Lepidopteran Pheromones; Exemption from the Requirement of a Tolerance, 45395-45400 [E6-12971]
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Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations
because it will not have a substantial
direct effect on one or more Indian
tribes, 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.
paragraph (34)(g) of the Instruction
applies.
A final ‘‘Environmental Analysis
Check List’’ and final ‘‘Categorical
Exclusion Determination’’ are available
in the docket where indicated under
ADDRESSES.
Energy Effects
List of Subjects in 33 CFR Part 165
We have analyzed this rule under
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use. We have
determined that it is not a ‘‘significant
energy action’’ under that order because
it is not a ‘‘significant regulatory action’’
under Executive Order 12866 and is not
likely to have a significant adverse effect
on the supply, distribution, or use of
energy. The Administrator of the Office
of Information and Regulatory Affairs
has not designated it as a significant
energy action. Therefore, it does not
require a Statement of Energy Effects
under Executive Order 13211.
Harbors, Marine Safety, Navigation
(water), Reporting and recordkeeping
requirements, Security measures,
Waterways.
Technical Standards
The National Technology Transfer
and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use
voluntary consensus standards in their
regulatory activities unless the agency
provides Congress, through the Office of
Management and Budget, with an
explanation of why using these
standards would be inconsistent with
applicable law or otherwise impractical.
Voluntary consensus standards are
technical standards (e.g., specifications
of materials, performance, design, or
operation; test methods; sampling
procedure; and related management
system practices) that are developed or
adopted by voluntary consensus
standards bodies.
This rule does not use technical
standards. Therefore, we did not
consider the use of voluntary consensus
standards.
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Environment
We have analyzed this rule under
Commandant Instruction M16475.lD
and Department of Homeland Security
Management Directive 5100.1, which
guide the Coast Guard in complying
with the National Environmental Policy
Act of 1969 (NEPA) (42 U.S.C. 4321–
4370f), and have concluded that there
are no factors in this case that would
limit the use of a categorical exclusion
under section 2.B.2 of the Instruction.
Therefore, this rule is categorically
excluded, under figure 2–1, paragraph
(34)(g), of the Instruction, from further
environmental documentation. Because
this event establishes a safety zone,
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For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 165 as follows:
I
PART 165—REGULATED NAVIGATION
AREAS AND LIMITED ACCESS AREAS
1. The authority citation for part 165
continues to read as follows:
I
Authority: 33 U.S.C. 1226, 1231; 46 U.S.C.
Chapter 701; 50 U.S.C. 191, 195; 33 CFR
1.05–1(g), 6.04–1, 6.04–6, and 160.5; Public
Law 107–295, 116 Stat. 2064; Department of
Homeland Security Delegation No. 0170.1.
I 2. A new temporary § 165.T09–114 is
added to read as follows:
§ 165.T09–114 Safety Zone; Cleveland
National Air Show, Lake Erie, OH.
(a) Location. The following is a safety
zone: All waters of Lake Erie and
Cleveland Harbor (near Burke Lakefront
Airport) from position 41°30.34′ N
081°42.33′ W to 41°30.84′ N 081°42.82′
W then to 41°32.15′ N 081°39.82′ W
then to 41°31.88′ N 081°39.40′ W then
east to 41°31.71′ N 081°39.76′ W. These
coordinates are based upon North
American Datum 1983 (NAD 83). The
event sponsor will establish marker
buoys to outline the safety zone at
regular intervals to assist vessels in
recognizing this area as a safety zone
during the times of enforcement.
(b) Effective Period. The safety zone in
paragraph (a) of this section is effective
from 10 a.m. on August 31, 2006
through 6 p.m. on September 4, 2006.
The rule will be enforced from 10 a.m.
to 6 p.m. on August 31, 2006; from 10
a.m. to 6 p.m. on September 1, 2006;
from 10 a.m. to 6 p.m. on September 2,
2006; from 10 a.m. to 6 p.m. on
September 3, 2006; and from 10 a.m. to
6 p.m. on September 4, 2006. All times
are local.
(c) Regulations. Entry into, transit
through, or anchoring within this safety
zone is prohibited unless authorized by
the Captain of the Port Buffalo or his
designated on-scene representative. The
designated on-scene representative will
be the Coast Guard Patrol Commander.
