64126 Federal Register / Vol. 65, No. 207 / Wednesday October 25, 2000 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 176

[OPP–181051A; FRL–6749–7]

RIN 2070–AD15

Time-Limited Tolerances for Pesticide

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This final rule governs the

establishment of time-limited tolerances

and exemptions for residues of a

pesticide chemical resulting from its

emergency use as authorized under

section 18 of the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA). The purpose of this rule is to

set into place a process that will ensure

timely decisions on any tolerance

related issue in response to a request for

an emergency use of a pesticide

chemical to be used in or on food or

feed. Under this rule, EPA will

implement the provisions of the Federal

Food, Drug, and Cosmetic Act (FFDCA)

related to FIFRA section 18 time-limited

tolerances by evaluating each petition

on a case-by-case basis to determine if

adequate reliable data are available to

make the required safety finding

mandated under FFDCA section 408.

This rule pertains only to regulatory

changes resulting from the 1996

enactment of the Food Quality

Protection Act (FQPA) which amended

FFDCA.

DATES: This rule is effective November

24, 2000.

FOR FURTHER INFORMATION CONTACT: For

general information contact: Joseph E.

Hogue, Office of Pesticide Programs

(7506C), Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308–9072; e-mail address:

hogue.joe@epa.gov.

For applicability questions contact:

Robert Forrest, Chief, Minor Use, Inerts

and Emergency Response Branch

(7505C), Registration Division, Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460;

telephone number: (703) 308–9376; email address: forrest.robert@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by

this final 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 are not

limited to:

Category NAICS codes Examples of potentially affected entities

Federal government 9241 Federal agencies that petition EPA for FIFRA section 18 use authorization

State or Territorial governments States or territories charged with pesticide authority that petition EPA for FIFRA section 18 use authorization

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in this table could

also be affected. The North American

Industrial Classification System

(NAICS) codes are provided to assist

you and others in determining whether

or not this action might apply to certain

entities. If you have questions regarding

the applicability of this action to a

particular entity, consult § 176.1 or the

person listed under FOR FURTHER

INFORMATION CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–181051A. The official record

consists of the documents specifically

referenced in this action, any public

comments received during an applicable

comment period, and other information

related to this action, including any

information claimed as Confidential

Business Information (CBI). This official

record includes the documents that are

physically located in the docket, as well

as the documents that are referenced in

those documents. The public version of

the official record does not include any

information claimed as CBI. The public

version of the official record, which

includes printed, paper versions of any

electronic comments submitted during

an applicable comment period, is

available for inspection in the Public

Information and Records Integrity

Branch (PIRIB), Room 119, Crystal Mall

#2, 1921 Jefferson Davis Hwy.,

Arlington, VA, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding

Federal holidays. The PIRIB telephone

number is (703) 305–5805.

II. Background

A. What Action is the Agency Taking?

The amendments to FFDCA, as

prescribed by FQPA, went into effect

immediately upon enactment on August

3, 1996. Under these amendments, EPA

is required to conduct all pesticide

tolerance-setting activities, including

those approved for section 18

emergency exemptions, under an

amended FFDCA section 408 with a

new safety standard and new regulatory

procedures. In the Federal Register of

June 3, 1999 (64 FR 29823) (FRL–5750–

1), EPA published, and opened for

public comment, proposed regulations

for setting time-limited tolerances for

section 18 emergency exemptions. In its

proposal, EPA described its current

emergency exemption program and the

interim practices taken to evaluate

requests for section 18 tolerances or

tolerance exemptions, and to establish

section 18 tolerances, prior to the

issuance of this final rule.

In the time period spanning from

August 1996 to the present, EPA has

been evaluating section 18 exemption

requests and issuing associated

tolerances or tolerance exemptions on a

case-by-case basis. These evaluations

have been determined based on

materials submitted by Federal and

State agencies in accordance with EPA

guidance and interim procedures sent to

them in September 1996 and further

elaborated in Pesticide Registration

Notice 97–1, dated January 1997, which

Federal Register / Vol. 65, No. 207 / Wednesday October 25, 2000 / Rules and Regulations 64127

is available in the OPP Docket (see Unit

I.B.2). This non-binding interim

approach to current section 18 tolerance

decisions has remained in place while

the Agency has developed this FFDCA

section 408(l)(6) procedural regulation.

