Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Asien, etc.,

[Federal Register: May 24, 2002 (Volume 67, Number 101)]

[Rules and Regulations]

[Page 36534-36539]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr24my02-18]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0030; FRL-6834-8]

RIN 2070-AC18

Pesticides; Tolerance Exemptions for Minimal Risk Active and Inert Ingredients

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is adding a new section which lists 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.'' The pesticide chemicals listed in the new section include both active and inert ingredients. Development of the new section will be accomplished over time in a multi-step process. As the first step, the existing tolerance exemptions for commonly consumed food commodities, animal feed items, and edible fats and oils are recodified in the newly created section, albeit in a different format. This new format provides greater clarification in defining a minimal risk pesticide chemical as well as increasing the number of substances that are currently considered to be minimal risk.

With the creation of the new section, the existing tolerance exemptions (in other sections of the CFR) for these chemical substances are no longer necessary. Therefore, this document revokes the tolerance exemptions for 40 inert ingredients. The Agency is acting on its own initiative.

DATES: This final rule is effective on May 24, 2002. Objections and requests for hearings, identified by docket ID number OPP-2002-0030, must be received on or before July 23, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit III. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket ID number OPP- 2002-0030 in the subject line on the first page of your response.

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: (703) 305-6304; fax number: (703) 305-0599; e-mail address: boyle.kathryn@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   1. Does this Action Apply to Me?

      You may be potentially affected by this action if you formulate or market pesticide products. Potentially affected

      [[Page 36535]]

      categories and entities may include, but are not limited to:

      Examples of Categories

      NAICS codes

      potentially affected entities

      Industry

      111

      Crop production 112............... Animal production 311............... Food manufacturing 32532............. Pesticide manufacturing

      Producers

      32561

      Antimicrobial pesticides

      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.

   2. 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 ID number OPP-2002-0030. 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 (703) 305-5805.

2. Background

   1. What Action is the Agency Taking?

      In the Federal Register of January 15, 2002 (67 FR 1925) (FRL-6807- 8), EPA issued a proposal pursuant to FFDCA section 408, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170) to amend 40 CFR by creating a new paragraph (g) in 40 CFR 180.1001. This new paragraph would contain a listing of pesticide chemicals that are considered to be of minimal risk. No comments were received at the OPP docket in response to this proposed rule. However, the Agency did receive three e-mails requesting additional information on the Agency's proposed action. Discussions with these individuals indicated support for the Agency's proposal but some confusion on language used to describe the excluded substances. The confusion resulted from the placement of the language describing the excluded substances, not the language itself. Based on the need for additional clarification, the Agency moved this language which provided greater clarity.

      However, since publication of the proposed rule the Agency has determined instead to create a new section, 40 CFR 180.950, to hold these tolerance exemptions.

      Based on the reasons set forth in the preamble to the proposed rule, EPA is creating a new section in 40 CFR part 180, subpart D. All commonly consumed food items and all animal feed items with the exception of the exclusions discussed in this document, are exempt from the requirement of a tolerance under the newly established 40 CFR 180.950.

      The following 40 tolerance exemptions are revoked:

      1. In 40 CFR 180.1001 (c): Almond shells; apple pomace; citrus meal; cocoa shells; coconut oil; corn cobs; corn meal; corn oil; cornstarch; corn syrup; cottonseed oil; dextrose; fish oil; grape pomace, dried; lard; lactose; molasses; oatmeal; oats; orange pomace; peanut shells; rice bran; soybean oil; starch (potato, tapioca, and wheat); and sucrose.

      2. In 40 CFR 180.1001 (d): Cinnamon; clove; coffee; corn; corn gluten meal, hydrolyzed; fenugreek; low erucic acid rapeseed oil, conforming to 21 CFR 184.1555(c) (CAS Reg. No. none); oat hulls; wheat; and wheat flour.

      3. In 40 CFR 180.1001 (e): Corn syrup; dextrose, and sucrose.

      4. Also, 40 CFR 180.1164 and 180.1194 are revoked.

      However, only 39 can be counted toward tolerance reassessment.

      The Agency is placing expiration dates on nine existing tolerance exemptions for known allergen-containing food commodities. At this time, the Agency cannot consolidate the overlapping and duplicative tolerance exemptions for allergen-containing commodities that currently exist in 40 CFR part 180.

