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cedar (natural) pesticides Regulation Exemptions 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.

.

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

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]