[Federal Register: January 7, 2009 (Volume 74, Number 4)]
[Rules and Regulations]
[Page 629-634]
[DOCID:fr07ja09-4]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0528; FRL-8396-2]

Extract of Chenopodium ambrosioides near ambrosioides; Exemption
from the Requirement of a Tolerance

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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SUMMARY:  This regulation establishes an exemption from the requirement
of a tolerance for residues of the Extract of Chenopodium ambrosioides
near ambrosioides on all food commodities when applied/used as a
biochemical insecticide/acaricide. AgraQuest, Inc. submitted a petition
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of Extract of Chenopodium ambrosioides near ambrosioides
on all food commodities.

DATES:  This regulation is effective January 7, 2009. Objections and
requests for hearings must be received on or before March 9, 2009, 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-2008-0528. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. 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-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT:  Chris Pfeifer, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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 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 electronically available documents 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 e-CFR site at http://www.gpoaccess.gov/
ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-
2008-0528 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 March 9, 2009.
    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-2008-0528, 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
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility'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 Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of July 31, 2008 (73 FR 44720) (FRL-8374-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 7F7299) by AgraQuest, Inc., 1540 Drew Avenue, Davis, CA,
95618. The petition requested that 40 CFR part 180 be amended by
establishing an exemption from the requirement of a tolerance for
residues of Extract of Chenopodium ambrosioides near ambrosioides. This
notice included a summary of the petition prepared by the petitioner
AgraQuest, Inc.. There were no substantive comments received in
response to the notice of filing. However, three letters of support
from prospective users expressed enthusiasm for the proposed new food
uses.
    Section 408(c)(2)(A)(i) of 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 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) of FFDCA, 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) of FFDCA, 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 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 FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, 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.
    Extract of Chenopodium ambrosioides near ambrosioides is a blended
extract derived from a flowering plant commonly known as American
Wormseed. It is an amber liquid that is semi-volatile, and has a
fruity, woodsy, aromatic smell. The extract is composed of many
constituent ingredients, the properties of which have all been assessed
previously in Agency reviews (Science Review in Support of the
Registration of the active ingredient Chenopodium ambrosioides near
ambrosioides, February 2008; Science Review and Tolerance Exemption
Petition Review In Support of the Registration of Requiem\TM\ 25EC
containing Extract of Chenopodium ambrosioides near ambrosioides as its
active ingredient, October 2008). It has had many historical medicinal
uses, and was cited in the U.S. Pharmacopoeia. Most recently, the
extract has been used as the active ingredient in a Federally
registered biopesticide product intended for non-food uses as a contact
insectidcide and acaracide on ornamentals. Extract ofChenopodium
ambrosioides near ambrosioides has a ``non-toxic'' mode of action,
which softens cuticles in target insects, resulting in a disruption of
insect respiration. This rule establishes the exemption of a tolerance
for Extract of Chenopodium ambrosioides near ambrosioides on all food
commodities.
    Extract of Chenopodium ambrosioides near ambrosioides contains
three major terpene constituents--[alpha]-terpinene, p-cymene, and d-
limonene--which occur naturally in fruits, vegetables, herbs, spices,
and other foods and beverages, and are defined as marker compounds in
the active ingredient. These three compounds are also permitted as food
and fragrance additives in the U.S. and Europe. These three
constituents have been fully characterized by EPA and have each been
assessed for their uses in pesticides for food uses in the October 2008
risk assessment referenced above. Based on the information before the
Agency, incidental exposures to these three compounds are without known
toxicological incident for humans. The general public is exposed daily
to low levels of these compounds via ingestion, dermal contact,
inhalation through consumption of foods and beverages and dermal
contact with cosmetics, in excess of any exposure expected to result
from the pesticidal use of this extract. The per capita daily
consumption of these terpene compounds as food additives alone amounts
to 13.325 milligrams (mg) in the U.S. and 40.397 mg in Europe (WHO.
Evaluation of Certain Food Additives. WHO Technical Report Series No.
928. Sixty-third Report of the Joint FAO/WHO Expert Committee on Food
Additives. 2005), amounts far in excess of any potential dietary
exposures resulting from exposures to residues from this pesticidal
extract, as discussed below. [alpha]-Terpinene is found in the
essential oils of a variety of plants including citrus, peppermint,
thyme,

