[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Rules and Regulations]
[Pages 57285-57289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22601]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0383; FRL-9398-4]


2,5-Furandione, Polymer With Ethenylbenzene, Hydrolyzed, 3-
(Dimethylamino)propyl Imide, Imide With Polyethylene-Polypropylene 
Glycol 2-Aminopropyl Me Ether, 2,2'-(1,2-Diazenediyl)bis[2-
Methylbutanenitrile]-Initiated; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of 2,5-furandione, polymer with 
ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with 
polyethylene-polypropylene glycol 2-aminopropyl me ether, 2,2'-(1,2-
diazenediyl)bis[2-methylbutanenitrile]-initiated (CAS Reg. No. 1062609-
13-5) when used as an inert ingredient in a pesticide formulation. 
Evonik Goldschmidt Corporation (Evonik) 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 2,5-furandione, polymer with ethenylbenzene, hydrolyzed, 3-

[[Page 57286]]

(dimethylamino)propyl imide, imide with polyethylene-polypropylene 
glycol 2-aminopropyl me ether, 2,2'-(1,2-diazenediyl)bis[2-
methylbutanenitrile]-initiated on food or feed commodities.

DATES: This regulation is effective September 18, 2013. Objections and 
requests for hearings must be received on or before November 18, 2013, 
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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2013-0383, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090 email address: [email protected].

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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. Can I file an objection or hearing request?

    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-2013-0383 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 
November 18, 2013. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2013-0383, by one of 
the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at  http://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of July 19, 2013 (78 FR 43115) (FRL-9392-
9), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the receipt of a pesticide petition (IN-10559) filed 
by Evonik Goldschmidt Corporation, P.O. Box 1299, 914 East Randolph Rd. 
Hopewell, VA 23860. The petition requested that 40 CFR 180.960 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of 2,5-furandione, polymer with ethenylbenzene, 
hydrolyzed, 3-(dimethylamino)propyl imide, imide with polyethylene-
polypropylene glycol 2-aminopropyl me ether, 2,2'-(1,2-
diazenediyl)bis[2-methylbutanenitrile]-initiated; CAS Reg. No. 1062609-
13-5. That document included a summary of the petition prepared by the 
petitioner and solicited comments on the petitioner's request. The 
Agency received one comment.
    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 exemption 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

[[Page 57287]]

harm will result from aggregate exposure to the inert ingredient, an 
exemption from the requirement of a tolerance may be established.
    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) for 2,5-furandione, polymer with 
ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with 
polyethylene-polypropylene glycol 2-aminopropyl me ether, 2,2'-(1,2-
diazenediyl)bis[2-methylbutanenitrile]-initiated 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.
    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.
    7. The polymer does not contain certain perfluoroalkyl moieties 
consisting of a CF3- or longer chain length as specified in 40 CFR 
723.250(d)(6).
    Additionally, the polymer also meets as required the following 
exemption criteria specified in 40 CFR 723.250(e).
    8. The polymer's number average MW of 5,816 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, 2,5-furandione, polymer with ethenylbenzene, hydrolyzed, 3-
(dimethylamino)propyl imide, imide with polyethylene-polypropylene 
glycol 2-aminopropyl me ether, 2,2'-(1,2-diazenediyl)bis[2-
methylbutanenitrile]-initiated 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 2,5-furandione, polymer with 
ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with 
polyethylene-polypropylene glycol 2-aminopropyl me ether, 2,2'-(1,2-
diazenediyl)bis[2-methylbutanenitrile]-initiated.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that 2,5-furandione, polymer with 
ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with 
polyethylene-polypropylene glycol 2-aminopropyl me ether, 2,2'-(1,2-
diazenediyl)bis[2-methylbutanenitrile]-initiated 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 2,5-furandione, polymer with ethenylbenzene, hydrolyzed, 
3-(dimethylamino)propyl imide, imide with polyethylene-polypropylene 
glycol 2-aminopropyl me ether, 2,2'-(1,2-diazenediyl)bis[2-
methylbutanenitrile]-initiated is 5,816 daltons. Generally, a polymer 
of this size would be poorly absorbed through the intact 
gastrointestinal tract or through intact human skin. Since 2,5-
furandione, polymer with ethenylbenzene, hydrolyzed, 3-
(dimethylamino)propyl imide, imide with polyethylene-polypropylene 
glycol 2-aminopropyl me ether, 2,2'-(1,2-diazenediyl)bis[2-
methylbutanenitrile]-initiated 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.

