[Federal Register Volume 60, Number 220 (Wednesday, November 15, 1995)]
[Proposed Rules]
[Pages 57379-57382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28070]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300402; FRL-4985-6]
RIN 2070-AC18
3,5-Dichloro-N-(1,1-Dimethyl-2- Propynyl)Benzamide; Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA has completed the reregistration process and issued a
Reregistration Eligibility Decision (RED) document for the pesticide
3,5-dichloro-N- (1,1-dimethyl-2-propynyl)benzamide, also known as
pronamide. In the reregistration process, all information to support a
pesticide's continued registration is reviewed for adequacy and, when
needed, supplemented with new scientific studies. Based on the RED
tolerance assessments for the pesticide chemical subject to this
proposed rule, EPA is proposing the following tolerance actions: to
delete individual tolerances and establish crop-grouping tolerances,
raise some tolerances and lower others, amend an incorrectly listed
tolerance, and modify the statement under 40 CFR 180.317 for the
pesticide pronamide.
DATES: Written comments, identified by the OPP document control number
[OPP-300402], must be received on or before January 16, 1996.
ADDRESSES: By mail, submit comments to Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, 401 M St., SW., Washington, DC 20460. In person,
deliver comments to Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis
Hwy., Arlington, VA.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number [OPP-300402]. No Confidential Business Information
(CBI) should be submitted through e-mail. Electronic comments on this
proposed rule may be filed online at many Federal Depository Libraries.
Additional information on electronic submissions can be found below in
this document.
FOR FURTHER INFORMATION CONTACT: The contact for the chemical listed
above is: Philip Poli, (703)-308-8038; e-mail:
poli.philip@epamail.epa.gov. By mail: Special Review and Reregistration
Division (7508W), Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location: Special Review Branch, Crystal
Station #1, 3rd Floor, 2800 Crystal Drive, Arlington, VA 22202.
SUPPLEMENTARY INFORMATION:
I. Legal Authorization
The Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 301 et
seq.)
[[Page 57380]]
authorizes the establishment of tolerances (maximum legal residue
levels) and exemptions from the requirement of a tolerance for residues
of pesticide chemicals in or on raw agricultural commodities pursuant
to section 408 (21 U.S.C. 346(a)). Without such tolerances or
exemptions, a food containing pesticide residues is considered to be
``adulterated'' under section 402 of the FFDCA, and hence may not
legally be moved in interstate commerce (21 U.S.C. 342). To establish a
tolerance or an exemption under section 408 of the FFDCA, EPA must make
a finding that the promulgation of the rule would ``protect the public
health'' (21 U.S.C. 346a(b)). For a pesticide to be sold and
distributed the pesticide must not only have appropriate tolerances
under the FFDCA, but also must be registered under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C. 136 et
seq.).
In 1988, Congress amended FIFRA and required EPA to review and
reassess the potential hazards arising from currently registered uses
of pesticides registered prior to November 1, 1984. As part of this
process, the Agency must determine whether a pesticide is eligible for
reregistration and if any subsequent actions are required to fully
attain reregistration status. EPA has chosen to include in the
reregistration process a reassessment of existing tolerances or
exemptions from the need for a tolerance. Through this reassessment
process, EPA can determine whether a tolerance must be amended,
revoked, or established, or whether an exemption from the requirement
of one or more tolerances must be amended or is necessary.
The procedure for establishing, amending, or repealing tolerances
or exemptions from the requirement of tolerances is set forth in the
Code of Federal Regulations, 40 CFR parts 177 through 180. The
Administrator of EPA or any person may initiate an action proposing to
establish, amend, revoke, or exempt a tolerance for a pesticide
registered for food uses. The proposal must explain the grounds for
such a proposed action and must be published as a public notice. Each
petition or request for a new tolerance, an amendment to an existing
tolerance, or a new exemption from the requirement of a tolerance must
be accompanied by a fee or a request for a waiver of such fee. Current
Agency policy on tolerance actions identified during the reregistration
process is to administratively process without requiring payment of a
fee tolerance actions for revision or revocation of an established
tolerance. Comments submitted in response to the Agency's published
proposals are reviewed; the Agency then publishes its final
determination regarding the specific tolerance actions.
II. Chemical-Specific Information and Proposed Actions
Pronamide: Amendment to 40 CFR 180.317
1. Regulatory background. Pronamide was registered in the United
States in 1972 for use as a herbicide to control grassy and broadleaf
weeds on field, vegetable, and orchard crops, forage and fodder, fallow
land, woody ornamentals, nursery stock, and Christmas tree plantations.
A Registration Standard for pronamide was issued in April 1986.
Under this standard, registrants were required to generate data, supply
missing data, and replace unacceptable data. A Data Call-In was issued
in 1990 for pronamide requiring additional data. The Reregistration
Eligibility Decision (RED) document of May 1994 reflects a reassessment
of all data which were submitted in response to the Registration
Standard and the Data Call-In.
