[Federal Register Volume 59, Number 178 (Thursday, September 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-22855]
[[Page Unknown]]
[Federal Register: September 15, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 152
[OPP-300350; FRL-4872-4]
RIN 2070-AC18
Pesticides; Exemption of Certain Substances from Federal
Insecticide, Fungicide, and Rodenticide Act Requirements
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This proposed rule would exempt from regulation under section
25(b)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) certain substances when used, sold, or distributed as pesticide
active ingredients. EPA believes regulation of these substances is not
necessary to prevent unreasonable adverse effects on the environment,
and these substances are not of a character necessary to be subject to
FIFRA in order to carry out its purposes. Substances exempted are
pesticides and would continue to be distributed and sold as pesticides
after promulgation of a final rule. If exemptions are established,
false claims and advertising would still be subject to jurisdiction of
the Federal Trade Commission or could result in civil liabilities for
the manufacturer and distributor. This proposal, and any subsequent
final rule, would not establish or alter exemptions or tolerances for
the listed substances under provisions of the Federal Food, Drug and
Cosmetic Act.
DATES: Written comments, identified by the document control number,
[OPP-300350], must be received on or before November 14, 1994.
ADDRESSES: Comments, in triplicate, should bear the document control
number and be 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 comments to: Rm. 1132, 1921 Jefferson Davis
Hwy., Crystal City, VA 22202.
Information submitted in any 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 to
the submitter. Written comments will be available for public inspection
in Rm. 1132 at the Virginia address given above from 8 a.m. to 4:30
p.m., Monday through Friday, except legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Richard F. Mountfort,
Registration Division, Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 713, 1921 Jefferson Davis Highway,
Arlington, VA 22202, 703-305-5446.
SUPPLEMENTARY INFORMATION:
I. Statutory and Regulatory Background
This rule is being proposed pursuant to authority of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. EPA regulates pesticides under FIFRA through a registration
system. Except as provided by other sections of FIFRA, section 3
provides that all pesticides must be registered by EPA prior to
distribution or sale. As defined by FIFRA section 2(u)(1), a pesticide
``is any substance or mixture of substances intended for preventing,
destroying, repelling, or mitigating any pest.'' The products that are
subject to this proposed rule are considered to be pesticides, for
example, if they are intended to kill or repel a pest, such as biting
flies, or to prevent or mitigate a pest, such as moths. EPA registers
pesticides on the basis of data adequate to show that the pesticide,
when used in compliance with the terms and conditions of registration
or in accordance with widespread and commonly recognized practice, will
not pose unreasonable adverse effects on the environment. The term
``unreasonable adverse effects on the environment'' means any
unreasonable effect to man or the environment, taking into account the
economic, social, and environmental costs and benefits of the use of
the pesticide.
FIFRA section 25(b) authorizes the Administrator to exempt, by
regulation, from the requirements of FIFRA any pesticide which she
determines to be of a character which is unnecessary to be subject to
the Act in order to carry out the purposes of FIFRA. EPA is proposing
to amend 40 CFR 152.25 to exempt from regulation under FIFRA the
following substances when used, sold, or distributed as an active
ingredient of a pesticide. EPA believes that regulation of these
substances under FIFRA is not necessary to prevent unreasonable adverse
effects on man or the environment. In addition, EPA believes that the
regulatory burden imposed by regulation as pesticides is not justified.
This action is being taken at EPA's initiative.
Castor oil (U.S.P. or equivalent)
Cedar oil
Cinnamon
Citric acid
Citronella
Cloves and clove oil
Corn gluten meal
Corn oil
Cottonseed oil
Dried blood
Eugenol
Garlic
Geraniol
Geranium oil
Lauryl sulfate
Lemongrass oil
Linseed oil
Malic acid
Mint and mint oil
Peppermint and peppermint oil
2-Phenethyl propionate (2-phenylethyl propionate)
Potassium sorbate
Putrescent whole egg solids
Rosemary and rosemary oil
Sesame (includes ground sesame plant)
Sodium chloride (common salt)
Sodium lauryl sulfate
Soybean oil
Thyme and thyme oil
White pepper
Zinc metal strips (consisting solely of zinc metal and
impurities)
In evaluating the risk to human health and the environment posed by
each of these substances when used, sold, or distributed as an active
ingredient of a pesticide, EPA assessed the pesticide according to the
following factors. The list is not meant to be exclusive; not every
factor is applicable to each substance proposed for exemption; and each
substance need not meet each factor. The list provides a common
starting point toward reaching a decision.
