[Federal Register Volume 65, Number 106 (Thursday, June 1, 2000)]
[Notices]
[Pages 35069-35090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-13708]


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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.

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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: <a href="/cdn-cgi/l/email-protection#7d11120a18531614101f180f11043d180d1c531a120b"><span class="__cf_email__" data-cfemail="98f4f7effdb6f3f1f5fafdeaf4e1d8fde8f9b6fff7ee">[email protected]</span></a>

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:

------------------------------------------------------------------------
                                                          Examples of
            Category                  NAICS Codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Food manufacturers                311                 Commercial food
                                                       processors
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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

[[Page 35070]]

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: <a href="/cdn-cgi/l/email-protection#fa958a8ad79e9599919f8eba9f8a9bd49d958c"><span class="__cf_email__" data-cfemail="b7d8c7c79ad3d8d4dcd2c3f7d2c7d699d0d8c1">[email protected]</span></a>. 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.

[[Page 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, 
health-based 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 non-occupational 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

[[Page 35072]]

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-by-case 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 non-dietary 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

[[Page 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 domestically-produced 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:
    <bullet> What international tolerances or MRLs exist?
    <bullet> Which countries export the commodity to the U.S.?
    <bullet> Major seasonal variations in imports of the commodity.
    <bullet> Percent of U.S. consumption which is imported.
    <bullet> Percent of crop treated in the exporting countries.
    <bullet> Significance of the food in the U.S. diet (see Table 10 in 
Unit VII.).
    <bullet> Effect of processing on the residues.
    <bullet> Available information on levels of residues found in 
samples of imported food (based on FDA, USDA, or other monitoring 
data).
    <bullet> 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

[[Page 35074]]

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.

[[Page 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), re-treatment 
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, 
re-treatment intervals, maximum application rate per year, and the pre-
slaughter 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

[[Page 35076]]

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.

[[Page 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 livestock-derived 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
----------------------------------------------------------------------------------------------------------------
                                                                 Application to Import
            Guideline No.                    Study Title               Tolerances           Test Substance \1\
----------------------------------------------------------------------------------------------------------------
830.1550                               Product Identity         No--Product Specific     N/A
                                                                 Requirement
----------------------------------------------------------------------------------------------------------------
830.1600
830.1620
830.1650                               Description of           Yes                      TGAI
                                        Manufacturing Process
----------------------------------------------------------------------------------------------------------------
830.1670                               Discussion on Formation  Yes--Agency is           TGAI
                                        of Impurities            especially concerned
                                                                 with impurities of
                                                                 toxicological concern
                                                                 (e.g. dioxins, HCB,
                                                                 nitrosamines)
----------------------------------------------------------------------------------------------------------------
830.1700                               Preliminary Analysis     Yes                      TGAI
----------------------------------------------------------------------------------------------------------------

[[Page 35078]]

 
830.1750                               Certified Limits         No--Product Specific     N/A
                                                                 Requirement
----------------------------------------------------------------------------------------------------------------
830.1800                               Enforcement Analytical   No--Product Specific     N/A
                                        Methods                  Requirement
----------------------------------------------------------------------------------------------------------------
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  Yes                      PAI
                                        Coefficient
----------------------------------------------------------------------------------------------------------------
830.7000                               pH                       Yes                      TGAI
----------------------------------------------------------------------------------------------------------------
830.6313                               Stability                Yes                      TGAI
----------------------------------------------------------------------------------------------------------------
830.6314                               Oxidation/Reduction      No--Product Specific     N/A
                                                                 Requirement
----------------------------------------------------------------------------------------------------------------
830.6315                               Flammability             No--Product Specific     N/A
                                                                 Requirement
----------------------------------------------------------------------------------------------------------------
830.6316                               Explodability            No--Product Specific     N/A
                                                                 Requirement
----------------------------------------------------------------------------------------------------------------
830.6317                               Storage Stability        No--Product Specific     N/A
                                                                 Requirement
----------------------------------------------------------------------------------------------------------------
830.6319                               Miscibility              No--Product Specific     N/A
                                                                 Requirement
----------------------------------------------------------------------------------------------------------------
830.6320                               Corrosion                No--Product Specific     N/A
                                        Characteristics          Requirement
----------------------------------------------------------------------------------------------------------------
830.6321                               Dielectric Breakdown     No--Product Specific     N/A
                                        Voltage                  Requirement
----------------------------------------------------------------------------------------------------------------
830.7100                               Viscosity                No--Product Specific     N/A
                                                                 Requirement
----------------------------------------------------------------------------------------------------------------
830.7050                               UV/Visible Absorption    No--Product Specific     N/A
                                                                 Requirement
----------------------------------------------------------------------------------------------------------------
\1\ TGAI = technical grade active ingredient; PAI = pure active ingredient


