[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: [email protected]
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
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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: [email protected]. 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:
What international tolerances or MRLs exist?
Which countries export the commodity to the U.S.?
Major seasonal variations in imports of the commodity.
Percent of U.S. consumption which is imported.
Percent of crop treated in the exporting countries.
Significance of the food in the U.S. diet (see Table 10 in
Unit VII.).
Effect of processing on the residues.
Available information on levels of residues found in
samples of imported food (based on FDA, USDA, or other monitoring
data).
Other information that would help the Agency determine if
residues in or on imported food are likely to contribute significantly
to dietary exposure or risk in the U.S. or to differ significantly from
residues in or on domestically-produced foods.
Following are two examples of how the Agency may use the above
information in determining the need for further data:
Example 1. A petitioner seeks a U.S. registration and tolerance for
a new pesticide use on cranberries. Less than 1% of cranberries
consumed in the U.S. are imported. Almost all imports are from Canada,
where growing conditions (e.g., use patterns, weather conditions, soil
type) are similar to those in the U.S. Cranberries account for an
extremely low percentage of the U.S. diet. In this case, EPA would
probably not require submission of foreign residue data because dietary
exposure to residues in imported cranberries is very low and EPA
determines that U.S. field trials would be representative of growing
conditions in Canada.
Example 2. A petitioner seeks to maintain a tolerance for residues
of a pesticide in bananas following the cancellation of the banana use
in the U.S. The vast majority of bananas consumed in the U.S. are
imported. Bananas are imported from Central and South America, and
cultural practices for bananas grown in the U.S. differ from those in
Latin America. Existing residue data consist of five U.S. field trials
in Hawaii and Puerto Rico. Bananas represent a relatively high
percentage of the U.S. diet, especially for children. To assess the
safety of the tolerance, EPA would likely require submission of
additional residue data based on the pesticide's use in major banana
exporting countries for the following reasons: Most of what is consumed
in the U.S. is imported and EPA has no data on such foreign uses;
cultural practices in other countries appear to differ from those in
the U.S.; and bananas represent a relatively high percentage of the
diet of a potentially sensitive subpopulation (children). The tolerance
petitioner would not necessarily have to conduct new trials; however,
since there may be existing, reliable residue data that supported a
Codex submission or an MRL approved by another regulatory body.
These examples are only for illustrative purposes to suggest how
the Agency might use the screening information in deciding whether to
require additional residue data. Other factors that would likely affect
the Agency's decision include the toxicity of the chemical, available
information on conditions of pesticide use in exporting countries, and
available monitoring data.
E. Data Requirements
Import tolerances generally require the same types of data as are
needed for tolerances with U.S. registrations, including toxicology
data, residue chemistry data, and data representative of actual growing
conditions. EPA needs these data to assess the potential dietary risk
and to make the required safety finding. EPA does not require worker
exposure and environmental fate and effects data to establish import
tolerances since these data are not needed to assess dietary risk,
although they would be required if the pesticide were to be registered
for use in the U.S. The data requirements described in Unit V.
interpret 40 CFR part 158 for purposes of characterizing residues in or
on imports, and are intended to apply to all new tolerance petitions
where there is no U.S. registration and to requests to modify or
maintain a tolerance for imports where the
[[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 [email protected].)
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