[Federal Register Volume 62, Number 29 (Wednesday, February 12, 1997)]
[Notices]
[Pages 6528-6530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3227]


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ENVIRONMENTAL PROTECTION AGENCY
[PF-694; FRL-5583-9]


Nayfa Industries Inc.; Pesticide Tolerance Petition Filing

AGENCY: Environmental Protection Agency (EPA)

ACTION: Notice of filing.

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SUMMARY: This notice announces the filing of a pesticide petition 
proposing an exemption from the requirement of a tolerance for residues 
of propionic acid in or on sugarbeet, potatoes and sweet potatoes. This 
notice includes a summary of the petition prepared by the petitioner 
Nayfa Industries Inc.

DATES: Comments, identified by the docket control number [PF-694], must 
be received on or before, March 14, 1997.

ADDRESSES: By mail, submit written comments to Public Response and 
Program Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M Street, SW., 
Washington, DC 20460. In person, bring comments to Rm. 1132, CM #2, 
1921 Jefferson Davis Highway, Arlington, VA 22202. Comments and data 
may also be submitted electronically by sending electronic mail (e-
mail) to: [email protected]. Electronic comments on this 
notice may be filed online at many Federal Depository Libraries. 
Additional information on electronic submissions can be found below 
this document.
    Information submitted as comments concerning this document may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). CBI should not be 
submitted through e-mail. Information marked as CBI 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 4:30 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Cynthia Giles-Parker, Product Manager 
(PM) 22, Registration Division, (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M. St., SW., Washington, DC. 
Office location, telephone number and e-mail address: Rm. 229, CM#2, 
1921 Jefferson Davis Highway, Arlington, VA 703-305-7740. e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition (PP) 
6F4770 from Nayfa Industries, Inc., c/o 1625 K St., NW., Suite 501, 
Washington, DC 20006, proposing pursuant to section 408(d) of the 
Federal Food, Drug and Cosmetic Act, 21 U.S.C. section 346(d), to amend 
40 CFR part 180 by an exemption from the requirement of a tolerance for 
residues of the herbicide propionic acid in or on the raw agricultural 
commodities sugarbeets, potatoes and sweet potatoes. EPA has determined 
that the petition contains data or information regarding the elements 
set forth in section 408(d)(2); however, EPA has not fully evaluated 
the sufficiency of the submitted data at this time or whether the data 
supports granting of the petition. Additional data may be needed before 
EPA rules on the petition.
    As required by section 408(d) of the FFDCA, as recently amended by 
the Food Quality Protection Act, Nayfa Industries, Inc. included in the 
petition a summary of the petition and authorization for the summary to 
be published in the Federal Register in a notice of receipt of the 
petition. The summary represents the views of Nayfa Industries, Inc. 
EPA is in the process of evaluating the petition. As required by 
section 408(d)(3) EPA is including the summary as a part of this notice 
of filing. EPA has made minor edits to the summary for the purpose of 
clarity.

I. Petition Summary

A. Residue Chemistry

    Propionic acid is currently exempt from the requirement of a 
tolerance (40 CFR 180.1023), when used as a fungicide for postharvest 
application to prevent fungal growth. The raw agricultural commodities 
include oat, corn, barley, wheat, rice and sorghum grains, hay, 
alfalfa, clover, cottonseed, timothy, vetch, sudan grass, rye grass, 
peanuts, orchard grass, lespedeza, fescue, brome grass, lupines, 
soybeans, Bermuda grass and bluegrass, cowpea, peanut, peavine and 
soybean hays, livestock and poultry drinking water, storage areas for 
silage and grain, and poultry litter.
    The formula statements dated January 4, 1991 are acceptable and 
have been included in this file. It is understood that the use of 
methylene chloride in this formulation is no longer consistent with the 
terms of its registration.
    Propionic acid naturally occurs in animals and in dairy products in 
small amounts. It is Generally Recognized As Safe (GRAS) [21 CFR 
184.1081], by FDA for use in food. Propionic Acid is exempt from the 
requirement of a tolerance when applied (as an inert ingredient) to 
growing crops or to raw agricultural commodities after harvest as 
described in 40 CFR 180.1001(c).
    Nayfa Industries, Inc. requested Residue Chemistry Data Waivers: 
All the residue chemistry data requirements covered under 40 CFR part 
158 (Guideline Series 171) which covers nature of residues in plants 
and animals; residue analytical methods for plants and animals; storage 
stability; magnitude of residues in sugarbeets, potatoes, and sweet 
potatoes and their processed products, meat, milk, poultry and eggs. 
The bases for waivers are prior clearances for propionic acid by EPA 
and FDA. The Agency has determined that propionic acid as an active 
ingredient in registered products may be used for both human food and 
animal feed.