The June 3, 1999 proposal was strictly

a procedural scheme and did not modify

any regulatory policies associated with

the approval of the emergency

exemption itself under FIFRA. EPA

proposed to establish a new part 176 in

the CFR to house exclusively

regulations governing the setting of

time-limited tolerances for emergency

exemptions. In summary, EPA proposed

to:

1. Review data for establishing a timelimited tolerance only after a section 18

request has been submitted;

2. Evaluate each submission

individually on a case-by-case basis to

determine if adequate reliable

information is available to make the

required safety finding;

3. Not routinely require additional

data to be generated and instead rely on

submitted data already reviewed and

evaluated; and

4. Strive to make a regulatory decision

in a timely manner.

If a tolerance could not be established

then the emergency exemption would

not be granted. Time-limited tolerances

would typically be set for a period of 24

months to allow the treated crop from

the previous year’s emergency

application to clear the channels of

trade.

In addition to the above proposed

procedure, EPA solicited comments on

several other options for addressing

time-limited tolerances. One approach

was to require a full data set to support

section 18 tolerances in the same

manner as is required for the

establishment of permanent tolerances.

EPA also considered requiring a

minimum data set in which the

applicant would need to provide a

specific subset of the data normally

required to establish a permanent

tolerance. Under this approach, the

Agency would evaluate only those

defined studies in making its safety

finding. EPA did not include either

approach as its primary option because

they did not allow for timely decisions.

Another approach for setting timelimited tolerances was suggested by the

National Food Processors’ Association.

If this approach were adopted, EPA

would not conduct a full-risk

assessment for a section 18 tolerance,

but would instead assess the

incremental risk of the proposed

emergency pesticide use, that is, the

amount that the proposed use would

increase dietary risk above the risk from

existing uses.

B. What is the Agency’s Authority for

Taking this Action?

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.’’

Regulations regarding EPA’s

implementation of FIFRA section 18 are

codified in 40 CFR part 166.

FQPA amended the FFDCA by

directing EPA to establish time-limited

tolerances or tolerance exemptions for

pesticide use authorized by EPA under

section 18 of FIFRA that may result in

residues in or on food or feed.

Specifically the FFDCA section 408(l)(6)

requires EPA to establish a tolerance or

exemption from the requirement of a

tolerance for pesticide chemical

residues in or on food that will result

from the use of a pesticide under an

emergency exemption. Section 408(l)(6)

also requires EPA to promulgate

regulations governing the establishment

of tolerances and tolerance exemptions

for pesticide uses approved for

emergency situations under FIFRA

section 18. Section 408(e)(1) authorizes

the Administrator to establish, modify,

suspend, or revoke any tolerance or

exemption from the requirement of a

tolerance on her own initiative, and to

establish general procedures and

requirements to implement section 408.

This final rule is issued under the

authority of sections 408(e)(1)(c) and

408(l)(6) of FFDCA, as amended by

FQPA.

III. Public Comment and EPA Response

EPA received a total of 10 comments

in response to its proposed rule. Five

States, two growers groups, two

pesticide manufacturing companies, and

one public interest group submitted

comments. In addition, the National

Food Processors’ Association attached

its previously submitted petition

requesting that EPA use an incremented

risk approach to its comments. This

petition, entitled ‘‘Petition To Issue A

Regulation Governing Establishment Of

Section 18 Tolerances,’’ was cosponsored by 19 associated grower

groups. Everyone expressed support of

EPA’s premise that timeliness and rapid

review of section 18 requests is the

essence of the program. In this regard,

all parties agreed that the Agency

should only utilize ‘‘available data in its

section 18 tolerance reviews.’’

EPA, in addition to considering

changes based on public comments, also

made minor changes to § § 176.5 and

176.11(a) in the final rule to clarify the

provisions and to conform to other

regulations (particularly 40 CFR part

166). EPA has also changed the text of

§ 176.3 slightly by changing ‘‘a State,

U.S. Territory, or Federal agency’’ to

‘‘any entity, authorized under section 18

of FIFRA to request an emergency

exemption,’’ and by changing

‘‘declares’’ a crisis exemption to

‘‘issues.’’ A similar change has been

made to § 176.15. These changes will

eliminate any future need to amend

these rules in the event that EPA’s

regulations or FIFRA are ever changed

so that an entity other than a State, U.S.

