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[Federal Register: December 13, 1995 (Volume
60, Number 239)]
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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. |
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 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.
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;
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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 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.
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. |
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