Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices 35069

application to which the filing refers.

Any of the above-named documents

must be filed by providing the original

and the number of copies provided by

the Commission’s regulations to: The

Secretary, Federal Energy Regulatory

Commission, 888 First Street NE,

Washington, DC 20426. An additional

copy must be sent to Director, Division

of Project Review, Federal Energy

Regulatory Commission, at the abovementioned address. A copy of any

notice of intent, competing application

or motion to intervene must also be

served upon each representative of the

Applicant specified in the particular

application.

Agency Comments—Federal, state,

and local agencies are invited to file

comments on the described application.

A copy of the application may be

obtained by agencies directly from the

Applicant. If an agency does not filed

comments within the time specified for

filing comments, it will be presumed to

have no comments. One copy of an

agency’s comments must also be sent to

the Applicant’s representatives.

Linwood A. Watson, Jr.,

Acting Secretary.

[FR Doc. 00–13622 Filed 5–31–00; 8:45 am]

BILLING CODE 6717–01–M

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–170005; FRL–6559–3]

Pesticides; Guidance on Pesticide

Import Tolerances and Residue Data

for Imported Food; Request for

Comment

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice and request for comment.

SUMMARY: This document provides

detailed guidance on applying current

U.S. data requirements for the

establishment or continuance of

tolerances for pesticide residues in or on

imported foods. The purpose of this

guidance is to promote greater

transparency and provide clear

guidance to interested parties on how to

obtain an import tolerance. This

guidance includes information on how

to adapt data requirements for U.S. food

uses to import tolerances, both for

establishing new import tolerances and

for modifying or maintaining existing

U.S. tolerances for import purposes

when U.S. uses or registrations are

canceled. The Agency is soliciting

comments on the approach reflected in

this detailed guidance.

In addition, the Agency expects to

consider certain information on

pesticide use outside the U.S. and

resulting pesticide chemical residues in

or on imported food to establish or

modify tolerances when there is a

corresponding U.S. registration and use.

EPA may also require additional

information and/or data to better

characterize the nature of residues in or

on imports when such information and/

or data are necessary to make the

required safety finding during

registration, reregistration, or tolerance

reassessment. This would apply to a

limited number of cases when imported

commodities comprise a high

percentage of U.S. consumption;

domestic residue data are not likely to

be representative of growing conditions

in other countries; and U.S. consumers

would likely be exposed to significant

residues in imported foods. The Agency

is developing criteria to implement this

requirement and is soliciting comments.

In addition to meeting the

requirements of the Federal Food, Drug,

and Cosmetic Act (FFDCA), as amended

by the Food Quality Protection Act of

1996 (FQPA), this guidance has been

developed consistent with the goals of

the North American Free Trade

Agreement (NAFTA), including

minimizing trade irritants among the

NAFTA countries. This document also

addresses the U.S. obligations under the

World Trade Organization Agreement

on the Application of Sanitary and

Phytosanitary Measures.

DATES: Comments, identified by the

docket number OPP–170005, must be

received on or before July 31, 2000.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

provided in Unit I. of the

SUPPLEMENTARY INFORMATION section of

this notice.

FOR FURTHER INFORMATION CONTACT:

Kimberly Lowe, Office of Pesticide

Programs, Special Review and

Reregistration Division (7508C),

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460, telephone number: 703–308–

8059; fax number: 703–308–8041, e-mail

address: lowe.kimberly@epa.gov

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

You may be affected by this notice if

you sell, distribute, manufacture, or use

pesticides for agricultural applications,

process food, distribute or sell food, or

implement governmental pesticide

regulations. Potentially affected

categories and entities may include, but

are not limited to the following:

Category NAICS Codes Examples of Potentially Affected Entities

Food manufacturers 311 Commercial food processors

Pesticide manufacturers 32532 Pesticide registrants

Pesticide producers

This table 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. If you have any

questions regarding the applicability of

this action to a particular entity, you can

consult with the person listed under

‘‘FOR FURTHER INFORMATION

CONTACT.’’

II. How Can I Get Additional

Information or Copies of this Document

or Other Documents?

1. Electronically. You may obtain

electronic copies of this document and

various support documents from the

EPA Internet Home Page at http://

www.epa.gov/. On the Home Page select

‘‘Laws and Regulations’’ 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 or by phone. If you have

any questions or need additional

information about this action, you may

contact the technical person identified

in the ‘‘FOR FURTHER INFORMATION

CONTACT’’ section. In addition, the

official record for this notice, including

the public version, has been established

under docket control number OPP–

170005, (including comments and data

submitted electronically as described

35070 Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices

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. The Public

Information and Records Integrity

Branch telephone number is 703–305–

5805.

III. How Can I Respond to This Notice?

A. How and to Whom Do I Submit

Comments?

You may submit comments through

the mail, in person, or electronically. Be

sure to identify the appropriate docket

number (i.e., ‘‘OPP–170005’’) in your

correspondence.

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, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

2. In person or by courier. Deliver

written comments to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, Rm. 119, Crystal

Mall #2, 1921 Jefferson Davis Highway,

Arlington, VA.

3. Electronically. Submit your

comments and/or data electronically by

e-mail to: opp-docket@epa.gov. Do not

submit any information electronically

that you consider to be Confidential

Business Information (CBI). Submit

electronic comments as an ASCII file,

avoiding the use of special characters

and any form of encryption. Comment

and data will also be accepted on

standard computer 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–170005. Electronic

comments on this notice may also be

filed online at many Federal Depository

Libraries.

B. How Should I Handle CBI

Information that I Want to Submit to the

Agency?

You may claim information that you

submit in response to this document as

CBI 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. If you have any questions about

CBI or the procedures for claiming CBI,

please consult with the technical person

identified in the ‘‘FOR FURTHER

INFORMATION CONTACT’’ section.

IV. Guidance on Import Tolerances

A. Introduction

This document describes the EPA

guidance regarding pesticide residues in

or on imported foods. In particular, by

this document, EPA is informing

interested parties of the steps they must

take to obtain a new import tolerance (a

tolerance that does not have a related

U.S. registration) or to maintain an

existing tolerance as an import tolerance

when the corresponding domestic use

has been canceled. In addition, EPA is

proposing guidance identifying the

information and data that EPA believes

are necessary to accurately reflect

residues in or on imported food for

certain tolerances with corresponding

domestic uses and to make a safety

finding for those tolerances. The same

food safety standards apply to

tolerances proposed for both

domestically-produced and imported

food; as a result, domestic and foreign

growers are treated equally. Interested

persons are invited to comment on any

aspect of this document, and in

particular, on the questions raised in

Unit IV.G.

EPA intends to achieve several

objectives by describing its historical,

current, and proposed process for

establishing, modifying and maintaining

tolerances with no corresponding

domestic registration and for tolerances

with domestic registrations:

1. Assure a safe food supply for the

general population and sensitive

subpopulations in particular, such as

infants and children.

2. Target import data requirements to

circumstances that are likely to affect

the risk assessment.

3. Maintain the Agency’s schedule for

reassessing tolerances under the Food

Quality Protection Act (FQPA).

4. Ensure that tolerance policies

remain consistent with international

obligations such as the provisions of the

World Trade Organization (WTO)

Agreements and the North American

Free Trade Agreement (NAFTA) chapter

on Sanitary and Phytosanitary (SPS)

Measures.

5. Promote greater transparency in

Agency policies by providing written

guidance and soliciting public

comment.

A U.S. tolerance (the equivalent of a

tolerance is sometimes called a

maximum residue limit, or MRL, in

other countries) is the maximum residue

level of a pesticide permitted in or on

food or feed grown in the U.S. and food

or feed imported into the U.S. from

other countries. Food may not lawfully

be sold in, or imported into, the United

States if the food contains detectable

pesticide residues above the level

permitted by a tolerance, or at any level

if no tolerance, or exemption from the

requirement of a tolerance, has been

established. Generally, tolerances are set

for raw agricultural commodities and

also apply to processed foods derived

from the commodities. This is because,

in most cases, processing results in

residues at or below the levels in the

raw commodity; EPA requires

processing data to ascertain this. If

residues in processed food concentrate

to higher levels than in the raw

commodity, separate tolerances will

need to be established to cover residues

in the processed food.

Typically, EPA establishes a tolerance

or tolerance exemption for a food

commodity at the same time that it

registers the use of a pesticide for that

commodity in the U.S. Where no U.S.

registration exists, interested persons

may submit a petition requesting that

EPA establish a tolerance or a tolerance

exemption for a pesticide residue on a

commodity that would allow treated

food to be legally imported into the

United States. The term ‘‘import

tolerance’’ is used as a convenience to

refer to a tolerance that exists where

there is no accompanying U.S.

registration. There is no statutory or

regulatory distinction between an

‘‘import tolerance’’ and any other

tolerance issued by EPA.

With this document, EPA provides

further clarification of its requirements

for import tolerances, and proposes a

modification of its approach to

registration to permit greater

consideration of residues in or on

imported food in establishing or

maintaining tolerances or tolerance

exemptions for food uses registered in

the U.S. This document explains the

need for foreign residue data for both

purposes and a process for the early

notification of other countries of the

potential for revocation of tolerances

following cancellation of a related U.S.

registration. This Notice also explains

that EPA intends to make use of existing

information to the greatest extent

appropriate, including data (and

associated reviews) that may have been

submitted in support of MRLs

established by the international Codex

Alimentarius Commission, or to

regulatory authorities in Canada,

Mexico, or other countries.

Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices 35071

Also, the U.S. is working with its

NAFTA partners in developing import

tolerance policies and other related

policies that will maintain and enhance

food safety while minimizing trade

irritants. The publication of U.S. import

tolerance guidance is one step in this

process.

The remainder of this unit provides

information on the legal basis for

requiring data for import tolerances and

how import tolerances fit in with EPA’s

general policies on pesticides; a general

description of the data requirements for

import tolerances; an outline of the

types of screening information on

residues in or on imported food that

EPA is proposing to require; and a brief

discussion of EPA’s obligations under

such international agreements as the

WTO and NAFTA SPS Agreements.

Unit V. of this Notice provides more

specific information on how to apply

existing U.S. data requirements to

tolerances that do not have

corresponding registration for U.S. food

uses.

B. Statutory Basis for Guidance

EPA regulates pesticides under two

major statutes: the Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA)

and the Federal Food, Drug, and

Cosmetic Act (FFDCA). FIFRA requires

that pesticides be registered (licensed)

by EPA before they may be sold or

distributed for use in the United States.

Section 408 of the FFDCA authorizes

EPA to establish, modify, or maintain

tolerances or tolerance exemptions for

pesticide residues in or on food. Once

established, a tolerance or tolerance

exemption applies equally to

domestically-produced and imported

food. Any food with pesticide residues

not covered by a tolerance or tolerance

exemption (or with residues in excess of

the tolerance) may be subject to

regulatory action by the U.S.

government (including seizure).

Pesticide tolerances and exemptions are

enforced by individual states and the

U.S. Food and Drug Administration

(FDA) for most foods, and by the U.S.

Department of Agriculture (USDA) for

meat, poultry, and some egg products.

EPA has an obligation under section

408 of the FFDCA to establish tolerances

for pesticide chemicals at levels that are

‘‘safe.’’ EPA also has an obligation to

ensure that the tolerances continue to be

‘‘safe’’ over time, since new information

may alter the Agency’s earlier safety

finding under the FFDCA.

The Food Quality Protection Act of

1996 (FQPA) made several changes to

the U.S. laws affecting pesticides

(FIFRA and FFDCA). Many of these

changes affect how tolerances are set,

notably: Establishing a single, healthbased standard (the ‘‘reasonable

certainty of no harm’’ standard) for all

pesticide residues in food; eliminating

past inconsistencies in how raw foods

and processed foods were dealt with;

specifying a broader assessment of

potential risks, with special emphasis

on potentially sensitive groups such as

infants and children; significantly

limiting the extent to which benefits can

be used in modifying or maintaining

existing tolerances; and requiring

reassessment of all existing tolerances in

accordance with the new safety

standard. All tolerances (including

import tolerances) must be evaluated

according to this new health standard.

In granting new tolerances and

reassessing existing tolerances to

determine if they meet FQPA standards,

EPA must consider available

information on aggregate nonoccupational exposure from the

pesticide (including exposure from

food, drinking water, and pesticides

used in and around the home),

cumulative effects from pesticides with

a common mechanism or mode of

toxicity; the potential increased

susceptibility of infants and children or

other sensitive subpopulations; and the

potential for estrogenic or other

endocrine effects.

