[Federal Register Volume 75, Number 131 (Friday, July 9, 2010)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-16765]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0237; FRL-8831- 4]
Terpene Constituents of the Extract of Chenopodium ambrosioides
near ambrosioides ([alpha]-Terpinene, d-Limonene and p-Cymene) as
Synthetically Manufactured; Exemption from the Requirement of a
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Terpene Constituents of the Extract of
Chenopodium ambrosioides near ambrosioides ([alpha]-terpinene, d-
limonene and p-cymene) as Synthetically Manufactured in or on all food
commodities when applied/used as a biochemical insecticide and
acaricide. AgraQuest, Incorporated 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 Terpene Constituents of the Extract of Chenopodium
ambrosioides near ambrosioides ([alpha]-terpinene, d-limonene and p-
cymene) as Synthetically Manufactured under FFDCA.
DATES: This regulation is effective July 9, 2010. Objections and
requests for hearings must be received on or before September 7, 2010,
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-2009-0237. 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 Office
of Pesticide Programs (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: (703) 308-0031; e-mail address: email@example.com.
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
B. How Can I Get Electronic Access to Other Related Information?
You may 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. How Can I File an Objection or Hearing Request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. 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-2009-0237 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
September 7, 2010. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
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. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2009-0237, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: OPP Regulatory Public Docket (7502P), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
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 (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of May 6, 2009 (74 FR 20946) (FRL-8411-2),
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
9F7551) by AgraQuest, Incorporated, 1540 Drew Avenue, Davis, CA 95618-
6320. The petition requested that 40 CFR part 180 be amended by
establishing an exemption from the requirement of a tolerance for
residues of Terpene Constituents of the Extract of Chenopodium
ambrosioides near ambrosioides ([alpha]-terpinene, d-limonene and p-
cymene) as Synthetically Manufactured. The notice referenced a summary
of the petition prepared by the petitioner, AgraQuest, Incorporated,
which is available in the docket, http://www.regulations.gov. There
were no comments received in response to the notice of filing.
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.
This active ingredient is a synthetic blend of the pesticidally
active terpene constituents that are found in the Extract of
Chenopodium ambrosioides near ambrosioides. Plant extracts are
comprised of many constituents, some of which give the extract its
pesticidal effects. The concentration of each of the terpene
constituents is the same as that of the natural extract.
There are non-terpene constituents in this synthetically
manufactured extract. These non-terpene constituents are pesticidally
inactive and virtually non-toxic. Likewise, there are non-terpene
constituents that are found in the natural extract. The non-terpene
constituents found in both the natural extract and this synthetically
manufactured extract have been assessed by EPA and determined not to be
of toxicological concern when used in pesticide products applied to
various food crops.
The terpene constituents of this synthetically manufactured extract
and the natural extract are the same and therefore this tolerance
exemption document focuses only on the terpene constituents. In
addition, based on this determination, the toxicological information
submitted in support of the tolerance exemption for Extract of
Chenopodium ambrosioides near ambrosioides were used to bridge to
satisfy the data requirements for this synthetically manufactured
extract (74 FR 629, January 7, 2009).
B. Constituents of ECANA as Synthetically Manufactured
The three major terpene constituents of this synthetically
manufactured extract are [alpha]-terpinene, p-cymene, and d-limonene.
These terpene constituents occur naturally in fruits, vegetables,
herbs, spices, and other foods and beverages. These three terpene
constituents are found naturally in food, permitted as food and
fragrance additives in the United States (U.S.) and Europe, and have
been fully characterized by EPA and assessed for their uses in
pesticide products applied to various food crops (Science Review in
Support of the Registration of the Active Ingredient ECANA, February
2008; Science Review and Tolerance Exemption Petition Review in Support
of the Registration of Requiem, October 2008). A summary description of
the Agency's dietary exposure to the terpene constituents follows:
1. [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, [alpha]-terpinene is permitted for direct addition to food
for human consumption.