Territory, or Federal agency would be

allowed to request an emergency

exemption. Other changes to the final

rule were made as discussed in this

unit. Following is a summary of the

significant comments received by EPA

and its response to these comments.

A. EPA Should Adopt an Incremental

Risk Approach to Setting Tolerances for

Emergency Exemptions

Eight submitters commented on the

approach EPA should take to establish

time-limited tolerances for emergencies.

Two commenters agreed with EPA’s

proposed scheme to set tolerances on a

case-by-case basis using available,

reliable information to make the

required safety finding. Six commenters,

while not critical of EPA’s proposed

approach, urged the Agency to instead

implement an accelerated review

process based on the incremental risk of

the emergency use. One commenter

thought that the minimum data set

approach was ‘‘intriguing’’ and could

deserve further consideration. This

approach, it was stated, had the

potential to lend clarity and objectivity

to the section 18 process and eliminate

the need for the Agency to use ‘‘best

judgement.’’

The proponents of the incrementalrisk approach argued that since

emergency exemptions are by their very

nature extreme situations, the process

for addressing them should take this

into account and they should be given

special treatment. Pesticide use in an

emergency is for a short term and

generally is limited to a singlegeographic area, therefore there is less

exposure to the pesticide and minimal

associated risk. One commenter noted

that the Agency’s policy of conducting

a full-risk assessment for section 18

tolerances does not consider the limited

scope and duration of the use. The

commenter stated that performing full

risk assessments each time a section 18

tolerance is requested not only slows

down the entire section 18 review

process, but also diverts Agency

resources. According to the commenter

64128 Federal Register / Vol. 65, No. 207 / Wednesday October 25, 2000 / Rules and Regulations

an incremental-risk approach would

eliminate the time pressures and would

avoid the disruption to EPA’s base

pesticide regulatory programs.

In spite of the thoughtful comments

on the fourth option, EPA believes that

the case-by-case approach outlined in

its proposal is the most practical

approach that does not significantly

sacrifice timeliness or efficiency and is

in compliance with the law. It allows

the Agency to make appropriate

decisions quickly while fully protecting

human health, especially infants and

children, and safeguarding the

environment. Moreover, this approach,

coupled with the Agency’s newly

established Threshold of Regulation

Policy for pesticide tolerances (see Unit

IV.) may resolve many concerns

expressed by those who favor the

incremental-risk approach.

EPA is not prepared at this time to

adopt the approach suggested by the

commenters. In addition to presenting

difficult legal issues, the incrementalrisk approach may not be needed to

address the commenters’ concerns

regarding purported EPA denial of

section 18 emergency exemption

petitions or a lack of timely review by

the Agency of such petitions. EPA’s

initial implementation of the new

tolerance requirement necessitated

adjusting Agency procedures and

involved some deviation from past EPA

review times in handling section 18

emergency exemption requests. Now

that EPA has had 4 years experience in

setting section 18 emergency exemption

tolerances, it believes that it has

adequately adapted the emergency

exemption process to deal with the

longer lead-time inherent in the

requirement for establishment of these

tolerances. Further, as noted in this

unit, the Agency’s newly established

Threshold of Regulation Policy for

pesticide tolerances (see Unit IV.) may

address many of the commenters’

concerns.

B. The Timely Establishment of a

Tolerance After Granting an Emergency

Exemption is Crucial

Several commenters said that EPA

should establish a tolerance at the time

of the section 18 approval. The

underlying concern was that the Agency

would not be able to establish a

tolerance before the crop is harvested or

the commodity enters into interstate

commerce. One person remarked that in

addition to the presence of an

emergency condition, growers are

subject to increased uncertainty and

anxiety the longer it takes the Agency to

establish a tolerance. The commenters

were concerned that crops treated in the

course of an emergency would be

considered adulterated and seized for

the lack of an established tolerance.

