[Federal Register Volume 59, Number 100 (Wednesday, May 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12697]
[[Page Unknown]]
[Federal Register: May 25, 1994]
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DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
40 CFR Part 180
[PP 9F3699, 9F3793 and 9F3799/R2057; FRL-4771-1]
RIN 2070-AB78
Pesticide Tolerances for Clofentezine
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes tolerances for residues of the
insecticide clofentezine in or on the following raw agricultural
commodities: peaches, nectarines, almonds, walnuts, apricots and
cherries and for clofentezine and its metabolite 3-(2-cloro-4-
hydroxphenyl)-6-(2-chlorophenyl)-1,2,4,5-tetrazine in or on meat, fat,
and meat byproducts of cattle, goats, hogs, horses, and sheep and milk.
Nor-Am Chemical Co. requested this regulation to establish maximum
permissible levels for residues of the insecticide.
EFFECTIVE DATE: This regulation became effective May 13, 1994.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 9F3699, 9F3793, and 9F3799/R2057], may be
submitted to: Hearing Clerk (1900), Environmental Protection Agency,
Rm. 3708, 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.
FOR FURTHER INFORMATION CONTACT: By mail: Dennis H. Edwards, Jr.,
Product Manager (PM) 19, Registration Division (7505C), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 207, CM #2, 1921 Jefferson Davis
Highway, Arlington, VA 22202, (703)-305-6386.
SUPPLEMENTARY INFORMATION: EPA issued rules, published in the Federal
Registers of June 28, 1990 (55 FR 26438), May 15, 1991 (56 FR 22333),
and June 12, 1991 (56 FR 26911), which announced that Nor-Am Chemical
Co. had submitted pesticide petitions (PP 9F3699, 9F3793, and 9F3799)
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 tolerances for clofentezine in or on peaches at 1.0 part per
million (ppm) and nectarines at 1.0 ppm (PP 9F3699); almond hulls at
5.00 ppm, almond nutmeat at 0.5 ppm, walnuts at 0.02 ppm (PP 9F3793);
apricots at 1.0 ppm and cherries at 1.0 ppm (PP 9F3799). The Agency
established these tolerances with an expiration date of September 30,
1994, to cover residues expected to be present from use during the
period of conditional registration for these uses. The conditional
registrations were to expire September 30, 1993. The Agency recently
extended the conditional registration expiration date to December 31,
1994.
The conditional registration required the following information to
be submitted. These studies were required because the chronic risk of
clofentezine to avian and aquatic species could not be fully evaluated.
1. Avian reproduction studies (bobwhite quail and mallard duck)
were required to be repeated.
2. Two aquatic studies, an aquatic invertebrate life-cycle study
and a fish life-cycle study, were required.
Studies have been submitted and are currently in review, but a
final review is not expected to be completed for some time. However,
the Agency has conducted a preliminary review of these studies and
determined that they are scientifically sound. Therefore, on the basis
of Nor-Am's compliance with the requirements of the conditional
registration, the Agency is removing the expiration date for the
tolerances of the commodities listed above. In the interim, until the
Agency is able to complete its final review and risk assessment a
conditional registration will remain in effect for the commodities
listed above.
In the Federal Register of February 9, 1994 (58 FR 42728), the
Agency announced receipt of a petition from Nor-Am Chemical Co.
requesting to make the tolerances permanent for residues on peaches,
nectarines, almonds, walnuts, apricots, and cherries and in or on meat,
fat, and meat byproducts of cattle, goats, hogs, horses, and sheep. No
comments were received in response to this notice of filing. As
described above, the Agency has decided to remove the expiration date
for these tolerances based on Nor-Am's submittal of the studies
requested in the conditional registration.
Based on the 1-year dog-feeding study with a NOEL of 1.25 mg/kg/day
and using a safety factory of 100, the acceptable daily intake (ADI)
for humans is 0.013 mg/kg of body weight/day. The current action will
contribute .0000519 mg/kg/day of residue to the human diet utilizing an
additional 4.0 percent the ADI. This results in a total utilization of
4.5 percent of the ADI.
The scientific data submitted in the petitions and other relevant
material have been reviewed. The toxicological data considered in
support of these tolerances are discussed in detail in previous final
rules establishing tolerances for clofentezine referenced earlier in
this document, i.e., the Federal Registers of June 28, 1990 (55 FR
26438), May 15, 1991 (56 FR 22333), and June 12, 1991 (56 FR 26911).
The nature of residue is understood. An adequate analytical method,
high-performance liquid chromatography (HPLC), is available for
enforcement. There are presently no actions pending against the
continued registration of this chemical. This pesticide is considered
useful for the purposes for which the tolerances are sought. Based on
the information and data considered, the Agency has determined that the
tolerances established by amending 40 CFR part 180 will protect the
public health. Therefore, the tolerances are 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 objection 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 feed 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 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
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 issue(s) in the manner
sought by the requestor would be adequate to justify the action
requested (40 CFR 17.32).
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 the Executive Order, EPA has determined
that the 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: May 13, 1994.
Douglas D. Campt,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is 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. 180.446, by revising the introductory texts of
paragraphs (b) and (c), to read as follows:
Sec. 180.446 Clofentezine; tolerances for residues.
* * * * *
(b) Tolerances are established for residues of the insecticide
clofentezine (3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine) in or on the
following raw agricultural commodities:
* * * * *
(c) Tolerances are established for the combined residues of
clofentezine and the 3-(2-chloro-4-hydroxyphenyl)-6-(2-chlorophenyl)-
1,2,4,5-tetrazine metabolite in or on the following commodities:
* * * * *
[FR Doc. 94-12697 Filed 5-24-94; 8:45 am]
BILLING CODE 6560-50-F