2. d-Limonene is a major terpene constituent of lemon oil, orange
oil, and grapefruit oil; a minor terpene constituent of other fruits,
vegetables, meats, and spices; widely used as a flavor and fragrance;
and generally recognized as safe (GRAS) by the Food and Drug
Administration (FDA) as a food additive or flavoring and as a fragrance
additive (21 CFR 182.60). Furthermore, d-limonene is a federally
registered active ingredient in 15 pesticide products with a tolerance
per 40 CFR 180.539. It is also used as a solvent or fragrance in 14
other food use pesticide products, where it is exempt from the
requirement of a tolerance as an inert ingredient (40 CFR 180.910 and
40 CFR 180.930).
3. 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).
The general public is exposed daily to low levels of these terpene
constituents via ingestion, dermal contact, and inhalation through
consumption of foods and beverages, as well as through dermal contact
with cosmetics, in excess of any exposure expected to result from the
pesticidal use of this synthetically manufactured extract, all without
toxicological incident to humans. The per capita daily consumption of
these terpene constituents as food additives alone amounts to 13.325
milligrams (mg) in the U.S. and 40.397 mg in Europe (Ref. 4), amounts
far in excess of any potential dietary exposures resulting from
exposure to residues from this pesticidal extract.
C. Biochemical Pesticide Human Health Assessment Data Requirements
Acute toxicity data were submitted for this synthetically
manufactured extract; all other toxicity information submitted in
support of the registration and food use of this synthetically
manufactured extract were bridged from the natural extract summaries of
the toxicological data supporting this exemption from the requirement
of a tolerance are as follows:
1. Acute toxicity. Acute toxicity studies, submitted to support the
registration of the end-use product (EP) containing this synthetically
manufactured extract indicate a low toxicity profile and support the
finding that this active ingredient poses no significant human health
risk with regard to food use.
a. The acute oral median lethal dose (LD50) in rats for
this synthetically manufactured extract was greater than 2,000
milligrams per kilogram (mg/kg) and confirmed negligible toxicity
through the oral route. There were no observed toxicological effects on
the test subjects in the the acute oral. (Master Record Identification
Number (MRID No.) 4762704). This synthetically manufactured extract is
Toxicity Category III for acute oral toxicity.
b. The acute dermal LD50 in rats was greater than 2,000
mg/kg for this synthetically manufactured extract. No toxic endpoints
were established. These data substantiated this synthetically
manufactured extract's relative dermal nontoxicity to the general
public (MRID No. 4762705). This synthetically manufactured extract is
Toxicity Category III for acute dermal toxicity.
c. The acute inhalation median lethal concentration
(LC50) for this synthetically manufactured extract was
greater than 2.03 milligrams per liter (mg/L) in rats and showed no
significant inhalation toxicity. No toxic endpoints were established.
This synthetically manufactured extract was tested to a limit dose of
5.14 mg/L (MRID No. 48064401). This synthetically manufactured extract
is Toxicity Category IV for acute inhalation toxicity.
d. Skin irritation studies on rabbits indicated that this
synthetically manufactured extract was an irritant to the skin (MRID
No. 48064403). This synthetically manufactured extract is Toxicity
Category IV for dermal irritation.
e. Data indicated this synthetically manufactured extract is not a
dermal sensitizer (MRID No. 48064404).
Data indicate that this synthetically manufactured extract is not
acutely toxic. No toxic endpoints were established, and no significant
toxicological effects were observed in any of the acute toxicity
2. Mutagenicity. Three mutagenicity studies, using the natural
extract as the test substance, were bridged to support this
synthetically manufactured extract. These studies are sufficient to
confirm that there are no expected dietary or non-occupational risks of
mutagenicity with regard to new food uses for this synthetically
manufactured extract. Although the natural extract and this
synthetically manufactured extract have non-terpene constituents that
are different, none of the constituents have been shown to present any
mutagenicity or any impact on mutagenicity and therefore, the data
submitted to support the natural extract demonstrates the lack
of mutagenicity of this synthetically manufactured extract.
a. The Reverse Mutation Assay (MRID No. 46456301) showed that the
natural extract did not induce mutant colonies relative to control
b. The In vitro Mammalian Cells in Culture Assay (MRID No.
