to their applications and petitions. The Agency also plans to issue a
final document once it has gained significant experience in reviewing
the applications and has put in place appropriate administrative
procedures. The final document will include revised policy decisions
and refinements of the items included in this PR Notice.
VII. FOR FURTHER INFORMATION
For further information, applicants may contact Stephen Johnson,
Director, Registration Division at 703-305-5447; Lois Rossi, Director,
Special Review and Reregistration Division at 703-308-8000; Janet
Andersen, Director, Biopesticides and Pollution Prevention Division at
703-308-8712, or Frank Sanders, Director, Antimicrobials Division at
703-305-5440.
(signed)
Date: 01/31/97 Daniel M. Barolo, Director
Office of Pesticide Programs
APPENDIX A
CONTENT OF SUPPLEMENTAL INFORMATION
As indicated at the beginning of the PR Notice, registrants,
applicants and petitioners are not currently required to submit any
additional information. Nevertheless, since the new statute requires
the Agency to consider additional information in order to make the
necessary decisions, EPA recognizes that many registrants, applicants
and petitioners may wish to provide the supplemental information to
the Agency even without a requirement to do so. For those
registrants, applicants or petitioners who wish to supplement their
original submissions with additional information, this Appendix
describes what information the Agency would consider helpful additions
for its review(*2).
(*2) An agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information
unless it either displays a currently valid OMB control
number or is imposed on the person by statute (5 CFR
1320.6(a)&(e)). The collection of information relating to
the registration, reregistration, and tolerance programs
have are approved under OMB Control Numbers 2070-0024
(expires: 6/30/99); 2070-0032 (expires: 5/3/98); 2070-0040
(expires: 11/30/99); 2070-0060 (expires: 5/31/98); 2070-0122
(expires: 11/30/97); 2070-0107 (expires: 7/31/99). If you
should have any comments on the collection activities,
please send them to the Director, OPPE Regulatory
Information Division, U.S. Environmental Protection Agency
(Mailcode 2137), 401 M St., S.W., Washington, D.C. 20460.
Include the OMB control number in any correspondence. Note
that this address is ONLY for comments on the collection
activity. Do not submit your information to this address.
All tolerances or tolerance exemptions and associated
registration actions under FIFRA section 3 or reregistration actions
under FIFRA section 4, whether pending or future, will need to comply
with the new safety standard of section 408(b)(2) of the Federal
Food, Drug and Cosmetic Act. In addition, because EPA intends to
apply a similar standard to actions involving non-food use pesticides
that may pose significant non-dietary risks to infants and children,
all registration and reregistration actions also will need to comply
with this standard with respect to the Agency's consideration of
infants and children exposure to the pesticide.
In preparing a package to be submitted, those seeking a
registration, reregistration, tolerance, or an exemption from the
requirement of a tolerance for a food use pesticide, or a registration
or reregistration of a non-food use pesticide that may result in
significant exposure to children, may need to provide additional
information and/or materials to address adequately the factors and
specific questions contained here. Those who wish to submit
additional information should keep in mind that the Agency will
consider each factor listed below (and perhaps others as Agency
policies are developed) in addition to any data and information
already required. In addition, it is important to note that the
information identified here may not be definitive in all cases.
Additional information or more detailed information may be needed in
individual cases. If a registrant, applicant, or petitioner can
identify additional information that would assist the Agency in
addressing the FQPA provisions, EPA welcomes such information.
Although the submission of this information is not currently required
by the regulations, if such information is not submitted, the Agency
must rely on previously submitted data, if applicable, or on broad or
default assumptions when considering the factors listed. As a result,
favorable action on an application, petition, or reregistration
decision may be significantly delayed or precluded altogether.
It would be helpful for any submitted documentation to contain a
discussion of each of the following factors as it relates to the
pesticide and proposed tolerance or tolerance exemption. If
information on any factor is not known, that fact, along with an
explanation, should be noted in the rationale. It is important to
note that EPA does not expect the registrant, applicant, or petitioner
at this time to perform any additional testing to derive the data
necessary to develop its rationales. However, if it has in its
possession data from preliminary reports of ongoing studies, articles
from published literature, unpublished report information, previously
unsubmitted studies, or supplemental data that are otherwise pertinent
to the Agency's concerns, the party is encouraged to submit them.
