pelargonic acid; Exemption from the Requirement of a Tolerance 2/96
[Federal Register: February 15, 1996 (Volume 61, Number 32)]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4F4396/R2202; FRL-5348-9]
Pelargonic Acid; Exemption From the Requirement of a Tolerance on
Apples and Pears
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This rule establishes an exemption from the requirement of a
tolerance for residues of pelargonic acid when used as a blossom
thinning agent on apples and pears. A request for an exemption from the
requirement of a tolerance was submitted by Mycogen Corporation. This
regulation eliminates the need to establish a maximum permissible level
for residues of this plant regulator on apples and pears.
EFFECTIVE DATE: Effective on February 14, 1996.
ADDRESSES: Written objections and hearing requests, identified bythe
docket number [PP 4F4396/R2202] may be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. 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 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 Highway, Arlington, VA. 22202. 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.
FOR FURTHER INFORMATION CONTACT: By mail: Mike Mendelsohn, Biopesticides and
Pollution Prevention Division, Office of Pesticide Programs, U. S.
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: 5th Floor CS, 2800 Crystal Drive, Arlington, VA
22202, (Telephone No. (703)-308-8715), e-mail:
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of February 8, 1995 (60 FR 7539), which announced that
Mycogen Corporation, 4980 Carroll Canyon Rd., San Diego, CA 92121 had
submitted a pesticide petition (PP) 4F4396 to EPA requesting that the
Administrator, pursuant to section 408(d) of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), establish an exemption
from the requirement of a tolerance for the plant growth regulator
pelargonic acid on apples and pears.
There were no adverse comments, or requests for referral to an
advisory committee received in response to the notice of filing of the
I. Existing Food Clearances
Pelargonic acid is an approved secondary direct food additive under
21 CFR 173.315 for use in the lye peeling of fruits and vegetables. An
aliphatic acid mixture of valeric, caproic, enanthoic, caprylic and
pelargonic acids may be used at a level not to exceed 1 percent in a
lye peeling solution. The conditions for use include a stipulation that
following the use of chemicals cleared under 21 CFR 173.315 the fruit and
vegetables must be rinsed with potable water to remove, to the extent
possible, residues of the chemical.
Pelargonic acid is listed by the U.S. Department of Agriculture
under the USDA List of Authorized Substances, 1990, section 5.14, Fruit
and Vegetable Washing Compounds.
Pelargonic acid is approved as part of a sanitizing solution for
use on food-processing equipment and utensils, and dairyprocessing
equipment. Its use must be in combination with decanoic acid,
phosphoric acid, propionic acid, and sodium 1octanesulfonate. The
pelargonic acid-containing sanitizing solution must be drained from the
treated equipment and utensils before contact with food. (21 CFR
Pelargonic acid also is approved as a synthetic food flavoring
agent (21 CFR 172.515) provided the minimum quantity required to
produce its intended effect is used in accordance with the principles
of good manufacturing practice.
II. Pelargonic Acid Natural Occurrence and Treated Apple Residue Data
Pelargonic acid is naturally present at levels up to 224 parts per
billion (ppb) in apples, 385 parts per million (ppm) in the skin of
grapes, and 143 ppm in grape pulp. It has been determined to be present
in a number of other foods as well. The highest residues of pelargonic
acid reported in apples subsequent to blossom treatment were less than
A. Toxicology Assessment; Supporting Data
1. Acute toxicology of a 60% pelargonic acid emulsifiable concentrate.
Acute Oral LD50 > 5,000 mg/kg
Acute Dermal LD50 > 2,000 mg/kg
Acute Inhalation LC50 = 5.29 mg/L
Primary Dermal Irritation - Moderate Irritant
Primary Eye Irritation - Severe Irritant
Dermal Sensitization - Non-sensitizer
2. Mammalian cells in culture gene mutation assay in mouse lymphoma
cells (L5178Y TK <plus-minus>). Pelargonic acid was considered weakly
positive for inducing mutations at the TK locus of culture mouse L5178Y
TK <plus-minus> cells in the presence of S9-induced metabolic
activation. Mutations were induced at levels greater than or equal to
50 <greek-m>g/ml. However, this occurred in the presence of increasing
moderate-to-severe cytotoxicity and small colony development and may
reflect gross chromosomal changes or damage rather than actual
mutational changes within the TK gene locus.
