Organophosphate Pesticides; Reassessment of Certain Non- Contributing Tolerances

 [Federal Register: May 22, 2002 (Volume 67, Number 99)]
[Notices]
[Page 35991-35996]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22my02-50]

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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2002-0060; FRL-7178-9]
 
Organophosphate Pesticides; Reassessment of Certain Non-
Contributing 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 275 OP tolerances 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 
discusses the concept and basis for this approach to reassessing 
selected OP tolerances based on available information relating to the 
OP cumulative risk assessment. EPA expects that additional tolerances 
will be appropriate for reassessment based on the kind of approach 
described in this Notice. This Notice also identifies the first non-
contributor tolerances that are considered reassessed (certain 
tolerances for meat commodities, animal feeds, refined sugars, and 
other uses), and seeks comment on EPA's approach to the identification 
of other non-contributors.

DATES: Comments, identified by the docket control number OPP-2002-0060, 
for approaches for identifying other tolerances that make, at most, a 
negligible contribution to the cumulative risk from OP pesticides must 
be received on or before June 21, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper 
receipt by EPA, it is imperative that you identify the docket control 
number OPP-2002-0060 in the subject line on the first page of your 
response.

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.

[[Page 35992]]

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/pesticides/cumulative under the heading ``Tolerance 
Activities.''
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-2002-0060. 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.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify the docket control number OPP-2002-0060 in the subject 
line on the first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB 
telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: opp-docket@epa.gov, or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in WordPerfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number OPP-2002-0060. Electronic comments 
may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI that I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the notice.
    7. Make sure to submit your comments by the deadline in this 
document.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

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 10-
year schedule for EPA to reassess all existing tolerances, with interim 
deadlines for completion of 33% and 66% of tolerance reassessments 3 
and 6 years, respectively, after the date of enactment. Pesticide 
tolerances subject to reassessment under 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,'' the inhibition of 
cholinesterase, 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

[[Page 35993]]

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 risk assessment (CRA) for all of the OPs and 
sought public comment on the assessment. The 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 http://
www.epa.gov/scipoly/sap/index.htm. EPA is in the process of revising 
the CRA, taking into account public comment and SAP advice.
    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).

III. What Action is the Agency Taking?

A. Reassessment of Non-Contributor Tolerances

    In this Notice, EPA identifies several categories of 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 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 will 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.
    EPA has determined that the tolerances identified in this Notice as 
reassessed contribute negligible, if any, residues and/or risk to the 
overall risks from OPs. These OP tolerances have been divided into four 
broad categories: (1) Certain animal commodities, including milk, eggs, 
poultry, and other meats (cattle, goats, hogs, horses, and sheep); (2) 
certain crops that are solely used as animal feeds; (3) certain crops 
that are refined sugars; and (4) certain other tolerances based on the 
nature of their use pattern.
    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. No 
tolerances are 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 (e.g., the animal 
feed tolerances are solely for crops fed to animals). 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 not to understate potential drinking 
water exposure. The OP preliminary 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 SAP advices, 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. Because these tolerances are to 
remain in effect, all of these pesticide/use pattern combinations that 
are included in the preliminary CRA 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 that 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.
Categories 1 and 2--Animal Commodities (Meats, Poultry, Milk, and 
Eggs), and Animal Feeds
    The first two categories, tolerances for human foods derived from 
animal sources (referred to as animal commodities) and tolerances for 
commodities consumed by animals (referred to as animal feeds), are 
discussed together because the same

[[Page 35994]]

information was used to evaluate the likelihood of exposure and risk 
for both categories of tolerances.
    EPA has determined that certain OP tolerances, listed later in the 
Notice, on animal commodities and animal feeds are reassessed at this 
time. 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 the 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 nine samples detected any OP residues (the 
residues ranged between 0.002 parts per million (ppm) and 0.009 ppm). 
Out of the approximately 500 poultry samples analyzed by PDP for 
multiple OPs for 1997 - 2000, only one 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 1 trace sample was detected out 
of approximately 1,300 samples analyzed by 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 preliminary CRA indicated 
that animal commodities do not significantly contribute to OP dietary 
exposure and total OP dietary risk.
    In light of all these considerations, the 172 OP meats (cattle, 
goats, hogs, horses, and sheep), poultry, milk, and egg tolerances 
listed in Table 1 are considered reassessed. In addition, because 
animal feeding and metabolism studies indicate that residue transfer to 
foods that humans eat will be minimal, and because the residues of OPs 
were detected only very rarely in meats, poultry, milk, and eggs, and 
only at very low levels, EPA concludes that OPs applied to animal feed 
crops (such as feed, forage, fodder, nut hulls, vines, and hays) will 
not be present to any significant extent in human food and such 
residues will make, at most, a negligible contribution to OP risk. 
Therefore, the 88 OP tolerances for animal feeds (such as feed, forage, 
fodder, nut hulls, vines, and hays) listed in Table 2 are also 
considered reassessed. It is important to note that these tolerances 
are solely for animal feeds, i.e, the tolerances do not include 
commodities that are also consumed by humans. 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.