As a general matter, the Agency agrees

with the submitter. For new pesticides,

the Agency grants a registration and

establishes the required tolerances

simultaneously. However, due to the

urgent nature of pest emergencies,

growers need to be able to lawfully

apply a pesticide as soon as possible or

face significant economic loss for that

year. If the Agency concludes that it is

unable to establish a time-limited

tolerance for that use, it will notify the

applicant immediately so that some

other method of control for the

emergency pest situation can be sought.

EPA often has to balance its workload

between establishing tolerances and

processing section 18 requests. During

peak periods for emergency exemption

requests, resources used to set a

tolerance could result in the delay of

another State’s section 18 application.

Nonetheless, EPA is committed to

working toward the goal of being able to

set a tolerance at the same time as

granting the emergency exemption. For

example, in Fiscal Year (FY) 1999,

EPA’s average time to establish a

tolerance once the exemption was

granted was 66 days. This is

significantly faster than the average of

87 days it took the Agency in FY 1998.

FFDCA section 408(l)(5) explains the

conditions upon which foods and feeds

may be subject to enforcement action

due to pesticide residues. Under this

subsection, if a tolerance is no longer in

effect, i.e., it has been revoked or has

expired, the crop may continue to be

marketed if:

1. The crop was treated with an

approved use of the pesticide at the time

of treatment, and

2. The level of the residues do not

exceed the tolerance in effect at the time

the pesticide was applied.

In the second instance, it is important

to note that the tolerance must be in

place at the time the pesticide is used.

This is why many States often submit

section 18 emergency exemption

requests several months prior to the

onset of the emergency in anticipation

of the 2–3 month time between issuing

the exemption and establishing the

tolerance. They acknowledge that for

residues resulting from the use to be

considered lawful once the tolerance

has expired, the tolerance must be in

place at the time of application, not the

time of harvest. Nonetheless, EPA’s

policy of setting tolerances for longer

duration than the exemption ensures

that crops treated during an emergency

situation should lawfully clear trade

channels while the tolerance is still in

effect.

C. All Emergency Exemptions Issued

Under Section 18 Should Be Covered

Under the ‘‘Pipeline’’ Provision

Many of those who submitted

comments thought that the ‘‘pipeline’’

provision of 408(l)(5) should apply to

exemptions declared under crisis

situations. The ‘‘pipeline’’ can be

described as those crops that have been

treated legally with a pesticide that are

still in the channels of trade when the

tolerance is either revoked or, as in the

case of an emergency exemption, has

expired. Those who commented on this

felt that although a tolerance is not in

place at the time the unregistered

pesticide is used, since the pesticide use

was legal under FIFRA section 18, any

resulting pesticide residues should also

be considered legal and not subject to

enforcement actions.

Crisis exemptions are by definition

unpredictable. In instances where an

emergency condition occurs suddenly

and there is no time to formally request

a specific emergency exemption, a State

or Federal agency may issue a crisis

exemption and permit the use of an

unregistered pesticide (40 CFR 166.40).

Under a crisis exemption a pesticide is

almost always used in the field prior to

the establishment of a tolerance.

However, this situation can occur for

specific exemptions as well. In many

instances, a specific exemption request

(especially with first-time tolerance

requests) is granted and the pesticide

may be used in the field prior to the

establishment of the time-limited

tolerance, where appropriate. EPA later

conducts a full review and establishes

the time-limited tolerance. If the timelimited tolerance is not set at a length

of time to allow for crops to clear trade

channels, or is not extended and

therefore expires, commodities treated

under these circumstances could be

adulterated and subject to seizure.

In both of these instances the

‘‘pipeline’’ provision does not apply

because a tolerance was not set at the

time the pesticide is applied. The

statutory requirement of FFDCA section

408(l)(5)(B) is not met. EPA cannot alter

the requirements in the FFDCA through

regulations. Nonetheless, as noted in

this unit, EPA’s policy of setting

tolerances for longer duration than the

section 18 exemption generally ensures

that crops treated during an emergency

situation should clear trade channels

while the tolerance is still in effect.

Some commenters expressed concern

that even though they legally applied a

pesticide under a crisis emergency

exemption, if after EPA review the

Federal Register / Vol. 65, No. 207 / Wednesday October 25, 2000 / Rules and Regulations 64129

necessary tolerance level would exceed

the safety standard and by law could not

be set, their entire crop could be subject

to Federal enforcement measures. To

avoid this potentially dire situation,

States and Federal agencies are urged to

consult with the Agency to determine

whether the pesticide in question has

particular safety issues or concerns

before declaring a crisis.

