[Federal Register Volume 67, Number 157 (Wednesday, August 14, 2002)]
[Notices]
[Pages 52987-52990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-20456]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0152; FRL-7192-6]


Organophosphate Pesticides; Reassessment of Additional 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 37 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 
tolerances are considered to be ``non-contributors'' based on the 
especially small number (less than 1 percent) of reported pesticide 
residue

[[Page 52988]]

detections in the monitoring data being used in the OP cumulative risk 
assessment (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 sec. 408 
(q). This notice discusses the concept and basis for this approach to 
reassessing selected OP tolerances based on available information 
relating to the revised OP cumulative risk assessment (CRA). Nothing in 
this notice is intended to modify in any way any determination or 
requirement set forth in individual pesticide 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 two previous Federal Register notices: The 
notice of July 17, 2002 (67 FR 46972, FRL-7186-8) in which EPA 
announced the reassessment of non-contributing tolerances for certain 
commodities with no pesticide residue detections in PDP, and the 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, 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 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-2002-0152. 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.

[[Page 52989]]

    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. EPA announced in a Federal Register notice of July 17, 
2002 (67 FR 46972, FRL-7186-8) the reassessment of non-contributing 
tolerances for certain commodities with no pesticide residue detections 
in PDP.

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 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. For each of the tolerances being reassessed, the 
Agency has issued an Interim Reregistration Eligibility Decision 
(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 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 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 
minimal. As part of its preliminary and revised cumulative risk 
assessments, 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 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 and 
revised 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 previous Federal Register 
notices 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, and July 17, 2002 (67 FR 
46972, FRL-7186-8) in which EPA announced the reassessment of non-
contributing tolerances for certain commodities with no pesticide 
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. Tolerances With Less Than One Percent 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 
minimal contribution to OP risk. The Agency examined the monitoring 
data being used in the OP cumulative risk assessment and found that 
pesticide residue was detected only in an insignificant number of the 
samples (less than one percent) that were analyzed for these food 
commodity/OP combinations, including the parent chemical and the 
degradates that were tested. In addition, the revised OP cumulative 
risk assessment indicates that relatively few pesticide/crop 
combinations account for the vast majority of exposure. These 
tolerances are not among those pesticide/crop

[[Page 52990]]

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/OP 
combinations ranged from 275 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 database 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 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 residues of the parent 
pesticide or any tested metabolite were reported in less than one 
percent of the samples analyzed for the 37 OP tolerances listed below. 
As a result, EPA has concluded that these tolerances make, at most, a 
minimal 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 fewer than one 
percent detections in PDP in future notices as appropriate in light of 
their individual OP assessments.
    The following 37 tolerances are considered reassessed at this time:

Azinphos methyl (40 CFR 180.154)
Fruit, citrus, group
Eggplant
Grape
Parsley, leaves
Parsley, root
Pepper
Spinach
Strawberry
Tomato, postharvest

Chlorpyrifos (40 CFR 180.342)
Bean, lima
Bean, snap
Brussels sprouts
Cabbage
Cabbage, chinese
Legume vegetables, succulent or dried (except soybean)
Pumpkin
Radish
Rutabaga
Strawberry
Turnip

Disulfoton (40 CFR 180.183)
Cabbage
Lettuce
Pepper
Potato
Soybean
Wheat, grain

Mevinphos (40 CFR 180.157)
Broccoli
Cucumber
Pepper
Strawberry
Tomato

Oxydemeton methyl (40 CFR 180.330)
Cucumber
Pepper
Squash, summer

Phorate (40 CFR 180.206)
Wheat, grain

Phosalone (40 CFR 180.263)
Apple

Phosmet (40 CFR 180.261)
Cherry

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. 02-20456 Filed 8-13-02; 8:45 am]
BILLING CODE 6560-50-S