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Fluchloralin (BASF). April 7, 1999. Proposed Tolerance Revocations. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/1999/April/Day-07/p8635.htm
[Federal Register: April 7, 1999 (Volume 64, Number 66)]
[Proposed Rules]
[Page 16874-16880]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ap99-18]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185 and 186
[OPP-300841; FRL-6075-1]
RIN 2070-AB78
Tolerance Revocations for Certain Pesticides
AGENCY: Environmental Protection Agency (EPA).
[[Page 16875]]
ACTION: Proposed rule.
SUMMARY: This document announces the proposed revocation of tolerances
listed in the regulatory text for the herbicides dalapon, fluchloralin,
metobromuron, paraquat, and sesone; the fungicides zinc sulfate,
glyodin, and manganous dimethyldithiocarbamate (manam); the
insecticides coumaphos, hydrogen cyanide and 0-Ethyl S-phenyl
ethylphosphonodithioate (fonofos); the plant growth regulator N,N-
dimethylpiperidinium chloride (mepiquat chloride); and the food
additive ethyl formate. Also, this notice proposes to revoke the
tolerance for residues of the nematocide and insecticide ethoprop in or
on mushrooms and soybeans; soybeans, forage; and soybeans, hay; and the
food additive tolerance for residues of the fungicide paraformaldehyde
in maple syrup. EPA expects to determine whether any individuals or
groups want to support these tolerances. 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 that were 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 206 tolerances and/or
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 June 7, 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-300841].
FOR FURTHER INFORMATION CONTACT: Amy Caicedo, 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, telephone number and e-mail
address: Special Review Branch, Crystal Mall 2, 6th floor, 1921
Jefferson Davis Highway, Arlington, Virginia, Telephone: (703) 308-
9399; e-mail: caicedo.amy@epa.gov.
SUPPLEMENTARY INFORMATION:
I. What is the Contribution to Tolerance Reassessment?
By law, EPA is required to reassess 33% of the tolerances that
were 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 206 tolerances and/or 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.
II. Does this Proposed Rule Apply to Me?
You may be affected by this proposed rule 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:
------------------------------------------------------------------------
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.
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/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-300841], 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
Virginia, 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 number
(i.e., [OPP-300841]) in your correspondence.
1. By mail. Submit written comments, identified by the docket
control number [OPP-300841], 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-300841], 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.
[[Page 16876]]
3. Electronically. Submit your comments and/or data electronically
by email to: oppt.ncic@epa.gov. Do not submit any information
electronically that you consider to be 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-300841]. 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 that 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 technical
person identified in the ``FOR FURTHER INFORMATION CONTACT'' section.
V. What Is a ``Tolerance''?
A ``tolerance'' represents the legally allowed 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, Pub. L. 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 can not 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 a number of these tolerance actions to implement
the tolerance recommendations made during the Reregistration
Eligibility Decision (RED) process, and as follow-up on canceled
pesticides and uses of pesticides. As part of the RED process, EPA is
required to determine whether each of the amended tolerances meets the
safety standards under the Food Quality Protection Act (FQPA). The
safety finding determination is found in detail in each RED for the
active ingredient. REDs propose certain tolerance actions to be
implemented to meet safety findings and change commodity names and
groupings in accordance with new EPA policy. Printed copies of the REDs
may be obtained from EPA's National Center for Environmental
Publications and Information (EPA/NCEPI), P.O. Box 42419, Cincinnati,
OH 45242-2419, telephone 1-800-490-9198; fax 513-489-8695 and from the
National Technical Information Service (NTIS), 5285 Port Royal Road,
Springfield, VA 22161, telephone 703-487-4650. Electronic copies of the
RED are available on the internet at http://www.epa.gov/REDs.