Three additional provisions of FFDCA

as amended by FQPA are particularly

important for this import tolerance

guidance: Section 408(b)(4)

International Standards; section 408(f)

Special Data Requirements; and section

408(l)(2) Revocation of Tolerance or

Exemption Following Cancellation of

Associated Registrations.

In establishing a tolerance, FFDCA

section 408(b)(4) requires EPA to

determine if the Codex Alimentarius

Commission has established a

maximum residue level. If EPA does not

adopt the Codex level, then the Agency

must publish a notice for public

comment explaining the reasons for the

deviation.

If EPA needs additional data to

support the continuance of a tolerance

or exemption, but there are no U.S.

registrants from whom the Agency can

obtain the data under FIFRA, EPA may

require data under section 408(f) of

FFDCA, and EPA intends to use that

authority to impose data requirements.

Section 408(f) of FFDCA allows the

Agency to publish a Notice in the

Federal Register describing the type of

data needed and inviting persons

willing to submit the necessary data to

support the tolerance to identify

themselves. Tolerances may be revoked

if no person commits to supply the

necessary data or if the appropriate data

are not submitted in a timely manner.

Finally, section 408(l) requires EPA to

revoke a tolerance within 180 days of

the cancellation of a FIFRA use if the

use was canceled for dietary risk

reasons.

Companies and others interested in

supporting a tolerance for import

purposes should familiarize themselves

with the changes in FFDCA brought

about by FQPA, since these changes will

affect how potential risks are assessed

and, ultimately, the Agency’s decision

on whether to grant a tolerance.

C. Summary of Guidance

To establish or modify a tolerance, or

to maintain an existing tolerance, EPA

must determine that the proposed or

existing tolerance is safe under section

408 of the FFDCA as amended by FQPA.

This safety finding is based, among

other things, on information about the

toxicity of the pesticide, likely residues

in or on the food in question, and

consumption patterns. For new

tolerances with no accompanying U.S.

registrations, the Agency will continue

to require that tolerance petitioners

provide EPA with the information and/

or data that EPA needs to make the

required safety finding. This usually

will include residue data representative

of the pesticide’s use in other countries

that export food to the U.S.

In addition, as domestic uses are

canceled during the pesticide

reregistration process, or for any other

reason (other than dietary risk), EPA

will consider requests for modifying or

maintaining the corresponding tolerance

to allow the continued import of treated

food into the U.S. As stated above, EPA

is required to make a safety finding and

may determine that additional data

reflecting foreign use patterns and likely

residues in or on imported food are

necessary for EPA to conclude that the

tolerance is safe. For example, if a

tolerance has not been reassessed and

the corresponding domestic registration

is being or has been canceled, old data

may not reflect current use patterns,

including uses abroad. To determine

what data are necessary, EPA will

consider information such as that

described in Unit IV.D. Therefore, it is

important that the data requirements for

import tolerances be clearly stated and

that the international community

understands the need for these data to

ensure the safety of imported food for

the American public.

Similarly, in those cases where EPA

establishes or maintains a tolerance

where there is a corresponding

registered U.S. food use, the Agency

typically has not estimated the specific

35072 Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices

contribution to the diet of residues in or

on imported food. This is because EPA

assumes that residues in or on imported

food will be the same as residues in or

on food that is domestically-produced;

information such as monitoring data is

generally consistent with that

assumption. However, in some

instances this assumption may under- or

overestimate residues in or on imported

food, and, as such, may under- or

overestimate the overall risks from

consumption of the imported food.

Therefore, the Agency expects to

consider additional data and/or

information about pesticide use in other

countries and residues in or on

imported food. Such information may

indicate the need to require additional

data and/or information when necessary

to support the establishment or

reassessment of tolerances with

corresponding domestic registrations

(i.e., to make the required safety finding)

such as information on foreign use

patterns and residues in or on imported

food. Such a requirement for additional

information would apply in a limited

number of cases in which imported

commodities comprise a high

percentage of U.S. consumption,

domestic residue data are not likely to

be representative of growing conditions

in other countries, and U.S. consumers

would likely be exposed to significant

residues in imported foods.

Accordingly, the Agency is issuing

current guidance for establishing import

tolerances and maintaining or

modifying tolerances where the

domestic use has been canceled, and

soliciting comments on further guidance

for determining when data on imported

foods are necessary to support

establishment of tolerances for selected

domestic registrations. Generally, EPA

intends to use the same kinds of

information and general concepts to

determine whether additional data

reflecting residues in or on imported

food are necessary to modify or

maintain a tolerance where the use has

been canceled and to establish, modify,

or maintain a tolerance with a

corresponding U.S. registered use.

1. Current guidance for establishing,

modifying, or maintaining import

tolerances—a. Establishing new

tolerances with no accompanying U.S.

registration. EPA will continue to

require toxicology data and data

representative of residues in or on

imported foods in making the required

safety findings. EPA generally requires

the same toxicology data and residue

data as are needed for U.S. food uses,

except that the data requirements

covering residues in or on imported

food are geared to use conditions in the

exporting countries. In the past, these

data have been required on a case-bycase basis. Unit V. of this Notice

provides more detailed written guidance

on the data requirements to establish a

tolerance for import purposes.

b. Modifying or maintaining

tolerances for imported food following

cancellation of U.S. uses. Registered

pesticide uses may be canceled for a

variety of reasons including internal

business reasons, dietary risk concerns,

or non-dietary risk concerns. In many

cases, a tolerance is no longer needed

after a registered use in this country is

canceled, and EPA routinely proposes to

revoke such tolerances. However, use in

other countries may continue and,

unless a use was canceled due to dietary

risk concerns, EPA will consider

requests (normally by petition) to

modify or maintain a tolerance as an

‘‘import tolerance.’’ EPA plans to use a

variety of means to provide an

opportunity for interested parties to

support the modification or

maintenance of a tolerance in these

circumstances. In cases where a

cancellation of a pesticide is for dietary

risk reasons, FFDCA section 408(1)

requires revocation of the tolerances

within 180 days of the cancellation.

When a pesticide is canceled based on

non-dietary risk concerns, such as

adverse effects on non-target species,

the corresponding tolerance may be

maintained provided that there is a need

for the tolerance because the pesticide is

used outside of the U.S. on commodities

intended for the U.S. market and a

proponent of the tolerance supplies

sufficient data or information to

demonstrate that a tolerance meets the

food safety requirements of FFDCA.

EPA’s tolerance setting authority is

based on food safety considerations. The

Agency has no authority to regulate

pesticide use in other countries. At the

same time, however, EPA promotes

public health and environmental

protection worldwide by providing

information designed to encourage safer,

well-informed pest control decisions on

an international level, consistent with

the Agency’s mandates under FIFRA.

This includes Agency actions based on

non-dietary as well as dietary risks.

Whenever EPA takes significant

cancellation actions based on nondietary risks, EPA will notify other

countries and share information with

other regulatory authorities for their use

in deciding whether conditions in their

countries warrant continued use of the

pesticide. Where appropriate, EPA will

also propose to include pesticides

canceled, whether or not for non-dietary

concerns in the international system of

information exchange known as the

‘‘prior informed consent’’ system.

When a registrant requests that a

registered use be deleted voluntarily,

the Agency will propose to cancel that

use in a Federal Register Notice in

accordance with section 6(f) of FIFRA.

Following the cancellation of a use, EPA

will typically propose to revoke the

tolerance. To provide interested parties

an early notification of the potential

revocation of the tolerance, the section

6(f) Notice will inform the public that

once the use is canceled, the Agency

may propose to revoke the tolerance

unless there is a request to modify or

maintain it as an import tolerance. In

addition, the interested party must

commit to supply the information

necessary for the Agency to make a

safety finding. The Notice will state the

Agency’s willingness to consider

requests to modify or maintain a

tolerance following the cancellation of

the accompanying registration and

indicate the process for doing so.

Interested parties may notify EPA of

their interest in supporting maintenance

or modification of a tolerance to cover

residues in or on imported food in

comments on the Notice. EPA will also

provide the public with information on

the EPA web site (www.epa.gov/

pesticides) about the potential loss of

the related tolerance and about how to

maintain a tolerance as an import

tolerance if the corresponding use is

canceled. These notices will also be

provided to other countries through the

WTO notification process.

If EPA receives a request to modify or

maintain a tolerance in response to a

section 6(f) Notice, the interested party

may identify or provide (consistent with

relevant provisions of FIFRA) existing

domestic or foreign data and the Agency

will determine if the data are sufficient.

EPA will consider the kind of

information specified in Unit IV.D. to

determine if additional data and/or

information are needed (and data

requirements must be satisfied) to

support continuation of the tolerance. If

so, the Agency may issue a Notice under

section 408(f) of FFDCA informing the

public of the data requirements and

stating the time period for submitting

the required data. Persons supporting

the maintenance or modification of

tolerances to cover residues in or on

imported food have the burden of

demonstrating the relevance of any

existing domestic data to foreign

growing conditions.

If EPA does not receive any indication

of support for an import tolerance

following the cancellation of the

registered food use, the Agency will

publish a Federal Register Notice that

Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices 35073

proposes to revoke the tolerance. The

Notice will again give interested parties

the opportunity to come forward to

support the maintenance of the

tolerance. To avoid the issuance of the

final tolerance revocation, interested

parties must demonstrate a need to

retain the tolerance and commit to

support the tolerance. Retaining the

tolerance may likely require submission

of data so that EPA can make safety

findings under FFDCA. EPA’s data

requirements for import tolerances are

further described in Unit V.

2. Further guidance under

development regarding U.S. registration

with an import component. The Agency

expects to require information on

residues in or on imported food in a

limited number of circumstances when

registering new U.S. uses and when

reassessing tolerances as required by

FQPA. In the past, EPA has not

expressly considered the unique

contribution of residues in or on

imported food when establishing (or

reassessing) tolerances with

accompanying U.S. registrations.

Currently, EPA assumes that the

residues in imported commodities will

be the same as in domesticallyproduced commodities. Additional

information will be required when

EPA’s assumption that residues in or on

imported foods will be the same as

residues in or on domestic foods is not

expected to be correct and/or additional

data to better reflect residues in or on

imports are necessary to support the

safety finding. Because, in this instance,

EPA’s assumption may under- or

overestimate risks from imported food,

and existing monitoring programs may

not provide sufficient information in all

cases to support the assumption and

safety finding, the Agency is developing

criteria to help determine the

circumstances in which residue data

based on pesticide use on crops

destined for import into the U.S. should

be required. When imported foods may

contribute significantly to dietary

exposure to the pesticides, those

interested in establishing or supporting

continuation of a tolerance with a U.S.

registered food use must provide basic

screening information about potential

residues in imported foods, as discussed

below, so that the Agency can determine

if additional data are needed.

It is important to emphasize that the

Agency expects that additional data will

be needed in very limited cases where

a high percentage of the commodity is

imported potentially resulting in

substantial dietary exposure. EPA is

seeking comment on the adequacy and

appropriateness of requiring this

information, as well as on the specific

questions posed on this issue later in

this document. While seeking comment

on this document and developing more

formal guidance, the Agency reserves

the right to require data based on

pesticide use in other countries on a

case-by-case basis, e.g., when a high

percentage of the commodity is

imported, and, thus, such information is

clearly necessary to make the required

safety findings under FFDCA.

D. Screening Information

The following types of screening

information will be considered in

establishing or reassessing a tolerance or

tolerance exemption to help the Agency

decide if additional information or data

are needed on imported foods,

regardless of whether the data are

supporting import tolerance or a

domestic registration with a significant

import component:

• What international tolerances or

MRLs exist?

• Which countries export the

commodity to the U.S.?

• Major seasonal variations in

imports of the commodity.

• Percent of U.S. consumption which

is imported.

• Percent of crop treated in the

exporting countries.

• Significance of the food in the U.S.

diet (see Table 10 in Unit VII.).

• Effect of processing on the residues.

• Available information on levels of

residues found in samples of imported

food (based on FDA, USDA, or other

monitoring data).

• Other information that would help

the Agency determine if residues in or

on imported food are likely to

contribute significantly to dietary

exposure or risk in the U.S. or to differ

significantly from residues in or on

domestically-produced foods.

