[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]
BILLING CODE 6560-50-F