[Federal Register Volume 67, Number 157 (Wednesday, August 14, 2002)]
[Notices]
[Pages 52985-52987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-20455]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: 
[email protected].

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

[[Page 52986]]

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

[[Page 52987]]

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]
BILLING CODE 6560-50-S