46396214) demonstrated that the natural extract did not damage
chromosomes in human lymphocyte cells.
c. A Deoxyribonucleic Acid (DNA) Repair Assay (MRID No. 46396215)
indicated no unscheduled DNA repair in rat hepatocytes exposed to the
3. Subchronic toxicity. When used as a contact insecticide,
residues of this synthetically manufactured extract are not expected to
result in any repeated and/or long-term exposure by the oral, dermal,
or inhalation routes. As a result, waiver requests for the subchronic
toxicity studies were approved, for the most part, based upon three
residue studies for the natural extract, which confirm the rapid
degradation of the terpene constituents in this synthetically
a. A residue decline study on primrose (MRID No. 47209101)
demonstrated that, when an EP containing the natural extract was
applied at four times the labeled application rate, the terpene
constituents were not detectable 10 minutes after application.
b. In another study, an EP containing the natural extract was
applied to tomatoes four times and at twice the labeled application
rate (MRID No. 46858903); residues of the terpene constituents 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.
c. In the final study (MRID No. 47548301), an EP containing the
natural extract was applied to mustard greens three times and at twice
the labeled application rate; residues of the terpene constituents had
dissipated to below the LOQ of 0.05 parts per million (ppm) at 1-4
hours after the last application.
These residue decline studies on the natural extract support the
finding that there is little potential for dermal or inhalation
exposure to residues of this synthetically manufactured extract based
on the rapid degradation of the terpene constituents that are the
principal constituents in the natural extract and this synthetically
manufactured extract. Therefore, no subchronic testing is needed.
4. Developmental toxicity. The Agency bridged from information on
the natural extract to support this synthetically manufactured extract.
The information from the open scientific literature characterizes the
developmental toxicity of the terpene constituents and satisfies the
data requirements for developmental and reproductive toxicity for this
synthetically manufactured extract (Refs. 1, 2, 3, and 4). The
information established that none of the terpene constituents in this
synthetically manufactured extract are developmental or reproductive
toxicants. The data submitted to support the natural extract
appropriately demonstrates the lack of developmental toxicity of this
synthetically manufactured extract.
The information established a conservative maternal no observable
adverse effect level (NOAEL) of 60 mg/kg per day and a developmental
NOAEL of 30 mg/kg per day. These levels greatly exceed any potential
dietary exposure, as discussed above in Unit III.C.3., from the use of
this synthetically manufactured extract and confirm the lack of risk
for developmental toxicity, even in a worst-case scenario.
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 this synthetically manufactured
extract is expected to be virtually nonexistent. Even in the event of
exposure, the information supporting this tolerance exemption
demonstrates that any dietary risks would be negligible.
1. Food. The pesticidal use of this synthetically manufactured
extract is not expected to result in any dietary exposure. Three
residue decline studies on the natural extract show that rapid
degradation of the terpene constituents of this synthetically
manufactured extract. A detailed discussion of those studies can be
found in Unit III.C.3. In sum, these data demonstrate that, by the time
this synthetically manufactured extract has dried on the plant, there
is no detectable residual product.
2. Drinking water exposure. Exposure of humans to this
synthetically manufactured extract in drinking water is unlikely
because associated pesticide products are labeled for applications
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 for the natural extract) further reduce the
potential for drinking water exposure.
B. Other Non-Occupational Exposure
Non-occupational exposure is not expected because this
synthetically manufactured extract is not approved for residential uses
and the active ingredient is applied directly to food commodities and
1. Dermal exposure. Non-occupational dermal exposures to this
synthetically manufactured extract are expected to be negligible
because of its directed agricultural use. In the event of dermal
exposure to residues, because of the non-toxic profile of this
synthetically manufactured extract (as described in Unit III.), use of
this synthetically manufactured extract is not expected to result in
any risks through this route of exposure.
2. Inhalation exposure. Non-occupational inhalation exposures are
not expected to result from the agricultural uses of this synthetically
manufactured extract. Any inhalation exposure associated with this
agricultural use pattern is expected to be occupational in nature.
