PESTICIDE REGISTRATION (PR) NOTICE 97-1

NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS, AND

REGISTRANTS OF PESTICIDE PRODUCTS

ATTENTION: Persons Responsible for the Registration and

Reregistration of Pesticides

SUBJECT: Agency Actions under the Requirements of the Food

Quality Protection Act

I. INTRODUCTION

The Food Quality Protection Act of 1996 (FQPA) requires the

Environmental Protection Agency (EPA) to consider new factors when

making pesticide regulatory decisions. Registrants, applicants, or

petitioners for pesticide product registrations or reregistrations, or

for tolerances or tolerance exemptions, whether pending or future, are

advised to consider comprehensively the provisions contained in the

Food Quality Protection Act (FQPA), specifically the factors relevant

to aggregate exposure assessment, children\'s exposure, and other

issues raised by the new statutory standard. This PR Notice explains

to registrants how EPA will, on an interim basis, implement the new

statutory provisions.

Although this PR Notice does not require registrants to submit

any additional information, the Agency recognizes that because the

Agency is required to consider additional information in order to make

the necessary decisions, many registrants, applicants and petitioners

may wish to provide the supplemental information to the Agency even

without a requirement to do so. The Agency has already received a

number of requests for information about the type of information that

the Agency will need to consider under the new statutory provisions,

as well as instructions for ensuring that the proper requests are

updated with any supplemental information the registrant, applicant or

petitioner wishes the Agency to consider. For those registrants,

applicants or petitioners who wish to supplement their original

submissions with additional information, the Appendices to this Notice

describe what information the Agency would consider helpful, when and

how material may be submitted to allow for the most efficient

processing and review(\*1).

(\*1) The collection of information related to the

registration, reregistration, and tolerance programs has

been approved by the Office of Management and Budget (OMB)

pursuant to the Paperwork Reduction Act under OMB Control

Numbers 2070-0024; 2070-0032; 2070-0040; 2070-0060; 2070-

0122; 2070-0107. These approvals cover the original

submissions by the registrant, applicant or petitioner. In

addition, EPA believes that the discussions within these

existing Information Collection Requests also serve to cover

any registrant\'s voluntary submission of information

intended to supplement their original submissions.

II\. APPLICABILITY

This Notice applies to most applicants with registration

applications, non-crop-destruct experimental use permit applications,

tolerance or tolerance exemption petitions, or reregistration

eligibility decisions pending within the Agency. It also applies to

most future applicants seeking new or amended pesticide registrations.

This Notice includes all actions for synthetic chemicals,

antimicrobials, biochemical and microbial pesticides. Those who may

be affected are pesticide manufacturing companies, Interregional

Research Project No. 4 (IR-4) petitioners, and other third party

registrants. This Notice, however, does not apply to applicants

seeking fast track \"me-too\" registrations or amendments not involving

new uses.

Although the new standard in FQPA is clearly applicable to food

use pesticides and chemicals related to such pesticides, EPA intends

to apply a similar standard to actions involving non-food use

pesticides that may pose significant non-dietary risks to infants and

children.

III\. EFFECTIVE DATE

This PR Notice is effective immediately.

IV\. BACKGROUND

On August 3, 1996, the Food Quality Protection Act was signed

into law. Effective upon signature, the new statute significantly

amended the Federal Insecticide, Fungicide, and Rodenticide Act

(FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA). It was

designed, among other things, to provide increased protection for

infants and children from pesticide risks.

FQPA

Title IV of the statute amends the Federal Food, Drug and

Cosmetic Act. The most important aspect of this title is the

establishment of a single, health-based standard for setting pesticide

residue tolerances. This eliminates the longstanding problems posed

by different standards for pesticides in raw and processed foods. The

provision removes the requirement of food additive tolerances for

processed foods and instead regulates them all under the same

tolerance provision. A tolerance (or exemption from tolerance) for a

pesticide residue on a raw agricultural commodity (RAC) also applies

to residues in a processed food derived from the RAC that are not

higher than the RAC tolerance. If the levels in the processed food

are higher, a separate tolerance must be set for that processed food.

Residue levels in both the RAC and the processed food must be

determined by EPA to be \"safe.\"

The new safety standard, provided in section 408(b)(2)(A)(ii) of

the statute, is a \"reasonable certainty of no harm\" standard for

aggregate exposure using dietary residues and all other reliable

exposure information. When setting new or reassessing existing

tolerances or tolerance exemptions under the new standard, EPA must

now focus explicitly on exposures and risks to children and infants.

EPA must, 1) explicitly determine that the tolerance, or exemption

from tolerance, is safe for children; 2) consider the need for an

additional safety factor of up to ten-fold to account for uncertainty

in the data base relative to children unless there is evidence that a

different factor should be used; and 3) consider children\'s special

sensitivities and often unique exposure patterns to pesticides.

