[Federal Register Volume 64, Number 76 (Wednesday, April 21, 1999)]
[Rules and Regulations]
[Pages 19489-19493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10006]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 185
[OPP-300836; FRL-6074-4]
RIN 2070-AB78
Dimethyl phosphate of 3-hydroxy-N-methyl-cis-crotonamide
(monocrotophos) Final rule; Tolerance Revocations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This final rule announces the revocation of tolerances for
Dimethyl phosphate of 3-hydroxy-N-methyl-cis-crotonamide
(monocrotophos) for residues of sugarcane, potatoes, cotton seed,
peanuts, peanut hulls, and tomatoes. The regulatory actions in this
document 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 indicated in this document pertain to the final
revocation of tolerances and/or 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.
DATES: This regulation becomes effective April 21, 1999. Objections and
requests for hearings must be received on or before July 20, 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 the SUPPLEMENTARY INFORMATION section of this
notice. Be sure to identify the appropriate docket number [OPP-300836],
which is an addendum to a previous docket.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Jamil Mixon, Reregistration Branch I, mail code (7508C), Special Review
and Reregistration Division, Office of Pesticide Programs, U.S.
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location: Reregistration Branch I, CM #2, 6th floor, 1921
Jefferson Davis Hwy., Arlington, VA. Telephone: (703) 308-8032; e-mail:
mixon.jamil @epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this Notice Apply to Me?
You may be affected by this notice 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. In this notice, the tolerance actions are proposed
in coordination with the cancellation of associated registrations.
Potentially affected categories and entities may include, but are not
limited to:
------------------------------------------------------------------------
Examples of Potentially
Category Affected Entities
------------------------------------------------------------------------
Agricultural Stakeholders................ Growers/Agricultural Workers
Contractors [Certified/
Commercial Applicators,
Handlers, Advisors, etc.]
Commercial Processors
Pesticide Manufacturers
User Groups
Food Consumers
Food Distributors......................... Wholesale Contractors
Retail Vendors
Commercial Traders/
Importers
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 technical
person listed in the ``FOR FURTHER INFORMATION CONTACT'' section.
[[Page 19490]]
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 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/homepage/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-300836], (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. Can I Challenge the Agency's Final Decision Presented in this
Document?
Yes. You can file a written objection or request a hearing by June
21, 1999 in the following manner:
A. By Paper
Written objections and hearing requests, identified by the document
control number [OPP-300836], may be submitted to: Hearing Clerk (1900),
Environmental Protection Agency, room M3708, 401 M St., SW.,
Washington, DC 20460. 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 any objections and hearing
requests filed with the Hearing Clerk should be identified by the
document control number and submitted to the Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, 401 M St., SW., Washington, DC
20460. In person, bring a copy of objections and hearing requests to
room 119, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
B. Electronically
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending e-mail to docket@epamail.epa.gov, per the instructions given in ``By Paper''
above. Electronic 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 5.1 or 6.1 file format or
ASCII file format. All copies of objections and hearing requests in
electronic form must be identified by the docket number [OPP-300836].
Do not submit CBI through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository libraries.
IV. Why Is EPA Revoking the Tolerances Discussed below?
On June 13, 1988, the producer of monocrotophos requested voluntary
cancellation of all registrations with a recall of all products in the
channels of trade that would not be used by September 30, 1989. The
last registered uses for monocrotophos were cancelled on January 22,
1991, for nonpayment of the March 1, 1990, maintenance fees. On June 9,
1993, the Agency's proposed revocation of tolerances for monocrotophos
was published in the Federal Register (FRL-4183-6). Comments were
received from Ciba-Geigy Corporation, now Novartis Crop Protection,
Inc. and Biologic Research & Development Inc., a U.S. regulatory
consultant for the Shell International Chemical Company, expressing
strong interest in maintaining tolerance on commodities imported into
the United States. As a result, the Agency allowed tolerances to remain
on peanut hulls, cottonseed, potatoes, sugarcane, and tomatoes.
On January 22, 1999, Novartis Crop Protection Inc. the sole
producer of monocrotophos, informed EPA that it no longer intended to
support monocrotophos tolerances for import purposes. Novartis
indicates that sale of monocrotophos will end in 1999, and has
requested that tolerances for import purposes be retained until
December 31, 2000, in order to fully utilize their existing stock. As
Novartis is the sole producer of monocrotophos, EPA believes that there
is no one else who will support tolerances for monocrotophos for import
commodities. Therefore, EPA is revoking these tolerances for
monocrotophos in or on peanuts, peanut hulls, tomatoes, cottonseed,
potatoes and sugarcane (Sec. 180.296) and in concentrated tomato
products (Sec. 185.2250).
V. What Action Is Being Taken?
This final rule revokes the FFDCA tolerances for residues of
certain specified pesticides in or on certain specified commodities.
EPA is revoking these 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. These pesticides are no longer used on commodities within the
United States and no person has provided comment identifying a need for
EPA to retain the tolerances to cover residues in or on imported foods.
EPA has historically expressed a concern that retention of tolerances
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 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.
