[Federal Register Volume 60, Number 182 (Wednesday, September 20, 1995)]
[Proposed Rules]
[Pages 48681-48682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22869]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 3F4258/P630; FRL-4973-8]
RIN 2070-AC18
Avermectin B1 and Its Delta-8,9-Isomer; 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 bell peppers. Merck Research
Laboratories requested the proposed regulation to establish a maximum
permissible level for residues of the insecticide pursuant to the
Federal Food, Drug and Cosmetic Act (FFDCA).
DATES: Comments, identified by the document control number [PP 3F4258/
P630], must be received on or before October 20, 1995.
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 Hwy., Arlington, VA 22202. Information submitted
as a comment concerning this document 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 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 in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number [PP 3F4258/P630]. No Confidential Business
Information (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 Hwy., Arlington, VA 22202, (703)-305-6100; e-mail:
larocca.george@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: On August 17, 1993, Merck Research
Laboratories, Inc., submitted a pesticide petition (PP 3F4258)
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-isomer in or on the raw
agricultural commodity (RAC) group, fruiting vegetables (tomatoes,
peppers, and eggplants) at 0.01 part per million (ppm). On August 9,
1994, Merck requested that the pesticide petition be amended by
withdrawing group tolerances and proposing tolerances for bell peppers
only at 0.01 ppm., since EPA had concluded there was insufficient data
to establish the crop group tolerance and insufficient data to
establish a tolerance on all varieties of peppers except for bell
peppers.
The data submitted in support of the tolerance and other relevant
material have been reviewed. The toxicological and metabolism data and
analytical methods for enforcement purposes considered in support of
the tolerance are discussed in detail in related documents published in
the Federal Registers of May 31, 1989 (54 FR 23209, cottonseed) and
August 2, 1989 (54 FR 31836, 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 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 0.000022 mg/kg/bwt/
day and utilizes 5.4 percent of the RfD for the U.S. population. For
nonnursing infants less than 1-year-old (the subgroup population with
the highest exposure level) the ARC for established tolerances and the
current action is estimated at 0.000072 mg/kg bwt/day and utilizes
17.9% of the RfD. Generally speaking, the Agency has no cause for
concern if the anticipated residue 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
[[Page 48682]]
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 age. 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. Secondary residues occurring in livestock and
their byproducts are not expected since there are no known animal feed
stock uses for bell peppers. 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 bell peppers. There are currently
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 document 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
document control number, [PP 3F4258/P630]. All written comments filed
in response to this petition will be available in the Public Response
and Program Resources Branch, at the address given above from 8 a.m. to
4 p.m., Monday through Friday, except legal holidays.
A record has been established for this rulemaking under docket
number [PP 3F4258/P630] (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., 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,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
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 for 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 ``ADDRESSES'' 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.
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 5 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 to this effect 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
recordkeeping requirements.
Dated: August 28, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is 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. By amending Sec. 180.449 in paragraph (b) in the table therein,
by adding and alphabetically inserting an entry for bell pepper, 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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* * * * *
Peppers, bell.............................................. 0.01
* * * * *
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[FR Doc. 95-22869 Filed 9-19-95; 8:45 am]
BILLING CODE 6560-50-F
