01-31802. Pesticide Chemicals Not Requiring a Tolerance or an Exemption from a Tolerance; Rhodamine B; Revocation of Unlimited Tolerance Exemption

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This final rule creates a new subpart E in 40 CFR part 180. This subpart will be titled: Pesticide Chemicals Not Requiring a Tolerance or an Exemption from a Tolerance. It will contain a list of the pesticide chemicals (including, as appropriate, their limitations and use patterns) for which the Agency has determined that neither a tolerance nor an exemption from the requirement of a tolerance is needed under the Federal Food, Drug, and Cosmetic Act (FFDCA). The Agency is acting on its own initiative. This document also revokes the unlimited tolerance exemption for the inert ingredient Rhodamine B in 40 CFR 180.1001 (c), and amends by time-limiting the unlimited tolerance exemption for Rhodamine B in 40 CFR 180.1001 (e). These regulatory actions are part of the tolerance reassessment requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q), as amended by the Food Quality Protection Act (FQPA) of 1996. By law, EPA is required to reassess 66% of the tolerances in existence on August 2, 1996, by August 2002, or about 6,400 tolerances. The regulatory actions taken in this document, would be counted toward the August 2002 deadline.

DATES:

This final rule is effective on December 27, 2001.

FOR FURTHER INFORMATION CONTACT:

Kathryn Boyle , Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 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 categories and entities may include, but are not limited to:

Categories	NAICS codes	Examples of potentially affected entities
Industry	111	Crop production
	112	Animal production
	311	Food manufacturing
	32532	Pesticide manufacturing

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 table could also be affected. The North American Industrial Classification System (NAICS) codes are provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/​. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr/​. A frequently updated electronic version of 40 CFR parts 153 and 180 are available at: http://www.access.gpo.gov/​nara/​cfr/​cfrhtml_​153/​Title_​40/​40cfr153_​00.html and http://www.access.gpo.gov/​nara/​cfr/​cfrhtml_​180/​Title_​40/​40cfr180_​00.html,, a beta site currently under development.

2. In person. The Agency has established an official record for this action under docket control number OPP-301026A. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

II. Background

In the Federal Register of August 2, 2001 (66 FR 40170) (FRL-6598-4), EPA issued a proposal pursuant to section 408 of the FFDCA, 21 U.S.C. 346a as amended by the FQPA (Public Law 104-170) to amend 40 CFR by creating a new subpart E, and to revoke two unlimited tolerance exemptions for the inert ingredient Rhodamine B (CAS Reg. No. 81-88-9). New subpart E will contain a list of the pesticide chemicals (including, as appropriate, their limitations and use patterns) for which the Agency has determined that neither a tolerance nor an exemption from the requirement of a tolerance is needed under the FFDCA. The only chemical included in subpart E at its creation is the inert ingredient Rhodamine B (CAS Reg. No. 81-88-9) when used as a dye for seed treatment. The revocations of the Rhodamine B tolerance exemptions were based on EPA's conclusion that the exemptions are for uses of Rhodamine B that are no longer extant other than the use included in subpart E. Three comments were received in response to the proposed rule.

The comments from both the American Chemistry Council and from Gustafson supported the creation of the new subpart E. Gustafson has also suggested an additional chemical (an active ingredient) that it believes could be appropriately added to the new subpart. The Agency will consider this request, and, if appropriate, initiate such procedures as necessary to add this additional chemical to subpart E. A comment was also received from Boehringer Ingelheim Vetmedica, Inc. (BIVI) informing the Agency that currently there are two animal ear tag products containing Rhodamine B that are being manufactured and distributed. BIVI has agreed to remove the Rhodamine B from their products. To allow time for BIVI to reformulate and then for the ear tags containing Rhodamine B to clear the channels of trade, the Agency will time-limit the Rhodamine B tolerance exemption under 40 CFR 180.1001 (e) to expire in 3 years.

Based on the reasons set forth in the preamble to the proposed rule, and considering the comments received by the Agency in response to the proposed rule, EPA is creating a new subpart E, revoking one unlimited tolerance exemption, and revising one tolerance exemption by time-limiting the exemption to expire in three years.

These regulatory actions are part of the tolerance reassessment requirements of section 408(q) of the FFDCA, as amended by the FQPA of 1996. By law, EPA is required to reassess 66% of the tolerances in existence on August 2, 1996, by August 2002, or about 6,400 tolerances. The regulatory actions in this document, the revocation of two tolerance exemptions, would be counted toward the August 2002 deadline.

