propazine (Milocep, Milogard) Proposed Tolerance Revocation 3/98
[Federal Register: March 18, 1998 (Volume 63, Number 52)]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Propazine; Proposed Revocation of Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: EPA is proposing to revoke the tolerances for residues of
propazine in or on sorghum fodder, sorghum forage, sorghum grain, and
sweet sorghum. EPA is proposing this action because the remaining
registration for propazine on sorghum was canceled in 1990.
DATES: Written comments, identified by the document control number
[OPP-300626], must be received on or before May 18, 1998.
ADDRESSES: By mail, submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, deliver comments to:
Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Comments and data may also be submitted electronically to: opp-
email@example.com. Follow the instructions under Unit VI of this
preamble. No Confidential Business Information (CBI) should be
submitted through e-mail.
Information submitted as a comment concerning this document may be
claimed confidential 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. The public docket is
available for public inspection in Rm. 119 at the Virginia address
given above, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding
FOR FURTHER INFORMATION CONTACT: By mail, Jeff Morris, Special Review
Branch (7508W), Office of Pesticide Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location and
telephone number: 3rd floor, Crystal Station, 2800 Crystal Drive,
Arlington, VA 22202, (703) 308-8029; e-mail:
Propazine (2-chloro-4,6-bis (isopropylamino)-s-triazine) is a
selective, pre-emergent herbicide used to control grassy and broadleaf
weeds on sorghum. Propazine belongs to the class of herbicides known as
chloro-s-triazines, which are currently undergoing a Special Review.
Propazine, like the other chloro-s-triazines, is classified as a Group
C, possible human carcinogen, based on studies showing induction of the
same tumor type by the various triazines. Propazine also demonstrates
environmental fate characteristics which raise concern for its
potential to contaminate ground water and thus enter sources of
II. Legal Authority
The Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et
seq., as amended by the Food Quality Protection Act of 1996 (FQPA),
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 pursuant to section 408, 21 U.S.C. 346(a), as amended.
Without a tolerance or exemption, food containing pesticide residues is
considered to be unsafe and therefore ``adulterated'' under section
402(a) of the FFDCA, and hence may not legally be moved in interstate
commerce (21 U.S.C. 331(a) and 342(a)). For a pesticide to be sold and
distributed, the pesticide must not only have appropriate tolerances or
exemptions under the FFDCA, but also must be registered under section 3
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7
U.S.C. 136a, or otherwise exempted from registration under the Act.
Under FFDCA section 408(f), if EPA determines that additional data
are needed to support continuation of a tolerance, EPA may require that
those data be submitted by registrants under FIFRA section 3(c)(2)(B),
by producers under the Toxic Substances Control Act (TSCA) section 4,
or by other persons by order after opportunity for hearing. EPA intends
to use Data Call-In (DCI) procedures for pesticide registrants, and
FFDCA section 408(f)(1)(C) orders for non-registrants as its primary
means of obtaining data. In general, EPA does not intend to use the
procedures under TSCA section 4, because such procedures generally will
not be applicable to pesticides.
Section 408(f) of the FFDCA states that if EPA determines that
additional data are needed to support the continuation of an existing
tolerance or exemption, EPA shall issue a notice that: (1) Requests
that any parties identify their interest in supporting the tolerance or
exemption, (2) solicits the submission of data and information from
interested parties, (3) describes the data and information needed to
retain the tolerance or exemption, (4) outlines how EPA will respond to
the submission of supporting data, and (5) provides time frames and
deadlines for the submission of such data and information.
III. Regulatory Background
Tolerances for propazine residues in or on sweet sorghum, sorghum
grain, sorghum fodder and sorghum forage, set at 0.25 ppm, were
established in 1968. In 1981, Ciba-Geigy submitted a petition to revise
the tolerances; the new tolerances would have included both the parent
compound and two propazine metabolites, G-30033 and G-28273. In
addition, the revised tolerances would have covered any secondary
residues in meat, milk and eggs. The proposed tolerances were to have
been set at 0.25 ppm for sorghum grain, 1 ppm for forage and fodder and
0.05 to 0.1 ppm for meat, milk and eggs.
At the same time, the International Research and Development
Corporation was conducting a 2-year feeding study on rats and mice. The
rat study was positive for oncogenicity and in 1983, the Agency
required additional data for residue chemistry and chronic toxicity.
Among the requirements were data on propazine metabolism, which was
needed before EPA could act on Ciba-Geigy's tolerance petition. In
1988, EPA issued the Registration Standard setting forth all of the
data requirements for maintaining the registration for propazine,
including acceptable studies on chronic toxicity and additional data on
storage stability, analytical methods, metabolites of concern and
ground water studies. Rather than generate the required data, Ciba-
Geigy requested voluntary cancellation.
