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tetrachlorvinphos (Gardcide, Gardona) Tolerances 7/02

ENVIRONMENTAL PROTECTION AGENCY
[OPP-2002-1531; FRL-7192-4]
Organophosphate Pesticides; Reassessment of Meat Commodity
Tolerances for Tetrachlorvinphos
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 11 meat commodity tolerances for tetrachlorvinphos 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 negligible contribution to the cumulative risk from OP
pesticides. This notice closely relates to a previous Federal Register
notice of May 22, 2002 (67 FR 35991, FRL-7178-9) in which EPA announced
the reassessment of non-contributing tolerances for certain meats,
animal feeds, and refined sugars. EPA expects that additional
tolerances will be appropriate for reassessment based on the kind of
approach described in this notice.
DATES: The reassessment of these tolerances is effective as of July 23,
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) 308-8004; 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 OPP-2002-1531. 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) 305-5805.
II. Background
    The Food Quality Protection Act of 1996 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 ten year schedule for EPA to
reassess all existing tolerances, with interim deadlines for completion
of 33 percent and 66 percent of tolerance reassessments three and six
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 organophosphate
pesticides as high priority for tolerance reassessment. EPA has
determined that the OPs share a ``common mechanism of toxicity,'' and
therefore that 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 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
cumulative risk assessment 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 www.epa.gov/scipoly/sap/index.htm. 
EPA has raised with stakeholders during a number of public meetings the
concept of reassessing selected OP tolerances because, based on
available data and assessments, EPA could determine that they make, at
most, no more than a negligible contribution to risk. Most recently,
the concept of reassessing such ``non-contributors'' was an agenda
topic for the February, 2002, meeting of the Committee to Advise on
Reassessment And Transition (CARAT). In a Federal Register notice of
May 22, 2002 (67 FR 35991, FRL-7178-9), EPA announced the reassessment
of non-contributing tolerances for certain meats, animal feeds, and
refined sugars, and requested suggestions on other approaches for
identifying tolerances that do not contribute risk to the OP cumulative
risk assessment.
III. What Action is the Agency Taking?
 A. Reassessment of Non-Contributor Tolerances
    In this notice, EPA identifies non-contributor meat commodity
tolerances for the OP pesticide tetrachlorvinphos and considers these
tolerances reassessed for the purposes of FQPA section 408 (q) as of
July 23, 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 Interim Reregistration Eligibility Decision (IRED) for
tetrachlorvinphos, 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 23, 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 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, no tolerance is herein reassessed as a non-contributor
unless all of the raw agricultural commodities (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 cumulative risk
assessment, 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 cancelled 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 and in a previous the Federal
Register notice of May 22, 2002 (67 FR 35991, FRL-7178-9) in which EPA
announced the reassessment of non-contributing tolerances for certain
meats, animal feeds, and refined sugars. 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. Meat Commodity Tolerances for Tetrachlorvinphos
    EPA has determined that 11 meat commodity tolerances for
tetrachlorvinphos, listed later in the notice, are reassessed at this
time. EPA reassessed other OP non-contributing meat tolerances in an
earlier Federal Register notice (May 22, 2002, 67 FR 35991, FRL-7178-
9). The assessment approach applied to those meat tolerances is now
being applied to the tetrachlorvinphos non-contributor meat commodity
tolerances listed in this notice, and is decsribed below.
    Currently, there are OP tolerances for many animal commodities:
Milk, eggs, poultry, and other meats (cattle, goats, hogs, horses, and
sheep). 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 that humans consume. EPA examined
the potential for the transfer to such human foods of OP residues from
animal feeds, and from the direct application of the OP to an animal
(e.g., to control nuisance pests such as biting flies), and concludes
that residue transfer generally does not occur, or if it does, the
transfer is minimal. The following summarizes the factors that the
Agency considered in making the decision to reassess these tolerances.
    The Agency examined the available study data for the OPs, which
includes extensive livestock feeding/metabolism studies. These study
results are confirmed by extensive monitoring data on animal
commodities reflecting all registered uses. There are very few
detectable residues in the OP monitoring data for animal commodities.
The extensive monitoring data are from the U.S. Department of
Agriculture's (USDA) Pesticide Data Program (PDP) and U.S. Food and
Drug Administration's (FDA) Total Diet Study (TDS) covering residues of
multiple OPs in meats and poultry. The residue monitoring data showed
infrequent detections, and those residues were detected at low levels.
Out of approximately 400 meat samples analyzed by the TDS for multiple
OPs from 1991-1999, only 9 samples detected any OP residues (the
residues ranged between 0.002 ppm and 0.009 ppm). Out of the
approximately 500 poultry samples analyzed by PDP for multiple OPs for
1997-2000, only 1 sample detected an OP residue (0.01 ppm) for a
pesticide that currently has a tolerance.
    For milk and eggs, extensive monitoring data are available from
USDA's PDP and FDA's Surveillance Program. The residue monitoring data
show no detectable OP residues in milk (there was only one trace sample
detected out of approximately 1,800 samples analyzed by PDP for
multiple OPs from 1996-1998). The residue monitoring for eggs also
showed no detectable OP residues (only one trace sample was detected
out of approximately 1,300 samples analyzed by the FDA's Surveillance
Program for multiple OPs from 1992-1998).
    In addition to an examination of the meat, poultry, milk, and egg
monitoring data, as described above, the potential risk associated with
the detected residues was addressed in the Agency's preliminary CRA of
the OP pesticides. Although EPA concluded that OP residues would not be
expected to occur in significant amounts in meat or milk, EPA
nonetheless made the conservative assumption that all meat food forms
contained OP residues equal to a level that was the highest found in
the FDA monitoring program (TDS). Despite the fact that this assumption
would overestimate potential exposure, the analysis in the OP CRA
indicated that animal commodities do not significantly contribute to OP
dietary exposure and total OP dietary risk.
    EPA expects to announce other meat/poultry/egg/milk and animal feed
tolerances as reassessed in future notices as appropriate in light of
their individual OP assessments. In addition, some of these tolerances
may be revoked in future notices in the Federal Register if EPA
determines that the tolerances are no longer needed. The Agency plans
to issue a notice announcing the Agency's intention to revoke several
animal meat tolerances because they are no longer necessary.
    The following 11 tetrachlorvinphos meat commodity tolerances (40
CFR 180.252) are considered reassessed:
Cattle, beef
Cattle, dairy
Cattle, fat
Egg
Goat, fat
Hog
Hog, fat
Horse
Horse, fat
Milk, fat
Poultry, fat
List of Subjects
    Environmental protection, Chemicals, Pesticides and pests.
    Dated: July 31, 2002.
Lois A. Rossi,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 02-20455 Filed 8-13-02; 8:45 am]