Tolerances for Pesticide Emergency Exemptions

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 176

[OPP-181051; FRL-5750-1]

RIN 2070-AD15

Tolerances for Pesticide Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing procedures and criteria under which EPA would

establish tolerances for residues of pesticide chemicals resulting from

emergency uses of pesticide chemicals authorized by EPA under section

18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

This regulation is required by the Federal Food, Drug, and Cosmetic Act

(FFDCA), which was amended by the Food Quality Protection Act (FQPA) of

1996. FQPA established a new safety standard with special protections

for infants and children and extends this new protection to the

emergency use of pesticide chemicals. Specifically, FQPA requires EPA

to establish time-limited tolerances, or an exemption from the

requirement for a time-limited tolerance, for any pesticide uses

authorized by EPA under section 18 of FIFRA that may result in residues

in or on food (including animal feed). EPA actions under section 18 of

FIFRA are taken in response to a petition submitted by a Federal or

state agency. These proposed procedures and criteria will ensure that

the Agency is able to address more quickly any tolerance related issues

in conjunction with any decision made on the petition. EPA believes

that the procedures proposed in this document will be protective of

public health, while continuing to ensure availability of pesticides in

emergency situations.

DATES: Written comments, identified by the docket control number OPP-

181051, must be received on or before August 2, 1999.

ADDRESSES: Comments may be submitted by mail, electronically, or in

person. Please follow the detailed instructions for each method as

provided in Unit I.C. of the SUPPLEMENTARY INFORMATION section of this

notice.

sure availability of pesticides in

emergency situations.

DATES: Written comments, identified by the docket control number OPP-

181051, must be received on or before August 2, 1999.

ADDRESSES: Comments may be submitted by mail, electronically, or in

person. Please follow the detailed instructions for each method as

provided in Unit I.C. of the SUPPLEMENTARY INFORMATION section of this

notice.

FOR FURTHER INFORMATION CONTACT:

Joseph E. Hogue, Policy and Regulatory Services Branch, Field and

External Affairs Division (7506C), Office of Pesticide Programs,

Environmental Protection Agency, 401 M St., SW., Washington, DC 20460,

telephone number: (703) 308-9072, e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Important Information

A. Does This Proposed Rule Apply to You?

You may be potentially affected by this proposed rule if you are

the Federal Government or a State or territorial government agency

charged with pesticide authority. Regulated categories and entities may

include, but is not limited to:

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Category Examples

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Federal Government................. Agencies that petition EPA for

section 18 pesticide use

authorization.

State and territorial government State that petition EPA for section

agencies charged with pesticide 18 pesticide use authorization.

authority.

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This table is not all inclusive, but is intended as a guide for

entities likely to be regulated by this action. To determine whether

this proposed rule applies to you, carefully read the applicability

criteria in a proposed Sec. 176.1. If you have any questions regarding

the applicability of this action to a particular entity, consult the

person listed in the FOR FURTHER INFORMATION CONTACT section.

B. How Can I Get Additional Information or Copies of Support Documents?

to be regulated by this action. To determine whether

this proposed rule applies to you, carefully read the applicability

criteria in a proposed Sec. 176.1. If you have any questions regarding

the applicability of this action to a particular entity, consult the

person listed in the FOR FURTHER INFORMATION CONTACT section.

B. How Can I Get Additional Information or Copies of Support Documents?

1. Electronically. You may obtain electronic copies of this

document and various support documents are available from the EPA Home

page at the Federal Register--Environmental Documents entry for this

document under ``Laws and Regulations'' (http://www.epa.gov/fedrgstr/).

2. In person. The official record for this proposed rule, as well

as the public version, has been established under docket control number

OPP-181051, (including comments and data submitted electronically as

described below). A public version of this record, including printed,

paper versions of any electronic comments, which does not include any

information claimed as CBI, is available for inspection in Rm. 119,

Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30

a.m. to 4 p.m., Monday through Friday, excluding legal holidays.

C. How and to Whom Do I Submit Comments to?

You may submit comments through the mail, in person, or

electronically:

1. By mail. Submit written comments to: Public Information and

Records Integrity Branch, Information Resources and Services Division

(7502C), Office of Pesticide Programs, Environmental Protection Agency,

401 M St., S.W., Washington, DC 20460.

2. In person. Deliver written comments to: Public Information and

mments to?

You may submit comments through the mail, in person, or

electronically:

1. By mail. Submit written comments to: Public Information and

Records Integrity Branch, Information Resources and Services Division

(7502C), Office of Pesticide Programs, Environmental Protection Agency,

401 M St., S.W., Washington, DC 20460.

2. In person. Deliver written comments to: Public Information and

Records Integrity Branch, in Rm. 119, CM #2, 1921 Jefferson Davis

Highway, Arlington, VA.

3. Electronically. Submit your comments and/or data electronically

to: ``[email protected].'' Please note that you should not

submit any information electronically that you consider to be CBI.

Electronic comments must be submitted as an ASCII file avoiding the use

of special characters and any form of encryption. Comments and data

will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file

format. All comments and data in electronic form must be identified by

the docket control number OPP-181051. Electronic comments on this

proposed rule may also be filed online at many Federal Depository

Libraries.

D. How Should I Handle Information That I Believe Is Confidential?

You may claim information that you submit in response to this

document as confidential by marking any part or all of that information

as CBI. Information so marked will not be disclosed except in

accordance with procedures set forth in 40 CFR part 2. A copy of the

comment that does not contain CBI must be submitted for inclusion in

the public record. Information not marked confidential will be included

in the public docket by EPA without prior notice.

II. Authority

This action is issued under the authority of the Federal Food,

Drug, and Cosmetic Act as amended by the Food Quality Protection Act of

1996.

III. Background

40 CFR part 2. A copy of the

comment that does not contain CBI must be submitted for inclusion in

the public record. Information not marked confidential will be included

in the public docket by EPA without prior notice.

II. Authority

This action is issued under the authority of the Federal Food,

Drug, and Cosmetic Act as amended by the Food Quality Protection Act of

1996.

III. Background

The Food Quality Protection Act of 1996 (FQPA) was signed into law

August 3, 1996. FQPA amends both the Federal Food, Drug, and Cosmetic

Act (FFDCA), 21 U.S.C. 201 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. Among

other things, FQPA amends FFDCA to bring all pesticide tolerance-

setting activities conducted by EPA under a new section 408 with a new

safety standard and new procedures. FQPA also amends FFDCA by directing

EPA to establish time-limited tolerances for any pesticide use

authorized by EPA under section 18 of FIFRA that may result in residues

in or on food (including animal feed). The FQPA amendments went into

effect immediately.

EPA is proposing regulations to govern the establishment of time-

limited tolerances for pesticide uses authorized by EPA under section

18 of FIFRA. This proposed rule pertains only to regulatory changes

resulting from enactment of FQPA.