In addition, when making a determination as to whether or not

there is a reasonable certainty that a pesticide chemical will cause

\"no harm,\" EPA must now consider other non-occupational sources of

pesticide exposure when performing risk assessments and setting

tolerances. This includes dietary exposure from drinking water,

non-occupational exposure, exposure from like pesticides that share a

common mechanism of toxicity as well as other exposure scenarios.

When setting new or reassessing existing tolerances and tolerance

exemptions, EPA must also evaluate the potential for endocrine

disruption. The new law directs the Agency to use its authority to

require specific tests and information on estrogenic effects for all

pesticide chemical residues.

Initial Communication to Registrants

EPA began the task of implementing the requirements of the FQPA

by explaining its goals and immediate plans in a letter sent August

21, 1996, to all current pesticide manufacturers, grower and other

pesticide user groups, industry, environmental, consumer, and public

interest groups. A second letter, containing more detailed

information, was sent on September 6, to all holders of pesticide

registrations. In its September 6 letter, the Agency stressed that

work was continuing on many registration and reregistration activities

and that interim decisions were being made. However, to ensure

compliance with the new law\'s provisions to protect against pesticide

uses which may pose unacceptable risks to children, additional time

was needed to adequately review certain applications, especially food

use applications. A letter has been sent to the States outlining the

additional materials and information needed to make section 18

emergency exemption tolerance decisions.

Program Implementation - Status of Food Use Phase-in Process

To deal with day-to-day decisions and procedural changes that

must occur, EPA has identified key implementation processes on which

to focus for all of the food and tolerance provisions of the Act. One

area of immediate concern is phasing-in and applying the new

requirements to currently pending registration, reregistration, and

tolerance decisions. The Agency is inventorying all pending actions,

and sorting them according to the applicable requirements of FQPA.

The Agency estimates that there are more than a thousand actions

pending at various stages of review. The inventory of all the

registration priority actions, biopesticide actions, and scheduled

reregistration actions is almost complete. Criteria for ranking the

inventory are being developed and, once actions are ranked, a process

for handling each category will be devised and put into place.

V. INTERIM APPROACH TO RISK MANAGEMENT

The Food Quality Protection Act does not provide an explicit

transition or phase-in period for many of the new requirements in the

law. Some of the new requirements call for scientific analyses which

have not been part of EPA\'s current risk assessment procedures. For

example, traditionally EPA has assessed pesticide exposures separately

by source and has not combined risks. Developing methodologies to

address these issues requires a new way of approaching risk assessment

and risk management.

While FQPA did not specify time frames for phasing in most of

these provisions (with the exceptions of the 3-year time frame for

developing a plan to assess endocrine effects, 1 year to develop an

antimicrobial program, and a few others), the law contains sufficient

flexibility to allow for a transition period while EPA develops new,

long-term assessment practices. Congress, in discussions regarding

the law, has confirmed this flexibility. EPA\'s goal even during this

interim period is to fulfill the intent of the new law to increase the

protectiveness of its regulatory process. While it is necessary to

develop new assessment procedures and policies to implement the new

requirements to the fullest, the Agency also needs to make timely

decisions about the use of pesticide products. Delaying decisions

does not achieve greater health protection and, in some instances, can

cause harm. An interim decision logic allows decisions to be made now

which are protective, more economic of resources, and which can be

revisited as knowledge increases. EPA has designed an interim

strategy to meet the new FQPA reasonable certainty of no harm standard

in the absence of full data and fully developed exposure and risk

assessment methodologies.

Interim Decision Logic for Aggregate Exposure

The Agency\'s interim decision logic is a screening process for

making regulatory decisions that are protective of public health and

are workable within the current risk assessment practices with

available data and methodologies. It also is designed to be flexible

so that when actual data are submitted, earlier assumptions can be

easily replaced with new information. Outcomes, at least initially,

will be conservative and any approvals will most likely result in time

limited or conditional decisions. As additional exposure data and

improved methods and models are developed, decisions based on the

interim logic will be revisited and modified as appropriate.

The new law says the Agency must now consider aggregate exposures

from dietary and non-occupational sources when assessing the risks of

a chemical and setting tolerances. In addition to dietary exposure,

such sources as drinking water, residential and lawn care use need to

be considered. For most pesticides, EPA has insufficient information

on specific exposures through these routes. While new data are being

generated and new exposure models developed, EPA will estimate the

exposure components and risk, and allocate portions of that total

aggregate risk to drinking water, and residential and lawn use

exposures (provided the pesticide is to be used indoors or on lawns).

The remainder of the aggregate risk will be allocated to dietary

exposure.

