cedar (natural) Requirement Exemptions 3/94
40 CFR Part 152
Pesticides; Exemption From Federal Insecticide, Fungicide and
Rodenticide Act Requirements for Natural Cedar Pesticides
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 natural cedar pesticides labelled, or for which
claims are made, only to repel arthropods other than ticks,
or to retard mildew growth.
EFFECTIVE DATE: March 21, 1994.
ADDRESSES: Written objections, identified by the document control
number, [OPP-250091B], must 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: Room 1132, CM #2, 1921 Jefferson Davis Highway, Crystal
City, VA 22202.
FOR FURTHER INFORMATION CONTACT: By mail: Richard F. Mountfort,
Registration Division [7505C], Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 713, CM
#2, 1921 Jefferson Davis Highway, Arlington, VA 22202, 703-305-
EPA issued a proposed rule, published in the Federal Register
of August 11, 1993 (58 FR 42711) to exempt natural cedar pesticides,
labelled, or for which claims are made, only to repel arthropods
other than ticks, or to retard mildew growth, from regulation
under FIFRA. The Agency concludes that use of these pesticides
for these purposes poses negligible risks to human health or
the environment and that the burden imposed by regulation is
not justified. Accordingly, EPA is establishing this final exemption.
Natural cedar pesticides labelled with claims of repelling ticks
or for which claims are made to repel or otherwise mitigate
ticks, are not included in the exemption. Ticks can be vectors
of significant diseases affecting humans, and EPA has not yet
fully evaluated whether or not such an exemption is justified.
Thus, regulation of such pesticides is appropriate.
This exemption will not apply to any cedarwood product that
is treated, combined or impregnated with any additional substances.
EPA has determined that natural cedar itself poses little or
no risk and does not pose unreasonable adverse effects on the
environment. However, EPA has not made any such finding for
cedar when it is mixed with any other ingredients. Thus, to
qualify for this exemption, the pesticide must only contain
natural cedar and cannot contain any inert ingredients. For
example, if cedar is painted or soaked in any substance, it
would not qualify for the exemption. Likewise, if cedar chips
or shavings are mixed with other ingredients, the exemption
would not apply. Natural cedar products, however, may be packaged
and still qualify for the exemption.
II. Public Comment and Agency Response
In the proposed rule, the Agency solicited comments on the
proposed exemption from regulation of cedar pesticides labelled
for use to repel arthropods (except ticks) or to retard mildew.
Six sets of comments were received. Three commenters supported
the proposed rule and three objected to it. EPA also invited
suggestions for additional candidates for consideration for
possible future exemption. Two commenters suggested such candidates.
EPA's proposal included the term ``chips'' to describe the
exempted pesticide. American Wood Fibers of Jessup Maryland,
Inc. requested that the word shavings be inserted in the rule
in addition to the term chips. Shavings is the term used more
often in the industry. In response to this comment, EPA has
added the term ``shavings'' to the final rule. This is not a
significant change since all forms of cedar products (except
cedar oil) were intended to be covered by the exemption.
American Zinc Association and Alltrista Zinc Products Company
and Roussel UCLAF Corporation responded to the Agency's invitation
to suggest other low-risk pesticide candidates for exemption
from regulation. American Zinc and Alltrista requested that
zinc metal strips used for preventing moss, fungus and mildew
on roofs be considered; Roussel UCLAF Corporation requested
review of rotenone.
As noted in the proposal to this exemption, EPA recognizes
that there may be other low-risk pesticides that would also
be appropriate for exemption under section 25(b). EPA is currently
evaluating existing pesticide registrations to identify other
potential candidates for exemption or reduced regulation. EPA
will include in this consideration the two pesticides, zinc
metal strips and rotenone, that were identified as potential
candidates in the comments submitted on the proposed cedarwood
exemption. Moroever, as discussed in the proposed exemption,
EPA plans to evaluate whether or not cedar oil extracted from
plant parts is appropriate for exemption. EPA also plans to
evaluate in the future whether or not it is appropriate to exempt
cedar products for which claims such as ``repels ticks'' are
made. If EPA determines that any of the above-described exemptions
are warranted, EPA will publish a proposed rule on such exemptions
and provide an opportunity for public comment.
The Chlorobenzene Producers Association [CPA]; Excell Products
Corporation; and Willert Home Products opposed the cedarwood
exemption. Each are, or represent, producers of alternative
products for moth repellence which compete with cedar products.
Their objections and the Agency's response to each are as follows:
1. Consumers will be harmed and cedar competitors placed
at a disadvantage if natural cedar pesticides are exempted.
CPA and Excell Products assert that a number of competing products
to cedar are produced and distributed by small businesses.
