Document ID: EPA-HQ-OPP-2008-0528-0003
Agency: epa
Document Type: Rule
Title: Extract of Chenopodium ambrosioides near ambrosioides; Exemption from the Requirement of a Tolerance
Posted Date: 2009-01-07T05:00Z

[Federal Register: January 7, 2009 (Volume 74, Number 4)]
[Rules and Regulations]               
[Page 629-634]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ja09-4]                         

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: (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 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

[[Page 630]]

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 (703) 305-5805.

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,

[[Page 631]]

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

[[Page 632]]

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

[[Page 633]]

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

[[Page 634]]

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