\"The Risk Cup\"

EPA\'s interim decision logic is based on the concept that the

total level of acceptable risk to a pesticide is represented by the

pesticide\'s Reference Dose (RfD). This is the level of exposure to a

specific pesticide that a person could receive every day over a

seventy-year period without significant risk of a long-term or chronic

non-cancer health effect. The analogy of a \"risk cup\" is being used

to describe aggregate exposure estimates. The full cup represents the

total RfD and each use of the pesticide contributes a specific amount

of exposure that adds a finite amount of risk to the cup. As long as

the cup is not full, meaning that the combined total of all estimated

sources of exposure to the pesticide has not reached 100% of the RfD,

EPA can consider registering additional uses and setting new

tolerances. If it is shown that the risk cup is full, no new uses

could be approved until the risk level is lowered. This can be done

by the registrant providing new data which more accurately represent

the risk or by implementing risk mitigation measures. While this

explanation is focused on chronic non-cancer risk, the Agency will use

a similar logic to assess acute risk and cancer risk.

The important issue for making interim decisions which take

aggregate exposure into account is how much of the \"risk cup\" should

be set aside or reserved for sources of possible exposure for which

the Agency has limited or no actual data. Unless actual exposure data

are available for these non-dietary pathways, the size of the

\"reserve\" portion will be based on various characteristics of the

pesticide, such as toxicity, mobility and persistence in soils, and

use pattern. It has been decided that, in general, between 5% and 20%

of the risk cup will be set aside for non-dietary exposures. The

remainder of the risk cup will be left for dietary risk for which

reliable data are available.

Interim Decision Logic for Common Mechanism of Toxicity

Similar to the decision logic for aggregate exposure, the Agency

has developed a conservative approach for assessing a common mechanism

of toxicity for pesticides, ensuring that it is protective of public

health, workable, and flexible for making timely regulatory decisions.

If a pesticide shares a common toxicological endpoint and structural

similarity with other substances, EPA will assume that a common

mechanism of toxicity may exist. For such pesticides, any approvals

will be time limited or conditional. As the Agency\'s understanding of

common mechanism of toxicity increases, it will revisit such time

limited or conditional decisions.

Making Interim Regulatory Decisions

The decision logic for aggregate and cumulative risk, as

described above, applies when EPA lacks data to estimate specific

exposures from the various routes. If data were submitted which

permitted a more precise estimate of exposure from a particular

source, that information would be used to assign the appropriate

portion of the risk cup for that source, rather than the more general

default assumption. Further, if a registration or reregistration

action did not pass the decision logic screen, additional data could

be used to reassess the risk or risk mitigation measures could be

adopted which could lower the risk sufficiently to grant the action.

Using this interim decision logic, EPA is making regulatory

decisions on pending actions, and registrants can now submit

applications as instructed in the Appendices of this PR Notice. Over

time, the decision logic will be revised and updated as new exposure

data are generated. The interim decisions made will also be

revisited, as necessary, based on new information and/or new

methodologies.

VI\. NEXT PR NOTICES

EPA places a very high priority on the development of new

policies and procedures to implement the new law quickly and

efficiently and to achieve its pre-enactment pace of regulatory

activities. Even while activities resulting from this PR Notice are

being put in place, work is continuing on many registration and

reregistration activities, and interim decisions are being made.

Biopesticide registration activities have continued although all

pending tolerance actions have to be reannounced to meet the new FQPA

requirements. For chemical pesticides, the Agency intends to issue a

PR Notice requesting that registrants submit their next round of five

priorities within several months. These priorities will include those

required under the new law for minor use pesticides. The Agency also

will be issuing a Notice similar to this one specifically directed to

the minor use registrant community.

As the Agency works on a number of fronts to implement the new

law fully and resume processing of all actions, it will provide

registrants and applicants early and continuous information relating

to their applications and petitions. The Agency also plans to issue a

final document once it has gained significant experience in reviewing

the applications and has put in place appropriate administrative

procedures. The final document will include revised policy decisions

and refinements of the items included in this PR Notice.

VII\. FOR FURTHER INFORMATION

For further information, applicants may contact Stephen Johnson,

Director, Registration Division at 703-305-5447; Lois Rossi, Director,

Special Review and Reregistration Division at 703-308-8000; Janet

Andersen, Director, Biopesticides and Pollution Prevention Division at

703-308-8712, or Frank Sanders, Director, Antimicrobials Division at

703-305-5440.

(signed)

Date: 01/31/97 Daniel M. Barolo, Director

Office of Pesticide Programs

APPENDIX A

CONTENT OF SUPPLEMENTAL INFORMATION

As indicated at the beginning of the PR Notice, registrants,

applicants and petitioners are not currently required to submit any

additional information. Nevertheless, since the new statute requires

the Agency to consider additional information in order to make the

necessary decisions, EPA recognizes that many registrants, applicants

and petitioners may wish to provide the supplemental information to

the Agency even without a requirement to do so. For those

registrants, applicants or petitioners who wish to supplement their

original submissions with additional information, this Appendix

describes what information the Agency would consider helpful additions

for its review(\*2).

