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diazinon (D.Z.N., Spectracide) Reassessment of More Non-Contributing Commodity Tolerances 8/02



ENVIRONMENTAL PROTECTION AGENCY
[OPP-2002-0191; FRL71949]

Organophosphate Pesticides; Reassessment of More Non-Contributing
Commodity Tolerances

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.

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SUMMARY: As part of its ongoing review of existing organophosphate (OP)
tolerances under the Food Quality Protection Act (FQPA), EPA has
determined that 16 OP tolerances can be reassessed at this time. EPA
has concluded that these tolerances make, at most, a minimal or
negligible contribution to the cumulative risk from OP pesticides.
These tolerances are considered to be ``non-contributors'' based on the
small number of reported pesticide residue detections in the monitoring
data being used in the OP cumulative risk assessment (CRA), the U.S.
Department of Agriculture's (USDA) Pesticide Data Program (PDP) and low
consumption in the most highly exposed subgroup (children ages 1 to 2).
These non-contributor tolerances meet the FQPA safety standard in
section 408(b)(2) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
and can be reassessed for the purposes of FFDCA section 408(q). This
notice discusses the concept and basis for this approach to reassessing
selected OP tolerances based on available information relating to the
revised OP CRA. Nothing in this notice is intended to modify in any way
any determination or requirement set forth in individual pesticide
Interim Reregistration Eligibility Decisions (IREDs), or affect
regulatory agreements or use cancellation actions required for some
other purpose (e.g., due to worker or ecological risk concerns).

DATES: The reassessment of these tolerances is effective as of July 31,
2002.

FOR FURTHER INFORMATION CONTACT: Karen Angulo, Special Review and
Reregistration Division (7805C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 3088004; e-mail address:
angulo.karen@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general who are interested
in the use of pesticides on food. As such, the Agency has not attempted
to specifically describe all the entities potentially affected by this
action. If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of This
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
On the Home Page select ``Laws and Regulations,'' ``Regulations and
Proposed Rules,'' and then look up the entry for this document under
the ``Federal Register--Environmental Documents.'' You can also go
directly to the Federal Register listings at http://www.epa.gov/
fedrgstr/. In addition, copies of this notice may also be accessed at
http: www.epa.gov/oppsrrd1/op.
    2. In person. The Agency has established an official record for
this action under docket ID number OPP20020191. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This officialrecord
includes the documents that are physically located in the docket, as
well as the documents that are referenced in those documents. The
public version of the official record does not include any information
claimed as CBI. The public version of the official record, which
includes printed, paper versions of any electronic comments submitted
during an applicable comment period is available for inspection in the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
The PIRIB telephone number is (703) 3055805.

II. Background

    FQPA significantly amended the FFDCA, creating a new safety
standard for judging the acceptability of tolerances for pesticide
residues in food. The new statutory standard allows EPA to approve a
new tolerance or leave an existing tolerance in place only if the
tolerance is ``safe.'' The statute defines ``safe'' to mean ``that
there is a reasonable certainty that no harm will result from aggregate
exposure to the pesticide chemical residue, including all anticipated
dietary exposures and all other exposures for which there is reliable
data'' FFDCA section 408(b)(2)(A)(ii). In making the safety
determination, EPA ``shall consider, among other relevant factors--
available information concerning the cumulative effects of such
residues and other substances that have a common mechanism of
toxicity.'' FFDCA section 408(b)(2)(D)(v). The FQPA amendments not only
made the new safety standard applicable to new tolerances, but also to
tolerances in existence when FQPA became law. FQPA set a 10year
schedule for EPA to reassess all existing tolerances, with interim
deadlines for completion of 33% and 66% of tolerance reassessments 3 to
6 years, respectively, after the date of enactment. Pesticide
tolerances subject to reassessment under the FQPA section 408(q) may
only remain in effect without modification if they meet the section
408(b)(2) safety standard. Finally, FQPA instructed EPA to give
priority to the review of tolerances which appear to pose the greatest
risk to public health.
    Consistent with the FQPA mandate, EPA identified OPs as high
priority for tolerance reassessment. EPA has determined that the OPs share a
``common mechanism of toxicity,'' and therefore the Agency will
consider the cumulative risks of OPs in making the safety determination
for any tolerance for a pesticide in this group. The Agency has
reviewed individual OP pesticides to determine whether they meet the
current health and safety standards of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and the FFDCA safety standard,
and has presented its determinations in documents called IREDs. When
the pesticide covered by an IRED shares a common mechanism of toxicity
with other pesticides, the IRED addresses the aggregate risk of the
chemical but does not take a position on the FFDCA standard until the
Agency has also considered the potential cumulative risks of the group
of pesticides.
    In addition to its consideration of individual OP pesticides, EPA
has also conducted a preliminary CRA for all of the OPs and sought
public comment on the assessment. The Agency recently released the
revised OP CRA for public comment. The preliminary and revised OP CRA
documents are available at http://www.epa.gov/pesticides/cumulative. In
addition, EPA presented the assessments to its FIFRA Scientific
Advisory Panel (SAP) for expert, independent scientific peer review.
The SAP provided a generally favorable review of the preliminary
assessment. See http://www.epa.gov/scipoly/sap/index.htm.

