[Federal Register Volume 64, Number 147 (Monday, August 2, 1999)]
[Rules and Regulations]
[Pages 41815-41818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19783]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300868A; FRL-6097-1]
RIN 2070-AB78
Formaldehyde; Revocation of Exemptions from the Requirement of
Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This final rule announces the revocation of exemptions from
the requirement of tolerances for residues found in 40 CFR 180.1032 for
formaldehyde or a mixture of methylene bispropionate and
oxy(bismethylene) bispropionate in or on the grains of barley, corn,
oats, sorghum, and wheat and the forages of alfalfa, Bermuda grass,
bluegrass, brome grass, clover, cowpea hay, fescue, lespedeza, lupines,
orchard grass, peanut hay, peavine hay, rye grass, soybean hay, sudan
grass, timothy, and vetch from postharvest application use as a
fungicide to treat animal feeds. This action is being taken because
there are no registered uses for formaldehyde on these commodities. The
regulatory actions in this notice are part of the Agency's
reregistration program under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), and the tolerance reassessment requirements of
the Federal Food, Drug, and Cosmetic Act (FFDCA). By law, EPA is
required to reassess 33% of the tolerances and exemptions in existence
on August 2, 1996, by August 1999, or about 3,200 tolerances and
exemptions. This document revokes 22 exemptions, which will be counted
among reassessments made toward the August 1999 review deadline of
FFDCA section 408(q), as amended by the Food Quality Protection Act
(FQPA) of 1996.
DATES: This final rule becomes effective November 1, 1999. Objections
and requests for hearings, identified by docket control number [OPP-
300868A] must be received by EPA on or before October 1, 1999.
ADDRESSES: Objections and hearing requests can be submitted by mail or
in person. Please follow the detailed instructions provided in Unit V
of the SUPPLEMENTARY INFORMATION section of this document. To ensure
proper identification of your objection or hearing request, you must
identify the docket control number [OPP-300868A] in the subject line on
the first page of your request.
FOR FURTHER INFORMATION CONTACT: For technical information, contact
Phil Budig, Special Review Branch, (7508C), Special Review and
Reregistration Division, Office of Pesticide Programs, U.S.
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location: Special Review Branch, CM #2, 6th floor, 1921
Jefferson Davis Hwy., Arlington, VA. Telephone: (703) 308-8029; e-mail:
budig.phil@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected categories and entities may include but are not
limited to:
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Examples of Potentially
Categories NAICS Affected Entities
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Industry............................. 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide manufacturing
------------------------------------------------------------------------
This listing is not exhaustive, but is a guide to entities likely
to be regulated by this action. The North American Industrial
Classification System (NAICS) codes will assist you in determining
whether this action applies to you. If you have questions regarding the
applicability of this action to a particular entity, consult the person
listed in the ``FOR FURTHER INFORMATION CONTACT'' section.
II. How Can I Get Additional Information or Copies of this or other
Support Documents?
A. Electronically
You may obtain electronic copies of this document and various
support documents from the EPA Internet Home Page at www.epa.gov. On
the Home Page, select ``Laws and Regulations,'' and then look up the
entry for this document under ``Federal Register - Environmental
Documents.'' You can also go directly to the ``Federal Register''
listings at www.epa.gov/fedrgstr.
B. In Person or by Phone
If you have any questions or need additional information about this
action, please contact the technical person identified in the ``FOR
FURTHER INFORMATION CONTACT'' section. In addition, the official record
for this notice, including the public version, has been established
under docket control number [OPP-300868A] (including comments and data
submitted electronically as described below). A public version of this
record, including printed, paper versions of any electronic comments,
which does not include any information claimed as Confidential Business
Information (CBI), is available for inspection in Room 119, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington VA, from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Public
Information and Records Integrity Branch telephone number is (703) 305-
5805.
III. What Action is being Taken?
This final rule revokes FFDCA exemptions from the requirement of
tolerances for residues of formaldehyde in or on certain specified
commodities. EPA is revoking these exemptions from the requirement of
tolerances because they are not necessary to cover residues of the
relevant pesticides in or on domestically treated commodities or
commodities treated outside but imported into the United States. This
pesticide is no longer used on these commodities within the United
States and no person has provided comment identifying a need for EPA to
retain the exemptions to cover residues in or on imported foods. EPA
has historically expressed a concern that retention of tolerances or
exemptions that are not necessary to cover residues in or on legally
treated foods has the potential to encourage misuse of pesticides
within the United States. Thus, it is EPA's policy to issue a final
rule revoking those tolerances for residues of pesticide chemicals for
which there are no active
[[Page 41816]]
registrations under FIFRA, unless any person, in comments on the
proposal, demonstrates a need for the tolerance to cover residues in or
on imported commodities or domestic commodities legally treated.