Of the chemicals in this Federal Register Notice, REDs have been
issued for Paraquat, Coumaphos, and Mepiquat chloride. The REDs for
Paraquat and Mepiquat chloride were issued after passage of FQPA so
they contain the Agency's evaluation of the database for these
pesticides, including requirements for additional data on the active
ingredients to confirm the potential human health and environmental
risk assessments associated with current product uses as well as the
Agency's decisions and conditions under which these uses and products
will be eligible for registration. A determination of safety by EPA
includes consideration of (a) potential cumulative effects with
pesticides that have a common mode of toxicity, (b) aggregate risks
resulting from exposure to residues in food and drinking water and
exposure occurring due to pesticide application in residential
settings, and (c) special sensitivity to children. FFDCA section
408(b)(2)(C) requires that when determining appropriate tolerances, EPA
apply an additional ten-fold safety factor for infants and children to
take into account potential pre- and post-natal toxicity and the
completeness of data on toxicity and exposure unless a different margin
of safety, on the basis of reliable data, will be safe for infants and
children. Retention, reduction, or removal of the ten-fold safety
factor is based on a weight of evidence evaluation of all applicable
data. This Federal Register proposal for Paraquat and Mepiquat chloride
only includes the tolerances proposed for revocation. At a later date,
EPA will issue a Federal Register proposal for the other tolerance
reassessments in the Paraquat and Mepiquat chloride REDs. An FQPA
assessment still remains to be done for Coumaphos since this RED was
completed before passage of FQPA.
In addition to implementing the tolerance recommendations found in
RED documents, this Federal Register notice proposes revocation for
canceled uses of certain pesticides. Registrations for Dalapon, Ethyl
Formate, Fluchloralin, Fonofos, Glyodin, Hydrogen Cyanide, Manam,
Metobromuron, Sesone, and Basic Zinc Sulfate were voluntarily canceled
by their respective registrants. It is EPA's general practice to
propose revocation of tolerances for residues of pesticide active
ingredients for which FIFRA registrations no longer exist. 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.
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 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.
For tolerances without U.S. registrations, EPA requires the same
[[Page 16877]]
toxicology and residue chemistry data requirements as are needed to
support U.S. food-use registrations. For import tolerances, EPA applies
these data requirements on a case-by-case basis to account for specific
growing conditions in foreign countries. (See 40 CFR part 158 for EPA's
data requirements to support domestic use of a pesticide and the
establishment and maintenance of a tolerance. EPA is developing a
guidance document concerning data requirements for import tolerance
support. This guidance will be made available to interested persons).
In most cases, 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 a pesticide and
any resulting tolerance(s) or exemption(s). Good Laboratory Practice
(GLP) requirements for studies submitted in support of tolerances and
exemptions for import purposes only are the same as for domestic
purposes; i.e., the studies are required to either fully meet GLP
standards, or have sufficient justification presented to show that
deviations from GLP requirements do not significantly affect the
results of the studies.
VII. Which Pesticides Are Covered by this Action?
The following pesticides are covered by this proposed rule:
1. Basic zinc sulfate is a fungicide used to control blight, brown
rot, leaf spot, and scab. It was manufactured by FMC Corp. Agricultural
Products Group, Griffin Corp., Marzone Inc., Puregro Co., Solaris Group
of The Monsanto Co., Sureco Inc., Tifchem Products Inc., and W.R. Grace
and Company.
2. Coumaphos [O,O-Diethyl O-(3-chloro-4-methyl-2-oxo-2H-1-
benzopyran-7-yl) phosphorothioate], trade names CO-Ral, Baymix, Bay 21/
199, Muscatox, Asuntol, Ent-17957, Resitox, is an organophosphate
insecticide used for control of a wide variety of livestock insects,
including cattle grubs, screw worms, lice, scabies, flies, and ticks.
It is used against ectoparasites, which are insects that live on the
outside of host animals such as sheep, goats, horses, pigs, and
poultry. It is added to cattle and poultry feed to control the
development of fly larvae that breed in manure. It is manufactured by
Bayer Corporation.
