81_FR_1530 81 FR 1522 - Methacrylate Type Copolymer, Compound With Aminomethyl Propanol; Tolerance Exemption

81 FR 1522 - Methacrylate Type Copolymer, Compound With Aminomethyl Propanol; Tolerance Exemption

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 8 (January 13, 2016)

Page Range1522-1526
FR Document2016-00533

This regulation establishes an exemption from the requirement of a tolerance for residues of 2-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C<INF>16</INF>-C<INF>18</INF>-alkyl ethers and vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-propanol when used as an inert ingredient in a pesticide chemical formulation. BASF Corporation 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-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C<INF>16</INF>-C<INF>18</INF>-alkyl ethers and vinylpyrrolidone, tert- Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1- propanol on food or feed commodities.

Federal Register, Volume 81 Issue 8 (Wednesday, January 13, 2016)
[Federal Register Volume 81, Number 8 (Wednesday, January 13, 2016)]
[Rules and Regulations]
[Pages 1522-1526]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-00533]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0718; FRL-9940-29]


Methacrylate Type Copolymer, Compound With Aminomethyl Propanol; 
Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of 2-propenoic acid, 2-methyl-, polymers 
with tert-Bu acrylate, Me methacrylate, polyethylene glycol 
methacrylate C16-C18-alkyl ethers and 
vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds 
with 2-amino-2-methyl-1-propanol when used as an inert ingredient in a 
pesticide chemical formulation. BASF Corporation 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

[[Page 1523]]

for residues of 2-propenoic acid, 2-methyl-, polymers with tert-Bu 
acrylate, Me methacrylate, polyethylene glycol methacrylate 
C16-C18-alkyl ethers and vinylpyrrolidone, tert-
Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-
propanol on food or feed commodities.

DATES: This regulation is effective January 13, 2016. Objections and 
requests for hearings must be received on or March 14, 2016, 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-2015-0718, 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), West William Jefferson Clinton 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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main 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://www.ecfr.gov/cgi-bin/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-2015-0718 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 
March 14, 2016. 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-2015-0718, 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 November 23, 2015 (80 FR 72941) (FRL-
9936-73), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-
10843) filed by BASF Corporation, 26 Davis Dr. Research Triangle Park, 
NC, 27709. The petition requested that 40 CFR 180.960 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of 2-propenoic acid, 2-methyl-, polymers with tert-Bu 
acrylate, Me methacrylate, polyethylene glycol methacrylate 
C16-C18-alkyl ethers and vinylpyrrolidone, tert-
Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-
propanol; CAS Reg. No. 1515872-09-9. That document included a summary 
of the petition prepared by the petitioner and solicited comments on 
the petitioner's request. EPA received one comment to the Notice of 
Filing.
    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

[[Page 1524]]

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). 2-Propenoic acid, 2-methyl-, polymers 
with tert-Bu acrylate, Me methacrylate, polyethylene glycol 
methacrylate C16-C18-alkyl ethers and 
vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds 
with 2-amino-2-methyl-1-propanol 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.
    Additionally, the polymer also meets as required the following 
exemption criteria specified in 40 CFR 723.250(e).
    7. The polymer does not contain, as an integral part of its 
composition, perfluoroalkyl moieties consisting of a CF3- or longer 
chain length.
    8. The polymer's number average MW of 2,600 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-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, 
Me methacrylate, polyethylene glycol methacrylate C16-
C18-alkyl ethers and vinylpyrrolidone, tert-Bu 2-
ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-
propanol 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-propenoic acid, 2-methyl-, polymers with tert-Bu 
acrylate, Me methacrylate, polyethylene glycol methacrylate 
C16-C18-alkyl ethers and vinylpyrrolidone, tert-
Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-
propanol.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that 2-propenoic acid, 2-methyl-, polymers 
with tert-Bu acrylate, Me methacrylate, polyethylene glycol 
methacrylate C16-C18-alkyl ethers and 
vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds 
with 2-amino-2-methyl-1-propanol 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-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me 
methacrylate, polyethylene glycol methacrylate C16-
C18-alkyl ethers and vinylpyrrolidone, tert-Bu 2-
ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-
propanol is 2600 daltons. Generally, a polymer of this size would be 
poorly absorbed through the intact gastrointestinal tract or through 
intact human skin. Since 2-propenoic acid, 2-methyl-, polymers with 
tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate 
C16-C18-alkyl ethers and vinylpyrrolidone, tert-
Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-
propanol 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-propenoic acid, 2-methyl-, polymers with tert-
Bu acrylate, Me methacrylate, polyethylene glycol methacrylate 
C16-C18-alkyl ethers and vinylpyrrolidone, tert-
Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-
propanol to share a common mechanism of toxicity with any other 
substances, and 2-propenoic acid, 2-methyl-, polymers with tert-Bu 
acrylate, Me methacrylate, polyethylene glycol methacrylate 
C16-C18-alkyl ethers and vinylpyrrolidone, tert-
Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-
propanol 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-propenoic acid, 2-methyl-, polymers with tert-Bu 
acrylate, Me methacrylate, polyethylene glycol methacrylate 
C16-C18-alkyl ethers and vinylpyrrolidone, tert-
Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-
propanol 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

[[Page 1525]]

safety will be safe for infants and children. Due to the expected low 
toxicity of 2-propenoic acid, 2-methyl-, polymers with tert-Bu 
acrylate, Me methacrylate, polyethylene glycol methacrylate 
C16-C18-alkyl ethers and vinylpyrrolidone, tert-
Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-
propanol, 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 2-propenoic acid, 2-methyl-, polymers 
with tert-Bu acrylate, Me methacrylate, polyethylene glycol 
methacrylate C16-C18-alkyl ethers and 
vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds 
with 2-amino-2-methyl-1-propanol.