D. Time-Limited Tolerances Should Be

Set for Longer Than 24 Months

A few commenters thought EPA

should consider establishing timelimited tolerances for longer than 2

years. One commenter remarked that

certain exemptions will likely be

needed for 3 or more years because

issues such as new pest pressures or the

development of resistance are not likely

to go away once they have appeared.

The commenter suggested EPA set

tolerances for 3 years upon initially

granting the section 18 request based on

circumstances which are likely to

persist over several years. The

commenter added that an exemption

such as one based on unusual weather

patterns probably will not reoccur in

succeeding years and a 2-year tolerance

is adequate in this situation.

Under EPA’s regulations, specific

exemptions and public health

exemptions can be authorized for

periods of up to 1 year (40 CFR

166.28(a)). Since actions taken under

this section are intended to address an

emergency need for temporary pest

relief, most section 18 exemptions are

granted for one growing season. In the

preamble to the proposed rule, EPA

stated that it will typically set a timelimited tolerance for a 2-year period.

This is expected to allow treated crops

from the previous year to clear the

channels of trade. The Agency is

flexible on this point and may set timelimited tolerances for longer time

periods if warranted. In addition, EPA

may modify or extend a time-limited

tolerance at any time on its own

initiative or at the applicant’s request.

EPA has changed § 176.13 in the final

rule to clarify that it may extend the

duration of a tolerance for various

reasons. EPA strongly recommends that

if an applicant believes that 24 months

is insufficient for a time-limited

tolerance, the applicant should request

a more appropriate length of time in the

initial section 18 request. This will

permit the Agency to judge whether a

longer period would be appropriate.

One commenter noted that in the

proposed regulatory text, the words

‘‘unless extended’’ should be added to

§ 176.11(b) to be consistent with the

language in § 176.13. Section 176.11(b)

states that ‘‘(b) Tolerances will

automatically expire and be revoked,

without further action by EPA, at the

time set out in the Federal Register

notice establishing the tolerance.’’ EPA

agrees with this suggestion and has

added the phrase to this section.

E. This Rulemaking Should Be

Considered a ‘‘Significant Action’’ that

Requires OMB Review

Two commenters disagreed with the

determination that the proposed rule

was not a ‘‘significant regulatory action’’

as defined under section 3(f) of

Executive Order 12866, entitled

Regulatory Planning and Review (58 FR

51735, October 4, 1993), and stated it

should have therefore undergone review

by the Office of Management and

Budget (OMB), and that the final rule

should be reviewed by OMB. One

commenter stated that emergency

exemptions are by definition ‘‘of

economic importance.’’ In addition,

crop losses associated with emergency

exemptions are routinely multi-million

dollar situations and that individual

States and individual growers are

‘‘significantly’’ impacted by a

cumbersome tolerance setting process. It

was suggested that OMB review the

potential impacts associated with delays

in establishing tolerances.

E.O. 12866 defines as ‘‘significant’’ a

regulatory action that is likely to:

1. Have an annual effect on the

economy of $100 million or more, or

adversely and materially affect a sector

of the economy; productivity;

competition; jobs; the environment;

public health or safety; or State, local,

or tribal governments or communities;

2. Create serious inconsistency or

otherwise interfere with an action taken

or planned by another agency;

3. Materially alter the budgetary

impacts of entitlements, grants, user

fees, or loan programs; or

4. Raise novel legal or policy issues.

The determination of whether or not

a regulatory action should be reviewed

by OMB under E.O. 12866 is made in

consultation with OMB. Since this rule

is a procedural rule that codifies the

internal process by which EPA will set

emergency tolerances, OMB determined

that it was not a significant regulatory

action that required OMB review under

E.O. 12866. As stated in the proposal’s

preamble, EPA estimates that the direct

cost of this rule will be minimal because

only EPA and applicants are directly

affected, and this action does not

require applicants to submit new or

additional information.

