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propazine (Milocep, Milogard) Proposed Tolerance Revocation 3/98


[Federal Register: March 18, 1998 (Volume 63, Number 52)]
[Proposed Rules]               
[Page 13156-13158]
>From the Federal Register Online via GPO Access []



40 CFR Part 180

[OPP-300626; FRL-5776-9]
RIN 2070-AB18

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- 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 
legal holidays.
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:

I. Introduction

    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 
drinking water.

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.

[[Page 13157]]

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 
review in

[[Page 13158]]

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 
Pesticide Programs.
    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]