

[Federal Register: August 9, 2006 (Volume 71, Number 153)]
[Rules and Regulations]               
[Page 45395-45400]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09au06-16]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0529; FRL-8083-8]

 
Lepidopteran Pheromones; Exemption from the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the existing exemption from the 
requirement of a tolerance for residues of the biochemicals classified 
as lepidopteran pheromones, which are naturally occurring compounds, or 
identical or substantially similar synthetic compounds to include use 
as a ``post-harvest treatment'' on all stored food commodities. 
Bedoukian Research, Inc. submitted a petition to EPA under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act of 1996 (FQPA), requesting an exemption from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of biochemicals 
classified as lepidopteran pheromones.

DATES: This regulation is effective August 9, 2006. Objections and 
requests for hearings must be received on or before October 10, 2006, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0529. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 

if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-

[[Page 45396]]

4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Andrew Bryceland, Biopesticides and 
Pollution Prevention Division (7511P), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6928; e-mail address: bryceland.andrew@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this ``Federal Register'' document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access OPPTS Harmonized Guidelines 

referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm
.


C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. You must file your objection or 
request a hearing on this regulation in accordance with the 
instructions provided in 40 CFR part 178. To ensure proper receipt by 
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0529 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk on or 
before October 10, 2006.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0529, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of April 12, 2006 (71 FR 18735-18736) (FRL-
7773-8), EPA issued a notice pursuant to section 408(d)(3) of the 
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
tolerance petition (PP 6F7044) by Bedoukian Research, Inc., 21 Finance 
Drive, Danbury, CT 06810-4192. The petition requested that 40 CFR part 
180 be amended by establishing an exemption from the requirement of a 
tolerance for residues of biochemicals classified as lepidopteran 
pheromones, which are naturally occurring compounds, or identical or 
substantially similar synthetic compounds, designated by an unbranched 
aliphatic chain (between 9 and 18 carbons) ending in an alcohol, 
aldehyde, or acetate functional group and containing up to 3 double 
bonds in the aliphatic backbone. This notice included a summary of the 
petition prepared by the petitioner Bedoukian Research, Inc.. There 
were no comments received in response to the notice of filing.
    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA 
defines ``safe'' to mean that ``there is a reasonable certainty that no 
harm will result from aggregate exposure to the pesticide chemical 
residue, including all anticipated dietary exposures and all other 
exposures for which there is reliable information.'' This includes 
exposure through drinking water and in residential settings, but does 
not include occupational exposure. Pursuant to section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C), which require EPA to give special consideration 
to exposure of infants and children to the pesticide chemical residue 
in establishing a tolerance and to ``ensure that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue.... '' 
Additionally, section 408(b)(2)(D) of the FFDCA requires that the 
Agency consider ``available information concerning the cumulative 
effects of a particular pesticide's residues '' and ``other substances 
that have a common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action and considered its validity,

[[Page 45397]]

