[Federal Register Volume 78, Number 176 (Wednesday, September 11, 2013)]
[Rules and Regulations]
[Pages 55641-55644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22104]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0284; FRL-9397-6]


Polyurethane-Type Polymers; 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 polymers produced by the reaction of 
either 1,6-hexanediisocyanate; 2,4,4-trimethyl-1,6-hexanediisocyanate; 
5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyIcyclohexane 
(isophoronediisocyanate); 4,4'-methylene-bis-1,1'-
cyclohexanediisocyanate; 4,4'-methylene-bis-1,1' benzyldiisocyanate; or 
1,3-bis-(2-isocyanatopropan-2-yl)benzene with polyethyleneglycol and 
end-capped with one or a mixture of more than one of octanol, decanol, 
dodecanol, tetradecanol, hexadecanol, octadecanol, and octadec-9-enol 
or polyethyleneglycol ethers of octanol, decanol, dodecanol, 
tetradecanol, hexadecanol, octadecanol, and octadec-9-enol (also known 
as polyurethane-type polymers), when used as an inert ingredient in a 
pesticide chemical formulation. Syngenta Crop Protection, LLC 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 polyurethane-type polymers on food or feed 
commodities.

DATES: This regulation is effective September 11, 2013. Objections and 
requests for hearings must be received on or before November 12, 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-2013-0284, 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-2013-0284 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 12, 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-2013-0284, 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 43117) (FRL-9392-
9), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a, 
announcing the receipt of a pesticide petition (IN-10553) filed by 
Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419-
8300. The petition requested that 40 CFR 180.960 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of polyurethane-type polymers produced by the reaction of 
either 1,6-hexanediisocyanate; 2,4,4-trimethyl-1,6-hexanediisocyanate; 
5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyIcyclohexane 
(isophoronediisocyanate); 4,4'-methylene-bis-1,1'-
cyclohexanediisocyanate; 4,4'-methylene-bis-1,1' benzyldiisocyanate; or 
1,3-bis-(2-isocyanatopropan-2-yl)benzene with polyethylenglycol and 
end-capped with one or a mixture of more than one of octanol, decanol, 
dodecanol, tetradecanol, hexadecanol,

[[Page 55642]]

octadecanol, and octadec-9-enol or polyethyleneglycol ethers of 
octanol, decanol, dodecanol, tetradecanol, hexadecanol, octadecanol, 
and octadec-9-enol (CAS Reg. Nos. 1161844-26-3, 1161844-30-9, 1161844-
43-4, 1161844-51-4, 1161844-53-6, 693252-31-2, 162993-60-4, and 630102-
86-2). That notice included a summary of the petition prepared by the 
petitioner and solicited comments on the petitioner's request. One 
comment was received for a notice of filing 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 FFDCA 
section 408, 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 
the 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 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 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). Polyurethane-type polymers 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 Toxic Substances Control Act 
(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 21,000 to 26,000 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, polyurethane-type polymers 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 
polyurethane-type polymers.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that polyurethane-type polymers 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 polyurethane-type polymers is 21,000 to 26,000 
daltons. Generally, a polymer of this size would be poorly absorbed 
through the intact gastrointestinal tract or through intact human skin. 
Since polyurethane-type polymers 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 polyurethane-type polymers to share a common 
mechanism of toxicity with any other substances, and polyurethane-type 
polymers do not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has assumed that polyurethane-type polymers do 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.

[[Page 55643]]

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 database unless EPA concludes that 
a different margin of safety will be safe for infants and children. Due 
to the expected low toxicity of polyurethane-type polymers, 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 polyurethane-type polymers.

VIII. Other Considerations

A. Existing Exemptions From a Tolerance

    There are no existing exemptions from a tolerance for polyurethane-
type polymers.

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 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 polyurethane-type polymers.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of polyurethane-type 
polymers 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. One comment was received 
for a notice of filing 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 FFDCA section 
408, 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 the statute.

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 Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

[[Page 55644]]

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: August 29, 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 entry 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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                              * * * * * * *
Polymers produced by the reaction   1161844-26-3, 1161844-30-9, 1161844-
 of either 1,6-hexanediisocyanate;   43-4, 1161844-51-4, 1161844-53-6,
 2,4,4-trimethyl-1,6-                693252-31-2, 162993-60-4, 630102-86-
 hexanediisocyanate; 5-isocyanato-   2.
 1-(isocyanatomethyl)-
 fxsp0;1,3,3fxsp0;-
 trimethyIcyclohexane
 (isophoronediisocyanate); 4,4'-
 methylene-bis-1,1'-
 cyclohexanediisocyanate; 4,4'-
 methylene-bis-1,1'
 benzyldiisocyanate; or 1,3-bis-(2-
 isocyanatopropan-2-yl)benzene
 with polyethylene glycol and end-
 capped with one or a mixture of
 more than one of octanol,
 decanol, dodecanol, tetradecanol,
 hexadecanol, octadecanol, and
 octadec-9-enol or
 polyethyleneglycol ethers of
 octanol, decanol, dodecanol,
 tetradecanol, hexadecanol,
 octadecanol, and octadec-9-enol,
 minimum number average molecular
 weight (in amu), 20,000.
 
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[FR Doc. 2013-22104 Filed 9-10-13; 8:45 am]
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