(\*2) An agency may not conduct or sponsor, and a person is

not required to respond to, a collection of information

unless it either displays a currently valid OMB control

number or is imposed on the person by statute (5 CFR

1320.6(a)&(e)). The collection of information relating to

the registration, reregistration, and tolerance programs

have are approved under OMB Control Numbers 2070-0024

(expires: 6/30/99); 2070-0032 (expires: 5/3/98); 2070-0040

(expires: 11/30/99); 2070-0060 (expires: 5/31/98); 2070-0122

(expires: 11/30/97); 2070-0107 (expires: 7/31/99). If you

should have any comments on the collection activities,

please send them to the Director, OPPE Regulatory

Information Division, U.S. Environmental Protection Agency

(Mailcode 2137), 401 M St., S.W., Washington, D.C. 20460.

Include the OMB control number in any correspondence. Note

that this address is ONLY for comments on the collection

activity. Do not submit your information to this address.

All tolerances or tolerance exemptions and associated

registration actions under FIFRA section 3 or reregistration actions

under FIFRA section 4, whether pending or future, will need to comply

with the new safety standard of section 408(b)(2) of the Federal

Food, Drug and Cosmetic Act. In addition, because EPA intends to

apply a similar standard to actions involving non-food use pesticides

that may pose significant non-dietary risks to infants and children,

all registration and reregistration actions also will need to comply

with this standard with respect to the Agency\'s consideration of

infants and children exposure to the pesticide.

In preparing a package to be submitted, those seeking a

registration, reregistration, tolerance, or an exemption from the

requirement of a tolerance for a food use pesticide, or a registration

or reregistration of a non-food use pesticide that may result in

significant exposure to children, may need to provide additional

information and/or materials to address adequately the factors and

specific questions contained here. Those who wish to submit

additional information should keep in mind that the Agency will

consider each factor listed below (and perhaps others as Agency

policies are developed) in addition to any data and information

already required. In addition, it is important to note that the

information identified here may not be definitive in all cases.

Additional information or more detailed information may be needed in

individual cases. If a registrant, applicant, or petitioner can

identify additional information that would assist the Agency in

addressing the FQPA provisions, EPA welcomes such information.

Although the submission of this information is not currently required

by the regulations, if such information is not submitted, the Agency

must rely on previously submitted data, if applicable, or on broad or

default assumptions when considering the factors listed. As a result,

favorable action on an application, petition, or reregistration

decision may be significantly delayed or precluded altogether.

It would be helpful for any submitted documentation to contain a

discussion of each of the following factors as it relates to the

pesticide and proposed tolerance or tolerance exemption. If

information on any factor is not known, that fact, along with an

explanation, should be noted in the rationale. It is important to

note that EPA does not expect the registrant, applicant, or petitioner

at this time to perform any additional testing to derive the data

necessary to develop its rationales. However, if it has in its

possession data from preliminary reports of ongoing studies, articles

from published literature, unpublished report information, previously

unsubmitted studies, or supplemental data that are otherwise pertinent

to the Agency\'s concerns, the party is encouraged to submit them.

Likewise, if a registrant, applicant, or petitioner believes that a

factor is not applicable to its product, a discussion as to why this

view is held should also be included. The Agency will consider all

relevant factors in determining an application\'s completeness and in

setting priorities for review.

Based on the new safety standard, EPA will need the following

additional information in order to make appropriate regulatory

decisions: (For details on each factor, please refer to the

explanations below in parts A and B.)

1\. An informative summary of the petition or application, including

a summary of the supporting data, information, accompanying

rationales, and a statement providing permission to publish such

summary, and

2\. Information and discussion pertaining to a specific safety

determination for infants and children including their special

susceptibilities and exposure patterns to the particular

pesticide.

A. Food Use Pesticides: Registration and Reregistration Actions,

Experimental Use Permits, Tolerance (or

Exemption) Petitions and Reassessments

In the format described in Appendix C of this PR Notice, address

each of the following with respect to the pesticide and its use(s):

Special Sensitivities

a\) Chronic Endpoints

For a chemical pesticide: Discuss and/or provide evidence as to

whether or not the current Reference Dose (RfD) is sufficient to

adequately protect infants and children. Discuss and/or provide

evidence as to whether or not infants and children are more

susceptible to the chemical. If you believe that an additional

safety factor of 10X, to take into account potential pre- and

post-natal toxicity to infants and children is not necessary,

provide evidence to support the additional safety factor, if any,

you believe to be more appropriate. Please bear in mind that the

Agency may accept a different margin of safety only if, based on

reliable data, EPA concludes that the margin will be safe for

infants and children.