completeness, and reliability and the relationship of this information 
to human risk. EPA has also considered available information concerning 
the variability of the sensitivities of major identifiable subgroups of 
consumers, including infants and children.
    A pheromone (including identical or substantially similar synthetic 
compounds) as defined by the Agency is a compound produced by an 
arthropod which, alone or in combination with other compounds, modifies 
the behavior of other individuals of the same species. Straight Chain 
Lepidopteran Pheromones (SCLPs) are those produced by a member of the 
order Lepidoptera, which includes butterflies and moths.
    The toxicity profile of SCLPs has already been assessed for their 
pesticidal use by the Agency and published in support of the tolerance 
exemption in or on all raw agricultural commodities for all straight 
chain lepidopteran pheromones (SCLPs) that are naturally occurring 
compounds, or identical or substantially similar synthetic compounds, 
designated by an unbranched aliphatic chain (between 9 and 18 carbons) 
ending in an alcohol, aldehyde or acetate functional group and 
containing up to 3 double bonds in the aliphatic backbone, when the 
pheromone is applied to growing crops at a rate not to exceed 150 grams 
active ingredient/acre/year in accordance with good agricultural 
practices. (See Sec.  180.1153, 60 FR 45060, August 30, 1995). This 
final rule is amending the current Lepidopteran pheromone tolerance 
exemption, 40 CFR 180.1153, to include indoor post-harvest treatment in 
or on all stored food commodities at a rate not to exceed 3.5 grams 
active ingredient/1,000 square feet/year (3.5 g a.i./1,000/
ft2/year) (equivalent to 150 grams active ingredient/acre/
year) in accordance with good agricultural practices. The toxicity 
profile and use pattern of SCLPs, as mentioned above, have been fully 
characterized by the Agency. SCLPs are lowly toxic, are released in 
very small quantities in the environment, and act on a select group of 
insects. They are biodegradable by enzyme systems present in most 
living organisms and therefore, there is a reasonable certainty that no 
harm will result from their use as pesticides on food. For the purposes 
of this tolerance exemption amendment, the Agency has relied on the 
data and/or information previously submitted, in addition to 
comprehensive reviews and risk assessments already conducted by the 
Agency, and has reassessed that data in order to evaluate the request 
to add post harvest uses to the tolerance exemption. The Agency 
believes that in combination, the data and other information relied 
upon for this tolerance exemption supports its conclusion that there is 
reasonable certainty of no harm from the use of SCLPs as a post-harvest 
treatment in or on all stored food commodities at a rate not to exceed 
3.5 grams active ingredient (a.i.)/1,000 ft2/year 
(equivalent of 150 grams a.i./acre/year in accordance with good 
agricultural practices.
    The registrant did not submit any toxicity data testing the 
technical grade of the active ingredient. Data waivers were requested 
by the registrant and granted by the Agency based on the body of 
extensive knowledge from the public literature and comprehensive 
reviews and risk assessments conducted by the Agency on SCLPs. The 
toxicity of the SCLPs via the oral, dermal, inhalation, eye, skin, and 
genotoxicity routes of exposure have been assessed by the Agency (Refs. 
1 and 5) and reassessed in light of the request to add indoor post 
harvest treatment. The toxicity profile of SCLPs when used as a post-
harvest treatment in or on all stored food commodities does not change, 
and SCLPs when used in this manner are lowly toxic. EPA therefore 
concludes that there is a reasonable certainty of no harm resulting 
from the use of SCLPs as indoor post-harvest treatment in or on all 
stored food commodities. The data waivers that were granted are as 
follows:
    1. OPPTS 870.1100 Acute oral toxicity (rat) (Ref 2)--LD50 
 5,000 milligrams/kilogram (mg/kg). The test material is 
classified as a Toxicity Category IV for acute oral toxicity and 
demonstrates that there is little potential of the active ingredient to 
cause acute toxic effects. There were no adverse effects reported at 
5,000 mg/kg.
    2. OPPTS 870.1200 Acute dermal toxicity (rat) (Ref 2)--LD50 
 2,000 mg/kg. The test material is classified as a Toxicity 
Category III for acute dermal toxicity and demonstrates that there is 
little potential for toxic effects. There were no adverse effects 
reported at 2,000 mg/kg.
    3. OPPTS 870.5100, 870.5300, and 870.5375 Genotoxicity (Ref. 2). No 
evidence of mutageniticity.
    4. OPPTS 870.3700 Teratogenicity (Ref. 7). A developmental toxicity 
study (rats), involving inhalation exposure to unbranched, primary 
alcohols with chain length C8 to C10, indicated 
no detectable developmental toxicity (Ref. 7).
    Published mammalian toxicity data on SCLPs indicate no significant 
acute toxicity to humans (Ref. 6). A 90-day feeding study (870.3100) 
(rats) was conducted at doses up to 1 g/kg, of a commercial blend of 
branched acetates with an aliphatic chain length between C10 
to C14. The results indicated no significant signs of 
toxicity other than those expected with longer term exposure to high 
doses of a hydrocarbon, namely, histopathologic evidence of nephropathy 
in males and increased liver and kidney weights in both sexes (Ref. 8).

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of the FFDCA directs 
EPA to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational exposures, 
including drinking water from ground water or surface water and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses).

A. Dietary Exposure

    The Agency calculated an estimate of total dietary exposure, for 
adults and children, to pheromones used in agricultural and food 
commodity storage areas. This estimate was calculated assuming an 
application rate of 3.5 g a.i./1,000 ft2/year (the maximum 
application rate for SCLPs), assuming 100% of commodities (fruits, 
vegetables, and grains) are treated, and assuming that stored 
commodities absorb 100% of the pheromone and that 100% of the 
population eats all three commodity types each day. This scenario 
produces a dietary exposure of 0.1 to 1 mg/kg/day. This calculation 
demonstrates that there is an unlikely potential for significant 
dietary exposure to SCLPs. As a result of the risk assessment the 
Agency concludes that the use of SCLPs as a indoor post-harvest 
treatment in or on all stored food commodities at the maximum use rate 
of 3.5 g a.i./1,000 ft2/year will not add any new exposures 
or risks and is considered safe.
    1. Food. The Agency has determined that post harvest treatment of 
SCLPs to stored food commodities at the maximum application rate of 3.5 
g a.i./1,000 ft2/year may reduce any new anticipated 
exposure of SCLPs due to their indoor use. However, even if dietary 
exposure to SCLPs are not reduced due to their use as pesticides, the 
acute toxicity information demonstrating relatively low mammalian 
toxicity (Refs 1, 2, 5, 6, 7, and 8) and biodegradability of SCLPs 
(Refs 1 and 5) indicate that any possible risk associated with acute 
exposures by the oral route would be low to non-existent.