basil, and papaya. Per 21 CFR 172.515, it is permitted for direct
addition to food for human consumption. d-Limonene is a major component
of lemon oil, orange oil, and grapefruit oil, and is a minor component
of other fruits, vegetables, meats, and spices. It is widely used as a
flavor and fragrance and is generally recognized as safe (GRAS) by the
Food and Drug Administation (FDA) as a food additive or flavoring, and
as a fragrance additive (21 CFR 182.60). Limonene is a federally
registered active ingredient in 15 pesticides and is exempt from the
requirement of a tolerance per 40 CFR 180.539. Humans regularly consume
p-Cymene through such foods as butter, carrots, nutmeg, orange juice,
oregano, raspberries, lemon oil, and spices. p-Cymene is permitted by
FDA for direct addition to food as a flavoring substance (21 CFR
172.515). For the reasons set forth below, EPA believes it reasonable
to conclude that the terpene exposures identified above will either
exceed or be comparable to exposures resulting from use of this extract
as a pesticide. The balance of the constituents, while not expected to
be active, are also regularly found in fruits, vegetables and plant
extracts and have been assessed by EPA and determined not to be of
toxicological concern when used in pesticides for food uses (Risk
Assessments for Extract of Chenopodium ambrosioides near ambrosioides
dated February 2008 and October 2008). Overall, a thorough analysis of
the constituent compounds of Extract of Chenopodium ambrosioides near
ambrosioides indicate a low toxicity profile and support this exemption
from the requirement of a tolerance.
    A low toxicity profile of the constituents, the fact that they have
been assessed by the Agency already, and the lack of detectable
residues for this contact insecticide support the Agency's
determination to establish an exemption from the requirement of a
tolerance. Three residue studies demonstrate that the rapid degradation
of the extract leaves no opportunity for post-application exposure. A
residue decline study on primrose demonstrated that when the extract is
sprayed at 4X the proposed application rate, residues of the three
major active ingredient components declined to non-detectable levels
within 10 minutes (MRID 47209101). A second study on tomatoes involving
four applications of the extract within a 24-hour period found no
detectable residues on any samples collected immediately following the
final application (MRID 46858903). A third residue study on mustard
greens involving three applications at twice the application rate found
no detectable residues within the hour after the third application
(MRID 47548301). Essentially, data demonstrate that by the time Extract
of Chenopodium ambrosioides near ambrosioides has dried on the plant
there is no detectable residual product. Accordingly, the dietary risk
assessment of Extract of Chenopodium ambrosioides near ambrosioides
suggests that the lack of exposure to residues of the extract obviate
any dietary hazard, and support an exemption from the requirement of a
tolerance.
    Summaries of the toxicological information submitted in support of
this exemption from the requirement of a tolerance follow:
    1. Acute toxicity. Acute toxicity studies submitted to support the
initial registration of the manufacturing use product containing the
active ingredient Extract of Chenopodium ambrosioides near ambrosioides
confirm a low toxicity profile, and support the finding that this
active ingredient poses no significant human health risk with regard to
food uses. A summary of the acute toxicity studies follows:
    i. The acute oral LD50s in rats were 2,000--5,000 mg/Kg
and confirm negligible toxicity through the oral route.
    ii. The acute dermal LD50 in rats for was greater than
5,000 mg/kg. These data substantiate the active ingredient's relative
dermal non-toxicity to both occupational users and the general public.
    iii. The acute inhalation LC50 is greater than 2.03 mg/L
in rats, and shows no significant inhalation toxicity.
    iv. A skin irritation study on rabbits indicated that the extract
was mildly irritating to the skin. Overall, the data further support
the finding of negligible dermal toxicity presented in the acute dermal
toxicity study.
    v. The extract has been classified as a dermal sensitizer; however,
no exposures (prolonged or otherwise) are expected due to the rapid
degradation of the extract.