Likewise, if a registrant, applicant, or petitioner believes that a
factor is not applicable to its product, a discussion as to why this
view is held should also be included. The Agency will consider all
relevant factors in determining an application's completeness and in
setting priorities for review.
Based on the new safety standard, EPA will need the following
additional information in order to make appropriate regulatory
decisions: (For details on each factor, please refer to the
explanations below in parts A and B.)
1. An informative summary of the petition or application, including
a summary of the supporting data, information, accompanying
rationales, and a statement providing permission to publish such
summary, and
2. Information and discussion pertaining to a specific safety
determination for infants and children including their special
susceptibilities and exposure patterns to the particular
pesticide.
A. Food Use Pesticides: Registration and Reregistration Actions,
Experimental Use Permits, Tolerance (or
Exemption) Petitions and Reassessments
In the format described in Appendix C of this PR Notice, address
each of the following with respect to the pesticide and its use(s):
Special Sensitivities
a) Chronic Endpoints
For a chemical pesticide: Discuss and/or provide evidence as to
whether or not the current Reference Dose (RfD) is sufficient to
adequately protect infants and children. Discuss and/or provide
evidence as to whether or not infants and children are more
susceptible to the chemical. If you believe that an additional
safety factor of 10X, to take into account potential pre- and
post-natal toxicity to infants and children is not necessary,
provide evidence to support the additional safety factor, if any,
you believe to be more appropriate. Please bear in mind that the
Agency may accept a different margin of safety only if, based on
reliable data, EPA concludes that the margin will be safe for
infants and children.
For a biochemical pesticide: Does the toxicity testing indicate
that the establishment of an RfD is warranted? If so, then
discuss whether or not the RfD is sufficient to adequately
protect infants and children. Discuss and/or provide evidence as
to whether or not infants and children are more susceptible to
the biochemical pesticide.
For a microbial pesticide: Discuss the potential for chronic
dietary risks for infants and children. Discuss and/or provide
evidence as to whether or not infants and children are more
susceptible to the microbial pesticide than is the adult
population.
b) Acute Endpoints
Discuss the potential for greater acute dietary risk for infants
and children. If the chemical or biochemical pesticide
demonstrates acute effects, then discuss the endpoint used to
perform the assessment including relevance to infants and
children and the details as to how the exposure assessment was
conducted and whether the estimated risk is within the Agency's
levels of concern.
c) Carcinogenic Endpoints
If the chemical or biochemical has been determined to be a
carcinogen and has a cancer potency factor (Q1*), discuss the
aggregate excess lifetime cancer risk resulting from exposure to
the chemical from residues in food and drinking water (ground and
surface water) and from residential and other non-occupational
source(s).
Aggregate Exposure
a) Water
For a chemical or biochemical pesticide: Discuss the potential
for the transfer of residues (of both the parent pesticide and
any degradates) to drinking water. The discussion should
include, but not be limited to, information indicating whether
the pesticide is persistent and/or mobile, relevant product
chemistry, and any available modeling data.
Has the chemical or any of its degradates been detected in ground
water or surface water? Would this chemical or any of its
degradates likely pass through primary or secondary drinking
water treatment into finished water? Are any States conducting
water monitoring programs for this pesticide? If so, data
collected by the States and all relevant information should also
be included.
For a microbial pesticide: Discuss the potential for the
transfer of the microbial pesticide to drinking water. The
discussion should include, but not be limited to, information
pertaining to the biology of the microorganism, and indicating
whether the pesticide is persistent and/or mobile or has the
potential for transport in air (spray drift and volatility data).