2. Proposed action--Modification of tolerance expression. The
Agency is proposing to modify the 40 CFR 180.317(a) and (b) tolerance
expressions to state that tolerances ``* * * are established for the
combined residues of the herbicide 3,5-dichloro-N-(1,1- dimethyl-2-
propynyl)benzamide and its metabolites (containing the 3,5-
dichlorobenzoyl moiety and calculated as 3,5-dichloro-N-(1,1-dimethyl-
2-propynyl)benzamide) * * *'' to clarify which metabolites of pronamide
are determined by the enforcement methods and are included in the
tolerance expression.
Tolerances Under 40 CFR 180.317(a)
It is the Agency's policy to set a crop group tolerance when there
is an established or proposed tolerance for all of the representative
commodities for a specific group or related commodities. This reduces
the number of tolerances in 40 CFR part 180 and allows the pesticide to
be used on all the commodities in the crop group. The procedures and
data requirements for establishing a group tolerance are described in
40 CFR 180.34(f).
A crop group tolerance of 10 parts per million (ppm) is proposed
for residues of pronamide in/on the forage and hay of the nongrass
animal feeds group. The available data satisfy the requirements for
crop group tolerance establishment. Concomitant with this tolerance
proposal, the established tolerances for ``alfalfa, fresh'', ``alfalfa,
forage'', ``alfalfa, hay'', ``clover'', ``crown vetch'', ``sainfoin'',
and ``trefoil'' will be deleted.
A crop group tolerance of 0.1 ppm is proposed for residues of
pronamide in/on the stone fruits group. Adequate data are available to
support the established tolerances for the representative commodities
cherries, nectarines, peaches, and plums/fresh prunes, all at 0.1 ppm.
Concomitant with this tolerance proposal, the established tolerances
for ``cherries'', ``nectarines'', ``peaches'', and ``plums'' will be
deleted.
The available residue data support a proposal to reduce the
tolerance for residues in/on endive from 2.0 ppm to 1.0 ppm.
As a result of the improvement in the enforcement method for animal
commodities, the Agency is proposing to amend the tolerances for the
kidney and liver of cattle, goats, hogs, horses, and sheep from 0.2 ppm
to 0.4 ppm. The improved enforcement method measured a higher
percentage of the residues of concern in the kidney and liver, plus the
residue data reflected an inadequate established tolerance. The Agency
has examined the added dietary exposure as a result of this tolerance
increase. Since exposure to kidney and liver amounts to approximately 5
percent of the total dietary intake, the additional risk is
insignificant. In addition, the tolerance for sheep meat was
incorrectly listed in 40 CFR 180.317(a) as 0.2 ppm and will be changed
to the correct tolerance of 0.02 ppm.
Confirmatory residue data are required for alfalfa seed; once these
data are received the Agency will reassess the tolerance for this
commodity. In the interim, the existing tolerance for alfalfa forage
will support the alfalfa seed use.
Tolerances Under 40 CFR 180.317(b)
Confirmatory residue data are required for dried winter peas; once
these data are received the Agency will reassess the tolerance for this
commodity. In the interim, alternate data from Europe are available to
support the present tolerance on dried winter peas.
III. Public Comment Procedures
Interested persons are invited to submit written comments,
information, or data in response to this proposed rule. Comments must
be submitted by January 16, 1996. Comments must bear a notation
indicating the document control number. Three copies of the comments
should be submitted to either
[[Page 57381]]
location listed under ADDRESSES above in this document. Information
submitted as a comment concerning this document may be claimed
confidential by marking any or all of that information as
``Confidential Business Information'' (CBI).
Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. A copy of a comment that
does not contain CBI must be submitted for inclusion in the public
record. Information not marked confidential may be disclosed publicly
by EPA without prior notice.
Any person who has registered or submitted an application for
registration of a pesticide, under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended, which contains any of the
ingredients listed herein, may request within 60 days after publication
of this notice in the Federal Register that this rulemaking proposal be
referred to an Advisory Committee in accordance with section 408(e) of
the FFDCA.
Documents considered and relied upon by EPA pertaining to this
action, and all written comments filed pursuant to this proposed rule,
will be available for public inspection in Rm. 1132, Crystal Mall #2,
1921 Jefferson Davis Highway, Arlington, VA, between 8 a.m. and 4:30
p.m., Monday through Friday, except legal holidays. Any person who has
registered, or who has submitted an application for registration under
FIFRA of any of the pesticide chemicals listed in this proposed rule,
may request that this proposal be referred to an advisory committee.
Such a request must be made within 60 days of the publication of this
proposal. To satisfy requirements for analysis specified by Executive
Order 12866 and the Regulatory Flexibility Act, EPA has considered the
impacts of this proposal.