Following are two examples of how

the Agency may use the above

information in determining the need for

further data:

Example 1. A petitioner seeks a U.S.

registration and tolerance for a new

pesticide use on cranberries. Less than

1% of cranberries consumed in the U.S.

are imported. Almost all imports are

from Canada, where growing conditions

(e.g., use patterns, weather conditions,

soil type) are similar to those in the U.S.

Cranberries account for an extremely

low percentage of the U.S. diet. In this

case, EPA would probably not require

submission of foreign residue data

because dietary exposure to residues in

imported cranberries is very low and

EPA determines that U.S. field trials

would be representative of growing

conditions in Canada.

Example 2. A petitioner seeks to

maintain a tolerance for residues of a

pesticide in bananas following the

cancellation of the banana use in the

U.S. The vast majority of bananas

consumed in the U.S. are imported.

Bananas are imported from Central and

South America, and cultural practices

for bananas grown in the U.S. differ

from those in Latin America. Existing

residue data consist of five U.S. field

trials in Hawaii and Puerto Rico.

Bananas represent a relatively high

percentage of the U.S. diet, especially

for children. To assess the safety of the

tolerance, EPA would likely require

submission of additional residue data

based on the pesticide’s use in major

banana exporting countries for the

following reasons: Most of what is

consumed in the U.S. is imported and

EPA has no data on such foreign uses;

cultural practices in other countries

appear to differ from those in the U.S.;

and bananas represent a relatively high

percentage of the diet of a potentially

sensitive subpopulation (children). The

tolerance petitioner would not

necessarily have to conduct new trials;

however, since there may be existing,

reliable residue data that supported a

Codex submission or an MRL approved

by another regulatory body.

These examples are only for

illustrative purposes to suggest how the

Agency might use the screening

information in deciding whether to

require additional residue data. Other

factors that would likely affect the

Agency’s decision include the toxicity

of the chemical, available information

on conditions of pesticide use in

exporting countries, and available

monitoring data.

E. Data Requirements

Import tolerances generally require

the same types of data as are needed for

tolerances with U.S. registrations,

including toxicology data, residue

chemistry data, and data representative

of actual growing conditions. EPA needs

these data to assess the potential dietary

risk and to make the required safety

finding. EPA does not require worker

exposure and environmental fate and

effects data to establish import

tolerances since these data are not

needed to assess dietary risk, although

they would be required if the pesticide

were to be registered for use in the U.S.

The data requirements described in Unit

V. interpret 40 CFR part 158 for

purposes of characterizing residues in or

on imports, and are intended to apply

to all new tolerance petitions where

there is no U.S. registration and to

requests to modify or maintain a

tolerance for imports where the

35074 Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices

corresponding U.S. use has been

canceled.

The data requirements described in

this Notice are the existing EPA field

trial guidance for U.S. registrations

adapted to growing conditions in other

countries. In the past, EPA did not have

written guidance for the number and

location of field trials to support

tolerances for residues in or on food

imported from other countries. Rather,

the Agency provided case-by-case

advice on adapting the data

requirements to import situations. Unit

V. provides written guidance on how to

determine the number and location of

field trials for new tolerances on

imported commodities.

F. Consistency with International

Obligations

1. Codex. The Codex Alimentarius

Commission of the Joint Food and

Agriculture Organization/World Health

Organization (FAO/WHO) Food

Standards Program establishes

international food standards, including

maximum pesticide residue limits, to

protect public health and promote

international trade. It is EPA’s policy to

harmonize its tolerances with the levels

established by Codex provided that the

Agency has sufficient information to

make a determination that the Codex

Maximum Residue Limits (MRLs) will

be protective of the health of the U.S.

public and meet FFDCA standards.

FQPA requires EPA to publish a notice

for public comment whenever the

Agency establishes a tolerance that

differs from an established Codex MRL.

EPA may set a tolerance that differs

from the Codex MRL if EPA explains the

reason for the difference. For example,

EPA may determine that the Codex MRL

does not meet FFDCA standards or is

inadequate in light of pesticide use

practices in the U.S.

2. International trade agreements. The

U.S. is a party to both the North

American Free Trade Agreement

(NAFTA) and the World Trade

Organization (WTO) Agreements. Both

agreements contain provisions

applicable to Sanitary and Phytosanitary

(SPS) Measures that include food safety

measures such as tolerances. Under

these agreements, individual countries

have the right to establish levels of

protection for human, animal, or plant

life or health that they deem appropriate

and to implement measures that will

achieve these levels of protection.

Measures are to be based on available

international standards, including

Codex MRLs, but may be more stringent

than international standards if there is

a scientific justification or to achieve a

greater level of protection. Measures are

to be based on scientific principles, not

be maintained without sufficient

scientific evidence, and be based on an

assessment, as appropriate to the

circumstances, of the risks; may not

arbitrarily or unjustifiably discriminate

between domestic and imported goods

or goods from different importers; and

are to be established through an open,

transparent process. The NAFTA further

states explicitly that efforts toward

greater harmonization and equivalence

in regulatory standards are to be

undertaken ‘‘without reducing the level

of protection of human, animal, or plant

life or health.’’

As stated in this Notice, EPA’s policy

is to harmonize its tolerances with

Codex MRLs to the extent possible,

provided that the MRLs achieve the

level of protection required under

FFDCA. Publication of this Notice will

enhance the transparency of EPA’s

requirements governing pesticide

residues in imported foods by providing

better guidance on the type of data

needed to support a tolerance. The

tolerance policies outlined in this

Notice are nondiscriminatory and

designed to ensure that both

domestically-produced and imported

foods meet the food safety standards

(level of protection) established by the

FFDCA. The same food safety standards

apply to domestically-produced and

imported foods.

3. NAFTA activities. As part of

NAFTA, a North American Pesticide

Initiative was created to improve

cooperation and sharing of data reviews

for pesticides among the three countries.

The U.S. is participating with its

NAFTA partners (Canada and Mexico)

in harmonizing data requirements and

policies to the extent possible. Canada

and the U.S. have made substantial

progress in harmonizing their data

requirements and have established zone

maps to permit pesticide residue data

from one country to be used by the other

for estimating MRLs and tolerances. A

similar effort is underway to develop

zone maps that will permit the use of

data from similar growing regions in

Mexico and the U.S. In addition, this

U.S. import tolerance guidance is

intended to form the basis for a NAFTA

guidance on import tolerances. EPA has

been working with its NAFTA partners

in developing this guidance.

G. Request for Comments

The Agency is interested in comments

on this Notice and, in particular, on its

proposed guidance for requiring data

and information on potential residues in

or on imported foods when there is a

corresponding U.S. registration. EPA is

specifically soliciting comments on the

following questions:

1. Under what circumstances should

EPA require data reflecting growing

conditions in other countries when a

pesticide also has U.S. registration for

the same food use?

2. Do the data requirements outlined

in this Notice provide a sufficient basis

for making the food safety

determination required by the FFDCA?

3. If a commenter believes that data

reflecting growing conditions in other

countries should not be required when

a pesticide is registered for the same use

in the U.S., how should the Agency

account for potential exposure to

residues in or on imported foods in

conducting its dietary risk assessments?

4. Should EPA be concerned with

potential shifts in the sources of

imported foods and changes in pesticide

use practices in exporting countries over

time? If so, how frequently should data

needs be reassessed? (After an initial

tolerance is granted, the crop in

question could be grown in other

countries that have different application

methods and climate, possibly resulting

in different residues in or on imported

food.)

5. Pesticides with U.S. registrations

require periodic review under U.S. laws

to ensure that the data supporting the

registration (and associated tolerances)

continue to meet up-to-date scientific

standards. How should EPA ensure that

import tolerances, which have no

corresponding U.S. registrations, are

similarly reviewed and updated? (The

Agency notes that FFDCA requires a

review of tolerances after five years

whenever anticipated residue data are

used in risk assessment.)

6. What criteria should be used in

deciding if further data are needed to

better capture the imported food

contribution to dietary risk when there

is a tolerance with a corresponding

domestic registration?

V. Import Tolerance Data Requirements

The data requirements in this Unit

apply to the following two scenarios

discussed in Unit IV:

1. Establishing new tolerances with

no accompanying U.S. registration.

2. Modifying or maintaining

tolerances for imported food following

cancellation of U.S. uses.

This part clarifies how existing U.S.

food use pesticide data requirements for

product chemistry, residue chemistry,

and toxicology studies apply to

petitions for tolerances to cover residues

in or on imported commodities

(scenario 1). These data requirements

also serve as target data requirements for

scenario 2.

Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices 35075

There are no additional types of

studies needed for import tolerances,

compared to tolerances that do have

corresponding domestic registrations. In

general, fewer studies are required than

for tolerances associated with U.S.

registrations because only those studies

specifically associated with a tolerance

petition are required. The guideline

requirement that requires the most

clarification for import tolerances is

OPPTS Guideline 860.1500, Field

Trials. These are the core studies from

which most tolerance values are

estimated.

If a registrant has an existing tolerance

and registered U.S. use, but intends to

withdraw the registered use and

maintain the tolerance for import

purposes, the Agency may need

additional residue data to better

determine the dietary exposure of U.S.

consumers to the pesticide. In such

cases, the registrant or other proponent

of the tolerance is advised to consult

with the Agency to determine what

studies are required to support the

tolerance.

The import tolerance petitioner may

not need to conduct new studies to

fulfill the data requirements. Interested

parties may support a new import

tolerance, or support maintenance or

modification of an existing tolerance,

with studies developed for a registration

in another country, for a Codex MRL,

and/or in support of the previous U.S.

registration and tolerance, provided that

they are able to demonstrate the

applicability of the studies to the

requirements in this Notice. The

petitioner or other interested parties

may consult with the Agency before

submitting the existing studies. All

studies must be formatted in accordance

with PR Notice 86-5, and, as such,

should contain a statement describing

the applicability of the U.S. (40 CFR

part 160) or Organization for Economic

Cooperation and Development (OECD)

requirements for Good Laboratory

Practices. The Agency strongly

recommends that petitioners attach a

copy of the study evaluation by the

registering country or by Codex to the

study report as an appendix.

An earlier version of the import

tolerances data requirements included

in this unit was presented to the FIFRA

Science Advisory Panel (SAP) in June

1997. The SAP was supportive of the

approach for determining number and

location of field trials and encouraged

international harmonization to the

extent possible. In addition to the SAP,

comments have been received from

Canada’s Pest Management Regulatory

Agency (PMRA) and the American Crop

Protection Association (ACPA) and

taken into consideration in this Notice.

A. Description of Format and Data

Requirements for an Import Tolerance

Petition

Tolerance petition requirements are

summarized in 40 CFR 180.7(b). Each

petition must contain seven parts,

labeled A through G. The requirements

for each section are listed below with a

description of the specific information

needed to establish an import tolerance.

This information is the same as or

similar to information needed to

support an existing tolerance where the

corresponding U.S. use has been

canceled.

1. Section A—The name, chemical

identity, and composition of the

pesticide chemical. Petitioners usually

reference product chemistry studies that

were submitted in support of a product

registration to fulfill these requirements.

Table 1 lists guideline numbers for

product chemistry studies along with

the information needed specifically for

import tolerances. The petitioner must

disclose the inert ingredients in the

formulation. Residue and safety data for

List 1 inert ingredients may be required

if List 1 inerts are present in the

formulation so that a dietary risk

assessment for the inert can be done by

the Agency. (A reference for the inert

classification system may be found at 54

FR 48314, November 22, 1989)

2. Section B—The amount, frequency,

and time of application of the pesticide

chemical. For all countries in which a

pesticide chemical is marketed and may

result in residues in food exported to

the U.S., the petitioner must submit a

description of the use of the pesticide

chemical. It is preferable to submit

copies of labels translated to English.

The information must include, but is

not limited to, the maximum single

application rate, the maximum annual

application rate, application timing (as

it relates to plant growth stage), retreatment interval, application tank-mix

preparation, volume of spray mix per

unit area, application equipment, and

the pre-harvest interval (PHI). The

application rates should be expressed in

units of pounds active ingredient per

acre (or kilograms per hectare). If the

pesticide chemical is applied directly to

livestock, then the use information

should include a description of the

application method (dip, spray, ear tag,

etc.), amount of active ingredient

applied per unit body weight, retreatment intervals, maximum

application rate per year, and the preslaughter interval.

