[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