[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:

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
                                                                        
Walnuts....................................................          0.1
                                                                        
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[FR Doc. 95-13250 Filed 5-30-95; 8:45 am]
BILLING CODE 6560-50-F