3. Section C—Safety data. Toxicology

data required to support an import

tolerance are largely the same as those

required to support a domestic tolerance

with the notable exceptions of most

acute toxicity studies and studies

reflecting administration via the dermal

or inhalation routes. In the case of

pesticides having at least one tolerance

associated with a U.S. registration, this

data subset would already have been

submitted to the Agency. Toxicology

data requirement guidelines are given in

Table 2 in Unit VI.

4. Section D—The results of test on

the amount of residue remaining,

including a description of the analytical

method used. Studies conducted under

the OPPTS Guideline 860 series

(formerly 171-4) are listed in this

section. These include metabolism

studies, analytical methods used,

information relating to the storage

stability of the parent compound and

metabolites of concern on the

appropriate commodity, and magnitude

of residue studies. Specific

requirements are further described

below in the section on residue

chemistry studies.

5. Section E—Practicable methods for

removing residue. This section is

primarily of concern if the proposed

tolerance results in an unacceptable

risk, when assuming that residues will

be ingested at the proposed tolerance

level. The petitioner may conduct

studies describing reduction of residues

through typical practices, including

washing, peeling, cooking, etc.

6. Section F—Proposed tolerance for

the pesticide chemical if tolerances are

proposed. The petitioner must propose

a tolerance based on the maximum

residues found in the magnitude of

residue studies. The Agency may choose

to adopt the Codex MRL, if one has been

established, as described in the

following section on residue chemistry

studies.

7. Section G—Reasonable grounds in

support of the petition. The petitioner

should present a rationale describing

how the residue data support the

proposed tolerance. A detailed

discussion of the information that

should be presented may be found in

OPPTS Guideline 860.1560.

B. Toxicology Data Requirements

Table 2 in Unit VI. lists the full

complement of toxicology data required

to support a tolerance as listed at 40

CFR part 158. Whether or not a given

study is required to support an import

tolerance is noted as are several

explanatory footnotes. The petitioner is

urged to refer to 40 CFR part 158 for the

test substance(s) and conditions under

which each study is required. Detailed

guidance on the conduct of the

35076 Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices

individual studies may be found in the

references cited at the end of this Unit.

In addition to the required studies, the

Agency welcomes the submission of

studies not required to support an

import tolerance if they have been

conducted to satisfy the registration/

tolerance-setting requirements of one or

more countries outside of the U.S. The

Agency also reserves the right to require

any study, including special studies, if

deemed necessary to assess the human

hazard, dietary risk, mode of toxicity, or

other aspect of the pesticide in question.

C. Residue Chemistry Data

Requirements

Table 3 in Unit VI. lists the Residue

Chemistry studies required to support

tolerances as outlined in 40 CFR part

158. The data required to support an

import tolerance are essentially the

same as for a tolerance associated with

a U.S. registration, but fewer studies

may be required under certain

conditions. More detailed guidance for

each type of study may be obtained from

the list of references at the end of this

Unit. Following is a description of the

differences in data requirements

(compared to requirements for a

tolerance associated with a domestic

use) for field trials, processing studies,

and livestock studies.

1. Field Trials (OPPTS Guideline

860.1500). Field trials are conducted to

determine the maximum residue that

may be expected in or on a raw

agricultural commodity as a result of the

legal use of the pesticide. The trials

must reflect label directions that would

be expected to result in the maximum

residue levels, e.g., the maximum label

rates, maximum number of applications,

minimum re-treatment interval, and

minimum PHI.

The Agency has prepared two tables

(Tables 4 and 5 in Unit VI.), that can be

used to determine the number of field

trials that should be conducted for an

import tolerance. The number of field

trials recommended was derived from

the number required for a tolerance

associated with a U.S. registration, and

also takes into consideration the

consumption of the commodity as a

percentage of the U.S. diet and the

relative amount imported into the U.S.

(percent imported averaged over 5

years). Detailed instructions on

determining the number and location of

field trials and examples are provided in

Unit VII. of this document. Table 10 in

Unit VII. provides information on

relative significance of each food in the

U.S. diet.

The U.S. and Canada use zone maps

to determine where field trials should

be conducted for tolerances associated

with a domestic registration. These

maps divide North America into regions

where growing conditions are similar.

Field trials conducted within the same

zone are considered interchangeable. In

the absence of zone maps for other

countries developed using similar

principles, the Agency requests data on

a country-by-country basis. Trials

should be conducted in countries in

relative proportion to the amount each

country exports into the United States.

Only those countries in which the

pesticide is marketed or proposed to be

marketed need to be represented. Trials

will generally need to be conducted in

all countries that export at least 5% of

the total amount of a specific

commodity imported into the U.S. The

petitioner should seek Agency approval

if substitution of data from one country

to another is desired. All major growing

areas within a country should be

represented, as is required for U.S.

registrations in OPPTS Guideline

860.1500. At least two individually

composited samples must be taken from

each test plot and analyzed.

All major formulation classes should

be represented. Petitioners are referred

to the section on formulations in the

residue chemistry OPPTS Test

Guideline, 860.1500(e)(2)(x). A full set

of trials must be conducted for each

major class. For later season uses, it will

likely be necessary to conduct trials on

the different formulations within a

class. If a petitioner has a chemical with

a 2–day PHI that is formulated as an

emulsifiable concentrate and a wettable

powder, a full set of trials would be

required for both formulations, unless

side-by-side plots at a few sites show

comparable residues from such

products. In the latter case, some

reduction of the total number of trials

may be warranted. Petitioners are

advised to consult the guidelines or

Agency staff if a reduced number of

trials is intended.

For crops requiring 8 or more trials,

the number of trials may be reduced up

to 25% if metabolism studies indicate

that residues are likely to be below the

limit of quantitation. If some trials show

quantifiable residues, then the full

number of trials must be conducted. The

limit of quantitation should be

sufficiently low from an analytical

chemistry standpoint and for risk

assessment purposes. The 25%

reduction in the number of field trials

may not be applied to representative

commodities used to support crop group

tolerances. For additional information,

the petitioner is advised to consult

OPPTS Guideline 860.1500(e)(2)(viii).

Data generated in the United States or

countries other than where the

petitioner has existing or proposed uses

may be substituted for up to half of the

required number of foreign trials, but a

minimum of three trials must be from

the countries in which the pesticide is

marketed. The petitioner should

demonstrate that crop cultural practices,

climatological conditions, and use

patterns are substantially similar

between the subject regions and regions

represented by the U.S. (or other) data.

The burden of proof is on the petitioner.

In the case of tolerances to cover

treated commodities imported from

Canada or Mexico only, it may be

acceptable for more than 50% of the

trials to be conducted in the U.S. As

mentioned above, as part of the

harmonization process under the

NAFTA, the crop field trial regions in

the U.S. guidelines have been extended

into Canada, and efforts are underway to

do the same into Mexico. This would

allow trials in the U.S. to support

registration and tolerances in Canada

and Mexico or vice versa. As a result,

among these three countries, for certain

crops most or all of the field trials could

be conducted in a different country than

the one in which the pesticide use is

registered. For example, if a tolerance is

desired to cover the export of

cranberries from Canada to the U.S.,

most of the trials could be conducted in

the northern regions of the U.S. even

though the pesticide is to be registered

in Canada. Similarly, for certain crops

being imported from Mexico, many of

the trials could be done in the

southwestern U.S. In the future, if other

countries develop zone maps employing

similar concepts, and the regions and

cultural practices are demonstrated to

be substantially similar to U.S. regions,

then the Agency may consider

substitution of U.S. data for those

countries as well.

Generally, a minimum of three trials

are required for any crop. In certain

cases, a petitioner may conduct fewer

than three trials if there is a low dietary

intake of commodity and if the amount

imported is relatively small. In such

cases, a greater number of samples

would be required from the test plot.

Petitioners should consult OPPTS

Guideline 860.1500 or submit a protocol

for review and comment by the Agency.

Table 9 in Unit VII. lists the number

of field trials and locations for

commodities for which import

tolerances are most frequently

requested. Petitioners interested in

establishing import tolerances for a crop

group are advised to consult with the

Agency for direction on number and

location of trials for each representative

commodity within the crop group.

Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices 35077

2. Processing Studies (OPPTS

Guideline 860.1520). Processing studies

must be conducted if there is likely to

be processing of the commodity once it

has been imported into the U.S. or if the

processed commodity is imported into

the U.S. Table 1 of the residue

chemistry testing guidelines (OPPTS

Guideline 860.1000) lists the processed

commodities for which data are

required. The petitioner is advised to

consult the Agency if the petitioner

believes a processing study is not

necessary when it normally would be

required. In a processing study, the raw

agricultural commodity (RAC) is

processed in a manner simulating

typical commercial practice. The RAC

should have detectable residues so a

concentration factor may be calculated.

Exaggerated rates and/or reduced PHIs

may be necessary to ensure that the RAC

to be processed bears quantifiable

residues.

3. Nature of the Residue—Animals

(OPPTS Guideline 860.1300). If the raw

agricultural commodity or processed

commodity associated with the crop to

be treated in the subject petition could

be used as an animal feed, oral livestock

metabolism and magnitude of residue

studies are required. Dermal metabolism

studies are required if the pesticide is

marketed as a dermal treatment for

livestock in countries that export a

significant quantity of animal products

to the U.S. The purpose of these studies

is to determine the identity of the

biotransformation products of the

pesticide. Ruminant and poultry studies

are normally required. EPA will assume

that all feed items included in Table 1

of OPPTS Guideline 860.1000 are feed

items for import tolerance purposes.

Any claims that these items are not

significant feed items in the country(s)

of concern will be considered only if

they are convincingly documented by

the petitioner.

Livestock metabolism, magnitude of

residue, and/or analytical method

studies would not be required under the

following conditions: (i) If animal

metabolism studies indicate that there is

no reasonable expectation of finite

residues in the animal commodity; (ii)

if it is unlikely the imported plant

commodity or its processed products

would be significant feed items (in the

U.S. or exporting country); or (iii) there

are not significant exports of livestockderived food products or commodities

from the countries of interest to the U.S.

and the commodity is not a feed item in

the U.S.

D. JMPR/Codex Considerations

The Agency requires the submission

of complete toxicology studies for

import tolerances even if they have

previously been submitted to the Joint

Meeting on Pesticide Residues (JMPR).

The Agency will conduct an

independent review of the data.

Summaries and/or JMPR reviews are not

an acceptable substitute, although they

may be submitted as supplemental

materials. However, in the future,

harmonization of OECD test guidelines

and data evaluations may allow the

Agency to use toxicology data reviews

from other countries for hazard

identification and risk assessment.

If a Codex MRL has been established,

the Agency may conduct a more limited

review of the residue chemistry data

under certain conditions. A detailed

description of the conditions and an

overview of how the Agency may

consider Codex MRLs as they relate to

the data requirements may be found in

Unit VIII. EPA is more likely to accept

Codex MRL levels as tolerance levels

with limited review if U.S. tolerances

for the pesticide are already established

on other commodities. Standard data

and review requirements would be

applied where exposure and/or risk

from the pesticide is high.

E. Good Laboratory Practice

Considerations

As described in 40 CFR 160.1(a) and

160.3(4) all submissions for pesticide

registrations and tolerance petitions

should be in accordance with Good

Laboratory Practices (GLP). If the study

deviates from GLPs, a statement must be

included in the study stating any

deviations and the effect on the study.

Any deviations should be duly noted in

the report.

F. Submittal of Samples

Registrants and petitioners are

normally required to submit samples of

the pesticide technical grade active

ingredient (TGAI) under OPPTS

Guideline 830.1900 and analytical

standards of the parent compound and

regulated metabolites under OPPTS

Guideline 860.1650. Unless the TGAI is

to be registered in the U.S., petitioners

for an import tolerance are not required

to submit samples of the product

because this is a requirement only for

the registration of a product. However,

the petitioners are still required to

submit the analytical standard under

OPPTS Guideline 860.1650 because this

is a requirement for a pesticide

tolerance petition.

G. Conclusion

Data requirements for a pesticide

tolerance in the absence of a U.S.

registration (i.e., import tolerance) have

been outlined in this part. Before

conducting any toxicology, product

chemistry, or residue chemistry studies,

prospective petitioners are strongly

urged to consult the OPPTS Guideline

series 870, 830, and 860. Petitioners

should submit protocols to EPA for

review and comment if they have any

questions regarding study design and

conduct. The Agency will attempt to

harmonize U.S. tolerances with

international standards to the maximum

extent possible, consistent with the food

safety standards of the FFDCA, and is

continuing to work towards greater

harmonization in international fora.