VIII. Other Considerations

A. Existing Exemptions From a Tolerance

    Not available.

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 2-propenoic acid, 2-methyl-
, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol 
methacrylate C16-C18-alkyl ethers and 
vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds 
with 2-amino-2-methyl-1-propanol.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of 2-propenoic acid, 
2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, 
polyethylene glycol methacrylate C16-C18-alkyl 
ethers and vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, 
compounds with 2-amino-2-methyl-1-propanol from the requirement of a 
tolerance will be safe.

X. Statutory and Executive Order Reviews

    This action 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 types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action 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 action 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 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 action 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. 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).
    EPA received one comment to the Notice of Filing. The commenter 
stated that the application of these chemicals on food should not be 
allowed and are poisoning the environment. The Agency understands the 
commenter's concerns and recognizes that some individuals believe that 
pesticides should be banned on agricultural crops and that they are 
poisoning the environment. However, the existing legal framework 
provided by section 408 of the Federal Food, Drug and Cosmetic Act 
(FFDCA) states that tolerances may be set when persons seeking such 
tolerances or exemptions have demonstrated that the pesticide meets the 
safety standard imposed by that statute. The citizen's comment appears 
to be directed at the underlying statute and not EPA's implementation 
of it; the citizen has made no contention that EPA has acted in 
violation of the statutory framework.

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).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides

[[Page 1526]]

and pests, Reporting and recordkeeping requirements.

    Dated: January 4, 2016.
G. Jeffery Herndon,
Acting 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.  180.960  Polymers; exemptions from the requirement of a 
tolerance.

* * * * *

------------------------------------------------------------------------
                       Polymer                              CAS No.
------------------------------------------------------------------------
 
                              * * * * * * *
2-propenoic acid, 2-methyl-, polymers with tert-Bu         1515872-09-9
 acrylate, Me methacrylate, polyethylene glycol
 methacrylate C16-C18-alkyl ethers and
 vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-
 initiated, compounds with 2-amino-2-methyl-1-
 propanol, minimum number average molecular weight
 (in amu), 2,600.....................................
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2016-00533 Filed 1-12-16; 8:45 am]
 BILLING CODE 6560-50-P



                                                  1522                 Federal Register / Vol. 81, No. 8 / Wednesday, January 13, 2016 / Rules and Regulations

                                                                                                  CALIFORNIA—2006 24-HOUR PM2.5 NAAQS—Continued
                                                                                                                              [Primary and secondary]

                                                                                                                                              Designation a                                               Classification
                                                                        Designated area
                                                                                                                              Date 1                                 Type                            Date 2                     Type

                                                      That portion of Riverside County which lies               .......................................   Nonattainment ..............   02/12/16 .......................   Serious.
                                                        to the west of a line described as follows:
                                                        Beginning at the Riverside-San Diego
                                                        County boundary and running north along
                                                        the range line common to Range 4 East
                                                        and Range 3 East, San Bernardino Base
                                                        and Meridian; then east along the Town-
                                                        ship line common to Township 8 South
                                                        and Township 7 South; then north along
                                                        the range line common to Range 5 East
                                                        and Range 4 East; then west along the
                                                        Township line common to Township 6
                                                        South and Township 7 South to the south-
                                                        west corner of Section 34, Township 6
                                                        South, Range 4 East; then north along the
                                                        west boundaries of Sections 34, 27, 22,
                                                        15, 10, and 3, Township 6 South, Range
                                                        4 East; then west along the Township line
                                                        common to Township 5 South and Town-
                                                        ship 6 South; then north along the range
                                                        line common to Range 4 East and Range
                                                        3 East; then west along the south bound-
                                                        aries of Sections 13, 14, 15, 16, 17, and
                                                        18, Township 5 South, Range 3 East;
                                                        then north along the range line common
                                                        to Range 2 East and Range 3 East; to the
                                                        Riverside-San Bernardino County Line
                                                        (excluding the lands of the Santa Rosa
                                                        Band of Cahuilla Mission Indians).
                                                      That part of the lands of the Santa Rosa                  .......................................   Nonattainment ..............   02/12/16 .......................   Serious.
                                                        Band of Cahuilla Mission Indians which is
                                                        excluded from the Riverside County (part)
                                                        nonattainment area.
                                                  San Bernardino County (part) ..............................   .......................................   Nonattainment ..............   02/12/16 .......................   Serious.
                                                      That portion of San Bernardino County                     .......................................   Nonattainment ..............   02/12/16 .......................   Serious.
                                                        which lies south and west of a line de-
                                                        scribed as follows: Beginning at the San
                                                        Bernardino-Riverside County boundary
                                                        and running north along the range line
                                                        common to Range 3 East and Range 2
                                                        East, San Bernardino Base and Meridian;
                                                        then west along the Township line com-
                                                        mon to Township 3 North and Township 2
                                                        North to the San Bernardino-Los Angeles
                                                        County boundary.
                                                      a Includes Indian Country located in each county or area, except as otherwise specified.
                                                      1 This date is 30 days after November 13, 2009, unless otherwise noted.
                                                      2 This date is July 2, 2014, unless otherwise noted.