IV. Emergency Exemptions under Section 18

Section 18 of FIFRA authorizes EPA to exempt any Federal or state

agency from any provision of FIFRA, if EPA determines that ``emergency

conditions exist which require such exemption.'' This provision was not

amended by FQPA. EPA has established regulations governing such

emergency exemptions in 40 CFR part 166. Generally, these regulations

allow a Federal or state agency to apply for an exemption to allow a

use of a pesticide that is not registered when such use is necessary to

alleviate an emergency condition

at ``emergency

conditions exist which require such exemption.'' This provision was not

amended by FQPA. EPA has established regulations governing such

emergency exemptions in 40 CFR part 166. Generally, these regulations

allow a Federal or state agency to apply for an exemption to allow a

use of a pesticide that is not registered when such use is necessary to

alleviate an emergency condition. A state, as defined by FIFRA section

2(aa), means a state, the District of Columbia, the Commonwealth of

Puerto Rico, the Virgin Islands, Guam, the Trust Territory of the

Pacific Islands and the American Samoa. The regulations set forth

information requirements, procedures, and standards for EPA's approval

or denial of such exemptions.

Federal and state agencies may petition EPA for a section 18

emergency exemption from FIFRA due to a public health emergency, a

quarantine emergency, or a ``specific'' emergency. Most exemptions from

FIFRA petitioned for or granted under section 18 fall under the

category of ``specific exemptions.'' Typical justifications for

specific exemptions include, but are not limited to, the introduction

of a new pest; the expansion of the range of a pest; the cancellation

or removal from the market of a previously registered and effective

pesticide product; and the development of resistance in pest to a

registered product, or loss of efficacy in available products for any

other reasons. Additionally, an emergency situation is generally

considered to exist when no other viable (chemical or non-chemical)

means of control exist, and where the emergency situation will cause

significant economic losses to affected individuals if the exemption is

not granted

development of resistance in pest to a

registered product, or loss of efficacy in available products for any

other reasons. Additionally, an emergency situation is generally

considered to exist when no other viable (chemical or non-chemical)

means of control exist, and where the emergency situation will cause

significant economic losses to affected individuals if the exemption is

not granted.

When a Federal or state agency petitions EPA under section 18, it

must submit a request in writing that documents the emergency

situation, the chemical(s) proposed for the use, the target pest, the

crop, the rate and number of applications to be made, the geographical

region where the chemical(s) would be applied, and a discussion of

risks which may be posed to human health or to the environment as a

result of the pesticide use (40 CFR 166.20). EPA conducts an expedited

review of the request, verifying the existence of the emergency,

assessing risks posed to human health through dietary exposure,

assessing risks posed to farmworkers and other handlers of the

pesticide, assessing any adverse effects on non-target organisms

(including federally listed endangered species), and assessing the

potential for contamination of ground and surface water. If an

application for the requested use has been made in previous years, EPA

does an assessment of the progress toward registration for the use of

the requested chemical on the requested crop, and considers this status

in the final determination to grant or deny the exemption. If EPA's

review concludes that the situation is an emergency, and that the use

of the pesticide under the exemption will not cause unreasonable

adverse effects on human health or the environment, then EPA may

authorize the pesticide to be used under section 18.

Section 18 pesticide uses for specific and public health exemptions

can be authorized for periods not to exceed 1 year; uses under

quarantine exemptions can be authorized for up to 3 years

ency, and that the use

of the pesticide under the exemption will not cause unreasonable

adverse effects on human health or the environment, then EPA may

authorize the pesticide to be used under section 18.

Section 18 pesticide uses for specific and public health exemptions

can be authorized for periods not to exceed 1 year; uses under

quarantine exemptions can be authorized for up to 3 years. Since

actions taken under section 18 are intended to address a time-specific

crisis or emergency need for temporary relief, most section 18

exemptions are specific exemptions which are granted for just one

growing season. Such actions should not, therefore, be reviewed as an

alternative to registering the use(s) needed for longer periods. If the

situation addressed with the section 18 exemption persists, or is

expected to persist, affected entities must take the proper steps to

amend the existing or seek a new registration to address that future

need.

In general, EPA attempts to form and communicate decisions on

section 18 requests within 50 calendar days of receipt of an exemption

application; in fiscal year 1998 (October 1, 1997--September 30, 1998),

EPA's average response time was 56 days. During FY98, EPA received

requests for 601 exemptions, of which 410 were approved (27 requests

were denied, 67 requests were withdrawn by states, and 97 requests were

still pending at the end of the fiscal year).

EPA maintains lines of communication with the State Departments of

Agriculture (or applicant) during the application review period so they

may keep growers informed on the status of the request. The Agency

works with the State Departments of Agriculture so that in case a

request might be denied, the affected growers may be able to find

alternative solutions. In the early stages of the development of this

proposed rule, EPA consulted with

tate Departments of

Agriculture (or applicant) during the application review period so they

may keep growers informed on the status of the request. The Agency

works with the State Departments of Agriculture so that in case a

request might be denied, the affected growers may be able to find

alternative solutions. In the early stages of the development of this

proposed rule, EPA consulted with

representatives from the States of North Carolina and Washington on

behalf of the State's FIFRA Issues Research and Evaluation Group

(SFIREG). SFIREG identifies, analyzes and provides State comments to

the Office of Pesticide Programs on matters relating to pesticide

registration, enforcement, training and certification, water quality,

disposal and other areas of environmental concern related to pesticide

manufacture, use and disposal. In addition, SFIREG provides a mechanism

for EPA to keep the states informed and up-to-date on its pesticide

regulatory programs.

In September 1997, the Office of Pesticide programs formed a minor

use office which focuses on the special needs of growers of minor use

crops. EPA has expanded work in this respect with Interregional

Research Project No. 4 (IR-4), a U.S. Department of Agriculture (USDA)

program which provides national leadership and coordination for

information on the clearance of minor use pesticides and generates data

to support minor-use registrations. IR-4 will often help support minor

use emergency exemptions petitions.

The section 18 program can be an important part of developing

reasonable transition approaches for certain crops, especially minor

use crops, in moving to safer pest control methods

l leadership and coordination for

information on the clearance of minor use pesticides and generates data

to support minor-use registrations. IR-4 will often help support minor

use emergency exemptions petitions.

The section 18 program can be an important part of developing

reasonable transition approaches for certain crops, especially minor

use crops, in moving to safer pest control methods. For example, in

certain situations, a pesticide needed for emergency use on minor use

crops might be registered for other use sites which have already filled

the ``risk cup.'' In order to address the needs of minor use farmers,

the Agency might work with pesticide registrants and growers to cap the

existing use on registered crops at a level that allows room in the

risk cup for use of the pesticide in combating an emergency. Under this

offset approach, the Agency could achieve either no risk increase or a

risk reduction and at the same time facilitate and permit critical

emergency exemptions.

In continuing efforts to implement FQPA, EPA is working together

with USDA to ensure that implementation of FQPA is informed by a sound

regulatory approach, by appropriate input from affected members of the

public, and by due regard for the needs of our Nation's agricultural

producers and other pesticide users.

V. Legal Basis of EPA Action

A. Residues in Food Prior to FQPA

Prior to enactment of FQPA, when EPA granted an emergency exemption

under section 18 for use of a pesticide that could result in residues

in or on food, EPA did not establish a tolerance or exemption from the

requirement for a tolerance under FFDCA. rather, EPA advised the Food

and Drug Administration (FDA) of the emergency exemption and the level

of residues that EPA concluded would be present in or on affected foods

as a result of the emergency use, and requested that FDA refrain from

enforcing against foods which contained residues of the pesticide due

to use under the exemption

ption from the

requirement for a tolerance under FFDCA. rather, EPA advised the Food

and Drug Administration (FDA) of the emergency exemption and the level

of residues that EPA concluded would be present in or on affected foods

as a result of the emergency use, and requested that FDA refrain from

enforcing against foods which contained residues of the pesticide due

to use under the exemption. Similarly, EPA informed the USDA of

pesticide use under an emergency exemption where residues would result

in meat, milk, or eggs.