VI. Tables

The following tables are provided as

additional information and are

referenced in this guidance document.

TABLE 1.—PRODUCT CHEMISTRY DATA REQUIREMENTS FOR IMPORT TOLERANCES

Guideline No. Study Title Application to Import Tolerances Test Substance 1

830.1550 Product Identity No—Product Specific Requirement N/A

830.1600

830.1620

830.1650 Description of Manufacturing Process Yes TGAI

830.1670 Discussion on Formation of Impurities Yes—Agency is especially concerned with

impurities of toxicological concern (e.g.

dioxins, HCB, nitrosamines)

TGAI

830.1700 Preliminary Analysis Yes TGAI

35078 Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices

TABLE 1.—PRODUCT CHEMISTRY DATA REQUIREMENTS FOR IMPORT TOLERANCES—Continued

Guideline No. Study Title Application to Import Tolerances Test Substance 1

830.1750 Certified Limits No—Product Specific Requirement N/A

830.1800 Enforcement Analytical Methods No—Product Specific Requirement N/A

830.6302 Color Yes TGAI

830.6303 Physical State Yes TGAI

830.6304 Odor Yes TGAI

830.7200 Melting Point Yes TGAI

830.7220 Boiling Point Yes TGAI

830.7300 Density Yes TGAI

830.7840

830.7860 Water Solubility Yes TGAI or PAI

830.7950 Vapor Pressure Yes TGAI or PAI

830.7370 Dissociation Constant Yes TGAI or PAI

830.7550

830.7560

830.7570 Octanol/Water Partition Coefficient Yes PAI

830.7000 pH Yes TGAI

830.6313 Stability Yes TGAI

830.6314 Oxidation/Reduction No—Product Specific Requirement N/A

830.6315 Flammability No—Product Specific Requirement N/A

830.6316 Explodability No—Product Specific Requirement N/A

830.6317 Storage Stability No—Product Specific Requirement N/A

830.6319 Miscibility No—Product Specific Requirement N/A

830.6320 Corrosion Characteristics No—Product Specific Requirement N/A

830.6321 Dielectric Breakdown Voltage No—Product Specific Requirement N/A

830.7100 Viscosity No—Product Specific Requirement N/A

830.7050 UV/Visible Absorption No—Product Specific Requirement N/A

1TGAI = technical grade active ingredient; PAI = pure active ingredient

TABLE 2.—TOXICOLOGY DATA REQUIREMENTS FOR IMPORT TOLERANCES

Guideline Reference Number Study Title Applicable to Import Tolerance Footnote Number

870.1100 Acute oral toxicity—rat Yes

870.1200 Acute dermal toxicity No 1, 2

870.1300 Acute inhalation toxicity—rat No 1, 2

870.2400 Acute eye irritation—rabbit No 1, 2

870.2500 Acute dermal irritation No 1, 2

870.2600 Skin sensitization No 1, 2

870.3100 90-Day Oral Toxicity—rodent Yes

870.3150 90-Day Oral Toxicity—non-rodent Yes

870.3200 21-Day dermal toxicity No 2

Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices 35079

TABLE 2.—TOXICOLOGY DATA REQUIREMENTS FOR IMPORT TOLERANCES—Continued

Guideline Reference Number Study Title Applicable to Import Tolerance Footnote Number

870.3250 90-Day dermal toxicity No 2

870.3465 90-Day inhalation—rat No 2

870.3700 Developmental toxicity study Yes

870.3800 Multi-Generation Reproduction Yes

870.4100 Chronic Toxicity Yes

870.4200 Carcinogenicity study Yes

870.4300 Combined chronic toxicity/carcinogenicity Yes

870.5100 to 870.5915 Mutagenicity Yes 3

870.6200 Neurotoxicity screening battery Yes

870.7200 Companion animal safety No 4

870.7485 Metabolism and pharmacokinetics Yes

870.7600 Dermal penetration No 2

1Study used largely to determine appropriate hazard statements required on U.S. pesticide product labels.

2Study reflects a route of exposure (dermal or inhalation) not expected to be applicable to dietary exposure, the only exposure route assumed

to be relevant to U.S. citizens via imported foods/feeds. 3An initial battery of the following three tests must be conducted: (1) Ames assay (S. typhimurium), (2) Mammalian cells in culture forward

gene mutation assay, and (3) in vivo cytogenetics assay. Details of the screening protocol may be found in Addendum 4 to the Series 84 guidelines, Document PB91-158394, available from the National Technical Information Service. 4Study is applicable only to direct application to domestic animals as opposed to dietary exposure via treated feed.

TABLE 3.—RESIDUE CHEMISTRY DATA REQUIREMENTS FOR IMPORT TOLERANCES

Guideline No. Study Title Required for Import Tolerance 1

860.1300 Nature of the Residue—Plants R

860.1300 Nature of the Residue—Animals CR 2

860.1340 Residue Analytical Methods—Plants and Animals R

860.1360 Multiresidue Methods R

860.1380 Storage Stability R

860.1480 Magnitude of Residue—Meat, Milk, Poultry, and Eggs CR 3

860.1500 Crop Field Trials R

860.1520 Processing Studies CR 4

860.1850 Confined Rotational Crop NR

860.1900 Field Rotational Crop NR

1 R = Required; CR = Conditionally Required; NR = Not Required. 2 Required if subject crop is an animal feed item, or if the pesticide will be applied directly to livestock exported to the U.S.

3 May not be required if crop is not an animal feed item, or if livestock metabolism studies indicate no potential for finite residues in edible commodities. Refer to text of this document for additional information. 4 May not be required if crop is not likely to be processed after export to the U.S., or if processed commodity is not shipped to the U.S. Refer

to text of this document for additional information.

TABLE 4.—NUMBER OF FIELD TRIALS REQUIRED FOR AN IMPORT TOLERANCE (LESS THAN 75% OF CROP AVAILABLE FOR

CONSUMPTION IMPORTED INTO U.S.) 1

Required No. of Field Trials for a U.S. Registration

Percentage of Commodity Imported into U.S. (Weight Basis)

0–10% 10–35% 35–75%

20 5 16 20

16 (15) 2 5 12 16

35080 Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices

TABLE 4.—NUMBER OF FIELD TRIALS REQUIRED FOR AN IMPORT TOLERANCE (LESS THAN 75% OF CROP AVAILABLE FOR

CONSUMPTION IMPORTED INTO U.S.) 1—Continued

Required No. of Field Trials for a U.S. Registration

Percentage of Commodity Imported into U.S. (Weight Basis)

0–10% 10–35% 35–75%

12 3 8 12

8 (9) 2 358

5 (6) 2 3 3 3 5

3 2 3 3 3 3

1The number of trials determined using this table may be reduced by 25% for crops needing 8 or more trials if metabolism studies and all the

trials show residues less than the limit of quantitation of the analytical method. Crops being used as representative commodities to obtain crop

group tolerances may not be reduced by an additional 25% even if metabolism studies and all the trials show residues of less than the limit of

quantitation. 2The numbers in parentheses refer to the number of trials required for representative crops being used toward a crop group tolerance. As described in OPPTS Guideline 860.1500, the number of field trials required for representative commodities that are being used to support a crop

group tolerance is 25% less than the number required to support a tolerance of a single commodity, provided greater than 8 trials are required

for the tolerance. 3Fewer than three trials may be conducted if the dietary consumption is very low and a relatively small amount of the commodity is imported

into the U.S. Four independent samples must be collected from each test plot if less than three trials are conducted. Petitioners should either

consult OPPTS Guideline 860.1500 or contact the Agency before proceeding if they believe that fewer trials are warranted.

TABLE 5.—NUMBER OF FIELD TRIALS

REQUIRED FOR AN IMPORT TOLERANCE (GREATER THAN 75% OF

CROP AVAILABLE FOR CONSUMPTION

IMPORTED INTO U.S.) 1

Maximum Percent of

U.S. Diet 2

No. of Trials Required

0—0.05 3 3

0.05—0.2 8

0.2—1.0 12

>1.0 16

1The number of trials determined using this

table may be reduced by 25% for crops needing 8 or more trials if metabolism studies and

all the trials show residues less than the limit

of quantitation of the analytical method and

the crops are not being used as representative

commodities to obtain crop group tolerances. 2 Highest percentage in the U.S. diet for any

of the following subgroups: general population,

children ages 1 to 6, and infants. Information

on percentages in the diet may be found in

Table 10 of this document. 3Fewer than three trials may be conducted

if the dietary consumption is very low and a

relatively small amount of the commodity is

imported into the U.S. Four independent samples must be collected from each test plot if

less than three trials are conducted. Petitioners should either consult OPPTS Guideline

860.1500 or contact the Agency before proceeding if they believe that fewer trials are

warranted.

VII. Instructions for Determining

Number and Location of Field Trials

Following is a step-by-step guide to

calculating the minimum number of

field trials that must be conducted using

Tables 4 and 5 in Unit VI. and Table 10

in this unit.

1. Average the amount of the crop

imported into the U.S. for the last 5

years (on a weight basis) from the

countries in which the pesticide is

marketed. Averaging over the previous 5

years allows for seasonal variability.

Information on agricultural imports may

be obtained from the U.S. Dept. of

Agriculture, the U.S. Dept. of

Commerce, and various private sources.

All forms of the commodity that are

imported (in significant amounts) must

be taken into consideration including

(but not limited to) juice, juice

concentrate, wine, and fresh produce.

The source of the import information

should be reported.

2. Using the value determined in step

1, calculate the percent of the crop

imported into the U.S. relative to the

total amount available for consumption

in the U.S. If less than 75% of the

commodity available for consumption

in the U.S. is imported, proceed to step

3. If greater than 75% of the commodity

available for consumption in the U.S. is

imported, proceed to step 4.

3. Refer to Table 4 in Unit VI. and

Table 10 in this unit. Determine the

number of field trials required for a U.S.

registration for the commodity of

interest from Table 10. Using that value

and the percentage imported into the

U.S., determine the minimum number

of field trials required for an import

tolerance using Table 4. Go to Step 5.

4. Refer to Table 5 in Unit VI. and

Table 10 in this unit. for commodities

for which the U.S. imports greater than

75% available for U.S. consumption.

The maximum percentage in the diet for

any commodity may be found in Table

10. Determine the minimum number of

field trials from Table 5 in Unit VI.

using the percentage in diet value. Go to

Step 5.

5. Determine the countries in which

the field trials should be conducted. All

countries (in which the pesticide is

marketed or intended to be marketed)

must be represented if the amount that

they export to the U.S. represents 5% or

more of U.S. imports of the subject crop.

A greater number of total trials and

trials per country than that determined

in steps 3 and 4 may be required to

ensure that all relevant countries and

the major growing regions within the

individual countries are represented.

Note 1: The number determined in

steps 3 and 4 is only the minimum

number required. Additional trials may

be required to ensure all major

formulation classes are represented.

Note 2: If the petitioner does not

market or does not intend to market the

subject pesticide in one of the top two

or three countries that export the subject

crop to the U.S., then the total percent

imported should not include the

countries in which the pesticide is not

marketed or intended to be marketed.

Examples of Calculating Number of

Field Trials

Several examples are provided below

illustrating different considerations

when calculating the numbers of field

trials. These are for illustrative purposes

only. Before submitting data or

conducting field trials, petitioners

should consult with the Agency.

i. The ABC Chemical Company

markets a granular nematicide for use

on bananas. This pesticide is marketed

in major banana producing countries.

ABC Chemical Company would like the

U.S. to establish a tolerance for their

chemical. No Codex MRL has been set.

a. Approximately 99.8% of all

bananas available in the U.S. are

imported. The highest consumption

level for any population sub-group is

0.96% of the diet for infants. Referring

to Table 5 in Unit VI., a minimum of 12

trials would be required.

Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices 35081

b. Table 6 below lists the countries

and amounts of bananas imported into

the U.S. To ensure that all countries that

account for greater than 5% of the

amount imported are represented, and

that the countries with the most

production are most heavily

represented, 12 trials will have to be

conducted (and 24 treated samples

analyzed) distributed among exporting

companies as listed below. Both bagged

and unbagged samples need to be

analyzed for bananas. Petitioners have

the option of analyzing one bagged

sample and one unbagged sample from

each site.