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 of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 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 control number OPP-301026A 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 February 25, 2002.

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 issues(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 (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. 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 [phone].

2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at [phone], by e-mail at [e-mail], or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301026A, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: [e-mail]. 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 issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

IV. Regulatory Assessment Requirements

The Agency is acting on its own initiative under FFDCA section 408(e) in revoking these tolerances and in establishing a new subpart E in 40 CFR part 180 that will contain a list of the pesticide chemicals (including, as appropriate, their limitations and use patterns) for which the Agency has determined that neither a tolerance nor an exemption from the requirement of a tolerance is needed under FFDCA. 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 by the Office of Management and Budget (OMB). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, 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).

This rule simply establishes a new subpart E in 40 CFR part 180 that will contain a list of the pesticide chemicals (including, as appropriate, their limitations and use patterns) for which the Agency has determined that neither a tolerance nor an exemption from the requirement of a tolerance is needed under FFDCA, and only amends an existing unlimited tolerance exemption to make it time limited. The Agency has determined that this action will not result in significant adverse economic impacts. Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether revocations of tolerances or tolerance exemptions might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. This analysis was published on December 17, 1997 (62 FR 66020), and was provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, the available information concerning the pesticide chemicals listed in this rule, the Agency knows of no extraordinary circumstances that exist as to the present revocation that would change EPA's previous analysis. Therefore, the Agency hereby certifies pursuant to the section 605(b) of the RFA that this rule will not have a 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 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 FFDCA section 408(n)(4).

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. Submission to Congress and the Comptroller General

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 Parts 153 and 180

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

Dated: December 14, 2001.

James Jones,

Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I be amended as follows:

PART 153—[AMENDED]

1. In part 153:

a. The authority citation for part 153 would continue to read as follows:

Authority: 15 U.S.C. 136 et seq.

b. Section 153.155 (c) is revised to read as follows.

§ 153.155

Seed treatment products.

* * * * *

(c) EPA-approved dyes for seed treatment are listed in:

(1) Section 180.1001(c) and (d) if an exemption from the requirement of a tolerance has been established.

(2) Section 180.2010 if EPA has determined that residues of the dye will be present, if at all, at levels that are below the threshold of regulation.

(3) Section 180.2020 if it has been determined that no tolerance or exemption from the requirement of a tolerance is needed as a result of a determination by EPA that the use is unlikely to result in residues in food/feed.

PART 180—[AMENDED]

2. In part 180:

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

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

b. In § 180.1001 the table in paragraph (c) is amended by removing the entry for “Rhodamine B” and in paragraph (e) the table is amended by revising the entry to read as follows:

§ 180.1001

Exemptions from the requirement of a tolerance.

* * * * *

(e) * * *

Inert ingredients	Limits	Uses
*         *         *         *         *         *         *
Rhodamine B	Expires December 27, 2004.	Dye for use in ear tags only
*         *         *         *         *         *         *

c. By adding new subpart E, consisting of § 180.2000-180.2020, to read as follows:

Subpart E—Pesticide Chemicals Not Requiring a Tolerance or an Exemption from a Tolerance

Sec.

180.2000

Scope.

180.2003

Definitions.

180.2010

Threshold of regulation determinations. [Reserved]

180.2020

Non-food determinations.

§ 180.2000

Scope.

This subpart sets forth the pesticide chemicals for use in agricultural or other food-related settings for which neither a tolerance nor an exemption is deemed to be needed by EPA.

§ 180.2003

Definitions.

(a) Food uses are the uses of a pesticide chemical that are likely to yield residues in food or feed crops, meat, milk, poultry or eggs.

(b) Non-food uses are those uses that are not likely to yield residues in food or feed crops, meat, milk, poultry or eggs.

§ 180.2010

Threshold of regulation determinations. [Reserved]

§ 180.2020

Non-food determinations.

The following pesticide chemical uses do not need a tolerance or exemption from the requirement of a tolerance based on EPA's determination that they are not likely to result in residues in or on food.

Pesticide Chemical	CAS Reg. No.	Limits	Uses
Rhodamine B	81-88-9	Not to exceed 2% by weight of the formulated product and 60 ppm on the treated seed	Dye for seed treatment