Document ID: EPA-HQ-OPP-2009-0889-0001
Agency: epa
Document Type: Notice
Title: Policy Paper on Revised Risk Assessment Methods for Workers, etc.; Availability
Posted Date: 2009-12-09T05:00Z

[Federal Register: December 9, 2009 (Volume 74, Number 235)]
[Notices]               
[Page 65121-65122]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09de09-51]                         

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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: smegal.deborah@epa.gov.

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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