formic acid Proposed Tolerance Exemptions 1/97
>ENVIRONMENTAL PROTECTION AGENCY
>40 CFR Part 180
>Formic Acid; Proposed Tolerance Exemptions
>AGENCY: Environmental Protection Agency (EPA).
>ACTION: Proposed rule.
>SUMMARY: EPA proposes to establish exemptions from the requirement of a tolerance for residues of the biochemical pesticide formic acid in or on honey and beeswax when used to control tracheal mites in bee colonies and applied in accordance with accepted apiarian practices. DATES: Comments, identified by the docket control number [OPP-300451], must be received on or before March 7, 1997.
>ADDRESSES: By mail, submit written comments to: Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person, deliver comments to: Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
>Information submitted as a comment concerning this document may be claimed confidential by marking any part or all of that information as ``Confidential Business Information'' (CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the comment that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential will be included in the public record by EPA without prior notice. The public record is available for public inspection in Rm. 1132 at the address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
>Comments and data may also be submitted electronically by sending electronic mail (e-mail) to: email@example.com. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on disks in WordPerfect in 5.1 file format or ASCII file format. All comments and data in electronic form must be identified by the docket control number, [OPP-300451]. No CBI should be submitted through e-mail. Electronic comments on this proposed rule may be filed online at many Federal Depository Libraries. Additional information on electronic submissions can be found in unit IV. of this preamble.
>FOR FURTHER INFORMATION CONTACT: By mail: Diana M. Horne, c/o Product Manager (PM) 90, Biopesticides and Pollution Prevention Division (7501W), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location, telephone number, and e-mail address: Rm. 5- W57, CSI, 2800 Crystal Drive, Arlington, VA, (703) 308-
>8367; e-mail: firstname.lastname@example.org. SUPPLEMENTARY INFORMATION: In the Federal Register of August 6, 1996 (61 FR 40841), EPA issued a notice (FRL-5389-1) that IR-4, Cook College, P.O. Box 231, Rutgers, The State University of New Jersey, New Brunswick, NJ 08903-0231, on behalf of Mann Lake, Ltd., County Road 40 and First St., Hackensack, MN, 56452, had submitted pesticide petition (PP) 6E4700 under section 408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA) 21 U.S.C. 346a, proposing to amend 40 CFR part 180 by exempting tolerances for residues of the biochemical pesticide formic acid in or on honey and beeswax. This document represents an EPA proposal to establish exemptions from the requirement of a tolerance for residues of the biochemical pesticide formic acid in or on honey and beeswax, when applied as a honeybee miticide in accordance with accepted apiarian practices. EPA is proposing this regulation pursuant to section 408(e)(1)(B) of FFDCA.
>I. Background and Statutory Authority
>The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170, 110 Stat. 1489) was signed into law August 3, 1996. FQPA amends both the FFDCA, 21 U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq.. The FQPA amendments went into effect immediately. Among other things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting activities under a new section 408 with a new safety standard and new procedures.
>New section 408(c)(2)(A)(i) allows EPA to establish an exemption from the requirement of a tolerance only if EPA determines that the exemption is ``safe.'' Section 408(c)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water, but does not include occupational exposure. Section 408(c)(2)(B) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue...'' and specifies factors EPA is to consider in establishing an exemption. Section 408(c)(3)(B) provides for circumstances where no need exists for a practical method for detecting and measuring levels of pesticide chemical residue in or on food.
>In light of FQPA, EPA is engaged in an intensive process, including consultation with registrants, States, and other interested stakeholders, to make decisions on the new policies and procedures that will be appropriate as a result of enactment of FQPA. This process will generally delay the review of food use applications, particularly those involving exposure to children. EPA will publish a notice in the Federal Register soon summarizing the requirements of FQPA, indicating how EPA intends to meet those requirements, and describing actions necessary to assure that EPA complies with the law. However, EPA also intends to continue to issue tolerances and exemptions in the interim pending publication of that notice. EPA also intends to issue interim guidance to States and others on how EPA will implement section 408 in the near future.
>In deciding to issue tolerances and exemptions early in the process of FQPA implementation, EPA recognizes that it will be necessary to make decisions about the new FFDCA section 408, including the new safety standard. In establishing tolerances and exemptions during this interim period before EPA makes its broad policy decisions concerning the interpretation and implementation of the new section 408, EPA does not intend to set precedents for the application of section 408 and the new safety standard to other tolerances and exemptions. Rather, these early tolerance and exemption decisions will be made on a case-by-case basis and will not bind EPA as it proceeds with further rulemaking and policy development. EPA intends to act on tolerances and exemptions that clearly qualify under the law.
