01-20391. Revocation of Unlimited Tolerance Exemptions

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Direct final rule.

SUMMARY:

EPA is amending 40 CFR part 180 subpart D to revoke various exemptions from the requirement of a tolerance. These exemptions from the requirement of a tolerance can be revoked because they are duplications. In this direct final rule, the Agency is revoking tolerance exemptions for 10 inert ingredients. The Agency is acting on its own initiative. These regulatory actions are part of the tolerance reassessment requirements of section 408(q) of the Federal Food, Drug, and Cosmetic Act (FFDCA) 21 U.S.C. 346a(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. This regulatory action will count for one reassessment toward the August 2002 deadline.

DATES:

If no relevant adverse comment is submitted on or before September 14, 2001, this action will become effective on November 13, 2001. If adverse comment is received, EPA will publish a timely withdrawal.

ADDRESSES:

Adverse comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-301152 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Treva C. Alston, 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 part 180 is available at http://www.access.gpo.gov/​nara/​cfr/​cfrhtml_​00/​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-301152. 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].

C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-301152 in the subject line on the first page of your response.

1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

3. Electronically. You may submit your comments electronically by e-mail to: [e-mail], or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP-301152. Electronic comments may also be filed online at many Federal Depository Libraries.

II. Issuance of this Action as a Direct Final Rule

EPA is issuing this action as a direct final rule without prior proposal because the Agency believes that this action is not controversial and will not result in any adverse comments. If no relevant adverse comment is submitted within 30 days of publication, this action will become effective 90 days after publication without any further action by the Agency. If, however, a relevant adverse comment is received during the comment period, this direct final rule will be withdrawn and the public comments received will be addressed in a subsequent final rule, or EPA may request additional public comments.

For the reasons set forth above, EPA believes that it is appropriate to issue this rule as a direct final rule. In addition, this rule also conforms with the “good cause” exemption under section 553(b)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(B)), which allows agencies to issue an action without additional notice and comment if further notice and comment would be unnecessary.

III. Background

A. What Action is the Agency Taking?

On its own initiative, the Agency is amending 40 CFR 180.1001 and 180.1026 by its intent to revoke exemptions from the requirement of a tolerance for 10 inert ingredients that are duplicates. No uses of these inert ingredients will be lost as a result of these tolerance exemption revocations.

1. In 40 CFR 180.1026 there is an exemption from the requirement of a tolerance for N,N-diallydichloroacetamide (dichlormid) when used as an inert ingredient in formulations of the herbicides S-ethyl diisobutylthiocarbamate, S-ethyl dipropylthiocarbamate, and S-propyl dipropylthiocarbamete when applied to cornfields before the corn plants emerge from the soil. The Agency's records indicate that dichormid is no longer used with any of these aformentioned active ingredients in pesticide products. This action revokes these exemptions. However, should any uses remain, they would be covered under the existing time-limited tolerances in 40 CFR 180.469 which the Agency established on March 27, 2000 (65 FR 16143) (6498-7). These time-limited tolerances are for residues of dichlormid (N,N-diallyldichloroacetamide (CAS Reg. No. 37764-25-3)) when used as an inert ingredient (safener) in pesticide formulations applied to corn commodities before the corn plants emerge from the soil in or on the following food commodities: corn, field, forage, 0.05 ppm; corn, field, grain, 0.05 ppm; corn, field, stover, 0.05 ppm; corn, pop, grain, 0.05 ppm; corn, pop, stover, 0.05 ppm. These tolerances expire March 27, 2002.

2. In 40 CFR 180.1001(c) there are two entries for poly(vinyl pyrrolidone). One has a molecular weight of 4,000 amu and the other has a molecular weight of 40,000 amu. In the Federal Register of August 31, 1994 (59 FR 44956) (FRL-4906-1), the Agency issued a proposed rule which discussed pesticide petition (PP) 4E4308. This petition requested to amend 40 CFR 180.1001(c) by revising the then currently listed exemption from the requirement of a tolerance for residues of poly(vinylpyrrolidone) to lower the molecular weight from 40,000 amu to 4,000 amu. In the final rule which was published in the Federal Register on November 2, 1994 (59 FR 54825) (FRL-4914-1), the Agency inadvertently established a new tolerance exemption for poly (vinyl pyrrolidone) with a molecular weight of 4,000 amu instead of amending the existing tolerance exemption for poly(vinylpyrrolidone) polymers. The lower molecular weight polymer tolerance exemption would include those with the higher molecular weights. For this reason, this action revokes the exemption for poly(vinyl pyrrlidone) of molecular weights greater than 40,000 since it is duplicative and therefore not necessary.

3. In 40 CFR 180.1001(e) there are two entries for FD&C Blue No. 1. One is specified for use as a dye and the other is specified for use as a dye, coloring agent. Since the listing solely as a dye is covered by the other FD&C Blue No. 1 entry and is therefore a duplication, this action revokes the FD&C Blue No. 1 entry for use as a dye.

