[Federal Register Volume 64, Number 99 (Monday, May 24, 1999)]
[Proposed Rules]
[Pages 27943-27947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13056]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300868; FRL-6083-3]
RIN 2070-AC18
Formaldehyde; Proposed Revocation of Exemptions from the
Requirement of Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes to revoke 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. EPA
expects to determine whether any individuals or groups want to support
these exemptions. The regulatory actions in this proposal 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 in existence on
August 2, 1996, by August 1999, or about 3,200 tolerances. The
regulatory actions proposed in this document pertain to the proposed
revocation of 22 exemptions, which would 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: Comments must be received on or before July 23, 1999.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit IV. of this proposal.
FOR FURTHER 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. What Is the Contribution to Tolerance Reassessment?
By law, EPA is required to reassess 33% of the tolerances in
existence on August 2, 1996, by August 1999, or about 3,200 tolerances.
As of March 1999, EPA has reassessed over 2,400 tolerances. The
regulatory actions proposed in this document pertain to the proposed
revocation of 22 exemptions, which count toward the August 1999 review
deadline of FFDCA section 408(q), as amended by the Food Quality
Protection Act (FQPA) of 1996.
II. Does This Proposal Apply To Me?
You may be affected by this proposal if you sell, distribute,
manufacture, or use pesticides for agricultural applications, process
food, distribute or sell food, or implement governmental pesticide
regulations. Pesticide reregistration and other actions (see FIFRA
section 4(g)(2)) include tolerance and exemption reassessment under
FFDCA section 408. Potentially affected categories and entities may
include, but are not limited to:
[[Page 27944]]
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Examples of Potentially
Category Affected Entities
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Agricultural stakeholders Growers/agricultural
workers, contractors
(certified/commercial
applicators, handlers,
advisors, etc.), commercial
processors, pesticide
manufacturers, user groups,
food consumers
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Food distributors Wholesale contractors,
retail vendors, commercial
traders/importers
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Intergovernmental stakeholders State, Local, and/or Tribal
government agencies
------------------------------------------------------------------------
Foreign entities Governments, growers, trade
groups
------------------------------------------------------------------------
This table is not intended to be exhaustive but, rather, provides a
guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this table could also be
affected. If you have any questions regarding the applicability of this
action to a particular entity, you can consult with the person listed
in the ``FOR FURTHER INFORMATION CONTACT'' section.
III. 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 http://
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 http://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 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-300868, (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 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.
IV. How Can I Respond To This Notice?
A. How and To Whom Do I Submit Comments To?
You may submit comments through the mail, in person, or
electronically. Be sure to identify the appropriate docket control
number (i.e., ``OPP-300868'') in your correspondence.
1. By mail. Submit written comments, identified by the docket
control number, OPP-300868, to: Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, U.S. Environmental Protection Agency, 401
M St., SW., Washington, DC 20460.
2. In person or by courier. Deliver written comments, identified by
the docket control number, OPP-300868, to: Public Information and
Records Integrity Branch, Office of Pesticide Programs, U.S.
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA.
3. Electronically. Submit your comments and/or data electronically
by E-mail to: opp-docket@epa.gov. Do not submit any information
electronically that you consider to be Confidential Business
Information (CBI). Submit electronic comments in ASCII file format,
avoiding the use of special characters and any form of encryption.
Comment and data will also be accepted on standard computer disks in
WordPerfect 5.1/6.1 or ASCII file format. All comments and data in
electronic form must be identified by the appropriate docket control
number, OPP-300868. You may also file electronic comments and data
online at many Federal Depository Libraries.
B. How Should I Handle CBI Information In My Comments?
You may claim information you submit in response to this document
as CBI 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. 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
docket by EPA without prior notice. If you have any questions about CBI
or the procedures for claiming CBI, please consult with the person
identified in the ``FOR FURTHER INFORMATION CONTACT'' section.
