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jojoba oil Exemption from Tolerance Requirement 10/95

[Federal Register: October 26, 1995 (Volume 60, Number 207)]
[Notices]               
[Page 54839-54840]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 3E4230/P634; FRL-4981-7]
RIN 2070-AC18
Jojoba Oil; Exemption from Tolerance Requirement
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish an exemption from the requirement 
for a tolerance for residues of jojoba oil in or on all raw 
agricultural commodities when applied at not more than 1.0% of the 
final spray as an insecticide or as a pesticide spray tank adjuvant in 
accordance with good agricultural practices. Amvac Chemical Corp. 
submitted a petition pursuant to the Federal Food, Drug and Cosmetic 
Act (FFDCA) requesting the proposed regulation to establish an 
exemption from the requirement of a tolerance.

DATES: Comments, identified by the document control number [PP 3E4230/P634], 
must be received on or before November 24, 1995.

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 St., SW., 
Washington, DC 20460. In person, bring comments to: Rm. 1132, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA 22202. Information submitted 
as a comment concerning this document may be claimed confidential by 
marking any part or all of that information as "Confidential Business 
Information" (CBI). Information so marked 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.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: 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. Comments and data will also be 
accepted on disks in WordPerfect in 5.1 file format or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket number [PP 3E4230/P634]. No Confidential Business 
Information (CBI) should be submitted through e-mail. Electronic 
comments on this proposed rule may be filed online at many Federal 
Depository Libraries. Additional information on electronic submissions 
can be found below in this document.

FOR FURTHER INFORMATION CONTACT: By mail: Michael L. Mendelsohn, 
Regulatory Action Leader, Biopesticides and Pollution Prevention 
Division (7501W), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location and telephone number: 5th Floor, CS #1, 2800 Crystal Drive, 
Arlington, VA 22202, (703)-308-8715; e-mail: 
                 mendelsohn.michael@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: Amvac Chemical Corp., 2110 Davie Ave., City 
of Commerce, CA 90040, has submitted pesticide petition (PP) 3E4230 to 
EPA proposing to amend 40 CFR part 180 by establishing a regulation 
pursuant to section 408(d) of the Federal Food, Drug and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(d), to exempt from the requirement of a 
tolerance simmondsia liquid wax (jojoba oil) and the product Detur for 
use as an inert ingredient in pesticide formulations applied to growing 
crops or to raw agricultural commodities after harvest. Subsequent to 
its petition, Amvac informed EPA that it had transferred all Detur 
assets to Imperial Jojoba Oils of El Centro, CA. EPA has, of its own 
initiative, expanded the original petition to include pesticidal uses 
of jojoba oil in this proposed exemption from the requirement of a 
tolerance.
    The data submitted in the petition and all other relevant material 
have been evaluated and a discussion of the submitted data and 
literature referenced follows.
    The source of jojoba oil is the Simmondsia chinensis shrub, 
commonly called the jojoba plant. The plant is a woody evergreen shrub, 
2 to 3 feet high with thick, leathery, bluish-green leaves and dark 
brown, nutlike fruit. Two techniques are used to release the oil from 
the plant fruit (also called a nut, bean, or seed). The oil may be 
extracted by pressing or by solvent extraction methods used 
commercially to isolate vegetable oils. The expressed oil is clear and 
golden in color.
    The exact composition of the oil varies dependent upon geographic 
location of the plant and can vary from bean to bean within a single 
plant. Jojoba oil is composed almost completely of wax esters of 
monounsaturated, straight-chain acids and alcohols with high molecular 
weights (C16-C26). Jojoba oil has been defined as a liquid 
wax ester with the generic formula RCOOR". RCO represents oleic acid, 
eicosanoic acid (C20:1), and/or erucic acid (C22:1) moieties. -OR" 
represents eicosenyl alcohol (C20:1), docosenyl alcohol (C22:1) and/or 
tetrasenyl alcohol (C24:1) moieties. Crude jojoba oil contains 0.8 ppm 
elemental lead (Pb) and less than 0.1 ppm arsenic (AS2S3).
    The jojoba bean contains 2 glycosides with toxic effects: 
simmondsin [2-(cyanomethylene)-3-hydroxy-4,5-dimethoxycyclohexyl-D-
glucoside] at 2.3% and simmondsin-2'-ferulate at 1% (Verbiscar and 
Banigan, 1978. J. Ag. Fd. Chem. 26:1456-60). In addition, related 
conjugated organonitriles including demethyl simmondsin and 
didemethylsimmondsin are present (Abbott, T.P., Nakamura, L.K., 
"Microbial Detoxification of Jojoba Toxins," Agricultural Research 
Service, 1990). As set forth below, this proposed exemption does not 
cover these ingredients, and they are therefore not permitted to be 
present in the jojoba oil subject to this exemption. A third toxic 
component which makes up to 14% of jojoba oil is erucic acid. Erucic 
acid is also found in rapeseed oil in amounts up to 50% ("The 
Chemistry and Technology of Jojoba Oil" by James Wisniak). The amount 
of erucic acid likely to be present in residues of jojoba oil under 
this exemption is less than 1/10 of the amount (2%) permitted in 
rapeseed oil defined by FDA as low erucic acid rapeseed oil.

