Document ID: EPA-HQ-OPP-2009-0237-0009
Agency: epa
Document Type: Rule
Title: Exemption from the Requirement of a Tolerance: Synthetically Manufactured Terpene Constituents of Extract of Chenopodium Ambrosioides Near Ambrosioides
Posted Date: 2010-07-09T04:00Z

[Federal Register: July 9, 2010 (Volume 75, Number 131)]
[Rules and Regulations]               
[Page 39450-39455]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy10-4]                         

=======================================================================
-----------------------------------------------------------------------

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 
Tolerance

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

[[Page 39451]]

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: pfeifer.chris@epa.gov.

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 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-
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 (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.

[[Page 39452]]

A. Overview

    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 
studies.
    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

[[Page 39453]]

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 
groups.
    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 
natural extract.
    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 
manufactured extract.
    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 
degrades rapidly.
    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 
Toxicity

    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.

[[Page 39454]]

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

    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 
Manufactured.

VIII. Conclusions

    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.

IX. References

    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 
Toxicology 34:477-482.
    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 
Hydrocarbons.
    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

[[Page 39455]]

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).

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 
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: June 30, 2010.
Martha Monell,
Acting Director, 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 180.1296 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 
tolerance.

    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