4. An exemption from the requirement of a tolerance for calcium hypochlorite for use as a sanitizing and bleaching agent is currently listed in both 40 CFR 180.1001(c) and (d). Residues of the inert ingredients contained in 40 CFR 180.1001(c) are exempted from the requirement of a tolerance when used in pesticide formulations that are applied to growing crops or to raw agricultural commodities after harvest in accordance with good agricultural practices. 40 CFR 180.1001(d) exempts residues of the inert ingredients when used in pesticide formulations that are applied to growing crops only. This action revokes the calcium hypochlorite tolerance exemption in 40 CFR 180.1001(d), since 40 CFR 180.1001(d) is actually a subset of 40 CFR 180.1001(c).

5. There are two entries in 40 CFR 180.1001(d) for diethylene glycol. The first entry is limited to use as a “deactivator for formulations used before the crop emerges from soil” and the second entry is limited to use as a “deactivator, adjuvant for formulations used before crop emerges from the soil.” These entries are duplicative. Therefore, this action revokes the diethylene glycol entry limited to use as a deactivator for formulations used before crop emerges from the soil.

6. There are duplicate exemptions from the requirement of a tolerance for 1,1,1-trichloroethane in 40 CFR 180.1001(e). One is limited to presence in formulations not to exceed 25% of the pesticide formulation while the other one does not have any limits. This action revokes the 1,1,1-trichloroethane exemption limited to exceed 25% of the pesticide formulation, since the unlimited tolerance exemption includes this limitation.

7. Exemptions from the requirement of a tolerance for isopropyl alcohol are in 40 CFR 180.1001(c) and (d). This action revokes the exemption from a requirement of a tolerance in 40 CFR 180.1001(d) for isopropyl alcohol since as previously stated 40 CFR 180.1001(d) is a subset of 40 CFR 180.1001(c).

8. There are duplicate exemptions from the requirement of a tolerance for n-propanol in 40 CFR 180.1001(c) and (d). The exemption from the requirement of a tolerance of n-propanol in 40 CFR 180.1001(c) is for use for a solvent and co-solvent. The exemption from the requirement of a tolerance for n-propanol in 40 CFR 180.1001(d) is for use as a solvent for blended emulsifiers. This action revokes the exemption in 40 CFR 180.1001(d) for n-propanol since this use is included in 40 CFR 180.1001(c).

9. There are duplicate exemptions from the requirement of a tolerance for epoxidized soybean oil in 40 CFR 180.1001(e). One has the use as a stabilizer, while the other has the use as a “stabilizer, plasticizer, component animal tag.” This action revokes the exemption for epoxidized soybean oil with the use as a stabilizer since the use as a stabilizer is included in the epoxidized soybean oil exemption with uses as a “stabilizer, plasticizer, and component of animal tag.”

10. Exemptions from the requirement of a tolerance for sodium mono-di-and tri-isopropyl napthalene sulfonate are in both 40 CFR 180.1001(c) and (d). This action revokes the exemption from a requirement of a tolerance in 40 CFR 180.1001(d) for sodium mono-di-and tri-napthalene sulfonate since as previously stated 40 CFR 180.1001(d) is a subset of 40 CFR 180.1001(c).

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

This direct final rule is issued pursuant to section 408(e) of FFDCA, 21 U.S.C. 346a(e), as amended by the FQPA (Public Law 104-170). 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 the 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)).

C. What is the Contribution to Tolerance Reassessment?

By law, EPA is required to reassess 66% or about 6,400 of the tolerances in existence on August 2, 1996, by August 2002. This direct final rule revokes 10 duplicative tolerance exemptions. Therefore, if there are no adverse comments, 90 days after publication of the direct final rule, one tolerance reassessment (for N,N diallydichloroacetamide) will be counted toward the August 2002 review deadline of FFDCA section 408(q), as amended by FQPA in 1996. The other revoked tolerance exemptions will be counted toward tolerance reassessment when the remaining associated tolerance exemption is reassessed.

III. Regulatory Assessment Requirements

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).

This direct 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 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).

Under section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that these proposed actions to amend/revise § 180.1001(c), (d), and (e) will not have a significant negative economic impact on a substantial number of small entities. This direct final rule will have no negative impact because it merely removes duplicative entries from the EPA regulations listing substances exempted from tolerances.

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 direct final rule does not affect States directly. 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.

IV. 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 Part 180

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

Dated: July 31, 2001.

James Jones,

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), 346(a) and 371.

§ 180.1001 [Amended]

2. Section 180.1001 is amended as follows:

i. The table in paragraph (c) is amended by removing the entire entry for Poly (vinyl pyrrolidone); molecular weight (in amu) 40,000 or over.

ii. The table in paragraph (d) is amended by removing the entire entry for Calcium hypochlorite; the entire second entry for Diethylene glycol; and the entire entries for Isopropyl alcohol; n-Propanol; and Sodium mono-, di-, and triisopropyl.

iii. The table in paragraph (e) is amended by removing the entire first entry for Epoxidized soybean oil; the entire first entry for FD&C Blue No. 1; and the entire second entry for 1,1,1-trichloroethane.

§ 180.1026 [Removed]

3. Section 180.1026 is removed.