Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Phosphine,

[Federal Register: December 29, 1999 (Volume 64, Number 249)]

[Rules and Regulations]

[Page 72947-72951]

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

[DOCID:fr29de99-24]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180, 185 and 186

[OPP-300961; FRL-6484-8]

RIN 2070-AB78

Phosphine; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: Tolerances are being revised and consolidated for residues of phosphine in or on certain agricultural commodities and animal feeds. None of these tolerances are new, although the change will facilitate new application methods. The Agency is merely changing the tolerance expression to eliminate references concerning how the phosphine is generated. The Agency published a detailed discussion of the change in the tolerance expression, including a risk assessment, on June 9, 1999, as a proposed rule.

DATES: This regulation is effective December 29, 1999. Objections and requests for hearings, identified by docket control number OPP-300961, must be received by EPA on or before February 28, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit III. of the ``SUPPLEMENTARY INFORMATION'' section. To ensure proper receipt by EPA, your objections and hearing requests must identify docket control number OPP-300961 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Dennis McNeilly, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; telephone number: (703) 308-6742; and e-mail address: McNeilly.Dennis@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   1. Does this Action Apply to Me?

      You may be 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:

      Examples of Categories

      NAICS

      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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been 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 in the ``FOR FURTHER INFORMATION CONTACT'' section.

   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'' 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/.

      2. In person. The Agency has established an official record for this action under docket control number OPP-300961. The official record consists of the documents specifically referenced in this action, 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,

      [[Page 72948]]

      excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

2. Background and Statutory Findings

   In the Federal Register of June 9, 1999 (64 FR 30939) (FRL-6082-4), EPA issued a proposed rule pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the revision of phosphine tolerances to eliminate references as to how the gas is generated and consolidating the tolerances for phosphine in 40 CFR 180.225. The proposed rule included a detailed discussion of the proposed change prepared by the Agency. The Agency completed the Reregistration Eligibility Decision (RED) for Aluminum and Magnesium Phosphide in December 1998 (EPA 738-R-98-017). That risk assessment evaluated the acute and chronic risk from dietary exposure to phosphine residues. For the reasons stated in the proposed rule, EPA concludes that modifying the phosphine tolerance as described above will be safe.

   EPA received several minor comments on the proposed rule and those comments are addressed below. EPA has made minor changes to the language in the tolerance regulation to clarify EPA's intent.

   1. Comment. Several individuals pointed out a typographical error in the listing of the tolerance for phosphine in or on animal feed. The existing aluminum phosphide and magnesium phosphide tolerances for animal feeds was incorrectly listed as 0.01 ppm rather than the actual value of 0.1 ppm.

      Response. The existing tolerances for residues of phosphine in or on animal feeds from fumigation with aluminum phosphide or magnesium phosphide is 0.1 ppm (40 CFR 186.200 and 40 CFR 186.3800). Tolerances will be consolidated into a new 40 CFR 180.225, the tolerance level published in this final rule remains unchanged, i.e., remains at the 0.1 ppm level. The Agency does note that the tolerance is associated with the requirement to aerate fumigated finished feed for 48 hours before use. The Agency is not modifing this restriction and it will remain in effect unless data are provided indicating some other time interval is more appropriate for any new products or new application method. The 48-hour aeration interval is appropriate for all currently registered products; however, in the future other products may apply phosphine gas in a different manner from the existing technology and any limitations or guidance to ensure that tolerances are not exceeded will be provided on the products labels.

   2. Comment. Legume vegetables (succulent or dried - excluding soybeans) are listed in the proposed tolerances under raw agricultural commodities (RACs). The present listing specifies vegetables, seed and pod (except soybeans). Are these listings equivalent?

      Response. The new listing ``Legume vegetables (succulent or dried - excluding soybeans)'' is equivalent to the previous tolerance listing with the exception that it does not include dill and okra. Therefore, tolerances for these two commodities dill and okra are added to 40 CFR 180.225 to make the transition equivalent. The additional tolerances for dill and okra do not change existing cultural practice or the dietary exposure of the U.S. population or any population subgroup to phosphine.

