[Federal Register Volume 63, Number 69 (Friday, April 10, 1998)]
[Rules and Regulations]
[Pages 17690-17692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9548]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300619A; FRL-5784-5]
RIN 2070-AB78


Prometryn; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
Prometryn in or on carrots to harmonize tolerances with Canada under 
the Federal Food, Drug and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (Pub. L. 104-170).

 DATES: This regulation is effective April 10, 1998. Objections and 
requests for hearings must be received by EPA on or before June 9, 
1998.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300619A], must be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: 
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and 
hearing requests filed with the Hearing Clerk identified by the docket 
control number, [OPP-300619A], must also be submitted 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, 
bring a copy of objections and hearing requests to Rm. 119, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any from of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1 file 
format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-300619A]. No Confidential Business Information (CBI) should 
be submitted through e-mail. Electronic copies of objections and 
hearing requests on this rule may be filed online at many Federal 
Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: James A. Tompkins, 
Registration Division 7505C, Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location, telephone number, and e-mail address: Crystal Mall #2, 
1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-5697, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

[[Page 17691]]

    In the Federal Register of February 28, 1998 (63 FR 9494)(FRL-5772-
7) EPA published a notice that EPA on its own initiative proposed to 
amend 40 CFR 180.222(a) by establishing tolerances for residues of the 
herbicide Prometryn, 2,4-bis(isopropylamino)-6-methylthio-s-triazine in 
or on carrots at 0.1 parts per million (ppm) without a U.S. 
registration under the Federal Insecticide Fungicide Act, as amended 
for carrots imported from Canada.
    There were no comments or requests for referral to an advisory 
committee received in response to the proposed rule.

I. Statutory Findings

    New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue*** .''

II. Final Action

    The proposed rule summarizes EPA's risk assessment process, the 
scientific data bearing on the risk presented by prometryn and EPA's 
assessment of the aggregate risk proposed by prometryn. In that 
document EPA concluded that there is a reasonable certainly that no 
harm will result to the general population and major identifiable 
population subgroups from aggregate exposure to prometryn.
    There are presently no actions pending against the continued 
registration of this chemical.
    Based on the information and data considered, the Agency has 
determined that the tolerance established by amending 40 CFR part 180 
would protect the public health. Therefore, the tolerance is 
established as set forth below.

 III. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) as was provided in the old section 408 
and in section 409. However, the period for filing objections is 60 
days, rather than 30 days. EPA currently has procedural regulations 
which govern the submission of objections and hearing requests. These 
regulations will require some modification to reflect the new law. 
However, until those modifications can be made, EPA will continue to 
use those procedural regulations with appropriate adjustments to 
reflect the new law.
    Any person may, by June 9, 1998, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of 
the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issues on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the requestor (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the material 
submitted shows the following: There is genuine and substantial issue 
of fact; there is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary; and resolution of the 
factual issues in the manner sought by the requestor would be adequate 
to justify the action requested (40 CFR 178.32). Information submitted 
in connection with an objection or hearing request 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 information 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.

IV. Public Docket and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control number [OPP-300619A] (including any comments and data submitted 
electronically). 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 public 
record is located in Room 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    [email protected].

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any from of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper from. Accordingly, 
EPA will transfer any copies of objections and hearing requests 
received electronically into printed, paper from 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 
Virginia address in ``ADDRESSES'' at the beginning of this document.

V. Regulatory Assessment Requirements

    This action finalizes a tolerance under FFDCA section 408(e). The 
Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled Regulatory 
Planning and Review (58 FR 51735, October 4, 1993). In addition, this 
final rule 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

[[Page 17692]]

58093, October 28, 1993), or 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 accordance with Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997).
    In addition, under the Regulatory Flexibility Act (RFA) (5 U.S.C. 
601 et seq.), the Agency previously assessed whether establishing 
tolerances, exemptions from tolerances, raising tolerance levels or 
expanding exemptions might adversely impact small entities and 
concluded, as a generic matter, that there is no adverse economic 
impact. The factual basis for the Agency's generic certification for 
tolerance actions published on May 4, 1981 (46 FR 24950), and was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration.

VI. Submission to Congress and the General Accounting Office

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: April 2, 1998.

Stephen L. Johnson,

Acting Director, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is 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. Section 180.222 is amended as follows:
    i. By adding a heading to paragraph (a).
    ii. By alphabetically adding the raw agricultural commodity 
``carrots'' to the table in paragraph (a).
    iii. By designating the text in paragraph (b) as paragraph (c), and 
adding a heading to newly designated paragraph (c).
    iv. By adding and reserving with headings new paragraphs (b) and 
(d).
    The additions read as follows:


Sec. 180.222   Prometryn; tolerances for residues.

    (a) General.  *     *     *

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                                                              Parts per 
                         Commodity                             million  
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Carrots\1\.................................................          0.1
                                                                        
                      *        *        *        *                      
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\1\ There are no U.S. registrations as of April 10, 1998 for use on     
  carrots.                                                              

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. *    *    *
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 98-9548 Filed 4-9-98; 8:45 am]
BILLING CODE 6560-50-F