Blane White, Minnesota State Apiarist, distributed the following notice about formic acid from the February 5, 1997 Federal Register. The notice requests comments regarding the EPA's proposal to establish exemptions from the requirement of a tolerance for formic acid in honey and beeswax.
Bart Smith
State Apiary Inspector
Maryland Department of Agriculture
50 Harry S. Truman Parkway
Annapolis, MD 21401
(410) 841-5920
e-mail: smithib@mda.state.md.us
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Forwarded Message Follows -------Date: Wed, 5
Feb 1997 10:56:12 -0500 Reply-to: epa-
pest@unixmail.rtpnc.epa.gov From: everybody
[Federal Register:
February 5, 1997 (Volume 62, Number 24)] [Proposed
Rules]
[Page 5370-5373]
>From the Federal Register Online via GPO Access
[wais.access.gpo.gov] 40 CFR Part
180 [OPP-300451; FRL-5584-6]
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:
opp-docket@epamail.epa.gov. 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. 5W57, CSI, 2800 Crystal
Drive, Arlington, VA, (703) 308-8367; e-mail:
horne.diana@epamail.epa.gov.
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.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
The results of these studies indicate that formic
acid has very low toxicity by the oral route. Formic
acid has an acute oral LD-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-50 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 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
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: opp-docket@epamail.epa.gov
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