Toxicology

    EPA's evaluation of the toxicological properties of jojoba oil is 
based in part upon numerous toxicology studies conducted both for the 
purposes of evaluating the use of jojoba oil in cosmetic products and 
as a pesticide. In addition, the Agency took into consideration the 
fact that jojoba oil has been widely distributed in commerce and 
available to the general public throughout the United States for 
cosmetic uses without any evidence of significant adverse effects to 
humans or the environment.
    Chronic data was not deemed necessary to support the proposed 
exemption because of the low application levels allowed and the fact 
that most of the jojoba oil injested orally is excreted in the feces 
(Yaron, A. "Metabolism and Physiological Effects of Jojoba Oil" in 
The Chemistry and Technology of Jojoba Oil, 1987, Wisniak, J.). The 
expected dietary exposure to humans as a result of the use of this 
substance as an inert or active pesticide ingredient applied at 1% of 
the final spray is far below levels that produced no adverse effects in 
laboratory animals.
    As noted above, formulations of jojoba oil may contain erucic acid 
and the glycosides simmondsin and simmondsin-2-ferulate (as well as 
related conjugated organonitriles including demethyl simmondsin and 
didemethylsimmondsin), ingredients which are of toxicological concern.
    Erucic acid, which has been identified as a potential contributing 
factor in heart disease, makes up approximately 14% of jojoba oil. 
However, this proposed exemption only exempts residues resulting from 
the application of a final spray diluted to no more than 1% jojoba oil, 
the level of erucic acid in the spray applied to raw agricultural 
commodities will fall from 14% to 0.14% This is less than one-tenth the 
2% erucic acid level permitted for low erucic acid rapeseed oil (see 
FDA regulations at 21 CFR 184.1555(c)), and therefore does not pose a 
hazard to human health.
    The Agency lacks sufficient information to conclude that simmondsin 
and simmondsin-2-ferulate as well as related conjugated organonitriles 
including demethyl simmondsin and didemethylsimmondsin would not cause 
adverse health effects when applied under the terms of this proposed 
exemption. For this reason, the proposed exemption only applies to 
formulations of jojoba oil not containing simmondsin and simmondsin-2-
ferulate.
    A summary of the the available toxicological data for simmondsin, 
simmondsin-2-ferulate, erucic acid, and jojoba oil is set forth below.