                                                  *       *        *       *      *                           ENVIRONMENTAL PROTECTION                                           tolerance for residues of 2-propenoic
                                                  [FR Doc. 2015–33304 Filed 1–12–16; 8:45 am]                 AGENCY                                                             acid, 2-methyl-, polymers with tert-Bu
                                                  BILLING CODE 6560–50–P                                                                                                         acrylate, Me methacrylate, polyethylene
                                                                                                              40 CFR Part 180                                                    glycol methacrylate C16-C18-alkyl ethers
                                                                                                                                                                                 and vinylpyrrolidone, tert-Bu 2-
                                                                                                              [EPA–HQ–OPP–2015–0718; FRL–9940–29]                                ethylhexaneperoxoate-initiated,
                                                                                                                                                                                 compounds with 2-amino-2-methyl-1-
                                                                                                              Methacrylate Type Copolymer,                                       propanol when used as an inert
                                                                                                              Compound With Aminomethyl
asabaliauskas on DSK5VPTVN1PROD with RULES




                                                                                                                                                                                 ingredient in a pesticide chemical
                                                                                                              Propanol; Tolerance Exemption                                      formulation. BASF Corporation
                                                                                                              AGENCY:  Environmental Protection                                  submitted a petition to EPA under the
                                                                                                              Agency (EPA).                                                      Federal Food, Drug, and Cosmetic Act
                                                                                                              ACTION: Final rule.                                                (FFDCA), requesting an exemption from
                                                                                                                                                                                 the requirement of a tolerance. This
                                                                                                              SUMMARY: This regulation establishes an                            regulation eliminates the need to
                                                                                                              exemption from the requirement of a                                establish a maximum permissible level


                                             VerDate Sep<11>2014       16:56 Jan 12, 2016   Jkt 238001   PO 00000   Frm 00042       Fmt 4700        Sfmt 4700   E:\FR\FM\13JAR1.SGM      13JAR1


                                                                   Federal Register / Vol. 81, No. 8 / Wednesday, January 13, 2016 / Rules and Regulations                                          1523

