03-9210. Pesticides; Minimal Risk Tolerance Exemptions

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This final rule reorganizes 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, certain chemical substances are now classified as “minimal risk,” and are therefore being shifted to the section of 40 CFR part 180 that holds minimal risk chemicals. The Agency is merely moving certain tolerance exemptions from one section of the Code of Federal Regulations to another. No existing tolerance exemptions are lost or expanded and no new tolerance exemptions are added as a result of this action.

DATES:

This final rule is effective on April 16, 2003.

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: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

You may be potentially affected by this action if you formulate or market pesticide products. Potentially affected categories and entities may include, but are not limited to:

• Crop production (NAICS 111)
• Animal production (NAICS 112)
• Food manufacturing (NAICS 311)
• Pesticide manufacturing (NAICS 32532)
• Antimicrobial pesticides (NAICS 32561

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 Get Copies Of This Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0126. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 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].

2. Electronic Access. 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 http://www.access.gpo.gov/​nara/​cfr/​cfrhtml_​00/​Title_​40/​40cfr180_​00. html, a beta site currently under development.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/​edocket/​ to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

II. What Action is the Agency Taking?

In a Federal Register Notice published on May 24, 2002, (67 FR 36534) (FRL-6834-8) EPA established a new § 180.950 to list the pesticide chemicals that are exempted from the requirement of a tolerance based on the Agency's determination that these chemicals are of “minimal risk.” As the first step in populating this section, the Agency shifted the existing tolerance exemptions for commonly consumed food commodities, animal feed items, and edible fats and oils to this section.

In a proposed rule published in the Federal Register on November 20, 2002, (67 FR 70036)(FRL-7278-3) the Agency proposed to shift almost 90 tolerance exemptions for certain inert ingredients that have been classified by the Agency as List 4A, “minimal risk” to 40 CFR 180.950. This action merely moves certain tolerance exemptions from one section of the CFR to another section: no existing tolerance exemptions are lost or expanded, and no new tolerance exemptions are added, as a result of this action.

Four comments were received in response to the publication of the proposed rule. All four sets of comments concerned only the group of chemical substances referred to as “weathered materials.” “Weathered materials” can be described as the materials in and of the earth, that is, rocks and minerals. This would include substances such as various clays, limestone, marble, graphite, gypsum, various silicates and various oxides. These “weathered materials” comprise over 40 tolerance exemptions. The Agency will address these comments at a later date through the publication of another proposed rule. No action on the Agency's prior proposal regarding weathered materials is being taken in this final rule.

However, no comments were received on shifting any of the other 44 tolerance exemptions such as the various citrate compounds or the various cellulose compounds. The decision documents supporting the minimal risk, List 4A classification were placed in the e-dockets for the proposed rule. Based on the information contained in those documents and in the proposed rule, and for the reasons explained above, 44 tolerance exemptions are being shifted to 40 CFR 180.950.

As explained in the proposed rule, for some of the chemical substances, EPA is making minor changes to the chemical names that were previously used, i.e., EPA is using different naming conventions for the chemicals to be listed in 40 CFR 180.950. Additionally, the Agency has attempted to identify each of the listed substances using the Chemical Abstracts Service Registry Number (CAS Reg. No.). The CAS Reg. No. provides one of the most distinct and universally accepted means of identifying chemical substances. The lack of a CAS Reg. No. will not preclude the Agency from including substances in 40 CFR 180.950. Generally, there will be only one CAS Reg. No. per listed substance; however, it is possible that more than one CAS Reg. No. may be appropriate for some substances, such as when there is both a hydrated and anhydrous form. EPA has both broadened and consolidated names to account for differing terminologies and current usage status.

The tolerance exemptions shifted from 40 CFR 180.2 to 40 CFR 180.950 are: Citric acid, fumaric acid, and sodium chloride.

The following tolerance exemptions are shifted from 40 CFR 180.1001(c): Animal glue; calcium citrate; α-cellulose; citric acid; coffee grounds; corn dextrin; dextrin; guar gum; hydroxyethyl cellulose; hydroxypropyl methylcellulose; lecithin; licorice root; methylcellulose; potassium chloride; potassium citrate; silica, hydrated; silicon dioxide, fumed, amorphous; sodium acetate; sodium alginate; sodium carboxymethylcellulose; sodium chloride; and xanthan gum.

The following tolerance exemptions are shifted from 40 CFR 180.1001(d): Cellulose acetate; hydroxypropyl cellulose; locust bean gum; paper fiber, deinked or recycled; paper fiber, produced by the kraft (sulfate) or sulfite pulping processes; silicon dioxide, fumed, amorphous; soapbark (quillaja); sodium citrate, and wool fat (anhydrous lanolin).

The following tolerance exemptions are shifted from 40 CFR 180.1001(e): Castor oil, u.s.p.; α-cellulose; citric acid; dextrin; methyl cellulose; potassium citrate; silica, amorphous, fumed (crystalline free)...; sodium carboxymethylcellulose, and xanthan gum.

The tolerance exemptions in § 180.1036 (hydrogenated castor oil) are also being shifted to § 180.950.

Because today's action merely moves certain tolerance exemptions from one section of the CFR to another section, it will have no substantive or procedural effect on the moved tolerance exemptions. No tolerance exemptions are lost as a result of this action.