B. FQPA Requirements

New section 408(l)(6) requires EPA to establish a tolerance or

exemption from the requirement for a tolerance for pesticide chemical

residues in or on food that will result from the use of a pesticide

under an emergency exemption granted by EPA under section 18 of FIFRA,

and requires that the tolerances be consistent with sections 408(b)(2)

and (c)(2) and FIFRA section 18. Section 408(l)(6) also requires EPA to

promulgate regulations governing the establishment of tolerances and

exemptions under section 408(l)(6). New FFDCA section 408(b)(2)(A)(i)

allows EPA to establish a tolerance (the maximum legal limit) for a

pesticide chemical residue in or on a food in accordance with the

following:

1. EPA must determine that the tolerance is ``safe.'' Section

408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable

certainty that no harm will result from aggregate exposure to the

pesticide chemical residue, including all anticipated dietary exposures

and all other exposures for which there is reliable information.''

Aggregate exposure includes exposure through food and drinking water,

as well as all non-occupational, non-dietary exposure, such as through

residential uses.

2

hat ``there is a reasonable

certainty that no harm will result from aggregate exposure to the

pesticide chemical residue, including all anticipated dietary exposures

and all other exposures for which there is reliable information.''

Aggregate exposure includes exposure through food and drinking water,

as well as all non-occupational, non-dietary exposure, such as through

residential uses.

2. Section 408(b)(2)(C) requires EPA to give special consideration

to exposure of infants and children to the pesticide chemical residue

in establishing a tolerance and to ``ensure that there is a reasonable

certainty that no harm will result to infants and children from

aggregate exposure to the pesticide chemical residue.* * *''

3. Section 408(b)(2)(D) specifies certain factors EPA is to

consider in establishing a tolerance. These factors include the use of

reliable data, nature of toxic effects, human risk involved, dietary

consumption patterns, cumulative effects of a pesticide residue with

other substances that have a common mechanism of toxicity, aggregate

exposure levels, variability of the sensitivities of subgroups of

consumers, endocrine disrupting effects, and appropriate safety

factors.

4. Section 408(b)(3) requires that there is a practical method for

detecting and measuring levels of the pesticide chemical residue in or

on food. A tolerance may only be established at a level at or above the

limit of detection of the designated method.

5. Section 408(c) governs EPA's establishment of exemptions from

the requirement for a tolerance using the same safety standard as

section 408(b)(2)(A) and incorporating the provisions of sections

408(b)(2)(C) and (D). In this preamble, EPA will use the terms

``tolerance'' to refer to exemptions from the requirement for a

tolerance as well.

Section 408(l)(6) requires EPA to establish tolerances in

connection with EPA's granting of FIFRA section 18 emergency

exemptions

t for a tolerance using the same safety standard as

section 408(b)(2)(A) and incorporating the provisions of sections

408(b)(2)(C) and (D). In this preamble, EPA will use the terms

``tolerance'' to refer to exemptions from the requirement for a

tolerance as well.

Section 408(l)(6) requires EPA to establish tolerances in

connection with EPA's granting of FIFRA section 18 emergency

exemptions. When EPA establishes a tolerance under section 408(l)(6),

it may do so without providing notice or a period for public comment.

Tolerances established under section 408(l)(6) must also be consistent

with the safety standards in section 408(b)(2) and (c)(2) that are

applicable to all tolerances under section 408, and with FIFRA section

18. Section 408(l)(6) specifies that such tolerances shall have an

expiration date, but does not specify the duration of the tolerance.

VI. Interim Section 18 Practices

Since August 3, 1996, EPA has been acting on requests for section

18 exemptions and has been issuing associated tolerances on a case-by-

case basis under the new safety standard mandated by FQPA. The Agency

sent a letter to Federal and state agencies in September 1996,

informing them of the new procedures and issued guidance on interim

procedures in Pesticide Regulation Notice 97-1 (January 31, 1997). In

establishing section 18-related tolerances during this interim period

before issuing the section 408(l)(6) procedural regulation and before

making broad policy decisions concerning the interpretation and

implementation of the new section 408, EPA does not intend to set

precedents for the application of section 408 and the new safety

standard to other tolerances and exemptions. Rather, these early

section 18 tolerance decisions are being made on a case-by-case basis

and will not bind EPA as it proceeds with further rulemaking and policy

development.

VII. EPA Proposal

A. Scope

rpretation and

implementation of the new section 408, EPA does not intend to set

precedents for the application of section 408 and the new safety

standard to other tolerances and exemptions. Rather, these early

section 18 tolerance decisions are being made on a case-by-case basis

and will not bind EPA as it proceeds with further rulemaking and policy

development.

VII. EPA Proposal

A. Scope

This proposal deals exclusively with procedures for setting time-

limited tolerances for pesticide chemical residues associated with

FIFRA section 18 emergency exemptions. The proposal does not modify any

regulatory policies or procedures associated with the issuance of an

emergency exemption itself, nor does it affect tolerance procedures

which fall under other sections of FIFRA or FFDCA.

B. Definitions

The terms defined in proposed Sec. 176.3 of the regulatory text

have the same meaning as FIFRA section 2, FFDCA section 201, and 40 CFR

part 166.

C. Request for a Section 18 Tolerance

Proposed Sec. 176.5 specifies that EPA will review data to

establish a time-limited tolerance for a pesticide to be used in an

emergency or crisis situation under section 18 only after it has

received the emergency exemption request or a crisis situation has been

declared.

D. Determining Reasonable Certainty of No Harm

In developing these proposed regulations, EPA considered several

approaches for assuring timely access to information adequate to ensure

that a section 18 tolerance, taking into account its limited duration

and emergency nature, meets the new FFDCA safety standard of reasonable

certainty of no harm.

For a number of reasons, EPA proposes to implement the new

provisions of FFDCA related to section 18 tolerances in Sec. 176.7 by

evaluating each submission on a case-by-case basis to determine if

adequate reliable data are available to make the ``reasonable certainty

of no harm'' finding mandated under section 408 of FFDCA

ets the new FFDCA safety standard of reasonable

certainty of no harm.

For a number of reasons, EPA proposes to implement the new

provisions of FFDCA related to section 18 tolerances in Sec. 176.7 by

evaluating each submission on a case-by-case basis to determine if

adequate reliable data are available to make the ``reasonable certainty

of no harm'' finding mandated under section 408 of FFDCA. EPA believes

that timeliness of review in a manner responsive to the requirements of

the situation is of critical importance. EPA must be able to conclude

rapidly whether it has enough reliable data readily available to make a

safety finding under FFDCA for the requested use. Even if EPA concludes

that it is unable to establish a time-limited tolerance for the

requested use, the Agency will strive to make that conclusion in

sufficient time for the applicant to search for some additional method

to control the emergency pest situation. This case-by-case evaluation

is consistent with EPA's traditional approach to section 18 exemption

requests and with the statutory mandate of FFDCA section 408(l)(6).