The Agency disagrees that the proposed exemption of natural
cedar will result in harm to consumers. As described in the
proposal, the risk to humans or the environment associated with
natural cedar is low. The natural oils in the wood and other
plant parts are present at low levels and little exposure to
users or the environment is likely. Cedar products have been
sold and widely used for many years with no known health or
environmental effects. EPA's regulatory authority under FIFRA
is primarily a licensing authority; 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 this exemption.
2. Cedar is ineffective for pest control purposes and cedar
companies will be emboldened to make false and misleading claims
without regulatory oversight. Marketing of refresher oils for
cedarwood strengthens the impression that natural cedar is limited
or ineffective in pest control.
The Agency is not endorsing the effectiveness of natural
cedar as a repellent or for mildew prevention purposes. Because
of the very low risk to man or the environment associated with
cedar products, even if the commenters' claims of low efficacy
are true, EPA believes the low risk nature of cedar justifies
this exemption. EPA believes the marketplace is sufficient to
suppress ineffective products. The Agency acknowledges that
excessive and misleading claims may be associated with any products
exempted from regulation, including cedar products. The Agency
does not endorse or encourage use of excessive or misleading
claims for cedar, but believes this is a circumstance where
market choices will restrain abuse and ineffective products.
3. The Agency has already assisted the cedar industry with
expedited review procedures.
Expedited review procedures were employed for several cedar
registrations in large part because the Agency considered these
pesticides to pose little or no risk to man or the environment.
All supporting data for natural cedar products were waived except
descriptions of processing the wood and analyses for oil content.
The Agency concludes that the low risk associated with natural
cedar does not justify the cost of regulation, including the
reduced costs associated with the expedited review procedures
cited above, for either society or the Agency.
4. This proposal improperly implies that natural substances
are safe and synthetics are hazardous.
The Agency agrees that not all natural substances are safe
and that not all synthetics are hazardous. Natural cedar, however,
is low-risk for both humans and the environment.
5. The public health risk from exposure to natural cedar
may not be negligible; lack of information suggesting risk does
not support a finding of no unreasonable risk. This commenter
[CPA] believes the statute requires a finding of no unreasonable
adverse effect on the environment to support the exemption.
CPA also concludes that exemption based on low exposure is inconsistent
with prior Agency pesticide policy and that EPA's statutory
obligations are not diminished when a pesticide also has non-
The Agency agrees that lack of information, in and of itself,
is not sufficient to justify exemption. In the case of cedar,
however, the point is reinforced from many years of distribution
and widespread use of cedar with no known adverse effect. There
is very little exposure likely for humans or the environment
to the natural oils. Cedarwood oil typically occurs in cedarwood
at low levels and cannot easily be separated from the wood or
plant product. Consumers using cedarwood products are unlikely
to be exposed to significant amounts of dust or oil either by
inhalation or through the dermal route. Moreover, EPA believes
that cedarwood oil, when used as it naturally occurs in blocks,
chips, or other plant parts, is not expected to result in any
significant environmental exposure and cedarwood oil is not
known to persist or bioaccumulate in the environment.
FIFRA section 25(b)(2) authorizes the Administrator to exempt
a pesticide if it is determined to be ``of a character which
is unnecessary to be subject to this Act in order to carry out
the purposes of this Act.'' Consistent with the comment from
CPA, EPA has determined that cedarwood products, as defined
in this rule, pose negligible risks to human health and the
environment and do not pose unreasonable adverse effects on
the environment. Thus, EPA has concluded that these products
are of a character which is unnecessary to be subject to the
Act. As discussed in the proposal of this rule, the term unreasonable
adverse effect is defined at FIFRA section 2(bb) as ``any unreasonable
risk to man or the environment, taking into account the economic,
social and environmental costs and benefits of the use of any
pesticide.'' EPA believes that natural cedar pesticides pose
little or no risk to human health or the environment and that
the regulatory burden imposed by registration of these products
is not justified by the negligible risk posed by them.
None of the commenters offered any evidence that would contradict
this finding. The only evidence of risk presented was reference
to mechanical injury if a child swallowed a small cedar ball.
This comment cited a reference in materials submitted by a cedar
registrant to their product and labelling warning to keep the
product away from children. The Agency agrees that any object
small enough to swallow should be kept from small children.
If the sole risk posed by cedarwood products is the risk of
children swallowing them, that alone is not a sufficient basis
for EPA to regulate them under FIFRA. FIFRA was designed to
address the unique concerns presented by pesticides. EPA does
not believe that this type of physical risk, in the absence
of any other pesticidal risk, justifies regulation under FIFRA.