In the Federal Register of May 24, 1999 (64 FR 27943) (FRL-6083-3),
EPA issued a proposed rule announcing the proposed revocation of
exemptions from the requirement of tolerances, in 40 CFR 180.1032, for
residues found for formaldehyde. No comments were received by the
Agency in response to the document published in the Federal Register of
May 24, 1999.
Therefore, EPA is revoking the exemptions from the requirement of
tolerances found in 40 CFR 180.1032 for residues of formaldehyde or a
mixture of methylene bispropionate and oxy(bismethylene) bispropionate
in or on the grains of barley, corn, oats, sorghum, and wheat and the
forages of alfalfa, Bermuda grass, bluegrass, brome grass, clover,
cowpea hay, fescue, lespedeza, lupines, orchard grass, peanut hay,
peavine hay, rye grass, soybean hay, sudan grass, timothy, and vetch
from postharvest application use as a fungicide to treat animal feeds.
IV. When Do these Actions Become Effective?
These actions become effective 90 days following publication of
this final rule in the Federal Register. EPA has delayed the
effectiveness of these revocations for 90 days to ensure that all
affected parties receive notice of EPA's action. Consequently, the
effective date is November 1, 1999. For this particular final rule, the
actions will affect uses which have been canceled for more than a year.
Therefore, commodities should have cleared the channels of trade.
Any commodities listed in the regulatory text of this document that
are treated with the pesticides subject to this notice, and that are in
the channels of trade following the revocation of exemptions from the
requirement of tolerances, shall be subject to FFDCA section 408(1)(5),
as established by the Food Quality Protection Act (FQPA). Under this
section, any residue of these pesticides in or on such food shall not
render the food adulterated, so long as it is shown to the satisfaction
of FDA that, (1) the residue is present as the result of an application
or use of the pesticide at a time and in a manner that was lawful under
FIFRA, and (2) the residue does not exceed the level that was
authorized at the time of the application or use to be present on the
food under a tolerance or exemption from tolerance. Evidence to show
that food was lawfully treated may include records that verify the
dates that the pesticide was applied to such food.
V. Can I Submit Objections or Hearing Requests?
Yes. Any person can file written objections to any aspect of this
regulation and can also request a hearing on those objections.
Objections and hearing requests are currently governed by the
procedures in 40 CFR part 178, modified as needed to reflect the
requirements of FFDCA section 408(g).
A. When and Where to Submit
Objections and hearing requests must be mailed or delivered to the
Hearing Clerk no later than October 1, 1999. The address of the Hearing
Clerk is: Hearing Clerk (1900), Environmental Protection Agency, Rm.
M3708, 401 M St., SW, Washington, DC 20460.
B. Fees for Submission
1. Each objection must be accompanied by a fee of $3,275 or a
request for waiver of fees. Fees accompanying objections and hearing
requests must be labeled ``Tolerance Petition Fees'' and forwarded to
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251.
2. EPA may waive any fee when a waiver or refund is equitable and
not contrary to the purposes of the Act. A request for a waiver of
objection fees should be submitted to James Hollins, Information
Resources and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW, Washington, D.C. 20460.
The request for a waiver must be accompanied by a fee of $1,650, unless
the objector has no financial interest in the matter. The fee, if
required, must be submitted to the address in Unit V.B.1. of this
document. For additional information on tolerance objection fee
waivers, contact James Tompkins, Registration Division (7505C), at the
same mailing address, or by phone at (703) 305-5697 or e-mail at
tompkins.jim@epa.gov.
C. Information to be Submitted
Objections must specify the provisions of the regulation considered
objectionable and the grounds for the objections. If a hearing is
requested, the objections must include a statement of the factual
issue(s) on which a hearing is requested, the requestor's contentions
on such issues, and a summary of any evidence relied upon by the
objector. You may claim information that you submit in response to this
document as confidential by marking any part or all of that information
as CBI. Information so marked will not be disclosed, except in
accordance with procedures set forth in 40 CFR, part 2.
