Document ID: EPA-HQ-OPP-2007-1025-0004
Agency: epa
Document Type: Rule
Title: Cold Pressed Neem Oil; Exemption from the Requirement of a Tolerance
Posted Date: 2009-10-28T04:00Z

[Federal Register: October 28, 2009 (Volume 74, Number 207)]
[Rules and Regulations]               
[Page 55458-55463]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc09-10]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-1025; FRL-8434-5]

 
Cold Pressed Neem Oil; Exemption from the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the biochemical pesticide, cold pressed 
neem oil on all food commodities when applied/used on/in food 
commodities. Plasma Power Limited of India 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 cold pressed neem oil.

DATES: This regulation is effective October 28, 2009. Objections and 
requests for hearings must be received on or before December 28, 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-2007-1025. 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: Driss Benmhend, Biopesticides and 
Pollution Prevention Division (7511P), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9525; e-mail address: benmhend.driss@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

[[Page 55459]]

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. To access the OPPTS Harmonized Guidelines referenced in this 
document, go directly to the guidelines at http://www.epa.gov/opptsfrs/
home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2007-1025 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 December 28, 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-2007-1025, 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 November 2, 2007 (72 FR 62237) (FRL-
8153-8), 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 7F7249) by Plasma Power Limited of India, c/o OMC Ag 
Consulting, 828 Tanglewood Lane, East Lansing, MI 48823. The petition 
requested that 40 CFR part 180 be amended by establishing an exemption 
from the requirement of a tolerance for residues of cold pressed neem 
oil. The notice included a summary of the petition prepared by the 
petitioner, Plasma Power Limited of India. One comment was received in 
response to the notice of filing. The commenter objected to the 
petition and expressed concerns about EPA's regulation of human 
exposure to toxic chemicals. The Agency understands the commenter's 
concerns regarding toxic chemicals and the potential effects to humans 
when exposed to toxic chemicals. Pursuant to its authority under the 
FFDCA, and as discussed further in this unit, EPA conducted a 
comprehensive assessment of cold pressed neem oil, including a review 
of acute toxicity, mutagenicity and developmental studies. Based on 
these data, the Agency has concluded that there is a reasonable 
certainty that no harm will result from dietary exposure to residues of 
cold pressed neem oil when used in or on the food and feed commodities.
    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 
sections 408(b)(2)(C) and (D) 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.
    Cold pressed neem oil is pressed directly from seeds of the neem 
tree (azadirachta indica), which is a tropical evergreen tree native to 
India and also found in other Southeast Asian and African countries. 
Cold pressed neem oil has a brown color, a bitter taste and a garlic/
sulfur smell. A single seed may contain up to 50% oil by weight. Cold 
pressed neem oil contains various compounds that have insecticidal and 
medicinal properties. It is used in making shampoos, toothpaste, soaps, 
cosmetics, mosquito repellants, creams, lotions, and pet products such 
as pet shampoo. It also contains vitamin E, other essential amino acids 
and some percentages of fatty acids. Cold pressed neem oil is used for 
treating many skin diseases viz, eczema, psoriasis, skin allergies, 
etc. and is being studied for

[[Page 55460]]