The rapid degradation of the extract is expected to preclude any route
of exposure, obviating all potential acute toxic effects. Nonetheless,
the acute toxicity data suggest that even in the event of any dietary
exposure that the dietary risk would be considered negligible.
    2. Genotoxicity. Three genotoxicity studies (a bacterial reverse
mutation assay, an in vitro mammalian chromosome aberration test, and
an unscheduled DNA repair assay) were performed on the active
ingredient Extract of Chenopodium ambrosioides near ambrosioides. The
reverse mutation assay (MRID 46456301) showed that the extract was not
mutagenic to bacterial strains TA98, TA100, TA1535, TA1537, and E. coli
strain WP2 uvrAW. The in vitro mammalian chromosome aberration test
(MRID 46396214) demonstrated that the extract produced no statistically
significant increases in chromosome/chromatid aberrations in human
lymphocytes with, or without, metabolic activation. The third study, a
DNA repair assay (MRID 46396215) was also negative because the extract
did not cause unscheduled DNA repair in cultured rat hepatocytes. The
mutagenicity studies are sufficient to confirm that there are no
expected dietary, occupational, or non-occupational risks of
mutagenicity with regard to new food uses.
    3. Subchronic toxicity. As a contact insecticide, residues of the
Extract of Chenopodium ambrosioides near ambrosioides in or on all food
commodities are not expected to result in any repeated and/or long-term
exposure by the oral, dermal or inhalation routes. As a result, no
subchronic studies are required to establish the food use pattern of
this extract or to exempt it from the requirement of a tolerance.
Waiver requests for the subchronic toxicity studies were approved in
large part on the basis of three residue studies, which confirm the
extract's rapid degradation. A residue decline study on primrose (MRID
4729101) demonstrated that when the end use product (EP) containing the
extract was applied at four times the application rate, the marker
components were not detectable 10 minutes after application. In a
second study, the EP was applied four times at twice the application
rate on tomatoes (MRID 46858903). Residues of the marker components
were below the limit of quantitation (LOQ) of 0.01 mg/kg when plant
samples were collected and checked at 0, 3, 6, and 24 hour intervals.
In another study on mustard greens (MRID 47548301), the EP was applied
three times at twice the application rate to mustard greens, residues
of the marker components had dissipated to below the LOQ of 0.05 ppm at
1-4 hours after the last application. With regard to subchronic dietary
exposure, potential exposure to the residues is unlikely to occur
because of the rapid degradation of the extract. Nonetheless, it is
noted that the constituent components of the extract are already a
regularized part of the

