[Federal Register Volume 62, Number 100 (Friday, May 23, 1997)]
[Rules and Regulations]
[Pages 28361-28364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13644]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300488/PP-6F04625; FRL-5716-9]
RIN 2070-AB78
Pelargonic Acid; Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes an exemption from the requirement of
a tolerance for residues of pelargonic acid when used as an herbicide
in or on all food commodities. Mycogen Corporation submitted a petition
to EPA under the Federal Food, Drug and Cosmetic Act (FFDCA) as amended
by the Food Quality Protection Act of l996 (FQPA) requesting the
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of this herbicide in or on all food commodities..
EFFECTIVE DATE: May 23, 1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300488/PP 6F04625], may be submitted to:
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M
St., SW., Washington, DC 20460. Fees accompanying objections and
hearing requests shall be labeled ``Tolerance Petition Fees'' and
forwarded to: EPA Headquarters Accounting Operations Branch, OPP
(Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any
objections and hearing requests filed with the Hearing Clerk should be
identified by the docket control number and submitted to: Public
Response and Program Resources 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 Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically to the OPP by sending
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Copies of
objections and hearing requests must be submitted as an ASCII file
avoiding the use of special characters and any form of encryption.
Copies of objections and hearing requests will also be accepted on
disks in WordPerfect in 5.1 file format or ASCII file format. All
copies of objections and hearing requests in electronic form must be
identified by the docket control number [OPP-300488/PP 6F04625]. No
Confidential Business Information (CBI) should be submitted through e-
mail. Electronic copies of objections and hearing requests on this rule
may be filed online at many Federal Depository Libraries. Additional
information on electronic submissions can be found in Unit VIII. of
this preamble.
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, telephone number, and e-mail
address: 5th Floor CS, 2800 Crystal Drive, Arlington, VA 22202, (703)-
308-8715); email: mendelsohn.mike@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 24, 1997
(62 FR 3688)(FRL-5579-3), EPA issued a notice pursuant to section
408(d) of FFDCA, 21 U.S.C. 346a(d) announcing the filing of a pesticide
petition for an exemption from the requirement of a tolerance by
Mycogen Corporation, 4980 Carroll Canyon Rd., San Diego, CA 92121. The
notice contained a summary of the petition prepared by the petitioner
and this summary contained conclusions and arguments to support its
conclusion that the petition complied with the FQPA (Pub. L. 104-170).
The petition requested that 40 CFR 180.1159 be amended to exempt
pelargonic acid from the requirement for a tolerance for all food
commodities (formerly raw agricultural commodities).
There were no comments received in response to the notice of
filing. The data submitted in the petition and other relevant material
have been evaluated. The toxicology data listed below were considered
in support of this exemption from the requirement of a tolerance.
I. Toxicological Profile
Pelargonic acid, at high dose levels, showed no significant effects
in a 14 day feeding study, a chronic dermal study, and a developmental
toxicity study. In addition, there was no mutagenicity in an in vivo
mouse micronucleus assay nor in a Salmonella reverse gene mutation
assay. Further, the purported mutation observed at cytotoxic levels
with S9 activation in the mouse lymphoma assay was determined not
relevant to dietary risk. The results of these studies were determined
applicable to evaluate human risk and the validity, completeness, and
reliability of the available data from the studies were considered.
A. Acute Toxicity
A battery of acute toxicity studies place technical pelargonic acid
in the following Toxicity Categories: primary eye irritation (Toxicity
Category II), primary dermal irritation (Toxicity Category II), oral
toxicity (Toxicity Category IV), dermal and inhalation toxicity
(Toxicity Category III). Based on the results from the sensitization
test, pelargonic acid was not considered a dermal sensitizer. (MRID
Nos. 438435-01, -02, -03, -04, -05, and -06)
B. Mutagenicity
Pelargonic acid was shown not to be mutagenic via the Ames test
(Salmonella/reverse mutation assay) or the in vivo cytogenetics study
using the micronucleus assay (MRID Nos. 436037-02, and -03). In a mouse
lymphoma forward mutation assay, pelargonic acid induced a purported
weak mutagenic response at levels greater than or equal to 50 g/ml in
[[Page 28362]]
mouse TK +/- lymphoma cells in the presence of S9 metabolic activation
(MRID No. 436037-01). However, this event occurred in the presence of
increasing toxicity and may indicate gross chromosomal changes or
damage rather than actual mutational changes within the TK gene locus.