                          Table 2.--Toxicology Data Requirements for Import Tolerances
----------------------------------------------------------------------------------------------------------------
                                                                  Applicable to Import
      Guideline Reference Number             Study Title               Tolerance             Footnote Number
----------------------------------------------------------------------------------------------------------------
870.1100                               Acute oral toxicity--    Yes
                                        rat
----------------------------------------------------------------------------------------------------------------
870.1200                               Acute dermal toxicity    No                       1, 2
----------------------------------------------------------------------------------------------------------------
870.1300                               Acute inhalation         No                       1, 2
                                        toxicity--rat
----------------------------------------------------------------------------------------------------------------
870.2400                               Acute eye irritation--   No                       1, 2
                                        rabbit
----------------------------------------------------------------------------------------------------------------
870.2500                               Acute dermal irritation  No                       1, 2
----------------------------------------------------------------------------------------------------------------
870.2600                               Skin sensitization       No                       1, 2
----------------------------------------------------------------------------------------------------------------
870.3100                               90-Day Oral Toxicity--   Yes
                                        rodent
----------------------------------------------------------------------------------------------------------------
870.3150                               90-Day Oral Toxicity--   Yes
                                        non-rodent
----------------------------------------------------------------------------------------------------------------
870.3200                               21-Day dermal toxicity   No                       2
----------------------------------------------------------------------------------------------------------------

[[Page 35079]]

 
870.3250                               90-Day dermal toxicity   No                       2
----------------------------------------------------------------------------------------------------------------
870.3465                               90-Day inhalation--rat   No                       2
----------------------------------------------------------------------------------------------------------------
870.3700                               Developmental toxicity   Yes
                                        study
----------------------------------------------------------------------------------------------------------------
870.3800                               Multi-Generation         Yes
                                        Reproduction
----------------------------------------------------------------------------------------------------------------
870.4100                               Chronic Toxicity         Yes
----------------------------------------------------------------------------------------------------------------
870.4200                               Carcinogenicity study    Yes
----------------------------------------------------------------------------------------------------------------
870.4300                               Combined chronic         Yes
                                        toxicity/
                                        carcinogenicity
----------------------------------------------------------------------------------------------------------------
870.5100 to 870.5915                   Mutagenicity             Yes                      3
----------------------------------------------------------------------------------------------------------------
870.6200                               Neurotoxicity screening  Yes
                                        battery
----------------------------------------------------------------------------------------------------------------
870.7200                               Companion animal safety  No                       4
----------------------------------------------------------------------------------------------------------------
870.7485                               Metabolism and           Yes
                                        pharmacokinetics
----------------------------------------------------------------------------------------------------------------
870.7600                               Dermal penetration       No                       2
----------------------------------------------------------------------------------------------------------------
\1\ Study used largely to determine appropriate hazard statements required on U.S. pesticide product labels.
\2\ Study 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.
\3\ An 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.
\4\ Study 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
------------------------------------------------------------------------
                                                         Required for
         Guideline No.               Study Title       Import Tolerance
                                                              \1\
------------------------------------------------------------------------
860.1300                         Nature of the        R
                                  Residue--Plants
------------------------------------------------------------------------
860.1300                         Nature of the        CR \2\
                                  Residue--Animals
------------------------------------------------------------------------
860.1340                         Residue Analytical   R
                                  Methods--Plants
                                  and Animals
------------------------------------------------------------------------
860.1360                         Multiresidue         R
                                  Methods
------------------------------------------------------------------------
860.1380                         Storage Stability    R
------------------------------------------------------------------------
860.1480                         Magnitude of         CR \3\
                                  Residue--Meat,
                                  Milk, Poultry, and
                                  Eggs
------------------------------------------------------------------------
860.1500                         Crop Field Trials    R
------------------------------------------------------------------------
860.1520                         Processing Studies   CR \4\
------------------------------------------------------------------------
860.1850                         Confined Rotational  NR
                                  Crop
------------------------------------------------------------------------
860.1900                         Field Rotational     NR
                                  Crop
------------------------------------------------------------------------
 \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\
----------------------------------------------------------------------------------------------------------------
                                               Percentage of Commodity Imported into U.S. (Weight Basis)
  Required No. of Field Trials for a  --------------------------------------------------------------------------
          U.S. Registration                     0-10%                    10-35%                   35-75%
----------------------------------------------------------------------------------------------------------------
20                                     5                        16                       20
----------------------------------------------------------------------------------------------------------------
16 (15) \2\                            5                        12                       16
----------------------------------------------------------------------------------------------------------------

