[Federal Register Volume 62, Number 223 (Wednesday, November 19, 1997)]
[Rules and Regulations]
[Pages 61645-61647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30382]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180 and 185

[OPP-300475A; FRL-5746-5]
RIN 2070-AC78


Hydroprene Biochemical Pest Control Agent; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final Rule.

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SUMMARY: This rule expands the tolerance for residues of hydroprene, 
[(S)-(Ethyl (2E,4E,7S)-3,7,11-trimethyl-2,4-odecadienoate)], an insect 
growth regulator, on all food items in food-handling establishments to 
include perimeters and pantries, and warehouses to the list of 
permissible food storage sites and ultra low volume (ULV) fogging as a 
permissible treatment method under certain precautions and conditions. 
This rule also permits the use of point source device treatments 
providing those devices do not come into direct contact with food 
preparation surfaces and are kept a minimum distance of 3 feet from 
exposed foods. This rule also restricts the tolerance expression to 
residues of [(S)-(Ethyl(2E,4E,7S)-3,7,11-trimethyl 2,4-
dodecadienoate)], the S-racemer of hydroprene since the R-racemer is no 
longer being supported in reregistration.
DATES: This regulation is effective November 19, 1997. Objections and 
requests for hearings must be received by EPA on or before January 20, 
1998.
ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300475A], 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-300475A], 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. 1132, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: [email protected]. Copies of

[[Page 61646]]

electronic objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 5.1/6.1 file format or ASCII 
file format. All copies of electronic objections and hearing requests 
must be identified by the docket number [OPP-300475A]. No Confidential 
Business Information (CBI) should be submitted through e-mail. Copies 
of electronic objections and hearing requests on this rule may be filed 
online at many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Diana Horne, c/o Product 
Manager (PM) 90, Biopesticides and Pollution Prevention Division 
(7511W) Office of Pesticide Programs, Environmental Protection Agency, 
401 M St. SW., Washington, DC 20460. Office location, telephone number 
and e-mail address: Room 5-W42, 5th Floor, CS#l, 2800 Crystal Drive, 
Arlington, VA (703) 308-8367; [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of June 4, 1997 (62 
FR 30549)(FRL-5600-6) EPA issued a proposal to amend 40 CFR parts 180 
and 185 by removing Sec. 185.3625 and adding Sec. 180.501, and by 
adding perimeters, pantries and warehouses to the list of permissible 
food storage sites and ultra low volume (ULV) fogging as a permissible 
treatment method under certain precautions and conditions. The Agency 
is also permitting the use of point source device treatments providing 
those devices do not come into direct contact with food preparation 
surfaces and must be kept a minimum distance of 3 feet from exposed 
foods. The Agency also proposed restricting the tolerance expression to 
residues of [(S)-(Ethyl (2E,4E,7S)-3,7,11-trimethyl-2,4-
dodecadienoate)], the S-racemer of hydroprene. The R-racemer is being 
removed from the tolerance expression since Sandoz Agro Inc., the 
manufacturer, is supporting only the reregistration of (S)-hydroprene 
and no longer manufacturers the R/S hydroprene racemic mixture.
    There were no comments in response to this proposed rule. The data 
submitted in the petition and other material have been evaluated.
    Based on the reasoning and findings set forth in the preamble to 
the proposed rule, 40 CFR part 180 is amended as set forth below.

I. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a regulation for an exemption from the 
requirement of a tolerance issued by EPA under new section 408(d) 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 governs 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 January 20, 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 under the ``ADDRESSES'' section (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 issue(s) on which a hearing is 
requested, the requestor's contentions on such issues, and a summary of 
any evidence relied upon by the objector (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 a 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 issue(s) 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.

II. Public Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
number [OPP-300475A] (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 1132 of the Public Response and Program 
Resources Branch, Field Operations 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 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 any copies of objections and hearing requests 
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.

III. Regulatory Assessment Requirements

    This action finalizes an exemption from the tolerance requirement 
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 61647]]

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.

XII. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in 
today's Federal Register. This is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects

40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Food additive, Pesticides and pests, 
Reporting and record keeping requirements.

40 CFR Part 185

    Environmental protection, Food additives, Pesticides and pests

    Dated: October 31, 1997.

Stephen L. Johnson,

Acting Director, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. In part 180:
    a. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 348.

    b. Section 180.501 is added to read as follows:


Sec. 180.501   Hydroprene; tolerances for residues.

    (a) General. A tolerance of 0.2 part per million is established for 
residues of hydroprene [(S)-(Ethyl (2E,4E,7S)-3,7,11-trimethyl-2,4-
dodecadienoate)], (CAS Reg. No. 65733-18-8) on all food items in food-
handing establishments in accordance with the following prescribed 
conditions:
    (1) Application shall be limited to spot, crack and crevice, 
perimeter and ultra low volume (ULV) fogging treatment in food storage 
or food-handling establishments, including warehouses, food service, 
manufacturing, and processing establishments such as restaurants, 
cafeterias, supermarkets, bakeries, breweries, dairies, meat 
slaughtering and packing plants, and canneries where food and food 
products are held, processed, and served: Provided that the food is 
removed or covered prior to such use, and food-processing surfaces are 
covered during treatment or thoroughly cleaned before using, or in the 
case of point-source device treatments, devices must not come into 
direct contact with food preparation surfaces and must be in a minimum 
distance of 3 feet from exposed foods.
    (2) To assure safe use of the insect growth regulator, the label 
and labeling shall conform to that registered by the U.S. Environmental 
Protection Agency, and it shall be used in accordance with such label 
and labeling.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

PART 185--[AMENDED]

    2. In part 185:
    a. The authority citation for part 185 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 348.

Sec. 185.3625 [Removed]

    b. Section 185.3625 is removed.

[FR Doc. 97-30382 Filed 11-18-97; 8:45 am]
BILLING CODE 6560-50-F