In addition to the practical limits on the time available for

decision-making, EPA believes it is reasonable to rely on available

data for several other reasons, even though those data will generally

be less than those required for the establishment of a permanent

tolerance. Dietary exposures to pesticide chemical residues from use

under a section 18 exemption are generally less than those associated

with permanent tolerances because section 18 uses are of limited

duration, and because section 18 uses generally do not involve the

entire U.S. production of any crop since they are granted on a state-

by-state basis. Moreover, substantial hazard and exposure data are

usually available. Many section 18 exemption requests are for new use

sites of currently registered pesticides or for uses of previously

registered pesticides which are no longer in use

mited

duration, and because section 18 uses generally do not involve the

entire U.S. production of any crop since they are granted on a state-

by-state basis. Moreover, substantial hazard and exposure data are

usually available. Many section 18 exemption requests are for new use

sites of currently registered pesticides or for uses of previously

registered pesticides which are no longer in use. Consequently, EPA may

already have an extensive data base readily available to make the

reasonable certainty of no harm determination to set the tolerance.

Using available data is less likely to require significant increases in

the resources necessary to support exemption requests. It would not

significantly increase the regulatory burden on applicants by creating

new data requirements for section 18 exemptions nor significantly

increase costs to EPA for evaluating the requests. It is important to

limit the resource requirements of the section 18 program so that both

the Agency and applicants have sufficient resources to carry out their

other responsibilities under FIFRA and FFDCA.

1. Data requirements. Under this approach, EPA will review data

that has been submitted as required in 40 CFR part 158 for FIFRA

section 18 requests and whatever additional useful data it has

available in order to make the safety determination required under

FFDCA for establishment of a time-limited tolerance for an emergency

exemption. Pesticide Registration (PR) Notice 97-1, issued January 31,

1997, provides additional guidance on what data to submit to the Agency

to enable EPA to make a ``reasonable certainty of no harm''

determination in order to issue a tolerance (for a copy of PR Notice

97-1, please contact the OPP docket, address above, or visit the EPA

web site). Because EPA already has in its files much of the data it

will review to make a determination on a section 18 tolerance, the

Agency does not expect such data to be submitted routinely with an

exemption request

``reasonable certainty of no harm''

determination in order to issue a tolerance (for a copy of PR Notice

97-1, please contact the OPP docket, address above, or visit the EPA

web site). Because EPA already has in its files much of the data it

will review to make a determination on a section 18 tolerance, the

Agency does not expect such data to be submitted routinely with an

exemption request. EPA will exercise its best scientific judgment and

rely on data submitted to support past and pending registration actions

for the subject or closely related chemical, or data submitted to EPA

as part of the reregistration process. When possible, applicants should

cite studies previously reviewed, and found acceptable by EPA, that

pertain to the requested use. EPA will not, however, conduct expedited

reviews of data submitted for permanent tolerances, or for registration

or reregistration actions, solely in order to ascertain the viability

of establishing a tolerance for a section 18 exemption request.

In all cases, applicants must include the earliest anticipated

harvest date of crops for which the section 18 exemption is being

requested. This information is useful for EPA to allocate the necessary

resources to establish the time-limited tolerances in time for the

harvest, and will also be useful to FDA and USDA in enforcing the

tolerances.

2. Agency review under a case-by-case approach. In order to

determine whether EPA will be able to establish a time-limited

tolerance for a requested section 18 use, EPA will consider available

information relevant to the factors listed in FFDCA section

408(b)(2)(D), including:

a. Aggregate exposure to the pesticide chemical residue through:

i. Dietary exposure, including drinking water.

ii. Non-dietary, non-occupational residential exposure [indoor and

out-door].

b. Cumulative effects of the pesticide chemical residue and other

substances that have a common mechanism of toxicity.

c. Extra sensitivity of infants and children.

d

A section

408(b)(2)(D), including:

a. Aggregate exposure to the pesticide chemical residue through:

i. Dietary exposure, including drinking water.

ii. Non-dietary, non-occupational residential exposure [indoor and

out-door].

b. Cumulative effects of the pesticide chemical residue and other

substances that have a common mechanism of toxicity.

c. Extra sensitivity of infants and children.

d. Potential to produce endocrine effects.

Because there is a significant scientific uncertainty at this time

about how to aggregate non-dietary risk factors with dietary risk, and

because generally EPA has limited data with which to evaluate common

mechanism of toxicity and endocrine disruption capacities of chemicals,

EPA will make its ``reasonable certainty of no harm determination''

based on available and reliable information coupled with best

scientific judgment as necessary. If EPA concludes that establishment

of the appropriate tolerance would result in ``a reasonable certainty

of no harm'' as defined in FFDCA section 408(b), then a tolerance may

be established for the requested use.

EPA will be unable to establish a time-limited tolerance for the

proposed emergency exemption use, and therefore will deny the exemption

request, if: (1) The Agency finds that the tolerance

does not meet the safety standard of reasonable certainly of no harm as

defined in FFDCA section 408, or (2) the Agency does not have enough

reliable data to make a determination that the safety standard is met.

3. Alternative approaches considered. EPA has identified other

possible approaches to establishing section 18 tolerances which it

could pursue. One approach was to require a full data set to support

section 18 tolerances as is required in 40 CFR part 158, subparts D and

F, for the establishment of permanent tolerances

ugh

reliable data to make a determination that the safety standard is met.

3. Alternative approaches considered. EPA has identified other

possible approaches to establishing section 18 tolerances which it

could pursue. One approach was to require a full data set to support

section 18 tolerances as is required in 40 CFR part 158, subparts D and

F, for the establishment of permanent tolerances. However, the Agency

recognized that adhering rigidly to all data specified in 40 CFR part

158, as they currently exist and as they may be modified in the future,

would effectively remove section 18 as a mechanism to address emergency

pest situations. Review and decisions would not be made in a timely or

responsive fashion, and the process of data collection, submission and

review would be equivalent to that required to establish a permanent

tolerance. This would be unduly burdensome to the applicants that

request emergency exemptions. They generally do not have resources to

develop the data themselves and so would have to rely upon data

developed by the producers of pesticide products. In sum, this approach

does not consider the emergency nature or short duration of most

exemption requests. Therefore, EPA believes that it would be

impractical, given the urgent nature of emergency conditions.

EPA also considered a minimum data set approach in which the

applicant would be required to provide a specific subset of the data

normally required to establish a full tolerance which would be

sufficient to support a safety determination given the time-limited

nature of section 18 tolerances and the urgent nature of emergency

situations. Under this approach, EPA would consider only those defined

data requirements in making a safety finding

n which the

applicant would be required to provide a specific subset of the data

normally required to establish a full tolerance which would be

sufficient to support a safety determination given the time-limited

nature of section 18 tolerances and the urgent nature of emergency

situations. Under this approach, EPA would consider only those defined

data requirements in making a safety finding. If EPA chose to implement

the new provisions of FFDCA in this fashion, applicants would likely

have to provide specific data to EPA to support a section 18 tolerance

in addition to data which must already be submitted for emergency

exemption requests in general, outlined in 40 CFR 166.20.