>II. Risk Assessment and Statutory Findings
>Consistent with section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. Formic acid occurs naturally in honey at levels up to 138 parts per million (ppm), with natural concentrations found most often in the 9 to 100 ppm range, depending upon the source of the nectar. It is also a natural component of cheeses (9 to 28 ppm), peaches (6.5 ppm), and other foods. In addition, the product label requires that formic acid treatment be discontinued at least 4 weeks before the beginning of surplus honey flow. This will effectively discontinue formic acid use 6 weeks before honey harvest. Residue studies suggest that this interval is sufficient to preclude residues of formic acid above background levels naturally found in honey. The U.S. Food and Drug Administration (FDA) permits formic acid to be used as a synthetic flavoring agent in foods (21 CFR 172.515), and has included ethyl formate in its listing of substances (21 CFR 184.1295) added directly to human food, which have been found to be Generally Recognized as Safe (GRAS).
>EPA has reviewed the toxicology data base for formic acid and has sufficient data to assess the hazards and to make a determination on aggregate exposure, consistent with section 408(c)(2), for the exemption from the requirement of a tolerance. EPA's assessment of the exposure, including dietary exposure, and risks associated with establishing this exemption follows.
>A. Toxicological Profile
>The mammalian toxicological data considered in support of the exemption from the requirement of a tolerance for formic acid include the following studies available in the published literature: Acute oral LD<INF>50 studies in rats, mice, and dogs; acute inhalation studies in rats and mice, eye and skin irritation studies in rabbits, subchronic inhalation studies in rats and mice, and an Ames/Salmonella mutagenicity assay with and without rat liver S9 activation.
>The results of these studies indicate that formic acid has very low toxicity by the oral route. Formic acid has an acute oral LD<INF>50 of 1,100 mg/kg in rats; 700 mg/kg in mice; and 4,000 mg/kg in dogs, However, formic acid is a severe eye irritant, and corrosive to the skin. The inhalation LC<INF>50 is 15 gm/m<SUP>3 in rats and 6,200 mg/ m<SUP>3 in mice. At 100 ppm the vapors are ``immediately dangerous to life and health'' for humans, causing respiratory irritation, tearing, coughing and headache followed in 6 to 8 hours by pulmonary edema, dizziness, frothy expectoration, and cyanosis (bluish skin discoloration due to lack of oxygen in the blood). Breathing lower concentrations over time can lead to erosion of the teeth, local tissue death in the jaw, bronchial irritation with chronic cough, frequent attacks of bronchial pneumonia, and gastrointestinal disturbances. The OSHA standard for occupational exposure is 5 ppm. Formic acid was not mutagenic in the Ames/Salmonella assay.
>B. Aggregate Exposure
>The potential dietary exposure of the general public to formic acid residues
>resulting from its use in bee hives for the control of tracheal mites is not expected to raise background levels naturally found in honey and beeswax. In general, other potential sources of exposure to pesticide residues are those found in drinking water and exposure from residential uses of pesticides. Since this use of formic acid is not expected to result in environmental residues of any kind, and since there are no other registered pesticidal uses of formic acid, either residential or otherwise, exposure from these additional sources is not expected. The public is exposed to formic acid through its use as a direct food additive and because, as mentioned, it is a naturally occurring substance in honey (and other foods).
>Because of the very low oral toxicity of formic acid and because of the fact that its presence in the diet is, for the most part, as a naturally-occurring food ingredient, EPA does not believe that there is any reason to be concerned about the potential for cumulative effects of formic acid and other substances that have a common mechanism of toxicity.
>C. Safety Determinations
>1. U.S. population in general. Formic acid occurs naturally in honey at varying levels depending upon the nectar source available to the bees. Data from oral studies shows formic acid to be of very low toxicity. The FDA allows the use of formic acid as a synthetic flavoring agent in foods, and has listed ethyl formate as GRAS. This use of formic acid is permitted only if the level in food of the added formic acid is far below the natural background levels of formic acid in honey. Use of formic acid against bee mites according to label directions is not expected to raise residues above background levels naturally occurring in honey and beeswax, or result in environmental residues of any kind. In addition, there currently exist no other registered pesticidal uses of formic acid.
>Because there are essentially no residues resulting from the proposed pesticidal use, EPA believes there are no dietary risk concerns with such use. Further, even taking into account natural sources of formic acid in the diet and formic acid's use as a food additive, EPA has concluded that aggregate exposure to residues of formic acid in food over a lifetime will not pose appreciable risks to human health. Thus, EPA finds that there is a reasonable certainty that no harm will result from aggregate exposure to formic acid residues. Accordingly, EPA determines that exempting formic acid from the requirement for a tolerance is safe. However, given the corrosive nature of formic acid, as it is applied in the beehive, potential acute effects resulting from occupational exposure are of concern to the Agency and will be addressed by precautionary labeling required for registration.
>2. Infants and children. EPA has determined that the toxicity and exposure data are sufficiently complete to adequately address the potential for additional sensitivity of infants and children to residues of formic acid. For the reasons given above, EPA concludes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to formic acid residues.
>D. Other Considerations
>The Agency proposes to establish exemptions from the requirement of a tolerance without any numerical limitation; therefore, the Agency has concluded that analytical methods are not required for enforcement purposes for formic acid.
