55458 Federal Register / Vol. 74, No. 207 / Wednesday, October 28, 2009 / Rules and Regulations 

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 exemption in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 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: October 18, 2009. 

Debra Edwards, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.1292 is added to 

subpart D to read as follows: 

§ 180.1292 Ulocladium oudemansii (U3 

Strain); exemption from the requirement of 

a tolerance. 

An exemption from the requirement 

of a tolerance is established in/on all 

food commodities for residues of 

Ulocladium oudemansii (U3 Strain), 

when applied or used pre-harvest-only, 

excluding applications made postharvest or to processed commodities, as 

a microbial fungicide in accordance 

with good agricultural practices. 

[FR Doc. E9–25969 Filed 10–27–09; 8:45 am] 

BILLING CODE 6560–50–S 

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. 

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 


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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 


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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 μL of 

cold pressed neem oil inhibited preimplantation 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 μL 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 threegeneration 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) 


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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, MultiDatabase, 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 nonoccupational 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) 

Terrestrial Matrix 

Dietary-based Estimated Environmental Concentrations 

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 nonoccupational, 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. Nonoccupational inhalation exposures to 

cold pressed neem oil when used as a 

pesticide are expected to be negligible 

because it is limited to agricultural use. 


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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 


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Federal Register / Vol. 74, No. 207 / Wednesday, October 28, 2009 / Rules and Regulations 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. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.1291 is added to 

subpart D to read as follows: 

§ 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0018; FRL–8795–3] 

Pyriproxyfen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyriproxyfen 

in or on artichoke, globe; asparagus; 

fruit, small, vine climbing subgroup, 

except grape 13–07E; vegetable, foliage 

of legume, group 7; vegetable, leafy, 

except brassica, group 4; vegetable, 

leaves of root and tuber, group 2; and 

watercress. It also removes the section 

18 time-limited tolerances on succulent 

bean, celery and strawberry since these 

tolerances have expired. Interregional 

Research Project Number 4 (IR-4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

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–2009–0018. 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: 

Barbara Madden, Registration Division, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6463; e-mail address: 

madden.barbara@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 those engaged in the 

following activities: 

• 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 to provide 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 EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

To access the OPPTS Harmonized Test 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods & Guidelines’’ on the left side 

navigation menu. 

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. 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–2009–0018 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 

as required by 40 CFR part 178 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 this copy, 

identified by docket ID number EPA– 

HQ–OPP–2009–0018, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 


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