human diet, and are not known to pose a hazard at the levels
approximated immediately after application (WHO, 2005). With regard to
subchronic dermal or inhalation exposure, the rapid degradation of the
extract, likewise, limits the potential for exposure.
    4. Developmental toxicity. The Agency accepted information from the
open scientific literature to address data requirements for
developmental and reproductive toxicity (Araujo, I.B., et al. 1996.
Study of the Embryofoetotoxicity of [alpha]-Terpinene in the Rat. Food
and Chemical Toxicology 34:477-482.; Cornell University. Medicinal
Plants Website. Medicinal Plants for Livestock, Beneficial or Toxic?
.http://www.ansci.cornell.edu/plants/medicinal/plants.html. 2008.; HPV.
The Flavor and Fragrance High Production Volume Consortia. The Terpene
Consortium: Test Plan for Aromatic Terpene Hydrocarbons. 2002.). The
residue data referenced in the ``subchronic toxicity'' section above
demonstrate that there should be no exposures that might precipitate
any developmental toxicity. All information submitted indicate that
when used as proposed, Extract of Chenopodium ambrosioides
nearambrosioides will not result in detectable residues. Dietary
exposure would not be expected to pose any quantifiable risk, due to a
lack of residues of toxicological concern. Moreover, information
submitted on the constituent components of the Extract of Chenopodium
ambrosioides near ambrosioides indicates that the extract is not a
developmental or reproductive toxicant. The Agency has risk assessments
for all the marker components in this extract on file. Those
assessments demonstrate that none of the marker constituents in the
extract are developmental or reproductive toxicants. Studies submitted
on the constituent components of the extract also allow EPA to
establish worst-case scenario toxicological endpoints - a conservative
maternal NOAEL of 60 mg/kg-day and a developmental NOAEL of 30 mg/kg-
day. Agency exposure assessments show all potential occupational
exposures to be substantially below the worst-case endpoints presented
here (BRAD on Extract of Chenopodium ambrosioides near ambrosioides).
Altogether, significant exposure to female humans is not expected to
occur at a level of toxicological concern based on the overall low
toxicity profile of the extract, the lack of exposure due to rapid
degradation of the extract, and the ubiquitous presence of the main
components of the extract in the environment, food and cosmetics, all
without reported hazard. Accordingly, the information submitted to the
Agency to demonstrates a clear lack of both dietary exposure and
developmental toxicity and supports the Agency's conclusion that there
is no risk of developmental toxicity associated with the new food uses.
    5. Immunotoxicity. A waiver request was accepted for immunotoxicity
for the following reasons:
    i. The potential for any immunotoxic effect is precluded by the
extract's rapid degradation.
    ii. The constituent components in the extract are ubiquitous in
nature; and our regular exposure to these compounds is without known
immunotoxicological incident.
    iii. There is a long history of intentional use of the constituent
compounds in food, fragrance, and flavoring, all without known
immunotoxicological incident.
    iv. The toxicological profile in acute toxicological studies does
not suggest any immunotoxicity.

All information points to the lack of dietary risk posed by the
immunotoxicity of Extract of Chenopodium ambrosioides near ambrosioides
residues, and supports the exemption from the requirement of a
tolerance.
    6. Effects on endocrine systems. There is no available evidence
demonstrating that Extract of Chenopodium ambrosioides near
ambrosioides is an endocrine disruptor in humans. As a result, the
Agency is not requiring information on the endocrine effects of Extract
of Chenopodium ambrosioides near ambrosioides at this time. However,
the Endocrine Disruption Screening Program (EDSP) is still in the
process of establishing a protocol; and the Agency reserves the right
to require new information, should the program require it. Presently,
based on the lack of exposure and the negligible toxicity profile of
the extract, no adverse effects to the endocrine or immune systems are
known or expected. Overall, the lack of evidence of endocrine
disruption is consistent with Extract of Chenopodium ambrosioides near
ambrosioides' low-toxicity profile, and supports this exemption from
the requirement of a tolerance.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of 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

    Dietary exposure to the residues of the contact insecticide Extract
of Chenopodium ambrosioides near ambrosioides, through food or water,
is expected to be virtually non-existent.
    1. Food. No dietary exposure to Extract of Chenopodium ambrosioides
near ambrosioides residues is expected because the extract degrades
soon after application. Residue decline studies on tomatoes, mustard
greens and primrose confirm that applications of the extract do not
result in detectable residues shortly after application. Accordingly,
data demonstrate that dietary exposure will be precluded. But even if
residues were found, they would not be cause for concern because
Extract of Chenopodium ambrosioides near ambrosioides has been fully
assesed and found not to be of toxicological concern. Humans regularly
consume all the constituent components in the extract through
consumption of fruits and vegetables. This regular dietary exposure has
not resulted in any known incidents of toxic effect. Moreover, the
three primary terpene constituents, comprising 70% of the active
ingredient, have been approved by FDA for use in cosmetics and as food
additives. Finally, information submitted on the acute toxicity,
developmental toxicty, and genotoxicity of Extract of Chenopodium
ambrosioides near ambrosioides confirm a very low toxicity profile. In
sum, no dietary exposure is expected; but any potential dietary
exposures would not be expected to pose any quantifiable risk, due to a
lack of residues of toxicological concern.
    2. Drinking water exposure. Exposure of humans to Extract of
Chenopodium ambrosioides near ambrosioides in drinking water is
unlikely because pesticidal applications are intended to be applied
directly to terrestrial plants and because any residues would have
significantly degraded in the advance of any rainfall event. Low
application rates and rapid biodegradation in water (an aqueous half
life of 36.11 hours) further reduce the potential for drinking water
exposure. Drinking water exposure is not expected to pose any
quantifiable risk due to a lack of residues of toxicological concern.

