[Federal Register Volume 60, Number 239 (Wednesday, December 13, 1995)]
[Rules and Regulations]
[Pages 63950-63953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29991]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 5F4467/R2193; FRL-4990-8]
RIN 2070-AB78


Neem Oil; Tolerance Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes an exemption from the requirement of a 
tolerance for residues of clarified hydrophobic extract of neem oil 
when used according to good agricultural practice as a broad-spectrum 
fungicide/insecticide/miticide on all greenhouse and terrestrial food 
crops. A request for an exemption from the requirement of a tolerance 
was submitted by W.R. Grace Co.-Conn. This regulation eliminates the 
need to establish a maximum 

[[Page 63951]]

permissible level for residues of this broad-spectrum fungicide/
insecticide/miticide on all greenhouse and terrestrial food crops when 
used according to good agricultural practice.

EFFECTIVE DATE: This rule becomes effective on December 13, 1995.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 5F4467/R2193], may be submitted to: 
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M 
St., SW., Washington, DC 20460. A copy of any objections and hearing 
requests filed with the Hearing Clerk should be identified by the 
document control number and submitted to: Public Response and Program 
Branch, Field Operations Division (7506C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. In person, bring copy of objections and hearing requests to: 
Rm. 1132, CM #2, 1921 Jefferson Davis Highway, Arlington, VA 22202. 
Fees accompanying objections shall be labeled ``Tolerance Petition 
Fees'' and forwarded to: EPA Headquarters Accounting Operations Branch, 
OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect in 5.1 
file format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket number [PP 
5F4467/R2193]. No Confidential Business Information (CBI) should be 
submitted through e-mail. Electronic copies of objections and hearing 
requests on this rule may be filed online at many Federal Depository 
Libraries. Additional information on electronic submissions can be 
found below in this document.

FOR FURTHER INFORMATION CONTACT: By mail: Paul Zubkoff, Biopesticides 
and Pollution Prevention Division (7501W), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location and telephone number: 5th Floor, CS #1, 2800 
Crystal Drive, Arlington, VA 22202, (703)-308-8694; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the 
Federal Register of September 29, 1995 (60 FR 50582), which announced 
that W.R. Grace Co.-Conn., 7379 Route 32, Columbia, MD 21044, had 
submitted a pesticide petition (PP) 5F4467 to EPA requesting that the 
Administrator, pursuant to section 408(d) of the Federal Food, Drug, 
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), establish an exemption 
from the requirement of a tolerance for the use of clarified 
hydrophobic extract of neem oil on all greenhouse and terrestrial food 
crops when used according to good agricultural practice. There were no 
adverse comments or requests for referral to an advisory committee 
received in response to the notice of filing of PP 5F4467.

Existing Food Clearances

    The clarified hydrophobic extract is prepared from the crude 
botanical extract of the seed kernels of the neem tree, Azadiracta 
indica. The constituents of clarified hydrophobic extract of neem oil 
are long-chain fatty acids and glycerides. Long-chain fatty acids and 
glycerides are Generally Recognized As Safe (GRAS) for use in foods by 
the U.S. Food and Drug Administration (FDA). Under title 21 of the Code 
of Federal Regulations (CFR) (21 CFR 172.860), oleic acid derived from 
tall oil fatty acids (21 CFR 172.862), and linoleic acid (21 CFR 
184.1065), glyceryl monooleate (21 CFR 184.1323), glyceryl monostearate 
(21 CFR 184.1324), and mono- and diglycerides (21 CFR 184.1505) are 
considered as GRAS.

Natural Occurrence

    Long-chain fatty acids and glycerides are readily synthesized by 
most forms of life and are common constituents of human, avian, and 
other mammalian diets. In most soil and aquatic environments, these 
constituents of clarified hydrophobic extract of neem oil would be 
readily metabolized by endemic microbial populations and should not 
accumulate. Because clarified hydrophobic extract of neem oil is a 
naturally occurring compound which displays a nontoxic mode of action 
to the target pest, the Agency classified the active ingredient as a 
biochemical pesticide.