Costa Rica—3 trials

Ecuador—3 trials

Honduras—2 trials

Guatemala—1 trial

Colombia—2 trials

Mexico 1—trial

TABLE 6.—BANANAS IMPORTED TO THE UNITED STATES (1991–1995 AVERAGE)

Trading Country Import Quantity (thousand lbs) Import Quantity (%)

Ecuador 2,076,329 25.55

Costa Rica 1,994,840 24.55

Colombia 1,312,890 16.16

Honduras 1,032,646 12.71

Guatemala 866,371 10.66

Mexico 559,385 6.88

Panama 191,409 2.36

Venezuela 11,416 0.14

Other Countries 81,366 1.00

Total 8,126,652 100.01

ii. The XYZ Pesticide company

intends to register a new insecticide for

oranges in most countries, but is not

pursuing a U.S. use.

a. Approximately 21% of all oranges

available in the U.S. (as juice or fresh

fruit) over the last 5 years were

imported. Referring to Table 10 in this

unit, 16 field trials are required for a U.S

registration. Using Table 4, oranges fall

in the range of 10-35% imported;

therefore a minimum of 12 trials (24

samples) must be conducted.

b. The countries that export fresh fruit

and juice to the U.S. are listed in Table

7 along with the amount imported.

Considering only the countries in which

the pesticide is marketed and represent

greater than 5% of the U.S. imports,

nine trials should be done in Brazil, and

three should be done in Mexico.

iii. The registrant also intends to

register another insecticide on oranges

in Mexico only, but does not intend to

market it elsewhere.

(1) Approximately 3% of all oranges

available in the U.S. (as juice or fresh

fruit) over the last 5 years were

imported from Mexico. Referring to

Table 10 below, 16 field trials are

required for a U.S registration. Using

Table 4 in Unit VI, oranges fall in the

range of 0-10% imported, Therefore a

minimum of 5 trials (10 samples) must

be conducted. All 5 trials would be

conducted in Mexico.

TABLE 7.—QUANTITY OF ORANGES AND ORANGE JUICE IMPORTED INTO U.S.

Trading Country Orange Juice, (Thousand liters)

Weight Orange Juice

(Thousand lb) 1

Weight Fresh Market

Oranges (Thousand

lb)

Total Weight Imported

(Thousand lb)

Percent Imported

Total

Brazil 1,042,756 2,294,063 (see footnote 2) 2,294,061 80.73

Mexico 140,403 308,887 29,938 338,825 11.92

Belize 29,784 65,525 — 65,525 2.31

Costa Rica 12,891 28,360 — 28,360 1.00

Honduras 12,440 27,368 — 27,368 0.96

Other (<1% from

each country) 9,769 21,492 7,050 28,542 1.00

Spain (see footnote 3) — 26,332 26,325 0.93

Morocco — 0 12,841 12,841 0.45

Australia — 0 9,691 9,691 0.34

35082 Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices

TABLE 7.—QUANTITY OF ORANGES AND ORANGE JUICE IMPORTED INTO U.S.—Continued

Trading Country Orange Juice, (Thousand liters)

Weight Orange Juice

(Thousand lb) 1

Weight Fresh Market

Oranges (Thousand

lb)

Total Weight Imported

(Thousand lb)

Percent Imported

Total

Dominican Republic — 0 6,873 6,873 0.24

Israel — 0 3,312 3,312 0.12

Total 1,248,040 2,745,689 96,035 2,841,723 100.00

1Assuming each liter of orange juice weighs 2.2 lbs.

2Fresh market oranges imported from this country represent less than 1% of the total orange imports and are therefore included in the ‘‘other’’

category. 3Orange juice imported from this country represents less than 1% of the total orange juice imports and is therefore included in the ‘‘other’’

category.

iv. MRE Pesticides has petitioned the

Agency for an import tolerance on

cherries for an insecticide used to kill

an insect found only in warmer

climates. They have proposed

conducting only three trials using only

the WP formulation, but an emulsifiable

concentrate is registered as well.

a. Approximately 2.3% of all cherries

available for U.S. consumption over the

last 5 years have been imported.

However, since the pesticide will not be

marketed in Canada, the percent

imported into the U.S. drops to 2%.

Eight trials are required for a tolerance

with a U.S. registration, according to

Table 10 in Unit VII. Referring to Table

4 in Unit VI., a minimum of 3 trials are

required for an import tolerance.

However since both formulations

should be tested, a minimum of 6 trials

(12 treated samples) are required, 3 with

each formulation.

b. Table 8 below shows the amount

imported into the U.S. Normally trials

would be required for both Chile and

Canada, but the pest controlled by the

product is only found in warmer

climates. Therefore all six trials should

be conducted in Chile.

TABLE 8.—AMOUNT OF CHERRIES IMPORTED INTO THE U.S.

Trading Country Average Amount Fruit/yr.

(short tons) % of Imports

Chile 1,633 85.50

Canada 252 13.19

Swaziland 12 0.63

Others (<1% each) 13 0.68

Total 1,910 100.00

TABLE 9.—NUMBER OF FIELD TRIALS REQUIRED FOR COMMODITIES FOR WHICH IMPORT TOLERANCES ARE COMMONLY

REQUESTED

Commodity Number of Field Trials Required Countries in Which Trials Should be Conducted 1

Coffee 8 Brazil (3), Columbia (3), Mexico (2)

Grapes 8 Chile (3), Italy (2), France (1), Mexico (1), Argentina (1)

Oranges 12 Brazil (9), Mexico (3)

Bananas 12 Ecuador (3), Costa Rica (3), Colombia (2), Honduras (2), Guatemala (1), Mexico (1)

Apples 12 Argentina (5), Germany (4), Chile (3)

Stone Fruit

Peaches

Cherries

Plums

3

3

5 2

Chile (3)

Chile (2), Canada (1)

Chile (5) 2

Tomatoes 12 Mexico (10), Italy (1), Chile (1)

Mangoes 3 Mexico

Kiwi 3 Chile (2), New Zealand (1)

1The number in the parentheses indicates the number of trials that should be conducted in the country specified.

2The number of field trials for plums may be reduced to 3 if a tolerance for the stone fruits crop group is proposed.

Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices 35083

TABLE 10.—PERCENT IN DIET VALUES AND NUMBER OF FIELD TRIALS REQUIRED FOR A TOLERANCE ASSOCIATED WITH A

U.S. REGISTRATION FOR MOST COMMODITIES

Raw Agricultural Commodity

% Contribution to Total Exposure No. of Field Trials for

Tolerance with A U.S.

1989-91 U.S. Population Registration 1989-91 Children

(ages 1-6) 1989-91 Infants

Acerola 0.000000 0.000000 0.000000 1 1

Almonds 0.007583 0.000043 0.000000 5

Apples 1.808737 4.012164 1.969677 16

Apricot 0.027213 0.032773 0.048144 5

Artichokes—Jerusalem 0.000000 0.000000 0.000000 3

Artichokes—globe 0.005846 0.001192 0.000000 3

Asparagus 0.023181 0.001589 0.000000 8

Atemoya 0.000000 0.000000 0.000000 1 1

Avocados 0.017335 0.005760 0.000000 5

Banana 0.577720 0.791826 0.957257 5

Barley 0.178596 0.023041 0.013825 12

Beans—Dry 2 0.180813 0.133279 0.005965 12

Beans—Succulent 2 0.320303 0.392089 0.220857 8 3

Beans—Lima— Dry Succulent 2 0.036485 0.029198 0.008702 8 3

Beets—Garden—Total 0.018545 0.010687 0.035230 5

Bitter Melon 0.000000 0.000000 0.000000 5

Blackberries—Total 0.006047 0.007746 0.000211 3 4

Blueberries 0.026205 0.025126 0.011018 8

Boysenberries 0.003024 0.005264 0.000140 2 1

Broccoli, Chinese (Gai Lon) 0.000000 0.000000 0.000000 2 1

Broccoli 0.229796 0.276191 0.008562 8

Brussels Sprouts 0.009071 0.000596 0.000983 3

Buckwheat 0.001209 0.000596 0.000000 5

Cabbage—green and red 0.146949 0.081040 0.001895 8

Cabbage—Chinese/celery/bok

choy 0.003225 0.003575 0.000000 3

Calabaza 0.000000 0.000000 0.000000 2 1

Canola Oil, Rape Seed Oil 0.009071 0.007746 0.001053 8

Carambola (Starfruit) 0.000000 0.000000 0.000000 2 1

Carob 0.000000 0.000199 0.000000 3

Carrots 0.352959 0.302509 0.683836 8

Casabas 0.000403 0.000000 0.000000 3

Cassava (Yuca Blanca) 0.003024 0.002483 0.014387 2 1

Cauliflower 0.039912 0.013805 0.000070 8

Celery 0.121550 0.087495 0.003439 8

35084 Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices

TABLE 10.—PERCENT IN DIET VALUES AND NUMBER OF FIELD TRIALS REQUIRED FOR A TOLERANCE ASSOCIATED WITH A

U.S. REGISTRATION FOR MOST COMMODITIES—CONTINUED

Raw Agricultural Commodity

% Contribution to Total Exposure No. of Field Trials for

Tolerance with A U.S.

1989-91 U.S. Population Registration 1989-91 Children

(ages 1-6) 1989-91 Infants

Cherries (sweet & sour) 0.040517 0.042605 0.014036 8 5

Chestnuts 0.000000 0.000000 0.000000 3

Chicory (french/belgian endive) 0.004435 0.000695 0.000000 2 1

Chocolate (cocoa bean) 0.067125 0.089978 0.002737 3

Coconut 0.056844 0.018075 1.023086 5

Cocoyam (tanier) 0.000000 0.000000 0.000000 2 1

Coffee 0.052006 0.000199 0.000000 5

Collards 0.023383 0.007746 0.000000 5

Corn/pop 0.047370 0.036249 0.000000 3

Corn/sweet 0.430767 0.556453 0.043863 12

Corn 1.828693 2.117263 0.883428 20

Cottonseed 0.052006 0.057006 0.004703 12

Crabapples 0.000000 0.000000 0.000000 3

Cranberry 0.052813 0.045883 0.005053 5

Crenshaws 0.000000 0.000000 0.000000 3

Cress—upland 0.000000 0.000000 0.000000 1 1

Cucumbers 0.145941 0.084717 0.000983 8

Currants 0.000000 0.000000 0.000000 2 1

Dandelion-greens 0.000202 0.000000 0.000000 1 1

Dates 0.002419 0.001887 0.002948 3

Dill 0.000000 0.000000 0.000000 2 1

Eggplant 0.006249 0.001589 0.000000 3

Elderberries 0.000000 0.000000 0.000000 3

Endive—curly and Escarole 0.005443 0.000695 0.000000 3

Figs 0.004838 0.004767 0.000000 3

Filberts (hazelnuts) 0.000403 0.000497 0.000000 3

Flax Seed 0.000000 0.000000 0.000000 5

Garlic 0.009272 0.007945 0.000842 3

Genip (Spanish Lime) 0.000000 0.000000 0.000000 1 1

Ginger 0.000403 0.000298 0.000000 2 1

Ginseng 0.000000 0.000000 0.000000 3

Gooseberries 0.000000 0.000000 0.000000 3

Grapefruit 0.255799 0.059290 0.000772 8

Grapes 0.694629 1.213610 0.449785 12

Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices 35085

TABLE 10.—PERCENT IN DIET VALUES AND NUMBER OF FIELD TRIALS REQUIRED FOR A TOLERANCE ASSOCIATED WITH A

U.S. REGISTRATION FOR MOST COMMODITIES—CONTINUED

Raw Agricultural Commodity

% Contribution to Total Exposure No. of Field Trials for

Tolerance with A U.S.