Other Federal, State and local authorities exist that could
be used to address this type of risk.
The CPA also commented that EPA is required to find that,
to be eligible for exemption under FIFRA section 25(b)(2), a
pesticide product satisfies ``other objectives'' of FIFRA such
as meeting statutory criteria for registration with respect
to labeling and composition. In the case of cedar, the Agency
concludes that labelling requirements typically applied to pesticides
are not necessary to prevent unreasonable risk to humans, including
children (excluding products with claims involving public health
issues). Determinations regarding product composition, labeling
or other aspects of regulatory constraint are unnecessary given
the low risk potential.
The Agency disagrees with CPA's assertion that consideration
of lack of exposure is inconsistent with prior EPA pesticide
policy. The Agency has previously exempted pheromones citing
low exposure as one factor in the decision to exempt [47 FR
6. Excell Products Corporation urged that registrations for
natural cedar pesticides issued prior to the exemption not be
continued if the exemption is established. They are concerned
that this would create a false impression of government endorsement
for the registered articles.
The Agency does not intend to register additional natural
cedar pesticides (unless claims for ticks are made - see discussions
above). It is expected that existing registrations will be voluntarily
cancelled after the rule becomes effective. Registration is
never an endorsement of a pesticide.
The low risk associated with pesticidal use of natural cedar
does not justify the cost of regulation to society or the Agency.
There is no reason to believe that mis-use or disposal of natural
cedar pesticides will increase potential risk. The Agency concludes
that use of natural cedar pesticides as described in the proposed
regulation will not cause unreasonable adverse effects on humans
or the environment, whether regulated under FIFRA or not. None
of the commenters offered any evidence that would contradict
This exemption will relieve regulatory burdens for those
companies and products consistent with the terms and conditions
In accordance with FIFRA section 25, the FIFRA Science Advisory
Panel (SAP) has waived review of the proposed and final rule.
The Secretary of Agriculture waived review of the proposed rule
and agreed to waive review of the final rule if it is the same
as the proposed rule. A copy of the final rule was forwarded
to the U. S. Department of Agriculture. Copies of the final
rule also were forwarded to the Committee on Agriculture of
the House of Representatives and the Committee on Agriculture,
Nutrition and Forestry of the Senate.
The Agency has considered the comments received in response
to the proposed rule. Except for the one minor change in wording,
the Agency concludes that the exemption is appropriate.
IV. Public Docket
The EPA has established a public docket for this rulemaking
(OPP-2500091 and 2500091B). All comments received in response
to the proposed and final rule are available in the public docket.
The public docket is located at the Virginia address given under
the ADDRESSES section above.
V. Regulatory Assessment 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.
Under the terms of this 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 given the impacts forecasted
pursuant to the analysis conducted under Executive Order 12866
as set forth above.
Accordingly, I certify that this rule does not require a
separate regulatory flexibility analysis under the Regulatory
C. Paperwork Reduction Act
This rule contains no information collection requirements.
Therefore, the Paperwork Reduction Act of 1980 is not applicable.
In accordance with FIFRA section 25, the FIFRA Science Advisory
Panel (SAP) has waived review of the proposed and final rule.
A copy of the final rule has been forwarded to the U.S. Department
of Agriculture before publication. Copies of the final rule
also were 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
Administrative practice and procedure, Pesticides and pests,
Reporting and recordkeeping requirements.
Dated: January 10, 1994.
Carol M. Browner,
Therefore, 40 CFR chapter I, part 152 is amended as follows:
1. The authority citation continues to read as follows:
Authority: 7 U.S.C. 136-136y.
2. In . 152.25 by adding a new paragraph (f) to read as follows:
152.25 Exemptions for pesticides of a character not requiring
* * * * *
(f) Natural cedar. (1) Natural cedar blocks, chips, shavings,
balls, chests, drawer liners, paneling, and needles that meet
all of the following criteria:
(i) The product consists totally of cedarwood or natural
(ii) The product is not treated, combined, or impregnated
with any additional substance(s).
(iii) The product bears claims or directions for use solely
to repel arthropods other than ticks or to retard mildew, and
no additional claims are made in sale or distribution. The labeling
must be limited to specific arthropods, or must exclude ticks
if any general term such as ``arthropods,'' ``insects,'' ``bugs,''
or any other broad inclusive term, is used. The exemption does
not apply to natural cedar products claimed to repel ticks.
(2) The exemption does not apply to cedar oil, or formulated
products which contain cedar oil, other cedar extracts, or ground
cedar wood as part of a mixture.
[FR Doc. 94-1244 Filed 1-18-94; 8:45 am]