Are any States conducting water monitoring programs for this
strain? If so, data collected by the States and all other
relevant information should also be included.
b) Non-occupational Exposures
Discuss the potential for significant exposure to the pesticide
of children by routes other than dietary. Are there any
non-occupational, structural, or residential uses (e.g., pet,
swimming pool, lawn and garden, or topical insect repellent)? Is
the pesticide used in or around schools, parks, or recreation
facilities? Provide all available exposure data. If the
pesticide demonstrates acute effects, then discuss the endpoint
used to perform the assessment, including relevance to infants
and children and the details of how the residential exposure
assessment was conducted and whether the estimated risk is within
the Agency's levels of concern.
c) Multiple Pathway Assessment
Discuss the chronic and/or acute risk of aggregate exposure via
multiple pathways for the general population, and for infants and
children. This should include a discussion of all assumptions
used and uncertainties. You should also identify, and include in
the discussion, any non-pesticidal uses of the chemical (e.g.,
industrial, pharmaceutical, cosmetic, food additive).
Cumulative Effects
Discuss the mechanism and mode of action of this pesticide.
Identify other chemicals that may fall into this category (both
pesticide and non-pesticide chemicals). Provide information
regarding common mechanisms and modes of action with other
chemical substances based on structural similarity, same or
similar endpoints, and other relevant criteria. Provide any data
and/or evidence illustrating similarities at the
cellular/molecular level.
Discuss the appropriateness of combining exposures in this
particular case. Where data are not available, discuss
appropriateness of using default assumptions and what defaults
should be used.
Endocrine Effects
Discuss and provide any evidence relevant to the possibility that
the pesticide may have endocrine disrupter effects individually
or in combination with another chemical. Include the potential
for synergistic effects of your chemical in combination with
other chemicals.
Identify any instances of reported (proven or alleged) adverse
reproductive or developmental effects to domestic animals or
wildlife as a result of exposure to your chemical, or that
occurred in an area where the chemical is known to have been
used. Provide all information regarding the circumstances,
estimated level of exposure, and details of the effect.
Residue Chemistry
Information should include a discussion of compatibility with
established Codex Alimentarius Commission Maximum Residue Levels
(MRLs), submission of a practical analytical method with an
appropriate limit of detection, and a discussion of the potential
need for tolerances for processed foods. For tolerance exemption
petitions, indicate if the chemical is on the Food and Drug
Administration's Generally Recognized As Safe (GRAS) list. A
summary of all tolerances and exemptions from tolerance being
proposed should also be included.
Benefits Information (For Reregistration Actions Only)
If the information and data submitted indicate that an existing
tolerance, reviewed according to the requirements of the new
legislation, should be determined to be unsafe (that is, to exceed the
"reasonable certainty of no harm" standard), the new law allows EPA to
consider pesticide benefits information in certain instances. An
"eligible pesticide chemical residue" (for which an "eligible
tolerance" may be applicable) is defined as a chemical residue for
which
1) EPA is unable to identify a level of exposure that will not
cause or contribute to a known or anticipated harm to human
health (that is, the effect is a non-threshold effect);
2) an appropriate quantitative risk assessment for the lifetime
risk of the non-threshold effect has been determined; and
3) if there are also threshold effects associated with the
chemical, EPA is able to identify a level at which the residue
will not cause any known or anticipated harm to human health and
that the level of aggregate exposure is safe.
Registrants who suspect that an existing tolerance for their
chemical, which has been classified by the Agency as exhibiting a
non-threshold effect, may exceed the new safety standard, and wish the
Agency to consider an eligible tolerance for residues of that
pesticide, may need to submit the following information:
Conditions Regarding the Use of the Pesticide
Information and/or data indicating that the use of the pesticide
chemical that produces the residue protects consumers from
adverse health effects that would pose a greater risk than the
dietary risk from the residue, OR
Information and/or data showing that the use of the pesticide
chemical that produces the residue is necessary to avoid a
significant disruption in the domestic production of an adequate,
wholesome, and economic food supply.
Conditions Regarding the Risk of a Pesticide
Evidence that the yearly risk associated with the nonthreshold
effect from aggregate exposure to the residue is not greater than
ten times the yearly risk allowed under the new safety standard,
AND
Evidence that the tolerance is limited to ensure that the
lifetime risk associated with the nonthreshold effect from
aggregate exposure to the residue is not greater than twice the
lifetime risk allowed under the new safety standard.
It is important to note that the above information does not
supersede any existing benefits requirements under FIFRA, such as
public health pests and benefits data necessary for a public interest
finding under FIFRA section (3)(c)(7).
