[Federal Register Volume 60, Number 177 (Wednesday, September 13, 1995)]
[Proposed Rules]
[Pages 47529-47531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22619]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4E4419/P626; FRL-4970-8]
RIN 2070-AC
Avermectin B1 and its Delta-8,9 Isomer
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA proposes to establish time-limited tolerances for the
combined residues of the insecticide avermectin B1 and its delta-
8,9-isomer in or on the raw agricultural commodities dried hops and
cattle fat. The proposed regulation to establish maximum permissible
levels for residues of the insecticide was requested in a petition
submitted by the Interregional Research Project No. 4 (IR-4). The time-
limited tolerances for dried hops and cattle fat would expire on April
30, 1996.
DATES: Comments, identified by the document control number [PP 4E4419/
P626], must be received on or before October 13, 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. Comments and data may
also be submitted to OPP 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 4E4419/P626]. Electronic comments
on this proposed rule may be filed online at many Federal Depository
Libraries. Additional information on electronic submissions can be
found in the ``SUPPLEMENTAL INFORMATION'' section of this document.
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 should not be submitted
through e-mail. Information marked as CBI 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.
FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson,
Registration Division (7505W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location and telephone number: Sixth Floor, Crystal Station #1,
2800 Jefferson Davis Hwy., Arlington, VA 22202, (703)-308-8783; e-mail:
jamerson.hoyt@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: The Interregional Research Project No. 4
(IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231,
Rutgers University, New Brunswick, NJ 08903, has submitted pesticide
petition (PP) 4E4419 to EPA on behalf of the Idaho, Oregon, and
Washington Hop Commissions, and the Hop Growers of America. This
petition requests that the Administrator, pursuant to section 408(e) of
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e),
amend 40 CFR 180.449 by establishing time-limited tolerances for the
combined residues of the insecticide avermectin B1 [a mixture of
avermectins containing greater than or equal to 80 percent avermectin
B1a (5-O-demethyl avermectin A1a and less than or equal to 20
percent avermectin B1b (5-O-demethyl-25-de(1-methylpropyl)-25-(1-
[[Page 47530]]
methylethyl) avermectin A1a)] and its delta-8,9-isomer in or on
the raw agricultural commodities dried hops at 0.5 part per million
(ppm) and cattle fat at 0.015 ppm.
The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological data considered in
support of the proposed tolerances include:
1. A 1-year feeding study with dogs fed diets containing 0.25,
0.50, or 1.0 milligram (mg)/kilogram (kg)/day with a no-observed-effect
level (NOEL) of 0.25 mg/kg/day. A high incidence of mydriasis
(excessive dilation of the pupil of the eye) was observed in male and
female dogs at the 0.50-mg/kg/day dose level.
2. A 2-year chronic toxicity/carcinogenicity study with rats fed
diets containing 0, 0.75, 1.5, or 2.0 mg/kg/day with a systemic NOEL of
1.5 mg/kg/day. Tremors were observed in male and female rats fed diets
containing 2.0 mg/kg/day. No carcinogenic effects were observed under
the conditions of the study.
3. A chronic toxicity/carcinogenicity study in mice fed diets
containing 0, 2.0, 4.0, or 8.0 mg/kg/day for 94 weeks with a systemic
NOEL of 4 mg/kg/day based on increased mortality, dermatitis, and
extramedullary hematopoiesis in the spleen of males, and body weight
loss in females at the 8.0 mg/kg/day dose level.
4. A two-generation reproduction study in rats fed diets containing
0, 0.06, 0.12, or 0.40 mg/kg/day with a NOEL of 0.12 mg/kg/day. The
lowest-observed-effect level (LOEL) was established at 0.40 mg/kg/day
based on increased retinal folds in weanlings, increased dead pups at
birth, decreased viability indices, decreased lactation indices, and
decreased pup body weights.
5. A developmental toxicity study with rats given gavage doses of
0, 0.4, 0.8, or 1.6 mg/kg/day with no developmental toxicity observed
under the conditions of the study.
6. A developmental toxicity study with mice given gavage doses at
0, 0.1, 0.2, 0.4, or 0.8 mg/kg/day. The LOEL for developmental toxicity
(cleft palate) was established at 0.4 mg/kg/day.
7. A developmental toxicity study with rabbits given gavage doses
with NOEL's for developmental and maternal toxicity at 1.0 mg/kg/day.
The LOEL for developmental toxicity was established at 2.0 mg/kg/day
based on cleft palate, clubbed foot, and delayed ossification.
8. Avermectin B1 tested negative for mutagenic effects in the
Ames assay, V-79 mammalian cell assay, structural chromosomal
aberration assay (in vitro in Chinese hamster ovary cells), and in vivo
bone marrow cytogenic study in male mice. Avermectin B1 produced
an increase in single strand DNA breaks in a rat in vitro hepatocyte
mutagenicity study. However, no mutagenic effects were observed when
the assay was carried out in vivo at 10.6 mg/kg.