EPA believes that both the creation of a new, specific minimum data

set to support section 18 time-limited tolerances, and the practical

implementation of those requirements, would result in significant

disruption to the availability of section 18 as a viable response to

emergency situations requiring use of pesticide products. EPA believes

that many applicants would have difficulty complying with a minimum

data set because these requirements would still represent levels of

technical data which most states do not have access to and currently

are unable to develop. As EPA's data requirements evolve, a defined

minimum data set might also require revision. Because a prescribed data

set is not necessary for the Agency to conclude that a tolerance is

safe and because it is EPA's belief that the amendments to FFDCA were

not intended to eliminate or significantly disrupt the availability of

emergency exemptions, EPA is not proposing to establish a minimum data

set required for tolerances associated with section 18 requests.

A fourth approach to setting tolerances under section 18 has been

suggested to the Agency

onclude that a tolerance is

safe and because it is EPA's belief that the amendments to FFDCA were

not intended to eliminate or significantly disrupt the availability of

emergency exemptions, EPA is not proposing to establish a minimum data

set required for tolerances associated with section 18 requests.

A fourth approach to setting tolerances under section 18 has been

suggested to the Agency. This approach was initially presented in a

paper developed by a work group of the Pesticide Program Dialogue

Committee and subsequently through a petition submitted by the National

Food Processor's Association. Under this approach, the Agency would not

conduct a full risk assessment under FQPA but would assess the

incremental risk of the proposed section 18 use. If the Agency were to

find the incremental risk insignificant, it would establish a time

limited tolerance and grant the section 18 use without conducting a

full aggregate risk assessment for the existing uses of the pesticide

chemical. This approach would take into account the limited scope and

duration of the emergency use of the pesticide. The NFPA petition

assets that limiting the Agency's review of a section 18 tolerance to

an incremental risk assessment might decrease the amount of time it

takes for the Agency to review the emergency exemption application,

thus taking into account the emergency nature and time sensitivity of

the use and potentially allowing Agency resources to be used in other

areas. In addition, the petitioners believe that the use of an

incremental risk assessment may reduce the time needed to establish a

tolerance after granting an emergency exemption. Although the Agency is

proposing to use a case-by-case approach including aggregate risk

assessment based on available data, the Agency is accepting comments on

all of these alternative approaches.

E. Publication of Tolerances

tion, the petitioners believe that the use of an

incremental risk assessment may reduce the time needed to establish a

tolerance after granting an emergency exemption. Although the Agency is

proposing to use a case-by-case approach including aggregate risk

assessment based on available data, the Agency is accepting comments on

all of these alternative approaches.

E. Publication of Tolerances

Tolerances established to support emergency exemption uses of

pesticide products would become effective upon publication of a final

rule under proposed Sec. 176.9. Shortly after promulgation of a

tolerance, EPA would publish a final rule in the Federal Register

establishing the tolerance and specifying the duration of the

tolerance. Section 408(l)(6) of the FFDCA allows EPA to establish a

tolerance without prior public notification or comment period.

Additionally, EPA intends to make tolerances established under FFDCA

section 408(l)(6) available electronically, so that there can be a

record of the most up-to-date tolerances, their expiration dates, and

any other information that can be of practical use to growers, states,

and other various enforcement agencies.

F. Duration of Tolerances

Section 408(l)(6) of FFDCA provides that tolerances for emergency

exemptions shall have an expiration date. Proposed Sec. 176.11

specifies that tolerances would expire and be revoked automatically at

such a time as determined by the Administrator. Timing of expiration

and revocation of the tolerance would be identified at the time of

establishment of the tolerance.

EPA anticipates that, typically, tolerances would not be

established for a period longer than 24 months. In its discretion, and

at its own initiative or at the request of an applicant, EPA may

establish a section 408(l)(6) tolerance for longer periods when

conditions merit such an extended time-frame

vocation of the tolerance would be identified at the time of

establishment of the tolerance.

EPA anticipates that, typically, tolerances would not be

established for a period longer than 24 months. In its discretion, and

at its own initiative or at the request of an applicant, EPA may

establish a section 408(l)(6) tolerance for longer periods when

conditions merit such an extended time-frame. If an applicant requests

a longer time-limited tolerance for a section 18 pesticide use, the

applicant must adequately justify the requested duration when making

its emergency exemption request, and EPA would have to consider whether

the extended tolerance could pose higher risks.

G. Lawful Residues After Expiration of Tolerances

Section 408(l)(5) of FFDCA specifies that, if a tolerance for a

pesticide chemical residue in or on a food has been revoked under

section 408, food containing the residue is not unsafe if ``the residue

is present as the result of an application or use of a pesticide at a

time and in a manner that was lawful'' under FIFRA and ``the residue

does not exceed a level that was authorized at the time of the

application or use to be present on the food under a tolerance * * *

then in effect under [FFDCA]. * * * ''

Taking sections 408(l) (5) and (6) together, EPA has concluded that

the best way to effect an ``expiration date'' for a tolerance

established in connection with EPA's granting of a FIFRA section 18

emergency exemption is to specify that the tolerance will expire and be

revoked automatically, without further

be present on the food under a tolerance * * *

then in effect under [FFDCA]. * * * ''

Taking sections 408(l) (5) and (6) together, EPA has concluded that

the best way to effect an ``expiration date'' for a tolerance

established in connection with EPA's granting of a FIFRA section 18

emergency exemption is to specify that the tolerance will expire and be

revoked automatically, without further

action by EPA, as of a specified date. That date will generally be 24

months or less from the date of issuance of the emergency exemption.

After a tolerance is automatically revoked, food that contains residues

of a pesticide chemical will still be legally marketable so long as the

residues are the result of lawful use of the pesticide under the terms

of the section 18 emergency exemption and are at levels within the

tolerance established under section 408(l)(6).

Occasionally, use of the pesticide might occur before EPA actually

establishes the necessary time-limited tolerance, such as in the case

of a crisis exemption. When a time-limited tolerance is established

after the time that use of the pesticide product is authorized, the

residues on the subject commodity are only legal during the period of

time prior to the expiration and revocation of the tolerance. In other

words, there would be no ``pipeline'' provision for treated commodities

if use occurred before a tolerance was set. In case of such a gap, EPA

will consider setting a longer duration for the time-limited tolerance

to ensure that the commodity will leave channels of trade before the

tolerance expires.

EPA believes that handling the section 18-related tolerances in

this manner will allow EPA to respond promptly to emergency conditions

and will ensure that food containing pesticide residues as a result of

use under an emergency exemption will not be considered adulterated.

H. Limitations of 408(l)(6) Tolerances

re that the commodity will leave channels of trade before the

tolerance expires.

EPA believes that handling the section 18-related tolerances in

this manner will allow EPA to respond promptly to emergency conditions

and will ensure that food containing pesticide residues as a result of

use under an emergency exemption will not be considered adulterated.

H. Limitations of 408(l)(6) Tolerances

Time-limited tolerances established under the authority of FFDCA

section 408(l)(6) apply to pesticide chemical residues resulting from

pesticide applications authorized by EPA under provisions of FIFRA

section 18. In addition, time-limited tolerances established under this

section will cover commodities imported into the United States during

the duration of the tolerance.