Toxicology Assessment

    All studies submitted for acute mammalian toxicology support the 
registration of the technical manufacturing product (Reg. No. 11688-8) 
and the end-use product for use on all terrestrial and greenhouse food 
crops. Summarized below are data and information for the registration 
of clarified hydrophobic extract of neem oil. EPA has examined the 
acute mammalian toxicology data related to human health submitted for 
clarified hydrophobic extract of neem oil. The mammalian toxicology 
data for clarified hydrophobic extract of neem oil indicate low acute 
toxicity following all routes of exposure. With the exceptions of the 
primary eye irritation study (toxicity category III) and the acute 
dermal study (toxicity category III), all other acute studies (oral, 
dermal irritation, and inhalation toxicity) were classified toxicity 
category IV. Based on the results from the sensitization test 
(Buehler), the clarified hydrophobic extract of neem oil is considered 
to be a mild (minimal) contact sensitizer. In addition, clarified 
hydrophobic extract of neem oil was shown not to be cytotoxic or 
mutagenic via the Ames test (Salmonella/reverse mutation assay). 
Further genotoxicity tests to address structural chromosomal 
aberrations and forward mutations have been waived based on the known 
composition (fatty acids and glycerides) and GRAS status of the 
technical manufacturing product (clarified hydrophobic extract of neem 
oil, the lack of mammalian and avian toxicity, and the negative results 
observed in the Ames tests). Consequently, at levels used on plants, 
human exposure is expected to be negligible and acute toxicity from 
such exposure is not expected.
    Tolerance exemptions are usually, in part, based on the results of 
subchronic (90-day) feeding and developmental toxicity studies 
submitted to support registration. However, these studies were waived 
for clarified hydrophobic extract of neem oil because of the low 
demonstrated acute toxicity, the GRAS nature of the naturally occurring 
components (saturated fatty acids and glycerides) of the active 
pesticidal ingredient, and the negligible exposure to humans and the 
environment owing to the low use rates. Such use rates would not 
significantly increase dietary intake over routine exposure from 
general consumption of fatty acids in foods. Moreover, the Agency knows 
of no reported cases of adverse effects from exposure to low amounts of 
fatty acids.

Residue Chemistry Data

    Residue chemistry data are usually required for biochemical 
pesticides only if the submitted mammalian toxicology studies indicate 
that additional Tier II or Tier III toxicology data would be required 
as specified in 40 CFR 158.165(e). The submitted toxicology data for 
this use indicate that the product is of low mammalian toxicity; it has 
naturally occurring components in many food plants and, therefore, it 
is 

[[Page 63952]]
a component of the normal human diet. Therefore, Tier II or Tier III 
data are not required. Based on the information considered, the Agency 
concludes that the establishment of a tolerance for the active 
ingredient, clarified hydrophobic extract of neem oil, is not necessary 
to protect the public health from food residues expected from the use 
of clarified hydrophobic extract of neem oil. Since this rule 
establishes an exemption from the requirement of a tolerance, the 
Agency has concluded that an analytical method is not required for 
enforcement purposes for clarified hydrophobic extract of neem oil.

Metabolism

    Clarified hydrophobic extract of neem oil consists of naturally 
occurring fatty acids and glycerides that are considered GRAS by the 
FDA. The oxidative degradation of fatty acids is a central metabolic 
pathway in animals, plants, and microbes. Glycerides are degraded into 
glycerol and fatty acids of varying chain lengths. Glycerol is readily 
metabolized or used as an energy source or as a precursor to other 
carbohydrates, lipids, or amino acids. Fatty acids are metabolized into 
two-carbon fragments through a sequence of enzyme-catalyzed reactions. 
The metabolic products are then incorporated into fats, carbohydrates, 
and amino acids.