Toxicity studies reviewed for the delta-8,9-isomer of avermectin
B1 include:
9. A developmental toxicity study in rats given gavage doses of 0,
0.25, 0.50, and 1.0 mg/kg/day with no developmental toxicity observed
under the conditions of the study.
10. A mouse developmental toxicity study with a NOEL of 0.06 mg/kg/
day based on developmental toxicity (cleft palate) at the 0.10 mg/kg/
day dose level.
11. A one-generation reproduction study with rats fed diets
containing 0, 0.06, 0.12, or 0.40 mg/kg/day with a NOEL for
reproductive effects at 0.40 mg/kg/day. There were no reproductive
effects observed under the conditions of the study.
12. An Ames mutagencity study was negative in the presence of S-9
activation.
Dietary risk assessements for avermectin indicate that there is
minimal risk from established tolerances and the proposed tolerances
for dried hops and cattle fat. Dietary risk assessments were conducted
using the Reference Dose (RfD) to assess chronic exposure and risk and
the Margin of Exposure (MOE) for acute toxicity.
The RfD is calculated at 0.0004 mg/kg/day, based on a NOEL of 0.12
mg/kg/of body weight/day from the two-generation reproduction study in
the rat and an uncertainty factor of 300. The anticipated residue
contribution (ARC) from existing tolerances and the proposed tolerances
for dried hops and cattle fat utilizes 6 percent of the RfD for the
general population and 21 percent of the RfD for nonnursing infants
(less than 1-year old).
The MOE is a measure of how closely the high-end acute dietary
exposure comes to the NOEL from the toxicity endpoint of concern. For
avermectin the MOE was calculated as a ratio of the NOEL (0.06 mg/kg/
day) from the mouse developmental toxicity study to dietary exposure,
as estimated for the population subgroup at greatest risk (females of
child-bearing age). The MOE for females of childbearing age is greater
than 100 for high-end exposure. Acute dietary MOE's of of less than 100
are generally of concern to EPA.
The nature of the residue in or on hops is adequately understood.
The enforcement method, which was developed by the registrant, Merck
Research Laboratories, has been validated by an independent laboratory.
The enforcement method will be submitted to the Food and Drug
Administration for publication in the Pesticide Analytical Manual,
Volume II (PAM II), when EPA's Analytical Chemistry Laboratory has
successfully completed its own validation of the enforcement method.
The analytical method is being made available, in the interim, to
anyone with an interest in pesticide enforcement when requested from:
Calvin Furlow, Public Response and Program Resources Branch, Field
Operations Divisions (7506C), Office of Pesticide Programs,
Environmental Protections 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)-305-5937.
Any secondary residues will be covered by existing tolerances for
meat, meat byproducts, and milk and the proposed tolerance for cattle
fat at 0.015 ppm. The established tolerances for meat, meat byproducts,
and milk will expire on April 30, 1996, which coincides with
conditional registrations for use of avermectin on cotton and citrus.
(See the Federal Registers of August 3, 1994 (59 FR 39505) and
September 30, 1994 (59 FR 49825), for additional information regarding
the conditional registrations for cotton and citrus.) The proposed
tolerance for cattle fat will expire on April 30, 1996, which also
coincides with the expiration date for time-limited tolerances for
meat, meat byproducts, and milk. EPA intends to make a decision on the
registrations for cotton and citrus prior to April 30, 1996. If full
registration is issued, the time-limited restrictions will be removed
from the avermectin tolerances for meat, meat byproducts, cattle fat,
and milk.
EPA is establishing the tolerance for dried hops with an expiration
date of April 30, 1996, to allow IR-4 time to submit additional residue
data in support of a permanent tolerance for dried hops, and to allow
EPA additional time to evaluate the enforcement method for dried hops.
A permanent tolerance for dried hops must also await establishment of
permanent tolerances for meat, meat byproducts, cattle fat, and milk.
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
[[Page 47531]]
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
document control number, [PP 4E4359/P626]. 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.
A record has been established for this rulemaking under docket
number [PP 4E4419/P626] (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.
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 30, 1995.
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 for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.449, by amending paragraph (a) in the table therein
by adding and alphabetically inserting listings for cattle fat and
dried hops and by amending paragraph (b) by revising the introductory
text, to read as follows:
Sec. 180.449 Avermectin B1 and its delta-8,9-isomer; tolerances
for residues.
(a) * * *
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
------------------------------------------------------------------------
Cattle, fat................................... 0.015 Do.
* * * * *
Hops, dried................................... 0.5 Do.
* * * * *
------------------------------------------------------------------------
(b) A tolerance is established for the combined residues of the
insecticide avermectin B1 [a mixture of avermectins containing greater
than or equal to 80 percent avermectin B1a (5-O-demethyl
avermectin A1a) and greater than or equal to 20 percent avermectin
B1b (5-O-demethyl-25-de(1-methylpropyl)-25-(1-methylethyl)
avermectin A1a)] and its delta-8,9-isomer in or on the following
commodities:
* * * * *
[FR Doc. 95-22619 Filed 9-12-95; 8:45 am]
BILLING CODE 6560-50-F