In the review of the blossom thinning tolerance exemption for
pelargonic acid (40 CFR 180.1159), the Agency used the mouse lymphoma
forward mutation assay mentioned above in the determination of
acceptable exposure limits for the active ingredient. The Agency has
reexamined that study along with related testing as part of the review
for the present proposed tolerance. As a result of the second review,
the Agency has determined that the sum of the toxicological information
submitted in support of the pelargonic acid tolerance exemption shows
that it is unnecessary to set dietary limits for the active ingredient
based upon a mutagenicity endpoint.
C. Oral Toxicity
A 14-day range-finding oral toxicity study in rats (MRID No.
438435-07) showed no systemic toxicity with either sex at the highest
dose tested, 20,000 ppm (1,834 mg/kg/day). Further, no adverse effects
on survival, clinical signs, body weight gain, food consumption,
hematology, clinical chemistry or gross pathology were observed. Three
animals per sex per dose were tested and organ weights and
histopathology data were not available. The Agency determined that a
90-day oral study was not necessary for dietary risk assessment due to
the following factors:
1. The lack of effects at extremely high doses in the range
finding study mentioned above. Further, it is doubtful that increasing
the number of animals from 3 to 10 per sex per dose and adding
histopathology data would alter the toxicology profile.
2. The nature of the pelargonic acid (i.e., fatty acid) and its
ubiquity in nature.
3. The use of pelargonic acid as a food additive (21 CFR 172.515
and 21 CFR 173.315).
4. The results from the acute mammalian toxicology studies.
5. The unlikelihood of prolonged human exposure via the oral route
due to the proposed use patterns (i.e., control weeds before planting
and prior to harvesting, burndown weeds to facilitate harvest, harvest
aid or desiccant to root and tuber vegetables, bulb vegetables or
cotton, and blossom thinning in tree fruits)and that dietary exposure
would be minimized via plant metabolism of pelargonic acid through
oxidative degradation pathways common for fatty acids.
D. Chronic Dermal Toxicity
In a chronic toxicity/carcinogenicity study in mice (MRID No.
439618-01), which evaluated the effects of pelargonic acid following
repeated dermal applications of 50 mg per mouse twice a week for 80
weeks, no treatment-related clinical signs of toxicity were observed at
any dose level. For example, mean body weights were similar between
treated and untreated control animals. Histopathology revealed no
treatment-related non-neoplastic or neoplastic lesions either of the
skin or the internal organs. Although classified as supplementary, the
study does provide scientifically valid information and adequately
assesses the chronic toxicity and the carcinogenic potential of
pelargonic acid by the dermal route.
A 90-day dermal study was not deemed necessary for dietary risk
assessment because no evidence of systemic toxicity or carcinogenicity
were observed in mice following repeated dermal applications as well as
limited exposure via the dermal route.
E. Developmental Toxicity
In a developmental toxicity study in rats (MRID No. 438435-08),
treatment had no adverse effects on clinical signs, body weights, body
weight gain, or food/water consumption. No fetal toxicity was observed
between the treated or the untreated controls. Moreover, the mean
number of viable fetuses, early or late resorptions, implantation
sites, corpora lutea, pre- and post-implantation losses, sex ratios and
fetal body weights were comparable to those of the control group. The
no observed effect level (NOEL) for maternal and developmental toxicity
was 1,500 mg/kg/day with the lowest oberved effect level (LOEL) greater
than 1,500 mg/kg/day.