The Agency determined that this rule,

once promulgated, is not expected to

significantly change applicant activities,

such that it would increase the current

burden to applicants and therefore is

unlikely to have a major economic

impact on the States or Federal agencies

that apply for section 18 exemptions. In

addition, EPA affirms that promulgation

of this rule will have no direct impact

on any other sector of the economy, or

on any other government entities,

programs, or policies. A copy of the

economic analysis is available in the

public version of the official record for

this rule (see Unit I.B.2.).

IV. Is a Tolerance Needed?

On October 27, 1999, EPA published

in the Federal Register a notice of

availability of a policy entitled,

‘‘Threshold of Regulation Policy—

Deciding Whether a Pesticide With a

Food Use Pattern Requires a Tolerance’’

(64 FR 57881) (FRL–6388–2). This

policy pertains to the use of a pesticide

(including an emergency use) on, in, or

near food which does not result in

residues that are detectable in food. EPA

is adopting this policy which sets forth

criteria to consider in evaluating

whether there is no ‘‘need’’ to establish

a tolerance, i.e., there is no reasonable

expectation of finite residues of the

pesticide in the food. If the criteria are

met, there is no requirement for a

tolerance or tolerance exemption. The

Threshold of Regulation policy will be

applicable for pesticide uses that result

in no detected residues in food and for

which the degree of potential risk posed

by any theoretically possible residues is

so minimal that tolerance setting serves

no purpose.

The Threshold of Regulation Policy

can apply to time-limited tolerances for

section 18 emergency exemptions. In

these instances, the Agency will

consider surrogate data in the case of

emergency exemption requests where

all the data needed on the performance

of the analytical method or the

magnitude of the residue as determined

by field trial studies on the subject

commodity are unavailable. Given the

emergency circumstances, EPA may

consider accepting data from a different

crop to establish eligibility for the

threshold of regulation. Persons wishing

a Threshold of Regulation policy

decision should make the request in

writing and submit materials and

information that are ordinarily required

to support time-limited tolerances or

tolerance exemptions.

V. Regulatory Assessment

Requirements

A. Executive Order 12866

Pursuant to Executive Order 12866,

entitled Regulatory Planning and

64130 Federal Register / Vol. 65, No. 207 / Wednesday October 25, 2000 / Rules and Regulations

Review (58 FR 51735, October 4, 1993),

it has been determined that this action

is not a ‘‘significant regulatory action’’

and is therefore not subject to review by

OMB. OMB has made this

determination because this final rule is

a procedural rule that codifies the

internal process by which EPA will set

emergency tolerances. Applicants for

section 18 emergency exemptions (i.e.,

Federal and State agencies) are the only

parties, other than EPA, directly affected

by this action. According to the

economic assessment conducted by the

Agency, the applicants of section 18

emergency exemptions are not expected

to experience any adverse impacts as a

result of this rule because the rule does

not require any new or additional data

from applicants.

A copy of the economic assessment is

available in the public version of the

official record for this rule (see Unit

I.B.2.).

B. Regulatory Flexibility Act

Pursuant to section 605(b) of the

Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.), the Agency hereby

certifies that this regulatory action does

not have a significant economic impact

on a substantial number of small

entities. Applicants for section 18

emergency exemptions are U.S. States,

territories, or Federal agencies which,

by definition, are not small entities

under the RFA. Applicants for section

18 emergency exemptions are the only

parties, other than EPA, directly affected

by this action.

Information regarding this

determination will be provided to the

Chief Counsel for Advocacy of the Small

Business Administration (SBA) upon

request.

C. Paperwork Reduction Act

Pursuant to the Paperwork Reduction

Act (PRA), 44 U.S.C. 3501 et seq., an

agency may not conduct or sponsor, and

a person is not required to respond to,

an information collection request unless

it displays a currently valid OMB

control number. The OMB control

numbers for EPA’s regulations, after

appearing in the preamble of the final

rule, are listed in 40 CFR part 9 and 48

CFR chapter 15, and included on the

related collection instrument. This

regulatory action does not contain any

new information collection

requirements that would require

additional OMB review and approval.

