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Cedar (Natural) Pesticides - Exemption from Regulation 1/94

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

 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]