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Organophosphate Pesticides; Reassessment of Diazinon Non-Contributor Tolerances

 [Federal Register: September 4, 2002 (Volume 67, Number 171)]
[Notices]
[Page 56557-56560]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04se02-66]

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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2002-0168; 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) 305-5805.

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

[[Page 56559]]

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

[[Page 56560]]

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. Exit Disclaimer
    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]
BILLING CODE 656050S

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