1989-91 U.S. Population Registration 1989-91 Children

(ages 1-6) 1989-91 Infants

Guar Beans 0.000000 0.000000 0.000000 3

Guava 0.002217 0.001688 0.000000 2 1

Hops 0.002217 0.000000 0.000000 3

Horseradish 0.000806 0.000298 0.000000 3

Huckleberries 0.000000 0.000000 0.000000 3

Kale 0.005039 0.005959 0.000000 3

Kiwi Fruit 0.007257 0.011818 0.000000 3

Kohlrabi 0.000000 0.000000 0.000000 3

Kumquats 0.000000 0.000000 0.000000 1 1

Leeks 0.000000 0.000000 0.000000 3

Lemons 0.056441 0.034164 0.000561 5

Lentils 0.003628 0.001589 0.000000 3

Lettuce (head & leaf) 0.412020 0.161881 0.002456 8 6

Limes 0.008869 0.004866 0.000211 3

Loganberries 0.000000 0.000000 0.000000 2 1

Longan 0.000000 0.000000 0.000000 1 1

Lotus Roots 0.000000 0.000298 0.000000 1 1

Lychees 0.000000 0.000000 0.000000 1 1

Macadamia Nuts (bush nuts) 0.000000 0.000000 0.000000 3

Maney (Mammee Apple) 0.000000 0.000000 0.000000 2 1

Mangoes 0.008869 0.003476 0.004070 3

Melon (including cantaloupe &

honeydew) 0.138079 0.062468 0.000000 5 and 8 7

Millet 0.000202 0.000000 0.000000 5

Mint 0.000000 0.000000 0.000000 5 8

Mulberries 0.000202 0.000397 0.000000 3

Mung Beans (sprouts) 0.026205 0.034859 0.000491 8

Mushrooms 0.059263 0.041811 0.001404 3

Mustard Greens 0.005846 0.001390 0.014036 5 9

Nectarines 0.026608 0.015791 0.000000 8

Oats 0.230602 0.455352 0.287037 16

Okra 0.016328 0.007449 0.000000 5

Olive 0.032655 0.021253 0.000983 3

Onion—Dry Bulb 0.333809 0.242921 0.038178 8

Onions-green 0.018747 0.011421 0.000211 3

35086 Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices

TABLE 10.—PERCENT IN DIET VALUES AND NUMBER OF FIELD TRIALS REQUIRED FOR A TOLERANCE ASSOCIATED WITH A

U.S. REGISTRATION FOR MOST COMMODITIES—CONTINUED

Raw Agricultural Commodity

% Contribution to Total Exposure No. of Field Trials for

Tolerance with A U.S.

1989-91 U.S. Population Registration 1989-91 Children

(ages 1-6) 1989-91 Infants

Orange 1.155632 1.651185 0.246403 16

Papaya 0.007660 0.001589 0.000000 3

Parsley 0.006652 0.007349 0.001263 3

Parsnips 0.000605 0.000000 0.000000 3

Passion Fruit 0.017134 0.037739 0.000070 2

Pawpaws 0.000000 0.000000 0.000000 3

Peaches 0.263056 0.343327 0.655904 12

Peanuts 0.154407 0.265266 0.005614 12

Pears 0.218508 0.240934 1.361074 8

Peas—dried 2 0.009474 0.006157 0.005053 5 3

Peas—succulent 2 0.235239 0.265862 0.167029 8 3

Pecans 0.006249 0.006157 0.000140 5

Pepper/black 0.001209 0.001092 0.001053 3

Peppers—sweet (garden) 0.080025 0.044890 0.002386 8

Peppers—non-bell 0.019754 0.006357 0.000000 3

Persimmons 0.000403 0.000000 0.005334 3

Pimento 0.003628 0.004270 0.000070 2 1

Pineapple 0.160656 0.218192 0.144431 8

Pistachio 0.001411 0.000000 0.000000 3

Plantains 0.013304 0.004866 0.003720 3

Plum 0.062690 0.061972 0.124360 8

Pomegranates 0.000000 0.000000 0.000000 3

Potato 1.791805 1.587823 0.217278 16

Pumpkin 0.010684 0.016784 0.015580 5

Quinces 0.000000 0.000000 0.000000 3

Radishes 0.010684 0.002681 0.000000 5

Radishes—Japanese (daikon) 0.000000 0.000000 0.000000 2 1

Raspberries 0.007861 0.003476 0.011650 3 4

Rhubarb 0.011691 0.007051 0.000000 2 1

Rice 0.463422 0.486456 0.652956 16

Rice-wild 0.001814 0.000199 0.000000 5

Rutabagas—tops and roots 0.002217 0.000000 0.000000 3

Rye 0.013707 0.006853 0.000000 5

Safflower—seed and oil 0.000202 0.000000 0.000000 5

Salsify (oyster plant) 0.000000 0.000000 0.000000 3

Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices 35087

TABLE 10.—PERCENT IN DIET VALUES AND NUMBER OF FIELD TRIALS REQUIRED FOR A TOLERANCE ASSOCIATED WITH A

U.S. REGISTRATION FOR MOST COMMODITIES—CONTINUED

Raw Agricultural Commodity

% Contribution to Total Exposure No. of Field Trials for

Tolerance with A U.S.

1989-91 U.S. Population Registration 1989-91 Children

(ages 1-6) 1989-91 Infants

Sesame 0.000403 0.000497 0.000000 3

Shallots 0.000000 0.000000 0.000000 1 1

Snowpeas 0.006854 0.005264 0.000000 3

Sorghum (including milo) 0.000000 0.000000 0.000000 12

Soybeans 0.801061 0.710290 1.257067 20

Spinach 0.053216 0.052835 0.034037 8

Squash—summer 0.079824 0.042804 0.000000 5

Squash—winter 0.038703 0.015791 0.459189 5

Strawberry 0.099578 0.107954 0.001263 8

Sugar Cane 0.520065 0.576415 0.312933 8

Sugar Apples (sweetssop) 0.000000 0.000000 0.000000 2 1

Sugar-beet 0.443458 0.491502 0.271878 12

Sunflower 0.007055 0.007449 0.000000 8

Sweet Potatoes (including yams) 0.055433 0.026219 0.355252 8

Swiss Chard 0.001008 0.000099 0.000000 3

Tangelos 0.000000 0.000000 0.000000 3

Tangerine 0.011490 0.016883 0.000000 5

Taro-root 0.002016 0.001092 0.014808 2 1

Tomato 1.662796 1.485630 0.218331 16

Turnip 0.021367 0.009931 0.000421 5

Walnuts 0.006854 0.005760 0.000140 3

Watercress 0.001209 0.000000 0.000000 2 1

Watermelon 0.141506 0.203096 0.012422 8

Wheat 2.983519 3.370301 0.360305 20

1 If one or two field trials are required, then four samples must be collected from each test plot.

2The percent in diet figures for peas, beans, and dry beans include different varieties that may require separate field trials. Petitioners are advised to consult OPPTS Guideline 860.1500 for additional information on numbers of field trials for individual varieties. 3These bean/pea commodities include more than one type of bean/pea. The specific commodities included in each of these groups are shown

below. The specific representative commodity for which field trials should be run in each case are those representative commodities provided in

crop subgroup in 40 CFR 180.41. Bean, edible podded: include those commodities listed in subgroup 6-A as Phaseolus spp., Vigna spp.,

jackbeans, soybeans (immature seed) and sword bean. Pea, edible podded: include those commodities listed in subgroup 6-A as Pisum spp.

and pigeon pea. Bean, succulent shelled: include those commodities listed in subgroup 6-B as Phaseolus spp., Vigna spp. and broad bean. Pea,

succulent shelled: include those commodities listed in subgroup 6-B as Pisum spp. and pigeon pea. Bean, dried shelled (except soybean): include those commodities listed in subgroup 6-C as Lupinus spp., Phaseolus spp., Vigna spp., guar and lablab beans. Pea, dried shelled: include

those commodities listed in subgroup 6-C as Pisum spp., lentil and pigeon pea. A minimum of three trials is required for field pea forage and hay

with Austrian winter pea the preferred cultivar. Field pea seeds will be considered dried shelled peas and required a minimum of five trials. The

number of trials required for dried shelled pea is based on combined acreage and consumption of dried garden pea (Pisum spp.) and lentil. 4A minimum of 5 trials (and 10 samples) is required on any one blackberry or any one raspberry if a tolerance is sought on ‘‘caneberries.’’ A

minimum of 3 trials (and 6 samples) is required if a tolerance is sought only on blackberries or only on raspberries. 5Eight trials each for sweet and sour cherries are required.

6Eight trials each for head and leaf lettuce are required.

7Five trials are required for honeydew melons and eight trials are required for cantaloupe. A tolerance for muskmelons may be obtained using

residue data for cantaloupes. 8A tolerance for mint may be obtained using residue data for spearmint and/or peppermint. If a tolerance is sought for either spearmint or peppermint separately, five trials are still required. 9A minimum of 8 trials (and 16 samples) are required on mustard greens if a tolerance is sought on the crop subgroup leafy Brassica greens.

35088 Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices

VIII. Consideration of Codex MRLs

When Establishing Import Tolerances

The 1996 FQPA amendments to

FFDCA codified a longstanding Agency

policy to harmonize U.S. tolerances

with Codex MRLs to the extent possible.

Recent trade agreements such as the

NAFTA and the WTO Agreement on the

Application of Sanitary and

Phytosanitary Measures further

encourage the use of international

standards such as Codex MRLs.

When establishing or reassessing

tolerances (including import tolerances),

the Agency takes into consideration the

Codex MRL level, the Codex commodity

definition, and the metabolite(s)

included in the Codex MRL definition.

If use patterns and risk assessments

permit, the Agency will harmonize

tolerances with the Codex levels. If not,

the Agency must explain why they

cannot be harmonized, in accordance

with FQPA.

If an existing U.S. tolerance exceeds

the Codex MRL and is sufficient to

cover the import use, there is no need

for a revision to accommodate the MRL.

During tolerance reassessment, the

Agency will evaluate whether the U.S.

tolerance can be lowered to the Codex

level and still accommodate any

existing U.S. use and/or import

tolerance needs. If that is not possible,

relevant information should be provided

to Codex in order to support a higher

Codex limit. If the Codex MRL exceeds

the existing U.S. tolerance or the

proposed import tolerance, then the

Codex MRL may be adopted as the U.S.

tolerance, provided the data support the

safety findings required by the FFDCA

at that level.

In the context of establishing import

tolerances, four common situations are

presented below that take into

consideration the presence or absence of

U.S. tolerances and Codex MRLs. The

potential effects of Codex MRLs on data

requirements for import tolerances are

described, as are the Agency’s

approaches to harmonizing new and

existing tolerances with MRLs.

1. A U.S. tolerance and Codex MRL

have been established for the chemical/

commodity combination of concern.

This situation might be encountered

when a U.S. registration is withdrawn or

proposed for cancellation and is most

likely to occur during the tolerance

reassessment or reregistration process.

Depending upon the status of the data

base, additional data may be required to

support maintenance of the U.S.

tolerance as an import tolerance.

Persons seeking to maintain the

tolerance should review this guidance

on the required number and location of

field trials when determining what

additional studies may be needed to

support the tolerance.

During the review of the data base, the

Agency will make every attempt to

harmonize with the Codex level in all

respects, including the numerical level

and definition of residue.

2. A Codex MRL has been established

for the chemical/commodity

combination of concern, but there is no

U.S. tolerance. This situation may occur

when a tolerance petition for imported

commodities has been submitted and

there are no corresponding U.S.

registrations for the commodities of

interest. Normally under these

circumstances the full range of data

must be provided to support an import

tolerance. Product chemistry data and

an acceptable tolerance enforcement

method must be submitted. At the same

time, efforts should be made to

harmonize proposed tolerance levels

with Codex MRLs.

If the following conditions are met,

the petitioner may propose the Codex

MRL as the tolerance level, and the

Agency may be able to complete its

assessment of the tolerance based on a

more limited review of the residue

chemistry data:

i. The dietary exposure to the

pesticide residue will be low, either due

to low consumption of the commodity

in the U.S. diet, or due to minimal

expected exposure to residues in higher

consumption commodities (for example,

if all residues are non-detectable).

ii. A U.S. use(s) or U.S. tolerance(s)

for the subject commodity(ies) has not

been canceled, suspended, revoked, or

denied or is not under consideration for

the same as a result of human dietary

risk concerns.

iii. Residues resulting from the

importation of the subject

commodity(ies) meet U.S. food safety

standards under FFDCA.

iv. An acceptable analytical method is

submitted with the petition (i.e., the

method should undergo an independent

lab validation and an EPA lab validation

if it is not already approved for

enforcement, and the applicability of

multi-residue method testing for the

parent compound and residues of

concern should be evaluated).

v. U.S./Codex commodity and residue

definitions are or can be made

compatible.

If the above criteria are not met,

standard data and review requirements

would apply. In either case, a dietary

risk assessment will be done using the

Codex MRL. The Codex MRL will be

established as the tolerance if FFDCA

food safety standards are satisfied.

