[Federal Register Volume 61, Number 45 (Wednesday, March 6, 1996)]
[Rules and Regulations]
[Pages 8876-8879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5240]



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


ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 152

[OPP-300350A; FRL 4984-8]
RIN 2070-AC67


Exemption of Certain Pesticide Substances From Federal 
Insecticide, Fungicide, and Rodenticide Act Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final Rule.

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

SUMMARY: This rule establishes an exemption from regulation under the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for certain 
pesticides. EPA has determined that these pesticides, under certain 
conditions, are of a character not necessary to be regulated under 
FIFRA in order to carry out the purposes of the Act. EPA has concluded 
that exemption of products covered by this final rule will not pose 
unreasonable risks to public health or the environment and will, at the 
same time, relieve producers of the burden associated with regulation. 
Pesticidal products that do not meet the conditions of this final rule 
will continue to be regulated under FIFRA.
DATES: This rule becomes effective May 6, 1996.

FOR FURTHER INFORMATION CONTACT: Robert S. Brennis, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington DC 20460. Office 
location: Room 713, CM #2, 1921 Jefferson Davis Highway, Arlington, VA. 
Telephone: 703-305-7501, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

 I. Background

     Authority: This rule is issued under the authority of FIFRA 
section 25(b).
    EPA issued a proposed rule in the Federal Register on September 15, 
1994 to exempt from FIFRA regulation certain pesticidal substances (59 
FR 47289). In its proposal, EPA identified a total of 31 pesticidal 
active ingredients that it believed were not of a character necessary 
to be regulated under FIFRA.
    In developing its list of exempted substances, EPA applied certain 
factors. Consideration was given to such factors as, (1) whether the 
pesticidal substance is widely available to the general public for 
other uses; (2) if it is a common food or constituent of a common food; 
(3) if it has a nontoxic mode of action; (4) if it is recognized by the 
Food and Drug Administration (FDA) as safe; (5) if there is no 
information showing significant adverse effects; (6) if its use pattern 
will result in significant exposure, and (7) if it is likely to be 
persistent in the environment.
    EPA also proposed, as a condition of exempted status, several 
restrictions. First, the proposal identified active ingredients and 
listed certain inert ingredients that would be permitted in exempted 
formulations. Pesticide formulations would qualify only if all of the 
ingredients contained in the product were exempt. All inert ingredients 
contained in the formulation would have to be from the list of inerts 
identified as minimum risk inerts as published in the Federal Register 
as List 4A inerts. This list was last published in the Federal 
Register, September 28, 1994 (59 FR 49400).
    Second, in order to qualify for the exemption, the pesticide 
product label must identify all the ingredients of the product. Third, 
labels must comply with established regulations regarding false and 
misleading statements (40 CFR 156.10(a)(5)(i) through (viii)). And 
fourth, the substance or product could not bear claims either to 
control or mitigate microorganisms that pose a threat to human health 
or carriers of such microorganisms.
    In its proposal, EPA solicited comments on the list of substances 
themselves, the evaluation factors and the conditions of exemption.
    EPA has determined, with the conditions imposed by this rule, that 
use of these pesticides poses insignificant risks to human health or 
the environment in order to carry out the purposes of the Act, and the 
burden imposed by regulation is, therefore, not justified. The Agency, 
in promulgating this rule, is responding to society's increasing demand 
for more natural and benign methods of pest control, and to the desire 
to reduce governmental regulations and ease the burden on the public. 
The regulatory steps required to register any pesticide substance are 
formidable, not only for the Agency but for the applicants, who often 
are small businesses. The novice registrant often requires extra 
attention and instruction. EPA believes that both the applicant and the 
Agency are consuming valuable time, energy, and money to register 
chemicals that pose such low risk.

II. Implementation

    Products registered with EPA which now qualify for exemption from 
pesticide regulation under this rule, will remain registered until 
further action is taken by the registrant. The Agency encourages 
voluntary cancellation of these registrations. Cancellation requests 
should be mailed to James A. Hollins, Office of Pesticide Programs 
(7502C) EPA, 401 M St., SW., Washington, DC 20460. The letter should 
request cancellation under FIFRA section 25(b) and specify the product 
to be canceled by both name and EPA registration number. Existing 
stocks may be distributed for 1 year after the date of cancellation. 
After that date, it will be a violation of FIFRA for the former 
registrant to sell or distribute stock with an EPA registration number 
displayed on the label. Products in channels of trade may be sold and 
used until supplies are exhausted.
    Producers of products that are exempted from regulation by this 
final rule, will not be obligated to comply with the established 
registration and reporting requirements of FIFRA, section 7 with 
respect to exempted products. Producers who wish to market exempted 
products do not need to notify the Agency or obtain confirmation that 
the product is exempt. Provided the producer complies with all 
conditions of this rule, product may be distributed. To comply, 
producers must refer to this rule, the most recently published 4A 
inerts list, and a copy of the false and misleading labeling 
requirements contained in 40 CFR 156.10(a)(5)(i) through (viii).
    It is important to note that this rule only affects Federal 
regulation of pesticide products. Pesticide producers of exempt 
products should contact the pesticide agency in each State in which 

[[Page 8877]]
they wish to market their products, to determine if there are State 
requirements which need to be met.

