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

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;

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.