The Coast Guard Patrol Commander
may be contacted via VHF Channel 16.
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45395
Dated: July 6, 2006.
S.J. Ferguson,
Captain, U.S. Coast Guard, Captain of the
Port Buffalo.
[FR Doc. E6–12937 Filed 8–8–06; 8:45 am]
BILLING CODE 4910–15–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0529; FRL–8083–8]
Lepidopteran Pheromones; Exemption
from the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
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Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations
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.
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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 https://
www.regulations.gov, you may access
this ‘‘Federal Register’’ document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://
www.gpoaccess.gov/ecfr. To access
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines at https://www.epa.gov/
opptsfrs/home/guidelin.htm.
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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: https://
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
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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,
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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
§ 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
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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
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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 nonoccupational 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 nonexistent.
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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 nonoccupational, non-dietary exposures to
SCLPs by the general population,
including infants and children, is highly
unlikely.
1. Dermal exposure. Nonoccupational 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. Nonoccupational inhalation exposures to
SCLPs silicate when used as a postharvest treatment to stored food
commodities are expected to be
negligible because they are limited to
agricultural use.
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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
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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
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
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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 207555350; telephone number: (410) 3052905; e-mail address:
residuemethods@epa.gov.
C. Codex Maximum Residue Level
A. Endocrine Disruptors
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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 endocrinerelated effects on the Agency’s safety
finding set forth in this final rule
amending the SCLPs exemption from
the requirement of a tolerance.
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.)
E:\FR\FM\09AUR1.SGM
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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. (https://
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
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16:38 Aug 08, 2006
Jkt 208001
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
PO 00000
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Fmt 4700
Sfmt 4700
45399
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.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1153 is revised to read
as follows:
I
§ 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
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Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations
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
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2005–0123; FRL–8077–6]
Inorganic Bromide; Tolerance Actions
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
EPA is revoking twelve
specific inorganic bromide tolerances
because they are no longer needed.
These twelve tolerances are for residues
of inorganic bromide from pre-plant
(non-food) use in or on raw agricultural
commodities grown in soil fumigated
with combinations of chloropicrin,
methyl bromide, and propargyl
bromide. Although methyl bromide is
used as an agricultural pesticide, the
Agency considers its application as a
soil fumigant to be a non-food use
because it is quickly degraded or
metabolized in the soil, and
subsequently incorporated into natural
plant constituents. Methyl bromide is
also emitted to the atmosphere.
Residues of the parent compound are
not likely to be found in foods as a
result of prior treatment of fields. While
residues of inorganic bromide may be
present, these residues are
indistinguishable from background
because of inorganic bromide’s ubiquity
in the environment. Consequently, EPA
is revoking them because no tolerances
are needed for those non-food uses.
Furthermore, since methyl bromide,
when applied as a pre-plant soil
fumigant is a non-food use, the Agency
is adding it as an entry to 40 CFR
180.2020 noting the non-food use
determination.
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
jlentini on PROD1PC65 with RULES
SUMMARY:
VerDate Aug<31>2005
16:38 Aug 08, 2006
Jkt 208001
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2005–0123. 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
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
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:
Steven Weiss, Special Review and
Reregistration Division (7508P), Office
of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (703) 308–
8293; e-mail address:
weiss.steven@epa.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
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 111), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
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
PO 00000
Frm 00038
Fmt 4700
Sfmt 4700
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 https://
www.regulations.gov, you may access
this ‘‘Federal Register’’ document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://
www.gpoaccess.gov/ecfr.
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–2005–0123 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–2005–0123, by one of
the following methods.
• Federal eRulemaking Portal: https://
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
E:\FR\FM\09AUR1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 153 (Wednesday, August 9, 2006)]
[Rules and Regulations]
[Pages 45395-45400]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12971]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://
www.regulations.gov, you may access this ``Federal Register'' document
electronically through the EPA Internet under the ``Federal Register''
listings at https://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 https://
www.gpoaccess.gov/ecfr. To access OPPTS Harmonized Guidelines
referenced in this document, go directly to the guidelines at https://
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: https://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. (https://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