III. Public Comment and Agency Response

    Fifty-six commenters responded to the proposed rule. Of these, 29 
(52%) generally opposed the proposal, and 23 (41%) generally supported 
it. Fourteen of the 29 commenters who opposed the rule as proposed, 
expressed support for some form of reduced regulation of low-risk 
pesticides.
    Supporters of the proposal include the ``organic'' industry, 
Greenpeace and companies likely to benefit from deregulation of these 
substances. Those opposed to the proposal include the States' FIFRA 
Issues Research Evaluation Group (SFIREG); State lead agencies with 
pesticide enforcement responsibilities in Arizona, California, New 
Jersey and Vermont; the Armed Forces Pest Management Board; the U.S. 
Department of Health and Human Services' Center for Disease Control; 
the National Coalition Against the Misuse of Pesticides (NCAMP); 
mosquito and vector control agencies; and several members of the 
regulated pesticide industry.
    The supporters of the proposal generally agreed with EPA that 
regulation of the listed substances is not necessary to prevent 
unreasonable adverse effects on human health or the environment. Many 
commented that deregulation would encourage the development and use of 
``safer'' pesticides and that the exemptions would benefit business, 
especially small business and the organic industry. Many supporters 
felt that EPA should more fully implement the proposal by greatly 
expanding the lists of exempted active ingredients and permitted 
inerts. Approximately 80 additional active ingredients and 50 inerts 
were proposed for future consideration. The Agency will evaluate each 
active ingredient and will include those it feels qualify for exemption 
in its next proposal. The inerts are presently being reviewed for 
possible inclusion in the next published list of inerts of minimum 
concern (inerts 4A list).
    Among objections to the proposal, the most often repeated concern 
was that deregulation would result in a proliferation of ineffective 
products making false or misleading claims about product performance 
and/or safety and that the public would pay the price for inadequate 
oversight by EPA and the Federal Trade Commission (FTC). SFIREG, the 
State Lead Agencies, and others expressed concern that deregulation 
would create a number of serious enforcement problems for States. Other 
significant concerns included the fear that deregulation of arthropod 
repellents would adversely affect public health; that certain 
substances proposed for exemption or included on the list of permitted 
inerts were not ``safe'' or could cause adverse effects when used in 
combination or in ways not anticipated by EPA; that EPA's factors and 
process for determining which substances to exempt or its process for 
revoking exemptions in the face of reported adverse effects were 
inadequate; and that deregulation of these substances would give an 
unfair competitive advantage to manufacturers of exempt pesticide 
products. Although more than 50 percent of the commenters opposed the 
proposed exemptions, nearly half (14 of 29) of the opponents expressed 
support for some form of reduced regulation of low-risk pesticides.
    In response to concerns regarding labeling and enforcement, the 
Agency has changed the rule to provide specific label requirements as 
indicated in the following section of this rule. If these conditions 
are not met by products being distributed, then the conditions for 
exemption from regulation have not been met, and the Agency retains 
authority to bring enforcement action under FIFRA.
    It is significant to point out, that since one condition for 
exemption is that the product label cannot make false or misleading 
claims, it is important for formulators and distributors of unregulated 
products to ensure that they are not making any unsupported efficacy 
claims for any pest, particularly for those which may be of a possible 
public health concern.
    The final rule clearly and concisely states which conditions 
manufacturers must meet to obtain exempted status for certain low-risk 
pesticides. States need only review whether a product meets those 
conditions to determine exempt status. The Agency is convinced that the 
deregulation of low risk products is wise. Exempted products should not 
require significant monitoring and it will not be difficult for States 
to identify properly exempted products. Those States which do not allow 
exemptions from State registration are free to continue to enforce 
their State provisions.
    Many commenters expressed concern that deregulation of some 
pesticides would give a competitive advantage to manufacturers of 
deregulated products. EPA's regulatory authority under FIFRA is 
primarily a licensing authority and every decision has some potential 
effect on competitors. The Agency does not consider potential impact on 
competitors to be a valid and sufficient reason to preclude an 
exemption under FIFRA.
    While no one submitted compelling evidence that the listed 
substances should not be exempted from regulation, several people took 
issue with the way EPA approached exempting pesticides in general and 
expressed concerns about the specific factors the Agency used to arrive 
at its selections. The Agency agrees that any one factor, taken alone, 
is insufficient to make a minimum risk determination. Admittedly, many 
chemicals that are available to the public on a daily basis, pose some 
level of risk, and several higher-risk pesticides were once listed on 
FDA's Generally Recognized As Safe (GRAS) list. It is important to 
stress that these factors were not applied exclusive of one another, 
but rather in conjunction with all of the others. Moreover, the factors 
themselves are not meant to be absolute criteria and certainly some 
factors are unsupported for some of the substances. But, taken as a 
whole, EPA believes that the factors applied to each of the substances 
indicate that the substances will not pose a risk that warrants 
regulation under FIFRA. EPA researched each substance prior to 
proposing it for exemption. A general literature search was performed 
in addition to an in-house search of the Agency's own data base.
    In its proposal, the Agency invited the public to add to the list 
of factors or submit information that might be appropriate to consider 
in determining whether a substance should be exempted from FIFRA 
regulation. No information was submitted by commenters about the 
proposed pesticides to support their comments. Any person may submit 
evidence that refutes the Agency's conclusions that any exempted 
pesticide should no longer be exempted because of newly uncovered risk. 
EPA will consider such information in determining whether the exemption 
should be continued.
    Commenters indicated that EPA should adopt a position similar to 
FDA's that allows cosmetics manufacturers to use the generic term 
``fragrance'' on their labels. The requirement to list all ingredients 
on the exempted product label presents problems, since fragrances are 
often purchased from independent vendors, and their formulations are 
proprietary. Fragrances can be skin sensitizers or have other adverse 
effects, particularly at higher concentrations. The Agency's evaluation 
of fragrances is concentration dependent; that is, it is based upon the 
amount of fragrance that will be used in 