B. Non-Food Use Pesticides: Registration or Reregistration Actions
In the format described in Appendix C of this PR Notice, address
each of the following with respect to the pesticide and its use(s):
Potential for Exposure to Children
Describe the use pattern of your chemical. If you believe that
its use(s) would not potentially result in significant exposure
to infants and children, provide a discussion and rationale as to
why this view is held. For chemicals that appear not to result
in a significant exposure to infants and children, no additional
information is needed.
If you believe that the use of your chemical may result in significant
children's exposure, the following factors may need to be addressed:
Special Sensitivities
Discuss and/or provide evidence as to whether or not infants and
children are more susceptible to the chemical than adults.
Discuss the potential for greater acute and/or chronic risk for
infants and children. If the pesticide demonstrates toxic
effects, then discuss the endpoint used to perform the assessment
including relevance to infants and children and the details as to
how the exposure assessment was conducted and whether the
estimated risk is within the Agency's levels of concern.
Aggregate Exposure
Discuss the potential for the transfer of residues of both the
parent chemical and any degradates or of the microbial pesticide
to drinking water. For chemical pesticides, the discussion
should include, but not be limited to, information indicating
whether the pesticide is persistent and/or mobile, the potential
for transport in air (spray drift and volatility data), and any
available modeling data. For microbial pesticides, the
discussion should instead include information pertaining to the
biology of the microorganism and indicate whether the pesticide
is persistent and/or mobile.
Has the chemical or any of its degradates been detected in ground
water or surface water? Would this chemical or any of its
degradates likely pass through primary or secondary drinking
water treatment into finished water? Are any States conducting
water monitoring programs for this pesticide? If so, data
collected by the States and all relevant information should also
be included.
Discuss the potential for significant exposure to the chemical of
children by non-dietary routes. Are there non-occupational,
structural, or residential uses (e.g., pet, swimming pool, lawn
and garden, or topical insect repellents)? Is the pesticide used
in or around schools, parks, or recreation facilities? Provide
all available exposure data.
Discuss the chronic and/or acute risk of aggregate exposure via
multiple pathways for the general population, infants and
children should include a discussion of all assumptions used and
uncertainties.
Identify other non-pesticidal uses of the chemical (e.g.,
industrial, pharmaceutical, cosmetic, food additive).
Cumulative Effects
Discuss the mechanism and mode of action of this pesticide.
Identify other chemicals that may fall into this category (both
pesticide and non-pesticide chemicals). Provide information
regarding common mechanisms and modes of action with other
chemical substances based on structural similarity, same or
similar endpoints, and other relevant criteria. Provide any data
and/or evidence illustrating similarities at the
cellular/molecular level.
Discuss the appropriateness of combining exposures in this
particular case. Where data are not available, discuss
appropriateness of using default assumptions and what defaults
should be used.
Endocrine Effects
Discuss and provide any evidence relevant to the possibility that
the chemical may have endocrine disrupter effects individually or
in combination with another chemical. Include the potential for
synergistic effects of your chemical in combination with other
chemicals and whether or not your chemical could act as a
catalyst for another hormone-disrupting chemical.
Identify any instances of reported (proven or otherwise) adverse
reproductive or developmental effects to domestic animals or
wildlife as a result of exposure to your chemical, or that
occurred in an area where the chemical is known to has been used.
Provide all information regarding the circumstances, estimated
level of exposure, and details of the effect.
APPENDIX B
INFORMATION NOW BEING ACCEPTED
As mentioned, EPA has developed and is now implementing an
interim strategy for phasing in and applying the requirements of the
new legislation to pending registration and reregistration decisions.
During this period, the Agency will be establishing new policies as
well as revising its current policies and, to the greatest extent
possible, will continue to make regulatory decisions.
A. Submissions Now Being Accepted for Priority Review.
1. Section 18 Emergency Exemptions.
The Agency's first priority is the review of pending section 18
specific and crisis emergency exemptions and the accompanying
determination of whether or not a tolerance can be established
consistent with requirements of the FQPA. A letter has been sent to
the States on October 24, 1996, which explains what additional
materials and information the Agency must consider in order to make a
tolerance decision. EPA is currently accepting supplemental
information for all pending requests for section 18 actions and for
all new emergency exemption requests.