The previous establishment of a 408(l)(6 ) tolerance does not alter

the requirement for applicants to submit formal emergency exemption

requests to EPA for review. Issuing a tolerance does not grant

authority to use a pesticide, but rather provides a legal limit on

residues of the pesticide on food shipped in interstate commerce. Even

if a time-limited tolerance for a pesticide has been established in

response to one applicant's (a state, U.S. territory, or Federal

agency) emergency exemption, other applicants must obtain an emergency

exemption for the use of that pesticide if they experience a pest

emergency which requires the use of that pesticide.

VIII. Additional Section 18 Concerns Not Addressed in This Proposed

Rule

if a time-limited tolerance for a pesticide has been established in

response to one applicant's (a state, U.S. territory, or Federal

agency) emergency exemption, other applicants must obtain an emergency

exemption for the use of that pesticide if they experience a pest

emergency which requires the use of that pesticide.

VIII. Additional Section 18 Concerns Not Addressed in This Proposed

Rule

On November 21 and 22, 1996, EPA hosted a public workshop to

discuss a range of issues related to emergency exemptions from FIFRA.

The purpose of the meeting was to informally establish a dialogue

amongst and solicit the opinions of a variety of individuals and groups

affected by section 18 decisions. During this meeting, EPA encouraged

discussion of various changes that may be made to regulations governing

section 18. Although the meeting had been planned prior to the passage

of FQPA because the new law had recently been enacted, some portions of

the meeting were devoted to discussions of how implementation of FQPA

could or would affect the section 18 process. Based on the November 21-

22 meeting, there may be additional concerns regarding the section 18

program aside from the tolerance setting procedures set forth in this

proposed rule that are of great interest to many section 18

stakeholders. EPA may, at a later date, prepare a formal proposal to

make changes to the section 18 regulations.

Although this proposed rule only addresses procedures for setting

tolerances in connection with section 18 exemptions, the following

recommendations were presented to EPA by the National Association of

State Departments of Agriculture (NASDA) and the Association of

American Pesticide Control Officials (AAPCO) in a letter dated February

28, 1997, addressed to Assistant Administrator for Prevention,

Pesticides and Toxic Substances, Dr. Lynn R. Goldman, M.D. NASDA and

AAPCO prepared this letter to capture the recommendations of their

membership following EPA's November 1996 Section 18 Stakeholder

Meeting

ments of Agriculture (NASDA) and the Association of

American Pesticide Control Officials (AAPCO) in a letter dated February

28, 1997, addressed to Assistant Administrator for Prevention,

Pesticides and Toxic Substances, Dr. Lynn R. Goldman, M.D. NASDA and

AAPCO prepared this letter to capture the recommendations of their

membership following EPA's November 1996 Section 18 Stakeholder

Meeting. Specifically, NASDA and AAPCO recommend that EPA implement the

following changes to the section 18 emergency exemption process:

1. Seek changes to current regulations which will allow EPA the

flexibility to base decisions on crop yield as opposed to crop value

(or profit loss) in situations where that is a better indicator of pest

damage.

2. Provide states general guidance regarding the appropriate

documentation of an ``urgent, non-routine situation'' and allow states

to certify that the ``urgent, non-routine situation'' exists based on

the guidance.

3. Implement a performance audit program to ensure compliance with

the guidance and give states justification to resist pressure to

certify an ``urgent, non-routine situation'' when it does not exist.

4. Delegate to the states authority to reissue the section 18

exemption for a second or third year, based on the state's

confirmation/certification that the basis for an emergency continues to

exist.

5. Actively support and coordinate regional section 18 requests.

6. Enter into discussions with the states to establish reasonable

monitoring criteria and approaches for wildlife and endangered species.

7. Support specific exemptions for resistance management where

there is documented scientific evidence of resistance to currently

registered pesticide or where valid research demonstrates that a

dynamic process of resistance is developing.

8. Amend 40 CFR 166.2 to include ``reduced risk'' as an acceptable

basis for granting a section 18 exemption

proaches for wildlife and endangered species.

7. Support specific exemptions for resistance management where

there is documented scientific evidence of resistance to currently

registered pesticide or where valid research demonstrates that a

dynamic process of resistance is developing.

8. Amend 40 CFR 166.2 to include ``reduced risk'' as an acceptable

basis for granting a section 18 exemption. The definition of ``reduced

risk,'' and the requirements for this request should allow states the

ability to request a section 18 to allow for a pesticide use that will

result in a lower potential for an adverse impact on human health or

any other non-target species, including but not limited to, pest

predators, pollinators, endangered species, and other organisms of

special concern. Requests should be limited to only those situations

where the ``reduced risk'' request will not result in additional risk

to any aspect of the environment. Such requests should only be

permitted where the proposed use is highly effective so that the

potential for an increase in pesticide applications is extremely low.

As stated above, by including the recommendations of NASDA and

AAPCO in this document, the Agency is not proposing to alter existing

regulations which govern implementation of FIFRA section 18, nor is the

Agency prepared to take a position on the propriety of any of the

recommendations. EPA will accept comments on the eight recommendations

presented by NASDA and AAPCO, should individuals or organizations wish

to comment at this time. Comments on these recommendations must be

identified by the docket control number, OPP-181052, rather than the

docket number for this proposed rule.

EPA does not expect to address any comments resulting from these

eight issues in promulgating final rules establishing procedures for

setting tolerances under FFDCA section 408(l)(6), nor does the Agency

intend to allow these issues to delay implementation of the tolerance

setting

t be

identified by the docket control number, OPP-181052, rather than the

docket number for this proposed rule.

EPA does not expect to address any comments resulting from these

eight issues in promulgating final rules establishing procedures for

setting tolerances under FFDCA section 408(l)(6), nor does the Agency

intend to allow these issues to delay implementation of the tolerance

setting

regulations. EPA does intend to develop a proposed rule which would

make various changes to the regulations governing section 18 exemptions

at a later date. At that time, the Agency will describe in much greater

detail these recommendations and any other changes it has considered,

and comments will be officially solicited and addressed as part of that

process.

The Agency is also seeking ideas on how to reduce the time from

when the emergency exemption is granted to when the tolerance is

established per the request of the NFPA petition.

IX. Regulatory Requirements

A. Executive Order 12866

Pursuant to Executive Order 12866, entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993), it has been determined that this

proposed action is not a ``significant regulatory action'' and is

therefore not subject to review by the Office of Management and Budget

(OMB). Applicants for section 18 emergency exemptions are the only

parties, other than EPA, directly affected by this proposed action.

According to the economic assessment conducted by the Agency, the

direct costs of this action are insignificant to the applicants

(Federal and state agencies) of section 18 emergency exemptions because

additional data are not readily accessible under case-by-case approach

of determining a reasonable certainty of no harm. A copy of the

economic assessment is available in the public docket for this proposed

rule.

B. Regulatory Flexibility Act

he Agency, the

direct costs of this action are insignificant to the applicants

(Federal and state agencies) of section 18 emergency exemptions because

additional data are not readily accessible under case-by-case approach

of determining a reasonable certainty of no harm. A copy of the

economic assessment is available in the public docket for this proposed

rule.

B. Regulatory Flexibility Act

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the

Agency has determined that this regulatory action does not impose any

direct adverse economic impact on small entities. Applicants for

section 18 emergency exemptions are U.S. states, territories, or

Federal agencies which, by definition, are not small entities.