Because Ciba-Geigy requested voluntary cancellation of its
propazine registration, EPA viewed the 1981 tolerance petition as
abandoned and did not act on the petition. Since the 1990 effective
date of the voluntary cancellation, EPA has granted section 18
emergency exemptions to several states for the use of propazine on
sorghum. For the 1993, 1994, 1995, 1996, and 1997 use seasons, EPA
granted section 18 emergency exemptions for the use of propazine on
sorghum to one or more of the following states: Colorado, Kansas, New
Mexico, Oklahoma, and Texas.
IV. Current Proposal
This document proposes to revoke the following tolerances
established under section 408 of FFDCA: sorghum, fodder, 0.25 ppm;
sorghum, forage, 0.25 ppm; sorghum, grain, 0.25 ppm; and sorghum,
sweet, 0.25 ppm.
EPA is proposing these revocations because the propazine sorghum
uses have been formally deleted from all propazine registrations, and
it is EPA's general practice to revoke tolerances where the associated
pesticide use has been deleted from all FIFRA labels. See 40 CFR
V. Effective Date
EPA proposes that these revocations become effective 30 days
following publication in the Federal Register of a final rule revoking
the tolerances. EPA is proposing this effective date because the
section 18 use expired on August 1, 1997, and no use of existing stocks
was authorized beyond that date.
Any sorghum commodities that are treated with propazine and that
are in the channels of trade following the tolerance revocations shall
be subject to FFDCA section 408(l)(5), as established by FQPA. Under
this section, any propazine residue 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 propazine 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
propazine was applied to such food.
VI. Public Comment Procedures
EPA invites interested persons to submit written comments,
information, or data in response to this proposed rule. After
consideration of comments, EPA will issue a final rule. Such rule will
be subject to objections. Failure to file an objection within the
appointed period will constitute waiver of the right to raise in future
proceedings issues resolved in the final rule.
Comments must be submitted by May 18, 1998. Comments must bear a
notation indicating the docket number [OPP-300626]. Three copies of the
comments should be submitted to either location listed under
``ADDRESSES'' at the beginning of this document.
This proposal provides 60 days for any interested person to request
that a tolerance be retained. If EPA receives a comment to that effect,
EPA will not revoke the tolerance, but will take steps to ensure the
submission of supporting data and will issue an order in the Federal
Register under FFDCA section 408(f). 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. Thereafter, if the data are not submitted as required, EPA
will take appropriate action under FIFRA or FFDCA.
VII. Public Record and Electronic Submissions
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket control
number [OPP-300626] (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 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The official rulemaking record is located at the Virginia
address in ``ADDRESSES'' at the beginning of this document.
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. Comment and data
will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file
format. All comments and data in electronic form must be identified by
the docket control number [OPP-300626]. Electronic comments on this
proposed rule may be filed online at many Federal Depository Libraries.
VIII. Regulatory Assessment Requirements
This is a proposed revocation of a tolerance established under
FFDCA section 408. The Office of Management and Budget (OMB) has
exempted this type of action, i.e., a tolerance revocation for which
extraordinary circumstances do not exist, from review under Executive
Order 12866, entitled Regulatory Planning and Review (58 FR 51735,
October 4, 1993). In addition, this proposal does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does
it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require special OMB
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health and Risks and Safety Risks (62 FR 19885,
April 23, 1997).
In addition, pursuant to the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), the Agency previously assessed whether the
revocations of tolerances might significantly impact a substantial
number of small entities and concluded that, as a general matter, these
actions do not impose a significant economic impact on a substantial
number of small entities. The factual basis and the Agency's
certification under section 605(b) for tolerance revocations was
published on December 17, 1997 (62 FR 66020), and was provided to the
Chief Counsel for Advocacy of the Small Business Administration. Since
no extraordinary circumstances exist as to the present revocation that
would change EPA's previous analysis, the Agency is able to reference
the general certification. Any comments about the Agency's
determination should be submitted to EPA along with comments on the
proposal, and will be addressed prior to issuing a final rule.
List of Subjects in 40 CFR Part 180
Enivornmental protection, Agricultural commodities, Pesticides and
pests, Reporting and recordkeeping requirements.
Dated: March 4, 1998.
Lois A. Rossi,
Director, Special Review and Reregistration Division, Office of
Therefore, 40 CFR chapter I, part 180 is proposed to be amended as
1. The authority citation for part 180 would continue to read as
Authority: 21 U.S.C. 346a and 371.
Sec. 180.243 [Removed]
2. Section 180.243 is removed.
[FR Doc. 98-6979 Filed 3-17-98; 8:45 am]
BILLING CODE 6560-50-F