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formic acid Tolerance Exemptions 1/99


[Federal Register: February 22, 1999 (Volume 64, Number 34)]
[Rules and Regulations]               
[Page 8526-8529]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22fe99-15]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300451A; FRL-5600-4]

 
Formic Acid; Tolerance Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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

[[Page 8527]]

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 
document.

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: horne.diana@epamail.epa.gov.

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, 
56452.

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

[[Page 8528]]

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:

    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.

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 
Business Administration.

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 
their communities.''
    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 
this rule.

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

[[Page 8529]]

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 
recordkeeping requirements.

    Dated: January 22, 1999.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    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 
tolerance.

    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