Environmental Protection Agency (EPA).
This notice announces the availability of EPA's draft ecological risk assessments for the registration review of both clomazone and fomesafen and opens a public comment period on these documents. At the same time, EPA is initiating consultation for clomazone and fomesafen with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service regarding potential effects to species listed as endangered or threatened under the Endangered Species Act. Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. As part of the registration review process, the Agency has completed comprehensive draft ecological risk assessments, including endangered species effects determinations, for all clomazone and fomesafen uses. After reviewing comments received during the public comment period, EPA will issue final risk assessments, explain any changes from the draft risk assessments, and respond to comments. Once the ecological risk assessments have been finalized, the Agency will issue its proposed registration review decisions for these pesticides and seek public comment on any proposed risk mitigation. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment.
Comments must be received on or before June 22, 2009.
Submit your comments identified by the docket identification (ID) number for the specific pesticide of interest provided in the table in Unit III.A., 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 the docket ID numbers listed in the table in Unit III.A. for the pesticides you are commenting on. 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.Start Further Info
FOR FURTHER INFORMATION CONTACT:
For pesticide specific information, contact: The chemical review manager identified in the table in Unit III.A. for the pesticide of interest.
For general questions on the registration review program, contact: Kevin Costello, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-5026; fax number: (703) 308-8090; e-mail address: costello.kevin @epa.gov.
For general questions on OPP's Endangered Species Protection Program, contact: Arty Williams, Environmental Fate and Effects Division (7507P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-7695; fax number: (703) 308-4776 ; e-mail address: email@example.com.End Further Info End Preamble Start Supplemental 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, farmworker, 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 person listed under FOR FURTHER INFORMATION CONTACT.Start Printed Page 18375
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.
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.
EPA is conducting its registration review of clomazone and fomesafen pursuant to section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations for Registration Review at 40 CFR part 155, subpart C. Section 3(g) of FIFRA provides, among other things, that the registrations of pesticides are to be reviewed every 15 years. Under FIFRA section 3(a), a pesticide product may be registered or remain registered only if it meets the statutory standard for registration given in FIFRA section 3(c)(5). When used in accordance with widespread and commonly recognized practice, the pesticide product must perform its intended function without unreasonable adverse effects on the environment; that is, without any unreasonable risk to man or the environment, or a human dietary risk from residues that result from the use of a pesticide in or on food.
III. Registration Reviews
What Action is the Agency Taking?
As directed by FIFRA section 3(g), EPA is reviewing registered pesticides containing clomazone or fomesafen to ensure that they continue to satisfy the FIFRA standard for registration—that is, that these pesticides can still be used without unreasonable adverse effects on human health or the environment. Clomazone is a broad spectrum herbicide used to control annual grasses and broadleaf weeds in a wide variety of crops and locations. EPA has completed a comprehensive draft ecological risk assessment, including an endangered species effects determination, for all clomazone uses. Fomesafen is a pre-plant, pre-emergence and post-emergence herbicide used on soybeans, snap beans, dry beans, and cotton to control broadleaf weeds, grasses, and sedges. It is also registered for use on agricultural fallow/idle land, nonagricultural uncultivated areas/soils, pine (forest/shelterbelt) and pine (seed orchard). EPA has completed a comprehensive draft ecological risk assessment, including an endangered species effects determination for all fomesafen uses.
At present, EPA is announcing the availability of EPA's draft ecological risk assessments for the cases identified in the following table and is opening the public comment period on these documents.
|Registration Review Case Name and Number||Docket ID Number||Chemical Review Manager, Telephone Number, E-mail Address|
|Clomazone (Case No.7203)||EPA-HQ-OPP-2006-0113||Karen Santora, (703) 347-8781 firstname.lastname@example.org|
|Fomesafen (Case No.7211)||EPA-HQ-OPP-2006-0239||Wilhelmena Livingston, (703) 308-8025 email@example.com|
Pursuant to 40 CFR 155.53(c), EPA is providing an opportunity, through this notice of availability, for interested parties to provide comments and input concerning the Agency's draft ecological risk assessments for clomazone and fomesafen. Such comments and input could address, among other things, the Agency's risk assessment methodologies and assumptions, as applied to these draft risk assessments. The Agency will consider all comments received during the public comment period and make changes, as appropriate, to the draft ecological risk assessments. EPA will then issue revised risk assessments, explain any changes to the draft ecological risk assessments, and respond to comments. Once the ecological risk assessments have been finalized, the Agency will issue its proposed registration review decisions for these pesticides and seek public comment on the proposed risk mitigation.