                Table 1.--Meats, Poultry, Milk, and Eggs
------------------------------------------------------------------------
                 Chemical                             Commodity
------------------------------------------------------------------------
Acephate (40 CFR part 180.108)              Cattle, fat
                                            Cattle, mbyp
                                            Cattle, meat
                                            Eggs
                                            Goats, fat
                                            Goats, mbyp
                                            Goats, meat
                                            Hogs, fat
                                            Hogs, mbyp
                                            Hogs, meat
                                            Horses, fat
                                            Horses, mbyp
                                            Horses, meat
                                            Milk
                                            Poultry, fat
                                            Poultry, mbyp
                                            Poultry, meat
                                            Sheep, fat
                                            Sheep, mbyp
                                            Sheep, meat
--------------------------------------------Chlorpyrifos (40 CFR part---

[[Page 35995]]

                          Table 2.--Animal Feed
------------------------------------------------------------------------
                 Chemical                             Commodity
------------------------------------------------------------------------
Acephate (formerly 40 CFR part 186.100)     Cotton, seed, hulls
                                            Mint, hay (40 CFR part
                                             180.108)
---------------------------------------------Azinphos methyl (40 CFR----

[[Page 35996]]

Category 3--Refined Sugars
    As discussed in the OP preliminary CRA, negligible OP residues are 
expected to occur for refined sugars produced from beets and sugarcane 
based on available monitoring data (USDA's PDP and FDA's TDS) and the 
nature of the refining process. PDP has analyzed high fructose corn 
syrup and found no pesticide residues. The TDS has analyzed refined 
sugar and maple sugar and found no OP residues in 26 market basket 
surveys. Knowledge of the highly refined nature of sugars and syrups 
also supports the conclusion that negligible residues are expected to 
occur in refined sugars from sugarcane and sugar beets. The following 
10 tolerances listed in Table 3 are considered reassessed:

                         Table 3--Refined Sugars
------------------------------------------------------------------------
                 Chemical                             Commodity
------------------------------------------------------------------------
Chlorpyrifos (40 CFR part 180.342)          Beets, sugar, molasses
                                            Beets, sugar, roots
--------------------------------------------Disulfoton (40 CFR part-----

Category 4 -- Use Pattern Consideration
    EPA has determined that an additional small number (five) of OP 
tolerances can be reassessed now based on the way the pesticides are 
used.
    For the following two pesticide active ingredients, cadusafos and 
propetamphos, negligible, if any, exposures (including in drinking 
water) are expected due to the nature of their use patterns. Each 
pesticide has one tolerance, and both are considered reassessed.
    £ Cadusafos (40 CFR part 180.461): One import 
tolerance on bananas. Cadusafos is used exclusively on imported 
bananas. No detectable food residues are expected from this use based 
on the nature of the use pattern (e.g., when the pesticide is typically 
applied) and a consideration of the nature of the commodity (i.e., the 
protective peel of the banana fruit).
    £ Propetamphos (40 CFR part 180.541): One 
tolerance for processed food. Propetamphos is used only as a crack and 
crevice treatment. It is not allowed to be used in structures that 
children or the elderly occupy, including homes, schools, day-cares, 
hospitals, and nursing homes with the exception of areas of food 
service within those structures when food is covered or removed prior 
to treatment. As the result of these restrictions, exposure is expected 
to be negligible.
    Chlorethoxyfos (40 CFR part 180.486) is a soil insecticide that is 
applied at planting to corn, and no detectable food residues are 
expected from this use. The chlorethoxyfos IRED states that field 
trials showed no residues (less than 0.01 ppm) of the parent in any of 
the corn raw agricultural commodities analyzed, even after treatment at 
a 10X rate. Chlorethoxyfos on corn was included in the OP preliminary 
CRA to assess its potential for contaminating drinking water. In the 
preliminary CRA, no drinking water risks were indicated even when high 
relative potency values were used (a screening relative potency factor 
(RPF) of 25 was used, which is approximately 200 times greater than the 
recently calculated RPF for this pesticide). Therefore, the following 
three chlorethoxyfos corn tolerances are considered reassessed: corn, 
pop, grain; corn, field, grain; and corn, sweet (K+CWHR) (i.e., kernel 
plus cob with husks removed).

IV. Approach for Identifying Other Non-Contributor Categories

    EPA is evaluating other potential non-contributor tolerances. For 
example, it is possible that non-contributor determinations could be 
made for certain categories or types of tolerances for foods that are 
reported to have little or no consumption, or where few or no residues 
are detected. In evaluating candidate tolerances, EPA would consider 
all relevant data and factors, including information from the 
individual OP aggregate risk assessments, before making a reassessment 
determination.
    The Agency seeks comment about the use of the approach described 
here and the factors that are relevant to reassessment determinations 
based on this approach. EPA will announce the reassessment of non-
contributor tolerances on the Agency's internet website (www.epa.gov/
pesticides/cumulative).

List of Subjects

    Environmental protection, Chemicals, Pesticides and pests.

    Dated: May 14, 2002.
Lois Rossi,
Director, Special Review and Reregistration Division, Office of 
Pesicide Programs.
[FR Doc. 02-12713 Filed 5-21-02; 8:45 am]
BILLING CODE 6560-50-S
Organophosphate Pesticides; Reassessment of Certain Non- Contributing Tolerances

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