A. Simmondsin and Simmondsin-2'-Ferulate

    Simmondsin and/or its breakdown products have been linked to diet 
rejection or restriction in rats (Booth, A.N., C.A. Elliger, A.J. 
Waiss, 1974. "Isolation of a Toxic Factor from Jojoba Meal," Life 
Sci. 15:1115). 
    Ingested Simmondsin, a glycoside in jojoba bean, caused rats to 
avoid food. Administration of 6,000 ppm of simmondsin in the diet of 
rats produced a 24% body weight decrease. Twenty percent of mice fed 
with 10% simmondsin in the diet died within 1 week (Letter from Andrew 
Laumbach (FDA) to Don Barioni (Jojoba Oil Oils, CA) dated July 8, 
1992). (Letter from Karen Korman to Don Barioni dated July 22, 1992).
    When weanling rats were given simmondsin orally for 5 days at 750 
mg/kg/day, all rats lost weight and died within 10 days (R.K. Locke, 
FDA memo 3/22/78)).
    A dose of 2.5 g/kg simmondsin orally did not decrease body weight 
in rats (Khalsa, J.H. FDA memo May 27, 1983; R.K. Locke, FDA memo 3/22/78).
    A dose of 3.6 g/kg simmondsin by i.p. injection had no effect on 
rats' body weight (Khalsa, J.H. FDA memo May 27, 1983; R.K. Locke, FDA 
memo 3/22/78).
    A single oral dose of 4 g/kg of simmondsin to weanling rats 
produced no effects during a 14-day observation (Khalsa, J.H. FDA memo 
May 27, 1983; R.K. Locke, FDA memo 3/22/78).
    A diet containing 0.6% of Simmondsin produced weight loss in rats 
as did a diet containing 10% jojoba oil (Locke, R.K. to L.J. Lin, FDA 
memo 3/22/78).

B. Erucic Acid

    Erucic acid (13%) in jojoba oil may contribute to heart disease. 
Nestle Technical Product Assistance-Orbe, Switzerland.
    Jojoba oil contains 14% of erucic acid which has been shown to 
cause myocardial fibrosis (Abdullatif, A.M.M. and E.O Vles, 1971. Nutr. 
Metabol. 13:63-74).

C. Jojoba Oil Acute Oral Toxicity Studies

    Fewer than 50% of rats died when orally administered 21.5 mL/kg of 
jojoba oil (Wisniak, J., 1977, "Jojoba Oil and Derivatives." Proc. 
Chem. Fats and Lipids 15(3):167-218.). Four groups (10 males and 10 
females/group) rats were orally administered 0.5, 0.75, 1.13 and 1.69 
mL/10 g of crude jojoba oil. After 7 days, rats were killed and 
necropsied. One rat died before the end of the 7 days; renal capsule 
discoloration was noted in all groups; peritonitis was noted in one 
1.69 mL/10g group (Taguchi, M. and Kunimoto, 1977. "Toxicity Studies 
on Jojoba Oil for Cosmetic Uses," Cosmetics Toiletries, 19:53-62 
(September issue).CS (RP)).
    The oral LD50 for crude jojoba oil in mice is greater than 
1.69 mL/10 g. No death or clinical signs were noted (Taguchi, Masayuki, 
1990. "Test Results on Safety on Jojoba oil to be Used for Cosmetics" 
in La Jojoba, Apache Junction, AZ; p 149-170.).
    Four groups (10 males and 10 females/group) of rats were fed basal 
diet (5g/feeding containing 0.5, 1.0, 2.0, and 3.0 g of refined jojoba 
oil. The first two groups were dosed for 7 days, and the last two 
groups were dosed for 4 days. Signs of toxicity were noted in five rats 
in the 1.0-g group and six rats each in the 2.0-g and 3.0-g groups. One 
rat died in each of the 1.0-, 2.0-, and 3.0-g dose groups (Hamm, D. J., 
1984. "Preparation and Evaluation of Trail-koxytricarballylate, 
Trialhoxycitrate, Trailkoxyglycerylether, Jojoba Oil and Sucrose 
Polyester as Low calories Replacements of edible Fats and Oils" J. of 
Food Science (49):419-428). (OW)
    Twenty percent of weanling mice died when fed a diet with 10% 
jojoba oil (Locke, R.K. to L.J. Lin, FDA memo, 3/22/1978).
    A single oral administration at 5,050 mg/kg of DETUR (a pesticide 
product containing 97.5% jojoba oil) to HSD:SD rats did not produce 
death in any animal. The oral LD50 for DETUR in HSD:SD rats is 
greater than 5,050 mg/kg body weight which is classified as toxicity 
category IV for pesticide precautionary labeling purposes.
    In the testing of a lip balm product containing 20% jojoba oil, 
none of the rats (5 males and 5 females) died when orally administered 
with 5.0 g/kg of 20% jojoba oil (lip balm product) (CTFA, 1985. CIR 
Safety Data Test Summary Response Form. Acute oral toxicity study on 
lip balm product containing 20% jojoba oil, 1 p.)