3. In vivo mammalian cytogenetics - mouse micronucleus assay. In an
in vivo mouse micronucleus assay, groups of ICR mice (15/sex/dose)
were administered single oral doses of 1,250, 2,500, and 5,000 mg/kg n-
pelargonic acid. The bone marrow cells were harvested 24, 48, and 72
hours post-treatment. No significant increases in the frequency of
micronucleated polychromatic erythrocytes (PCEs) were observed in
either sex at any dose; thus, n-pelargonic acid was negative in the
4. Reverse gene mutation assay (Ames Test). Pelargonic acid was not
mutagenic under the conditions of the study.
5. Metabolism. Pelargonic acid is a naturally occurring, nine-
carbon saturated fatty acid. The oxidative degradation of fatty acids
is a central metabolic pathway in both animals and plants. Fatty acids
of varying chain lengths are metabolized into two-carbon fragments
through a sequence of enzyme-catalyzed reactions. The metabolic
products are then incorporated into fats, carbohydrates and amino
6. Carcinogenicity. A summary of the results of a dermal
carcinogenicity study in mice with pelargonic acid was submitted. Fifty
mice were treated twice-weekly with 50 mg doses of undiluted pelargonic
acid for 80 weeks. No evidence of severe dermal or systemic toxicity
was seen. Histopathology revealed no tumors of the skin or the internal
7. Developmental toxicity. The results of a developmental toxicity
study in rats with pelargonic acid was submitted. Groups of 22 pregnant
CD rats were given oral administration of 0 mg (corn oil) or 1,500 mg/
kg pelargonic acid during days 6 through 15 of gestation. No evidence
of maternal toxicity was seen. Maternal body weights and weight gain
were comparable to that of the controls. No treatment-related effects
were seen at C-section. No developmental toxicity was seen. Based on
the above information, EPA concludes that the quantity of pelargonic
acid that is proposed for use will not be harmful to humans since:
(1) The lowest level shown to weakly induce mutations in an in
vitro test system in the presence of cytotoxicity was at the 50,000
parts per million level and the highest residues seen in treated apples
were less than 360 parts per billion (ppb).
(2) Other than weak mutation at high levels in an in vitro test
system and eye irritation, the data on pelargonic acid show no other
(3) The maximum application rate of pelargonic acid for blossom-
thinning is 4.2 pounds per acre in a spray solution containing up to
0.31% pelargonic acid.
(4) Pelargonic acid is applied before fruit set.
B. Analytical Enforcement Method
This rule establishes an exemption from the requirement of a
tolerance; therefore, the Agency has concluded that a analytical method
is not required for enforcement purposes for pelargonic acid.
Based on the low toxicity of pelargonic acid and the low residue
levels expected in apples and pears, the Agency concludes that
establishment of a tolerance is not necessary to protect the public
health for blossom thinning uses. Therefore, the exemption from
tolerance is established as set forth below.
IV. Filing of Objections
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).
V. Regulatory Assessment Requirements
A. Executive Order 12866
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 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
B. Regulatory Flexibility Act
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
Dated: February 6, 1996.
Daniel1 M. Barolo,
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. In subpart D, by adding Sec. 180.1159, to read as follows:
Sec. 180.1159 Pelargonic acid.
Pelargonic acid is exempt from the requirement of a tolerance on
apples and pears provided it is used as a blossom thinner only and is
in a dilution of 100 gallons of water applied to blooms at a rate not
to exceed 4.2 lbs/acre with the maximum number of applications not
exceeding two per year.