making contraceptives in India (DAI, 2009).
    Cold pressed neem oil is a mixture of several C26 terpenoids which 
are naturally occurring organic compounds composed of a five-carbon 
skeleton (simple terpenoids) or complex terpenoids with structures that 
possess between 20 and 40 carbon atoms. Azadirachtin is the most common 
terpenoid in cold pressed neem oil, the most thoroughly characterized 
and is a federally registered active ingredient pesticide. Cold pressed 
neem oil also contains steroids, fatty acids, and a number of essential 
oils.
    Cold pressed neem oil has been used for hundreds of years in 
controlling plant pests and diseases (DAI, 2009). Research has 
demonstrated that the spray solution of cold pressed neem oil helps to 
control common pests such as white flies, aphids, scales, mealy bugs, 
spider mites, locusts, thrips, and Japanese beetles. Cold pressed neem 
oil is also used as a fungicide and helps control powdery mildew. Data 
submitted and reviewed by EPA show that cold pressed neem oil acts by 
affecting the insect's growth, thus preventing the larval stage to molt 
into an adult. It also acts as a repellent and feeding inhibitor by 
leaving a very bitter taste on sprayed plants, making them very 
distasteful for the insects to feed on.
    Based on all the data submitted and available in the literature, 
the Agency determined that cold pressed neem oil and its components 
have low toxicity via all routes of exposure. Moreover, EPA conducted 
further modeling of potential residue on sprayed fruits and vegetables 
with 100% cold pressed neem oil and concluded that residues of cold 
pressed neem oil are very low and that these residues will decline 
rapidly (details in Unit III.A.)
    All the data requirements to support a tolerance exemption were 
fulfilled by the applicant. EPA concluded that the data are acceptable 
and that no data gaps exist and no additional data are required. No 
acute, subchronic, or chronic toxicity endpoints were identified in 
guideline studies or in data obtained from the open technical 
literature. Moreover, cold pressed neem oil is not a mutagen, and is 
not a developmental toxicant. There are no known effects on endocrine 
systems via oral, dermal, or inhalation exposure.
    1. Acute toxicity (OPPTS Harmonized Guideline 870.1100-870.2600). 
Tier I toxicity data submitted and reviewed showed that cold pressed 
neem oil is a Toxicity Category IV (low toxicity) compound via acute 
oral and acute inhalation routes of exposure. Cold pressed neem oil is 
in Toxicity Category III (slightly toxic) for acute dermal irritation. 
Cold pressed neem oil is not an eye or skin irritant, and it is not a 
dermal sensitizer.
    2. 90-Day oral feeding (OPPTS Harmonized Guideline 870.3100). To 
address this data requirement, the applicant submitted data obtained 
from the technical public literature in lieu of a guideline study. The 
study showed that test animals did not exhibit any clinical signs of 
toxicity that were statistically different from untreated controls. 
There were no significant changes in body weight, serum liver damage 
indicators, direct bilirubin and total bilirubin, or other blood 
parameters during the 90-day study period. The 90-day oral feeding 
LD50 is higher than 5,000 milligrams (mg) crude cold pressed 
neem oil/kilogram (kg) body weight. Based on the review of this data, 
EPA concluded that no subchronic oral toxicity is expected to occur 
when this compound is used in accordance with good agricultural 
practices.
    3. Tier I developmental toxicity (teratogenicity) (OPPTS Harmonized 
Guideline 870.3500). Several technical public literature studies were 
submitted in lieu of guideline studies to satisfy the developmental 
toxicity data requirement.
    In vitro studies showed that cold pressed neem oil may inhibit the 
development of two-cell mouse embryos (Juneja and Williams, 1993; 
Juneja et al., 1994) and mouse sperm-egg interaction (Juneja and 
Williams, 1993). Sharma et al. (1996) found that a cold pressed neem 
oil fraction (designated NIM-76) placed in contact with cells in vitro 
selectively killed human sperm but did not affect normal cells of 
monkey kidney, human fetal lung, or peritoneal macrophages. In in vivo 
studies, Upadhyay et al. (1990) found that a single intrauterine dose 
of 100 [micro]L of cold pressed neem oil inhibited pre-implantation in 
Wistar rats for up to 180 days. However, the effect was reversible, as 
treated rats regained fertility and delivered normal litters within 5 
months post-treatment. A later study (Kaushic and Upadhyay, 1995) in 
rats showed that the anti-fertility effect of cold pressed neem oil was 
localized and 100 [micro]L administered to one uterine horn produced 
abnormal cleavage. Subcutaneous application of cold pressed neem oil to 
cyclic rats produced significant damage to the luminal epithelium of 
the uterus and to the uterine glands (Tewari et al., 1989). Glycogen 
and total protein in the ovary and uterus were also decreased. 
Ovariectomized rats administered cold pressed neem oil also showed 
decreased glycogen and protein content in the uterus, but when cold 
pressed neem oil was administered with or without estradiol 
dipropionate or progesterone, there were no significant differences 
between rats receiving cold pressed neem oil alone or in conjunction 
with the hormones. Tewari et al. (1989) concluded that the histological 
and biochemical changes seen were due to the toxicological potential of 
the cold pressed neem oil rather than to hormonal properties. 
Intravaginal application of a formulated product containing cold 
pressed neem oil (praneem polyherbal cream) was an effective 
contraceptive in rabbits up to 1 hour post-application, but was less 
effective after 90 minutes and ineffective after 12 hours (Garg et al., 
1993). The conception rate of monkeys receiving the cream was only 
2.27%. In a three-generation reproduction study (Chinnasamy et al. 
(1993)) in which rats were fed a diet containing 10% cold pressed neem 
oil or 10% groundnut oil, the results from both matings in all three-
generations did not show any adverse effects on the reproductive 
parameters of rats fed cold pressed neem oil compared to groundnut oil. 
No other toxicological effects were reported.
    Based on the in vitro and in vivo studies, and subcutaneous and 
intravaginal applications of cold pressed neem oil, it seems that 
developmental toxicity may occur when exposure to cold pressed neem oil 
occurs by intravaginal, intrauterine, subcutaneous injection, or by 
direct exposure to mammalian sperm and eggs in in vitro laboratory 
studies. However, the three-generation study in rats fed cold pressed 
neem oil in the diet demonstrates that chronic oral ingestion of food 
commodities containing cold pressed neem oil residues will not result 
in any mammalian developmental toxicity. Therefore, no developmental 
toxicity is expected to occur from the use of cold pressed neem oil as 
a pesticide.
    4. Mutagenicity testing (OPPTS Harmonized Guideline 870.5100, 
870.5300, and 870.5375). The technical documents from the public 
literature and the guideline study submitted, performed using the TGAI 
as the test substance, showed no mutagenicity/genotoxicity effects.
    Cold pressed neem oil and its components are not structurally 
related to known mutagens, nor do they belong to any chemical class of 
compounds containing known mutagens. Humans are regularly exposed to 
this substance via oral exposure (as a traditional folk medicinal 
product) and dermal exposure (when used on skin and hair)