2. Time-Limited Tolerances and Registrations.
EPA will also give top priority to the review of expiring time-limited
tolerances, inert ingredient tolerances or exemption requests, and
registrations that have expired or will expire by January 30, 1997.
Registrants of these uses have been notified by the Agency that they
should address the FQPA factors and must have submitted the
information by October 1, 1996, and that the additional materials must
have been submitted either in the form of a tolerance petition and/or
a registration amendment. The Agency will continue to accept any
supplemental information relative to these actions, but cannot
guarantee a decision before the expiration date of existing
time-limited tolerances.
3. Reduced Risk Pesticides.
Work will continue on all pending and any new food use registration
requests for active ingredients and tolerances that are submitted in
conjunction with the Agency's Reduced Risk Program. For priority
review, these applications must clearly meet the new statutory
standard of reasonable certainty of no harm, especially as it relates
to special subpopulations, such as children. The Agency is currently
accepting supplemental information for all pending (food and non-food
use) reduced risk applications, and is also accepting new registration
applications for reduced risk active ingredients or new food uses of
existing pesticides registered under the reduced risk program. All
pending tolerances for these affected actions will need to be refiled
regardless of whether the Agency has published a Notice of Filing
prior to August 3, 1996.
4. Biological Pesticides.
Priority will also be given to the review of biochemical and microbial
pesticide active ingredients, tolerances, or exemptions from
tolerance. For biopesticides, a complete package is required before a
pending review can be completed. The Biopesticides and Pollution
Prevention Division will continue to review pending applications and
does not intend to reprioritize the in-house applications based on
submitted information. The Agency is currently accepting supplemental
information for all pending (food and non-food use) biopesticide
applications and is also accepting any new applications for new
biopesticide active ingredients for both food and non-food use
registrations. All pending tolerances for these affected actions will
need to be refiled regardless of whether the Agency has published a
Notice of Filing prior to August 3, 1996.
5. Planned Priority System Actions.
Consistent with the priorities identified in items 1-4, the Agency is
now resuming work on the review of all in-house actions for which a
human health risk assessment was completed by August 3, 1996, but
further assessment is now required due to the passage of the FQPA.
These include actions that were submitted as part of the Agency's
current planned priority system, which includes new active
ingredients, significant new food uses, and inert tolerances or
exemption requests. Registrants should be aware of the status of
their affected applications. All pending tolerances for these
affected actions will need to be refiled regardless of whether the
Agency has published a Notice of Filing prior to August 3, 1996.
B. Other Submissions Now Being Accepted for Pending Actions
Registrants and applicants may now submit the supplemental
information outlined in this Notice for all other actions that are
currently pending within the Agency. These types of submissions
include, but are not limited to:
1. Pending Applications.
Supplemental information may be submitted for registration
applications of new chemical or new uses of existing chemical that
were submitted to the Agency before August 3, 1996. These include any
pending food use applications and tolerance petitions, non-food uses
with the potential for significant children's exposure, and for
chemical pesticide registration actions requiring a human health risk
assessment.
2. Reregistration.
Work has resumed on the pesticide chemical cases scheduled for
reregistration eligibility decisions in FY 1997. The Agency is
finalizing its list of chemicals for '97 REDs and will be notifying
affected registrants by letter. Supplemental information should be
submitted for these chemical cases only. As required by FQPA, EPA
will be focusing its efforts on groups of chemicals, such as the
organophosphates, carbamates and B2 carcinogens. In order for EPA to
most effectively utilize the information, however, and not be put in a
position requiring reliance on broad assumptions and default
judgements, registrants are advised to submit the information in a
timely fashion.
C. Submissions Which Will Receive Lower Priority at this Time
1. New Applications.
In the interest of greatest efficiency, for both the Agency and
registrants, the Agency would prefer that registrants continue to hold
applications for new pesticide chemical registration and tolerance
actions, except for Emergency Exemptions, Reduced Risk and Biological
Pesticides, and time-Limited Tolerances and Registrations, as outlined
in section A above. EPA expects to issue another PR Notice in March,
which will update information about our priorities and request the
next group of registrants' priorities. While the Agency will not
refuse to accept a complete registration application package
(including the supplemental information outlined in this notice) for
any new chemical pesticide or new use of an existing chemical
pesticide, EPA encourages the registrants to await the March notice.