The information collection activities

related to the procedures for emergency

exemptions under section 18 of FIFRA,

which are contained in 40 CFR part 166,

are already approved by OMB under

OMB control number 2070–0032 (EPA

ICR No. 596), and the process and

informational needs for requesting that

the Agency establish or provide an

exemption from the establishment of a

tolerance or maximum-residue level for

the use of a pesticide on food or feed

crops, which are contained in 40 CFR

part 180, are already approved by OMB

under OMB control number 2070–0024

(EPA ICR No.597). As described in the

information collection instruments, the

annual respondent burden for the

information collection activities in 40

CFR part 166 is estimated to average 103

hours per application, including time

for reading the regulations, processing,

compiling and reviewing the requested

data, generating application

correspondence or summary reports,

and storing, filing, and maintaining the

data. The annual respondent burden for

the information collection activities in

40 CFR part 180 is estimated to average

1,726 hours per petition, including time

for reading the regulations, processing,

compiling and reviewing the requested

data, generating the request, storing,

filing, and maintaining the data.

As defined by the PRA and 5 CFR

1320.3(b), ‘‘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.

This 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.

D. Environmental Justice Considerations

This final rule does not involve

special considerations of

environmental-justice issues pursuant to

Executive Order 12898, entitled Federal

Actions to Address Environmental

Justice in Minority Populations and

Low-Income Populations (59 FR 7629,

February 16, 1994). The Agency has

determined that this final rule does not

affect the environmental and health

conditions in low-income and minority

communities because this rule codifies

the internal process by which EPA will

set emergency tolerances, and only

applies to applicants for section 18

emergency exemptions (i.e., Federal and

State agencies). In general, low-income

and minority communities are more

likely to benefit from the risk

assessment process needed for the

establishment of tolerances for section

18 actions that might impact their

community.

E. Unfunded Mandates Reform Act

Under Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA)

(Public Law 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 1 year. As

applicants for section 18 emergency

exemptions, Federal and State agencies

are the only parties, other than EPA,

directly affected by this action. The

potential impact on State agencies,

however, is expected to be minimal

because this action does not require

applicants to submit new or additional

information. In addition, EPA has

determined that this rule does not

significantly or uniquely affect small

governments. Accordingly, this action is

not subject to the requirements of

sections 202, 203, 204, and 205 of

UMRA.

F. Federalism

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999), requires EPA to develop an

accountable process to ensure

‘‘meaningful and timely input by State

and local officials in the development of

regulatory policies that have federalism

implications.’’ ‘‘Policies that have

federalism implications’’ is defined in

the Executive Order to include

regulations that have ‘‘substantial direct

effects on the States, on the relationship

between the national government and

the States, or on the distribution of

power and responsibilities among the

various levels of government.’’ This

final rule will not have substantial

direct effects on the States, on the

relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132. Since this rule

codifies an internal process for the

Agency, and does not impose

requirements on others, the Agency

determined that this rule will not

adversely impact the entities that apply

for section 18 exemptions. The process

established by this final rule will more

likely benefit applicants and others by

establishing an effective and efficient

process for the Agency to take the

necessary tolerance actions in a timely

manner. Thus, the requirements of

Federal Register / Vol. 65, No. 207 / Wednesday October 25, 2000 / Rules and Regulations 64131

section 6 of the Executive Order do not

apply to this rule. Nevertheless, the

Agency provided an opportunity for

Federal and State agencies to review

and provide comments on the proposed

process. A discussion of the comments

EPA received, which includes

comments from several State and local

officials, and how those comments are

addressed in the final rule, is provided

in Unit III.

G. Consultation and Coordination with

Indian Tribal Governments

Under Executive Order 13084,

entitled Consultation and Coordination

with Indian Tribal Governments (63 FR

27655, May 19,1998), EPA may not

issue a regulation that is not required by

statute, that significantly or uniquely

affects the communities of Indian tribal

governments, and that imposes

substantial direct compliance costs on

those communities, unless the Federal

government provides the funds

necessary to pay the direct compliance

costs incurred by the tribal

governments. This final rule

implements requirements specifically

set forth by the Congress in FFDCA

section 408(l)(6) without the exercise of

any discretion by EPA. The final rule

does not significantly or uniquely affect

the communities of Indian tribal

governments. Accordingly, the

requirements of section 3(b) of

Executive Order 13084 do not apply to

this final rule.