B. 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. Statutory and Executive Order Reviews

This final rule merely shifts existing exemptions in 40 CFR part 180. This has no substantive effect and hence causes no impact. The Agency is acting on its own initiative under FFDCA section 408(e) in shifting these existing tolerance exemptions to a new section. The Office of Management and Budget (OMB) has exempted these types of actions 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 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). Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et. seq.), the Agency hereby certifies that these proposed actions will not have significant negative economic impact on a substantial number of small entities. As noted above, this action will have no substantive or procedural effect on the tolerance exemptions affected. However, by grouping tolerance exemptions that have qualified as minimal risk inerts in one location in the CFR, this action will make it easier for small entities to efficiently use EPA's tolerance regulations. 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.

IV. 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 practices and procedures, pesticides and pests, reporting and recordkeeping requirements

Dated: April 8, 2003.

Peter Caulkins,

Acting Director, Registration Division.

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.

§ 180.2 

[Amended]

2. In § 180.2, paragraph (a), is amended by removing the terms “citric acid,” “fumaric acid,” and “sodium chloride.”

3. In § 180.950 the table to paragraph (e) is amended by adding alphabetically the following entries.

§ 180.950

Tolerance exemptions for minimal risk active and inert ingredients.

* * * * *

(e) * * *

Chemical	CAS No.
Acetic acid, sodium salt	127-09-3
Animal glue	None
Carob gum (locust bean gum)	9000-40-2
Castor oil	8001-79-4
Castor oil, hydrogenated	8001-78-3
Cellulose	9004-34-6
Cellulose acetate	9004-35-7
Cellulose, carboxy methyl ether, sodium salt	9004-32-4
Cellulose, 2-hydroxyethyl ether	9004-62-0
Cellulose, 2-hydroxypropyl ether	9004-64-2
Cellulose, 2-hydroxypropyl methyl ether	9004-65-3
Cellulose, methyl ether	9004-67-5
Cellulose, mixture with cellulose carboxymethyl ether, sodium salt	51395-75-6
Cellulose, pulp	65996-61-4
Cellulose, regenerated	68442-85-3
Citric acid	77-92-9
Citric acid, calcium salt	7693-13-2
Citric acid, calcium salt (2:3)	813-94-5
Citric acid, dipotassium salt	3609-96-9
Citric acid, disodium salt	144-33-2
Citric acid, monohydrate	5949-29-1
Citric acid, monopotassium salt	866-83-1
Citric acid, monosodium salt	18996-35-5
Citric acid, potassium salt	7778-49-6
Citric acid, tripotassium salt	866-84-2
Citric acid, tripotassium salt, monohydrate	6100-05-6
Citric acid, sodium salt	994-36-5
Citric acid, trisodium salt	68-04-2
Citric acid, trisodium salt, dihydrate	6132-04-3
Citric acid, trisodium salt, pentahydrate	6858-44-2
Coffee grounds	68916-18-7
Dextrins	9004-53-9
Fumaric acid	110-17-8
Guar gum	9000-30-0
Lanolin	8006-54-0
Lecithins	8002-43-5
Lecithins, soya	8030-76-0
Licorice Extract	68916-91-6
Maltodextrin	9050-36-6
Paper	None
Potassium chloride	7447-40-7
Silica, amorphous, fumed (crystalline free)	112945-52-5
Silica, amorphous, precipitated and gel	7699-41-4
Silica gel	63231-67-4
Silica gel, precipitated, crystalline-free	112926-00-8
Silica, hydrate	10279-57-9
Silica, vitreous	60676-86-0
Soapbark (Quillaja saponin)	1393-03-9
Sodium alginate	9005-38-3
Sodium chloride	7647-14-5
Xanthan gum	11138-66-2

§ 180.1001 

[Amended]

Section 180.1001 is amended as follows:

4. The table in paragraph (c) is amended by removing the following entries: Animal glue; Calcium citrate; α-Cellulose; Citric acid; Coffee grounds; Corn dextrin; Dextrin; Guar gum; Hydroxyethyl cellulose; Hydroxypropyl methylcellulose; Lecithin; Licorice root; Methyl cellulose; Potassium chloride; Potassium citrate (CAS Reg. No. 866-84-2); Silica, hydrated; Silicon dioxide, fumed, amorphous; Sodium acetate; Sodium alginate; Sodium carboxymethylcellulose; Sodium chloride; Xanthan Gum.

5. The table in paragraph (d) is amended by removing the following entries: Cellulose acetate (CAS Reg. No. 9004-35-7), minimum number average molecular weight, 28,000; Hydroxypropyl cellulose; Locust bean gum; Paper fiber, deinked or recycled, conforming to 21 CFR 109.30(a)(9) and 21 CFR 176.260; Paper fiber, produced by the kraft (sulfate) or sulfite pulping processes; Silicon dioxide, fumed, amorphous; Soapbark (quillaja); Sodium citrate, Wool fat (anhydrous lanolin).

6. The table in paragraph (e) is amended by removing the following entries: Castor oil, U.S.P.; α-Cellulose; Citric acid; Dextrin (CAS Reg. No. 9004-53-9); Methylcellulose; Potassium citrate (CAS Reg. No. 866-84-2); Silica, amorphous, fumed (crystalline free) (CAS Reg. No. 112945-52-5); Sodium alginate; Sodium carboxymethylcellulose, Xanthan gum.

§ 180.1036 

[Removed]

7. Section 180.1036 is removed in its entirety