Concurrent with opening the public comment periods for the draft ecological risk assessments for clomazone and fomesafen, the Agency will initiate consultation with the U.S. Fish and Start Printed Page 18376Wildlife Service (FWS) and the National Marine Fisheries Service (NMFS) (jointly referred to as “the Services”) regarding potential effects from these pesticides to federally listed threatened or endangered species (listed species) and habitat designated as critical to such species. The result of consultation will be a biological opinion issued by the Services that expresses whether they believe the pesticide's use is likely to jeopardize the continued existence of any listed species or destroy or adversely modify habitat designated as critical to any listed species. If the Services determine there is likely jeopardy or adverse modification, they will provide reasonable and prudent alternatives to the action. If the Services conclude the action will result in “take” of any individuals of a listed species, they will specify reasonable and prudent measures to minimize such impact. The Agency will review and consider both the public comments received on the draft ecological risk assessments and, if provided, the information in the Service's biological opinions when developing its proposed registration review decisions.
As described in detail in the “Clomazone Summary Document Registration Review: Initial Docket (January 2007), Section IV—Human Health Effects Scoping Document” (see docket ID number EPA-HQ-OPP-2006-0113), the Agency believes that the human health assessments completed prior to registration review are adequate, and there are no dietary risks that exceed the Agency's level of concern. In addition, there are no residential uses of clomazone and all worker margins of exposure (MOEs) are below the Agency's level of concern. Thus, no additional human health data are needed for the registration review of clomazone.
Also, as described in detail in the “Fomesafen Summary Document Registration Review: Initial Docket (March 2007), Section IV - Human Health Effects Scoping Document” (see docket ID number EPA-HQ-OPP-2006-0239), the Agency believes that the human health assessments completed prior to registration review are adequate and there are no dietary risks that exceed the Agency's level of concern. In addition, there are no residential uses of fomesafen. The occupational scenarios do not result in risk concerns, with the exception of inhalation risks to mixer/loaders for aerial application. This risk was mitigated below the Agency's level of concern with the following change that is currently on the label: “In addition, for aerial applications, mixers and loaders handling more than 140 gallons of Reflex Herbicide in any single workday must wear dust/mist filtering NIOSH-approved respirator with any N, R, P, or HE filter.”
1. Other related information. More information on EPA's review of these cases is available on the Registration Review Status web page, http://www.epa.gov/oppsrrd1/registration_review/reg_review_status.htm. Information such as the active ingredients in each case, may be found in the registration review schedule on the Agency's website at http://www.epa.gov/oppsrrd1/registration_review/schedule.htm. Information on the Agency's registration review program and its implementing regulation is available at http://www.epa.gov/oppsrrd1/registration_review.
2. Information submission requirements. Anyone may submit data or information in response to this document. To be considered during a pesticide's registration review, the submitted data or information must meet the following requirements:
- To ensure that EPA will consider data or information submitted, interested persons must submit the data or information during the comment period. The Agency may, at its discretion, consider data or information submitted at a later date.
- The data or information submitted must be presented in a legible and useable form. For example, an English translation must accompany any material that is not in English and a written transcript must accompany any information submitted as an audiographic or videographic record. Written material may be submitted in paper or electronic form.
- Submitters must clearly identify the source of any submitted data or information.
- Submitters may request the Agency to reconsider data or information that the Agency rejected in a previous review. However, submitters must explain why they believe the Agency should reconsider the data or information in the pesticide's registration review.
As provided in 40 CFR 155.58, the registration review docket for each pesticide case will remain publicly accessible through the duration of the registration review process; that is, until all actions required in the final decision on the registration review case have been completed.Start List of Subjects
List of SubjectsEnd List of Subjects Start Signature
Dated: April 13, 2009.
Richard P. Keigwin, Jr.,
Director, Special Review and Reregistration Review Program.
[FR Doc. E9-9231 Filed 4-21-09; 8:45 am]
BILLING CODE 6560-50-S