Applicants for section 18 emergency exemptions are the only parties,

other than EPA, directly affected by this proposed action. Therefore,

pursuant to section 605(b), the agency hereby certifies that this

action will not have a significant adverse impact on a substantial

number of small entities. Information regarding this determination will

be provided to the Chief Counsel for Advocacy of the Small Business

Administration (SBA) upon request. Any comments regarding the impacts

that this action may impose on small entities should be submitted to

the Agency at the address listed above.

C. Paperwork Reduction Act

This proposed regulatory action does not contain any new

information collection requirements that would require additional

approval by OMB under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501

et seq. The information collection requirements that are related to

this proposed rule have already been approved by OMB under control No.

2070-0032 (EPA ICR No. 596) and control No. 2070-0024 (EPA ICR No.

597). Specifically, EPA regulations at 40 CFR part 166 allow a state,

U.S

requirements that would require additional

approval by OMB under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501

et seq. The information collection requirements that are related to

this proposed rule have already been approved by OMB under control No.

2070-0032 (EPA ICR No. 596) and control No. 2070-0024 (EPA ICR No.

597). Specifically, EPA regulations at 40 CFR part 166 allow a state,

U.S. territory, or Federal agency to apply for an emergency exemption

pursuant to section 18 of FIFRA, which would allow for a pesticide to

be used for a use for which that pesticide is not registered when such

use is necessary to alleviate an emergency condition. The regulations

set forth information requirements, procedures, and standards for EPA's

approval or denial of such exemptions. OMB has approved the information

collection requirements contained in part 166 under OMB control No.

2070-0032 (EPA ICR No. 596). In addition, EPA regulations in 40 CFR

part 180 described the process and informational needs for requesting

that the Agency establish or provide an exemption for the establishment

of a tolerance or maximum residue level for the use of a pesticide on

food crops. OMB has approved the information collection requirements

contained in part 180 under OMB control No. 2070-0024 (EPA ICR NO.

597).

The public reporting and recordkeeping burden for the collection of

information related to a section 18 exemption is estimated to average

103 hours per response annually. This estimation is based on the number

of requests for section 18 exemptions that the Agency received in

fiscal year 1996 (October 1, 1995-September 30, 1996), and the

estimated burden associated with submitting information related to a

request for the establishment of a tolerance or an exemption for a

tolerance. In FY 1996, EPA received requests for 478 emergency

exemptions pursuant to section 18. According to EPA ICR No

number

of requests for section 18 exemptions that the Agency received in

fiscal year 1996 (October 1, 1995-September 30, 1996), and the

estimated burden associated with submitting information related to a

request for the establishment of a tolerance or an exemption for a

tolerance. In FY 1996, EPA received requests for 478 emergency

exemptions pursuant to section 18. According to EPA ICR No. 597, the

Agency has estimated the annual burden to be 1,442 hours for providing

information in support of a full tolerance request under section 3 of

FIFRA.

In general, ``burden'' means the total time, effort, or financial

resources expended by persons to generate, maintain, retain, or

disclose or provide information to or for a Federal agency. The

includes the time needed to review instructions; develop, acquire,

install, and utilize technology and systems for the purposes of

collecting, validating, and verifying information, processing and

maintaining information, and disclosing and providing information;

adjust the existing ways to comply with any previously applicable

instructions and requirements; train personnel to be able to respond to

a collection of information; search data sources; complete and review

the collection of information; and transmit or otherwise disclose the

information. An Agency may not conduct or sponsor, and a person is not

required to respond to a collection of information that requires

approval under the PRA, unless it displays a currently valid OMB

control number. The OMB control numbers for EPA's regulations are

listed in 40 CFR part 9 and 48 CFR chapter 15.

Comments are requested on the Agency's need for this information,

the accuracy of the provided burden estimates, and any suggested

methods for minimizing respondent burden, including through the use of

automated collection techniques

e PRA, unless it displays a currently valid OMB

control number. The OMB control numbers for EPA's regulations are

listed in 40 CFR part 9 and 48 CFR chapter 15.

Comments are requested on the Agency's need for this information,

the accuracy of the provided burden estimates, and any suggested

methods for minimizing respondent burden, including through the use of

automated collection techniques. Send comments on the ICR to EPA as

part of your overall comments on this proposed action at the address

provided above, or to the Director, OPPE Regulatory Information

Division, Environmental Protection Agency (Mail Code 2137), 401 M St.,

SW., Washington, DC 20460, with a copy of any ICR comments to the

Office of Information and Regulatory Affairs, Office of Management and

Budget, 725 17th St., NW., Washington, DC 20503, marked ``Attention:

Desk Officer for EPA.'' Please remember to include the ICR number in

any correspondence. In developing the final rule, the Agency will

address any comments received regarding the information collection

requirements contained in this proposal.

D. Environmental Justice Considerations

Pursuant to Executive Order 12898 (59 FR 7629, February 16, 1994),

entitled Federal Actions to Address--Environmental Justice in Minority

Population and Low-Income Populations, the Agency has considered

environmental justice related issues with regard to the potential

impacts of this action on the environmental and health conditions in

low-income and minority communities. The Agency has found that this

proposed rule does not directly affect minority populations or low-

income groups, but will be more protective of certain subpopulations

such as infants and children.

E. Unfunded Mandates Reform Act

Under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA)

(Pub. L. 104-4), EPA has determined that this action does not contain a

and minority communities. The Agency has found that this

proposed rule does not directly affect minority populations or low-

income groups, but will be more protective of certain subpopulations

such as infants and children.

E. Unfunded Mandates Reform Act

Under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA)

(Pub. L. 104-4), EPA has determined that this action does not contain a

Federal mandate that may result in expenditures of $100 million or more

for State, local, and tribal governments, in the aggregate, or the

private sector in any one year. The costs associated with this action

are described in the Executive Order 12866 section above. Therefore,

this action is not subject to the requirements of sections 202 and 205

of the UMRA.

F. Enhancing Intergovernmental Partnerships

Under Executive Order 12875, entitled Enhancing Intergovernmental

Parnterships (58 FR 58093, October 28, 1993), EPA may not issue a

regulation that is not required by statute and that creates a mandate

upon a State, local or tribal government, unless the Federal government

provides the funds necessary to pay the direct compliance costs

incurred by those governments. Today's proposal would implement

requirements specifically set forth by the Congress in FFDCA section

408(l)(6) without the exercise of any discretion by EPA. EPA consulted

with various state officials during the development of this proposal,

including representatives from the States of North Carolina and

Washington, who acted as representatives of SFIREG.

G. Consultation and Coordination With Indian Tribal Governments

Safety Risks (62 FR 19885, April 23, 1997), because that is not an

economically significant regulatory action as defined by Executive

Order 12866 (see Unit IX.A.). In addition, this proposed rule is

procedural in nature and does not involve decisions on environmental

health risks or safety risks that may disproportionately affect

children.

I. National Technology Transfer and Advancement Act

This proposed regulatory action does not involve any technical

standards that would require Agency consideration of voluntary

consensus standards pursuant to section 12(d) of the National

Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law

104-113, section 12(d) (15 U.S.C. 272 note). Section 12(d) directs EPA

to use voluntary consensus standards in its regulatory activities

unless to do so would be inconsistent with applicable law or otherwise

impractical. Voluntary consensus standards are technical standards

(e.g., materials specifications, test methods, sampling procedures,

business practices, etc.) that are developed or adopted by voluntary

consensus standards bodies. The NTTAA requires EPA to provide Congress,

through OMB, explanations when the Agency decides not to use available

and applicable voluntary consensus standards. EPA invites public

comment on this conclusion.

