avermectin (Agri-Mek, Affirm) Pesticide Tolerance 3/96
[Federal Register: March 8, 1996 (Volume 61, Number 47)]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4F4354/R2196; FRL-4993-5]
Pesticide Tolerance; Avermectin B1 and Its Delta-8,9-Isomer
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This rule establishes a tolerance for combined residues of the
insecticide avermectin B1 and its delta-8,9-isomer in or on the
raw agricultural commodities cucurbit vegetables group (cucumbers,
melons, and squashes). The regulation to establish a maximum
permissible level for residues of the insecticide was requested in a
petition submitted by the Merck Research Laboratories.
EFFECTIVE DATE: This regulation becomes effective March 8, 1996.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 4F4354/R2196], 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
docket 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.
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.
An electronic copy of objections and hearing requests filed with
the Hearing Clerk may be submitted to OPP by sending electronic mail
Copies of electronic objections and hearing requests must be
submitted as an ASCII file avoiding the use of special characters and
any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 5.1 file format
or ASCII file format. All copies of electronic objections and hearing
requests must be identified by the docket number [PP 4F4354/R2196]. No
Confidential Business Information (CBI) should be submitted through e-mail.
Copies of electronic 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
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, telephone number, and e-mail address: Rm. 204, CM #2, 1921 Jefferson
Davis Hwy., Arlington, VA, (703)-305-6100; e-mail:
SUPPLEMENTARY INFORMATION: EPA issued a notice published in the Federal
Register of November 2, 1994 (59 FR 54911), and September 28, 1994 (59
FR 49392), which announced that Merck Research Laboratories had
submitted pesticide petition (PP) 4F4354 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 commodities (RACs) cucurbit
vegetables group (cucumbers, melons, and squashes) at 0.005 part per
million (ppm). No comments were received in response to the notice of
The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological 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 intraspecies
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 body weight(bwt) /day), and
(4) cleft palate in the mouse developmental toxicity study with isomer
(NOEL = 0.06 mg/kg bwt/day). Thus, based on a NOEL of 0.12 mg/kg bwt/
day from the two-generation rat reproduction and an uncertainty factor
of 300, the RfD is 0.0004 mg/kg/ 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 3.2% 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 0.000018 mg/kg bwt/day and utilizes 4.5%
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 years 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 years and above. The MOE is 150. 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 by-products are not expected since there are no known animal feed
stock uses for cucurbits. An adequate analytical method (HPLC-
Fluorescence Method) 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 required
from Calvin Furlow, Public Response and Program Resources 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 cucurbits (cucumbers, melons, and
squashes). There are currently no actions pending against the continued
registration of this chemical. The pesticide is considered useful for
the purpose for which it is intended.
Based on the information and data considered, the Agency has
determined that the tolerance established by amending 40 CFR part 180
will protect the public health. Therefore, the tolerance is 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 to the regulation and may also request a hearing on
those objections. Objections and hearing requests must be filed 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 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 of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issue(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 the docket
number [PP 4F4354/R2196] (including any comments and data submitted
electronically). 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 22202.
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 any copies of objections and hearing requests
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, October 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
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: February 23, 1996.
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
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 the table in paragraph (b) by
adding alphabetically an entry for cucurbits, to read as follows:
Sec. 180.449 Avermectin B1 and its delta-8,9-isomer; tolerances
* * * * *
(b) * * *
* * * * *
Cucurbits (cucumbers, mellons, and squashes)............... 0.005
* * * * *