06-574. Pesticides: Minimal Risk Tolerance Exemptions

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

This document proposes to reorganize certain existing tolerance exemptions. All of these chemical substances were reviewed as part of the tolerance reassessment process required under the Food Quality Protection Act of 1996 (FQPA). As a result of that review, 13 chemical substances are now classified as “minimal risk.” The Agency intends to shift the existing tolerance exemptions for these chemicals to 40 CFR 180.950(e). The Agency is merely moving certain tolerance exemptions from one section of the CFR to another section: No tolerance exemptions are lost or added as a result of this action.

DATES:

Comments must be received on or before March 27, 2006.

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ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2005-0487, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov/​. Follow the on-line instructions for submitting comments.
• Agency Website: http://www.epa.gov/​edocket/​. EDOCKET, EPA's electronic public docket and comment system, is EPA's preferred method for receiving comments. Follow the on-line instructions for submitting comments.
• E-mail: Comments may be sent by e-mail to [e-mail], Attention: Docket ID number EPA-HQ-OPP-2005-0487.
• 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, Attention: Docket ID number EPA-HQ-OPP-2005-0487.
• Hand delivery: Public Information and Records Integrity Branch (PIRIB), 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-2005-0487. 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-2005-0487. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.epa.gov/​edocket/​, 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 EDOCKET, regulations.gov, or e-mail. The EPA EDOCKET and the regulations.gov websites are anonymous access systems, 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 EDOCKET or regulations.gov, your e-mail address will be automatically captured 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 EDOCKET on-line or see the Federal Register of May 31, 2002 (67 FR 38102) (FRL-7181-7).

Docket: 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. This Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is [phone].

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: [phone]; fax number: [phone]; e-mail address: [e-mail].

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)

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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/​.

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

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1. Submitting CBI. Do not submit this information to EPA through EDOCKET, 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 rulemaking 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. What is the Agency's Authority for Taking this Action?

This proposed rule is issued under section 408 of FFDCA, 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170). Section 408(e) of FFDCA authorizes EPA to establish, modify, or revoke tolerances, or exemptions from the requirement of a tolerance for residues of pesticide chemicals in or on raw agricultural commodities and processed foods.

III. What Action is the Agency Taking?

In the Federal Register of May 24, 2002 (67 FR 36534) (FRL-6834-8) EPA established a new section 180.950 to list the pesticide chemical substances that are exempted from the requirement of a tolerance based on the Agency's determination that these chemical substances are of “minimal risk.” This proposed rule shifts existing tolerance exemptions for certain inert ingredients that have been classified by the Agency as List 4A, “minimal risk,” to 40 CFR 180.950(e). The decision documents supporting the minimal risk, List 4A classification, are in the docket. Because this action merely moves certain tolerance exemptions from one section of CFR to another section, it will have no substantive or procedural effect on the moved tolerance exemptions. No tolerance exemptions are lost or added as a result of this action.

The Agency is proposing to shift the following tolerance exemptions to 40 CFR 180.950(e):

• From 40 CFR 180.910: Ascorbic acid (CAS Reg, No. 50-1-7); beeswax; carnauba wax; glycerol; isopropyl alcohol; soap (sodium or potassium salts of fatty acids); sodium benzoate; sodium bicarbonate; sorbitol; and sperm oil conforming to 21 CFR 172.210;
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• From 40 CFR 180.920: Vanillin
• From 40 CFR 180.930: Carnauba wax (CAS Reg. No. 8015-86-9); glycerol(glycerin); isopropyl alcohol; and sodium benzoate
• From 40 CFR 180.940(a): 2-propanol(isopropanol); and sodium bicarbonate
• From 40 CFR 180.940(b): 2-propanol(isopropanol)
• From 40 CFR 180.940(c): 2-propanol(isopropanol); and sodium bicarbonate
• One of the exemptions (sorbic acid, and potassium salt) covers two chemicals. One of the chemicals has been determined to be List 4A and other List 4B. Another tolerance exemption (potassium carbonate) covers three chemicals. One of the chemicals has been determined to be List 4A, and the other two are List 4B. Therefore, these tolerance exemptions are essentially “split” with only the 4A chemicals to be shifted to 40 CFR 180.950, while the 4B chemicals are to remain where currently established. Therefore, these two existing tolerance exemptions are to be revised to specify only the List 4B chemicals.

