E6-4568. Methyl Bromide Revised Risk Assessment for Uses in Enclosures, Chambers and Structural Food Processing/Storage Facilities; Notice of Availability and Solicitation of Risk Reduction Options

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of EPA's revised risk assessment for the pesticide methyl bromide's uses in enclosures, chambers and structural food processing/storage facilities. In addition, this notice solicits public comment on risk reduction options for methyl bromide's commodity uses. The public is encouraged to suggest risk management ideas or proposals to address the risks identified. EPA is developing a Reregistration Eligibility Decision (RED) for uses in enclosures, chambers and structural food processing/storage facilities of methyl bromide (i.e. uses that result in a food tolerance) through the full, 6-Phase public participation process that the Agency uses to involve the public in developing pesticide reregistration and tolerance reassessment decisions. Through these programs, EPA is ensuring that all pesticides meet current health and safety standards.

DATES:

Comments must be received on or before May 30, 2006.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2005-0123, by one of the following methods:

• http://www.regulations.gov/​. Follow the on-line instructions for submitting comments.
• Mail: Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Hand Delivery: Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID number EPA-HQ-OPP-2005-0123. The docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the docket facility is [phone]. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

Instructions: Direct your comments to docket ID number EPA -HQ-OPP-2005-0123. EPA's policy is that all comments received will be included in the public 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 captured automatically and included as part of the comment that is placed in the public 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. For additional information about EPA's public docket, visit the EPA Docket Center homepage at http://www.epa.gov/​epahome/​docket.htm/​.

Docket: All documents in the docket are listed in the regulation.gov index. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically at http://www.regulations.gov/​ or in hard copy at the Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. The docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the docket facility is [phone].

FOR FURTHER INFORMATION CONTACT:

Steven Weiss, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

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, 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.

B. What Should I Consider as I Prepare My Comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through www.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 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. Background

A. What Action is the Agency Taking?

EPA is making available the Agency's revised risk assessment for methyl bromide use in enclosures, chambers and structural food processing/storage facilities, initially issued for comment through a Federal Register notice published on July 13, 2005, 70 FR 40336, (FRL-7721-3) a response to comments; and related documents for methyl bromide. EPA also is soliciting public comment on risk reduction options for methyl bromide's uses in enclosures, chambers and structural food processing/storage facilities and EPA's initial assessment of the impacts of these risk reduction options. EPA developed the risk assessment for methyl bromide as part of its public process for making pesticide reregistration eligibility and tolerance reassessment decisions. Through these programs, EPA is ensuring that pesticides meet current standards under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

The risk assessment includes methyl bromide uses that have accompaning food residue tolerances such as post-harvest fumigation of food commodities in chambers at ports or specialized structural fumigations at food processing facilities. Although some methyl bromide uses such as fumigation of timber, wood products, and industrial equipment do not require a food residue tolerance, they have been included in this assessment since they are performed in similar facilities and were assessed with similar methods.

EPA plans to release a revised assessment (Phase 5) for all other uses of methyl bromide, mainly soil fumigant applications, later this year. The Agency is delaying the soil fumigant component of methyl bromide reregistration in response to stakeholder comments that the risks, benefits, and risk management of soil fumigation uses of methyl bromide and its alternatives should be considered in the same general time frame. Alternatives currently in the reregistration process include metam sodium, dazomet, and chloropicrin. In particular, stakeholders have noted that chloropicrin is frequently applied in conjunction with methyl bromide and thus commenters have asserted that it makes sense to consider risk management strategies jointly for these chemicals. The Agency agrees with this logic and thus has separated the assessments so that risk management decisions can be made as expeditiously as feasible for all uses.

EPA estimated the methyl bromide usage in the U.S. for 2004 based on information from the methyl bromide critical use exemption process, U.S. Department of Agriculture, Animal and Plant Health Inspection Service, and EPA proprietary sources. Based on these sources EPA estimates there was a total of 23 million pounds of methyl bromide used in the U.S. in 2004 with 3 million pounds used on commodities, food processing facilities, and food quarantine uses, and 20 million pounds used for all other uses, mainly pre-plant soil applications.

Application rates for commodity fumigations can range from 1 to 20 lb ai/1000 ft³ but most are in the 1 to 9 lb ai/1000 ft³ range. Likewise, structural fumigations are in the 1 to 9 lb ai/1000 ft³ range. For structural, commodity and other types of applications, an application rate of 9 lb ai/1000 ft³ was used as the basis for risk assessment purposes.

EPA is providing an opportunity, through this notice, for interested parties to provide risk management proposals or otherwise comment on risk management for methyl bromide. Regarding risks to humans from methyl bromide commodity uses, there are no aggregate dietary risks of concern resulting from acute and chronic exposures (food and water only). Risks of concern associated with the use of methyl bromide commodity uses are:

1. Occupational exposures during treatment and aeration processes and;

2. Bystander exposure during treatment and aeration processes. In targeting these risks of concern, the Agency solicits information on effective and practical risk reduction measures.

EPA's Office of Atmospheric Programs (OAP) has also estimated the number of UV-related skin cancer incidents and deaths due to ozone depletion caused by methyl bromide's uses in enclosures, chambers, and structural food processing/storage facilities. OAP's assessment is also included in the docket for public comment. The Agency believes it is appropriate to consider these cancer risks as part of the reregistration process because the risks clearly result from use of methyl bromide products registered for use under FIFRA.

EPA is applying the principles of public participation to all pesticides undergoing reregistration and tolerance reassessment. The Agency's Pesticide Tolerance Reassessment and Reregistration; Public Participation Process, published in the Federal Register on May 14, 2004, (69 FR 26819) (FRL-7357-9) explains that in conducting these programs, EPA is tailoring its public participation process to be commensurate with the level of risk, extent of use, complexity of issues, and degree of public concern associated with each pesticide. Due to its uses, risks, and other factors, methyl bromide is being reviewed through the full 6-Phase public participation process.

All comments should be submitted using the methods in ADDRESSES, and must be received by EPA on or before the closing date. Comments and proposals will become part of the Agency Docket for methyl bromide. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. After considering comments received, EPA will develop and issue for comment the methyl bromide RED.

B. What is the Agency's Authority for Taking this Action?

Section 4(g)(2) of FIFRA as amended directs that, after submission of all data concerning a pesticide active ingredient, “the Administrator shall determine whether pesticides containing such active ingredient are eligible for reregistration,”before calling in product specific data on individual end-use products and either reregistering products or taking other “appropriate regulatory action.”

Section 408(q) of the FFDCA, 21 U.S.C. 346a(q), requires EPA to review tolerances and exemptions for pesticide residues in effect as of August 2, 1996, to determine whether the tolerance or exemption meets the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review is to be completed by August 3, 2006.

List of Subjects

• Environmental protection
• Pesticides and pests

Dated: March 22, 2006.

Debra Edwards,

Director, Special Review and Reregistration Division, Office of Pesticide Programs.