H. Children’s Health Protection

This final rule is not subject to

Executive Order 13045, entitled

Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997),

because this is not an economically

significant regulatory action as defined

by Executive Order 12866 (see Unit

V.A.). In addition, this final rule is

procedural in nature and does not

involve decisions on environmental

health or safety risks that may

disproportionately affect children.

I. National Technology Transfer and

Advancement Act

This 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.

J. Civil Justice Reform

In issuing this rule, EPA has taken the

necessary steps to eliminate drafting

errors and ambiguity, minimize

potential litigation, and provide a clear

legal standard for affected conduct, as

required by section 3 of Executive Order

12988, entitled Civil Justice Reform (61

FR 4729, February 7, 1996).

K. Constitutionally Protected Property

Rights

EPA has complied with Executive

Order 12630, entitled Governmental

Actions and Interference with

Constitutionally Protected Property

Rights (53 FR 8859, March 15, 1988),

by examining the takings implications

of this rule in accordance with the

‘‘Attorney General’s Supplemental

Guidelines for the Evaluation of Risk

and Avoidance of Unanticipated

Takings’’ issued under the Executive

Order.

VI. Submission to Congress and the

General Accounting Office

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of the rule in

the Federal Register. This action is not

a ‘‘major rule’’ as defined by 5 U.S.C.

804(2).

List of Subjects in 40 CFR Part 176

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: October 16, 2000.

Carol M. Browner,

Administrator.

Therefore, 40 CFR chapter I is

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 Publication 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.

§ 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 use of

pesticides under 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.

§ 176.3 Definitions.

The 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 § 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 any entity

authorized under section 18 of FIFRA to

request an emergency exemption that

requests such an exemption under

§ 166.20 of this chapter, or issues a

crisis exemption under § 166.40 of this

chapter.

Crisis exemption means an exemption

authorized under FIFRA section 18, in

accordance with § § 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

§ § 166.20 through 166.35 of this

chapter.

EPA means the U.S. Environmental

Protection Agency.

64132 Federal Register / Vol. 65, No. 207 / Wednesday October 25, 2000 / Rules and Regulations

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 part, the term

‘‘tolerance’’ shall include an exemption

from the requirement of a tolerance.

§ 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, if EPA authorizes an

emergency exemption or a crisis

exemption. EPA will consider

establishing such a tolerance only if an

applicant acting under authority of

FIFRA section 18 either has requested

an emergency exemption, has stated its

intention to issue a crisis exemption, or

has issued a crisis exemption for a use

that may result, directly or indirectly, in

pesticide chemical residues in food or

feed.

§ 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, and based on the available

data the Agency cannot conclude that

there is a reasonable certainty that no

harm will result from the use proposed

by the applicant or granted pursuant to

a crisis exemption, 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.

§ 176.9 Publication of a tolerance.

(a) If EPA issues an emergency

exemption or crisis exemption under

FIFRA section 18, and EPA concludes

that the tolerance for residues resulting

from use of the pesticide under the

exemption will be safe, then EPA will

establish the tolerance by publishing an

amendment to 40 CFR part 180 in the

Federal Register.

(b) A tolerance under this part may be

established without prior publication of

a proposed tolerance or comment

period.

§ 176.11 Duration of a tolerance.

(a) Tolerances issued under this part

will become effective upon publication

in the Federal Register, unless

otherwise specified by the

Administrator.

(b) Unless extended, tolerances will

automatically expire and be revoked,

without further action by EPA, at the

time set out in the final rule published

in Federal Register.

(c) The Administrator may revoke a

tolerance at any time if the

Administrator determines that the

tolerance is no longer safe.

§ 176.13 Modification of a time-limited

tolerance.

If additional emergency or crisis

exemptions are authorized that would

extend use beyond the date originally

authorized, or if EPA determines that

the duration of a time-limited tolerance

is insufficient to allow treated

commodities to clear the channels of

trade, EPA may modify the time-limited

tolerance by publication of a final rule

in the Federal Register. EPA will use

the same criteria and procedures for

modification as for establishing

tolerances under this part.

§ 176.15 Effect of a tolerance.

The establishment of a tolerance

under this part does not alter the

requirement that any applicant comply

with procedures established in part 166

of this chapter for emergency

exemptions of FIFRA.

[FR Doc. 00–27405 Filed 10–24–00; 8:45 am]

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