[[Page 45398]]

    2. Drinking water exposure. No significant drinking water exposure 
is expected to result from the use of SCLPs when applied as a post-
harvest treatment in or on all stored food commodities because they are 
applied in storage facilities, biodegradable, and are lowly toxic.

B. Other Non-Occupational Exposure

    There are no residential, school or day care uses proposed for this 
product. Since this use pattern is for agricultural food crops and 
indoor post-harvest treatment in or on all stored food commodities, the 
potential for non-occupational, non-dietary exposures to SCLPs by the 
general population, including infants and children, is highly unlikely.
    1. Dermal exposure. Non-occupational dermal exposures to SCLP when 
used as a post-harvest treatment to stored food commodities are 
expected to be negligible because it is limited to agricultural use.
    2. Inhalation exposure. Non-occupational inhalation exposures to 
SCLPs silicate when used as a post-harvest treatment to stored food 
commodities are expected to be negligible because they are limited to 
agricultural use.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider available information concerning the cumulative effects of a 
particular pesticide's residues and other substances that have a common 
mechanism of toxicity. The information available at this time indicates 
that SCLPs, when applied at a rate not greater than 3.5 g a.i./1,000 
ft2/year, do not have a toxic effect. Therefore accumulative 
effects form residues of SCLPs are not anticipated.

VI. Determination of Safety for U.S. Population, Infants and Children

    1. U.S. population. The Agency has determined that there is a 
reasonable certainty that no harm will result to the U.S. population 
from aggregate exposure to residues of SCLPs when used for post harvest 
treatment in or on all stored food commodities at a rate not to exceed 
3.5 g a.i./1,000 ft2/year. This includes all anticipated 
dietary exposures and other non-occupational exposures for which there 
is reliable information. The Agency arrived at this conclusion based on 
the low acute and subchronic toxicity of these pheromones, the 
metabolic pathways for long-chain fatty acids derived from straight 
chain alcohols, aldehydes and acetates are well understood, the low 
exposure to these pheromones subsequent to application from aging, 
volatilization, and the new use will be indoors, found that there is a 
reasonable certainty of no harm that will result form the use of SCLP 
and as a post-harvest treatment in or on all stored food commodities.
    2. Infants and children. FFDCA section 408 provides that EPA shall 
apply an additional tenfold margin of exposure for infants and children 
in the case of threshold effects. Margins of exposure are often 
referred to as uncertainty or safety factors, and are used to account 
for potential prenatal and postnatal toxicity and any lack of 
completeness of the data base. Based on available data and other 
information, EPA may determine that a different margin of exposure will 
define a level of concern for infants and children or that a margin of 
exposure approach is not appropriate. Based on all the available 
information the Agency reviewed on SCLPs, including a lack of threshold 
effects, the Agency concluded that SCLPs are practically non-toxic to 
mammals, including infants and children. Since there are no effects of 
concern, the provision requiring an additional margin of safety does 
not apply

VII. Other Considerations

A. Endocrine Disruptors

    EPA is required under section 408(p) of FFDCA, as amended by FQPA, 
to develop a screening program to determine whether certain substances 
(including all pesticide active and other ingredients) ``may have an 
effect in humans that is similar to an effect produced by a naturally 
occurring estrogen, or other such endocrine effects as the 
Administrator may designate.'' Following the recommendations of its 
Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), 
EPA determined that there were scientific bases for including, as part 
of the program, the androgen and thyroid hormone systems, in addition 
to the estrogen hormone system. EPA also adopted EDSTAC's 
recommendation that the Program include evaluations of potential 
effects in wildlife. For pesticide chemicals, EPA will use Federal 
Insecticide, Fungicide and Rodenticide Act (FIFRA) and, to the extent 
that effects in wildlife may help determine whether a substance may 
have an effect in humans, FFDCA has authority to require the wildlife 
evaluations. As the science develops and resources allow, screening of 
additional hormone systems may be added to the Endocrine Disruptor 
Screening Program (EDSP).
    At this time, the Agency is not requiring information on the 
endocrine effects of SCLPs. Based on the weight of the evidence of the 
available data and the absence of any reports to the Agency of 
sensitivity or other adverse effects, no endocrine system related 
effects are identified for SCLPs and none are expected because of their 
use. To date there is no evidence that SCLPs affect the immune system, 
functions in a manner similar to any known hormones, or that they act 
as endocrine disruptors. Thus, there is no impact via endocrine-related 
effects on the Agency's safety finding set forth in this final rule 
amending the SCLPs exemption from the requirement of a tolerance.