For a biochemical pesticide: Does the toxicity testing indicate

that the establishment of an RfD is warranted? If so, then

discuss whether or not the RfD is sufficient to adequately

protect infants and children. Discuss and/or provide evidence as

to whether or not infants and children are more susceptible to

the biochemical pesticide.

For a microbial pesticide: Discuss the potential for chronic

dietary risks for infants and children. Discuss and/or provide

evidence as to whether or not infants and children are more

susceptible to the microbial pesticide than is the adult

population.

b\) Acute Endpoints

Discuss the potential for greater acute dietary risk for infants

and children. If the chemical or biochemical pesticide

demonstrates acute effects, then discuss the endpoint used to

perform the assessment including relevance to infants and

children and the details as to how the exposure assessment was

conducted and whether the estimated risk is within the Agency\'s

levels of concern.

c\) Carcinogenic Endpoints

If the chemical or biochemical has been determined to be a

carcinogen and has a cancer potency factor (Q1\*), discuss the

aggregate excess lifetime cancer risk resulting from exposure to

the chemical from residues in food and drinking water (ground and

surface water) and from residential and other non-occupational

source(s).

Aggregate Exposure

a\) Water

For a chemical or biochemical pesticide: Discuss the potential

for the transfer of residues (of both the parent pesticide and

any degradates) to drinking water. The discussion should

include, but not be limited to, information indicating whether

the pesticide is persistent and/or mobile, relevant product

chemistry, and any available modeling data.

Has the chemical or any of its degradates been detected in ground

water or surface water? Would this chemical or any of its

degradates likely pass through primary or secondary drinking

water treatment into finished water? Are any States conducting

water monitoring programs for this pesticide? If so, data

collected by the States and all relevant information should also

be included.

For a microbial pesticide: Discuss the potential for the

transfer of the microbial pesticide to drinking water. The

discussion should include, but not be limited to, information

pertaining to the biology of the microorganism, and indicating

whether the pesticide is persistent and/or mobile or has the

potential for transport in air (spray drift and volatility data).

Are any States conducting water monitoring programs for this

strain? If so, data collected by the States and all other

relevant information should also be included.

b\) Non-occupational Exposures

Discuss the potential for significant exposure to the pesticide

of children by routes other than dietary. Are there any

non-occupational, structural, or residential uses (e.g., pet,

swimming pool, lawn and garden, or topical insect repellent)? Is

the pesticide used in or around schools, parks, or recreation

facilities? Provide all available exposure data. If the

pesticide demonstrates acute effects, then discuss the endpoint

used to perform the assessment, including relevance to infants

and children and the details of how the residential exposure

assessment was conducted and whether the estimated risk is within

the Agency\'s levels of concern.

c\) Multiple Pathway Assessment

Discuss the chronic and/or acute risk of aggregate exposure via

multiple pathways for the general population, and for infants and

children. This should include a discussion of all assumptions

used and uncertainties. You should also identify, and include in

the discussion, any non-pesticidal uses of the chemical (e.g.,

industrial, pharmaceutical, cosmetic, food additive).

Cumulative Effects

Discuss the mechanism and mode of action of this pesticide.

Identify other chemicals that may fall into this category (both

pesticide and non-pesticide chemicals). Provide information

regarding common mechanisms and modes of action with other

chemical substances based on structural similarity, same or

similar endpoints, and other relevant criteria. Provide any data

and/or evidence illustrating similarities at the

cellular/molecular level.

Discuss the appropriateness of combining exposures in this

particular case. Where data are not available, discuss

appropriateness of using default assumptions and what defaults

should be used.

Endocrine Effects

Discuss and provide any evidence relevant to the possibility that

the pesticide may have endocrine disrupter effects individually

or in combination with another chemical. Include the potential

for synergistic effects of your chemical in combination with

other chemicals.

Identify any instances of reported (proven or alleged) adverse

reproductive or developmental effects to domestic animals or

wildlife as a result of exposure to your chemical, or that

occurred in an area where the chemical is known to have been

used. Provide all information regarding the circumstances,

estimated level of exposure, and details of the effect.

Residue Chemistry

Information should include a discussion of compatibility with

established Codex Alimentarius Commission Maximum Residue Levels

(MRLs), submission of a practical analytical method with an

appropriate limit of detection, and a discussion of the potential

need for tolerances for processed foods. For tolerance exemption

petitions, indicate if the chemical is on the Food and Drug

Administration\'s Generally Recognized As Safe (GRAS) list. A

summary of all tolerances and exemptions from tolerance being

proposed should also be included.