Acute Dermal Toxicity Studies

    A single dose of 2,020 mg/kg of DETUR (a pesticide product 
containing 97.5% jojoba oil) was topically applied to the shaved intact 
skin of 5 male and 5 female rabbits for 24 hours and treated rabbits 
were observed for 14 days. No mortality was noted; transient skin 
irritation and diarrhea were noted; one female had mottled liver. The 
acute dermal LD50 of DETUR is greater than 2,020 mg/kg body weight 
and classified as Toxicity category III for pesticide precautionary 
labeling purposes.

Primary Eye Irritation Studies

    Instillation of refined Jojoba Oil (0.1 mL) into the eyes of six 
male rabbits produced slight ablepharia and slight conjunctival 
hyperemia at 1 hour after instillation. All signs cleared by 24 hours 
post-instillation (Taguchi, M. and Kunimoto, 1977. "Toxicity Studies 
on Jojoba Oil for Cosmetic Uses," Cosmetics Toiletries, 19:53-62 
(September issue). CS (RP) Instillation of lip balm product containing 
20% of jojoba oil (0.1 mL) into the eyes of six rabbits produced eye 
irritation score of 0.3 <plus-minus> 0.8 (Draize scale) at 24 hours 
post-instillation. All reactions were cleared at 48 hours post-
instillation (CTFA, 1985 as reported in Diener, Robert M. ed., 1992. 
"Final Report on the Safety Assessment of Jojoba Oil and Jojoba Wax." 
Nineteenth Report of the Cosmetic Ingredient Review Expert Panel. J. 
American College of Toxicology, Vol. 11(1):57-82).
    Administration of DETUR (a pesticide product containing 97.5% 
jojoba oil) into rabbit eyes caused positive conjunctival irritation in 
rabbits for 48 hours. DETUR is considered to be a mild eye irritant and 
is classified as EPA toxicity category III for precautionary labeling 
purposes.

Primary Dermal Irritation Studies

    Refined jojoba oil (0.5 mL) as well as olive oil and light liquid 
paraffin (0.5 mL) serving as controls were topically applied to the 
shaved skin of three groups of 5 guinea pigs daily for 15 days. The 
same procedure was conducted in the other three groups of 5 guinea pigs 
daily for 30 days. A Draize scoring system was used. No significant 
reactions to jojoba oil and olive oil were noted. Flare reactions to 
liquid paraffin were noted on the third day of the study (Taguchi, M. 
and Kunimoto, 1977. "Toxicity Studies on Jojoba Oil for Cosmetic 
Uses." Cosmetics Toiletries, 19:53-62 (September issue)). CS (RP).
    Jojoba oil (10.0% w/w in refined Jojoba oil) was topically applied 
to albino marmots according to Draize method. No skin reactions were 
noted in any animals (Taguchi, Masayuki, 1990. "Test Results on Safety 
on Jojoba oil to be Used for Cosmetics" in La Jojoba, Apache Junction, 
AZ; p. 149-170.).
    A topical application of lip balm product containing 20% jojoba oil 
to New Zealand white rabbits produced a primary irritation score of 
0.33--minimally irritating (CTFA, 1985 as reported in Diener, Robert 
M., ed., 1992. "Final Report on the Safety Assessment of Jojoba Oil 
and Jojoba Wax. Nineteenth Report of the Cosmetic Ingredient Review 
Expert Panel." J. American College of Toxicology, Vol. 11(1): 57-82.).
    Application of 0.5 mL of DETUR (a pesticide product containing 
97.5% jojoba oil) on the shaved dorsal skin of 6 rabbits did not 
produce deaths or other signs of systemic toxicity. Transient erythema/
eschar formation was seen in two males and two females. Within 24 hours 
all treated skin sites were normal. The primary dermal irritation index was 
0.17. DETUR is considered to be slightly irritating and in EPA's toxicity 
category IV for precautionary labeling purposes.

