[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]
-----------------------------------------------------------------------
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
[[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: opp-docket@epamail.epa.gov. 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:
zubkoff.paul@epamail.epa.gov.
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-Docket@epamail.epa.gov
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