B. Other Non-Occupational Exposure

    No new non-occupational exposure is expected to result from the new
agricultural uses of Extract of

Chenopodium ambrosioides near ambrosioides. The active ingredient is
applied directly to food commodities and degrades extremely rapidly.
However, the Agency notes that no health risks are expected from any
pesticidal exposure to this active ingredient in any event. An April
2008 risk assessment of Extract of Chenopodium ambrosioides near
ambrosioides makes clear that even regular occupational exposures that
are associated with this active ingredient pose negligible risks.
    1. Dermal exposure. No new non-occupational dermal exposures are
expected to result from the new agricultural uses of Extract of
Chenopodium ambrosioides near ambrosioides. Any new dermal exposure
associated with this new agricultural use pattern is expected to be
occupational in nature.
    2. Inhalation exposure. No new non-occupational inhalation
exposures are expected to result from the new agricultural uses of
Extract of Chenopodium ambrosioides near ambrosioides. Any new
inhalation exposure associated with this new agricultural use pattern
is expected to be occupational in nature.

V. Cumulative Effects

    Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered
available information concerning the cumulative effects of Extract of
Chenopodium ambrosioides near ambrosioides residues and other
substances that have a common mechanism of toxicity. These
considerations include the cumulative effects on infants and children
of Extract of Chenopodium ambrosioides near ambrosioides residues and
other substances with a common mechanism of toxicity. Because no
exposure to residues are expected with this application, and the
components of the extract have a long history of use without incident,
the Agency concludes that there are no cumulative effects arising from
Extract of Chenopodium ambrosioides near ambrosioides residues in or on
food commodities.

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

    Health risks to humans, including infants and children, are
considered negligible with regard to the pesticidal use of Extract of
Chenopodium ambrosioides near ambrosioides. Acute toxicity studies
indicate that Extract of Chenopodium ambrosioides near ambrosioides has
negligible toxicity. Notably, the constituent ingredients of the
extract are ubiquitous in nature and present in a multitude of fruits
and vegetables; and to date, there is no history of toxicological
incident involving their consumption. Indeed, the marker constituents
of the extract are approved as direct food additives by the FDA. Most
importantly however, no exposure to the residues of Extract of
Chenopodium ambrosioides near ambrosioides are expected. Pesticidal
applications are applied directly to commercial crops; and data confirm
that detectable residues do not persist beyond the time for the active
ingredient to dry on to foliar surfaces. Accordingly, no dietary
exposure is expected. As such, the Agency has determined that this food
use of Extract of Chenopodium ambrosioides near ambrosioides poses no
foreseeable risks to human health or the environment. There is a
reasonable certainty of no harm to the general U.S. population,
including infants and children, from exposure to this active
ingredient.

VII. Other Considerations

A. Endocrine Disruptors

    There is no evidence, at this time, that suggests the Extract of
Chenopodium ambrosiodes near ambrosioides will compromise the immune or
endocrine systems, or that it functions in a manner similar to any
known hormone, or that it acts as an endocrine disruptor.

B. Analytical Method

    Through this action, the Agency proposes an exemption from the
requirement of a tolerance of Extract of Chenopodium ambrosiodes near
ambrosioides when used on food commodities, without any numerical
limitations for residues. EPA has determined that residues resulting
from the pesticidal uses of Extract of Chenopodium ambrosiodes near
ambrosioides are unlikely, and that there are no significant toxicity
concerns in the event that residues of the active ingredient were
somehow present. As a result, the Agency has concluded that an
analytical method is not required for enforcement purposes for this
proposed use of Extract of Chenopodium ambrosiodes near ambrosioides.