A record has been established for this rulemaking under docket
number [OPP-300402] (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments can be sent directly to EPA at:
opp-Docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in ADDRESSES at the beginning of
this document.
IV. Regulatory Assessment Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in a rule: (1) having an annual effect on the
economy of $100 million or more, or adversely and materially affecting
a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local or tribal
governments or communities (also referred to as ``economically
significant''); (2) creating serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially altering the budgetary impacts of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) raising novel legal or policy issues arising out of
legal mandates, the President's priorities, or the principles set forth
in this Executive Order. Pursuant to the terms of this Executive Order,
it has been determined that this rule is not a ``significant regulatory
action,'' because it does not meet any of the regulatory-significance
criteria listed above.
B. Regulatory Flexibility Act
This proposed rule has been reviewed under the Regulatory
Flexibility Act of 1980 (Pub. L. 96-354; 94 Stat. 1164, 5 U.S.C. 601 et
seq.), and EPA has determined that it will not have a significant
economic impact on any small businesses, governments, or organizations.
Accordingly, I certify that this proposed rule does not require a
separate regulatory flexibility analysis under the Regulatory
Flexibility Act.
C. Paperwork Reduction Act
This proposed regulatory action does not contain any information
collection requirements subject to review by OMB under the Paperwork
Reduction Act of 1980, 44 U.S.C. 3501 et seq.
D. Unfunded Mandates
This proposed rule contains no Federal mandates under Title II of
the Unfunded Mandates Reform Act of 1995, Pub. L. 104-4, for State,
local, or tribal governments or the private sector because it would not
impose enforceable duties on them.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: November 1, 1995.
Jack E. Housenger,
Chief, Special Review Branch, Special Review and Reregistration
Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. By revising Sec. 180.317 to read as follows:
Sec. 180.317 3,5-Dichloro-N-(1,1-dimethyl-2-propynyl)benzamide;
tolerances for residues.
(a) Tolerances are established for the combined residues of the
herbicide 3,5-dichloro-N-(1,1-dimethyl-2-propynyl)benzamide and its
metabolites (containing the 3,5-dichlorobenzoyl moiety and calculated
as 3,5-dichloro-N-(1,1-dimethyl-2-propynyl)benzamide) in or on the
following raw agricultural commodities:
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Parts per
Commodity million
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Apples..................................................... 0.1
Artichokes................................................. 0.1
Blackberries............................................... 0.05
Blueberries................................................ 0.05
Boysenberries.............................................. 0.05
Cattle, fat................................................ 0.02
Cattle, kidney............................................. 0.4
Cattle, liver.............................................. 0.4
Cattle, mbyp (except kidney, liver)........................ 0.02
Cattle, meat............................................... 0.02
[[Page 57382]]
Eggs....................................................... 0.02
Endive (escarole).......................................... 1.0
Goats, fat................................................. 0.02
Goats, kidney.............................................. 0.4
Goats, liver............................................... 0.4
Goats, mbyp (except kidney, liver)......................... 0.02
Goats, meat................................................ 0.02
Grapes..................................................... 0.1
Hogs, fat.................................................. 0.02
Hogs, kidney............................................... 0.4
Hogs, liver................................................ 0.4
Hogs, mbyp (except kidney, liver).......................... 0.02
Hogs, meat................................................. 0.02
Horses, fat................................................ 0.02
Horses, kidney............................................. 0.4
Horses, liver.............................................. 0.4
Horses, mbyp (except kidney, liver)........................ 0.02
Horses, meat............................................... 0.02
Lettuce.................................................... 1.0
Milk....................................................... 0.02
Nongrass animal feeds...................................... 10.0
Pears...................................................... 0.1
Poultry, fat............................................... 0.02
Poultry, kidney............................................ 0.2
Poultry, liver............................................. 0.2
Poultry, mbyp (except kidney, liver)....................... 0.02
Poultry, meat.............................................. 0.02
Raspberries................................................ 0.05
Sheep, fat................................................. 0.02
Sheep, kidney.............................................. 0.4
Sheep, liver............................................... 0.4
Sheep, mbyp (except kidney, liver)......................... 0.02
Sheep, meat................................................ 0.02
Stone fruits............................................... 0.1
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(b) Tolerances with regional registrations are established for the
combined residues of the herbicide 3,5-dichloro-N-(1,1-dimethyl-2
propynyl)benzamide and its metabolites (containing the 3,5
dichlorobenzoyl moiety and calculated as 3,5-dichloro-N-(1,1-dimethyl-
2- propynyl)benzamide) in or on the following raw agricultural
commodities:
------------------------------------------------------------------------
Parts per
Commodity million
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Peas, dried (winter)....................................... 0.05
Rhubarb.................................................... 0.1
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[FR Doc. 95-28070 Filed 11-14-95; 8:45 am]
BILLING CODE 6560-50-F