B. Toxicological Profile

    1. Acute toxicity. Acute oral: > 2 g/kg (Category III); acute 
dermal: > 2 g/kg (Category III); acute inhalation: > 0.5 through 5 mg/L 
(Category III); eye irritation: corrosive (Category I); dermal 
irritation: corrosive (Category I); skin sensitization: not available 
and Nayfa believes this data requirement should be waived.
    Contact with concentrated solutions of propionic acid may cause 
local damage to skin, eye, or mucosa. Tissue necrosis was caused by 10 
mg/24 hr with propionic acid in a rabbit skin irritation test, but the 
same quantity of propionic acid as a 10 percent solution in acetone had 
little effect. The acid has been called moderately toxic for rabbits 
but corrosive for guinea pigs in skin irritation tests. Rats survived 
an eight hour exposure to concentrated vapor of propionic acid.
    2. Genotoxicity. Propionic acid gave negative results in 
mutagenicity assays in 5 strains of Salmonella typhimurium

[[Page 6529]]

and one of Saccharomyces cerevisiae, with and without activation.
    Additional data on calcium and sodium propionate indicate that:
    a. Calcium propionate tested in three strains of S. typhimurium and 
one strain of S. cerevisiae, with several activation systems, gave 
negative results.
    b. Sodium propionate showed higher incidence of abnormalities in 
developing chick embryos only at the highest level (10 mg/egg) by air 
cell administration, not in yolk treatment; however, 5 and 10 mg/egg 
levels had increased mortality.
    3. Reproductive and developmental toxicity. Based on the available 
data:
    a. No maternal or fetal effects were seen upon feeding calcium 
propionate to pregnant animals at rates up to 300 mg/kg/day for rats 
and mice, or up to 400 mg/kg/day for hamsters and rabbits.
    b. No teratogenicity was found in developing chick embryos when up 
to 100 mg/kg calcium propionate was injected into the yolk or air cell, 
although there was increased mortality at 5 and 10 mg/kg.
    4. Subchronic toxicity. Data on calcium and sodium propionate were 
used to assess subchronic toxicity of propionic acid. When rats were 
fed calcium or sodium propionate at 1 percent of the diet (equivalent 
to about 750 mg/kg/day of propionic acid) for 4 weeks followed by 3 
percent (equivalent to about 1,200 mg/kg/day propionic acid) for 3 
weeks, they had no changes in weight gain compared to controls. Rats 
fed 5 percent propionic acid in the diet (about 5,000 mg/kg body 
weight) for 110 days developed lesions of the forestomach.
    Propionic acid was given in the feed to dogs at 220, 735, or 2,066 
mg/kg/day (3,000, 10,000, and 30,000 ppm) for 90 days. The high dose 
dogs showed reduced food consumption, increased incidence of epithelial 
hyperplasia in the esophagus, and increased nitrite in the urine. These 
effects were no longer present in dogs held for a 6 week recovery 
period. A limited study with calcium propionate in dogs for 90 days 
showed vomiting and diarrhea in animals fed 2,523 mg/kg/day (43,500 
ppm).
    Addition of sodium propionate to the diet of chicks and young rats 
accentuated the growth depression seen when their diet was deficient in 
vitamin B12. Body weight gain in young lambs was not affected by 5,600 
mg/kg/day of sodium propionate in the diet for 50 days.
    When an adult male human was fed 6.0 g/day sodium propionate, the 
only effect noted was slightly alkaline urine.
    5. Chronic toxicity. Twenty male rats per group were fed 0.4 or 4.0 
percent propionic acid in the diet for 2 years. The high dose animals 
had hyperplasia and hyperplastic ulcers in the forestomach. (The rat 
forestomach has no counterpart in human anatomy).
    Data on calcium and sodium propionate indicate that rats fed bread 
containing sodium propionate (4,000 mg/kg/day) for a year showed no 
adverse effects, nor did rats fed a similar diet for 32 weeks, other 
than an initial depression of growth.
    6. Animal metabolism. Propionic acid is rapidly absorbed from the 
mammalian gastro-intestinal tract. Propionic acid is a normal 
intermediary metabolite in the body. It is utilized by most organs and 
tissues, and can be metabolized to glucose, carbohydrates, amino acids, 
and lipids. It is produced in large quantities in ruminants. In non-
ruminants, propionic acid is one of the metabolic products from the 
breakdown of several amino acids. Propionic acid is formed in the 
oxidation of fatty acids and from the side chain of cholesterol.
    7. Metabolite toxicology. All the metabolites of propionic acid are 
naturally occurring and are utilized by humans and animals. Nayfa 
believes that the metabolite toxicity data requirements should be 
waived because these metabolites are not of toxicological concern.

