[Federal Register Volume 67, Number 137 (Wednesday, July 17, 2002)]
[Notices]
[Pages 46972-46975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17987]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0111; FRL-7186-8]


Organophosphate Pesticides; Reassessment of Certain 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 47 OP tolerances can be reassessed at this time. EPA 
has concluded that these tolerances make, at most, a negligible 
contribution to the cumulative risk from OP pesticides. These ``non-
contributor'' tolerances have no reported pesticide residue detections 
in the monitoring data being used in the OP cumulative risk assessment 
(CRA)(U.S. Department of Agriculture's (USDA) Pesticide Data Program 
(PDP). 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 
OP CRA. Nothing in this Notice is intended to

[[Page 46973]]

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). This Notice closely relates to a previous Federal Register 
Notice of (May 22 2002, 66 FR 35991), (FRL-7178-9) in which 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.

DATES: The reassessment of these tolerances is effective as of July 17, 
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-2002-0111. 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 FQPA 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 10 year 
schedule for EPA to reassess all existing tolerances, with interim 
deadlines for completion of 33% and 66% of tolerance reassessments 
three and 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 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 comments. The preliminary and revised OP 
cumulative risk assessment documents are available at www.epa.gov/pesticides/cumulative. In addition, EPA presented the assessment 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 the Federal Register of (May 22 
2002, 66 FR 35991), 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.

[[Page 46974]]

III What Action is the Agency Taking?

A. Reassessment of Non-Contributor Tolerances

    In this Notice, EPA identifies non-contributor tolerances and 
considers these tolerances reassessed for the purposes of FQPA section 
408 (q) as of today's date. Pesticide tolerances 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 today's date.
    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 (RAC), no tolerance is herein reassessed as a non-contributor 
unless all of the RAC (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, 66 FR 35991 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. Tolerances With No Residue Detections in PDP

    EPA has determined that certain OP tolerances, listed later in the 
Notice, are reassessed at this time because they make, at most, a 
negligible contribution to OP risk. The Agency examined the monitoring 
data being used in the OP cumulative risk assessment and found that no 
residues were detected for these food commodity/OP combinations, 
including the parent chemical and the degradates that were tested. 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 almost 200 to 2,600 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

[[Page 46975]]

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 cumulative risk assessment and tolerance reassessment as 
discussed in this Notice.
    EPA has examined the PDP data that is being used for the OP 
cumulative risk assessment and found that no residues for the parent 
pesticide or any tested metabolite were reported for the 47 OP 
tolerances listed below. As a result, EPA has concluded that these 
tolerances make, at most, a negligible contribution to the cumulative 
risk from OP pesticides, and, therefore, these tolerances are 
considered reassessed. EPA expects to announce as reassessed other 
tolerances that have no detections in PDP in future Notices as 
appropriate in light of their individual OP assessments.
    The following 47 tolerances are considered reassessed at this time:
Azinphos methyl (40 CFR 180.154)
    Brussels sprouts
Chlorpyrifos (40 CFR 180.342)
    Banana, whole
    Bananas, pulp with peel removed
    Corn, field, grain
    Corn, fresh (inc. sweet, kernel plus cob with husks removed)
Disulfoton (40 CFR 180.183)
    Bean, dry
    Bean, lima
    Bean, snap
    Broccoli
    Brussels sprouts
    Cauiflower
    Peanut
    Pea
    Spinach
Mevinphos (40 CFR 180.157)
    Melon (incl. Cantaloupe, melon, honeydew, and muskmelon, determined 
on the edible portion with rind removed)
    Pea
    Watermelon
Oxydemeton methyl (40 CFR 180.330)
    Apple
    Apricot
    Bean, lima
    Bean, snap
    Brussels sprouts
    Cabbage
    Eggplant
    Grapefruit
    Grape
    Lemon
    Melon
    Oranges
    Pear
    Plum, prune, fresh
    Pumpkin
    Squash, winter
    Strawberry
    Turnip
Phorate (40 CFR 180.206)
    Bean
    Corn, grain
    Corn, sweet, kernel plus cob with husks removed
    Soybean
Phosalone (40 CFR 180.263)
    Apricot
    Cherry
    Grape
    Peach
    Pear
    Plum, prune, fresh
Phosmet (40 CFR 180.261)
    Pea
    Potato

List of Subjects

    Environmental protection, Chemicals, Pesticides and pests.


    Dated: July 8, 2002.
Lois Rossi,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. 02-17987 Filed 7-16-02; 8:45 am]
BILLING CODE 6560-50-S