[Federal Register Volume 61, Number 143 (Wednesday, July 24, 1996)]
[Proposed Rules]
[Pages 38428-38430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18392]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 5F4508/P673; FRL-5385-2]
RIN 2070-AC18
Avermectin B1 and Its Delta-8,9-Isomer; Proposed Pesticide
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed Rule.
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SUMMARY: EPA proposes to establish a tolerance for combined residues of
the insecticide Avermectin B1 and its delta-8,9-isomer in or on
the raw agricultural commodity potatoes. The proposed regulation to
establish a maximum permissible level for residues of the insecticide
was requested in a petition submitted by the Merck Research
Laboratories, Division of Merck Co., Inc.
DATES: Comments, identified by the docket number [PP 5F4508/P673], must
be received on or before August 23, 1996.
ADDRESSES: By mail, submit written comments to: Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person, bring comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Highway, Arlington, VA 22202. Information
submitted as a comment concerning this notice may be claimed
confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). Information so marked will
not be disclosed except in accordance with
[[Page 38429]]
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 may be disclosed publicly by EPA
without prior notice. All written comments will be available for public
inspection in Rm. 1132 at the address given above, from 8 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to opp-docket@epamail.epa.gov. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect 5.1 file format or ASCII file format.
All comments and data in electronic form must be identified by the
docket number [PP 5F4508/P673]. No CBI should be submitted through e-
mail. Electronic comments on this proposed rule may be filed online at
many Federal Depository Libraries. Additional information on electronic
submissions can be found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: George LaRocca, Product
Manager (PM) 13, Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St. SW., Washington,
DC 20460. Office location and telephone number: Rm. 204, CM #2, 1921
Jefferson Davis Highway, Arlington, VA 22202. (703) 305-6100, e-mail:
larocca.george@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: On April 19, 1995, Merck Research
Laboratories, Inc. submitted a pesticide petition (PP 5F4508)
requesting that the Administrator, pursuant to section 408(d) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d),
establish a tolerance for combined residues of the insecticide
avermectin B1 and its delta-8,9-isomers in or on the raw
agricultural commodity (RAC) potatoes at 0.002 parts per million (ppm).
On February 20, 1996, at the request of EPA, Merck amended the
pesticide petition proposing an increase in the tolerance from 0.002
ppm to 0.005 ppm based on the limits of the analytical methodology
testing.
The data submitted in support of this tolerance and other relevant
material have been reviewed. The toxicological and metabolism data and
analytical methods for enforcement purposes considered in support of
this tolerance are discussed in detail in related documents published
in the Federal Register of May 31, 1989 (54 FR 23209) (for cottonseed)
and August 2, 1989 (54 FR 31836) (for citrus).
The Agency used a two-generation rat reproduction study with an
uncertainty factor of 300 to establish a Reference Dose (RfD). The 300-
fold uncertainty factor was utilized for (1) inter- and intra-species
differences, (2) the extremely serious nature (pup death) observed in
the reproduction study, (3) maternal toxicity (lethality) no-
observable-effect level (NOEL) (0.05 mg/kg/day), and (4) cleft palate
in the mouse developmental toxicity study with isomer (NOEL = 0.06 mg/
kg/day). Thus, based on a NOEL of 0.12 mg/kg/day from the two-
generation rat reproduction study and an uncertainty factor of 300, the
RfD is 0.0004 mg/kg/body weight(bwt)/day.
A chronic dietary exposure/risk assessment has been performed for
avermectin B1 using the above RfD. Available information on
anticipated residues and 100% crop treated was incorporated into the
analysis to estimate the Anticipated Residue Contribution (ARC). The
ARC is generally considered a more realistic estimate than an estimate
based on the tolerance-level residues. The ARC for established
tolerances and the current action is estimated at 0.000017 mg/kg/bwt/
day and utilizes 4.2 percent of the RfD for the U.S. population. For
non-nursing infants less than 1 year old (the sub-group population with
the highest exposure level) the ARC for established tolerances and the
current action is estimated at 0.000040 mg/kg bwt/day and utilizes
10.0% of the RfD. Generally speaking, the Agency has no cause for
concern if anticipated residues contribution for all published and
proposed tolerances is less than the RfD.