List of Subjects in 40 CFR Part 176

Environmental protection, Administrative practice and procedure,

Agricultural commodities, Pesticides and pests, Reporting and

recordkeeping requirements.

Dated: May 24, 1999.

Carol M. Browner,

Administrator.

Therefore, it is proposed that 40 CFR chapter I be amended by

adding new part 176 to read as follows:

PART 176--TIME-LIMITED TOLERANCES FOR EMERGENCY EXEMPTIONS

ts in 40 CFR Part 176

Environmental protection, Administrative practice and procedure,

Agricultural commodities, Pesticides and pests, Reporting and

recordkeeping requirements.

Dated: May 24, 1999.

Carol M. Browner,

Administrator.

Therefore, it is proposed that 40 CFR chapter I be amended by

adding new part 176 to read as follows:

PART 176--TIME-LIMITED TOLERANCES FOR EMERGENCY EXEMPTIONS

Sec.

176.1 Scope and applicability.

176.3 Definitions.

176.5 Establishment of a time-limited tolerance or exemption.

176.7 Information needed to establish a tolerance.

176.9 Publications of a tolerance.

176.11 Duration of a tolerance.

176.13 Modification of a time-limited tolerance.

176.15 Effect of a tolerance.

Authority. 21 U.S.C. 346a and 371.

Sec. 176.1 Scope and applicability.

This part describes the procedures and criteria under which EPA

will establish time-limited tolerances and exemptions from the

requirement of a tolerance for pesticide chemical residues associated

with emergency or crisis exemptions under FIFRA section 18. This part

applies only to tolerances issued on the initiative of EPA as the

result of the issuance of an emergency exemption or the declaration of

a crisis exemption. This part does not cover time-limited tolerances in

any other circumstances.

Sec. 176.3 Definitions.

Terms have the same meaning as in the Federal Insecticide,

Fungicide, and Rodenticide Act section 2, and in the Federal Food,

Drug, and Cosmetic Act section 201 and Sec. 166.3 of this chapter. In

addition, the following terms are defined for the purposes of this

part.

Agency means the U.S. Environmental Protection Agency.

Applicant means a State, U.S. Territory, or Federal Agency that

requests an emergency exemption under Secs. 166.20 through 166.35 of

this chapter or declares a crisis exemption under Secs. 166.40 through

166.53 of this chapter.

Crisis exemption means an exemption authorized under FIFRA section

18, in accordance with Secs. 166.40 through 166.53 of this chapter

Environmental Protection Agency.

Applicant means a State, U.S. Territory, or Federal Agency that

requests an emergency exemption under Secs. 166.20 through 166.35 of

this chapter or declares a crisis exemption under Secs. 166.40 through

166.53 of this chapter.

Crisis exemption means an exemption authorized under FIFRA section

18, in accordance with Secs. 166.40 through 166.53 of this chapter.

Emergency exemption means a specific, quarantine or public health

exemption authorized under FIFRA section 18 and the regulations at

Secs. 166.20 through 166.35 of this chapter.

EPA means the U.S. Environmental Protection Agency.

FFDCA means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321

et seq.)

FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act

(7 U.S.C. 136 et seq.)

Tolerance means the maximum amount of a pesticide chemical residue

that may lawfully be present in or on a raw agricultural commodity, or

processed food, or animal feed, expressed as parts per million by

weight of the pesticide chemical residue in the food or feed.

Tolerance exemption means a formal determination by the Agency

pursuant to FFDCA section 408(c), 21 U.S.C. 346a(c), that no tolerance

is needed for a given pesticide chemical residue in or on a particular

food commodity. For purposes of this subpart, the term ``tolerance''

shall include an exemption from the requirement of a tolerance.

Sec. 176.5 Establishment of a time-limited tolerance or exemption.

EPA will establish a time-limited tolerance for pesticide chemical

residues in or on raw or processed food

or feed resulting from the use of a pesticide chemical when EPA

authorizes an emergency exemption or a crisis exemption. EPA will

consider establishing such a tolerance only if an applicant under FIFRA

section 18 either has requested an emergency exemption, or has stated

its intention to declare a crisis exemption under FIFRA section 18 for

a use that may result, directly or indirectly, in pesticide chemical

residues in food or feed.

de chemical when EPA

authorizes an emergency exemption or a crisis exemption. EPA will

consider establishing such a tolerance only if an applicant under FIFRA

section 18 either has requested an emergency exemption, or has stated

its intention to declare a crisis exemption under FIFRA section 18 for

a use that may result, directly or indirectly, in pesticide chemical

residues in food or feed.

Sec. 176.7 Information needed to establish a tolerance.

(a) EPA will establish a time-limited tolerance only if EPA can

determine that the tolerance is safe, that is, there is a reasonable

certainty that no harm will result from aggregate exposure to the

pesticide chemical residue. EPA will base its determination upon data

submitted by the applicant and other readily available data. If, taking

into account the limited duration and emergency nature of a section 18

application, the available data are not adequate to support a

reasonable certainty of no harm determination, EPA will not establish a

tolerance.

(b) Data and other relevant information to support the

establishment of a time-limited tolerance may be submitted by the

applicant, or by any other person, in support of the time-limited

tolerance. The applicant may also cite relevant data previously

submitted to the Agency.

Sec. 176.9 Publication of a tolerance.

(a) If EPA concludes that the tolerance will be safe, it may issue

a regulation establishing the tolerance and publish a notice to that

effect in the Federal Register.

(b) A tolerance under this part may be established without prior

public notification of a proposed tolerance or comment period.

Sec. 176.11 Duration of a tolerance.

(a) Tolerances under this part become effective upon publication in

the Federal Register, unless otherwise specified by the Administrator.

(b) Tolerances will automatically expire and be revoked, without

further action by EPA, at the time set out in the Federal Register

notice estabishing the tolerance.

fication of a proposed tolerance or comment period.

Sec. 176.11 Duration of a tolerance.

(a) Tolerances under this part become effective upon publication in

the Federal Register, unless otherwise specified by the Administrator.

(b) Tolerances will automatically expire and be revoked, without

further action by EPA, at the time set out in the Federal Register

notice estabishing the tolerance.

(c) The Administrator may revoke a tolerance at any time if the

Administrator determines that the tolerance is no longer safe.

Sec. 176.13 Modification of a time-limited tolerance.

If additional emergency or crisis exemptions are authorized that

would extend use beyond the date of expiration or revocation of a time-

limited tolerance, EPA may modify the time-limited tolerance by

extending its duration. EPA will use the same criteria and procedures

for modification as for establishing tolerances under this part.

Sec. 176.15 Effect of a tolerance.

The establishment of a tolerance under this part does not alter the

requirement that any State, U.S. Territory, or Federal Agency comply

with procedures established in part 166 of this chapter for emergency

exemptions of FIFRA.

[FR Doc. 99-14070 Filed 6-2-99; 8:45 am]

BILLING CODE 6560-50-M