[Federal Register Volume 75, Number 144 (Wednesday, July 28, 2010)]
[Proposed Rules]
[Pages 44181-44184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-18541]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0423; FRL-8835-7]
Mevinphos; Proposed Data Call-in Order for Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed order.
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SUMMARY: This document proposes to require the submission of various
data required to support the continuation of the tolerances for the
pesticide mevinphos. Pesticide tolerances are established under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: Comments must be received on or before September 27, 2010.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0423, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2010-0423. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: K. Avivah Jakob, Pesticide Re-
evaluation Division, Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460-
0001; telephone number: (703) 305-1328; e-mail address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
[[Page 44182]]
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. 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. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes 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 docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. FFDCA Data Call-In Authority
In this document, EPA proposes to issue an order requiring the
submission of various data to support the continuation of the mevinphos
tolerances at 40 CFR 180.157. Under section 408(f) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(f), EPA is authorized to
require, by order, submission of data ``reasonably required to support
the continuation of a tolerance'' when such data cannot be obtained
under the Data Call-In authority of section 3(c)(2)(B) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C.
136a(c)(2)(B), or section 4 of the Toxic Substances Control Act (TSCA),
15 U.S.C. 2603. A section 408(f) Data Call-In order may only be issued
following notice and a comment period of not less than 60 days.
A section 408(f) Data Call-In order must contain the following
elements:
1. A requirement that one or more persons submit to EPA a notice
identifying the person(s) who commit to submit the data required in the
order.
2. A description of the required data and the required reports
connected to such data.
3. An explanation of why the required data could not be obtained
under section 3(c)(2)(B) of FIFRA or section 4 of TSCA.
4. The required submission date for the notice identifying one or
more interested persons who commit to submit the required data and the
required submission dates for all the data and reports required in the
order. (21 U.S.C. 346a(f)(1)(C)).
EPA may by order modify or revoke the affected tolerances if any
one of the following submissions is not made in a timely manner:
A notice identifying one or more interested persons who
commit to submit the data.
The data itself.
The reports required under a section 408(f) order are not
submitted by the date specified in the order. (21 U.S.C. 346a(f)(2)).
III. Regulatory Background for Mevinphos
Mevinphos is a contact/systemic insecticide-acaricide. It is not
currently registered under FIFRA and may not be sold, distributed, or
used in the United States. Mevinphos' FIFRA registration was canceled
in 1994. However, 15 FFDCA tolerances remain for residues of mevinphos
on the following commodities: Broccoli, cabbage, cauliflower, celery,
cucumbers, grapes, lettuce, melons, peas, peppers, spinach,
strawberries, summer squash, tomatoes, and watermelon (40 CFR 180.157).
Since there are currently no domestic registrations for mevinphos,
these tolerances are referred to as ``import tolerances.''
Mevinphos is a member of a family of pesticides known as the
organophosphates. EPA has concluded mevinphos and other organophosphate
pesticides share a common mechanism of toxicity. As with other
organophosphates, the principal toxic effects induced by mevinphos are
related to its cholinesterase-inhibiting activity. It produces the
associated clinical signs such as tremors, unsteady gait, decreased
activity, salivation, disturbed balance in rats and rabbits, and
decreased cholinesterase activity (plasma, brain) in rats and rabbits
following acute, subchronic, and chronic oral exposure.
In September 2000, EPA issued an Interim Tolerance Reassessment
Eligibility Decision (ITRED) for mevinphos in connection with its
obligation under the Food Quality Protection Act of 1996 (FQPA), to
evaluate whether all tolerances in existence at the time of the passage
of FQPA met the revised safety standard that the FQPA adopted for FFDCA
section 408. In the ITRED, EPA concluded that the risks of mevinphos
when evaluated in isolation from other organophosphates met the revised
safety standard in FFDCA section 408. This conclusion was labeled
``interim,'' however, because EPA had not yet completed a cumulative
risk assessment for the organophosphates. In July 2006, EPA completed
its cumulative risk assessment for the organophosphate pesticides
finding that these tolerances met the revised safety standard.
