[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]
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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.
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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: brennis.robert@epamail.epa.gov.
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
