[Federal Register Volume 60, Number 206 (Wednesday, October 25, 1995)]
[Proposed Rules]
[Pages 54637-54641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26325]
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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
[[Page 54638]]
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).
[[Page 54639]]
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 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
[[Page 54640]]
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 2 ppm was found in the refined oil which translated
to an upper limit of 160 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,
[[Page 54641]]
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.
[FR Doc. 95-26325 Filed 10-24-95; 8:45 am]
BILLING CODE 6560-50-F