B. Analytical Method(s)

    An enforcement analytical method (OPPTS Harmonized Guideline 
830.1800) was provided by the petitioner. The method is gas 
chromatography with flame ionization detection. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Sciece Center, 701 Mapes Rd., Ft. Mead, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.

C. Codex Maximum Residue Level

    There are no CODEX maximum residue levels for residues for any 
SCLPs for indoor post-harvest treatment in or on all stored food 
commodities.

VIII. Conclusions

    The Agency concludes that if products containing SCLPs as active 
ingredients are applied for post harvest treatment in or on all stored 
food commodities at a rate not to exceed 3.5 g a.i./1,000 
ft2/year, there is a reasonable certainty that no harm to 
the U.S. population, including infants and children, will result from 
aggregate exposure to residue of SCLPs, when used in or on all stored 
food commodities.

IX. References

    1. Toughey, J.G. (ca 1990). ``White Paper - A review of the current 
bases for the United States Environmental Protection Agency's policies 
for the regulation of pheromones and other semiochemicals, together 
with the review of the available relevant data which may impact the 
assessment of risk for these classes of chemicals. Part No.1, Straight 
Chain Alcohols, Acetate Esters, and Aldehydes.'' (unpublished report, 
474 pp.)

[[Page 45399]]

    2. Federal Register. 59 FR 3687-3684, Jan. 26, 1994. EPA Notice: 
Arthropod pheromones in solid matrix dispensers; Experimental Use 
Permits.
    3. Federal Register. 59 FR 34812-34814, Jul. 7, 1994. EPA Notice: 
Arthropod pheromones; Experimental Use Permits.
    4. Federal Register. 60 FR 45060-45062, Aug. 30,1995. EPA Rule: 
Lepidopteran pheromones; Tolerance Exemption.
    5. EPA Final Rule: Lepidopteran Pheromones: Tolerance 
Exemption.Environmental Directorate, 26 February, 2002, OECD Series on 
Pesticides No. 12. Guidance for Registration Requirements for 
Pheromones and Other Semiochemicals Used for Arthropod Pest Control. 
ENV/JM/MONO(2001)12, Organization of Economic Co-operation and 
Development. Paris, France. (http://www.epa.gov/ pesticides/ 

biopesticides/ regtools/ index.htm).
    6. Inscoe & Ridgway. 1992.
    7. Nelson et al. 1990.
    8. Daughtrey et al. 1990.

IX. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a 
tolerance under section 408(d) of the FFDCA in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the exemption from 
the requirement of a tolerance in this final rule, do not require the 
issuance of a proposed rule, the requirements of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, 
the Agency has determined that this action will not have a substantial 
direct effect on States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: July 26, 2006.
Phil Hutton,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. Section 180.1153 is revised to read as follows:


Sec.  180.1153  Lepidopteran pheromones; exemption from the requirement 
of a tolerance.

    Lepidopteran pheromones that are naturally occurring compounds, or 
identical or substantially similar synthetic compounds, designated by 
an unbranched aliphatic chain (between 9 and 18 carbons) ending in an 
alcohol, aldehyde or acetate functional group and containing up to 3 
double bonds in the aliphatic backbone, are exempt from the requirement 
of a tolerance in or on

[[Page 45400]]

all raw agricultural commodities. This exemption only pertains to those 
situations when the pheromone is: Applied to growing crops at a rate 
not to exceed 150 grams active ingredient/acre/year in accordance with 
good agricultural practices; and applied as a post-harvest treatment to 
stored food commodities at a rate not to exceed 3.5 grams active 
ingredient/1,000 ft2/year (equivalent to 150 grams active 
ingredient/acre/year) in accordance with good agricultural practices.
[FR Doc. E6-12971 Filed 8-8-06; 8:45 am]

BILLING CODE 6560-50-S