      These regulatory actions are part of the tolerance reassessment requirements of the FFDCA section 408(q), as amended by FQPA. 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. These regulatory actions, the reassessment of 39 tolerance exemptions, would be counted toward the August 2002 deadline.

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

      This final rule is issued under FFDCA section 408, 21 U.S.C. 346a, as amended by 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.

      [[Page 36536]]

3. 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 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 FFDCA 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 FFDCA 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.

   1. 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-2002-0030 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 July 23, 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 (202) 260-4865.

      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 (703) 305-5697, by e-mail at tompkins.jim@epa.gov, 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 ID number OPP-2002-0030 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: 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.

   2. 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).

4. Regulatory Assessment Requirements

   The Agency is acting on its own initiative under FFDCA section 408(e) in revoking these 40 tolerance exemptions and in establishing a new section in 40 CFR part 180, subpart D. 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 final rule has been exempted from review under Executive Order 12866 due to its lack of significance, this final rule is not subject to Executive Order 13211, entitled 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).

   [[Page 36537]]

   This final rule simply establishes a new section in 40 CFR part 180, subpart D that contains a list of minimal risk pesticide chemicals. Under section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that reorganizing 40 CFR part 180 does not have significant negative economic impact on a substantial number of small entities. Creating a new section does not have a substantive effect and hence causes no impact.

   This final rule places expiration dates on nine existing tolerance exemptions for various known allergen-containing food commodities. Currently, the Agency's regulatory approach as written in various CFR paragraphs and sections is inconsistent. This 3-year transition period will allow sufficient time to examine the uses of these food commodities, and discuss product re-formulation with affected registrants. At the completion of this process there will be a single consistent approach for all food commodities used as pesticide chemicals.

   This final rule also revokes 40 tolerance exemptions, including:

   1. Revoking duplicative and overlapping tolerance exemptions for commonly consumed (non-allergen) food commodities.

   2. Revoking and consolidating the existing tolerance exemptions for animal feed items. Further the final rule allows the use of additional minimal risk animal feed items not previously exempted for use in pesticide products, and establishes a tolerance exemption for the use of edible oils derived from allergens since the available information indicates that the use of these oils is not of concern.

   Pursuant to the RFA, the Agency hereby certifies that establishing new tolerance exemptions for edible oils derived from allergens and animal feed items not previously exempted does not have significant negative economic impact on a substantial number of small entities. By contrast, the amendments and revisions that expand tolerance exemptions are beneficial to the regulated community by increasing the number of minimal risk inert ingredients for use in pesticide formulations.

   Pursuant to the RFA, the Agency previously assessed whether revocations of tolerances or tolerance exemptions for pesticide products no longer in use in the United States 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) (FRL-5753-1), 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 final rule, the transition time for the known allergen containing commodities and considering that all of the revoked tolerance exemptions are covered in the established 40 CFR 180.950, the Agency certifies that this action does not have a significant economic impact on a substantial number of small entities. Furthermore, the Agency knows of no extraordinary circumstances that exist that change EPA's previous analysis.

   In addition, the Agency has determined that this action does 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 final 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 final rule does 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 final rule.

5. 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: May 14, 2002. Marcia E. Mulkey, Director, 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 readas follows:

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

   2. A new [sect] 180.950 is added to read as follows:

      [sect] 180.950 Tolerance exemptions for minimal risk active and inert ingredients.

      Unless specifically excluded, residues resulting from the use of the following substances as either an inert or an active ingredient in a pesticide chemical formulation, including antimicrobial pesticide chemicals, are exempted from the requirement of a tolerance under

      [[Page 36538]]

      FFDCA section 408, if such use is in accordance with good agricultural or manufacturing practices.

      (a) Commonly consumed food commodities. Commonly consumed food commodities means foods that are commonly consumed for their nutrient properties. The term commonly consumed food commodities shall only apply to food commodities (whether a raw agricultural commodity or a processed commodity) in the form the commodity is sold or distributed to the public for consumption.

      (1) Included within the term commonly consumed food commodities are:

      (i) Sugars such as sucrose, lactose, dextrose and fructose, and invert sugar and syrup.

      (ii) Spices such as cinnamon, cloves, and red pepper.

      (iii) Herbs such as basil, anise, or fenugreek.

      (2) Excluded from the term commonly consumed food commodities are:

      (i) Any food commodity that is adulterated under 21 U.S.C. 342.

