2010-20176. Propionic Acid and Salts, and Urea Sulfate; Registration Review Proposed Decisions; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of EPA’s proposed registration review decisions for the pesticides propionic acid and salts, and urea sulfate and opens a public comment period on the proposed decisions. 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, that the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. 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.

DATES:

Comments must be received on or before October 18, 2010.

ADDRESSES:

Submit your comments, identified by the docket identification (ID) number for the specific pesticide of interest provided in the table in Unit II.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 [phone].

Instructions: Direct your comments to the docket identification (ID) number listed in the table in Unit II.A. for the pesticide 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 [phone].

FOR FURTHER INFORMATION CONTACT:

For pesticide-specific information, contact: The chemical review manager identified in the table in Unit II.A. for the pesticide of interest.

For general information on the registration review program, contact: Kevin Costello, Pesticide Re-evaluation Division (7508P), 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, 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 that is identified in the table in Unit II.A. for the pesticide of interest.

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. Background

A. What Action is the Agency Taking?

Pursuant to 40 CFR 155.58, this notice announces the availability of EPA’s proposed registration review decision for the pesticides shown in the following table, and opens a 60-day public comment period on the proposed decisions. The active ingredient propionic acid is a fungicide and bactericide that is used to control fungi and bacteria in stored hay and grains, inhibit bacterial growth in drinking water for livestock and poultry, control mold and fungi in poultry litter and animal feed, and sanitize pre-cleaned food contact surfaces. Propionic acid is also used as an inert ingredient in pesticide formulations. Propionic acid and its salts, sodium and calcium propionates, are approved by the Food and Drug Administration (FDA) in the United States as Generally Recognized As Safe (GRAS) for use in food. Propionic acid and salts, are exempt from the requirement of a tolerance. Urea sulfate is used as a desiccant on cotton. No food crop uses remain and all tolerances for urea sulfate have been deleted.

Registration Review Proposed Decisions

Registration Review Case Name and Number	Pesticide Docket ID Number	Chemical Review Manager,Telephone Number, E-mail Address
Propionic Acid and Salts Case Number 4078	EPA-HQ-OPP-2008-0024	Wilhelmena Livingston [phone] [e-mail]
Urea Sulfate Case Number 7213	EPA-HQ-OPP-2007-0202	Andrea Carone [phone] [e-mail]

The registration review docket for a pesticide includes earlier documents related to the registration review of the case. For example, the review opened with the posting of a Summary Document, containing a Preliminary Work Plan, for public comment. A Final Work Plan was posted to the docket following public comment on the initial documents.

For propionic acid and salts, an endangered species assessment was conducted for all uses of propionic acid; however, the Agency determined that a health risk assessment was not needed. In addition, no data were required at this time to support registrations containing propionic acid and salts. The Agency has considered propionic acid and salts in light of the standard for registration and safety factors in FIFRA and FFDCA, as amended by FQPA. EPA has found that there are not likely to be any unreasonable adverse effects to the U.S. population in general, and to infants and children in particular, or to non-target organisms or the environment from the use of registered pesticide products containing propionic acid and salts when currently required label instructions are followed. In addition, the Agency has made a “No Effect” determination for endangered species for propionic acid and salts. This proposed registration review decision is described in more detail in the Propionic Acid and Salts Proposed Registration Review Decision, available in the propionic acid and salts docket.

For urea sulfate, after the publication of the Urea Sulfate Final Work Plan, pursuant to section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, the Agency received a request to voluntarily cancel all but one registered label for use on cotton and then granted the voluntary cancellation request on October 14, 2008, for all registered use sites besides cotton of urea sulfate in the United States. The Agency described the impact of the cancellations on the registration review of urea sulfate in the Revised Registration Review Ecological Risk Assessment and Effects Determination for Urea Sulfate, which was issued on September 3, 2009. In this assessment, the Agency made a “No Effect” determination for federally listed species and designated critical habitats. This proposed registration review decision is described in more detail in the Urea Sulfate Proposed Registration Review Decision, available in the urea sulfate docket.

Following public comment, the Agency will issue registration review decisions for products containing propionic acid and salts, and urea sulfate.

The registration review program is being conducted under congressionally mandated time frames, and EPA recognizes the need both to make timely decisions and to involve the public. Section 3(g) of FIFRA, as amended, required EPA to establish by regulation procedures for reviewing pesticide registrations, originally with a goal of reviewing each pesticide’s registration every 15 years to ensure that a pesticide continues to meet the FIFRA standard for registration. The Agency’s final rule to implement this program was issued in August 2006, and became effective in October 2006, and appears at 40 CFR part 155 subpart C. The Pesticide Registration Improvement Act of 2003 (PRIA) was amended and extended in September 2007. FIFRA, as amended by PRIA in 2007, requires EPA to complete registration review decisions by October 1, 2022, for all pesticides registered as of October 1, 2007.

The registration review final rule at 40 CFR 155.58(a) provides for a minimum 60-day public comment period on all proposed registration review decisions. This comment period is intended to provide an opportunity for public input and a mechanism for initiating any necessary amendments to the proposed decision. All comments should be submitted using the methods in ADDRESSES, and must be received by EPA on or before the closing date. These comments will become part of the docket for propionic acid and salts. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.

The Agency will carefully consider all comments received by the closing date and will provide a “Response to Comments Memorandum” in the docket. The registration review decision will explain the effect that any comments had on the decision and provide the Agency’s response to significant comments.

Background on the registration review program is provided at: http://www.epa.gov/​oppsrrd1/​registration_​review. A link to earlier documents related to the registration review of propionic acid and salts, and urea sulfate is provided at: http://www.epa.gov/​oppsrrd1/​registration_​review/​reg_​review_​status.htm.

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

Section 3(g) of FIFRA and 40 CFR part 155, subpart C, provide authority for this action.

List of Subjects

• Environmental protection
• Administrative practice and procedure
• Pesticides and pests, propionic acid and salts, and urea sulfate

Dated: August 8, 2010

Richard P. Keigwin, Jr.,

Director, Pesticide Re-evaluation Division, Office of Pesticide Programs.