                                                  for residues of 2-propenoic acid, 2-                    B. How can I get electronic access to                  II. Background and Statutory Findings
                                                  methyl-, polymers with tert-Bu acrylate,                other related information?                                In the Federal Register of November
                                                  Me methacrylate, polyethylene glycol                                                                           23, 2015 (80 FR 72941) (FRL–9936–73),
                                                  methacrylate C16-C18-alkyl ethers and                     You may access a frequently updated
                                                                                                          electronic version of 40 CFR part 180                  EPA issued a document pursuant to
                                                  vinylpyrrolidone, tert-Bu 2-                                                                                   FFDCA section 408, 21 U.S.C. 346a,
                                                  ethylhexaneperoxoate-initiated,                         through the Government Printing
                                                                                                          Office’s e-CFR site at http://                         announcing the receipt of a pesticide
                                                  compounds with 2-amino-2-methyl-1-                                                                             petition (PP IN–10843) filed by BASF
                                                  propanol on food or feed commodities.                   www.ecfr.gov/cgi-bin/text-
                                                                                                          idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                   Corporation, 26 Davis Dr. Research
                                                  DATES: This regulation is effective                     40tab_02.tpl.                                          Triangle Park, NC, 27709. The petition
                                                  January 13, 2016. Objections and                                                                               requested that 40 CFR 180.960 be
                                                  requests for hearings must be received                  C. Can I file an objection or hearing                  amended by establishing an exemption
                                                  on or March 14, 2016, and must be filed                 request?                                               from the requirement of a tolerance
                                                  in accordance with the instructions                                                                            for residues of 2-propenoic acid,
                                                                                                            Under FFDCA section 408(g), 21
                                                  provided in 40 CFR part 178 (see also                                                                          2-methyl-, polymers with tert-Bu
                                                                                                          U.S.C. 346a, any person may file an
                                                  Unit I.C. of the SUPPLEMENTARY                                                                                 acrylate, Me methacrylate, polyethylene
                                                                                                          objection to any aspect of this regulation
                                                  INFORMATION).                                                                                                  glycol methacrylate C16-C18-alkyl ethers
                                                                                                          and may also request a hearing on those
                                                  ADDRESSES:    The docket for this action,               objections. You must file your objection               and vinylpyrrolidone, tert-Bu 2-
                                                  identified by docket identification (ID)                or request a hearing on this regulation                ethylhexaneperoxoate-initiated,
                                                  number EPA–HQ–OPP–2015–0718, is                         in accordance with the instructions                    compounds with 2-amino-2-methyl-1-
                                                  available at http://www.regulations.gov                 provided in 40 CFR part 178. To ensure                 propanol; CAS Reg. No. 1515872–09–9.
                                                  or at the Office of Pesticide Programs                  proper receipt by EPA, you must                        That document included a summary of
                                                  Regulatory Public Docket (OPP Docket)                   identify docket ID number EPA–HQ–                      the petition prepared by the petitioner
                                                  in the Environmental Protection Agency                  OPP–2015–0718 in the subject line on                   and solicited comments on the
                                                  Docket Center (EPA/DC), West William                    the first page of your submission. All                 petitioner’s request. EPA received one
                                                  Jefferson Clinton Bldg., Rm. 3334, 1301                 objections and requests for a hearing                  comment to the Notice of Filing.
                                                  Constitution Ave. NW., Washington, DC                                                                             Section 408(c)(2)(A)(i) of FFDCA
                                                                                                          must be in writing, and must be
                                                  20460–0001. The Public Reading Room                                                                            allows EPA to establish an exemption
                                                                                                          received by the Hearing Clerk on or
                                                  is open from 8:30 a.m. to 4:30 p.m.,                                                                           from the requirement for a tolerance (the
                                                                                                          before March 14, 2016. Addresses for
                                                  Monday through Friday, excluding legal                                                                         legal limit for a pesticide chemical
                                                                                                          mail and hand delivery of objections
                                                  holidays. The telephone number for the                                                                         residue in or on a food) only if EPA
                                                                                                          and hearing requests are provided in 40
                                                  Public Reading Room is (202) 566–1744,                                                                         determines that the exemption is ‘‘safe.’’
                                                                                                          CFR 178.25(b).
                                                  and the telephone number for the OPP                                                                           Section 408(c)(2)(A)(ii) of FFDCA
                                                                                                            In addition to filing an objection or                defines ‘‘safe’’ to mean that ‘‘there is a
                                                  Docket is (703) 305–5805. Please review                 hearing request with the Hearing Clerk
                                                  the visitor instructions and additional                                                                        reasonable certainty that no harm will
                                                                                                          as described in 40 CFR part 178, please                result from aggregate exposure to the
                                                  information about the docket available                  submit a copy of the filing (excluding
                                                  at http://www.epa.gov/dockets.                                                                                 pesticide chemical residue, including
                                                                                                          any Confidential Business Information                  all anticipated dietary exposures and all
                                                  FOR FURTHER INFORMATION CONTACT:                        (CBI)) for inclusion in the public docket.             other exposures for which there is
                                                  Susan Lewis, Registration Division                      Information not marked confidential                    reliable information.’’ This includes
                                                  (7505P), Office of Pesticide Programs,                  pursuant to 40 CFR part 2 may be                       exposure through drinking water and
                                                  Environmental Protection Agency, 1200                   disclosed publicly by EPA without prior                use in residential settings, but does not
                                                  Pennsylvania Ave. NW., Washington,                      notice. Submit the non-CBI copy of your                include occupational exposure. Section
                                                  DC 20460–0001; main telephone                           objection or hearing request, identified               408(b)(2)(C) of FFDCA requires EPA to
                                                  number: (703) 305–7090; email address:                  by docket ID number EPA–HQ–OPP–                        give special consideration to exposure
                                                  RDFRNotices@epa.gov.                                    2015–0718, by one of the following                     of infants and children to the pesticide
                                                  SUPPLEMENTARY INFORMATION:                              methods.                                               chemical residue in establishing an
                                                                                                            • Federal eRulemaking Portal: http://                exemption from the requirement of a
                                                  I. General Information                                  www.regulations.gov. Follow the online                 tolerance and to ‘‘ensure that there is a
                                                  A. Does this action apply to me?                        instructions for submitting comments.                  reasonable certainty that no harm will
                                                                                                          Do not submit electronically any                       result to infants and children from
                                                     You may be potentially affected by                   information you consider to be CBI or                  aggregate exposure to the pesticide
                                                  this action if you are an agricultural                  other information whose disclosure is                  chemical residue . . .’’ and specifies
                                                  producer, food manufacturer, or                         restricted by statute.                                 factors EPA is to consider in
                                                  pesticide manufacturer. The following
                                                  list of North American Industrial                         • Mail: OPP Docket, Environmental                    establishing an exemption.
                                                  Classification System (NAICS) codes is                  Protection Agency Docket Center (EPA/                  III. Risk Assessment and Statutory
                                                  not intended to be exhaustive, but rather               DC), (28221T), 1200 Pennsylvania Ave.                  Findings
                                                  provides a guide to help readers                        NW., Washington, DC 20460–0001.
                                                                                                                                                                    EPA establishes exemptions from the
                                                  determine whether this document                           • Hand Delivery: To make special                     requirement of a tolerance only in those
                                                  applies to them. Potentially affected                   arrangements for hand delivery or                      cases where it can be shown that the
                                                                                                          delivery of boxed information, please
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                                                  entities may include:                                                                                          risks from aggregate exposure to
                                                     • Crop production (NAICS code 111).                  follow the instructions at http://                     pesticide chemical residues under
                                                     • Animal production (NAICS code                      www.epa.gov/dockets/contacts.html.                     reasonably foreseeable circumstances
                                                  112).                                                   Additional instructions on commenting                  will pose no appreciable risks to human
                                                     • Food manufacturing (NAICS code                     or visiting the docket, along with more                health. In order to determine the risks
                                                  311).                                                   information about dockets generally, is                from aggregate exposure to pesticide
                                                     • Pesticide manufacturing (NAICS                     available at http://www.epa.gov/                       inert ingredients, the Agency considers
                                                  code 32532).                                            dockets.                                               the toxicity of the inert in conjunction


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                                                  1524             Federal Register / Vol. 81, No. 8 / Wednesday, January 13, 2016 / Rules and Regulations

