Document ID: EPA-HQ-OPP-2006-0658-0003
Agency: epa
Document Type: Rule
Title: Polymer of 2-Ethyl-2-(Hydroxymethyl)-1,3-Propanediol, Oxirane, Methyloxirane, 1,2-Epoxyalkanes; Tolerance Exemption
Posted Date: 2007-03-07T05:00Z

[Federal Register: March 7, 2007 (Volume 72, Number 44)]
[Rules and Regulations]               
[Page 10074-10077]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07mr07-12]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0658; FRL-8116-9]

 
Polymer of 2-Ethyl-2-(Hydroxymethyl)-1,3-Propanediol, Oxirane, 
Methyloxirane, 1,2-Epoxyalkanes; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance for residues of polymer of 2-ethyl-2-(hydroxymethyl)-1,3-
propanediol, oxirane, methyloxirane, 1,2-epoxyalkanes; when used as 
inert ingredients in a pesticide chemical formulation. BASF Corporation 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended by the Food Quality Protection Act of 1996 
(FQPA) requesting an exemption from the requirement of a tolerance. 
This regulation eliminates the need to establish a maximum permissible 
level for residues of polymer of 2-ethyl-2-(hydroxymethyl)-1,3-
propanediol, oxirane, methyloxirane, 1,2-epoxyalkanes.

DATES: This regulation is effective March 7, 2007. Objections and 
requests for hearings must be received on or before May 7, 2007, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0658. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 

Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov web site to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the

[[Page 10075]]

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 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.

FOR FURTHER INFORMATION CONTACT: Bipin Gandhi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8380; e-mail address: gandhi.bipin@epa.gov.

SUPPLEMENTARY INFORMATION:

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:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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 an electronic copy of this Federal 
Register document through the electronic docket 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 e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    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-2006-0658 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 May 7, 2007.
    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-2006-0658, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of December 20, 2006 (71 FR 76321) (FRL-
8104-4), 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 6E7079) by BASF Corporation, 100 
Campus Drive, Florham Park, NJ 07932. The petition requested that 40 
CFR 180.960 be amended by establishing exemptions from the requirement 
of a tolerance for residues of polymer of 2-ethyl-2-(hydroxymethyl)-
1,3-propanediol, oxirane, methyloxirane, 1,2-epoxyalkanes; CAS Reg. No. 
903890-89-1 when 1,2-epoxyalkane is 1,2-epoxydodecane; CAS Reg. No. 
903890-90-4 when 1,2-epoxyalkane is 1,2-epoxyhexadecane; and CAS Reg. 
No. 893427-80-0 when 1,2-epoxyalkane is 1,2-epoxyoctadecane. 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 is ``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.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents;

[[Page 10076]]

and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. 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 the 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 that should present 
minimal or no risk. The definition of a polymer is given in 40 CFR 
723.250(b). The following exclusion criteria for identifying these low 
risk polymers are described in 40 CFR 723.250(d).
    1. The polymers are not cationic polymers nor are they reasonably 
anticipated to become a cationic polymers in a natural aquatic 
environment.
    2. The polymers do contain as an integral part of its composition 
the atomic elements carbon, hydrogen, and oxygen.
    3. The polymers do 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 polymers are neither designed nor can they be reasonably 
anticipated to substantially degrade, decompose, or depolymerize.
    5. The polymers are 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 polymers are not water absorbing polymers with a number 
average molecular weight (MW) greater than or equal to 10,000 daltons.
    Additionally, the polymers, also meet as required the following 
exemption criteria specified in 40 CFR 723.250(e).
    7. The polymers' number average MW of 16,000 to 20,000 are greater 
than or equal to 10,000 daltons. The polymers contain less than 2% 
oligomeric material below MW 500 and less than 5% oligomeric material 
below MW 1,000.
    Thus, the polymer of 2-ethyl-2-(hydroxymethyl)-1,3 propanediol, 
oxirane, methyloxirane, 1,2-epoxyalkanes meets all the criteria for a 
polymers 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 polymer of 2-ethyl-2-
(hydroxymethyl)-1,3 propanediol, oxirane, methyloxirane, 1,2-
epoxyalkanes.

V. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that polymer of 2-ethyl-2-(hydroxymethyl)-1,3 
propanediol, oxirane, methyloxirane, 1,2-epoxyalkanes could be present 
in all raw and processed agricultural commodities and drinking water, 
and that non-occupational non-dietary exposures were possible. The 
number average MW of polymer of 2-ethyl-2-(hydroxymethyl)-1,3 
propanediol, oxirane, methyloxirane, 1,2-epoxyalkanes is in the range 
of 16,000 to 20,000 daltons. Generally, a polymer of this size would be 
poorly absorbed through the intact gastrointestinal tract or through 
intact human skin. Since polymer of 2-ethyl-2-(hydroxymethyl)-1,3 
propanediol, oxirane, methyloxirane, 1,2-epoxyalkanes 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.

VI. 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.'' EPA does not 
have, at this time, available data to determine whether polymer of 2-
ethyl-2-(hydroxymethyl)-1,3 propanediol, oxirane, methyloxirane, 1,2-
epoxyalkanes 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 polymer of 2-ethyl-2-
(hydroxymethyl)-1,3 propanediol, oxirane, methyloxirane, 1,2-
epoxyalkanes and any other substances and polymer of 2-ethyl-2-
(hydroxymethyl)-1,3 propanediol, oxirane, methyloxirane, 1,2-
epoxyalkanes do not appear to produce toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that polymer of 2-ethyl-2-(hydroxymethyl)-1,3 
propanediol, oxirane, methyloxirane, 1,2-epoxyalkanes have 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 website at http://www.epa.gov/pesticides/cumulative.

VII. Additional Safety Factor for the Protection of Infants and 
Children

    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 polymer of 2-ethyl-2-
(hydroxymethyl)-1,3 propanediol, oxirane, methyloxirane, 1,2-
epoxyalkanes, EPA has not used a safety factor analysis to assess the 
risk. For the same reasons the additional tenfold safety factor is 
unnecessary.

[[Page 10077]]

VIII. 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 polymer of 2-ethyl-2-(hydroxymethyl)-
1,3 propanediol, oxirane, methyloxirane, 1,2-epoxyalkanes.

IX. Other Considerations

A. Endocrine Disruptors

    There is no available evidence that polymer of 2-ethyl-2-
(hydroxymethyl)-1,3 propanediol, oxirane, methyloxirane, 1,2-
epoxyalkanes are endocrine disruptors.

B. 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.

C. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
polymer of 2-ethyl-2-(hydroxymethyl)-1,3 propanediol, oxirane, 
methyloxirane, 1,2-epoxyalkanes nor have any CODEX Maximum Residue 
Levels (MRLs) been established for any food crops at this time.

X. Conclusion

    Accordingly, EPA finds that exempting residues of polymer of 2-
ethyl-2-(hydroxymethyl)-1,3 propanediol, oxirane, methyloxirane, 1,2-
epoxyalkanes from the requirement of a tolerance will be safe.

XI. 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 types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866, this rule is not 
subject to Executive Order 13211, 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 require any special considerations 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    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. 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 6, 
2000) do not apply to this rule. In addition, This 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) (Pub. L. 
104-4).
    This action does not 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 104-113, section 12(d) (15 U.S.C. 272 
note).

XII. 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: February 27, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 1 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.960 the table is amended by adding alphabetically 
polymers to read as follows:

Sec.  180.960  Polymers; exemptions from the requirement of a 
tolerance.

* * * * *

------------------------------------------------------------------------
                  Polymer                              CAS No.
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                                * * * * *
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Oxirane, decyl-, reaction products with     903890-89-1
 polyethylene-polypropylene glycol ether
 with trimethylolpropane (3:1).
------------------------------------------------------------------------
Oxirane, hexadecyl-, reaction products      893427-80-0
 with polyethylene-polypropylene glycol
 ether with trimethylolpropane (3:1).
------------------------------------------------------------------------
Oxirane, methyl-, polymer with oxirane,     903890-90-4
 ether with 2-ethyl-2-(hydroxymethyl) -
 1,3 - propanediol (3:1), reaction
 products with tetradecyloxirane.
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E7-4083 Filed 3-6-07; 8:45 am]

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