V. Cumulative Effects From Substances With a Common Mechanism of 
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA has not found 2,5-furandione, polymer with ethenylbenzene, 
hydrolyzed, 3-(dimethylamino)propyl imide, imide with polyethylene-
polypropylene glycol 2-aminopropyl me ether, 2,2'-(1,2-
diazenediyl)bis[2-methylbutanenitrile]-initiated to share a common 
mechanism of toxicity with any other substances, and 2,5-furandione, 
polymer with ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl iide, 
imide with polyethylene-polypropylene glycol 2-aminopropyl me ether, 
2,2'-(1,2-diazenediyl)bis[2-methylbutanenitrile]-initiated does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
2,5-furandione, polymer with ethenylbenzene, hydrolyzed, 3-
(dimethylamino)propyl imide, imide with polyethylene-polypropylene 
glycol 2-aminopropyl me ether, 2,2'-(1,2-diazenediyl)bis[2-
methylbutanenitrile]-initiated 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 Web site 
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 2,5-furandione, polymer 
with ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide 
with polyethylene-polypropylene glycol 2-aminopropyl me ether, 2,2'-
(1,2-diazenediyl)bis[2-methylbutanenitrile]-initiated, EPA has not used 
a safety factor analysis to assess the risk. For the same reasons the 
additional tenfold safety factor is unnecessary.

[[Page 57288]]

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 2,5-furandione, polymer with 
ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with 
polyethylene-polypropylene glycol 2-aminopropyl me ether, 2,2'-(1,2-
diazenediyl)bis[2-methylbutanenitrile]-initiated.

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 Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for 2,5-furandione, polymer 
with ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide 
with polyethylene-polypropylene glycol 2-aminopropyl me ether, 2,2'-
(1,2-diazenediyl)bis[2-methylbutanenitrile]-initiated.

C. Response to Comments

    The one comment received was an anonymous public comment regarding 
the acceptability of the polymer under 40 CFR 180.960 and whether it 
met the 40 CFR 723.250 low risk polymer exemption. The comment stated, 
``When DMAPA (dimentylaminopropyl amine) is reacted into the polymer to 
form the imide, that leaves a tertiary amine (dimethylpropyl amine) 
that can be protonated to become cationic when dispersed in water. If 
there are more than one of these DMAPAs per polymer molecule the 
equivalent weight will be below the 5,000 amu required to meet 40 CFR 
723.250 low risk polymer exemption from both TSCA and to get approval 
on 40 CFR 180.960.'' While this polymer does contain a tertiary amine 
functional group, the functional group equivalent weight is greater 
than 5,000 daltons. Therefore, this polymer is a cationic polymer of 
low cationic density and not excluded from the polymer exemption 
criteria given at 40 CFR 723.250(d).

IX. Conclusion

    Accordingly, EPA finds that exempting residues of 2,5-furandione, 
polymer with ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, 
imide with polyethylene-polypropylene glycol 2-aminopropyl me ether, 
2,2'-(1,2-diazenediyl)bis[2-methylbutanenitrile]-initiated from the 
requirement of a tolerance will be safe.

X. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under FFDCA section 408(d) 
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) (15 U.S.C. 272 
note).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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 on 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) (2 U.S.C. 1501 et seq.).
    Although this action does not 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), EPA seeks to achieve 
environmental justice, the fair treatment and meaningful involvement of 
any group, including minority and/or low-income 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

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal

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Register. This action 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: September 9, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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


0
2. In Sec.  180.960, alphabetically add the following polymer to the 
table to read as follows:


Sec.  [emsp14]180.960  Polymers; exemptions from the requirement of a 
tolerance.

* * * * *

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                       Polymer                             CAS No.
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                              * * * * * * *
2,5-Furandione, polymer with ethenylbenzene,              1062609-13-5
 hydrolyzed, 3-(dimethylamino)propyl imide, imide
 with polyethylene-polypropylene glycol 2-
 aminopropyl me ether, 2,2'-(1,2-diazenediyl)bis[2-
 methylbutanenitrile]-initiated, minimum number
 average molecular weight (in amu), 5,816...........
 
                              * * * * * * *
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[FR Doc. 2013-22601 Filed 9-17-13; 8:45 am]
BILLING CODE 6560-50-P