The ITRED called attention to several data gaps for mevinphos
including:
1. A developmental neurotoxicity (DNT) study in rats (with expanded
protocol to extend the postnatal treatment period and to measure
cholinesterase inhibition in offspring) as was required for all
organophosphate pesticides.
2. Various studies evaluating mevinphos residue levels on treated
crops. EPA noted that it would be taking steps to require the
submission of this data. Subsequently, the manufacturer of mevinphos
submitted residue data for grapes and frozen storage stability data for
broccoli, cucumbers, lettuce, tomatoes, and strawberries. However, the
registrant has not submitted a DNT study or residue data for the
remaining imported commodities.
Under section 3(g) of FIFRA and implementing regulations, EPA has
[[Page 44183]]
established a review program for pesticides registered under FIFRA. The
goal of that program is a periodic review of pesticide registrations
every 15 years to ensure that the registrations satisfy FIFRA standards
and are based on ``current scientific and other knowledge regarding the
pesticide.'' (40 CFR 155.40(a)). EPA is in the preliminary stages of
the registration review process for organophosphate pesticides.
Although mevinphos is not registered under FIFRA, EPA will be re-
examining mevinphos with the other registered organophosphates because
of the organophosphates shared mechanism of toxicity.
In re-examining mevinphos, EPA has identified several studies noted
in the ITRED as data gaps for which data have not been submitted and
one new regulatory data requirement for which a study is needed. These
data are necessary to support the continuation of mevinphos tolerances
and are listed below.
IV. Data Requirements
A. Required Data and Reports
Pursuant to FFDCA section 408(f), EPA has determined that
additional data are reasonably required to support the continuation of
the tolerances for mevinphos which are codified at 40 CFR 180.157.
Accordingly, EPA proposes to issue a final order requiring the
submission of the following data:
1. Comparative Cholinesterase Assay (Test Guideline 870.6300). A
protocol and a final report are required.
Rationale. As an organophosphate pesticide (OP), inhibition of
acetylcholinesterase (AChE) is the critical effect for use in human
health risk assessment. Many OPs were subject to a Data-Call-In for the
developmental neurotoxicity study (DNT). This DCI also included the
requirement for AChE inhibition data to evaluate comparative
sensitivity in juvenile and adult rats. These data are most often
collected in a study called the comparative cholinesterase assay (CCA).
Since that time, CCA studies for more than 20 OPs have been submitted
to OPP. Although for some OPs no difference in sensitivity has been
observed in juvenile and adult animals, for many of the OPs, juveniles
have been shown to be more sensitive. At this time, OPP has determined
that a CCA is required for mevinphos to evaluate the potential for
increased sensitivity in juvenile animals compared with that of adult
animals. Given that the AChE data provided in the CCAs have provided
more sensitive results than DNT studies for the OPs, a DNT study for
mevinphos is not required at this time.
2. Immunotoxicity Study (Test Guideline 870.7800). A final report
and protocol are required.
Rationale. This is a new data requirement under 40 CFR part 158 as
a part of the data requirements for registration of a pesticide (food
and non-food uses).
The Immunotoxicity Test Guideline (Harmonized Guideline 870.7800)
prescribes functional immunotoxicity testing and is designed to
evaluate the potential of a repeated chemical exposure to produce
adverse effects (i.e., suppression) on the immune system.
Immunosuppression is a deficit in the ability of the immune system to
respond to a challenge of bacterial or viral infections such as
tuberculosis (TB), severe acquired respiratory syndrome (SARS), or
neoplasia.
3. Directions for Use (Test Guideline 860.1200)
Rationale. The Agency needs use directions, which appear on the
Mexico label(s).
4. Crop Field Trials (Test Guideline 860.1500) - (broccoli,
cabbage, cauliflower, celery, grapes, lettuce, peas, peppers, spinach,
strawberries, summer squash, and tomatoes.)
Rationale. Field trials are required for each commodity/commodity
group according to guidelines that take into account where the crop is
grown and how much of the crop is grown. Field trials are required for
each type of formulation because the formulation can have significant
effect on the magnitude of the pesticide residue left on the crop.