[[Page 55461]]

at levels that are significantly greater than that which would be 
expected from the product as a pesticide under conditions of use. In 
addition, an extensive literature search of several scientific 
databases (i.e., ChemIDPlus, HSDB, Toxline, CCCRIS, DART, GENETOX, 
IRIS, ITER, LactMed, Multi-Database, TRI, HazMap, Household Products, 
TOXMAP and TOXNET) for the period 1980 to 2008 using cold pressed neem 
oil as the search parameter was unable to locate any other data/
information regarding mutagenicity or genotoxicity of cold pressed neem 
oil. As a result, EPA concludes that cold pressed neem oil is not 
mutagenic or genotoxic.

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).
    There is reasonable certainty that no harm to the U.S. population 
will result from aggregate exposure to residues of 100% cold pressed 
neem oil. This includes all exposures for which there is reliable 
information. The Agency arrived at this conclusion based on the low 
level of toxicity of cold pressed neem oil and the current use of cold 
pressed neem oil on skin in traditional medicinal products, cosmetics, 
and shampoos at levels that are substantially greater than that which 
would be expected from the product as a pesticide under conditions of 
use. The risks from aggregate exposure via oral, dermal and inhalation 
exposure are a compilation of three low-risk exposure scenarios (oral, 
dermal, and inhalation) and are negligible. Since there are no 
threshold effects of concern, and no known toxic endpoints, the 
provision requiring an additional margin of safety does not apply. 
Therefore, the Agency has not used a margin of exposure (MOE) (safety) 
approach to assess the safety of cold pressed neem oil.