      (ii) Both the raw and processed forms of peanuts, tree nuts, milk, soybeans, eggs, fish, crustacea, and wheat.

      (iii) Alcoholic beverages.

      (iv) Dietary supplements.

      (b) Animal feed items. Animal feed items means meat meal and all items derived from field crops that are fed to livestock excluding both the raw and processed forms of peanuts, tree nuts, milk, soybeans, eggs, fish, crustacea, and wheat. Meat meal is an animal feed composed of dried animal fat and protein that has been sterilized. Other than meat meal, the term animal feed item does not extend to any item designed to be fed to animals that contains, to any extent, components of animals. Included within the term animal feed items are:

      (1) The hulls and shells of the commodities specified in paragraph (a)(2)(ii) of this section, and cocoa beans.

      (2) Bird feed such as canary seed.

      (3) Any feed component of a medicated feed meeting the definition of an animal feed item.

      (c) Edible fats and oils. Edible fats and oils means all edible (food or feed) fats and oils, derived from either plants or animals, whether or not commonly consumed, including products derived from hydrogenating (food or feed) oils, or liquefying (food or feed) fats.

      (1) Included within the term edible fats and oils are oils (such as soybean oil) that are derived from the commodities specified in paragraph (a)(2)(ii) of this section when such oils are highly refined via a solvent extraction procedure.

      (2) Excluded from the term edible fats and oils are plant oils used in the pesticide chemical formulation specifically to impart their characteristic fragrance and/or flavoring.

   3. Section 180.1001 is amended as follows:

      (a) In the table in paragraph (c) remove the entries for: Almond shells; apple pomace; citrus meal; cocoa shells; coconut oil; corn cobs; corn meal; corn oil; cornstarch; corn syrup; cottonseed oil; dextrose; fish oil; grape pomace, dried; lard; lactose; molasses; oatmeal; oats; orange pomace; peanut shells; rice bran; soybean oil; starch (potato, tapioca, and wheat); and sucrose.

      (b) In the table in paragraph (d) remove the entries for: Cinnamon; clove; coffee; corn; corn gluten meal, hydrolyzed; fenugreek; low erucic acid rapeseed oil, conforming to 21 CFR 184.1555(c) (CAS Reg. No. None); oat hulls; wheat; and wheat flour.

      (c) In the table in paragraph (e) remove the entries for: Corn syrup; dextrose, and sucrose.

   4. Section 180.1001 is further amended by:

      (a) Revising the following entries in the tables to paragraphs (c), (d), and (e) and

      (b) Adding the entry ``wheat, including flour, bran, and starch'' to the table in paragraph (c).

      [sect] 180.1001 Exemptions from the requirement of a tolerance.

      * * * * *

      (c) * * *

      Inert ingredients

      Limits

      Uses

      * * * * * * * Casein........................ Expires May 24, 2005. Surfactant, emulsifier, wetting agent * * * * * * * Fish meal..................... Expires May 24, 2005. Solid diluent, carrier * * * * * * * Soy protein, isolated......... Expires May 24, 2005. Adhesive Soybean flour................. Expires May 24, 2005. Surfactant * * * * * * * Wheat, including flour, bran, Expires May 24, 2005. Solid diluent and starch.

      carrier, attractant * * * * * * *

      (d) * * *

      Inert ingredients

      Limits

      Uses

      * * * * * * * Sodium caseinate.............. Expires May 24, 2005. Suspending agent and binder * * * * * * *

      (e) * * *

      Inert ingredients

      Limits

      Uses

      * * * * * * * Soy protein, isolated......... Expires May 24, 2005. Adhesive * * * * * * * Wheat shorts.................. Expires May 24, 2005. Solid diluent * * * * * * *

      [[Page 36539]]

   5. Section 180.1071 is revised to read as follows:

      [sect] 180.1071 Egg solids (whole); time-limited exemption from the requirement of a tolerance.

      A time-limited tolerance exemption expiring May 24, 2005, is established for residues of whole egg solids (of at least feed grade quality) when used as an animal repellent in or on almonds and applied to the growing crop in accordance with good agricultural practices.

      [sect] 180.1164 [Removed]

   6. Section 180.1164 is removed.

      [sect] 180.1194 [Removed]

   7. Section 180.1194 is removed.

      [FR Doc. 02-12973Filed5-23-02; 8:45 am]

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