                                                  with possible exposure to residues of                   average molecular weight (MW) greater                  vinylpyrrolidone, tert-Bu 2-
                                                  the inert ingredient through food,                      than or equal to 10,000 daltons.                       ethylhexaneperoxoate-initiated,
                                                  drinking water, and through other                          Additionally, the polymer also meets                compounds with 2-amino-2-methyl-1-
                                                  exposures that occur as a result of                     as required the following exemption                    propanol conform to the criteria that
                                                  pesticide use in residential settings. If               criteria specified in 40 CFR 723.250(e).               identify a low-risk polymer, there are no
                                                  EPA is able to determine that a finite                     7. The polymer does not contain, as                 concerns for risks associated with any
                                                  tolerance is not necessary to ensure that               an integral part of its composition,                   potential exposure scenarios that are
                                                  there is a reasonable certainty that no                 perfluoroalkyl moieties consisting of a                reasonably foreseeable. The Agency has
                                                  harm will result from aggregate                         CF3- or longer chain length.                           determined that a tolerance is not
                                                  exposure to the inert ingredient, an                       8. The polymer’s number average MW                  necessary to protect the public health.
                                                  exemption from the requirement of a                     of 2,600 is greater than 1,000 and less
                                                                                                          than 10,000 daltons. The polymer                       V. Cumulative Effects From Substances
                                                  tolerance may be established.                                                                                  With a Common Mechanism of Toxicity
                                                    Consistent with FFDCA section                         contains less than 10% oligomeric
                                                  408(b)(2)(D), EPA has reviewed the                      material below MW 500 and less than                       Section 408(b)(2)(D)(v) of FFDCA
                                                  available scientific data and other                     25% oligomeric material below MW                       requires that, when considering whether
                                                  relevant information in support of this                 1,000, and the polymer does not contain                to establish, modify, or revoke a
                                                  action and considered its validity,                     any reactive functional groups.                        tolerance, the Agency consider
                                                                                                             Thus, 2-propenoic acid, 2-methyl-,                  ‘‘available information’’ concerning the
                                                  completeness and reliability and the
                                                                                                          polymers with tert-Bu acrylate, Me                     cumulative effects of a particular
                                                  relationship of this information to
                                                                                                          methacrylate, polyethylene glycol                      pesticide’s residues and ‘‘other
                                                  human risk. EPA has also considered
                                                                                                          methacrylate C16-C18-alkyl ethers and                  substances that have a common
                                                  available information concerning the
                                                                                                          vinylpyrrolidone, tert-Bu 2-                           mechanism of toxicity.’’
                                                  variability of the sensitivities of major
                                                                                                          ethylhexaneperoxoate-initiated,                           EPA has not found 2-propenoic acid,
                                                  identifiable subgroups of consumers,
                                                                                                          compounds with 2-amino-2-methyl-1-                     2-methyl-, polymers with tert-Bu
                                                  including infants and children. In the
                                                                                                          propanol meets the criteria for a                      acrylate, Me methacrylate, polyethylene
                                                  case of certain chemical substances that                polymer to be considered low risk under                glycol methacrylate C16-C18-alkyl ethers
                                                  are defined as polymers, the Agency has                 40 CFR 723.250. Based on its                           and vinylpyrrolidone, tert-Bu 2-
                                                  established a set of criteria to identify               conformance to the criteria in this unit,              ethylhexaneperoxoate-initiated,
                                                  categories of polymers expected to                      no mammalian toxicity is anticipated                   compounds with 2-amino-2-methyl-1-
                                                  present minimal or no risk. The                         from dietary, inhalation, or dermal                    propanol to share a common mechanism
                                                  definition of a polymer is given in 40                  exposure to 2-propenoic acid, 2-methyl-                of toxicity with any other substances,
                                                  CFR 723.250(b) and the exclusion                        , polymers with tert-Bu acrylate, Me                   and 2-propenoic acid, 2-methyl-,
                                                  criteria for identifying these low-risk                 methacrylate, polyethylene glycol                      polymers with tert-Bu acrylate, Me
                                                  polymers are described in 40 CFR                        methacrylate C16-C18-alkyl ethers and                  methacrylate, polyethylene glycol
                                                  723.250(d). 2-Propenoic acid,                           vinylpyrrolidone, tert-Bu 2-                           methacrylate C16-C18-alkyl ethers and
                                                  2-methyl-, polymers with tert-Bu                        ethylhexaneperoxoate-initiated,                        vinylpyrrolidone, tert-Bu 2-
                                                  acrylate, Me methacrylate, polyethylene                 compounds with 2-amino-2-methyl-1-                     ethylhexaneperoxoate-initiated,
                                                  glycol methacrylate C16-C18-alkyl ethers                propanol.                                              compounds with 2-amino-2-methyl-1-
                                                  and vinylpyrrolidone, tert-Bu 2-                                                                               propanol does not appear to produce a
                                                  ethylhexaneperoxoate-initiated,                         IV. Aggregate Exposures
                                                                                                                                                                 toxic metabolite produced by other
                                                  compounds with 2-amino-2-methyl-1-                         For the purposes of assessing                       substances. For the purposes of this
                                                  propanol conforms to the definition of                  potential exposure under this                          tolerance action, therefore, EPA has
                                                  a polymer given in 40 CFR 723.250(b)                    exemption, EPA considered that 2-                      assumed that 2-propenoic acid, 2-
                                                  and meets the following criteria that are               propenoic acid, 2-methyl-, polymers                    methyl-, polymers with tert-Bu acrylate,
                                                  used to identify low-risk polymers.                     with tert-Bu acrylate, Me methacrylate,                Me methacrylate, polyethylene glycol
                                                    1. The polymer is not a cationic                      polyethylene glycol methacrylate C16-                  methacrylate C16-C18-alkyl ethers and
                                                  polymer nor is it reasonably anticipated                C18-alkyl ethers and vinylpyrrolidone,                 vinylpyrrolidone, tert-Bu 2-
                                                  to become a cationic polymer in a                       tert-Bu 2-ethylhexaneperoxoate-                        ethylhexaneperoxoate-initiated,
                                                  natural aquatic environment.                            initiated, compounds with 2-amino-2-                   compounds with 2-amino-2-methyl-1-
                                                    2. The polymer does contain as an                     methyl-1-propanol could be present in                  propanol does not have a common
                                                  integral part of its composition the                    all raw and processed agricultural                     mechanism of toxicity with other
                                                  atomic elements carbon, hydrogen, and                   commodities and drinking water, and                    substances. For information regarding
                                                  oxygen.                                                 that non-occupational non-dietary                      EPA’s efforts to determine which
                                                    3. The polymer does not contain as an                 exposure was possible. The number                      chemicals have a common mechanism
                                                  integral part of its composition, except                average MW of 2-propenoic acid, 2-                     of toxicity and to evaluate the
                                                  as impurities, any element other than                   methyl-, polymers with tert-Bu acrylate,               cumulative effects of such chemicals,
                                                  those listed in 40 CFR 723.250(d)(2)(ii).               Me methacrylate, polyethylene glycol                   see EPA’s Web site at http://
                                                    4. The polymer is neither designed                    methacrylate C16-C18-alkyl ethers and                  www.epa.gov/pesticides/cumulative.
                                                  nor can it be reasonably anticipated to                 vinylpyrrolidone, tert-Bu 2-
                                                  substantially degrade, decompose, or                    ethylhexaneperoxoate-initiated,                        VI. Additional Safety Factor for the
                                                  depolymerize.                                           compounds with 2-amino-2-methyl-1-                     Protection of Infants and Children
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                                                    5. The polymer is manufactured or                     propanol is 2600 daltons. Generally, a                   Section 408(b)(2)(C) of FFDCA
                                                  imported from monomers and/or                           polymer of this size would be poorly                   provides that EPA shall apply an
                                                  reactants that are already included on                  absorbed through the intact                            additional tenfold margin of safety for
                                                  the TSCA Chemical Substance                             gastrointestinal tract or through intact               infants and children in the case of
                                                  Inventory or manufactured under an                      human skin. Since 2-propenoic acid, 2-                 threshold effects to account for prenatal
                                                  applicable TSCA section 5 exemption.                    methyl-, polymers with tert-Bu acrylate,               and postnatal toxicity and the
                                                    6. The polymer is not a water                         Me methacrylate, polyethylene glycol                   completeness of the data base unless
                                                  absorbing polymer with a number                         methacrylate C16-C18-alkyl ethers and                  EPA concludes that a different margin of