A. Dietary Exposure

    1. Food. The most likely human exposure to cold pressed neem oil 
will occur via dietary exposure (consumption) to treated fruits, seeds, 
or leafy vegetables. EPA modeling (using the terrestrial exposure model 
(T-REX; EPA, 2005) of potential residues of cold pressed neem oil 
following terrestrial treatments indicated that following 12 
consecutive applications of 100% cold pressed neem oil at 7-day 
intervals, the maximum dietary residues present would be approximately 
881 parts per million (ppm) on broadleaf plant foliage; and 
approximately 98 ppm on fruits, pods, and seeds (see table below). The 
modeling indicated that residues would decline rapidly between foliar 
applications (approximately 245-440 ppm on broadleaf foliage; and 27-49 
ppm on fruits, pods, and seeds) and following the final application 
(see table below). As stated in Unit III.1. cold pressed neem oil is a 
Toxicity Category IV for oral exposure (LD50 = >5,000 mg/
kg). The estimated maximum theoretical residues likely to be present on 
edible commodities are 882 ppm. This residue level is approximately 5-
fold less than the highest doses used in acute and subchronic 
laboratory testing (5,000 mg/kg) and approximately 20-fold less than 
chronic laboratory testing (10% in the diet) at which no mortalities or 
other signs of clinical toxicity were observed.
    Therefore, based on a lack of acute, subchronic, or chronic 
toxicity in laboratory testing, estimated maximum residues that are 
well below the doses used in laboratory testing, and the rapid 
degradation of neem oil in the environment, it is highly unlikely that 
that there will be any adverse effects to humans resulting from dietary 
exposure to neem oil.

Estimated Cold Press Neem Oil Residues On Terrestrial Matrices Using The Terrestrial Exposure Model (T-Rex; EPA,
                                                      2005)
----------------------------------------------------------------------------------------------------------------
                                                  Dietary-based Estimated Environmental Concentrations
          Terrestrial Matrix          --------------------------------------------------------------------------
                                        0 Days After Last App    86 Days After Last App  106 Days After Last App
----------------------------------------------------------------------------------------------------------------
Edible Broadleaf Plant Folage                           881.20                     0.04                     0.00
----------------------------------------------------------------------------------------------------------------
Fruits. Pods, and Seeds                                  97.91                     0.00                     0.00
----------------------------------------------------------------------------------------------------------------

    Moreover, humans are regularly exposed to this compound via 
consumption of cold pressed neem oil medicinal products, and at levels 
that are significantly greater than what would be expected from 
pesticide applications. The Agency is not concerned about dietary 
exposure because of the low toxicity of this active ingredient and the 
history of its use without any reports of adverse effects.
    2. Drinking water exposure. No significant drinking water exposure 
or residues are expected to result from the pesticidal usage of cold 
pressed neem oil. The active ingredient is intended for use as a foliar 
application on food commodities and not to be applied directly to water 
or to areas where surface water is present. If used in accordance with 
EPA-approved labeling, is not likely to accumulate in drinking water. 
In the unlikely event that exposure via drinking water did occur from 
accidental spraying, the health risk would be expected to be minimal, 
based on the low acute oral toxicity and the long history of human 
exposure to cold pressed neem oil without adverse effects. As a result, 
dietary and drinking water exposure to residue of cold pressed neem oil 
are expected to be minimal.

B. Other Non-Occupational Exposure

    There are no residential, school or day care uses proposed for this 
product. Since the proposed use pattern is for all food commodities, 
the potential for non-occupational, non-dietary exposures to cold 
pressed neem oil by the general population, including infants and 
children, is highly unlikely.
    1. Dermal exposure. Humans are regularly exposed to cold pressed 
neem oil via dermal exposure when used on skin and hair at levels that 
are significantly greater than that which would be expected from the 
product use as a pesticide. Non-occupational dermal exposures to cold 
pressed neem oil when used as a pesticide are expected to be negligible 
because it is limited to agricultural use.
    2. Inhalation exposure. Non-occupational inhalation exposures to 
cold pressed neem oil when used as a pesticide are expected to be 
negligible because it is limited to agricultural use.

