hydroprene Pesticide Tolerance 10/97
[Federal Register: November 19, 1997 (Volume 62, Number 223)]
[Rules and Regulations]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 185
Hydroprene Biochemical Pest Control Agent; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final Rule.
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,
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: firstname.lastname@example.org. Copies of
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@example.com.
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:
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
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
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
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:
1. In part 180:
a. The authority citation for part 180 continues to read as
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
(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
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
2. In part 185:
a. The authority citation for part 185 continues to read as
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]
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