[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: [email protected]. 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: [email protected].
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:
    [email protected].

    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