Because of the developmental effects seen in animal studies, the
Agency used the mouse teratology study (with a NOEL of 0.06 mg/kg/day
for developmental toxicity for the delta-8,9 isomer) to assess acute
dietary exposure and determine a margin of exposure (MOE) for the
overall U.S. population and certain subgroups. Since the toxicological
end point pertains to developmental toxicity, the population group of
interest for this analysis is women aged 13 and above, the subgroup
which most closely approximates women of child bearing ages. The MOE is
calculated as the ratio of the NOEL to the exposure. For this analysis,
the Agency calculated the MOE for the high-end exposures for women ages
13 and above. The MOE is 120. Generally speaking, MOEs greater than 100
for developmental toxicity do not raise concerns.
The metabolism of the chemical in plants and animals for the use is
adequately understood. The established tolerances for cattle meat, meat
byproducts, milk and fat are adequate to cover the increased dietary
burden from the addition of the feed items potato culls and processed
potato waste. There is no reasonable expectation of finite residues in
poultry and swine, therefore no tolerances are necessary at this time.
Adequate analytical methodology (HPLC-Fluorescence Methods) is
available for enforcement purposes. Prior to publication in the
Pesticide Analytical Manual, Vol II, the enforcement methodology is
being made available in the interim to anyone who is interested in
pesticide enforcement when requested from Calvin Furlow, Public
Response and Program Resource Branch, Field Operations Division
(7506C), Office of Pesticide Programs, U.S. Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location and
telephone number: Rm. 1132, CM #2, 1921 Jefferson-Davis Hwy.,
Arlington, VA 22202, (703) 305-5232.
The tolerances established by amending 40 CFR part 180 will be
adequate to cover residues in or on potatoes. 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, it is proposed that the tolerance
be established as set forth below.
Any person who has registered or submitted an application for
registration of a pesticide, under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended, which contains any of the
ingredients listed herein, may request within 30 days after publication
of this notice in the Federal Register that this rulemaking proposal be
referred to an Advisory Committee in accordance with section 408(e) of
the FFDCA.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
docket number, [PP 5F4508/P673].
A record has been established for this rulemaking under docket
number [PP 5F4508/P673](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 a.m. to 4:30 p.m.,
[[Page 38430]]
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 (7506C), Office of Pesticide
Programs, Environmental Protection Agency, CM #2, 1921 Jefferson Davis
Highway, Arlington, VA 22202.
Electronic comments can be sent directly to EPA at:
opp-docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record of this rulemaking, as well as the public
version, as described above, will be kept in paper form. Accordingly,
EPA will transfer all comments 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 ADDRESSEES at the beginning
of this document.
Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency
must determine whether the regulatory action is ``significant'' and
therefore subject to all the requirements of the Executive Order (i.e.,
Regulatory Impact Analysis, review by the Office of Management and
Budget (OMB)). Under section 3(f), the order defines ``significant'' as
those actions likely to lead to a rule (1) having an annual effect on
the economy of $100 million or more, or adversely and materially
affecting a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local or tribal
governments or communities (also known as ``economically
significant''); (2) creating serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially altering the budgetary impacts of entitlement, grants, user
fees, or loan programs; or (4) raising novel legal or policy issues
arising out of legal mandates, the President's priorities, or the
principles set forth in this Executive Order.
Pursuant to the terms of this Executive Order, EPA has determined
that this rule is not ``significant'' and is therefore not subject to
OMB review.
This action does not impose any enforceable duty, or contain any
``unfunded mandates'' as described in Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled Enhancing the Intergovernmental Partnership, or special
consideration as required by Executive Order 12898 (59 FR 7629,
February 16, 1994).
Pursuant to the requirements of the Regulatory Flexibility Act
(U.S.C. 601-612), the Administrator has determined that regulations
establishing new tolerances or raising tolerance levels or establishing
exemptions from tolerance requirements do not have a significant
economic impact on a substantial number of small entities. A
certification statement explaining the factual basis for this
determinations was published in the Federal Register of May 4, 1981 (46
FR 24950).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and record
keeping requirements.
Dated: July 10, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:
PART 180--[AMENDED]
1. The authority citation of part 180 continues to read as follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.449 the table in paragraph (b) is amended by adding
alphabetically an entry for the commodity ``potatoes,'' to read as
follows:
Sec. 180.449 Avermectin B1 and its delta-8,9-isomer; tolerances
for residues.
* * * * *
(b) * * *
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Parts per
Commodity million
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* * * * *
Potatoes................................................... 0.005
* * * * *
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[FR Doc. 96-18392 Filed 7-23-96; 8:45 am]
BILLING CODE 6560-50-F