III. What Action is the Agency Taking?

A. Reassessment of Tolerances

    In this notice, EPA identifies tolerances and considers them
reassessed for the purposes of FQPA section 408(q) as of July 31, 2002.
A pesticide tolerance subject to reassessment under the FQPA section
408(q) may only remain in effect without modification if it meets the
section 408(b) safety standard. This standard is met if EPA finds that
``there is a reasonable certainty that no harm will result from
aggregate exposure to the pesticide chemical residue.'' In evaluating
tolerances under the standard, the FQPA also instructs the Agency to
consider the cumulative effects of the pesticide and other substances
that have a common mechanism of toxicity. For each of the tolerances
being reassessed, the Agency has issued an IRED, which found that,
apart from consideration of the potential cumulative risks from all of
the OPs, each of the tolerances would meet the FFDCA safety standard.
EPA has now considered the impact of these cumulative risks in the
reassessment of these tolerance and has determined that these
tolerances make, at most, only a negligible contribution to the overall
risks from OPs. Therefore, these tolerances can be maintained
regardless of the outcome of the OP cumulative assessment and any
potential regulatory action taken as a result of that assessment.
Accordingly, EPA believes it is appropriate to consider these
tolerances reassessed for the purposes of FQPA section 408(q) as of
July 31, 2002.
    In making the determination that these tolerances contribute
negligible (if any) residues and/or risk, EPA considered, among other
things, the nature of the use of the pesticide, the data used in
conducting aggregate risk assessments for each individual OP, the
potential for drinking water contamination, and other data and analyses
available to the Agency (such as food residue monitoring and other
information that the Agency is using for the CRA). The Agency concludes
that these pesticide uses result in minimal detectable residues in
food, and have no or negligible effects through drinking water. Because
a tolerance may apply to more than one raw agricultural commodity
(RAC), no tolerance is herein reassessed as a non-contributor unless
all of the RACs (food forms) that are part of that tolerance are also
considered to be non-contributors. EPA also considered the potential
impacts of future OP risk management decisions and determined that such
decisions would be very unlikely to increase the use of the pesticide
on these use sites in a manner or to a degree that the potential
exposure under the tolerance would no longer be minimal. As part of its
preliminary and revised CRAs, the Agency developed an estimate of the
potential contribution that OP pesticides used in different parts of
the country could make to overall risk as a result of the presence of
residues of such pesticides in drinking water. Because of the nature of
the available data, EPA's estimate employs assumptions that are
designed not to understate potential drinking water exposure. The OP
preliminary and revised CRA concluded that drinking water was not a
significant source of potential exposure. In reaching the determination
to reassess these tolerances, EPA has considered this analysis, the
public comment and the SAP's advice, as well as the information
developed to assess the aggregate exposure from drinking water for each
of the individual pesticides being reassessed.
    The Agency's assessment of these tolerances is effectively complete
and the tolerances are considered reassessed. Nothing in this notice is
intended to modify in any way any determination or requirement set
forth in individual pesticide IREDs, or affect regulatory agreements or
use cancellation actions required for some other purpose (e.g., due to
worker or ecological risk concerns). For any of the uses that may be
canceled pursuant to any such decision, EPA expects that the associated
tolerance would be revoked at the appropriate time unless it is
properly supported for an import tolerance. In addition, all of these
pesticide/use pattern combinations are included in the preliminary and
revised CRA and will remain in the CRA even though they involve
exposures that pose negligible/minimal risk.
    No conclusions about reassessment should be drawn about tolerances
that are not identified, as in this notice. Additional tolerances may
be reassessed without the need for regulation upon completion of the
CRA. In other words, the failure of a tolerance to be identified in
this or any other announcement does not imply that the pesticide/use
combination will ultimately be subject to regulatory action. For
tolerances reassessed as announced in this notice or using the approach
described herein, EPA has concluded that the decision to reassess these
tolerances will have no impact on any subsequent determination or
decisions that may be necessary if the CRA were to conclude that
cumulative exposure to the OPs poses risks of concern.

