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clomazone (Command) Pesticide Tolerance 3/93

40 CFR Part 180
[PP 0E3844/R1131; FRL-3946-8]
RIN 2070-AB78
Pesticide Tolerance for 2-(2-Chlorophenyl)Methyl-4,4-Dimethyl-
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
40 CFR Part 180
[PP 0E3844/R1131; FRL-3946-8]
RIN 2070-AB78
Pesticide Tolerance for 2-(2-Chlorophenyl)Methyl-4,4-Dimethyl-
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This document establishes a tolerance for the residues 
of the herbicide 2-(2-chlorophenyl)methyl-4,4-dimethyl-3-isoxazolidinone 
(also referred to as clomazone) in or on the raw agricultural 
commodity winter squash. This regulation was requested in a 
petition submitted by the Interregional Research Project No. 
4 (IR-4). 
EFFECTIVE DATE: This regulation becomes effective March 24, 
ADDRESSES: Written objections, identified by the document control 
number, [PP 0E3844/R1131], may be submitted to: Hearing Clerk 
(A-110), Environmental Protection Agency, rm. M3708, 401 M St., 
SW., Washington, DC 20460.
FOR FURTHER INFORMATION CONTACT: By mail: Hoyt Jamerson, Emergency 
Response and Minor Use Section (H-7505W), Registration Division, 
Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location and telephone number: No. 1, 6th Floor, 
CS #1, 2800 Jefferson Davis Highway, Arlington, VA 22202, (703)-
SUPPLEMENTARY INFORMATION: In the Federal Register of August 
28, 1991 (56 FR 42574), EPA issued a proposed rule that gave 
notice that the Interregional Research Project No. 4 (IR-4), 
New Jersey Agricultural Experiment Station, P.O. Box 231, Rutgers 
University, New Brunswick, NJ 08903, had submitted pesticide 
petition (PP) 0E3844 to EPA on behalf of the IR-4 and the Agricultural 
Experiment Stations of New Jersey, North Carolina, and Tennessee.
   The petition requested that the Administrator, pursuant to 
section 408(e) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 346a(e)), propose the establishment of a tolerance for 
residues of the herbicide 2-(2-chlorophenyl)methyl-4,4-dimethyl-
3-isoxazolidinone in or on the raw agricultural commodity winter 
squash at 0.1 part per million (ppm).
   There were no requests for referral to an advisory committee 
received in response to the proposed rule.
   However, one comment was received opposing the proposed establishment 
of the tolerance in or on winter squash. The commenter, generally, 
asserts that EPA has failed to conclude that the tolerance would 
be protective of the public health. EPA disagrees. The proposed 
rule states, and supports by analysis, that the tolerance would 
result in a negligible increase in dietary exposure to residues 
of clomazone. The tolerance process is highly protective in 
that it is based on the most sensitive animal test results available 
and a combination of highly conservative assumptions and risk 
assessment practices.
   The commenter asserts that the tolerance is unnecessary since 
there is "no actual demonstrated need" for the proposed use 
of clomazone in order to produce an adequate or safe food supply 
and no emergency condition which is uncontrollable with herbicides 
for which tolerances already exist. The commenter implies that 
EPA should not allow the tolerance or use of clomazone on winter 
squash unless EPA can "conclusively and effectively" demonstrate 
that other herbicides, already registered and with tolerances 
for winter squash, are inadequate to provide for a safe and 
reliable supply of that food commodity.
   EPA believes that the commenter has incorrectly interpreted 
the standard for approval of tolerances under FFDCA section 
408. EPA construes the requirement in sec. 408 to consider the 
"necessity for the production of an adequate, wholesome, and 
economical food supply" to prevent the Agency from denying a 
tolerance solely on the basis of a calculation of the risks 
posed by pesticide residues on agricultural products. Instead, 
the Agency must balance these risks against the benefits of 
the pesticide for food production. The commenter's reading of 
the FFDCA would negate this balancing by preventing issuance 
of a tolerance solely on the basis of failure of the pesticide 
to meet one possible aspect of the benefits consideration, i.e., 
essentiality. Although essential pesticides would clearly provide 
large benefits for food production, the statute in no way suggests 
that only essential pesticides provide benefits worthy of consideration 
in the risk/benefit weighing mandated by section 408.
   This construction of FFDCA sec. 408 is supported by sec. 
3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA). EPA must consider the provisions of the FFDCA and 
the FIFRA together and construed in a manner that is harmonious 
if possible, given EPA's overlapping responsibilities under 
the two statutes-to regulate the use of pesticides under FIFRA 
and to regulate pesticide residues in food under FFDCA. FIFRA 
sec. 3(c)(5) provides in part the following:
   The Administrator shall not make any lack of essentiality 
a criterion for denying registration of any pesticide. Where 
two pesticides meet the requirements of this paragraph, one 
should not be registered in preference to the other. 
If EPA were to deny a pesticide tolerance under FFDCA solely 
because there are other adequate pesticides for the affected 
crop, EPA's registration decisions under FIFRA would be negated 
by the tolerance determination. Thus, the FIFRA language on 
essentiality would become a nullity.
   The commenter is further concerned that the tolerance would 
allow the unnecessary introduction of clomazone residues into 
the environment and ground and surface waters of the U.S.
   The Agency points out that the FFDCA is not the mechanism 
through which EPA considers pesticide effects on public health 
that occur through other than dietary routes. FFDCA section 
408 only refers to tolerances on raw agricultural commodities. 
Other pesticidal effects are appropriately considered under 
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
when a pesticide is registered. Under sec. 4(c)(5) of FIFRA, 
the Agency registers a pesticide, generally, if it wll not cause 
"unreasonable adverse effects on the environment." FIFRA sec. 
2(j) defines "environment" to include "water, air, land, and 
all plants and man and other animals living therein, and the 
interrelationships which exist among these."
   The data submitted in the petition and other relevant material 
have been evaluated and discussed in the proposed rule. Based 
on the data and information considered, the Agency concludes 
that the tolerance 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 with the Hearing Clerk, at the address 
given above. 40 CFR 178.20. 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 each such issue, 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 a 
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.
   The Office of Management and Budget has exempted this rule 
from the requirements of section 3 of Executive Order 12291.
   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
   Administrative practice and procedure, Agricultural commodities, 
Pesticides and pests, Reporting and recordkeeping requirements.
Dated: March 15, 1993.
Douglas D. Campt,
Director, 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. Section 180.425 is amended in the table therein by adding 
and alphabetically inserting the raw agricultural commodity 
winter squash, to read as follows:
180.425   2-(2-Chlorophenyl)methyl-4,4-dimethyl-3-isoxazolidinone; 
tolerances for residues.
*     *     *     *     *     
                           Commodity                              Parts per   
               *              *              *              *              *  
Squash, winter.................................................          0.1  
               *              *              *              *              *