Benefits Information (For Reregistration Actions Only)

If the information and data submitted indicate that an existing

tolerance, reviewed according to the requirements of the new

legislation, should be determined to be unsafe (that is, to exceed the

\"reasonable certainty of no harm\" standard), the new law allows EPA to

consider pesticide benefits information in certain instances. An

\"eligible pesticide chemical residue\" (for which an \"eligible

tolerance\" may be applicable) is defined as a chemical residue for

which

1\) EPA is unable to identify a level of exposure that will not

cause or contribute to a known or anticipated harm to human

health (that is, the effect is a non-threshold effect);

2\) an appropriate quantitative risk assessment for the lifetime

risk of the non-threshold effect has been determined; and

3\) if there are also threshold effects associated with the

chemical, EPA is able to identify a level at which the residue

will not cause any known or anticipated harm to human health and

that the level of aggregate exposure is safe.

Registrants who suspect that an existing tolerance for their

chemical, which has been classified by the Agency as exhibiting a

non-threshold effect, may exceed the new safety standard, and wish the

Agency to consider an eligible tolerance for residues of that

pesticide, may need to submit the following information:

Conditions Regarding the Use of the Pesticide

Information and/or data indicating that the use of the pesticide

chemical that produces the residue protects consumers from

adverse health effects that would pose a greater risk than the

dietary risk from the residue, OR

Information and/or data showing that the use of the pesticide

chemical that produces the residue is necessary to avoid a

significant disruption in the domestic production of an adequate,

wholesome, and economic food supply.

Conditions Regarding the Risk of a Pesticide

Evidence that the yearly risk associated with the nonthreshold

effect from aggregate exposure to the residue is not greater than

ten times the yearly risk allowed under the new safety standard,

AND

Evidence that the tolerance is limited to ensure that the

lifetime risk associated with the nonthreshold effect from

aggregate exposure to the residue is not greater than twice the

lifetime risk allowed under the new safety standard.

It is important to note that the above information does not

supersede any existing benefits requirements under FIFRA, such as

public health pests and benefits data necessary for a public interest

finding under FIFRA section (3)(c)(7).

B. Non-Food Use Pesticides: Registration or Reregistration Actions

In the format described in Appendix C of this PR Notice, address

each of the following with respect to the pesticide and its use(s):

Potential for Exposure to Children

Describe the use pattern of your chemical. If you believe that

its use(s) would not potentially result in significant exposure

to infants and children, provide a discussion and rationale as to

why this view is held. For chemicals that appear not to result

in a significant exposure to infants and children, no additional

information is needed.

If you believe that the use of your chemical may result in significant

children\'s exposure, the following factors may need to be addressed:

Special Sensitivities

Discuss and/or provide evidence as to whether or not infants and

children are more susceptible to the chemical than adults.

Discuss the potential for greater acute and/or chronic risk for

infants and children. If the pesticide demonstrates toxic

effects, then discuss the endpoint used to perform the assessment

including relevance to infants and children and the details as to

how the exposure assessment was conducted and whether the

estimated risk is within the Agency\'s levels of concern.

Aggregate Exposure

Discuss the potential for the transfer of residues of both the

parent chemical and any degradates or of the microbial pesticide

to drinking water. For chemical pesticides, the discussion

should include, but not be limited to, information indicating

whether the pesticide is persistent and/or mobile, the potential

for transport in air (spray drift and volatility data), and any

available modeling data. For microbial pesticides, the

discussion should instead include information pertaining to the

biology of the microorganism and indicate whether the pesticide

is persistent and/or mobile.

Has the chemical or any of its degradates been detected in ground

water or surface water? Would this chemical or any of its

degradates likely pass through primary or secondary drinking

water treatment into finished water? Are any States conducting

water monitoring programs for this pesticide? If so, data

collected by the States and all relevant information should also

be included.

Discuss the potential for significant exposure to the chemical of

children by non-dietary routes. Are there non-occupational,

structural, or residential uses (e.g., pet, swimming pool, lawn

and garden, or topical insect repellents)? Is the pesticide used

in or around schools, parks, or recreation facilities? Provide

all available exposure data.

Discuss the chronic and/or acute risk of aggregate exposure via

multiple pathways for the general population, infants and

children should include a discussion of all assumptions used and

uncertainties.

Identify other non-pesticidal uses of the chemical (e.g.,

industrial, pharmaceutical, cosmetic, food additive).

Cumulative Effects

Discuss the mechanism and mode of action of this pesticide.

Identify other chemicals that may fall into this category (both

pesticide and non-pesticide chemicals). Provide information

regarding common mechanisms and modes of action with other

chemical substances based on structural similarity, same or

similar endpoints, and other relevant criteria. Provide any data

and/or evidence illustrating similarities at the

cellular/molecular level.

Discuss the appropriateness of combining exposures in this

particular case. Where data are not available, discuss

appropriateness of using default assumptions and what defaults

should be used.

Endocrine Effects

Discuss and provide any evidence relevant to the possibility that

the chemical may have endocrine disrupter effects individually or

in combination with another chemical. Include the potential for

synergistic effects of your chemical in combination with other

chemicals and whether or not your chemical could act as a

catalyst for another hormone-disrupting chemical.