   3. Comment. It has been suggested that residues from zinc phosphide be included in this tolerance expression.

      Response. The Agency considered this but decided that the use patterns of this rodenticide is significantly different from the fumigation uses of phosphine gas and therefore any residues from that type of use are not specifically included in this tolerance document. In addition, separate REDs were prepared for these very different formulations and use patterns. Aluminum and magnesium phosphide were also evaluated together in the same RED, while zinc phosphide was evaluated in a separate RED.

   4. Comment. Under RACs, the tolerance for coffee, bean, green is listed as 0.1 ppm. What is the tolerance for roasted coffee beans? The tolerance as presently written does not distinguish between the green and roasted beans.

      Response. The Agency revised tolerance nomenclature to avoid ambiguity. The previous tolerance was for ``beans, coffee'' while the new definition makes it clear that the tolerance is for ``Coffee, beans, green.'' Unless processed commodities have different tolerances, the established tolerance for the RAC applies, in this case 0.1 ppm. A similar comment/question was also asked concerning cottonseed, i.e. what is the tolerance for delinted cottonseed? The new listing is for ``cotton, seed, undelinted.'' Once again, unless a tolerance is established for a processed commodity the tolerance for the commodity's RAC applies, in this case the tolerance for ``cotton, seed, undelinted'' which is 0.1 ppm. As stated in the summary, this rule eliminates references as to how the phosphine gas is generated, no tolerance levels are changed in this rule.

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 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.

   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 control number OPP-300961 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 28, 2000.

      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, 401 M St., SW., Washington, DC 20460. You may also

         [[Page 72949]]

         deliver your request to the Office of the Hearing Clerk in Room M3708, 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, 401 M St., SW., 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, 401 M St., SW., 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 III.A. of this preamble, 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. of this preamble. Mail your copies, identified by docket number OPP-300961, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. of this preamble. 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 file format 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

   This final rule establishes a new tolerance expression for phosphine under section 408(d) of the FFDCA. 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). 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 prior consultation with State, local, and tribal government officials as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998), or special consideration of environmental justice related issues 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 require 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).

   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 fumigators, 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).

   In addition, under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether establishing tolerances, exemptions from tolerances, raising tolerance levels or expanding exemptions might adversely impact entities and concluded, as a generic matter, that there is no adverse economic impact. The factual basis for the Agency's generic certification for tolerance actions published on May 4, 1981 (46 FR 24950), and was provided to the Chief Counsel for Advocacy of the Small Business Administration.

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 to 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 this rule in the Federal Register. This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

   [[Page 72950]]

   List of Subjects

   40 CFR Part 180

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

   40 CFR Part 185

   Environmental protection, Food additives, Pesticides and pests.

   40 CFR Part 186

   Environmental protection, Animal feeds, Pesticides and pests.

   Dated: December 17, 1999.

   Peter Caulkins,

   Acting Director, Registration Division, Office of Pesticide Programs.

   Therefore, 40 CFR chapter I is amended as follows:

   PART 180--[AMENDED]

   1. In part 180:

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

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

      2. Section 180.225 is revised to read as follows:

         Sec. 180.225 Phosphine; tolerances for residues.

         (

      1. General. (1) Tolerances are established for residues of phosphine in or on the following raw agricultural commodities (RACs) resulting from post-harvest fumigation for the control of insects with phosphine gas or phosphide compounds that produce phosphine gas.

         Commodity

         Parts per million

         Almond...........................................................

