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diazinon (D.Z.N., Spectracide) Reassessment of Diazinon Non- Contributor Tolerances 8/02


ENVIRONMENTAL PROTECTION AGENCY

[OPP20020168; FRL71948]


Organophosphate Pesticides; Reassessment of Diazinon Non-
Contributor 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 26 tolerances for diazinon can be reassessed at this
time. 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). EPA has concluded that these tolerances make, at most, a
minimal or negligible contribution to the cumulative risk from OP
pesticides. This notice closely relates to previous Federal Register
notices in which EPA announced the reassessment of non-contributing OP
tolerances for certain meats, animal feeds, refined sugars, and
commodities that have few or no residue detections in the U.S.
Department of Agriculture's (USDA) Pesticide Data Program (PDP).

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://

[[Page 56558]]

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 OPP20020168. 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 official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), 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 OP pesticides 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 Interim Reregistration Eligibility Decisions (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 cumulative risks assessment (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 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 Diazinon Non-Contributor and Minimal Contributor
Tolerances

    In this notice, EPA identifies non-contributor and minimal-
contributor tolerances for the OP pesticide diazinon and considers
these tolerances 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. The Agency has now
completed the IRED for diazinon, 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 minimal or 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
minimal or negligible 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 or no 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 negligible.
As part of its preliminary CRA, 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 existing or future
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 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 non-contributors in this notice. EPA expects
that additional tolerances will be appropriate for reassessment based
on the kind of approach described here, in the previous Federal
Register notices of May 22, 2002 (66 FR 35991) (FRL71789), in which EPA
announced the reassessment of non-contributing tolerances for certain
meats, animal feeds, and refined sugars, Federal Register notice of
July 17, 2002 (67 FR 46972) (FRL71868), reassessment of non-
contributing tolerances for certain commodities with no pesticide
residue detections in PDP, and Federal Register notice of August 14,
2002 (67 FR 52987) (FRL71926), reassessing tolerances for certain
commodities with a small number (less than 1%) of residue detections in
PDP. 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 as a non-contributor 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. Animal Commodities and Animal Feed Tolerances for Diazinon.

    EPA has determined that four animal commodities and four animal
feed tolerances for diazinon, listed in List 1 and 2 below, are
reassessed at this time. EPA announced the reassessment of many OP non-
contributing animal commodity and feed tolerances in an earlier Federal
Register notice of May 22, 2002. The assessment approach applied to
those OP meat and feed tolerances is now being applied to the diazinon
non-contributor meat and feed tolerances listed in this notice, and is
briefly described below.
    Human exposure to pesticide residues can occur as a consequence of
the use of a pesticide on animals or their feed if the residues
transfer to the animal commodities (e.g., cattle, goats, and sheep)
that humans consume. EPA examined the potential for the transfer to
such human foods of OP residues from animal feeds and concludes that
residue transfer generally does not occur, or if it does, the transfer
is minimal. EPA concludes that OPs applied to animal feed crops (such
as forage, fodder, and hays) will not be present to any significant
extent in human food, and such residues will make, at most, a
negligible contribution to the OP cumulative risk assessment. As
discussed in the previous Federal Register notice (May 22, 2002), that
reassessed other OP non-contributing animal feed tolerances, animal
feeding and metabolism studies indicate that residue transfer to foods
that humans eat will be minimal, and residues of OPs were detected only
very rarely in meats, poultry, milk, and eggs, and only at very low
levels. Therefore, the four diazinon tolerances for animal meat
commodities listed in List 1, and the four diazinon tolerances for
animal feeds listed in List 2 are considered reassessed. It is
important to note that these animal feed tolerances are solely for
animal feeds, i.e, the tolerances do not include commodities that are
also consumed by humans.
List 1.--Diazinon Animal Commodity Tolerances (40 CFR part 180.153)
    Cattle, fat, (pre-S appli)
    Sheep, fat, (pre-S appli)
    Sheep, meat byproducts (fat basis), (pre-S appli)
    Sheep, meat (fat basis), (pre-S appli)
List 2.--Diazinon Animal Feed Tolerances (40 CFR part 180.153)
    Almond, hulls
    Animal feed
    Peavines
    Peasvine hay

C. Tolerances With No and Less Than 1% Residue Detections in PDP

    EPA has determined that 18 diazinon tolerances, in Lists 3 and 4,
are reassessed at this time because they make, at most, a minimal or
negligible contribution to OP risk. The Agency examined the monitoring
data being used in the OP CRA and found that pesticide residue was not
detected in the samples analyzed for certain OP/crop combination,
including the parent chemical and the degradates that were tested. In
addition, for certain other OP/crop combinations, residues were
detected only in an insignificant number of the samples (less than 1%)
that were analyzed. The revised OP CRA indicates that relatively few
pesticide/crop combinations 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/
diazinon combinations ranged from 275 to 2,400 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 are primarily 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 the internet at 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 diazinon or any tested metabolite were reported
in no samples analyzed for 6 diazinon tolerances listed in List 3,
below, and in less than 1% of the samples analyzed for 12 diazinon
tolerances listed in List 4, below. As a result, EPA has concluded that
these tolerances make, at most, a negligible or minimal contribution to
the cumulative risk from OP pesticides, and, therefore, these
tolerances are considered reassessed.
List 3.--Diazinon Tolerances With No Detections in PDP Samples (40 CFR
part 180.153)
    Banana
    Banana, pulp (no peel)
    Citrus
    Nectarine
    Pineapple
    Vegetable, brassica, leafy, group
List 4.--Diazinon Tolerances With Detection in Less Than 1% of PDP
Samples (40 CFR part 180.153)
    Apple
    Cherry
    Cucumber
    Grape
    Melon
    Pea with pods (determined on pea after removing any shell present
when marketed)
    Potato
    Potato, sweet
    Squash, summer
    Squash, winter
    Strawberry
    Tomato

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. 0222237 Filed 9302; 8:45 am]