[Federal Register Volume 74, Number 235 (Wednesday, December 9, 2009)]
[Notices]
[Pages 65121-65122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-29209]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2009-0889; FRL-8803-2]
Policy Paper on Revised Risk Assessment Methods for Workers,
Children of Workers in Agricultural Fields, and Pesticides with No Food
Uses; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of Availability.
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SUMMARY: EPA is making available for comment a policy paper entitled
``Revised Risk Assessment Methods for Workers, Children of Workers in
Agricultural Fields, and Pesticides with No Food Uses,'' that describes
how the Agency will assess pesticide risks not governed by the Federal
Food, Drug and Cosmetic Act. To provide comprehensive and consistent
evaluation of potential risks of food use pesticides, non-food use
pesticides, and related occupational exposures, EPA intends to apply
risk assessment techniques developed in implementing the Food Quality
Protection Act of 1996 to any pesticide risk assessment, whether it
falls under FQPA or not, as long as applying the risk assessment
technique is consistent with good scientific practice and is not
otherwise prohibited by law. Specifically, this will include using an
additional safety/uncertainty factor to protect children, considering
aggregate exposures to pesticides from multiple sources, and
considering cumulative effects which may occur from exposure to
multiple pesticides with a common mechanism of toxicity. Moreover,
risks will be explicitly reported for individuals who had not been
explicitly considered, specifically workers age 12-17 and children
taken into agricultural fields. Taking this step at this time has
important environmental justice ramifications. EPA anticipates that
implementing this policy will increase protections, especially for
agricultural workers and children of workers in agricultural fields.
DATES: Comments must be received on or before February 8, 2010.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0889, 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-
2009-0889. 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: Deborah Smegal, Health Effects
Division, Office of Pesticide Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number: (703) 308-0175; fax number: (703) 305-5147; 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, and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the
[[Page 65122]]
chemical industry; pesticide users; and members of the public
interested in the sale, distribution, or use of pesticides. Since
others also may be interested, the Agency has not attempted to describe
all the specific entities that may be affected by this action. If you
have any questions regarding the applicability of this action to a
particular entity, consult the chemical review manager 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. What Action is the Agency Taking?
EPA is releasing and inviting comment on a policy paper that
describes how the Agency plans to use revised methods in conducting
risk assessments for pesticide uses and exposures not governed by the
Federal Food, Drug and Cosmetic Act (FFDCA). Implementing this policy
will increase protections, especially for workers and children of
workers in agricultural fields.
EPA licenses or registers pesticides for sale and distribution
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
The Agency establishes tolerances, limits for pesticide residues in or
on food, under section 408 of FFDCA. In contrast to the risk/benefit
standard for registration under FIFRA, FFDCA applies a risk-only
standard for tolerances and explicitly sets certain approaches for
assessing risks. These risk assessment approaches include incorporating
an additional safety factor to protect children, aggregating all non-
occupational (food, water and residential) exposures to a pesticide,
and considering the cumulative effects of pesticides with a common
mechanism of action. The risk-only standard and the mandated risk
assessment approaches were added to FFDCA by the Food Quality
Protection Act of 1996 (FQPA). FIFRA does not require EPA to use these
risk assessment approaches in assessing worker risks or non-food use
pesticides. Also, historically, EPA has not considered children in
assessing worker risks.
To provide more comprehensive and consistent evaluation of
potential risks of food use pesticides, non-food use pesticides, and
related occupational exposures, EPA intends to apply risk assessment
techniques developed in implementing FQPA to any pesticide risk
assessment, whether it falls under FQPA or not, so long as application
of the risk assessment technique is consistent with good scientific
practice and is not otherwise prohibited by law. Specifically, this
will include using an additional safety/uncertainty factor to protect
children, considering aggregate exposures to pesticides from multiple
sources, and considering cumulative effects which may occur from
exposure to multiple pesticides with a common mechanism of toxicity.
Moreover, risks will be explicitly reported for individuals who had not
been explicitly considered, specifically workers age 12 to 17 and
children taken into agricultural fields.
Taking this step at this time has important environmental justice
ramifications. EPA's commitment to environmental justice compels the
Agency to act expeditiously, where consistent with statutory authority,
to incorporate the risk assessment techniques developed in the
implementation of FQPA in assessing pesticide risks under FIFRA.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: December 1, 2009.
Debra Edwards,
Director, Office of Pesticide Programs.
[FR Doc. E9-29209 Filed 12-08-09; 8:45 am]
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