[Federal Register Volume 60, Number 244 (Wednesday, December 20, 1995)]
[Rules and Regulations]
[Pages 65577-65578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30975]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 9F3787/R2194; FRL-4991-1]
RIN 2070-AB78
Avermectin B1 and Its Delta-8,9-Isomer; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This document establishes a tolerance for combined residues of
the insecticide avermectin B1 and its delta-8,9-isomer in or on
the raw agricultural commodity pears. Merck Research Laboratories
requested this regulation to establish a maximum permissible level for
residues of the insecticide pursuant to the Federal Food, Drug and
Cosmetic Act (FFDCA).
EFFECTIVE DATE: This regulation becomes effective December 20, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number [PP 9F3787/R2194], may be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. A copy of any objections and hearing
requests filed with the Hearing Clerk should be identified by the
document control number and submitted 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 copy of objections and hearing
requests to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA
22202. Fees accompanying objections 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 objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect in 5.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number [PP
9F3787/R2194]. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of objections and hearing
requests on this 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:
[email protected]
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of November 1, 1989 (54 FR 46118), which announced
that Merck Research Laboratories, Inc., Hillsborough Rd., Three
Bridges, NJ 98887, had submitted a pesticide petition (PP 9F3787) to
EPA 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) pears at 0.035 part per million (ppm). In
a letter dated September 22, 1993, Merck requested that the pesticide
petition be amended by proposing a lower tolerance on pears at 0.02
ppm. No comments were received in response to the notice of filing (See
58 FR 64583; Dec. 8, 1993).
The data submitted in support of this tolerance and other relevant
material have been reviewed. The toxicological and metabolism data
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, 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 0.000013 mg/kg/bwt/
day and utilizes 3.4 percent of the RfD for the U.S. population. For
nonnursing 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 0.000030 mg/kg bwt/day and utilizes 7.5%
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 1,000. Generally speaking, MOEs greater than
100 for
[[Page 65578]]
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 by-products are not expected since there are no known animal feed
stock uses for pears. Adequate analytical methodology (HPLC-
Fluorescence Methods) is available for enforcement purposes. The
enforcement methodology has been submitted to the Food and Drug
Administration for publication in the Pesticide Analytical Manual, Vol.
II (PAM II). Because of the long lead time for publication of the
method in PAM II, the analytical methodology is being made available in
the interim to anyone 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 pears. 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 adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections and/or request a hearing with the Hearing Clerk, at
the address given above (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 or the requestor, taking into account uncontested claims or facts
to the contrary; and resolution of the factual issues(s) in the manner
sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32).
A record has been established for this rulemaking under docket
number [PP 9F3787/R2194] (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper version 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,
Crystall Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments can be sent directly to EPA at:
oop-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: December 7, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR part 180 continues to read 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(b) in the table therein by adding and
alphabetically inserting an entry for pears, to read as follows:
Sec. 180.449 Avermectin B1 and its delta-8,9-isomer; tolerances
for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Pears...................................................... 0.02
* * * * *
------------------------------------------------------------------------
[FR Doc. 95-30975 Filed 12-19-95; 8:45 am]
BILLING CODE 6560-50-F