>E. Response to Comments
>Four comments were received in response to the notice of the petition. Three of the commenters urged the Agency to proceed with registration and to grant the tolerance exemption for formic acid. The emergency situation which exists among apiarists nation-wide due to the impacts of tracheal mites on bee survival and honey production was cited in support of the registration and tolerance exemption. In addition, it was noted that formic acid is currently used in parts of Europe and in Canada, and that tons of European honey are imported into the United States annually. Finally, it was noted that formic acid is naturally occurring in honey to a variable degree, depending upon the source of the nectar. One commenter expressed concern regarding impacts of formic acid on bee egg hatchability, larval survivability, and bee behavior, noting a lack of studies designed to assess these potential impacts. Although these last comments relate primarily to whether the pesticide should be registered under FIFRA, EPA will explain here its response. The Agency is aware of formic acid use experience in Canada, where dehydrated eggs, dead young larvae, and dead queens were observed, when 85 percent formic acid was applied, or when application occurred at extremely high temperatures. However, minimal negative impact was noted when 65 percent formic acid was applied. Proposed label statements warn of potential queen rejection and a possible slight increase in bee mortality if formic acid is applied at temperatures above 90 deg. F. Finally, section 6(a)(2) of FIFRA requires the registrant to submit to the Agency any factual information regarding unreasonable adverse effects on the environment that might be caused by a registered pesticide.
>Based on the information and data considered, EPA proposes that the exemptions from the requirement of a tolerance be established as set forth below.
>III. Public Comments
>Under FFDCA, section 408(e)(2), EPA must provide for a public comment period before issuing a final tolerance or tolerance exemption under 408(e)(1). The public comment period is to be for 60 days unless the Administrator for good cause finds that it is in the public interest to reduce that comment period. Based on several factors, EPA believes there is good cause for reducing the comment period on these exemptions. First, notice was already provided, in accordance with the FFDCA prior to its recent amendment, for the exemption for formic acid. The Agency believes that the comments received in response to that notice have been adequately addressed. In addition, residues resulting from this use of formic acid are not expected to exceed background levels naturally found in honey and beeswax. Given the emergency situation that currently exists among beekeepers regarding bee mortality resulting from tracheal mite infestations, the Agency is allowing a 30-day instead of a 60-day public comment period for these proposed tolerance exemptions.
>Interested persons are invited to submit written comments on the proposed regulation. Comments must bear a notation indicating the docket control number, [OPP-300451]. All written comments filed in response to this petition will be available in the Public Response and Program Resources Branch at the address given above from 8:30 a.m. to 4 p.m., Monday through Friday, except legal holidays.
>IV. Public Docket
>A record has been established for this rulemaking under docket control number [OPP-300451] (including comments and data submitted electronically as described below). A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
>holidays. The public record is located in Room 1132 of the Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202.
>Electronic comments can be sent directly to EPA at: email@example.com
>Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption.
>The official record for this rulemaking, as well as the public version, as described above will be kept in paper form. Accordingly, EPA will transfer all comments received electronically into printed, paper form as they are received and will place the paper copies in the official rulemaking record which will also include all comments submitted directly in writing. The official rulemaking record is the paper record maintained at the address in ``ADDRESSES'' at the beginning of this document.
>V. Regulatory Assessment Requirements
>Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a ``significant regulatory action'' and, since this action does not impose any information collection requirements as defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is not subject to review by the Office of Management and Budget. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior consultation with State officials as specified by Executive Order 12875 (58 FR 58093, October 28, 1993), or special considerations as required by Executive Order 12898 (59 FR 7629, February 16, 1994).
>Pursuant to the requirements of the Regulatory Flexibility Act (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator has determined that regulations establishing new tolerances or raising tolerance levels or establishing exemptions from tolerance requirements do not have a significant economic impact on a substantial number of small entities. A certification statement explaining the factual basis for this determination was published in the Federal Register of May 4, 1981 (46 FR 24950).
>Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act (APA) as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted 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 General Accounting Office prior to publication in today's Federal Register. This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2) of the APA as amended.
>List of Subjects in 40 CFR Part 180
>Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
>Dated: January 28, 1997.
>Janet L. Anderson,
>Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.
>Therefore, it is proposed that 40 CFR Chapter I be amended as follows:
>PART 180-- [AMENDED]
>1. The authority citation for part 180 is revised to read as follows:
>Authority: 21 U.S.C. 346a and 371.
>2. By adding new Sec. 180.1178 to read as follows:
>Sec. 180.1178 Formic acid; exemption from the requirement of a tolerance.
>The biochemical pesticide formic acid is exempted from the requirement of a tolerance in or on honey and beeswax when used to control tracheal mites in bee colonies, and applied in accordance with accepted apiarian practices.
>[FR Doc. 97-2712 Filed 2-4-97; 8:45 am] BILLING CODE 6560-50-F