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pelargonic acid; Exemption from the Requirement of a Tolerance 2/96

[Federal Register: February 15, 1996 (Volume 61, Number 32)]
[Page 5976-5977]
40 CFR Part 180
[PP 4F4396/R2202; FRL-5348-9]
RIN 2070-AC78
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 
PP 4F4396.
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 
360 ppb.
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 
micronucleus assay.
    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 
adverse effects.
    (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.
III. Conclusion
    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 
OMB review.
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 
recordkeeping requirements.
    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.