C. Codex Maximum Residue Level

    There are no codex maximum residue levels established for residues
of Extract of Chenopodium ambrosioides near ambrosioides.

VIII. Conclusions

    Based on the information submitted, and other information available
to the Agency, EPA is establishing an exemption from the tolerance
requirements pursuant to FFDCA section 408(c) for residues of Extract
of Chenopodium ambrosioides near ambrosioides in or on all agricultural
commodities.

IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
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 final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). 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., 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).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the 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.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR

67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not 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).
    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).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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: December 12, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.
    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 180.1287 is added to subpart D to read as follows:

Sec.  180.1287  Extract of Chenopodium ambrosioides near ambrosioides;
exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
the residues of Extract of Chenopodium ambrosioides near ambrosioides
when used as an insecticide/acaricide on all food commodities.

[FR Doc. E8-31408 Filed 1-6-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 77, Number 151 (Monday, August 6, 2012)]
[Notices]
[Pages 46774-46775]
[FR Doc No: 2012-19084]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copy Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Form N-5, SEC File No. 270-172, OMB Control No. 3235-0169.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    Form N-5 (17 CFR 239.24 and 274.5)--Registration Statement of Small
Business Investment Companies Under the Securities Act of 1933 (15
U.S.C. 77a et seq.) and the Investment Company Act of 1940 (15 U.S.C.
80a-1 et seq.) Form N-5 is the integrated registration

statement form adopted by the Commission for use by a small business
investment company which has been licensed as such under the Small
Business Investment Act of 1958 and has been notified by the Small
Business Administration that the company may submit a license
application, to register its securities under the Securities Act of
1933 (``Securities Act''), and to register as an investment company
under section 8 of the Investment Company Act of 1940 (``Investment
Company Act''). The purpose of registration under the Securities Act is
to ensure that investors are provided with material information
concerning securities offered for public sale that will permit
investors to make informed decisions regarding such securities. The
Commission staff reviews the registration statements for the adequacy
and accuracy of the disclosure contained therein. Without Form N-5, the
Commission would be unable to carry out the requirements of the
Securities Act and the Investment Company Act for registration of small
business investment companies. The respondents to the collection of
information are small business investment companies seeking to register
under the Investment Company Act and to register their securities for
sale to the public under the Securities Act.
    Based on discussions with fund representatives and the Commission's
experience with the filing of Form N-5 and with disclosure documents
generally, we estimate that the reporting burden of compliance with
Form N-5 is approximately 352 hours per respondent. The Commission has
received one Form N-5 filing in the last three years, for an average
annual hourly burden of 117 hours. The cost of compliance varies
considerably depending on factors such as whether a filing is a new
registration statement or an update to a previously effective
registration statement; whether the fund being registered presents
novel or complex legal issues or is similar to other funds; whether
amendments are required in response to staff comments; and whether
outside counsel and accountants are necessary for preparation of the
filing. Based on discussions with fund representatives and the
Commission's experience with the filing of Form N-5 and with comparable
disclosure documents, we estimate that the cost of compliance may range
from less than $15,000 (for a routine filing) to over $60,000 (for a
registration statement presenting significant legal issues per
response) with an average cost per filing of $30,000. There has been
one Form N-5 filing in the last three years. We therefore estimate that
the average annual cost burden to the industry is $10,000.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Thomas Bayer, Director/Chief
Information Officer, Securities and Exchange Commission, C/O Remi
Pavlik-Simon, 6432 General Green Way, Alexandria, VA 22312; or send an
email to<EMAIL_ADDRESS>
    Dated: July 31, 2012.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-19084 Filed 8-3-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 184 (Monday, September 27, 2021)]
[Notices]
[Page 53297]
[FR Doc No: 2021-20896]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 6951-018]

Tallassee Shoals, LLC; Notice of Application Tendered for Filing
With The Commission and Soliciting Additional Study Requests and
Establishing Procedural Schedule for Relicensing and a Deadline for
Submission of Final Amendments

