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napropamide (Devrinol) Proposed Pesticide Tolerance 4/93

Pesticide Tolerance for N,N-Diethyl-2-(1-Naphthalenyloxy) Propionamide 
AGENCY: Environmental Protection Agency (EPA). 
ACTION: Proposed rule. 
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SUMMARY: This document proposes that a tolerance be established 
for residues of the herbicide N,N-diethyl-2-(1-naphthalenyloxy) 
propionamide (also referred to as napropamide) in or on the 
raw agricultural commodity sweet potato. The proposed regulation 
to establish a maximum permissible level for residues of the 
herbicide in or on the commodity was requested in a petition 
submitted by the 
Interregional Research Project No. 4 (IR-4). 
DATES: Comments, identified by the document control number [PP 
2E4108/P558], must be received on or before May 14, 1993. 
ADDRESSES: By mail, submit written comments to: Public Response 
and Program Resources Branch, Field Operations Division (H7506C), 
Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. In person, bring comments 
to: Rm. 1132, CM 1B2, 1921 Jefferson Davis Hwy., Arlington, 
VA 22202.
   Information submitted as a comment concerning this document 
may be claimed confidential by marking any part or all of that 
information as "Confidential Business Information" (CBI). Information 
so marked will not be disclosed except in accordance with procedures 
set forth in 40 CFR part 2. A copy of the comment that does 
not contain CBI must be submitted for inclusion in the public 
record. Information not marked confidential may be disclosed 
publicly by EPA without prior notice. All written comments will 
be available for public inspection in Rm. 1132 at the address 
given above, from 8 a.m. to 4 p.m., Monday through Friday, excluding 
legal holidays. 
FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson, 
Emergency Response and Minor Use Section (H7505W), Registration 
Division, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location and telephone number: 6th Floor, CS 
1B1, 2800 Jefferson Davis Hwy., Arlington, VA 22202, (703)-
308-8783. 
SUPPLEMENTARY INFORMATION: The Interregional Research Project 
No. 4 (IR-4), New Jersey Agricultural Experiment Station, P.O. 
Box 231, Rutgers University, New Brunswick, NJ 08903, has submitted 
pesticide petition (PP) 2E4108 to EPA on behalf of the Agricultural 
Experiment Stations of California, North Carolina, and Louisiana. 
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 N,N-diethyl-2-(1-naphthalenyloxy)propionamide 
in or on the raw agricultural commodity sweet potato at 0.1 
part per million (ppm).
   The data submitted in the petition and other relevant material 
have been evaluated. The 
toxicological data considered in support 
of the proposed tolerance include:
   1. A chronic toxicity feeding study in dogs fed diets containing 
10, 70, or 500 milligrams (mg)/kilogram (kg)/day with a no-observed-
effect level (NOEL) of 70 mg/kg day based on decreased body 
weight gain and food consumption in male and female beagle dogs.
   2. A development toxicity study in rats given gavage dosages 
of 100, 300, or 1,000 mg/kg with a maternal NOEL of 300 mg/kg/day 
based on decreased body weight gain and no developmental toxicity 
observed under the conditions of the study.
   3. A developmental toxicity study in rabbits given gavage 
dosages of 100, 300, or 1,000 mg/kg with a maternal NOEL of 
300 mg/kg/day based on decreased body weight gain and decreased 
food consumption at the highest dose tested (1,000 mg/kg/day) 
and no developmental toxicity observed under the conditions 
of the study.
   4. A three-generation reproduction study in rats fed diets 
containing 10, 30, or 100 mg/kg/day with NOEL's for parental 
and fetal effects (decreased weight gain) at 30 mg/kg/day. No 
reproductive effects were observed under the conditions of the 
study.
   5. A 2-year feeding/carcinogenicity study in rats fed diets 
containing 10, 30, or 100 
mg/kg/day with a systemic NOEL of 
30 mg/kg/day based on body weight inhibition at the 100 mg/kg/day 
dose. There were no carcinogenic effects observed under the 
conditions of the study at any dosage level tested.
   6. A 2-year carcinogenicity study in mice fed diets containing 
60, 450, 3,500 or 7,000 ppm with NOEL's for systemic effects 
of 450 ppm (equivalent to 55/70 mg/kg/day for male/female) based 
on decreased body weight gain. The study was negative for carcinogenic 
effects at all dosage levels tested.
   7. Napropamide did not induce gene mutation in bacteria (Ames 
test). Napropamide did not induce forward mutations in Chinese 
hamster ovary cells, and no unscheduled DNA synthesis was noted 
in tests using primary hepatocytes from male rats. Napropamide 
did induce gene mutation in Chinese hamster lung cells with 
S9 activation, but was negative without S9 activation.
   Data current lacking include other genotoxic effects, and 
a general metabolism study.
   The reference dose (RfD), based on the three-generation reproduction 
study in rats with a NOEL of 30 mg/kg/day and using an uncertainty 
factor of 300, is calculated to be 0.1 mg/kg of body weight 
(bw)/day. The theoretical maximum residue contribution (TMRC) 
from published tolerances and the proposed tolerance for sweet 
potatoes utilizes less 
than 1 percent of the RfD for the general 
population, and 2 percent of the RfD for the most highly exposed 
subgroup (nonnursing infants less than 1 year old).
   The nature of the residue is adequately understood for the 
purpose of this tolerance. An adequate analytical method, gas 
chromatography, is available for enforcement purposes in the 
Pesticide Analytical Manual, Vol. II (PAM-II).
   No secondary residues are expected to occur in meat, milk, 
poultry, or eggs since sweet potato is not considered a livestock 
feed item. There are presently no actions pending against the 
continued registration of this chemical.
   Based on the above information considered by the Agency, 
the tolerance established by amending 40 CFR 180.328 would protect 
the public health. Therefore, it is proposed that the tolerance 
be established as set forth below.
   Any person who has registered or submitted an application 
for registration of a pesticide, under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) as amended, which contains 
any of the ingredients listed herein, may request within 30 
days after publication of this notice in the Federal Register 
that this rulemaking proposal be referred to an Advisory Committee 
in accordance with section 408(e) of the Federal Food, Drug, 
and Cosmetic Act.
   Interested persons are invited to submit written comments 
on the proposed regulation. Comments must bear a notation indicating 
the document control number, [PP 2E4108/P558]. All written comments 
filed in response to this petition will be available in the 
Public Response and Program Resource Branch, at the address 
given above from 8 a.m. to 4 p.m., Monday through Friday, except 
legal holidays.
   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: April 2, 1993.
Lawrence E. Culleen,
Acting Director, Registration Division, Office of Pesticide 
Programs.
   Therefore, it is proposed that 40 CFR part 180 be 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 1A180.328, paragraph (a) table is amended by adding 
and alphabetically inserting the raw agricultural commodity 
sweet potato, to read as follows:
1A180.328   N,N-Diethyl-2-
(1-naphthalenyloxy)propionamide; 
tolerances for residues. 
   (a) * * *
                                                                              
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                          Commodities                             Parts per   
                                                                   million    
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               *              *              *              *              *  
Sweet potato...................................................          0.1  
                                                                              
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[FR Doc. 93-8728 Filed 4-13-93; 8:45 am]
BILLING CODE 6560-50-F</ARTICLE>