V. Cumulative Effects from Substances with a Common Mechanism of
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.''
EPA has not found this synthetically manufactured extract to share
a common mechanism of toxicity with any other substances, and this
synthetically manufactured extract does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that this synthetically
manufactured extract does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.
VI. Determination of Safety for the U.S. Population, Infants, and
FFDCA section 408(b)(2)(C) provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues, and the cumulative effects on infants and children
of the residues and other substances with a common mechanism of
toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA
shall apply an additional tenfold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database unless EPA
determines that a different margin of safety will be safe for infants
and children. Margins of exposure (safety), which are often referred to
as uncertainty factors, are incorporated into EPA risk assessments
either directly or through the use of a margin of exposure analysis, or
by using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk.
Health risks to humans, including infants and children, are
considered negligible with regard to the pesticidal use of this
synthetically manufactured extract. Toxicity information submitted in
support of the application for this synthetically manufactured extract
demonstrates that the active ingredient has negligible toxicity. In
addition, the terpene constituents of this synthetically manufactured
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. As discussed earlier, the terpene
constituents of this synthetically manufactured extract are approved as
direct food additives by the FDA. Most importantly, however, exposure
to the residues of this synthetically manufactured extract are not
expected. Pesticidal applications are applied directly to commercial
crops, and data confirm that detectable residues do not persist beyond
the time for this synthetically manufactured extract to dry on to
foliar surfaces. As such, the Agency has determined that this food use
of this synthetically manufactured extract poses no foreseeable risks
to human health or the environment. There is a reasonable certainty
that no harm will result to the general U.S. population, including
infants and children, from aggregate exposure to residues of this
synthetically manufactured extract.
VII. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for Terpene Constituents
([alpha]-terpinene, d-limonene and p-cymene) of the Extract of
Chenopodium ambrosioides near ambrosioides as Synthetically
The Agency concludes that there is a reasonable certainty that no
harm will result to the United States population, including infants and
children, from aggregate exposure to residues of this synthetically
manufactured extract. Therefore, an exemption is established for
residues of Terpene Constituents ([alpha]-terpinene, d-limonene and p-
cymene) of the Extract Chenopodium ambrosioides near ambrosioides as
Synthetically Manufactured in or on all food commodities.
1. Araujo IB, Souza CAM, De-Carvalho RR, Kuriyama SN, Rodrigues RP,
Vollmer RS, Alves EN, Paumgartten FJR. 1996. Study of the
embryofoetotoxicity of [alpha]-terpinene in the rat. Food and Chemical
2. Cornell University. 2008. Medicinal Plants Website. Medicinal
Plants for Livestock, Beneficial or Toxic? Available from http://www.ansci.comell.edu/plants/medicinal/plants.html.
3. Flavor and Fragrance High Production Volume Consortia (FFHPVC).
2002. The Terpene Consortium: Test Plan for Aromatic Terpene
4. World Health Organization (WHO). 2005. Evaluation of Certain
Food Additives. WHO Technical Report Series No. 928. Sixty-third Report
of the Joint FAO/WHO Expert Committee on Food Additives.
X. Statutory and Executive Order Reviews
This final rule establishes a tolerance exemption 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
exemption 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
XI. 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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: June 30, 2010.
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1296 is added to subpart D to read as follows:
Sec. 180.1296 Terpene Constituents [alpha]-terpinene, d-limonene and
p-cymene, of the Extract of Chenopodium ambrosioides near ambrosioides
as Synthetically Manufactured; exemption from the requirement of a
An exemption from the requirement of a tolerance is established for
the residues of the biochemical pesticide Terpene Constituents [alpha]-
terpinene, d-limonene and p-cymene, of the Extract of Chenopodium
ambrosioides near ambrosioides as Synthetically Manufactured when used
as an insecticide/acaricide in or on all food commodities.
[FR Doc. 2010-16765 Filed 7-8-10; 8:45 am]
BILLING CODE 6560-50-S