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                                                                   Federal Register / Vol. 81, No. 8 / Wednesday, January 13, 2016 / Rules and Regulations                                          1525

                                                  safety will be safe for infants and                     methacrylate, polyethylene glycol                      have a substantial direct effect on States
                                                  children. Due to the expected low                       methacrylate C16-C18-alkyl ethers and                  or tribal governments, on the
                                                  toxicity of 2-propenoic acid, 2-methyl-,                vinylpyrrolidone, tert-Bu 2-                           relationship between the national
                                                  polymers with tert-Bu acrylate, Me                      ethylhexaneperoxoate-initiated,                        government and the States or tribal
                                                  methacrylate, polyethylene glycol                       compounds with 2-amino-2-methyl-1-                     governments, or on the distribution of
                                                  methacrylate C16-C18-alkyl ethers and                   propanol.                                              power and responsibilities among the
                                                  vinylpyrrolidone, tert-Bu 2-                                                                                   various levels of government or between
                                                                                                          IX. Conclusion
                                                  ethylhexaneperoxoate-initiated,                                                                                the Federal Government and Indian
                                                  compounds with 2-amino-2-methyl-1-                        Accordingly, EPA finds that                          tribes. Thus, the Agency has determined
                                                  propanol, EPA has not used a safety                     exempting residues of 2-propenoic acid,                that Executive Order 13132, entitled
                                                  factor analysis to assess the risk. For the             2-methyl-, polymers with tert-Bu                       ‘‘Federalism’’ (64 FR 43255, August 10,
                                                  same reasons the additional tenfold                     acrylate, Me methacrylate, polyethylene                1999) and Executive Order 13175,
                                                  safety factor is unnecessary.                           glycol methacrylate C16-C18-alkyl ethers               entitled ‘‘Consultation and Coordination
                                                                                                          and vinylpyrrolidone, tert-Bu 2-                       with Indian Tribal Governments’’ (65 FR
                                                  VII. Determination of Safety                            ethylhexaneperoxoate-initiated,                        67249, November 9, 2000) do not apply
                                                    Based on the conformance to the                       compounds with 2-amino-2-methyl-1-                     to this action. In addition, this action
                                                  criteria used to identify a low-risk                    propanol from the requirement of a                     does not impose any enforceable duty or
                                                  polymer, EPA concludes that there is a                  tolerance will be safe.                                contain any unfunded mandate as
                                                  reasonable certainty of no harm to the                                                                         described under Title II of the Unfunded
                                                                                                          X. Statutory and Executive Order
                                                  U.S. population, including infants and                                                                         Mandates Reform Act (UMRA) (2 U.S.C.
                                                                                                          Reviews
                                                  children, from aggregate exposure to                                                                           1501 et seq.).
                                                  residues of 2-propenoic acid,                              This action establishes a tolerance
                                                                                                          under FFDCA section 408(d) in                             This action does not involve any
                                                  2-methyl-, polymers with tert-Bu
                                                                                                          response to a petition submitted to the                technical standards that would require
                                                  acrylate, Me methacrylate, polyethylene
                                                                                                          Agency. The Office of Management and                   Agency consideration of voluntary
                                                  glycol methacrylate C16-C18-alkyl ethers
                                                                                                          Budget (OMB) has exempted these types                  consensus standards pursuant to section
                                                  and vinylpyrrolidone, tert-Bu 2-
                                                                                                          of actions from review under Executive                 12(d) of the National Technology
                                                  ethylhexaneperoxoate-initiated,
                                                                                                          Order 12866, entitled ‘‘Regulatory                     Transfer and Advancement Act
                                                  compounds with 2-amino-2-methyl-1-
                                                                                                          Planning and Review’’ (58 FR 51735,                    (NTTAA) (15 U.S.C. 272 note).
                                                  propanol.
                                                                                                          October 4, 1993). Because this action                     EPA received one comment to the
                                                  VIII. Other Considerations                              has been exempted from review under                    Notice of Filing. The commenter stated
                                                  A. Existing Exemptions From a                           Executive Order 12866, this action is                  that the application of these chemicals
                                                  Tolerance                                               not subject to Executive Order 13211,                  on food should not be allowed and are
                                                                                                          entitled ‘‘Actions Concerning                          poisoning the environment. The Agency
                                                    Not available.                                                                                               understands the commenter’s concerns
                                                                                                          Regulations That Significantly Affect
                                                  B. Analytical Enforcement Methodology                   Energy Supply, Distribution, or Use’’ (66              and recognizes that some individuals
