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Pesticide Registration

PRN 97-1: Agency Actions under the 

Requirements of the Food Quality Protection 

Act

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

On This Page

I. Inroduction

II. Applicability

III. Effective Date

IV. Background

V. Interim Approach To Risk Management

VI. Next PR Notices

VII. For Further Information

VIII. Appendix A

IX. Appendix B

I. Inroduction

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.

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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

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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 nonoccupational 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, 

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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 

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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 nonoccupational 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 noncancer 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.

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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

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VIII. Appendix A

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.

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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.

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):

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

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A. Food Use Pesticides: Registration and Reregistration Actions, Experimental Use 

Permits, Tolerance (or Exemption) Petitions and Reassessments

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 nonoccupational source(s).

Aggregate Exposure

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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

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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.

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 nonthreshold effect);

2. an appropriate quantitative risk assessment for the lifetime risk of the nonthreshold 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.

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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.

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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 nondietary 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.

IX. Appendix B

Information Now Being Accepted

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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.

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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.

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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.

X. 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.

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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.

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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

Last updated on February 11, 2015

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