F. Metabolism in Plants and Animals
Pelargonic acid, commonly referred to as nonanoic acid, is a nine
(9)-carbon straight-chain fatty acid found naturally in apples (224
ppb), in the skin of grapes (385 ppm), in grape pulp (143 ppm), and in
other foods such as cheese and milk, rice, beans, oranges, and potatoes
at levels of 10 to 100 ppm (MRID Nos. 429005-01, -02). The oxidative
degradation of fatty acids, such as pelargonic acid, into two (2)-
carbon fragments through enzymatically-catalyzed reactions is a well-
documented central metabolic pathway in animals and plants.
Residue chemistry data were not required for a human health effects
assessment of the subject active ingredient because of the lack of
mammalian toxicity. Both available information concerning the dietary
consumption patterns of consumers, and major identifiable subgroups of
consumers including infants and children, and safety factors which, in
the opinion of experts qualified by scientific training and experience
to evaluate the safety of food additives, are generally recognized as
appropriate for the use of animal experimentation data were not
evaluated because the lack of mammalian toxicity at high levels of
exposure demonstrate the safety of the product at levels above possible
maximum exposure levels.
II. Cumulative Effects
The Agency has considered available information on the cumulative
effects of such residues and other substances that have a common mode
of toxicity. These considerations included the cumulative effects on
infants and children of such residues and other substances with a
common mechanism of toxicity. Because there is no indication of
mammalian toxicity to pelargonic acid, there are no cumulative effects.
III. Aggregate Exposures
The Agency has considered available information on the aggregate
exposure levels of consumers (and major identifiable subgroups of
consumers) to the pesticide chemical residue and to other related
substances. These considerations include dietary exposure under the
tolerance exemption and all other tolerances or exemptions in effect
for the pesticide's chemical residue, and exposure from non-
occupational sources.
Pelargonic acid is cleared by the Food and Drug Administration as a
synthetic food flavoring agent (21 CFR 172.515), as an adjuvant,
production aid and sanitizer to be used in contact with food (21 CFR
178.1010(b)), and in washing or to assist in lye peeling of fruits and
vegetables (up to 1%) (21 CFR 173.315). Application of the end-use
products will not directly contact edible portions of desirable food
commodities. For pelargonic acid's use to control weeds before planting
and as a blossom thinner in tree fruits, dietary exposure would be
minimized via plant metabolism of pelargonic acid through oxidative
degradation pathways common for fatty acids. For pelargonic acid's use
as a harvest aid or desiccant to root and tuber vegetables, bulb
vegetables, or cotton, dietary exposure is minimized by the 24-hour
pre-harvest interval, via
[[Page 28363]]
plant metabolism of pelargonic acid through oxidative degradation
pathways common for fatty acids, and the fact that pelargonic acid is
not systemic. For pelargonic acid's use in controlling weeds prior to
harvesting and burndown of weeds to facilitate harvest, any residues on
food commodities will occur primarily as a result of spray drift. In an
effort to estimate the worst case dietary exposure due to spray drift,
Mycogen used the application of pelargonic acid between grape vine rows
as a model (MRID No. 438435-09). They estimated a worst case deposition
of 10% of the pelargonic acid (not the diluted end-product) applied per
acre with 2 applications at a maximum application rate of 42 lbs
pelargonic acid per acre. Thus, they estimated a maximum application
rate to grapes via spray drift of 8.4 lbs pelargonic acid/acre. Mycogen
then went on to estimate the daily consumption level of pelargonic acid
from treated grapes using the worst case scenario to be 0.397 mg/kg/
day. The Agency agrees that this is a representative worst case and
notes that this exposure dose is well below the highest daily feeding
dose of 1,834 mg/kg/day (20,000 ppm) used in the 14-day oral range-
finding study which showed no signs of toxicity or abnormalities.
Exposure via the skin or inhalation route is possible through
residential use of the herbicide product. Oral exposure may occur from
ingestion of produce and drinking water.
IV. Safety Determination for U.S. Population, Infants and Children
A. Population in General
A determination of safety for the population in general has been
made by the Agency due to the insignificant exposure expected beyond
the naturally occurring background levels, the metabolism of fatty
acids in mammalian systems, and the toxicology profile.