EPA is not issuing today a final rule to revoke those tolerances
for which EPA received comments demonstrating a need for the tolerance
to be retained. Generally, EPA will proceed with the revocation of
these tolerances on the grounds discussed above only if, prior to EPA's
issuance of a section 408(f) order requesting additional data or
issuance of a section 408(d) or (e) order revoking the tolerances on
other grounds, commenters retract the comment identifying a need for
the tolerance to be retained or EPA independently verifies that the
tolerance is no longer needed.
In the Federal Register of June 9, 1993, (OPP-300836) (FRL 4183-6),
EPA issued a proposed rule for specific pesticides announcing the
proposed revocation of tolerances for canceled food uses and inviting
public comment for consideration and for support of tolerance retention
under FFDCA standards. The following comments were received by the
agency in response
[[Page 19491]]
to the document published in the Federal Register:
1. Comments from a letter received from Ciba-Geigy Corporation
July 27, 1993, stated that, `` Monocrotophos is used extensively in
many countries around the world. The major uses in these countries are
on crops such as sugarcane, potatoes and cottonseed.'' In addition
Ciba-Geigy requested that, ``the Agency withhold preceding to revoke
residue tolerances for monocrotophos on cottonseed, potatoes and
sugarcane at this time. Revoking these tolerances could create a non
tariff trade barrier and should therefore be avoided to the extent
possible. Ciba's proposal is to convert these domestic tolerances `` to
import tolerances which will help facilitate free trade.''
Agency Response. The Agency allowed tolerances to remain on peanut
hulls, tomatoes, cottonseed, potatoes and sugarcane (Sec. 180.296) and
in concentrated tomato products (Sec. 185.2250).
2. Comments from correspondence received August 4, 1993, from
Biologic Research & Development Inc., than a U.S. regulatory consultant
for the Shell International Chemical Company, requested that EPA
reconsider its proposal to revoke the existing U.S. tolerances for
monocrotophos, but rather allow for a review of those tolerances in
recognition of on going international uses of this compound and those
residues likely to occur in commodities imported into the U.S.
Agency Response. The Agency allowed tolerances to remain on
peanuts, peanut hulls, tomatoes, cottonseed, potatoes and sugarcane
(Sec. 180.296) and in concentrated tomato products (Sec. 185.2250).
VI. When do These Actions become Effective?
Tolerance revocation for monocrotophos becomes effective December
31, 2000, per the manufacturer's request to fully utilize its remaining
existing stock. If you have comments regarding existing stocks, please
submit comments as described in Unit IV of the SUPPLEMENTARY
INFORMATION section of this notice.
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Parts per Expiration/
Section Commodity million Revocation Date
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180.296....................................... Peanuts hulls 0.5 12/31/2000
............................................ Tomatoes 0.5 12/31/2000
............................................ Cottonseed 0.1 12/31/2000
............................................ Potatoes 0.1 12/31/2000
............................................ Sugarcane 0.1 12/31/2000
............................................ Peanuts 0.05 12/31/2000
185.2250...................................... Tomato concentrated products 2.0 12/31/2000
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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 tolerance revocations, 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.
VII. How do the regulatory assessment requirements apply to this
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 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 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 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 Action Contain Any Reporting or Recordkeeping
Requirements?
No. This 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 Action Involve Any ``Unfunded Mandates''?
No. This 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 (Pub. L. 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
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
[[Page 19492]]
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.
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 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.
E. Does Executive Order 12898 Apply to this Action?
No. This final rule 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 Action Have a Potentially Significant Impact on a
Substantial Number of Small Entities?
No. The Agency has certified that tolerance actions, including the
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 Action Involve Technical Standards?
No. This 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), Pub. L. 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 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 is developing a guidance concerning
submissions for import tolerance support. This guidance will be made
available to interested stakeholders.
I. Is this 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, 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 action
is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
40 CFR Part 185
Environmental protection, Food additive, Pesticides and pest.
Dated: April 12, 1999.
Lois Rossi,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
Therefore, 40 CFR parts 180 and 185 are amended as follows:
PART 180--[AMENDED]
1. In part 180:
a. The authority citation for part 180 is amended to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 374.
b. By revising Sec. 180.296 to read as follows:
Sec. 180.296 Dimethyl phosphate of 3-hydroxy-N-methyl-cis-crotonamide;
tolerance for residues.
(a) General. Tolerances are established for residues of the
insecticide Dimethyl phosphate of 3-hydroxy-N-methyl-cis-crotonamide in
or on the following raw agricultural commodities:
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Expiration/
Commodity Parts per Revocation
million date
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Cottonseed...................................... 0.1 12/31/00
Peanuts......................................... 0.05 12/31/00
[[Page 19493]]
Potatoes........................................ 0.1 12/31/00
Sugarcane....................................... 0.1 12/31/00
Tomato.......................................... 0.5 12/31/00
Tomato, concentrated products................... 2.0 12/31/00
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(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
2. In part 185:
PART 185-- [AMENDED]
a. The authority citation for part 185 is revised to read as
follows:
Authority: 21 U.S.C. 346(a) and 348.
Sec. 185.2250 [Removed]
b. By removing Sec. 185.2250 Dimethyl phosphate of 3-hydroxy-N-
methyl-cis-crotonamide; tolerance for residues.
[FR Doc. 99-10006 Filed 4-20-99; 8:45 am]
BILLING CODE 6560-50-F