An assessment will need to be made

as to whether the Codex MRL will

accommodate the import tolerance

need. If the Codex MRL is not high

enough to accommodate the import

tolerance need, it will not be adopted as

the U.S. tolerance level. In these

circumstances, data must be provided to

support the higher level before EPA can

evaluate the establishment of an import

tolerance. The Agency would also

recommend that the tolerance petitioner

provide the relevant data to Codex to

support a revised Codex limit.

3. A U.S. tolerance has been

established but there is no Codex MRL

for the chemical/commodity

combination of concern. Assessment of

the need for an import tolerance will

need to take into account whether the

U.S. tolerance supports an existing U.S.

use for the commodity in question or

whether the U.S. tolerance has been

maintained to accommodate residues in

or on imported commodities after a U.S.

use has been canceled. If the former, the

assessment will need to determine

whether the existing U.S. tolerance will

accommodate the import tolerance

need. If so, no import tolerance petition

is necessary. If not, the data

requirements outlined in this guidance

apply. Persons supporting maintenance

or modification of a U.S. tolerance that

has been maintained after cancellation

of U.S. uses also may need to provide

additional data. Residue field trial data

requirements may be partly satisfied by

U.S. data, if adequately justified.

In either case, the Agency also

recommends that the petitioner provide

the relevant data to Codex to support a

Codex limit for the subject commodities.

4. Neither a Codex MRL nor a U.S.

tolerance has been established for the

chemical/commodity combination of

concern. All toxicology and product and

residue chemistry studies as described

in this document are required for

establishment of the import tolerance.

U.S. import tolerances will be

established provided that FFDCA food

safety standards are met. The Agency

also recommends that the petitioner

provide the relevant data to Codex to

support establishment of a Codex limit

for the subject commodities.

Examples:

Following are two examples

illustrating the consideration of Codex

MRLs and other factors in deciding

whether the Agency can conduct a more

limited review of an import tolerance

petition.

Example 1. ABC Company has

petitioned for an import tolerance for an

insecticide used on olives. There are

U.S. tolerances and registrations for

Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices 35089

several other commodities, and a Codex

MRL has been established for olives.

The U.S. and Codex have the same

definition of ‘‘olives.’’ The U.S.

tolerance expression and the Codex

MRL definition are compatible. There

are no dietary risk concerns with the

existing tolerances, and the data base

supporting them is up-to-date. There is

an acceptable enforcement method in

the FDA Pesticide Analytical Manual for

plant commodities.

In this case, only a limited review of

this chemical would be required

initially. Olives are a low consumption

commodity, 0.033% of the U.S. diet. A

risk assessment would be done using

the Codex MRL. If the assessment

concludes that there are no dietary risk

concerns, no further data would be

required.

Example 2. Acme Chemicals would

like to obtain an import tolerance for an

insecticide on lima beans, and no

tolerance has been established in the

U.S. for this commodity. This chemical

is undergoing reregistration in the U.S.

and is used on several commodities.

Dietary risk concerns have delayed the

Reregistration Eligibility Decision. A

Codex MRL has been established and

the company has proposed conducting a

risk assessment using the Codex MRL

without submitting data. The U.S.

tolerance expression for other

commodities includes the parent

compound, a sulfoxide, and a sulfone

metabolite. The Codex MRL includes

the parent only.

This proposed tolerance is not a good

candidate for limited review. Although

it involves a low consumption food item

(0.036% of the U.S. diet), there is an

existing risk concern with the chemical.

Additionally, the tolerance expression

differs from the Codex MRL expression,

and the Agency’s review must therefore

include consideration of harmonization

in the residue chemistry assessment.

IX. References

The following is a list of documents

that are referenced in this guidance

document, and that are available as

described in Unit II.

1. PR Notice 96-1, ‘‘Tolerance

Enforcement Methods—Independent

Laboratory Validation by Petitioner,’’

February 7, 1996. (http://www.epa.gov/

opppmsd1/PR—Notices)

2. PR Notice 86-5, ‘‘Standard Format

for Data Submitted Under the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA) and Certain Provisions of

the Federal Food, Drug, and Cosmetic

Act (FFDCA),’’ July 29, 1986. (http://

www.epa.gov/opppmsd1/PR—Notices)

3. OPPTS Test Guidelines, Series 830,

Product Chemistry (August 1996).

(http://www.epa.gov/docs/OPPTS—

Harmonized/830—Product—

Properties—Test—Guidelines/)

4. OPPTS Test Guidelines, Series 860,

Residue Chemistry (August 1996).

(http://www.epa.gov/docs/OPPTS—

Harmonized/860—Residue—

Chemistry—Test—Guidelines/)

5. OPPTS Test Guidelines, Series 870,

Health Effects (August 1998). (http://

www.epa.gov/docs/OPPTS—

Harmonized/870—Health—Effects—

Test—Guidelines/)

6. Federal Register. 54 FR 48314;

November 22, 1989, List 1 and 2 Inert

Ingredients.

7. Pesticide Assessment Guidelines,

Subdivision F, Hazard Evaluation—

Human and Domestic Animals. Series

84, Mutagenicity. Addendum 9. (1991).

(Available from the National Technical

Information Service under order number

PB91-158394INZ. To order, call 1–800–

553–6847 or e-mail

orders@ntis.fedworld.gov.)

X. Intended Legal Effect of this

Guidance Document

This document provides detailed

guidance for EPA staff and outside

parties on how U.S. data requirements

apply for the establishment or

continuance of tolerances for pesticide

residues in or on imported foods. The

purpose of this guidance is to promote

greater transparency and provide clear

guidance to interested parties on how to

obtain an import tolerance. As guidance,

this document is not binding on either

EPA or any outside parties, and this

document is not intended, nor can it be

relied upon, to create any rights

enforceable by any party in litigation

with the United States.

Although this guidance provides

information on the applicability of U.S.

data requirements for the establishment

or continuance of tolerances for

pesticide residues in or on imported

foods, EPA will depart from its policy

where the facts or circumstances

warrant. In such cases, EPA will explain

why a different course was taken.

Similarly, outside parties remain free to

assert that the application of this

guidance is not appropriate for a

specific circumstance or that the

circumstances surrounding a specific

pesticide demonstrate that this guidance

should not be applied.

In addition, the Agency is providing

an opportunity for public comment on

the guidance provided in this document

and may also request feedback through

other venues. After reviewing comments

received, this document may be revised

and the Agency may announce its

availability in the Federal Register. This

guidance may be used by both EPA staff

and outside parties in the interim. If

additional changes are necessary at

some point in the future, the Agency

may revise, clarify, or update the text of

this guidance without public notice.

XI. Regulatory Assessment

A. General Requirements

As indicated previously, this

document provides guidance for EPA

staff and outside parties and is not a

rulemaking. As such, the regulatory

assessment requirements imposed on

rulemakings do not apply to this action.

B. Paperwork Reduction Act Notice

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 guidance document does not

contain any new information collection

requirements that would require

additional OMB review and approval.

The information collection activities

related to 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). 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

35090 Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Notices

information; search data sources;

complete and review the collection of

information; and transmit or otherwise

disclose the information.

Comments regarding 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, should be sent to the

Director, Collection Strategies Division,

Office of Environmental Information,

U.S. Environmental Protection Agency

(Mail Code 2822), 1200 Pennsylvania

Avenue, NW., Washington, DC 20460.

Include the OMB control number in any

correspondence, but do not submit the

requested information to this address.

The requested information should be

submitted in accordance with the

instructions accompanying the form, or

as specified in the corresponding

regulation.

XII. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

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

Business Regulatory Enforcement

Fairness Act of 1996, does not apply

because this action is not a rule for

purposes of 5 U.S.C. 804(3).

List of Subjects

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Tolerance and tolerances,

Import and Imports, Reporting and

recordkeeping requirements.

Dated: May 23, 2000.

Marcia E. Mulkey,

Director, Office of Pesticide Programs.

[FR Doc. 00–13708 Filed 5–31–00; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL COMMUNICATIONS

COMMISSION

Notice of Public Information

Collection(s) Being Reviewed by the

Federal Communications Commission,

Comments Requested

May 24, 2000.

SUMMARY: The Federal Communications

Commission, as part of its continuing

effort to reduce paperwork burden

invites the general public and other

Federal agencies to take this

opportunity to comment on the

following information collection, as

required by the Paperwork Reduction

Act of 1995, Public Law 104–13. An

agency may not conduct or sponsor a

collection of information unless it

displays a currently valid control

number. No person shall be subject to

any penalty for failing to comply with

a collection of information subject to the

Paperwork Reduction Act (PRA) that

does not display a valid control number.

Comments are requested concerning (a)

whether the proposed collection of

information is necessary for the proper

performance of the functions of the

Commission, including whether the

information shall have practical utility;

(b) the accuracy of the Commission’s

burden estimate; (c) ways to enhance

the quality, utility, and clarity of the

information collected; and (d) ways to

minimize the burden of the collection of

information on the respondents,

including the use of automated

collection techniques or other forms of

information technology.

DATES: Written comments should be

submitted on or before July 31, 2000. If

you anticipate that you will be

submitting comments, but find it

difficult to do so within the period of

time allowed by this notice, you should

advise the contact listed below as soon

as possible.

ADDRESSES: Direct all comments to Les

Smith, Federal Communications

Commissions, 445 12th Street, S.W.,

Room 1–A804, Washington, DC 20554

or via the Internet to lesmith@fcc.gov.

FOR FURTHER INFORMATION CONTACT: For

additional information or copies of the

information collections contact Les

Smith at (202) 418–0217 or via the

Internet at lesmith@fcc.gov.

SUPPLEMENTARY INFORMATION:

OMB Control Number: 3060–XXXX.

Title: Amendment of the

Commission’s Rules to Establish New

Personal Communications Services,

Narrowband PCS.

Form Number: N/A.

Type of Review: New collection.

Respondents: Business or other forprofit; Individuals or households; Notfor-profit institutions; Federal

Government; and State, Local or Tribal

Government.

Number of Respondents: 1,500.

Estimated Time Per Response: 3.5 hrs.

(avg.).

Frequency of Response: On occasion.

Total Annual Burden: 5,250 hours.

Total Annual Costs: $1,050,000.

Needs and Uses: The amendments to

the Commission’s narrowband Personal

Communications Services rules adopted

in this proceeding will improve the

efficiency of spectrum use, reduce the

regulatory burden on spectrum users,

encourage competition, and promote

service to the largest feasible number of

users.

Federal Communications Commission.

Magalie Roman Salas,

Secretary.

[FR Doc. 00–13591 Filed 5–31–00; 8:45 am]

BILLING CODE 6712–01–P

FEDERAL COMMUNICATIONS

COMMISSION

Notice of Public Information

Collection(s) Being Reviewed by the

Federal Communications Commission

May 24, 2000.

SUMMARY: The Federal Communications

Commission, as part of its continuing

effort to reduce paperwork burden

invites the general public and other

Federal agencies to take this

opportunity to comment on the

following information collection(s), as

required by the Paperwork Reduction

Act of 1995, Public Law 104–13. An

agency may not conduct or sponsor a

collection of information unless it

displays a currently valid control

number. No person shall be subject to

any penalty for failing to comply with

a collection of information subject to the

Paperwork Reduction Act (PRA) that

does not display a valid control number.

Comments are requested concerning (a)

whether the proposed collection of

information is necessary for the proper

performance of the functions of the

Commission, including whether the

information shall have practical utility;

(b) the accuracy of the Commission’s

burden estimate; (c) ways to enhance

the quality, utility, and clarity of the

information collected; and (d) ways to

minimize the burden of the collection of

information on the respondents,

including the use of automated

collection techniques or other forms of

information technology.

DATES: Written comments should be

submitted on or before July 3, 2000. If

you anticipate that you will be

submitting comments, but find it

difficult to do so within the period of

time allowed by this notice, you should

advise the contact listed below as soon

as possible.

ADDRESSES: Direct all comments to Judy

Boley, Federal Communications

Commission, Room 1–C804, 445 12th

Street, SW, DC 20554 or via the Internet

to jboley@fcc.gov.

FOR FURTHER INFORMATION CONTACT: For

additional information or copies of the

information collection(s), contact Judy

Boley at 202–418–0214 or via the

Internet at jboley@fcc.gov.

SUPPLEMENTARY INFORMATION:

OMB Control No.: 3060–XXXX.