V. What Is A ``Tolerance''?
A ``tolerance'' represents the maximum level for residues of
pesticide chemicals in or on raw agricultural commodities and processed
foods. Section 408 of FFDCA, 21 U.S.C. 301 et seq., as amended by the
FQPA of 1996, Public Law 104-170, authorizes the establishment of
tolerances (maximum residue levels), exemptions from the requirement of
a tolerance, modifications in tolerances, and revocation of tolerances
for residues of pesticide chemicals in or on raw agricultural
commodities and processed foods (21 U.S.C. 346(a)). Without a tolerance
or exemption, food containing pesticide residues is considered to be
unsafe and therefore ``adulterated'' under section 402(a) of the FFDCA.
If food containing pesticide residues is considered to be
``adulterated,'' you cannot distribute the product in interstate
commerce (21 U.S.C. 331(a) and 342(a)). For a food-use pesticide to be
sold and distributed, the pesticide must not only have appropriate
tolerances under the FFDCA, but also must be registered under section 3
of FIFRA (7 U.S.C. et seq.). To retain these tolerances and exemptions,
EPA must make a finding that the tolerances and exemptions are safe. To
make this safety finding, EPA needs data and information indicating
that there is a reasonable certainty that no harm will result from
aggregate exposure to the pesticide residues covered by the tolerances
and exemptions.
Monitoring and enforcement of pesticide tolerances and exemptions
are carried out by the U.S. Food and Drug Administration (FDA) and the
U.S. Department of Agriculture (USDA). This includes monitoring for
pesticide residues in or on commodities imported into the United
States.
VI. Why Is EPA Proposing the Tolerance Actions Discussed Below?
EPA is proposing to revoke exemptions from the requirement of
tolerances for residues of formaldehyde on commodities listed in 40 CFR
180.1032 because no active registrations exist for these uses. None of
these commodities have been on an active formaldehyde label since 1994.
It is EPA's general practice to propose revocation of tolerances
and tolerance exemptions for residues of pesticide active ingredients
on crop uses for
[[Page 27945]]
which FIFRA registrations no longer exist. EPA has historically
expressed a concern that retention of tolerances and 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. However, in accordance with FFDCA section 408, EPA will not
revoke any tolerance or exemption proposed for revocation if any person
demonstrates a need for the retention of the tolerance, and if
retention of the tolerance will meet the tolerance standard established
under FQPA. Generally, interested parties support the retention of such
tolerances and exemptions in order to permit treated commodities to be
legally imported into the United States, since raw agricultural
commodities or processed food or feed commodities containing pesticide
residues not covered by a tolerance or exemption are considered to be
adulterated.
Tolerances and exemptions established for pesticide chemicals with
FIFRA registrations cover residues in or on both domestic and imported
commodities. To retain these tolerances and exemptions, EPA must make a
finding that the tolerances and exemptions are safe. To make this
safety finding, EPA needs data and information indicating that there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide residues covered by the tolerances and exemptions.
To assure that all food marketed in the U.S. is safe, under FFDCA,
EPA requires the same technical chemistry and toxicology data for such
import tolerances (tolerances without related U.S. registrations) as
are required to support U.S. food use registrations and any resulting
tolerances. In addition, EPA requires residue chemistry data (crop
field trials) that are representative of growing conditions in
exporting countries in the same manner that EPA requires representative
residue chemistry data from different U.S. regions to support domestic
use of the pesticide and tolerance. Interested parties should contact
EPA for written guidance on adapting U.S. residue chemistry data
requirements to non-U.S. growing conditions in order to support an
import tolerance.
VII. Which Pesticides Are Covered By This Action?
Formaldehyde is an antimicrobial fungicide and germicide used as a
non-food disinfect.
VIII. What Action Is Being Taken?
EPA is proposing to revoke exemptions from the requirement of
tolerances established under section 408 of FFDCA for residues of
formaldehyde 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 of formaldehyde or a mixture of
methylene bispropionate and oxy(bismethylene) bispropionate when used
as a fungicide. These exemptions apply only to use of the exempted
tolerances as animal feeds. The Agency is proposing to revoke the
exemptions for formaldehyde by removing 40 CFR 180.1032.