Conclusion

    Based on the information considered, the Agency concludes that 
establishment of a tolerance for clarified hydrophobic extract of neem 
oil (Reg. No. 11688-8) is not necessary to protect the public health. 
Therefore, the exemption from tolerance is established as set forth 
below.
    Any person adversely affected by this regulation may, within 30 
days after publication of this document in the Federal Register, file 
written objections to the regulation and may also request a hearing on 
those objections. Objections and hearing requests must be filed with 
the Hearing Clerk, at the address given above (40 CFR 178.20). A copy 
of the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rule-making. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issue(s) on which a hearing is requested, the 
requestor's contentions on such issues, a summary of any evidence 
relied upon by the objector as well as the other materials required by 
40 CFR 178.27. A request for a hearing will be granted if the 
Administrator determines that the material submitted shows the 
following: There is genuine and substantial issue of fact; there is 
reasonable possibility that available evidence identified by the 
requestor would, if established, resolve one or more of such issues in 
favor of the requestor, taking into account uncontested claims or facts 
to the contrary; and resolution of the factual issue(s) in the manner 
sought by the requestor would be adequate to justify the action 
requested (40 CFR 178.32).
     A record has been established for this rulemaking under docket 
number [PP 5F4467/R2193] (including objections and hearing requests 
submitted electronically as described below). A public version of this 
record, including printed, paper versions of electronic comments, which 
does not include any information claimed as CBI, is available for 
inspection from 8 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. The public record is located in Rm. 1132 of the Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Written objections and hearing requests, identified by the document 
control number [PP 5F4467/R2193], may be submitted to the Hearing Clerk 
(1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW., 
Washington, DC 20460.
    A copy of electronic objections and hearing requests filed with the 
Hearing Clerk can be sent directly to EPA at:
    opp-D[email protected]


    A copy of electronic objections and hearing requests filed with the 
Hearing Clerk must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer any objections and hearing requests received 
electronically into printed, paper form as they are received and will 
place the paper copies in the official rulemaking record which will 
also include all objections and hearing requests submitted directly in 
writing. The official rulemaking record is the paper record maintained 
at the address in ADDRESSES at the beginning of this document.
    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to all the requirements of the Executive Order 
(i.e., Regulatory Impact Analysis, review by the Office of Management 
and Budget (OMB)). Under section 3(f), the order defines 
``significant'' as those actions likely to lead to a rule (1) having an 
annual effect on the economy of $100 million or more, or adversely and 
materially affecting a sector of the economy, productivity, 
competition, jobs, the environment, public health or safety, or State, 
local or tribal governments or communities (also known as 
``economically significant''); (2) creating serious inconsistency or 
otherwise interfering with an action taken or planned by another 
agency; (3) materially altering the budgetary impacts of entitlement, 
grants, user fees, or loan programs; or (4) raising novel legal or 
policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in this Executive Order. 
Pursuant to the terms of this Executive Order, EPA has determined that 
this rule is not ``significant'' and is therefore not subject to OMB 
review. Pursuant to the requirements of the Regulatory Flexibility Act 
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator 
has determined that regulations establishing new tolerances or raising 
tolerance levels or establishing exemptions from tolerance requirements 
do not have a significant economic impact on a substantial number of 
small entities. A certification statement to this effect was published 
in the Federal Register of May 4, 1981 (46 FR 24950).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: November 30, 1995.

Daniel M. Barolo,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 is amended as follows:

PART 180--[AMENDED]

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

    Authority: 21 U.S.C. 346a and 371.

    2. In subpart D, by adding new Sec. 180.1161, to read as follows:
    
[[Page 63953]]



Sec. 180.1161   Clarified hydrophobic extract of neem oil; exemption 
from the requirement of a tolerance.

    Clarified hydrophobic extract of neem oil (Reg. No. 11688-8) is 
exempt from the requirement of a tolerance on all raw agricultural 
commodities when used as a botanical fungicide/insecticide/miticide.

[FR Doc. 95-29991 Filed 12-12-95; 8:45 am]
BILLING CODE 6560-50-F