         0.1 Avocado..........................................................

         0.01 Banana (includes Plantains)......................................

         0.01 Barley, grain....................................................

         0.1 Brazil nut.......................................................

         0.1 Cabbage, Chinese.................................................

         0.01 Cacao bean, dried bean...........................................

         0.1 Cashew...........................................................

         0.1 Citrus citron....................................................

         0.01 Coffee, bean, green..............................................

         0.1 Corn, field, grain...............................................

         0.1 Corn, pop, grain.................................................

         0.1 Cotton, undelinted seed..........................................

         0.1 Date, dried fruit................................................

         0.1 Dill, seed.......................................................

         0.01 Eggplant.........................................................

         0.01 Endive...........................................................

         0.01 Filbert..........................................................

         0.1 Grapefruit.......................................................

         0.01 Kumquat..........................................................

         0.01 Legume vegetables (succulent or dried group, excluding soybeans).

         0.01 Lemon............................................................

         0.01 Lettuce..........................................................

         0.01 Lime.............................................................

         0.01 Mango............................................................

         0.01 Millet, grain....................................................

         0.1 Mushroom.........................................................

         0.01 Oat, grain.......................................................

         0.1 Okra.............................................................

         0.01 Orange...........................................................

         0.01 Papaya...........................................................

         0.01 Peanut...........................................................

         0.1 Pecan............................................................

         0.1 Pepper...........................................................

         0.01 Persimmon........................................................

         0.01 Pimento..........................................................

         0.01 Pistachio........................................................

         0.1 Rice, grain......................................................

         0.1 Rye, grain.......................................................

         0.1 Safflower, seed..................................................

         0.1 Salsify tops.....................................................

         0.01 Sesame, seed.....................................................

         0.1 Sorghum, grain...................................................

         0.1 Soybean, seed....................................................

         0.1 Sunflower, seed..................................................

         0.1 Sweet potato.....................................................

         0.01 Tangelo..........................................................

         0.01 Tangerine........................................................

         0.01 Tomato...........................................................

         0.01 Walnut...........................................................

         0.1 Wheat, grain.....................................................

         0.1

         [[Page 72951]]

         (2) Tolerances are established for residues of the fumigant in or on all RACs resulting from preharvest treatment of pest burrows in agricultural and non-crop land areas.

         Commodity

         Parts per million

         All RACs resulting from preharvest treatment of pest

         0.01 burrows.............................................

         (3) Residues resulting from fumigation of processed foods:

         Commodity

         Parts per million

         Processed foods......................................

         0.01

         (4) Residues resulting from fumigation of animal feeds:

         Commodity

         Parts per million

         Animal feeds.........................................

         0.1

         (5) To assure safe use of this pesticide, it must be used in compliance with the labeling conforming to that registered by the U.S. Environmental Protection Agency (EPA) under FIFRA. Labeling shall bear a restriction to aerate the finished food/feed for 48 hours before it is offered to the consumer, unless EPA specifically determines that a different time period is appropriate. Where appropriate, a warning shall state that under no condition should any formulation containing aluminum or magnesium phosphide be used so that it will come in contact with any processed food, except processed brewer's rice, malt, and corn grits stored in breweries for use in the manufacture of beer.

         (b) Section 18 emergency exemptions. [Reserved]

         (c) Tolerances with regional registrations. [Reserved]

         (d) Indirect or inadvertant residues. [Reserved]

         Sec. 180.375 [Removed]

      2. Section 180.375 is removed.

         PART 185--[AMENDED]

   2. In part 185:

      1. The authority citation for part 185 continues to read as follows:

         Authority: 21 U.S.C. 346a and 348.

         Sec. 185.200 [Removed]

      2. Section 185.200 is removed.

         Sec. 185.3800 [Removed]

      3. Section 185.3800 is removed.

         PART 186--[AMENDED]

   3. In part 186:

      1. The authority citation for part 186 continues to read as follows:

         Authority: 21 U.S.C. 342, 348, and 371.

         Sec. 186.200 [Removed]

      2. Section 186.200 is removed.

         Sec. 186.3800 Removed

      3. Section 186.3800 is removed.

         [FR Doc. 99-33332Filed12-28-99; 8:45 am]

         BILLING CODE 6560-50-F