3. Dalapon (2,2-dichloropropionic acid, trade names Dalapon 85 and
GX Dalapon) is an herbicide used to control Bermuda grass, oxtails,
Johnson grass, quackgrass, and other perennial and annual grasses, as
well as cattails and rushes. It was manufactured by Aceto Agriculture
Chemicals Corp. and by Garden Exchange Ltd.
4. Ethoprop (O-ethyl S,S-dipropyl phosphorodithioate, trade name
Mocap) is a nematocide and insecticide used to control aphids, beetles,
billbugs, grubs, nematodes, rootworms, weevils, and wireworms. It is
manufactured by Rhone-Poulenc AG Company.
5. Ethyl formate is a food additive used to control the flour
beetle, Indian meal moth, and raisin moth. It was manufactured by Coast
Laboratories and by International Minerals and Chemical Corporation.
6. Fluchloralin (N-(2-chloroethyl)-1-a,a,a-trifluoro-2,6-dinitro-N-
propyl-p-toluidine, trade name Basalin) is a selective herbicide used
to control broadleaf weeds, crabgrass, oxtails, goosegrass, Johnson
grass, and pigweed. It was manufactured by BASF Corporation.
7. O-Ethyl S-phenyl ethylphosphonodithioate (Fonofos, trade names
Dyfonate, N-2790, Ent-25,796, Stauffer N-2790) is a soil applied
organophosphate insecticide. It was manufactured by Zeneca Ag Products.
8. Glyodin (2-heptadecyl-2-imidazoline acetate or 2-heptadecyl-2-
imidazoline (base)) is a fungicide used to control black rot, black
spot, brown rot, leaf spot, powdery mildew, scab, and sooty blotch. It
was manufactured by Agway Inc., Grower Service Corp., and Union Carbide
Corporation.
9. Hydrogen cyanide is an insecticide and rodenticide fumigant used
to control beetles, cockroaches, mealworms, mice, moths, rats, and
weevils. It was manufactured by Degesch America, Inc. and by Fumico
Incorporated.
10. Manganous dimethyldithiocarbamate (manam, trade names Fundex,
Tricarbamix, and Niagara niacide) is a fungicide used to control leaf
spot, rust and scab. It was manufactured by Aceto Agriculture Chemicals
Corp., ELF Atochem North America Inc., and FMC Corp. Agricultural
Products Group.
11. Metobromuron (N'-(4-bromophenyl)-N-methoxy-N-methylurea) is a
selective herbicide used to control barnyard grass, carpetweed,
chickweed, crabgrass, goose grass, pigweed, and ragweed. It was
manufactured by Aceto Agriculture Chemicals Corporation.
12. N,N-dimethylpiperidinium chloride (mepiquat chloride, trade
name Pix) is a plant growth regulator. It is manufactured by BASF
Corporation.
13. Paraformaldehyde (trade names Flomor, Ma-pel, Sapflo) is a
fungicide and bacteriocide used to control pathogenic fungi, pathogenic
bacteria, and mold/mildew. It is manufactured by Lamb Natural Flow,
Inc., Sugar Bush Supply Co., and Reynolds Sugar Bush Incorporated.
14. Paraquat (trade names Cyclone, Gramoxone, and Surefire) is a
herbicide used to control a broad spectrum of emerged weeds. It is
manufactured by Zeneca Ag Products.
15. Sesone (sodium 2,4-dichlorophenoxyethyl sulfate) is a herbicide
used to control barnyard grass, carpetweed, chickweed, crabgrass,
foxtail, and pigweed. It was manufactured by Landia Chemical Co. and by
Tifchem Products Incorporated.
