Federal Register: November 5, 2008 (Volume 73, Number 215)
DOCID: fr05no08-5 FR Doc E8-26396
ENVIRONMENTAL PROTECTION AGENCY
Environmental Protection Agency
CFR Citation: 40 CFR Part 180
DOCUMENT ID: Silane, trimethoxy[3-(oxiranylmethoxy)propyl]-, hydrolysis
EPA ID: [EPA-HQ-OPP-2008-0571; FRL-8386-1]
ACTION: Tolerance Exemption:
DOCUMENT ACTION: Final rule.
products with silica; Tolerance Exemption
DATES: This regulation is effective November 5, 2008. Objections and requests for hearings must be received on or before January 5, 2009, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
This regulation establishes an exemption from the requirement of a
tolerance for residues of silane, trimethoxy[3
(oxiranylmethoxy)propyl], hydrolysis products with silica (CAS Reg. No. 68584827); when used as an inert ingredient in a pesticide chemical formulation under 40 CFR 180.960. Keller and Heckman LLP, 1001 G St., NW, Suit, 500 Washington, DC 20001 as U.S. agent for Eka Chemicals AB, 455 80 Bobus, Sweden 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 silane, trimethoxy[3 (oxiranylmethoxy)propyl], hydrolysis products with silica on food or feed commodities.
Silane, Trimethoxy[3-(Oxiranylmethoxy)Propyl]-, Hydrolysis Products with Silica,
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing electronically available documents at http://www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot eCFR site at http:// www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 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. 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 EPAHQOPP20080571. 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 January 5, 2009.
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 EPAHQOPP20080571, by one of the following methods.
In the Federal Register of August 13, 2008 (73 FR 47184) (FRL8376 8), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP 8E7397) filed by Keller and Heckman LLP, 1001 G St., NW, Suit, 500 Washington, DC 20001 as U.S. agent for Eka Chemicals AB, 455 80 Bobus, Sweden. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of silane, trimethoxy[3(oxiranylmethoxy)propyl], hydrolysis products with silica; CAS Reg. No. 68584827. That notice included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. The Agency received one comment. One comment was received from a private citizen who opposed the authorization to sell any pesticide that leaves a residue on food.
The Agency understands the commenter's concerns and recognizes that
some individuals believe that no residue of pesticides should be
allowed. However, under the existing legal framework provided by
section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) EPA is authorized to establish pesticide tolerances or
exemptions where persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute.
Section 408(c)(2)(A)(i) of 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 is ``safe.'' Section 408(c)(2)(A)(ii) of 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 use in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of 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. III. Risk Assessment and Statutory Findings
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with section 408(b)(2)(D) of FFDCA, 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 lowrisk polymers are described in 40 CFR 723.250(d). Silane, trimethoxy[3
(oxiranylmethoxy)propyl], hydrolysis products with silica conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify lowrisk polymers.
1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.
2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.
3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.
5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.
6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.
Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e).
7. The polymer's number average MW of 640,000 daltons is greater than or equal to 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000.
Thus, silane, trimethoxy[3(oxiranylmethoxy)propyl], hydrolysis
products with silica meets the criteria for a polymer to be considered
low risk under 40 CFR 723.250. Based on its conformance to the criteria
in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to silane, trimethoxy[3
(oxiranylmethoxy)propyl], hydrolysis products with silica.
IV. Aggregate Exposures
For the purposes of assessing potential exposure under this exemption, EPA considered that silane, trimethoxy[3
(oxiranylmethoxy)propyl], hydrolysis products with silica could be present in all raw and processed agricultural commodities and drinking water, and that nonoccupational nondietary exposure was possible. The number average MW of silane, trimethoxy[3(oxiranylmethoxy)propyl], hydrolysis products with silica is 640,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since silane, trimethoxy[3(oxiranylmethoxy)propyl], hydrolysis products with silica conform to the criteria that identify a lowrisk 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.
V. Cumulative Effects
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.'' For the purposes of this tolerance action, EPA has not assumed that silane, trimethoxy[3(oxiranylmethoxy)propyl], hydrolysis products with silica has a common mechanism of toxicity with other substances, based on the anticipated absence of mammalian toxicity. 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 website at http://www.epa.gov/pesticides/cumulative. VI. Additional Safety Factor for the Protection of Infants and Children
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 silane, trimethoxy[3(oxiranylmethoxy)propyl], hydrolysis products with silica, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.
VII. Determination of Safety
Based on the conformance to the criteria used to identify a low
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from aggregate exposure to residues of silane, trimethoxy[3
(oxiranylmethoxy)propyl], hydrolysis products with silica.
VIII. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.
B. International Tolerances
The Agency is not aware of any country requiring a tolerance for silane, trimethoxy[3(oxiranylmethoxy)propyl], hydrolysis products with silica nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.
Accordingly, EPA finds that exempting residues of silane, trimethoxy[3(oxiranylmethoxy)propyl], hydrolysis products with silica from the requirement of a tolerance will be safe.
X. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these rules from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104113, section 12(d) (15 U.S.C. 272 note).
Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes, or otherwise have any unique impacts or local governments. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 1044).
Although this action does not require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and LowIncome Populations (59 FR 7629, February 16, 1994), EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or lowincome populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. As such, to the extent that information is publicly available or was submitted in comments to EPA, the Agency considered whether groups or segments of the population, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticide discussed in this document, compared to the general population.
XI. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this rule in the Federal Register. This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: October 27, 2008.
Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.960, the table is amended by adding alphabetically the following polymer to read as follows:
Sec. 180.960 Polymers; exemptions from the requirement of a tolerance.
* * * * *
Polymer CAS No. * * * * *
Silane, trimethoxy[3 68584827
products with silica, minimum number
average molecular weight (in amu),
* * * * *
[FR Doc. E826396 Filed 11408; 8:45 am]
BILLING CODE 656050S
FOR FURTHER INFORMATION CONTACT
Karen Samek, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001; telephone number: (703) 3478825; email address: email@example.com.