D. Granting a Hearing Request
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following:
1. There is a genuine and substantial issue of fact.
2. 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 requestor, taking into account
uncontested claims or facts to the contrary.
3. Resolution of the factual issue(s) in the manner sought by the
requestor would be adequate to justify the action requested.
VI. How Do the Regulatory Assessment Requirements Apply to this
Final Action?
A. Is this a ``Significant Regulatory Action''?
No. Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), this final action is not a
``significant regulatory action.'' The Office of Management and Budget
(OMB) has determined that tolerance actions, in general, are not
``significant,'' unless the action involves the revocation of a
tolerance that may result in a substantial adverse and material affect
on the economy. In addition, this final action is not subject to
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997), because this final action is not an economically significant
regulatory action, as defined by Executive Order 12866. Nonetheless,
environmental health and safety risks to children are considered by the
Agency when determining appropriate tolerances. Under FQPA, EPA is
required to apply an additional 10-fold safety factor to risk
assessments, in order to ensure the protection of infants and children,
unless reliable data supports a different safety factor.
B. Does this Final Action Contain Any Reporting or Recordkeeping
Requirements?
No. This final action does not impose any information collection
requirements subject to OMB review or approval pursuant to the
Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
[[Page 41817]]
C. Does this Final Action Involve Any ``Unfunded Mandates''?
No. This final action does not impose any enforceable duty, or
contain any ``unfunded mandates,'' as described in Title II of the
Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
D. Do Executive Orders 12875 and 13084 Require EPA to Consult with
States and Indian Tribal Governments Prior to Taking the Final Action
in this Document?
No. 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 the Office of Management and Budget (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 final 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.
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 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 final rule does not significantly or uniquely affect the
communities of Indian tribal governments. This final 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.
E. Does this Final Action Involve Any Environmental Justice Issues?
No. This action does not involve special considerations of
environmental-justice related issues pursuant to Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
F. Does this Final Action Have a Potentially Significant Impact on a
Substantial Number of Small Entities?
No. The Agency has certified that tolerance actions, including the
tolerance final actions in this document, are not likely to result in a
significant adverse economic impact on a substantial number of small
entities. The factual basis for the Agency's determination, along with
its generic certification under section 605(b) of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), appears at 63 FR 55565,
October 16, 1998 (FRL-6035-7). This generic certification has been
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
G. Does this Final Action Involve Technical Standards?
No. This tolerance final action does not involve any technical
standards that would require Agency consideration of voluntary
consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law
104-113, section 12(d) (15 U.S.C. 272 note). Section 12(d) directs EPA
to use voluntary consensus standards in its regulatory activities,
unless to do so would be inconsistent with applicable law or otherwise
impractical. Voluntary consensus standards are technical standards
(e.g., materials specifications, test methods, sampling procedures,
business practices, etc.) that are developed or adopted by voluntary
consensus standards bodies. The NTTAA requires EPA to provide Congress,
through OMB, explanations when the Agency decides not to use available
and applicable voluntary consensus standards.
H. Are There Any International Trade Issues Raised by this Final
Action?
EPA is working to ensure that the U.S. tolerance reassessment
program under FQPA does not disrupt international trade. EPA considers
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in
reassessing them. MRLs are established by the Codex Committee on
Pesticide Residues, a committee within the Codex Alimentarius
Commission, an international organization formed to promote the
coordination of international food standards. When possible, EPA seeks
to harmonize U.S. tolerances with Codex MRLs. EPA may establish a
tolerance that is different from a Codex MRL; however, FFDCA section
408(b)(4) requires that EPA explain in a Federal Register document the
reasons for departing from the Codex level. EPA's effort to harmonize
with Codex MRLs is summarized in the tolerance reassessment section of
individual REDs. The U.S. EPA has developed guidance concerning
submissions for import tolerance support. This guidance will be made
available to interested persons.
I. Is this Final Action Subject to Review under the Congressional
Review Act?
Yes. The Congressional Review Act, 5 U.S.C. Sec. 801 et seq., as
amended 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 to the
Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
U.S. House of Representatives, and Comptroller General of the United
States, prior to publication of the rule in the Federal Register. This
action 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,
[[Page 41818]]
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 28, 1999.
Jack E. Housenger,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
Therefore, 40 CFR, part 180, 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.
Sec. 180.1032 [Removed]
2. By removing Sec. 180.1032.
[FR Doc. 99-19783 Filed 7-30-99; 8:45 am]
BILLING CODE 6560-50-F
