[Federal Register Volume 60, Number 104 (Wednesday, May 31, 1995)]
[Rules and Regulations]
[Pages 28345-28347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13250]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4F4280/R2135; FRL-4954-4]
RIN 2070-AB78
Benzoic Acid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes a tolerance for residues of the
insecticide benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl)hydrazide, in or on the raw agricultural commodity
walnuts. The Rohm & Haas Co. requested this regulation pursuant to the
Federal Food, Drug and Cosmetic Act (FFDCA). The regulation establishes
a maximum permissible level for residues of benzoic acid in or on the
commodity.
EFFECTIVE DATE: This regulation becomes effective May 31, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 4F4280/R2135], may be submitted to:
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M
St., SW., Washington, DC 20460. 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 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.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected]. 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
4F4280/R2135]. 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: Richard P. Keigwin, Jr.,
Product Manager (PM) 10, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: Rm. 214, CM
#2, 1921 Jefferson Davis Highway, Arlington, VA 22202, (703)-305-7001;
e-mail: K[email protected].
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of April 5, 1995 (60 FR 17357), which announced that
Rohm & Haas Co. had submitted pesticide petition PP 4F4280 to EPA
requesting that the Administrator, pursuant to section 408(d) of the
Federal Food, [[Page 28346]] Drug, and Cosmetic Act (FFDCA), 21 U.S.C.
346a(d), establish a tolerance for residues of the insecticide benzoic
acid, 3,5-dimethyl-1,1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide,
in or on the raw agricultural commodity walnuts at 0.1 part per million
(ppm).
The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological data considered in
support of the tolerance include:
1. A 1-year dog feeding study with a lowest-observable-effect level
(LOEL) of 250 ppm (9 mg/kg/day for male and female dogs ) based on
decreases in RBC, HCT, and HGB, increases in Heinz bodies,
methemoglobin, MCV, MCH, reticulocytes, platelets, plasma total
bilirubin, spleen weight, and spleen/body weight ratio, and liver
weight and liver/body weight ratio. Hematopoiesis and sinusoidal
engorgement occurred in the spleen, and hyperplasia occurred in the
marrow of the femur and sternum. The liver showed an increased pigment
in the Kupffer cells. The no-observable-effect level (NOEL) for
systemic toxicity in both sexes is 50 ppm (1.9 mg/kg/day).
2. An 18-month mouse carcinogenicity study with no carcinogenicity
observed at dosage levels up to and including 1,000 ppm.
3. A 2-year rat carcinogenicity study with no carcinogenicity
observed at dosage levels up to and including 2,000 ppm (97 mg/kg/day
and 125 mg/kg/day for males and females, repectively).
4. A two-generation rat reproduction study with a NOEL of 150 ppm
(12.1 mg/kg/day) for reproductive effects compared to a systemic NOEL
of 10 ppm (0.85 mg/kg/day).
5. A rat developmental study with a NOEL of 1,000 mg/kg/day for
developmental toxicity.
6. A rabbit developmental study with a NOEL of 1,000 mg/kg/day for
developmental toxicity.
7. Several mutagenicity tests which were all negative. These
include an Ames assay with and without metabolic activation, an in vivo
cytogenetic assay in rat bone marrow cells, an in vitro chromosome
aberration assay in CHO cells, a CHO/HGPRT assay, a reverse mutation
assay with E. coli, and an unscheduled DNA synthesis assay (UDS) in rat
hepatocytes.
The reference dose (RfD), for chronic toxicity as defined in a 1-
year chronic dog study is 0.019 mg/kg/day based upon a NOEL of 1.9 mg/
kg/day in dogs of both sexes and applying an uncertainty factor of 100.
The theoretical maximum residue contribution (TMRC) for this first food
use of benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl)hydrazide on walnuts for the overall U.S. population is
less than 0.000001 mg/kg/day and represents 0.003% of the RfD. The TMRC
for the highest exposed subgroup, children (ages 1 6 years old), is
less than 0.000001 mg/kg/day and represents 0.008% of the RfD.
The metabolism of benzoic acid, 3,5-dimethyl-1-(1,1dimethylethyl)-
2-(4-ethylbenzoyl)hyrazide, is adequately understood. An adequate
analytical method, HPLC separation with UV detection, is available for
enforcement purposes and is being provided to FDA for inclusion in the
Pesticide Analytical manual, Vol. II.
There are currently no actions pending against the registration of
this chemical. There is no expectation of residues occurring in meat,
milk, poultry, or eggs from this tolerance.
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 docket
number [PP 4F4280/R2135] (including objections and hearing requests
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 Rm. 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.
Written objections and hearing requests, identified by the document
control number [PP 4F4280/R2135], may be submitted to the Hearing Clerk
(1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW.,
Washington, DC 20460.
A copy of electronic objections and hearing requests can be sent
directly to EPA at:
opp-D[email protected]
A copy of electronic objections and hearing requests 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 any 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 objections and hearing requests 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 [[Page 28347]] 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: May 12, 1995.
Daniel M. Barolo,
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. By adding new Sec. 180.842, to read as follows:
Sec. 180.842 Benzoic acid; tolerances for residues.
A tolerance is established for residues of the insecticide benzoic
acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide,
in or on the following raw agricultural commodity:
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Parts per
Commodity million
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Walnuts.................................................... 0.1
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[FR Doc. 95-13250 Filed 5-30-95; 8:45 am]
BILLING CODE 6560-50-F