IX. When Do These Actions Become Effective?
EPA proposes that these actions become effective 90 days following
publication of a final rule in the Federal Register. EPA is proposing
the effective date because EPA believes that, by the date, all existing
stocks of pesticide products labeled for uses associated with the
tolerances proposed for revocation will have been exhausted for more
than 1 year, giving ample time for any treated products to clear trade
channels. None of these commodities have been on an active formaldehyde
label since 1994. Therefore, EPA believes the effective date proposed
in this document--90 days following publication of the final rule--
should be reasonable. However, if EPA is presented with information
that there would be existing stocks still available for use after the
expiration date and that the information is verified, EPA will consider
extending the expiration date of the tolerance. If you have comments
regarding existing stocks, please submit comments as described in Unit
IV. of this proposal.
Any commodities listed in this document that are treated with the
pesticide subject to this proposal, and are in the channels of trade
following the tolerance revocations, shall be subject to FFDCA section
408(1)(5), as established by FQPA. Under this section, any residue of
the pesticide 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 a tolerance. Evidence to show that food was lawfully
treated may include records that verify the dates the pesticide was
applied to such food.
X. What Can I Do If I Wish the Agency to Maintain a Tolerance that
the Agency Proposes to Revoke?
In addition to submitting comments in response to this proposal,
you may also submit an objection. EPA subsequently issues a final rule
after considering the comments that are submitted in response to this
proposal. If you fail to file an objection to the final rule within the
time period specified, you will have waived the right to raise any
issues resolved in the final rule. After the specified time, issues
resolved in the final rule cannot be raised again in any subsequent
proceedings.
This proposed rule provides a comment period of 60 days for any
interested person to demonstrate a need for retaining a tolerance, if
retention of the tolerance will meet the tolerance standard established
under FQPA. If EPA receives a comment to that effect, EPA will not
proceed to revoke the tolerance immediately. However, EPA will take
steps to ensure the submission of any needed supporting data and will
issue an order in the Federal Register under FFDCA section 408(f), if
needed. The order would specify the data needed and time frames for its
submission, and would require that within 90 days some person or
persons notify EPA that they will submit the data. If the data are not
submitted as required in the order, EPA will take appropriate action
under FIFRA or FFDCA.
XI. How Do the Regulatory Assessment Requirements Apply to This
Action?
A. Is This a Significant Regulatory Action Involving Health and Safety
Risks To Children?
No. Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), this action is not a
``significant regulatory action.'' The Office of Management and Budget
(OMB) has determined that, in general, tolerance actions 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 proposed 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 action is not an economically significant
regulatory action, as defined by Executive Order 12866. Nonetheless,
environmental health and safety risks to children are
[[Page 27946]]
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 protection of infants and
children, unless reliable data support a different safety factor.
B. Does This Proposed Action Contain Any Reporting or Recordkeeping
Requirements?
No. This proposed 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.).
C. Does This Proposed Action Involve Any ``Unfunded Mandates''?
No. This proposed 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 Action in This
Proposed Document?
No. Under Executive Order 12875, entitled Enhancing
Intergovernmental Partnerships (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 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 proposed rule does not create an unfunded Federal mandate
on State, local, or tribal governments. The proposed 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 proposed 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 proposed 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 proposed rule.
E. Does This Action Involve Any Environmental Justice Issues?
No. This proposed rule does not involve special consideration 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 Proposed Action Have a Potentially Significant Impact on a
Substantial Number of Small Entities?
No. The Agency has certified that tolerance actions, including the
proposed tolerance 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 Proposed Action Involve Technical Standards?
No. This proposed tolerance 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), Pubic 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. EPA invites public
comment on this conclusion.
H. Are There Any International Trade Issues Raised By This Action?
These proposed revocations will not become final if comments are
received which demonstrate the need to maintain the tolerance to cover
residues in or on imported commodities. However, data must be submitted
supporting the continued tolerance. 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. EPA is developing a guidance
concerning submissions for import tolerance support. This guidance will
be made available to interested parties.
[[Page 27947]]
I. Is This Proposed Action Subject to Review Under the Congressional
Review Act?
No. This action is not a final rule. 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
Public Law 104-121, 110 Stat. 847), only final rules must be submitted
to the U.S. Senate, U.S. House of Representatives, and Comptroller
General of the United States prior to publication in the Federal
Register.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 18, 1999.
Lois A. Rossi,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended to read
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. 99-13056 Filed 5-21-99; 8:45 am]
BILLING CODE 6560-50-F