B. Infants and Children
A determination of safety for infants and children has been made by
the Agency due to the insignificant exposure expected beyond the
naturally occurring background levels, the metabolism of fatty acids in
mammalian systems, and the toxicology profile. FFDCA section 408
provides that EPA shall apply an additional tenfold margin of exposure
(safety) for infants and children in the case of threshold effects to
account for pre- and post-natal toxicity and the completeness of the
database unless EPA determines that a different margin of exposure
(safety) will be safe for infants and children. In this instance, EPA
believes there is reliable data to support the conclusion that
pelargonic acid is not toxic to mammals, including infants and
children, and thus there are no threshold effects of concern. As a
result, the provision requiring an additional margin of exposure does
not apply.
V. Endocrine Effects
EPA does not have any information on pelargonic acid regarding
endocrine effects. The Agency is not requiring information on the
endocrine effects of pelargonic acid or any other fatty acids at this
time; Congress allowed 3 years after August 3, 1996, for the Agency to
implement a screening and testing program with respect to endocrine
effects.
VI. Conclusion
There is a reasonable certainty that no harm will result from
aggregate exposure to the United States population, including infants
and children, to pelargonic acid. As a result, EPA modifies the
exemption from tolerance requirements for pelargonic acid as provided
herein.
VII. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a regulation for an exemption from the
requirement of a tolerance issued by EPA under new section 408(d) as
was provided in the old section 408 and in section 409. However, the
period for filing objections is 60 days, rather than 30 days. EPA
currently has procedural regulations which governs the submission of
objections and hearing requests. These regulations will require some
modification to reflect the new law. However, until those modifications
can be made, EPA will continue to use those procedural regulations with
appropriate adjustments to reflect the new law.
Any person may, by July 22, 1997, file written objections to any
aspect of this regulation (including the automatic revocation
provision) and may also request a hearing on those objections.
Objections and hearing requests must be filed with the Hearing Clerk,
at the address given under the ADDRESSES section (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 a 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). Information
submitted in connection with an objection or hearing request may be
claimed confidential by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. A copy of the information
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.
VIII. Public Docket
EPA has established a record for this rulemaking under docket
control number [OPP-300488] (including any comments and data submitted
electronically). 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 Room 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 may be sent directly to EPA at:
opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
[[Page 28364]]
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
This document finalizes an exemption from the tolerance requirement
under section 408 of the FFDCA and therefore does not impose any other
regulatory requirements. As such, the Office of Management and Budget
(OMB) has exempted these types of actions from review under Executive
Order 12866, entitled Regulatory Planning and Review (58 FR 51735,
October 4, 1993). Since this final rule does not impose any
requirements, it does not contain any information collections subject
to approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or require any other action under Title II of the Unfunded
Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does it require
any prior consultation as specified by Executive Order 12875, entitled
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28,
1993), or special considerations as required by Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16,
1994),), or require OMB review in accordance with Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997).
In addition, pursuant to section 605(b) of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby
certifies that this rule will not have a significant adverse economic
impact on a substantial number of small entities. This determination is
based on the fact that this action does not impose any requirements and
therefore does not have any adverse economic impacts. In accordance
with Small Business Administration (SBA) policy, this determination
will be provided to the Chief Counsel for Advocacy of the SBA upon
request.
X. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the General Accounting Office prior to publication of this rule in
today's Federal Register. This is not a major rule as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 6, 1997.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
Therefore, 40 CFR Chapter I is 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. Section 180.1159 is revised to read as follows:
Sec. 180.1159 Pelargonic acid; exemption from the requirement of
tolerances.
(a) Pelargonic acid is exempt from the requirement of a tolerance
on tree fruits 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.
(b) Pelargonic acid when used as an herbicide is exempt from the
requirement of a tolerance on all plant food commodities provided that:
(1) Applications are not made directly to the food commodity except
when used as a harvest aid or desiccant to: any root and tuber
vegetable, bulb vegetable or cotton.
(2) When pelargonic acid is used as a harvest aid or desiccant,
applications must be made no later than 24 hours prior to harvest.
[FR Doc. 97-13644 Filed 5-22-97; 8:45 am]
BILLING CODE 6560-50-F