1. The pesticide is a substance that is widely distributed in
commerce and available to the general public throughout the United
States for nonpesticidal uses without any evidence of significant
adverse effects to humans or the environment.
2. The pesticide is a substance that has a nontoxic mode of action
and/or is generally considered nontoxic. For example, putrescent whole
egg solids (rotten eggs) repel deer because of the eggs' strong
offensive odor. Other qualifying substances might be common human foods
or substances listed by the Food and Drug Administration as Generally
Recognized As Safe (GRAS) in 21 CFR part 182, 184, or 186.
3. The Agency is unaware of any experimental data, including
laboratory animal toxicity tests, or other information, either in
Agency files (data submissions, section 6(a)(2) reports, etc.) or
published literature, indicating that the pesticide substance or
structurally related substances have the potential for significant
adverse effects to humans or the environment.
4. The pesticide's use patterns (application rate, frequency,
manner of application) result in negligible incremental human or
environmental exposure.
5. The pesticide is presumed to be nonpersistent because its
composition consists of materials known to rapidly degrade in the
environment to environmental constituents by normal biological,
physical or chemical processes that can be reasonably expected to exist
where the pesticide is applied.
The substances affected by this proposal would be exempt when used,
sold, or distributed as single-ingredient pesticides. Pesticide
products (formulations) containing active ingredients that would be
exempt under this proposal are eligible if the only other ingredients
are (1) active ingredients named in this exemption; or (2) inert
ingredients named in this exemption. The inert ingredients included
have been identified by EPA as Minimal Risk Inerts (List 4A). The
Agency is issuing Minimal Risk Inerts (List 4A) in a separate notice
appearing in this issue of the Federal Register.
Proposed Sec. 152.25(g)(2) would require that, to qualify for
exemption, each pesticide product containing the substance bear a label
that clearly and intelligibly identifies all ingredients. It would not
be necessary to list percentages of ingredients or use EPA format in
listing ingredients.
Products containing these substances that claim either to control
or mitigate microorganisms that pose a threat to human health, or
carriers of such microorganisms, would be excluded from the exemption
under proposed Sec. 152.25(g)(3). Those uses involve public health
issues, and lack of efficacy cannot be determined by the user.
EPA invites comment on the substances included in the proposal and
comment on the factors used in this proposal.
In addition, EPA invites suggestions for additional substances for
such exemption (these may be substances not currently contained in any
pesticide product) and other factors that might be appropriate to
consider in determining whether a substance should be exempted from
regulation under section 25(b). Persons identifying additional
candidates for exemption should explain how these factors apply to the
pesticide or offer any other relevant explanation to support their
proposal. The Agency will consider such suggestions for future
rulemaking or other reduced regulation.
II. Agency Determination
The pesticide active ingredients proposed in this document for
exemption have been considered as follows:
1. Widely distributed in commerce and available to the general
public. Castor oil, cedar oil, cinnamon, citric acid, citronella,
cloves, corn gluten meal, corn oil, cottonseed oil, dried blood,
garlic, geraniol, geranium oil, lauryl sulfate, lemongrass oil, linseed
oil, malic acid, mint, peppermint, rosemary, sesame, soybean oil,
sodium chloride (common salt), sodium lauryl sulfate, and zinc metal
strips.
2. Common foods or constituents of common foods. Cinnamon, citric
acid, cloves, corn gluten meal, corn oil, garlic, malic acid, mint,
peppermint, rosemary, sesame, soybean oil, sodium chloride (common
salt), thyme, and white pepper.
3. Listed by the Food and Drug Administration as GRAS. Cinnamon,
citric acid, citronella, eugenol, garlic, geraniol, geranium oil,
lemongrass oil, malic acid, mint, peppermint, 2-phenethyl propionate,
rosemary, sodium chloride (common salt), thyme, and white pepper.
4. Nontoxic mode of action. All listed pesticides have nontoxic
modes of action except sodium chloride (common salt).
5. No significant adverse effects to humans or the environment. The
Agency is unaware of any information or data showing significant
adverse effects to man or the environment for any of the pesticides or
structurally related substances included in this proposal. The public
is invited to cite or submit any information regarding the effects of
any of these substances. The Agency will remove a pesticide from
exemption if data which document significant adverse effects to humans
or the environment are submitted.