VIII. What Action Is Being Taken?
This notice proposes revocation of all FFDCA tolerances for
residues of the herbicides dalapon, 40 CFR 180.150, 185.1500, and
186.1500; fluchloralin, Sec. 180.363; metobromuron Sec. 180.250; and
sesone, Sec. 180.102; the fungicides basic zinc sulfate, Sec. 180.244;
glyodin, Sec. 180.124; and manganous dimethyldithiocarbamate,
Sec. 180.161; the insecticides fonofos, Sec. 180.221; and hydrogen
cyanide, Sec. 180.130; and the food additive ethyl formate,
Sec. 180.520; because no registered uses exist. The registrations for
these pesticide chemicals were canceled because the registrant failed
to pay the required maintenance fee and/or the registrant voluntarily
canceled all registered uses of the pesticide.
For the following pesticides, certain tolerances for specific
commodities are proposed to be removed.
1. Ethoprop. The following tolerances for residues in 40 CFR
180.262(a) on mushrooms; soybeans; soybeans, forage; and soybeans, hay
are being proposed for revocation for Ethoprop because uses no longer
exist for mushrooms, and the registrant voluntarily canceled the
soybean uses.
2. Paraformaldehyde. The paraformaldehyde tolerance in 40 CFR
185.4650 for residues in maple syrup is being proposed for revocation
because the use was voluntarily canceled by the registrant.
3. Coumaphos. The tolerances in 40 CFR 180.189 for residues of
coumaphos for residues on eggs; poultry, fat; poultry, meat
byproducts(mbyp); and poultry, meat are being proposed for revocation
because these uses were voluntarily canceled by the registrant.
4. N,N-dimethylpiperidinium chloride. This notice also proposes
revocation of FFDCA tolerances in 40 CFR 180.384 for residues of the
plant
[[Page 16878]]
growth regulator N,N-dimethylpiperidinium chloride (mepiquat chloride)
in or on cotton, forage because it is no longer considered a
significant livestock feed item. Tolerances on eggs; milk; poultry,
fat; poultry, mbyp; poultry, meat are being proposed for revocation
because there is no reasonable expectation of finite residues and
therefore a tolerance is unnecessary (40 CFR 180.6(b)). The tolerance
for cottonseed meal is being revoked because it will be covered within
the reassessed raw agricultural commodities tolerance.
5. Paraquat. EPA proposes to revoke the tolerances for rye grain
and oat grain in 40 CFR 180.205(a) because no registered uses exist.
The Agency proposes to revoke the tolerances for poultry, fat; meat;
and poultry, mbyp in 40 CFR 180.205(a) because data indicate that no
residues are expected. The statement of policy is given in 40 CFR
180.6(a)(3). In such cases, the Agency proposes to revoke the existing
tolerances because they are unnecessary. Also, the Agency proposes to
revoke the tolerances for bean straw; hops, fresh; hop vines; lentil,
hay; peanut, vines; and sunflower, seed hulls in 40 CFR 180.205(a)
because they are no longer considered raw agricultural commodities.
It is EPA's general practice to propose revocation of those
tolerances for residues of pesticide chemicals for which there are no
active registrations. These revocations will become final unless any
person in commenting on the proposal demonstrates a need for the
tolerance to cover residues in or on imported commodities or domestic
commodities legally treated.
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
this effective date because EPA believes that by this date all existing
stocks of pesticide products labeled for the uses associated with the
tolerances proposed for revocation will have been exhausted for more
than 1 year; giving ample time for any treated fresh produce to clear
trade channels. Therefore, EPA believes revocation after a 90-day
period should be reasonable. However, if EPA is presented with
information that there are existing stocks still available for use and
that information is verified, EPA will consider extending the
expiration date of the tolerance. If you have comments regarding
existing stocks and whether the effective date accounts for these
stocks, please submit comments as described in Unit IV of the
SUPPLEMENTARY INFORMATION section of this notice.
Any commodities listed in the regulatory text of this notice 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 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.
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 proposed
rule, you may also submit an objection. EPA subsequently issues a final
rule after considering the comments that are submitted in response to
this notice. 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, the issues
resolved in the final rule cannot be raised again in any subsequent
proceedings.