Identify any instances of reported (proven or otherwise) adverse

reproductive or developmental effects to domestic animals or

wildlife as a result of exposure to your chemical, or that

occurred in an area where the chemical is known to has been used.

Provide all information regarding the circumstances, estimated

level of exposure, and details of the effect.

APPENDIX B

INFORMATION NOW BEING ACCEPTED

As mentioned, EPA has developed and is now implementing an

interim strategy for phasing in and applying the requirements of the

new legislation to pending registration and reregistration decisions.

During this period, the Agency will be establishing new policies as

well as revising its current policies and, to the greatest extent

possible, will continue to make regulatory decisions.

A. Submissions Now Being Accepted for Priority Review.

1\. Section 18 Emergency Exemptions.

The Agency\'s first priority is the review of pending section 18

specific and crisis emergency exemptions and the accompanying

determination of whether or not a tolerance can be established

consistent with requirements of the FQPA. A letter has been sent to

the States on October 24, 1996, which explains what additional

materials and information the Agency must consider in order to make a

tolerance decision. EPA is currently accepting supplemental

information for all pending requests for section 18 actions and for

all new emergency exemption requests.

2\. Time-Limited Tolerances and Registrations.

EPA will also give top priority to the review of expiring time-limited

tolerances, inert ingredient tolerances or exemption requests, and

registrations that have expired or will expire by January 30, 1997.

Registrants of these uses have been notified by the Agency that they

should address the FQPA factors and must have submitted the

information by October 1, 1996, and that the additional materials must

have been submitted either in the form of a tolerance petition and/or

a registration amendment. The Agency will continue to accept any

supplemental information relative to these actions, but cannot

guarantee a decision before the expiration date of existing

time-limited tolerances.

3\. Reduced Risk Pesticides.

Work will continue on all pending and any new food use registration

requests for active ingredients and tolerances that are submitted in

conjunction with the Agency\'s Reduced Risk Program. For priority

review, these applications must clearly meet the new statutory

standard of reasonable certainty of no harm, especially as it relates

to special subpopulations, such as children. The Agency is currently

accepting supplemental information for all pending (food and non-food

use) reduced risk applications, and is also accepting new registration

applications for reduced risk active ingredients or new food uses of

existing pesticides registered under the reduced risk program. All

pending tolerances for these affected actions will need to be refiled

regardless of whether the Agency has published a Notice of Filing

prior to August 3, 1996.

4\. Biological Pesticides.

Priority will also be given to the review of biochemical and microbial

pesticide active ingredients, tolerances, or exemptions from

tolerance. For biopesticides, a complete package is required before a

pending review can be completed. The Biopesticides and Pollution

Prevention Division will continue to review pending applications and

does not intend to reprioritize the in-house applications based on

submitted information. The Agency is currently accepting supplemental

information for all pending (food and non-food use) biopesticide

applications and is also accepting any new applications for new

biopesticide active ingredients for both food and non-food use

registrations. All pending tolerances for these affected actions will

need to be refiled regardless of whether the Agency has published a

Notice of Filing prior to August 3, 1996.

5\. Planned Priority System Actions.

Consistent with the priorities identified in items 1-4, the Agency is

now resuming work on the review of all in-house actions for which a

human health risk assessment was completed by August 3, 1996, but

further assessment is now required due to the passage of the FQPA.

These include actions that were submitted as part of the Agency\'s

current planned priority system, which includes new active

ingredients, significant new food uses, and inert tolerances or

exemption requests. Registrants should be aware of the status of

their affected applications. All pending tolerances for these

affected actions will need to be refiled regardless of whether the

Agency has published a Notice of Filing prior to August 3, 1996.

B. Other Submissions Now Being Accepted for Pending Actions

Registrants and applicants may now submit the supplemental

information outlined in this Notice for all other actions that are

currently pending within the Agency. These types of submissions

include, but are not limited to:

1\. Pending Applications.

Supplemental information may be submitted for registration

applications of new chemical or new uses of existing chemical that

were submitted to the Agency before August 3, 1996. These include any

pending food use applications and tolerance petitions, non-food uses

with the potential for significant children\'s exposure, and for

chemical pesticide registration actions requiring a human health risk

assessment.

2\. Reregistration.

Work has resumed on the pesticide chemical cases scheduled for

reregistration eligibility decisions in FY 1997. The Agency is

finalizing its list of chemicals for \'97 REDs and will be notifying

affected registrants by letter. Supplemental information should be

submitted for these chemical cases only. As required by FQPA, EPA

will be focusing its efforts on groups of chemicals, such as the

organophosphates, carbamates and B2 carcinogens. In order for EPA to

most effectively utilize the information, however, and not be put in a

position requiring reliance on broad assumptions and default

judgements, registrants are advised to submit the information in a

timely fashion.

