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Notices Pesticide Registration (PR) Notice 97-1 

Pesticide Registration (PR) Notice 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 

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 

Resources 

Pesticide Registration 

Notices 

Pesticides: Regulating Pesticides 

http://www.epa.gov/PR_Notices/pr97-1.html

Last updated on Wednesday, May 09, 2012

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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 

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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 

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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 

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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 

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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 

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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

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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. 

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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

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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

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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.

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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. 

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

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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

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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

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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

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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 

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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 

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