Cumulative Risk Assessments: Pyrethrins/Pyrethroid

This Notice document was issued by the Environmental Protection Agency (EPA)

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[EPA-HQ-OPP-2011-0746; FRL-8888-9]

Pyrethrins/Pyrethroid Cumulative Risk Assessment; Notice of Availability


Environmental Protection Agency (EPA).




This notice announces the availability of EPA's cumulative risk assessment for the naturally occurring pyrethrins and synthetic pyrethroid pesticides (often collectively called the `pyrethroids') and opens a public comment period on this document and other supporting documents which are available in the docket. The Food Quality Protection Act of 1996 (FQPA) requires the EPA to consider available information concerning the cumulative effects on human health resulting from exposure to multiple chemicals that have a common mechanism of toxicity when making regulatory decisions. The Agency has identified a common mechanism of toxicity for the naturally occurring pyrethrins and synthetic pyrethroid pesticides, and has conducted a screening-level cumulative risk assessment for all pesticidal uses for the pyrethroids. Based on this assessment, EPA has concluded that the cumulative risks from existing pyrethroid uses are below the Agency's level of concern. Because this cumulative assessment uses a number of very conservative assumptions, EPA is providing an opportunity, through this notice, for interested parties to provide comments and input on any additional information that may be used to further refine the very conservative nature of this cumulative risk assessment.


Comments must be received on or before January 9, 2012.


Submit your comments identified by the docket identification (ID) number EPA-HQ-OPP-2011-0746, by one of the following methods:

• Federal eRulemaking Portal: 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 the docket ID number EPA-HQ-OPP-2011-0746. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at, 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 or email. The Web site 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 email comment directly to EPA without going through, your email 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 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, 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

For pesticide specific information contact: Dana L. Friedman, Chemical Review Manager, Pesticide Re-evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 347-8827; fax number: (703) 308-7070; email address:

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 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 underFOR 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 or email. 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 Registerdate 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.

3. Environmental justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides discussed in this document, compared to the general population.

II. Authority

Section 408(b)(2)(D)(v) of the Federal Food, Drug, and Cosmetic Act (FFDCA) directs the Agency to consider available information on the cumulative risk from substances sharing a common mechanism of toxicity. On June 30, 2011, the Agency determined that the naturally occurring pyrethrins and synthetic pyrethroid pesticides share a common mechanism of toxicity. This determination can be found in the document entitled “Draft Science Policy Paper for the Proposed Common Mechanism Grouping for the Pyrethrins and Synthetic Pyrethroids,” which is available in the docket EPA-HQ-OPP-2011-0746.

List of Subjects

Environmental protection, Cumulative Risk Assessment, Pesticides and pests, Pyrethrins and Pyrethroids.

Dated: October 28, 2011.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide Programs.
[FR Doc. 2011-29089 Filed 11-8-11; 8:45 am]
Comment Period Closed
Jan 9 2012, at 11:59 PM ET
ID: EPA-HQ-OPP-2011-0746-0001
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Document Information

Date Posted: Nov 9, 2011
Federal Register Number: 2011-29089
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Comments Received*
See attached file(s) My letter to you is the attatchment labeled permethrin letter.docx. The rest are copies of studies that document the harmful effects of...
The Utah Physicians for a Healthy Environment wish to comment on the EPA's proposed risk assessment for pyrethroid insecticides. Please see the attached...
See attached file(s)

Docket Information

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Related Dockets: None
Related RINs: None
Related Comments:

* This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.

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