[Federal Register Volume 62, Number 24 (Wednesday, February 5, 1997)]
[Proposed Rules]
[Pages 5370-5373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2712]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300451; FRL-5584-6]


Formic Acid; Proposed Tolerance Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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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 protected]. 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-

[[Page 5371]]

8367; e-mail: [email protected].
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 
LD50 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 LD50 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 LC50 is 15 gm/m3 in rats and 6,200 mg/
m3 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

[[Page 5372]]

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.

F. Conclusion

    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

[[Page 5373]]

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 protected]

    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