This proposal provides 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, the 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''?
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
Notice?
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 Office of Management
[[Page 16879]]
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 proposed 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 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 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 doing 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,
explanation 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 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 that
support the continued tolerance. The U.S. EPA is developing guidance
concerning data requirements for import tolerance support. This
guidance will be made available to interested persons.
I. Is this 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 Pub.
L. 104-121, 110 Stat. 847), only final rules must be submitted to the
U.S. Senate, the U.S. House of Representatives, and the Comptroller
General of the United States prior to publication in the Federal
Register.
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 additives, Pesticide and pest.
40 CFR Part 186
Environmental Protection, Animal feeds, Pesticide and pest.
Dated: March 31, 1999.
Lois Rossi,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
Therefore, it is proposed that 40 CFR parts 180, 185 and 186 be
amended as follows:
PART 180--[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
Secs. 180.102, 180.124, 180.130, 180.150, and 180.161 [Removed]
b. By removing Secs. 180.102, 180.124, 180.130, 180.150 and
180.161.
c. Section 180.189 is revised to read as follows:
Sec. 180.189 Coumaphos; tolerances for residues.
Tolerances for residues of the insecticide coumaphos (O,O-diethyl
0-3-chloro-4-methyl-2-oxo- 2H-1-benzopyran-7-yl phosphorothioate and
its oxygen analog (O,O-diethyl 0-3-chloro-4-methyl-2-oxo- 2H-1-
benzopyran-7-yl phosphate) in or on raw food commodities as follows:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, fat................................................ 1.0
Cattle, meat............................................... 1.0
[[Page 16880]]
Cattle, mbyp............................................... 1.0
Goat, fat.................................................. 1.0
Goat, meat................................................. 1.0
Goat, mbyp................................................. 1.0
Hog, fat................................................... 1.0
Hog, meat.................................................. 1.0
Hog, mbyp.................................................. 1.0
Horse, fat................................................. 1.0
Horse, meat................................................ 1.0
Horse, mbyp................................................ 1.0
Milk, fat (=n in whole milk)............................... 0.5
Sheep, fat................................................. 1.0
Sheep, meat................................................ 1.0
Sheep, mbyp................................................ 1.0
------------------------------------------------------------------------
Sec. 180.205 [Amended]
d. By removing from Sec. 180.205(a), Paraquat, the entries for bean
straw; hops, fresh; hop vines; lentil, hay; oat grain; peanut, vines;
poultry, fat; poultry, meat; poultry, mbyp; rye grain, and sunflower,
seed hulls.
Secs. 180.221, 180.244, and 180.250 [Removed]
e. By removing Secs. 180.221, 180.244, and 180.250.
Sec. 180.262 [Amended]
f. By removing, from Sec. 180.262(a), Ethoprop; tolerances for
residues, the entry for mushrooms.
Sec. 180.363 [Removed]
g. By removing Sec. 180.363.
Sec. 180.384 [Amended]
h. By removing from Sec. 180.384(a), N,N-dimethylpiperidinium
chloride; tolerances for residues, the entries for cotton forage;
cottonseed; cottonseed meal; eggs; milk; poultry, fat; poultry, mbyp;
and poultry, meat.
Sec. 180.520 [Removed]
i. By removing Sec. 180.520.
PART 185--[AMENDED]
1. In part 185:
a. The authority citation for part 185 continues to read as
follows:
Authority: 21 U.S.C. 346a, 348.
Secs. 185.1500 and 185.4650 [Removed]
b. By removing Secs. 185.1500 and 185.4650.
PART 186--[AMENDED]
1. In part 186:
a. The authority citation for part 186 continues to read as
follows:
Authority: 21 U.S.C. 342, 348, and 371.
Secs. 186.1500 [Removed]
b. By removing Sec. 186.1500.
[FR Doc. 99-8635 Filed 4-6-99; 8:45 am]
BILLING CODE 6560-50-F