[Federal Register Volume 59, Number 12 (Wednesday, January 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1244]


[[Page Unknown]]

[Federal Register: January 19, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 152

[OPP-250091B; FRL-4744-6]

 

Pesticides; Exemption From Federal Insecticide, Fungicide and 
Rodenticide Act Requirements for Natural Cedar Pesticides

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 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, 703-305-5446.
SUPPLEMENTARY INFORMATION:

I. Background

    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-pesticidal uses.
    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 33717].
    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 these 
conclusions.
    This exemption will relieve regulatory burdens for those companies 
and products consistent with the terms and conditions described.
    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.

III. Conclusion

    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 Flexibility Act.

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,
Administrator.

    Therefore, 40 CFR chapter I, part 152 is amended as follows:

PART 152--[AMENDED]

    1. The authority citation continues to read as follows:

    Authority: 7 U.S.C. 136-136y.

    2. In Sec. 152.25 by adding a new paragraph (f) to read as follows:


Sec. 152.25   Exemptions for pesticides of a character not requiring 
FIFRA regulation.

*   *   *   *   *
    (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 cedar.
    (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]
BILLING CODE 6560-50-F