Source: https://www.federalregister.gov/documents/2006/07/26/E6-11720/butene-homopolymer-tolerance-exemption
Timestamp: 2017-08-23 19:59:00
Document Index: 486812896

Matched Legal Cases: ['art 178', 'art 178', 'art 178', 'art 178', 'art 2', '§\u2009180']

Federal Register :: Butene, Homopolymer; Tolerance Exemption
Butene, Homopolymer; Tolerance Exemption
A Rule by the Environmental Protection Agency on 07/26/2006
This regulation is effective July 26, 2006. Objections and requests for hearings must be received on or before September 25, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.
71 FR 42274
42274-42278 (5 pages)
EPA-HQ-OPP-2006-0552
FRL-8075-8
E6-11720
https://www.federalregister.gov/d/E6-11720 https://www.federalregister.gov/d/E6-11720
This regulation revises the exemption from the requirement of a tolerance for residues of butene, homopolymer when used as an inert ingredient in a pesticide chemical formulation. Miller Chemical and Fertilizer Corporatation submitted a petition to EPA under the Federal Food, Start Printed Page 42275Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA) requesting a revision of an exemption (which has already been established) from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of butene, homopolymer.
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2006-0552. All documents in the docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305-5805.
Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. 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-2006-0552 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before September 25, 2006.
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 that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0552, by one of the following methods.
In the Federal Register of January 25, 2006 (71 FR 4138) (FRL-7744-4), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 5E6958) by Miller Chemical and Fertilizer Corporation, P. O. Box 333, 120 Radio Road, Hanover, PA 17331. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of butene, homopolymer; CAS Reg.No. 9003-29-6. That notice included a summary of the petition prepared by the petitioner. There were no comments in response to the notice of filing.
Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance “safe.” Section 408(c)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue” and specifies factors EPA is to consider in establishing an exemption.Start Printed Page 42276
1. The polymer, butene, homopolymer, is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.
Additionally, the polymer, butene, homopolymer, also meets as required the following exemption criteria specified in 40 CFR 723.250(e).
7. The polymer's number average molecular weight (MW) of 1100 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.
Thus, butene, homopolymer meet all the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the above criteria, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to butene, homopolymer.
For the purposes of assessing potential exposure under this exemption, EPA considered that butene, homopolymer 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 butene, homopolymer is 1100 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since butene, homopolymer conform 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.
Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, the Agency consider “available information” concerning the cumulative effects of a particular chemical's residues and “other substances that have a common mechanism of toxicity.” EPA does not have, at this time, available data to determine whether butene, homopolymer has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to butene, homopolymer and any other substances and butene, homopolymer does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that butene, homopolymer has 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 the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's Web site at http://www.epa.gov/​pesticides/​cumulative.
Section 408 of the 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 butene, homopolymer, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.
Based on the conformance to the criteria used to identify a low risk polymer, EPA concludes that there is a Start Printed Page 42277reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of butene, homopolymer.
There is no available evidence that butene, homopolymer is an endocrine disruptor.
The Agency is not aware of any country requiring a tolerance for butene, homopolymer nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.
Accordingly, EPA finds that exempting residues of butene, homopolymer from the requirement of a tolerance will be safe.
2. In § 180.960 the table is amended by revising the entry for “Butene, homopolymer minimum number average molecular weight (in amu), 1,330” to read as follows:
Butene, homopolymer 9003-29-6
[FR Doc. E6-11720 Filed 7-25-06; 8:45 am]