formic acid Tolerance Exemptions 1/99
[Federal Register: February 22, 1999 (Volume 64, Number 34)]
[Rules and Regulations]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Formic Acid; Tolerance Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of the pesticide formic acid in or on honey
and beeswax when used to control tracheal mites and suppress varroa
mites in bee colonies and applied in accordance with label directions.
DATES: This regulation becomes effective February 22, 1999. Objections
and requests for hearings must be received by EPA on April 23, 1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket number [OPP-300451A], may be submitted to Hearing Clerk (1900),
Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington,
DC 20460. A copy of any objections and hearing requests filed with the
Hearing Clerk should be identified by the document control number and
submitted 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, bring copy of objections and hearing
requests to: Rm. 119, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees
accompanying objections and hearing requests shall be labeled
``Tolerance Petition Fees'' and forwarded to: EPA Headquarters
Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M,
Pittsburgh, PA 15251.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail. epa.gov.
Copies of objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption. Copies of objections and hearing requests will also be
accepted on disks in WordPerfect in 5.1 file format or ASCII format.
All copies of objections and hearing requests in electronic form must
be identified by the docket number (OPP-300451A). No Confidential
Business Information (CBI) should be submitted through e-mail.
Electronic copies of objections and hearing requests on this rule may
be filed online at many Federal Depository Libraries. Additional
information on electronic submissions can be found below in this
FOR FURTHER INFORMATION CONTACT: By mail: Diana Horne, c/o Product
Manager (PM) 90, Biopesticides and Pollution Prevention Division
(7511C), Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location, telephone number, and e-mail address: Rm.
902, Crystal Mall 2, 1921 Jefferson Davis Highway, Arlington, VA 22202,
(703) 308-8367; e mail: email@example.com.
SUPPLEMENTARY INFORMATION: In the Federal Register of February 5, 1997
(62 FR 5370) (FRL-5584-6), EPA issued a proposal to amend 40 CFR part
180 by establishing a regulation pursuant to section 408(e) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, to exempt
from the requirement of a tolerance the residues of the pesticide
formic acid in or on honey and beeswax. The proposal came in response
to a petition filed by 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,
I. Response to Comments
There were 12 comments received in response to the notice of filing
of the petition to exempt formic acid from the requirement of a
tolerance. Nine of the commenters urged the Agency to proceed with
registration and to grant the tolerance exemption for formic acid. Most
of the comments which raised questions regarding use of formic acid,
related to the FIFRA registration decision. Although these comments
were not strictly relevant to this tolerance exemption, EPA has
responded to all of the comments below.
One of these nine commenters expressed concern regarding impacts of
formic acid on short and long-term brood survivability, and potential
absorption into brood nest wax, which might later be rendered and
introduced into the market. It should be noted that in the United
States, brood nest honey and wax are generally recycled in the bee
colony, and not harvested for sale as either liquid or comb honey.
However, if brood nest wax were to be marketed for non-food use, it
would likely be heavily processed due to the marked discoloration of
brood nest wax, thereby reducing potential formic acid residues.
Regarding the brood survivability issue, one commenter submitted a
research report entitled Sublethal Effects of Three Acaricide
Treatments on Honey Bee Colony Development and Honey Production. This
study investigated the effects of fluvalinate, menthol and formic acid
(2 application methods) on colony development and honey production.
Worker bee longevity, colony weight gain, adult bee mortality, brood
viability, sealed brood area, returning foragers, pollen load weight,
and emerged bee weight were not statistically different between
fluvalinate- and formic acid-treated colonies, and control colonies.
Brood viability, adult bee population, returning foragers, and honey
production were not statistically different between menthol- and formic
acid-treated colonies, and control colonies. Queen behavior patterns
and the number of workers attending the queen were not statistically
significant before versus after colonies were treated with formic acid.
There were, however, small, but statistically significant decreases in
bee longevity and sealed brood area in formic acid-treated colonies as
compared to fluvalinate-treated colonies and controls. In addition,
formic acid-treated colonies experienced slightly lower honey
production than either menthol-treated or control colonies. The overall
conclusions of the researcher are that formic acid is not detrimental
to colony development or surplus honey production, and that the
benefits gained from using formic acid to control parasitic bee mites
far outweigh the slight decrease in sealed brood. One commenter urged
the use of spearmint oil, which he considers less invasive, and one
commenter expressed concern that beekeepers do not monitor the presence
or numbers of tracheal mites before or after applying miticides. This
same commenter urged the use of menthol as a less invasive alternative.
The Agency supports the use of Integrated Pest Management (IPM) wherein
pest population levels are monitored before application of a pesticide,
and actively promotes the adoption of IPM practices using less
environmentally invasive alternatives.
Based on the information, data, and findings described in the
preamble to the proposed rule, EPA establishes the exemptions from the
requirement of a tolerance as set forth below.
II. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance exemption regulation issued by
EPA under new section 408(e) as was provided in the old section 408.
However, the period for filing objections is 60 days, rather than 30
days. EPA currently has procedural regulations which govern the
submission of objections and hearing requests. These regulations will
require some modification to reflect the new law. However, until those
modifications can be made, EPA will continue to use those procedural
regulations with appropriate adjustments to reflect the new law.
Any person may by April 23, 1999 file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requester's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is 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 requester, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues in the manner sought by
the requestor would be adequate to justify the action requested (40 CFR
178.32). Information submitted in connection with an objection or
hearing request 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 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.
III. Public Docket
A record has been established for this rulemaking under docket
number [OPP-300451A] (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 119 of the Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), 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:
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.
IV. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under section 408 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) (Pub. L. 104-4). Nor does it require any prior consultation as
specficed by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
special considerations as required by 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 in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, since tolerances and exemptions that are established
under section 408(l)(6) of FFDCA, such as the tolerance/exemption in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. Nevertheless, the Agency previously assessed
whether establishing tolerances, exemptions from tolerances, raising
tolerance levels or expanding exemptions might adversely impact small
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
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
IV. 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 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 the rule in the Federal Register. This rule is
not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: January 22, 1999.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as
Authority: 21 U.S.C. 321(q), 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
The pesticide formic acid is exempted from the requirement of a
tolerance in or on honey and beeswax when used to control tracheal
mites and suppress varroa mites in bee colonies, and applied in
accordance with label use directions.
[FR Doc. 99-4295 Filed 2-19-99; 8:45 am]
BILLING CODE 6560-50-F