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###### Environmental Protection Agency

          - 40 CFR Part 180
          - [OPP-2005-0238; FRL-7735-8]

# AGENCY:

Environmental Protection Agency (EPA).

# ACTION:

Final rule.

# SUMMARY:

EPA is removing time-limited tolerance exemptions for several pesticide chemicals. These time-limited tolerance exemptions are being removed because they have expired and are obsolete, and to ensure that the regulatory listings of tolerance exemptions are properly updated.

# DATES:

This final rule is effective on November 22, 2005.

# ADDRESSES:

                        EPA has established a docket for this action under Docket identification (ID) number OPP-2005-0238. All documents in the docket are listed in the EDOCKET index at                         *http://www.epa.gov/​edocket*. 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, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in EDOCKET or in hard copy at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305-5805.                    

# FOR FURTHER INFORMATION CONTACT:

                        Kathryn Boyle, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-6304; fax number: (703) 305-0599; e-mail address:                         *boyle.kathryn@epa.gov*.                    

# SUPPLEMENTARY INFORMATION:

## I. General Information

### A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
    - Crop production (NAICS code 111)
    - Animal production (NAICS code 112)
    - Food manufacturing (NAICS code 311)
    - Pesticide manufacturing (NAICS code 32532)

                    This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. 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. How Can I Access Electronic Copies of this Document and Other Related Information?

                    In addition to using EDOCKET                     *(http://www.epa.gov/​edocket/​)*, you may access this                     **Federal Register**                     document electronically through the EPA Internet under the “                    **Federal Register**                    ” listings at                     *http://www.epa.gov/​fedrgstr/​*. A frequently updated electronic version of 40 CFR part 180 is available at E-CFR Beta Site Two at                     *http://www.gpoaccess.gov/​ecfr/​*.                

## II. Background

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

This final rule is issued pursuant to section 408(e) of the Federal Food, Drug, and Comestic Act (FFDCA), as amended by the Food Quality Protection Act (FQPA) (21 U.S.C. 346a(e)). Section 408 of FFDCA authorizes the establishment of tolerances, exemptions from the requirement of a tolerance, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Without a tolerance or tolerance exemption, food containing pesticide residues is considered to be unsafe and therefore, “adulterated” under section 402(a) of FFDCA. If food containing pesticide residues is found to be adulterated, the food may not be distributed in interstate commerce (21 U.S.C. 331(a) and 342 (a)).

### B. Why is EPA Issuing this as a Final Rule?

                    Section 553 of the Administrative Procedure Act, 5 U.S.C. 553(b)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's rule final without prior proposal and opportunity for comment because the actions taken in this final rule represent technical corrections to the regulations and do not involve substantive Agency action. The removal of an expired time-limited tolerance exemption from 40 CFR part 180 does not involve any substantive Agency action. The expiration date for                           ( print page 55732)                        the time-limited tolerance exemption is set when the Agency issues the final rule that originally establishes, or a subsequent final rule that amends, the specific time-limited tolerance exemption. Once that time-limited tolerance expires, the associated listing in 40 CFR part 180 is obsolete and its removal is a ministerial act without substantive or procedural effects.                

For this reason, notice and public procedure are unnecessary. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B).

### C. What Action is EPA Taking?

The following time-limited tolerance exemptions are removed from 40 CFR part 180 because they have expired: Casein; fish meal; soy protein, isolated; soybean flour; wheat, including flour, bran, and starch; sodium caseinate; Rhodamine B; and wheat shorts.

## III. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of the FFDCA, as was provided in the old FFDCA sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

### A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2005-0238 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 22, 2005.

                    1.                     *Filing the request*. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issue(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.                

Mail your written request to: Office of the Hearing Clerk (1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., Washington, DC 20005. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 564-6255.

                    2.                     *Copies for the Docket*. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit XI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in                     **ADDRESSES**                    . Mail your copies, identified by docket ID number OPP-2005-0238, to: Public Information and Records Integrity Branch, Information Technology and Resource Management Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in                     **ADDRESSES**                    . You may also send an electronic copy of your request via e-mail to:                     *opp-docket@epa.gov*. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.                

### B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issue(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

## IV. Statutory and Executive Order Reviews

                    This final rule removes obsolete (expired) time-limited exemptions from the tolerance requirement that were previously established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted actions such as these revocations from review under Executive Order 12866, entitled                     *Regulatory Planning and Review*                     (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211,                     *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use*                     (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501*et seq.*, or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled                     *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations*                     (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled                     *Protection of Children from Environmental Health Risks and Safety Risks*                     (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).                

                    Because the Agency has made a good cause finding that this action is not subject to notice-and-comment requirements under the Administrative Procedure Act or any other statute (see Unit II.B.), it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601*et seq.*) In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between                           ( print page 55733)                        the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled                     *Federalism*                     (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled                     *Consultation and Coordination with Indian Tribal Governments*                     (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.                

## V. Congressional Review Act

                    The Congressional Review Act, 5 U.S.C. 801*et seq.*, as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the Agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the                     **Federal Register**                    . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).                

# List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: September 19, 2005.

Lois Rossi,

Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

# PART 180—[AMENDED]

1. The authority citation for part 180 continues to read as follows: 

Authority:21 U.S.C. 321(q), 346a and 371.

§ 180.910

2. Section 180.910 is amended by removing, in the table, the following entries: Casein; fish meal; soy protein, isolated; and wheat, including flour, bran, and starch. 

§ 180.920

3. Section 180.920 is amended by removing, in the table, the following entry: Sodium caseinate. 

§ 180.930

4. Section 180.930 is amended by removing, in the table, the following entries: Rhodamine B; soy protein, isolated; and wheat shorts. 

[FR Doc. 05-19056 Filed 9-22-05; 8:45 am]

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