[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: opp-docket@epamail.epa.gov. 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:
giles-parker.cynthia@epamail.epa.gov.
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:
opp-docket@epamail.epa.gov
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