Dermal Sensitization Studies

    The skin sensitization potential of jojoba alcohol (10.0% w/w in 
refined Jojoba oil) was evaluated according to the maximization test 
using albino marmots (10 males and 10 females). Two groups of marmots 
(10 males and 10 females) were used as the controls. No sensitization 
reaction was observed 24 or 48 hours after the challenge application 
(Taguchi, Masayuki, 1990. "Test Results on Safety on Jojoba oil to be 
Used for Cosmetics." La Jojoba, Apache Junction, AZ; p. 149-170.).
    Five out of six human subjects suspected to be sensitive to jojoba 
oil had positive reactions when patch tested with jojoba olive oil and 
jojoba oil-petrolatum mixtures. Twenty-eight human subjects with no 
known sensitivities did not have sensitization reactions to pure jojoba 
oil (Scott, M.J. and M.J. Scott, Jr., 1982, "Jojoba Oil," J. Am. 
Acad. Dermatology 6(4):545.).
    The skin irritation and sensitization test of lip balm product 
containing 20% jojoba oil in humans produced no skin sensitization and 
irritation (CTFA, 1988, as reported in Diener, Robert M., ed., 1992. 
"Final Report on the Safety Assessment of Jojoba Oil and Jojoba Wax. 
Nineteenth Report of the Cosmetic Ingredient Review Expert Panel." J. 
American College of Toxicology, Vol. 11(1): 57-82.).
    The skin irritation and sensitization test of topical product 
containing 10% jojoba oil was conducted in humans using the Draize-
Shelanski repeat insult patch test. No skin sensitization or irritation 
was evident (CTFA, 1988 as reported in Diener, Robert M., ed., 1992. 
"Final Report on the Safety Assessment of Jojoba Oil and Jojoba Wax. 
Nineteenth Report of the Cosmetic Ingredient Review Expert Panel." J. 
American College of Toxicology, Vol. 11(1): 57-82).

90-Day Feeding Toxicity Study in Rodents and Dogs

     Jojoba oil incorporated in the diet of rat at 0.5, 5.0, and 10.0% 
(w/w) for 2 months produced elevations of transaminase and alkaline 
phosphatase at weeks 4 and 13 of the study period. Nestle Product 
Technical Assistance - Orbe, Switzerland (n.d)

Metabolism and Absorption Studies

Effects of Ingestion of Jojoba Oil on Blood Cholesterol Levels and 
Lipoprotein Patterns in New Zealand White Rabbits

    This study was conducted to determine the cholesterol-lowering 
effect of crude jojoba if fed to animals. Six groups (4 per group) of 
New Zealand White Rabbits were fed for 30 days with various combination 
of basal diet mixed with cholesterol, jojoba oil, and safflower. Blood 
cholesterol was then determined. Two or six percent crude jojoba oil 
added to the atherogenic diet containing 1% cholesterol resulted in a 
40% reduction of blood cholesterol as compared to cholesterol control 
rabbits. Under the same conditions, 2% safflower oil was not effective 
in lowering blood cholesterol levels. The authors suggested that jojoba 
oil was absorbed across the intestinal mucosa, contrary to the 
hypothesis that it is totally excreted and not metabolized (Clarke, 
J.A. and D.M. Yermanos, 1981. "Effects of Ingestion of Jojoba Oil on 
Blood Cholesterol Levels and Lipoprotein Patterns in New Zealand White 
Rabbits." Biochemical and Biophysical Research Communication 
102(4):14091415).