C. Submissions Which Will Receive Lower Priority at this Time

1\. New Applications.

In the interest of greatest efficiency, for both the Agency and

registrants, the Agency would prefer that registrants continue to hold

applications for new pesticide chemical registration and tolerance

actions, except for Emergency Exemptions, Reduced Risk and Biological

Pesticides, and time-Limited Tolerances and Registrations, as outlined

in section A above. EPA expects to issue another PR Notice in March,

which will update information about our priorities and request the

next group of registrants\' priorities. While the Agency will not

refuse to accept a complete registration application package

(including the supplemental information outlined in this notice) for

any new chemical pesticide or new use of an existing chemical

pesticide, EPA encourages the registrants to await the March notice.

If a submission is made, it must be one of the registrant\'s next five

priorities (Registration Priority Actions 11-15). Given our current

priority workload and in fairness to all registrants, if such an

application is received, it will not be placed in the priority queue

until the Agency is able to schedule all of the Registration Priority

Actions 11-15.

2\. Reregistration.

Recognizing that the FQPA did not amend the FIFRA Section 4

reregistration deadlines, registrants for future (FY 1998 and beyond)

RED chemicals should continue to satisfy existing data requirements

and be ready to submit required information as soon as it is requested

by the Agency.

APPENDIX C

FORMATTING AND SUBMITTAL PROCEDURES

A. Format

If, as a registrant or applicant, you choose to submit

information, please provide a separate FQPA Supplemental Information

Document on a floppy disc WordPerfect 5.1 format. For pending

registration applications, tolerance, or tolerance exemption petitions

that must be refiled, and for applicable reregistration actions

scheduled for FY 97 eligibility decisions, all additional information

required by FQPA should be submitted according to this Notice. This

information is in addition to, and does not substitute for, data and

information already required under FIFRA or FFDCA. The Transmittal

Letter must include a statement that the petitioner agrees that the

summary or any information it contains may be published as a part of

the Agency\'s notice of filing of the petition and as part of a

proposed or final regulation. The Supplemental Information Document

(Part II - Statutory Findings and Information Summary\--see below) and

any supporting data must comply with PR Notice 86-5 formatting

requirements.

As mentioned, the Agency is not requiring any additional testing

at this time. If a registrant or applicant chooses to submit

additional information, the Agency would appreciate it if the

applicant or registrant could submit the information in support of

their new or pending actions in the format outlined below.

I. Transmittal Letter

II\. Statutory Findings and Information Summaries

1\. Executive Summary

2\. Background Information and Use profile

3\. Risk Assessment and Statutory Findings

a\) Toxicology Profile

\(I\) Data Summary

\(ii\) Acute Toxicity

(iii)Developmental/Reproductive Effects

\(iv\) Chronic Effects

\(v\) Carcinogenicity

\(vi\) Endocrine Effects

b\) Aggregate Exposure

\(I\) Dietary Exposure

\(ii\) Drinking Water Exposure

(iii)Non-occupational Exposure

c\) Cumulative Risk

d\) Safety Determination

\(I\) U.S. General Population

\(ii\) Infants and Children

e\) Other Considerations

4\. Residue Chemistry Data Summary

a\) Residues in the Raw Agricultural Commodity and

Processed Food/Feed

b\) List International Tolerances (Codex MRLs)

c\) Practical Analytical Method

d\) List of All Pending Tolerances and Exemptions

5\. Environmental Fate Data Summary

6\. Benefits Information (only applicable to chemicals

identified in section VI)

III\. Supporting Evidence and Data

B. Submittal Procedures

For actions that are currently pending within the Agency,

registrants and applicants are directed to indicate in the Transmittal

Letter the appropriate Agency pending registration number, the

petition number, or the reregistration case number, which the

supplemental information submission supports. This procedure will

enable the Agency to identify easily the supplemental information and

link it with the appropriate pending action. Registrants and

applicants are asked to submit their documentation on a floppy disc

using WordPerfect 5.1 format.

Submissions should be directed to the OPP Document Processing

Desk and must include the following distribution code: (FQPA

Supplemental Information).

By mail, submission packages should be sent to OPP at the following

address:

Document Processing Desk (FQPA Supplemental Information)

Office of Pesticide Programs - 7504C

U.S. Environmental Protection Agency

401 M Street, S.W.

Washington, DC 20460-0001

By personal or courier delivery, submissions (with appropriate

distribution code) should be brought to the Document Processing Desk

between the hours of 8:00 a.m. and 4:00 p.m., Monday through Friday,

excluding federal holidays. OPP\'s Document Processing Desk is located

at the following address:

Office of Pesticide Programs (FQPA Supplemental Information)

Room 266A, Crystal Mall No. 2

1921 Jefferson Davis Highway

Arlington, Virginia