                                                     An analytical method is not required                 FR 28355, May 22, 2001) or Executive                   believe that pesticides should be banned
                                                  for enforcement purposes since the                      Order 13045, entitled ‘‘Protection of                  on agricultural crops and that they are
                                                  Agency is establishing an exemption                     Children from Environmental Health                     poisoning the environment. However,
                                                  from the requirement of a tolerance                     Risks and Safety Risks’’ (62 FR 19885,                 the existing legal framework provided
                                                  without any numerical limitation.                       April 23, 1997). This action does not                  by section 408 of the Federal Food, Drug
                                                                                                          contain any information collections                    and Cosmetic Act (FFDCA) states that
                                                  C. International Residue Limits                         subject to OMB approval under the                      tolerances may be set when persons
                                                     In making its tolerance decisions, EPA               Paperwork Reduction Act (PRA) (44                      seeking such tolerances or exemptions
                                                  seeks to harmonize U.S. tolerances with                 U.S.C. 3501 et seq.), nor does it require              have demonstrated that the pesticide
                                                  international standards whenever                        any special considerations under                       meets the safety standard imposed by
                                                  possible, consistent with U.S. food                     Executive Order 12898, entitled                        that statute. The citizen’s comment
                                                  safety standards and agricultural                       ‘‘Federal Actions to Address                           appears to be directed at the underlying
                                                  practices. EPA considers the                            Environmental Justice in Minority                      statute and not EPA’s implementation of
                                                  international maximum residue limits                    Populations and Low-Income                             it; the citizen has made no contention
                                                  (MRLs) established by the Codex                         Populations’’ (59 FR 7629, February 16,                that EPA has acted in violation of the
                                                  Alimentarius Commission (Codex), as                     1994).                                                 statutory framework.
                                                  required by FFDCA section 408(b)(4).                       Since tolerances and exemptions that                XI. Congressional Review Act
                                                  The Codex Alimentarius is a joint                       are established on the basis of a petition
                                                  United Nations Food and Agriculture                     under FFDCA section 408(d), such as                      Pursuant to the Congressional Review
                                                  Organization/World Health                               the tolerance in this final rule, do not               Act (5 U.S.C. 801 et seq.), EPA will
                                                  Organization food standards program,                    require the issuance of a proposed rule,               submit a report containing this rule and
                                                  and it is recognized as an international                the requirements of the Regulatory                     other required information to the U.S.
                                                  food safety standards-setting                           Flexibility Act (RFA) (5 U.S.C. 601 et                 Senate, the U.S. House of
                                                  organization in trade agreements to                     seq.), do not apply.                                   Representatives, and the Comptroller
                                                  which the United States is a party. EPA                    This action directly regulates growers,             General of the United States prior to
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                                                  may establish a tolerance that is                       food processors, food handlers, and food               publication of the rule in the Federal
                                                  different from a Codex MRL; however,                    retailers, not States or tribes, nor does              Register. This action is not a ‘‘major
                                                  FFDCA section 408(b)(4) requires that                   this action alter the relationships or                 rule’’ as defined by 5 U.S.C. 804(2).
                                                  EPA explain the reasons for departing                   distribution of power and
                                                                                                                                                                 List of Subjects in 40 CFR Part 180
                                                  from the Codex level.                                   responsibilities established by Congress
                                                     The Codex has not established a MRL                  in the preemption provisions of FFDCA                   Environmental protection,
                                                  for 2-propenoic acid, 2-methyl-,                        section 408(n)(4). As such, the Agency                 Administrative practice and procedure,
                                                  polymers with tert-Bu acrylate, Me                      has determined that this action will not               Agricultural commodities, Pesticides


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                                                  1526               Federal Register / Vol. 81, No. 8 / Wednesday, January 13, 2016 / Rules and Regulations

                                                  and pests, Reporting and recordkeeping                         PART 180—[AMENDED]                                             § 180.960 Polymers; exemptions from the
                                                  requirements.                                                                                                                 requirement of a tolerance.
                                                     Dated: January 4, 2016.                                     ■ 1. The authority citation for part 180                       *       *        *       *       *
                                                                                                                 continues to read as follows:
                                                  G. Jeffery Herndon,
                                                  Acting Director, Registration Division, Office                     Authority: 21 U.S.C. 321(q), 346a and 371.
                                                  of Pesticide Programs.                                         ■ 2. In § 180.960, alphabetically add the
                                                    Therefore, 40 CFR chapter I is                               following polymer to the table to read as
                                                  amended as follows:                                            follows:

                                                                                                                             Polymer                                                                                  CAS No.