6. Negligible human or environmental exposure. None of the proposed
candidates has significant additional exposure potential for humans or
the environment when used as a pesticide. This conclusion is based on
either an understanding of current pesticide use patterns or widespread
distribution and use for nonpesticidal purposes.
7. Nonpersistance. All of the listed pesticides would be expected
to rapidly degrade in the environment; are naturally occurring; or are
otherwise not considered to be persistent based on their
characteristics, properties, and known degradation pathways.
Cedar oil, citronella, geranium oil, and lemongrass oil are
generally constituents of lotions and other products for use directly
on human skin. The substances are also commonly used in perfumery.
Citronella, geranium oil, and lemongrass oil are essential oils and
listed as GRAS substances by FDA. Exposure of or effects on humans or
the environment attributable to use of these substances as arthropod
repellents is indistinguishable from use as fragrances/perfumes. The
Agency believes that it is unnecessary to regulate these substances as
pesticides in order to carry out the purposes of FIFRA.
The Agency also invites comment on other essential oils that may be
suitable candidates for exemption. There are many essential oils used
in preparation of perfumes and fragrances. The Agency considers the
variety and potential range of toxicity of substances included under
the term ``essential oils'' to be too broad for ``essential oils'' to
be exempted generically.
Potassium sorbate is a common food additive and preservative and is
permitted under Food and Drug Administration regulations as a
preservative.
These proposed exemption determinations are based on EPA's
assessment of currently available information. Once finalized,
exemption determinations are subject to change through further
rulemaking if EPA becomes aware of information indicating that
continued exemption of a substance from regulation under FIFRA section
25(b) is not consistent with the purposes of FIFRA.
III. Further Reduced Regulation Activity
The Agency intends to pursue additional reduced regulation
initiatives where such activity can relieve regulatory burdens without
endangering public health or environmental protection. There may be a
number of possible options such as reduced data requirements and
specific review procedures for reduced risk pesticides in addition to
exemption by rulemaking. The Agency invites suggestions and comments on
additional regulatory relief measures.
For pesticides currently registered and eligible for exemption
under this proposed rule, the Agency would invite requests for
voluntary cancellation of affected product registrations after
publication of a final rule. The Agency does not intend to process
further applications to register products eligible for exemption after
publishing a final rule.
IV. Regulatory Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to all the requirements of the Executive Order
(i.e., Regulatory Impact Analysis, review by the Office of Management
and Budget (OMB)). Under section 3(f), the order defines
``significant'' as those actions likely to lead to a rule (1) having an
annual effect on the economy of $100 million or more, or adversely and
materially affecting a section of the economy, productivity,
competition, jobs, the environment, public 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. The Agency has determined
that this rule is ``not significant'' within the meaning of that term
as set forth in section 3(f) of Executive Order 12866. Under the terms
of the executive order, EPA has determined that this rule is ``not
significant'' and is, therefore, not subject to OMB review.
B. Regulatory Flexibility Act
This rule has been reviewed under the Regulatory Flexibility Act of
1980 (Pub. L. 96-354; 94 Stat. 1164, 5 U.S.C. 601 et seq.). EPA has
determined that this rule will not have a significant economic impact
on a substantial number of small businesses, small governments, or
small organizations.
Accordingly, I certify that this rule does not require a separate
regulatory flexibility analysis under the Regulatory Flexibility Act.
C. Paperwork Reduction Act
This rule contains no information collection requests. Therefore,
the Paperwork Reduction Act of 1980 is not applicable.
D. Other Statutory Requirements
In accordance with FIFRA section 25, a draft of this proposal was
submitted to the FIFRA Science Advisory Panel (SAP) and to the U.S.
Department of Agriculture (USDA). The Science Advisory Panel has waived
review of the proposed rule and will waive a review of the final rule
if it is issued. The USDA has responded that it has no objections to
the proposed rule.
Copies of the proposed rule were also forwarded to the Committee on
Agriculture of the House of Representatives and the Committee on
Agriculture, Nutrition and Forestry of the Senate.
List of Subjects in 40 CFR Part 152
Environmental protection, Agricultural commodities, Administrative
practice and procedure, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 8, 1994.
Carol M. Browner,
Administrator.
Therefore, it is proposed that 40 part 152 be amended as follows:
PART 152--[AMENDED]
1. The authority citation for part 152 continues to read as
follows:
Authority: 7 U.S.C. 136-136y.