[[Page 8878]]
a given formulation. What is acceptable at 0.1% concentration, may not 
be acceptable at 2%. In deregulating, the Agency would not be able to 
regulate the concentration of these fragrances in a formulation. The 
Agency understands the proprietary nature of many fragrance 
formulations, and we have evaluated ways of including fragrances on 
inerts list 4A. The Agency has found no workable solutions for this 
issue. The rule has not been changed.
    All public comments and more detailed responses to specific issues, 
are available in the public docket.

IV. Revisions Made to the Rule in Response to Comments

    The Agency has made the following changes from the proposed rule in 
response to the comments it received.
    1. The ingredients cinnamon, citronella, garlic, and sesame have 
been revised to include their oils.
    2. The requirement that the product label must indicate the 
percentage (by weight) of active ingredient(s) contained in the product 
has been added.
    3. The requirement, ``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'', has been amended to 
read, ``The substance or product must not bear claims either to control 
or mitigate microorganisms that pose a threat to human health, 
including, but not limited to disease transmitting bacteria or viruses, 
or claims to control insects or rodents carrying specific diseases, 
including, but not limited to ticks that carry Lyme disease.''
    4. The requirement that products must not include any false and 
misleading labeling statements, including those listed in 40 CFR 
156.10(a)(5)(i) - (viii) has been added.

V. Public Docket

    EPA has established a public docket for this rulemaking (OPP-300350 
and 300350A). All comments received in response to the proposed and 
final rule are available in the public docket. 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 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. Please 
address all written inquiries to the Public Response Section, Field 
Operations Division (7506C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.

VI. Regulatory Assessment Requirements

A. Executive Order 12866

    Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), it has 
been determined that this rule is not ``significant'' and is therefore 
not subject to review by the Office of Management and Budget.

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 have a positive economic impact on a 
substantial number of small businesses which will no longer be subject 
to FIFRA regulation, thereby reducing their costs and regulatory 
burdens.
    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 requirements. 
Therefore, the Paperwork Reduction Act is not applicable.

D. SAP, USDA and Congressional Review

    In accordance with FIFRA section 25, the FIFRA Scientific Advisory 
Panel (SAP) has waived review of this rule. A copy of the rule has been 
forwarded to the U.S. Department of Agriculture before publication. 
Copies of the final rule also were forwarded to the Committee of 
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, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and record 
keeping requirements.

    Dated: February 28, 1996.

Carol M. Browner,

Administrator.

    Therefore, 40 CFR chapter I, part 152 is 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 a 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) Exempted products. Products 
containing the following active ingredients are exempt from the 
requirements of FIFRA, alone or in combination with other substances 
listed in this paragraph, provided that all of the criteria of this 
section are met.
    Castor oil (U.S.P. or equivalent)
    Cedar oil
    Cinnamon and cinnamon oil
    Citric acid
    Citronella and Citronella oil
    Cloves and clove oil
    Corn gluten meal
    Corn oil
    Cottonseed oil
    Dried Blood
    Eugenol
    Garlic and garlic oil
    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) and sesame oil
    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)

    (2) Permitted inerts. A pesticide product exempt under paragraph 
(g)(1) of this section may only include inert ingredients listed in the 
most current List 4A. This list is updated periodically and is 
published in the Federal Register. The most current list may be 
obtained by writing to Registration Support Branch (4A Inerts List) 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington DC 20460.
    (3) Other conditions of exemption. All of the following conditions 
must be met for products to be exempted under this section:
    (i) Each product containing the substance must bear a label 
identifying the name and percentage (by weight) of each active 
ingredient and the name of each inert ingredient.

[[Page 8879]]

    (ii) The product must not bear claims either to control or mitigate 
microorganisms that pose a threat to human health, including but not 
limited to disease transmitting bacteria or viruses, or claims to 
control insects or rodents carrying specific diseases, including, but 
not limited to ticks that carry Lyme disease.
    (iii) The product must not include any false and misleading 
labeling statements, including those listed in 40 CFR 156.10(a)(5)(i) 
through (viii).

[FR Doc. 96-5240 Filed 3-5-96; 8:45 am]
BILLING CODE 6560-50-F