If a submission is made, it must be one of the registrant's next five
priorities (Registration Priority Actions 11-15). Given our current
priority workload and in fairness to all registrants, if such an
application is received, it will not be placed in the priority queue
until the Agency is able to schedule all of the Registration Priority
Actions 11-15.
2. Reregistration.
Recognizing that the FQPA did not amend the FIFRA Section 4
reregistration deadlines, registrants for future (FY 1998 and beyond)
RED chemicals should continue to satisfy existing data requirements
and be ready to submit required information as soon as it is requested
by the Agency.
APPENDIX C
FORMATTING AND SUBMITTAL PROCEDURES
A. Format
If, as a registrant or applicant, you choose to submit
information, please provide a separate FQPA Supplemental Information
Document on a floppy disc WordPerfect 5.1 format. For pending
registration applications, tolerance, or tolerance exemption petitions
that must be refiled, and for applicable reregistration actions
scheduled for FY 97 eligibility decisions, all additional information
required by FQPA should be submitted according to this Notice. This
information is in addition to, and does not substitute for, data and
information already required under FIFRA or FFDCA. The Transmittal
Letter must include a statement that the petitioner agrees that the
summary or any information it contains may be published as a part of
the Agency's notice of filing of the petition and as part of a
proposed or final regulation. The Supplemental Information Document
(Part II - Statutory Findings and Information Summary--see below) and
any supporting data must comply with PR Notice 86-5 formatting
requirements.
As mentioned, the Agency is not requiring any additional testing
at this time. If a registrant or applicant chooses to submit
additional information, the Agency would appreciate it if the
applicant or registrant could submit the information in support of
their new or pending actions in the format outlined below.
I. Transmittal Letter
II. Statutory Findings and Information Summaries
1. Executive Summary
2. Background Information and Use profile
3. Risk Assessment and Statutory Findings
a) Toxicology Profile
(I) Data Summary
(ii) Acute Toxicity
(iii)Developmental/Reproductive Effects
(iv) Chronic Effects
(v) Carcinogenicity
(vi) Endocrine Effects
b) Aggregate Exposure
(I) Dietary Exposure
(ii) Drinking Water Exposure
(iii)Non-occupational Exposure
c) Cumulative Risk
d) Safety Determination
(I) U.S. General Population
(ii) Infants and Children
e) Other Considerations
4. Residue Chemistry Data Summary
a) Residues in the Raw Agricultural Commodity and
Processed Food/Feed
b) List International Tolerances (Codex MRLs)
c) Practical Analytical Method
d) List of All Pending Tolerances and Exemptions
5. Environmental Fate Data Summary
6. Benefits Information (only applicable to chemicals
identified in section VI)
III. Supporting Evidence and Data
B. Submittal Procedures
For actions that are currently pending within the Agency,
registrants and applicants are directed to indicate in the Transmittal
Letter the appropriate Agency pending registration number, the
petition number, or the reregistration case number, which the
supplemental information submission supports. This procedure will
enable the Agency to identify easily the supplemental information and
link it with the appropriate pending action. Registrants and
applicants are asked to submit their documentation on a floppy disc
using WordPerfect 5.1 format.
Submissions should be directed to the OPP Document Processing
Desk and must include the following distribution code: (FQPA
Supplemental Information).
By mail, submission packages should be sent to OPP at the following
address:
Document Processing Desk (FQPA Supplemental Information)
Office of Pesticide Programs - 7504C
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, DC 20460-0001
By personal or courier delivery, submissions (with appropriate
distribution code) should be brought to the Document Processing Desk
between the hours of 8:00 a.m. and 4:00 p.m., Monday through Friday,
excluding federal holidays. OPP's Document Processing Desk is located
at the following address:
Office of Pesticide Programs (FQPA Supplemental Information)
Room 266A, Crystal Mall No. 2
1921 Jefferson Davis Highway
Arlington, Virginia