C. Aggregate Exposure

    1. Dietary exposure. Since propionic acid is utilized by most 
organs and tissues, and is metabolized to glucose, carbohydrates, amino 
acids and lipids when ingested by livestock and poultry, residues in 
meat, milk or poultry are considered to be negligible. Propionic acid 
or mixtures of methylene bispropionate and oxy (bismethylene) 
bispropionate are exempt from the requirements of a tolerance when used 
as a post-harvest fungicide on alfalfa, barley grain, Bermuda grass, 
bluegrass, brome grass, clover, corn grain, cowpea hay, fescue, 
lespedeza, lupines, oat grain, orchard grass, peanut hay, peavine hay, 
rye grass, sorghum grain, soybean hay, sudan grass, timothy, vetch, and 
wheat grain (40 CFR 180.1023). Propionic acid is also exempt from the 
requirement of a tolerance when applied (as an inert ingredient) to 
growing crops or to raw agricultural commodities after harvest as 
described in 40 CFR 180.1001(c). Propionic acid is Generally Recognized 
As Safe (GRAS) (21 CFR 184.1081), by FDA for use in food.
    2. Non-dietary exposure. The only non-dietary exposure to propionic 
acid is the occupational exposure. Propionic acid end-use products are 
sprayed on grain and forage at application rates ranging from 1 - 4 
gallons of 85% - 100% a.i., depending on the moisture content of grain 
or forage, and type and length of storage desired. They are also 
applied to livestock and poultry drinking water and grain storage 
areas. Based on the use patterns, the potential exposure of applicators 
to propionic acid could be significant as well as to workers in the 
spray area. The potential for post-application exposure should be 
minimal (assuming the area is adequately ventilated).
    Certain protective clothing is appropriate for propionic acid users 
due to eye and skin hazards. The Agency requires applicators to wear 
protective clothing if the products contain in excess of 63% propionic 
acid as active ingredient.

D. Cumulative Effects

    1. Environmental fate assessment. Under anaerobic conditions 
propionic acid acts as a carbon source for various microbes and is 
metabolized to acetic acid, methane, carbon dioxide and water. The only 
incident reports concerning propionic acid were detections in the 
tissue of the mussel (Mytilus Sdulis) and in ground water as the result 
of the break-down of petroleum pollution. All environmental fate data 
requirements are waived for the currently registered uses based on the 
fact that propionic acid tends to be used as a carbon source by many 
microbes and is metabolized to carbon dioxide and water.

E. Safety Determination

    1. Human health assessment.
    a. U.S. population. Propionic acid is a normal component of 
metabolism in the human body and humans ordinarily consume propionic 
acid as a natural component of common foods and as an added ingredient. 
It is a natural component of butter and cheese, and may constitute as 
much as 1 percent of Swiss cheese. Dietary exposure from pesticidal use 
would be very low.
    b. Infants and children. As noted above, propionic acid is produced 
by human body. The humans include not only adult population but also 
children and infants who receive propionic acid through common foods 
including those that contain this ingredient as a food additive. 
Additionally, children and infants consume dairy products such as 
butter and cheese which contain propionic acid. Therefore, dietary 
exposure from pesticidal use would be very minimal.

[[Page 6530]]

F. International Tolerances

    There are no known international tolerances for residues of 
propionic acid in food or animal feed.

G. Tolerance Exemptions for Proposed Uses

    The petitioner proposes new uses which include application of 
propionic acid to sugar beets, potatoes and sweet potatoes. The 
petitioner requests tolerance exemption for residues of propionic acid 
in or on sugar beets, potatoes and sweet potatoes. The petitioner also 
requests waivers for all tests for determining the residues including 
the analytical method.
    The petitioner proposes tolerance exemption for propionic acid for 
its use on or in:
    a. Sugarbeets (stored sugarbeets and seed sugarbeets, and also 
dried-pulp and dried-molasses intended for animal feed);
    b. Potatoes (stored potatoes - marketable and frozen and stored 
seed potatoes, and also stored potatoes for animal feed); and,
    c. Sweet potatoes (stored sweet potato and stored seed sweet 
potatoes).
    The maximum amount of propionic acid applied to these RACs during 
storage will be 6 lb/ton.

II. Administrative Matters

    EPA invites interested persons to submit comments on this notice of 
filing. Comments must bear a notification indicating the document 
control number [PF-694]. All written comments filed in response to this 
petition will be available, in the Public Response and Program 
Resources Branch, at the address given above from 8:30 a.m. to 4 p.m., 
Monday through Friday, except legal holidays.
    A record has been established for this notice under docket control 
number [PF-694] (including comments and data 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 8:30 
a.m. to 4 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.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this notice, as well as the public version, 
as described above will be kept in paper form. Accordingly, EPA will 
transfer all comments received electronically into printed, paper form 
as they are received and will place the paper copies in the official 
record which will also include all comments submitted directly in 
writing. The official record is the paper record maintained at the 
address in ``ADDRESSEES'' at the beginning of this document.

    Authority: 21 U.S.C. 346a.

List of Subjects

    Environmental Protection, Administrative practice and procedure, 
Agricultural commodities, pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 3, 1997.

Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.

[FR Doc. 97-3227 Filed 2-11-97; 8:45 am]
BILLING CODE 6560-50-F