[[Page 55462]]

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish an exemption from 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.'' These considerations 
include the possible cumulative effects of such residues on infants and 
children.
    EPA has considered the potential for cumulative effects of cold 
pressed neem oil and other substances in relation to a common mechanism 
of toxicity. However, because of its low toxicity to mammalian systems, 
the Agency does not expect any cumulative or incremental effects from 
exposure to residues of cold pressed neem oil when applied/used as 
directed on the label and in accordance with good agricultural 
practices.

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

    There is reasonable certainty that no harm will result from 
aggregate exposure to residues of cold pressed neem oil to the U.S. 
population, infants, and children. This includes all anticipated 
dietary exposures and all other exposures for which there is reliable 
information. The Agency arrived at this conclusion based on the low 
level of toxicity of cold pressed neem oil and the already widespread 
human use and exposure to cold pressed neem oil without any reported 
adverse effects on human health. The risks from aggregate exposure via 
oral, dermal and inhalation exposure are a compilation of three low-
risk exposure scenarios and are negligible. Since there are no 
threshold effects of concern, the provision requiring an additional 
margin of safety does not apply. Moreover, cold pressed neem oil is 
widely used in cosmetics (soap, hair products, hand creams, etc.), 
traditional medicine (acne, fevers, rheumatism, diuretics, 
inflammations, etc.), as an insect repellent and an insecticide, as a 
nematicide and fungicide, and as a fertilizer. Humans have had frequent 
physical contact with cold pressed neem oil with no negative health 
effects. Therefore, the Agency has not used a MOE (safety) approach to 
assess the safety of cold pressed neem oil.

VII. Other Considerations

A. Endocrine Disruptors

    EPA is required under section 408(p) of the FFDCA, as amended by 
the Food Quality Protection Act (FQPA), to develop a screening program 
to determine whether certain substances (including all pesticide active 
and other ingredients) ``may have an effect in humans that is similar 
to an effect produced by a naturally-occurring estrogen, or such other 
endocrine effect as the Administrator may designate.''
    Cold pressed neem oil is not a known endocrine disruptor nor is it 
related to any class of known endocrine disruptors. Thus, there is no 
impact via endocrine-related effects on the Agency's safety finding set 
forth in this final rule for cold pressed neem oil.

B. Analytical Methods

    Through this action, the Agency proposes to establish an exemption 
from the requirement of a tolerance for cold pressed neem oil when used 
on fruit and vegetable crops. For the same reasons that support the 
granting of this tolerance exemption, the Agency has concluded that an 
analytical method is not required for enforcement purposes for these 
proposed uses of cold pressed neem oil.

C. Codex Maximum Residue Level

    There are no codex maximum residue levels established for cold 
pressed neem oil.

VIII. Conclusions

    There are no human health concerns when end use products containing 
the active ingredient cold pressed neem oil are applied according to 
label use directions. The data submitted by the applicant and reviewed 
by the Agency support the petition for an exemption from the 
requirement of tolerances for cold pressed neem oil on food when the 
product is applied/used as directed on the label and in accordance with 
good agricultural practices. The toxicology data submitted are 
sufficient to demonstrate that no foreseeable human health hazard is 
likely to arise from the use of cold pressed neem oil.

 IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller

[[Page 55463]]

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: October 15, 2009.
Keith A. Matthews,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.1291 is added to subpart D to read as follows:

Sec.  180.1291   Cold pressed neem oil; exemption from the requirement 
of a tolerance.

    Residues of the biochemical pesticide cold pressed neem oil are 
exempt from the requirement of a tolerance in or on all food 
commodities.
[FR Doc. E9-25455 Filed 10-27-09; 8:45 am]

BILLING CODE 6560-50-S