Preparation and Evaluation of Trailkoxytricarballylate, 
Trialkoxycitrate, Trailkoxyglycerylether, Jojoba Oil, and Sucrose 
Polyester as Low Calories Replacements of Edible Fats and Oils

     This study evaluated the digestibility and caloric availability of 
test oils including refined jojoba oil. Crude jojoba oil was refined by 
a standard alkali refining process which is used to refine edible 
vegetable oils. In the refined jojoba oil, free fatty acids were 
reduced to 0.023% from 1.45% in the crude oil. A trace nitrogen level 
of 6 <plus-minus> 2 ppm was found in the refined oil which translated 
to an upper limit of 160 <plus-minus> 54 ppm of Simmondsin in the 
finished oil. Simmondsin and/or its breakdown products have been linked 
with the diet rejection or restriction in rats. Four groups of 10 
Sprague-Dawley rats each were fed with 0.5, 1.0, 2.0, and 3.0 grams of 
refined jojoba oil once a day for 7 consecutive days. Feces were 
collected, weighed and then the percentages of water, ash, fat, 
protein, and carbohydrate were analyzed. No diet rejection was noted in 
any dose group. Weakness and depression were noted in 50% of 1.0-g 
dosed rats and in all 2.0- and 3.0-gms dosed rats; one rat in each of 
these dose groups died during the study. Jojoba oil was poorly absorbed 
and resistant to digestion, but anal leakage was noted. Jojoba oil can 
act as a laxative and interfere with certain vitamin and mineral 
absorption from the gut. (Hamm, D. J., 1984. "Preparation and 
Evaluation of Trailkoxytricarballylate, Trialhoxycitrate, 
Trailkoxyglycerylether, Jojoba Oil and Sucrose Polyester as Low 
calories Replacements of Edible Fats and Oils," J. of Food Science 
(49):419-428). (OW)

Conclusion

    The Agency estimates that the dietary exposure to humans from 
jojoba oil when applied in accordance with the limitations set forth in 
this proposed exemption is far below the levels that produced no 
adverse effects in laboratory animals. For this reason, and upon review 
of its use, EPA has determined that jojoba oil, when used in accordance 
with good agricultural practices is useful and poses no hazard to the 
public health. Accordingly, EPA proposes to exempt jojoba oil from the 
requirements of a tolerance under the conditions set forth below.
    Any person who has registered or submitted an application for 
registration of a pesticide, under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA) as amended, which contains any of the 
ingredients listed herein, may request within 30 days after publication 
of this notice in the Federal Register that this rulemaking proposal be 
referred to an Advisory Committee in accordance with section 408(e) of 
the FFDCA.
    Interested persons are invited to submit written comments on the 
proposed regulation. Comments must bear a notation indicating the 
document control number, [PP 3E4230/P634]. 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 a.m. to 
4:30 p.m., Monday through Friday, except legal holidays.
     A record has been established for this rulemaking under docket 
number [PP 3E4230/P634] (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 a.m. to 4:30 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 can 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 all comments received electronically into printed, 
paper form as they are received and will place the paper copies in the 
official rulemaking record which will also include all comments 
submitted directly in writing. The official rulemaking record is the 
paper record maintained at the address in "ADDRESSES" at the 
beginning of this document.
    Under Executive Order 12866 (58 FR 51735, Oct. 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.
    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).
    This proposed rule contains no Federal mandates under Title II of 
the Unfunded Mandates Reform Act of 1995. Pub. L. 104-4 for State, 
local, or tribal governments or the private sector because it would not 
impose enforceable duties on them.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: September 29, 1995.

Janet L. Andersen,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR part 180 be 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. In subpart D, by adding new Sec. 180.1160, to read as follows:


Sec. 180.1160 Jojoba oil; exemption from the requirement of a tolerance.

    The insecticide and spray tank adjuvant jojoba oil is exempted from 
the requirement of a tolerance in or on all raw agricultural 
commodities when applied at the rate of 1.0% or less of the final spray 
in accordance with good agricultural practices, provided the jojoba oil 
does not contain simmondsin, simmondsin-2-ferulate and related 
conjugated organonitriles including demethyl simmondsin and 
didemethylsimmondsin.