2. In Sec. 152.25, by adding new paragraph (g) to read as follows:
Sec. 152.25 Exemptions for pesticides of a character not requiring
FIFRA regulation.
* * * * *
(g) Minimum Risk Pesticides--(1) Active ingredients. The following
active ingredients are exempt from the requirements of FIFRA when used,
sold, or distributed alone or in combination with other substances
listed in this paragraph, provided that all of the criteria of this
paragraph (g)(1) are met.
Castor oil (U.S.P. or equivalent)
Cedar oil
Cinnamon
Citric acid
Citronella
Cloves and clove oil
Corn gluten meal
Corn oil
Cottonseed oil
Dried blood
Eugenol
Garlic
Geraniol
Geranium oil
Lauryl sulfate
Lemongrass oil
Linseed oil
Malic acid
Mint and mint oil
Peppermint and peppermint oil
2-Phenethyl propionate (2-phenylethyl propionate)
Potassium sorbate
Putrescent whole egg solids
Rosemary and rosemary oil
Sesame (includes ground sesame plant)
Sodium chloride (common salt)
Sodium lauryl sulfate
Soybean oil
Thyme and thyme oil
White pepper
Zinc metal (strips consisting solely of zinc metal and
impurities)
(i) Each product containing the substance must bear a label
identifying all ingrtedients of the product. Such identification need
not conform to the requirements of part 156 of this chapter, but must
identify ingredients by common or chemical name.
(ii) The substance or product must not bear claims either to
control or mitigate microorganisms that pose a threat to human health
or carriers of such microorganisms.
(2) Permitted inerts. A pesticide product exempt under paragraph
(g)(1) shall not lose that exemption by inclusion in such product of
one or more of the following ingredients:
Acetic acid
Agar
Alfalfa
Alfalfa meal
Almond hulls
Almond shells
Alpha cellulose
Apple pomace
Attapulgite-type clay
Beef fat
Beeswax
Beet powder
Bentonite
Bone meal
Bran
Bread crumbs
Calcareous shale
Calcite
Calcium carbonate
Canary seed
Cane syrup
Carbon dioxide
Cardboard
Carrageenan
Carrots
Casein
Cheese
Chlorophyll
Cinnamon
Citric acid
Citrus meal
Citrus pectin
Citrus pulp
Clam shells
Cloves
Cocoa
Cocoa shells
Coco shell flour
Cod liver oil
Coffee grounds
Cookies
Cork
Corn
Corn cobs
Corn flour
Corn meal
Corn oil
Cornstarch
Corn syrup
Cotton
Cottonseed meal
Cottonseed oil
Cracked oats
Cracked wheat
Dextrin
Dextrose
Dolomite
Douglas-fir bark, ground
Eggs
Egg shells
Edible fish meal
Edible fish oil
Flour
Fuller's earth
Gelatin
Glue, as depolymerized animal collagen
Glycerin
Granite
Grape pomace
Graphite
Ground oats
Guar gum
Gum arabic
Gum tragacanth
Gypsum
Hearts of corn flour
Hydrogenated vegetable oils
Honey
Invert sugar
Invert syrup
Kaolinite-type clay
Lactose
Lanolin
Lard
Latex
Lecithin
Lime
Limestone
Linseed oil
Malt flavor
Meat meal
Meal scraps
Medicated feed
Mica
Milk
Millet seed
Mineral oil, U.S.P.
Molasses
Montmorillonite-type clay
Nitrogen
Nutria meat
Nylon
Oatmeal
Oats
Olive oil
Onions
Orange pulp
Oyster shells
Paper
Paprika
Paraffin wax
Peanut butter
Peanut oil
Peanuts
Peanut shells
Peat moss
Pecan shell flour
Pectin
Polyethylene film
Polyethylene pellets
Potatoes
Pumice
Raisins
Red cedar chips
Red dog flour
Rice
Rice hulls
Rubber
Rye flour
Safflower oil
Sawdust
Seaweed, edible
Shale
Soapstone
Sodium bicarbonate
Sodium chloride
Sorbitol
Soybean hulls
Soybean meal
Soybean oil
Soy flour
Soy protein
Sucrose
Sugarbeet meal
Sunflower seeds
Tallow
Vanillin
Vermiculite
Vitamin C
Vitamin E
Walnut flour
Walnut shells
Water
Wheat
Wheat germ oil
Whey
Wintergreen oil
Wool
Xanthan gum
Yeast
[FR Doc. 94-22855 Filed 9-14-94; 8:45 am]
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