Source: https://www.federalregister.gov/articles/2010/07/14/2010-17153/castor-oil-ethoxylated-oleate-tolerance-exemption
Timestamp: 2015-09-04 18:53:25
Document Index: 35185414

Matched Legal Cases: ['art 178', 'art 178', 'art 178', 'art 178', 'art 2', '§ 180', '§ 180']

Federal Register | Castor Oil, Ethoxylated, Oleate; Tolerance Exemption
Dates: This regulation is effective July 14, 2010. Objections and requests for hearings must be received on or before September 13, 2010 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
-40754 (4 pages)
EPA-HQ-OPP-2010-0231
FRL-8834-4
Document Number: 2010-17153
Shorter URL: https://federalregister.gov/a/2010-17153 Related Topics
This regulation establishes an exemption from the requirement of a tolerance for residues of castor oil, ethoxylated, oleate (CAS Reg. No. 220037-02-5) with a minimum number average molecular weight (in amu) of 1,600 when used as an inert ingredient in a pesticide chemical formulation under 40 CFR 180.960. SciReg. Inc. on behalf of Rhodia, Inc, 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 castor oil, ethoxylated, oleate on food or feed commodities.
A. Existing Exemptions from the Requirement of a Tolerance
This regulation is effective July 14, 2010. Objections and requests for hearings must be received on or before September 13, 2010 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2010-0231. 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.
Under FFDCA section 408(g), 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-2010-0231 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before September 13, 2010. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
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. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2010-0231, by one of the following methods.
In the Federal Register of May 19, 2010 (75 FR 28009) (FRL-8823-2), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP 0E7692) filed by SciReg, Inc, on behalf of Rhodia Inc., 12733 Director's Loop, Woodbridge, VA 22192. The petition requested that the exemption from the requirement of a tolerance for castor oil, ethoxylated, oleate, minimum number average molecular weight (in amu) 2,000, (CAS Reg. No. 220037-02-5) when used as an inert ingredient in pesticide chemical formulations listed under 40 CFR 180.960 be amended to allow for a minimum number average molecular weight (in amu) of 1,200. That notice included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. The Agency did not receive any comments.
Based upon review of the data supporting the petition, EPA has modified the exemption requested by limiting the minimum number average molecular weight (in amu) to 1,600. Therefore, the exemption from the requirement of a tolerance being established in this final rule is for residues of castor oil, ethoxylated, oleate (CAS Reg. No. 220037-02-5) with a minimum number average molecular weight (in amu) of 1,600.
Consistent with FFDCA section 408(b)(2)(D), 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. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). Castor oil, ethoxylated, oleate conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.
7. The polymer's number average MW of 1,600 daltons is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups.
For the purposes of assessing potential exposure under this exemption, EPA considered that castor oil, ethoxylated, oleate could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of castor oil, ethoxylated, oleate is 1,600 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since castor oil, ethoxylated, oleate conforms to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.
EPA has not found castor oil, ethoxylated, oleate to share a common mechanism of toxicity with any other substances, and castor oil, ethoxylated oleate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that castor oil, ethoxylated, oleate does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of castor oil, ethoxylated oleate, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.
Castor oil, ethoxylated, oleate, minimum number average molecular weight (in amu) 2,000, (CAS Reg. No. 220037-02-5) is exempted from the requirement of a tolerance under 40 CFR 180.960 when used as an inert ingredient in pesticide chemical formulations.
The Codex has not established a MRL for castor oil, ethoxylated, oleate.
Accordingly, EPA finds that exempting residues of castor oil, ethoxylated, oleate from the requirement of a tolerance will be safe. X. Statutory and Executive Order Reviews Back to Top
2.In § 180.960, the table is amended by revising the following polymer to read as follows: § 180.960 Polymers; exemptions from the requirement of a tolerance.
[FR Doc. 2010-17153 Filed 7-13-10; 8:45 am]