avermectin (Agri-Mek, Affirm) Proposed Pesticide Tolerance 9/95
[Federal Register: September 20, 1995 (Volume 60, Number 182)]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 3F4258/P630; FRL-4973-8]
Avermectin B1 and Its Delta-8,9-Isomer; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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: email@example.com. 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: firstname.lastname@example.org.
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,
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 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:
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
Dated: August 28, 1995.
Stephen L. Johnson, Director, Registration Division, Office of Pesticide
Therefore, 40 CFR part 180 is amended as follows:
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
Sec. 180.449 Avermectin B1 and its delta-8,9-isomer; tolerances for
* * * * * (b) * * *
* * * * *
Peppers, bell 0.01
* * * * *