Residue trials also need to represent the maximum application rate on
the label and have a geographic distribution representative of the
commodity/commodity group. On June 1, 2000 (65 FR 35069) (FRL-6559-3),
EPA published in the Federal Register, a Notice which provided detailed
guidance on applying current U.S. data requirements for the
establishment or continuance of tolerances for pesticide residues in or
on imported foods. A copy of that Notice is available in the docket of
this proposed order. That Notice contains instructions for determining
number and location of field trials.
5. Processing Study (tomatoes) (Test Guideline 860.1520)
Rationale. Processing studies are required to determine whether
residues in raw commodities may be expected to degrade or concentrate
during food processing. If residues concentrate in a processed
commodity, a food or feed additive tolerance must be established. If
residues do not concentrate in a processed commodity, the tolerance for
the raw agricultural commodity applies to all processed food or feed
derived from it.
B. Persons who Commit to Submit the Required Data
After this 60-day comment period closes, the Agency will respond to
comments, if appropriate, and may issue a final order requiring the
submission of various data for mevinphos in the Federal Register. If
EPA issues such an order, persons who are interested in the
continuation of the mevinphos tolerances must notify the Agency by
completing and submitting the required ``Sec. 408(f) Order Response''
form (available in the docket) within 90 days after publication of the
final order in the Federal Register.
The ``Sec. 408(f) Order Response Form'' requires the identification
of persons who will submit the required data and lists the options
available to support the required data:
i. Develop new data.
ii. Submit an Existing Study -- submit existing data not
submitted previously to the Agency by anyone,
iii. Upgrade a Study - submit or cite data to upgrade a study
classified by EPA as partially acceptable and upgradable,
iv. Cite an Existing Study - cite an existing study that EPA
classified as acceptable or an existing study that has been
submitted but not reviewed by the Agency.
C. Required Dates for Submission of Data/Reports
The table below lists the time allocated for both the completion
and submission of each study. The required submission date is
calculated from the date of publication in the Federal Register of the
final order.
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Timeframe for protocol Timeframe for data
Guideline Requirement Number Study Title submission submission
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860.1200 Directions for use Not required 12 months
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[[Page 44184]]
860.1500 Crop Field Trials Not Required 24 months
(broccoli, cabbage,
cauliflower, celery,
grapes, lettuce, peas,
peppers, spinach,
strawberries, summer
squash, and tomatoes)
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860.1520 Processing studies Not Required 24 months
(tomatoes)
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870.6300 Comparative 6 months 12 months
Cholinesterase Assay
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870.7800 Immunotoxicity Study 6 months 12 months
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D. Failure to Submit
If the Agency does not receive a Sec. 408(f) Response Form
identifying a person who agrees to submit the required data within 90
days after publication of the final order, EPA will proceed to revoke
the mevinphos tolerances at 40 CFR 180.157. Such revocation order is
subject to the objection and hearing procedure in FFDCA section
408(g)(2) but the only material issue in such a procedure is whether a
submission required by the order was made in a timely fashion.
Additional events that may be the basis for modification or
revocation of mevinphos tolerances include, but are not limited to the
following:
1. No person submits on the required schedule an acceptable
proposal or final protocol when such is required to be submitted to the
Agency for review.
2. No person submits on the required schedule an adequate progress
report on a study as required by the order.
3. No person submits on the required schedule acceptable data as
required by the final order.
4. No person submits supportable certifications as to the
conditions of submitted data, where required by order and where no
other cited or submitted study meets the data requirements the study
was intended to fulfill.
V. Statutory and Executive Order Reviews
As required by statute, this proposal to require submission of data
in support of tolerances is in the form of an order and not a rule. (21
U.S.C. 346a(f)(1)(C)). Under the Administrative Procedures Act, orders
are expressly excluded from the definition of a rule. (5 U.S.C.
551(4)). Accordingly, the regulatory assessment requirements imposed on
rulemaking do not, therefore, apply to this action.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 22, 2010.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2010-18541 Filed 7-27-10; 8:45 am]
BILLING CODE 6560-50-S