tebuthiuron (Graslan, Spike) Proposed Tolerances 12/95
[Federal Register: December 6, 1995 (Volume 60, Number 234)]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: EPA has completed the reregistration process and issued a
Reregistration Eligibility Document (RED) for tebuthiuron. In the
reregistration process, all information to support this pesticide's
continued registration is reviewed for adequacy and, when needed,
supplemented with new scientific studies. Based on the RED tolerance
assessment for the pesticide chemical subject to this proposed rule,
EPA is proposing to lower the tolerance for grass hay and grass
rangeland forage and change the commodity name grass, rangeland forage
to grass, forage.
DATES: Written comments, identified by the OPP document control number
[OPP-300403], must be received on or before January 5, 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: email@example.com. Electronic
comments must be submitted in 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
docket number [OPP-300403]. No CBI should be submitted through e-mail.
Electronic comments on this proposed rule may be filed online at many
Federeal Depository Libraries. Additional information on electronic
submissions can be found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: Ben Chambliss, 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, (703)-308-8174; e-mail: firstname.lastname@example.org.
I. Legal Authorization
The Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et
seq., 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
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. Pursuant to
40 CFR 180.32, EPA is proposing the amendment of the following
tolerances. 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. 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. Current Agency policy on tolerance actions identified during the
reregistration process is to waive the payment of fees if the tolerance
action concerns 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
Tebuthiuron: Amendment to 40 CFR 180.390
1. Regulatory background. Tebuthiuron is a nonselective soil
activated herbicide used to control broadleaf and woody weeds, grasses,
and brush on terrestrial feed crop and terrestrial nonfood crop sites.
Tolerances exist for tebuthiuron use on grass hay and forage as well as
secondary residues in meat of cattle, goats, horses, sheep, and in
milk. Tebuthiuron was registered by the Elanco Products Co. in 1974.
The registration was later transferred to DowElanco in 1989. A
Registration Standard was issued in July 1987 for all pesticide
products containing tebuthiuron. Under this standard, registrants were
required to generate and supply missing data and to replace
unacceptable data. In June 1994, the Agency issued the Reregistration
Eligibility Document for Tebuthiuron. This document reflects a
reassessment of all data submitted in response to the Registration
Standard of Tebuthiuron.
2. Proposed action--a. Lower the tolerance for grass hay and forage
from 20 parts per million (ppm) to 10 ppm. A tolerance reduction from
20 ppm to 10 ppm is recommended for grass hay and forage based on data
showing that combined residues of tebuthiuron and it's regulated
metabolites did not exceed 10 ppm on any grass forage or hay sample in
field trials conducted under label conditions.
b. Amend the commodity definition listed in 40 CFR 180.390 to
conform to commodity definitions currently used by EPA to read as
follows: "Grass, rangeland, forage" is proposed to read as "Grass,
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 5, 1996. Comments must bear a notation
indicating the document control number. Three copies of the comments
should be submitted to either location listed under ADDRESSES.
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 30 days after publication
of this document 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. To satisfy
requirements for analysis specified by Executive Order 12866 and the
Regulatory Flexibility Act, EPA has considered the impacts of this
A record has been established for this rulemaking under docket
number [OPP-300403] (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:
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
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
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 a substantial number of small businesses, small
governments, or small organizations.
Accordingly, I certify that this proposed rule does not require a
separate regulatory flexibility analysis under the Regulatory
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
Dated: November 30, 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:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.390, by amending the table therein by revising the
entries for grass, hay and grass, rangeland, forage to read as follows:
Sec. 180.390 Tebuthiuron; tolerances for residues.
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Grass, hay................................................. 10.0
Grass, forage.............................................. 10.0
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