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New License.
    b. Project No.: 6951-018.
    c. Date filed: September 15, 2021.
    d. Applicant: Tallassee Shoals, LLC.
    e. Name of Project: Tallassee Shoals Hydroelectric Project
(project).
    f. Location: On the Middle Oconee River, in Athens-Clarke and
Jackson Counties, Georgia. The project does not occupy any federal
land.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Walter Puryear, Tallassee Shoals, LLC, 2399
Tallassee Road, Athens, Georgia 30607; Phone at<PHONE_NUMBER>, or
email at<EMAIL_ADDRESS>    i. FERC Contact: Michael Spencer at<PHONE_NUMBER>, or
<EMAIL_ADDRESS>    j. Cooperating agencies: Federal, state, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item l below. Cooperating agencies should note
the Commission's policy that agencies that cooperate in the preparation
of the environmental document cannot also intervene. See 94 FERC ]
61,076 (2001).
    k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's
regulations, if any resource agency, Indian Tribe, or person believes
that an additional scientific study should be conducted in order to
form an adequate factual basis for a complete analysis of the
application on its merit, the resource agency, Indian Tribe, or person
must file a request for a study with the Commission not later than 60
days from the date of filing of the application, and serve a copy of
the request on the applicant.
    l. With this notice, we are designating Tallassee Shoals, LLC as
the Commission's non-federal representative for carrying out informal
consultation pursuant to section 7 of the Endangered Species Act; and
consultation pursuant to section 106 of the National Historic
Preservation Act.
    m. Deadline for filing additional study requests and requests for
cooperating agency status: November 14, 2021.
    The Commission strongly encourages electronic filing. Please file
additional study requests and requests for cooperating agency status
using the Commission's eFiling system at https://ferconline.ferc.gov/FERCOnline.aspx. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, you may submit a paper copy.
Submissions sent via the U.S. Postal Service must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE, Room 1A, Washington, DC 20426. Submissions sent via
any other carrier must be addressed to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville,
Maryland 20852. All filings must clearly identify the project name and
docket number on the first page: Tallassee Shoals Hydroelectric Project
(P-6951-018).
    n. The application is not ready for environmental analysis at this
time.
    o. Project Description: The existing Tallassee Shoals Project
consists of: (1) A 365-foot-long, 25-foot-high concrete dam; (2) a 100-
kilowatt fixed Kaplan unit within the dam; (3) a 1,400-foot-long
headrace canal from the dam to the powerhouse; (4) an 80-foot-long, 11-
foot-diameter penstock; (5) a powerhouse containing a single 2.2-
megawatt (MW) adjustable Kaplan unit; (6) a 75-foot-long tailrace; and
(7) a 100-foot-long, 42-kilovolt transmission line. The project creates
a 2,100-foot-long bypassed reach of the Middle Oconee River. The
project's total capacity is 2.3 MW and its average annual generation is
approximately 6,100 megawatt-hours.
    Tallassee Shoals, LLC does not propose any changes to the project's
run-of-river operation and required 70 cubic-feet-per-second minimum
flow.
    p. In addition to publishing the full text of this notice in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this notice, as well
as other documents in the proceeding (e.g., license application) via
the internet through the Commission's Home Page (http://www.ferc.gov)
using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document (P-
6951). At this time, the Commission has suspended access to the
Commission's Public Reference Room due to the proclamation declaring a
National Emergency concerning the Novel Coronavirus Disease (COVID-19)
issued on March 13, 2020. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or (202)
502-8659 (TTY).
    You may also register online at https://ferconline.ferc.gov/FERCOnline.aspx to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    q. Procedural schedule: The application will be processed according
to the following preliminary schedule. Revisions to the schedule will
be made as appropriate.

Issue Deficiency Letter (if necessary)--January 2022
Request Additional Information--January 2022
Issue Acceptance Letter--March 2022
Issue Scoping Document 1 for comments--April 2022
Issue Notice of Ready for Environmental Analysis--July 2022

    r. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

    Dated: September 21, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-20896 Filed 9-24-21; 8:45 am]
BILLING CODE 6717-01-P