                                                           *                    *                    *                        *                                 *                                *                       *
                                                  2-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16-C18-alkyl
                                                    ethers and vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-propanol, min-
                                                    imum number average molecular weight (in amu), 2,600 .........................................................................................................   1515872–09–9

                                                              *                          *                           *                          *                        *                           *                   *



                                                  [FR Doc. 2016–00533 Filed 1–12–16; 8:45 am]                    information about the docket available                         C. How can I file an objection or hearing
                                                  BILLING CODE 6560–50–P                                         at http://www.epa.gov/dockets.                                 request?
                                                                                                                 FOR FURTHER INFORMATION CONTACT:                                 Under FFDCA section 408(g), 21
                                                                                                                 Susan Lewis, Registration Division                             U.S.C. 346a, any person may file an
                                                  ENVIRONMENTAL PROTECTION
                                                                                                                 (7505P), Office of Pesticide Programs,                         objection to any aspect of this regulation
                                                  AGENCY
                                                                                                                 Environmental Protection Agency, 1200                          and may also request a hearing on those
                                                  40 CFR Part 180                                                Pennsylvania Ave. NW., Washington,                             objections. You must file your objection
                                                                                                                 DC 20460–0001; main telephone                                  or request a hearing on this regulation
                                                  [EPA–HQ–OPP–2014–0680; FRL–9940–90]                            number: (703) 305–7090; email address:                         in accordance with the instructions
                                                                                                                 RDFRNotices@epa.gov.                                           provided in 40 CFR part 178. To ensure
                                                  Propyzamide; Pesticide Tolerances
                                                                                                                 SUPPLEMENTARY INFORMATION:
                                                                                                                                                                                proper receipt by EPA, you must
                                                  AGENCY:  Environmental Protection                                                                                             identify the request by the docket ID
                                                  Agency (EPA).                                                  I. General Information                                         number EPA–HQ–OPP–2014–0680 in
                                                  ACTION: Final rule.                                            A. Does this action apply to me?                               the subject line on the first page of your
                                                                                                                                                                                submission. All objections and requests
                                                  SUMMARY:   This regulation establishes a                          You may be potentially affected by                          for a hearing must be in writing, and
                                                  tolerance for residues of propyzamide,                         this action if you are an agricultural                         must be received by the Hearing Clerk
                                                  also known as pronamide, in or on leaf                         producer, food manufacturer, or                                on or before March 14, 2016. Addresses
                                                  lettuce. Dow AgroSciences, LLC                                 pesticide manufacturer. The following                          for mail and hand delivery of objections
                                                  requested this tolerance under the                             list of North American Industrial                              and hearing requests are provided in 40
                                                  Federal Food, Drug, and Cosmetic Act                           Classification System (NAICS) codes is                         CFR 178.25(b).
                                                  (FFDCA).                                                       not intended to be exhaustive, but rather                        In addition to filing an objection or
                                                  DATES: This regulation is effective                            provides a guide to help readers                               hearing request with the Hearing Clerk
                                                  January 13, 2016. Objections and                               determine whether this document                                as described in 40 CFR part 178, please
                                                  requests for hearings must be received                         applies to them. Potentially affected                          submit a copy of the filing (excluding
                                                  on or before March 14, 2016, and must                          entities may include:                                          any Confidential Business Information
                                                  be filed in accordance with the                                   • Crop production (NAICS code 111).                         (CBI)) for inclusion in the public docket.
                                                  instructions provided in 40 CFR part                                                                                          Information not marked confidential
                                                                                                                    • Animal production (NAICS code
                                                  178 (see also Unit I.C. of the                                                                                                pursuant to 40 CFR part 2 may be
                                                                                                                 112).
                                                  SUPPLEMENTARY INFORMATION).                                                                                                   disclosed publicly by EPA without prior
                                                                                                                    • Food manufacturing (NAICS code                            notice. Submit the non-CBI copy of your
                                                  ADDRESSES: The docket for this action,
                                                  identified by docket identification (ID)                       311).                                                          objection or hearing request, identified
                                                  number EPA–HQ–OPP–2014–0680, is                                   • Pesticide manufacturing (NAICS                            by docket ID number EPA–HQ–OPP–
                                                  available at http://www.regulations.gov                        code 32532).                                                   2014–0680, by one of the following
                                                  or at the Office of Pesticide Programs                         B. How can I get electronic access to                          methods:
                                                  Regulatory Public Docket (OPP Docket)                          other related information?                                       • Federal eRulemaking Portal: http://
                                                  in the Environmental Protection Agency                                                                                        www.regulations.gov. Follow the online
                                                  Docket Center (EPA/DC), West William                              You may access a frequently updated                         instructions for submitting comments.
                                                  Jefferson Clinton Bldg., Rm. 3334, 1301                        electronic version of EPA’s tolerance                          Do not submit electronically any
                                                  Constitution Ave. NW., Washington, DC                          regulations at 40 CFR part 180 through                         information you consider to be CBI or
asabaliauskas on DSK5VPTVN1PROD with RULES




                                                  20460–0001. The Public Reading Room                            the Government Printing Office’s e-CFR                         other information whose disclosure is
                                                  is open from 8:30 a.m. to 4:30 p.m.,                           site at http://www.ecfr.gov/cgi-bin/text-                      restricted by statute.
                                                  Monday through Friday, excluding legal                         idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                             • Mail: OPP Docket, Environmental
                                                  holidays. The telephone number for the                         40tab_02.tpl. To access the OCSPP test                         Protection Agency Docket Center (EPA/
                                                  Public Reading Room is (202) 566–1744,                         guidelines referenced in this document                         DC), (28221T), 1200 Pennsylvania Ave.
                                                  and the telephone number for the OPP                           electronically, please go to http://                           NW., Washington, DC 20460–0001.
                                                  Docket is (703) 305–5805. Please review                        www.epa.gov/test-guidelines-pesticides-                          • Hand Delivery: To make special
                                                  the visitor instructions and additional                        and-toxic-substances.                                          arrangements for hand delivery or


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Document Created: 2016-01-13 01:01:09
Document Modified: 2016-01-13 01:01:09
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective January 13, 2016. Objections and requests for hearings must be received on or March 14, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactSusan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation81 FR 1522 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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