B. Tolerances With Low Residue Detections in PDP and Low Consumption

    EPA has determined that certain OP tolerances, listed later in the
notice, are reassessed at this time because they make, at most, a
minimal contribution to OP risk. The Agency examined the monitoring
data being used in the OP CRA and found that pesticide residue was
detected in a small number of samples that were analyzed for these food
commodity/OP combinations, including the parent chemical and the
degradates that were tested. In addition, these commodities have low
consumption in the most highly exposed subgroup (children ages 1 to 2).
The revised OP CRA indicates that relatively few pesticide/
cropcombinations account for the vast majority of exposure. These
tolerances are not among those pesticide/crop combinations that are
major contributors to risk.

    The monitoring data being used in the OP cumulative assessment,
USDA's PDP data, are the Agency's preferred data for risk assessment.
The number of samples analyzed in the PDP for these food commodity/OP
combinations ranged from 176 to nearly 3,400 samples. USDA's PDP
program has been collecting data on pesticide residues found on foods
since 1991, primarily for purposes of estimating dietary exposure to
pesticides. For several years, EPA has routinely used the PDP data base
in developing assessments of dietary risk. The PDP's sampling
procedures were designed to capture actual residues of the pesticide
and selected metabolites in the food supply as close as possible to the
time of consumption. Data collected close to actual consumption, such
as PDP data, depicts a more realistic estimate of exposure, i.e.,
residues that could be encountered by consumers. The real-world nature
of PDP data makes it preferable for the purposes of this assessment
than pesticide field trials, which are another data source available to
the Agency. Field trial data are designed to test for residues under
exaggerated application scenarios, and areprimarily used in
establishing tolerances.
    The PDP is designed to focus on foods highly consumed by children
and to reflect foods typically available throughout the year. PDP's
commodity testing profile includes not only fresh fruits and
vegetables, but also canned and frozen fruits/vegetables, fruit juices,
whole milk, wheat, soybeans, oats, corn syrup, peanut butter, rice,
poultry, beef, and drinking water. The PDP generally collects foods at
wholesale distribution centers and stores them frozen until analysis.
Foods are washed and inedible portions are removed before analysis, but
these foods are not further cooked or processed. A complete description
of the PDP and all data through 1999 are available on theinternet at
http://www.ams.usda.gov/science/pdp.
    PDP data are not available for all food commodities with current OP
registrations, including a limited number of food commodity tolerances
that are listed in this notice. When PDP data are not available for a
commodity, EPA uses data when it is appropriate to do so from
commodities that are measured by PDP to serve as surrogate data
sources. This well established practice of using surrogate, or
``translated,'' data is based upon the concept that families of
commodities with similar cultural practices and insect pests are likely
to have similar pesticide use patterns. For example, data on peaches
can be used as surrogate data for apricots. The practice of translating
data from tested sources to similar situations that have not been
directly tested has been used for some time by EPA in the development
of pesticide-specific dietary exposure assessments when monitoring data
are unavailable. The methods of translation, specifically, what
commodities may be used to represent other commodities, have been made
public. EPA is using translated data where appropriate for the purposes
of the OP CRA and tolerance reassessment as discussed in this notice.
    EPA has examined the PDP data that is being used for the OP CRA and
found that residues of the parent pesticide or any tested metabolite
were reported in a small number of samples analyzed for the 16 OP
tolerances listed below. As a result, EPA has concluded that these
tolerances make, at most, a minimal or negligible contribution to the
cumulative risk from OP pesticides, and, therefore, these tolerances
are considered reassessed.
    The following 16 tolerances are considered reassessed at this time:
    1. Chlorpyrifos (40 CFR part 180.342)
    Cherry
    Cucumber
    Vegetable, brassica, leafy, group
    2. Diazinon (40 CFR part 180.153)
    Apricot
    Endive (escarole)
    Lettuce
    Parsley
    Parsnip
    Pepper
    Plum, prune, fresh
    Radicchio
    Radish
    Rutabagas
    Spinach
    Swiss chard
    Turnip, roots

List of Subjects

    Environmental protection, Chemicals, Pesticides and pests.

    Dated: August 20, 2002.
 Lois A. Rossi,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 0222236 Filed 9302; 8:45 am]