[[Page 35080]]

 
12                                     3                        8                        12
----------------------------------------------------------------------------------------------------------------
8 (9) \2\                              3                        5                        8
----------------------------------------------------------------------------------------------------------------
5 (6) \2\                              3 \3\                    3                        5
----------------------------------------------------------------------------------------------------------------
3                                      2 \3\                    3 \3\                    3
----------------------------------------------------------------------------------------------------------------
\1\ The 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.
\2\ The 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.
\3\ Fewer 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
------------------------------------------------------------------------
\1\ The 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.
\3\ Fewer 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.

[[Page 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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Weight Fresh Market      Total Weight
              Trading Country                   Orange Juice,      Weight Orange Juice    Oranges (Thousand    Imported (Thousand     Percent Imported
                                              (Thousand liters)     (Thousand lb) \1\            lb)                   lb)                  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
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 35082]]

 
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Assuming each liter of orange juice weighs 2.2 lbs.
\2\ Fresh market oranges imported from this country represent less than 1% of the total orange imports and are therefore included in the ``other''
  category.
\3\ Orange 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.
----------------------------------------------------------------------------------------------------------------
                                                        Average Amount Fruit/yr.
                   Trading Country                            (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
------------------------------------------------------------------------
                                                      Countries in Which
            Commodity               Number of Field    Trials Should be
                                    Trials Required      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                         3                   Chile (3)
  Cherries......................  3.................  Chile (2), Canada
  Plums.........................  5 \2\.............   (1)
                                                      Chile (5) \2\
------------------------------------------------------------------------
Tomatoes                          12                  Mexico (10), Italy
                                                       (1), Chile (1)
------------------------------------------------------------------------
Mangoes                           3                   Mexico
------------------------------------------------------------------------
Kiwi                              3                   Chile (2), New
                                                       Zealand (1)
------------------------------------------------------------------------
\1\ The number in the parentheses indicates the number of trials that
  should be conducted in the country specified.
\2\ The number of field trials for plums may be reduced to 3 if a
  tolerance for the stone fruits crop group is proposed.


[[Page 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           % Contribution to Total Exposure
                                                     --------------------------------------------------------------------------- No. of Field Trials for
             Raw Agricultural Commodity                                        1989-91 Children  (ages                            Tolerance with A U.S.
                                                      1989-91 U.S. Population            1-6)               1989-91 Infants            Registration
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 35084]]


    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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           % Contribution to Total Exposure
                                                     --------------------------------------------------------------------------- No. of Field Trials for
             Raw Agricultural Commodity                                        1989-91 Children  (ages                            Tolerance with A U.S.
                                                      1989-91 U.S. Population            1-6)               1989-91 Infants            Registration
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           % Contribution to Total Exposure
                                                     --------------------------------------------------------------------------- No. of Field Trials for
             Raw Agricultural Commodity                                        1989-91 Children  (ages                            Tolerance with A U.S.
                                                      1989-91 U.S. Population            1-6)               1989-91 Infants            Registration
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 35086]]


    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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           % Contribution to Total Exposure
                                                     --------------------------------------------------------------------------- No. of Field Trials for
             Raw Agricultural Commodity                                        1989-91 Children  (ages                            Tolerance with A U.S.
                                                      1989-91 U.S. Population            1-6)               1989-91 Infants            Registration
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           % Contribution to Total Exposure
                                                     --------------------------------------------------------------------------- No. of Field Trials for
             Raw Agricultural Commodity                                        1989-91 Children  (ages                            Tolerance with A U.S.
                                                      1989-91 U.S. Population            1-6)               1989-91 Infants            Registration
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
\2\ The 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.
\3\ These 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.
\4\ A 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.
\5\ Eight trials each for sweet and sour cherries are required.
\6\ Eight trials each for head and leaf lettuce are required.
 \7\ Five 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.
\8\ A 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.
\9\ A minimum of 8 trials (and 16 samples) are required on mustard greens if a tolerance is sought on the crop subgroup leafy Brassica greens.


[[Page 35088]]

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

[[Page 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 <a href="/cdn-cgi/l/email-protection#711e0315140302311f0518025f171415061e031d155f161e07"><span class="__cf_email__" data-cfemail="d1bea3b5b4a3a291bfa5b8a2ffb7b4b5a6bea3bdb5ffb6bea7">[email protected]</span></a>.)

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

[[Page 35090]]

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


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