IV. Nomenclature Changes

For most of the chemical substances that are being shifted to 40 CFR 180.950(e), EPA is changing the chemical substance names that were previously used. The Agency has attempted to identify each of the listed chemical substances using the Chemical Abstracts Service Registry Number (CAS No.). The CAS No. provides one of the most distinct and universally accepted means of identifying chemical substances. Generally, there will be only one CAS No. per listed substance. EPA has both broadened and consolidated names to account for differing terminologies and current usage status. These name changes are not intended to broaden or narrow the scope of the existing exemption but rather to define the scope of the exemption more precisely.

V. Statutory and Executive Order Reviews

This proposed rule merely re-organizes existing exemptions in 40 CFR part 180. This has no substantive effect and hence causes no impact. On its own initiative, the Agency is acting under section 408(e) of the FFDCA in shifting these existing tolerance exemptions to a different section of CFR. Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993) this action is not a “significant regulatory action” subject to review and by the Office of Management and Budget (OMB). Because the proposed rule has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed 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 proposed 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). Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that this proposed action will not have significant negative economic impact on a substantial number of small entities. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, 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 proposed 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 proposed 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 proposed 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 proposed rule.

List of Subjects in 40 CFR Part 180

• Environmental protection
• Administrative practice and procedure
• Pesticides and pests
• Reporting and recordkeeping requirements

Dated: January 12, 2006.

Lois Rossi,

Director, Registration Division, Office of Pesticide Programs.

Therefore, it is proposed that 40 CFR chapter I be amended as follows:

PART 180—[AMENDED]

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

Authority: 21 U.S.C. 321(q), 346(a) and 374

2. In §180.910, the table is amended by removing the following entries: Ascorbic acid (CAS Reg, No. 50-81-7); beeswax; carnauba wax; glycerol; isopropyl alcohol; soap (sodium or potassium salts of fatty acids); sodium benzoate; sodium bicarbonate; sorbitol; and sperm oil conforming to 21 CFR 172.210; and by revising the entry for sorbic acid (and potassium salt) to read as follows:.

§ 180.910

Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance.

* * * * *

Inert Ingredients	Limits	Uses
*         *         *         *         *         *         *
Sorbic acid (CAS Reg. No. 110-44-1)		Preservative for formulations
*         *         *         *         *         *         *

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3. In §180.920, the table is amended by removing the entry for vanillin; and the entry for potassium carbonate is removed and replaced with two new entries to read as follows:

§ 180.920

Inert ingredients used pre-harvest; exemptions from the requirement of a tolerance.

* * * * *

Inert Ingredients	Limits	Uses
*         *         *         *         *         *         *
Carbonic acid, dipotassium salt (CAS Reg. No. 584-08-7)		Buffering agent
Carbonic acid, dipotassium salt, trihydrate (CAS Reg. No. 18662-52-7)		Do.
*         *         *         *         *         *         *

§ 180.930

[Amended]

4. In §180.930 the table is amended by removing the following entries: Carnauba wax (CAS Reg. No. 8015-86-9); glycerol(glycerin); isopropyl alcohol; and sodium benzoate.

§ 180.940

[Amended]

5. In §180.940, the table in paragraph (a) is amended by removing the entries for 2-propanol(isopropanol) and sodium bicarbonate; the table in paragraph (b) is amended by removing the entry for 2-propanol(isopropanol); and the table in paragraph (c) is amended by removing the entries for 2-propanol(isopropanol) and sodium bicarbonate.

6. In §180.950, the table in paragraph (e) is amended by adding alphabetically the following entries to read as follows:

§ 180.940

Tolerance exemptions for minimal risk active and inert ingredients.

* * * * *

(e) * * *

Chemical Name	CAS Reg. No.
*
*         *         *         *         *         *         *
Ascorbic acid (vitamin C)	50-81-7
Beeswax	8012-89-3
Benzoic acid, sodium salt	532-32-1
*
*         *         *         *         *         *         *
Carnauba wax	8015-86-9
Carbonic acid, monopotassium salt	298-14-6
Carbonic acid, monosodium salt (sodium bicarbonate)	144-55-8
*
*         *         *         *         *         *         *
D-Glucitol (sorbitol)	50-70-4
Glycerol (glycerin) (1,2,3-propanetriol)	56-81-5
*
*         *         *         *         *         *         *
2-Propanol (isopropyl alcohol)	67-63-0
*
*         *         *         *         *         *         *
Soap (The water soluble sodium or potassium salts of fatty acids producted by either the saponification of fats and oils, or the neutralization of fatty acid	None
Sorbic acid, potassium salt	24634-61-5
Sperm oil	8002-24-2
*
*         *         *         *         *         *         *
Vanillin	121-33-5