80_FR_61318 80 FR 61122 - Cellulose Carboxymethyl Ether, Potassium Salt; Tolerance Exemption

80 FR 61122 - Cellulose Carboxymethyl Ether, Potassium Salt; Tolerance Exemption

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 196 (October 9, 2015)

Page Range61122-61125
FR Document2015-25689

This regulation establishes an exemption from the requirement of a tolerance for residues of cellulose carboxymethyl ether, potassium salt; when used as an inert ingredient in a pesticide chemical formulation. Spring Trading Company on behalf of Lamberti USA, Incorporated 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 cellulose carboxymethyl ether, potassium salt on food or feed commodities.

Federal Register, Volume 80 Issue 196 (Friday, October 9, 2015)
[Federal Register Volume 80, Number 196 (Friday, October 9, 2015)]
[Rules and Regulations]
[Pages 61122-61125]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-25689]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0482; FRL-9934-45]


Cellulose Carboxymethyl Ether, Potassium Salt; 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 cellulose carboxymethyl ether, potassium 
salt; when used as an inert ingredient in a pesticide chemical 
formulation. Spring Trading Company on behalf of Lamberti USA, 
Incorporated 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

[[Page 61123]]

permissible level for residues of cellulose carboxymethyl ether, 
potassium salt on food or feed commodities.

DATES: This regulation is effective October 9, 2015. Objections and 
requests for hearings must be received on or before December 8, 2015, 
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-2015-0482, 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-2015-0482 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 
December 8, 2015. 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-2015-0482, 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 August 26, 2015 (80 FR 51759) (FRL-9931-
74), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the receipt of a pesticide petition (PP IN-10821) 
filed by Spring Trading Company (203 Dogwood Trail Magnolia, Texas 
77354) on behalf of Lamberti USA, Incorporated, 161 Washington Street 
Eight Tower Bridge, Suite 1000 Conshohocken, PA 19428. The petition 
requested that 40 CFR 180.960 be amended by establishing an exemption 
from the requirement of a tolerance for residues of cellulose 
carboxymethyl ether, potassium salt; CAS Reg. No. 54848-04-3. That 
document included a summary of the petition prepared by the petitioner 
and solicited comments on the petitioner's request. The Agency did not 
receive any comments.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and use in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing an exemption from the 
requirement of a tolerance and to ``ensure that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue. . .'' and 
specifies factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be shown that the risks from aggregate 
exposure to pesticide chemical residues under reasonably foreseeable 
circumstances will pose no appreciable risks to human health. In order 
to determine the risks from aggregate exposure to pesticide inert 
ingredients, the Agency considers the toxicity of the inert in 
conjunction with possible exposure to residues of the inert ingredient 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings. If EPA is able to 
determine that a finite tolerance is not necessary to ensure that there 
is a reasonable certainty that no harm will result from aggregate

[[Page 61124]]

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). cellulose carboxymethyl ether, 
potassium salt 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's number average MW of 9587 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, cellulose carboxymethyl ether, potassium salt 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 
cellulose carboxymethyl ether, potassium salt.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that cellulose carboxymethyl ether, potassium 
salt 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 cellulose carboxymethyl ether, 
potassium salt is 9587 daltons. Generally, a polymer of this size would 
be poorly absorbed through the intact gastrointestinal tract or through 
intact human skin. Since cellulose carboxymethyl ether, potassium salt 
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 cellulose carboxymethyl ether, potassium salt to 
share a common mechanism of toxicity with any other substances, and 
cellulose carboxymethyl ether, potassium salt does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
cellulose carboxymethyl ether, potassium salt does not have a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base unless EPA concludes 
that a different margin of safety will be safe for infants and 
children. Due to the expected low toxicity of cellulose carboxymethyl 
ether, potassium salt, 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 cellulose carboxymethyl ether, 
potassium salt.

VIII. Other Considerations

A. Existing Exemptions From a Tolerance

    There are no existing exemptions from a tolerance for cellulose 
carboxymethyl ether, potassium salt polymers.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of cellulose 
carboxymethyl ether, potassium salt from the requirement of a tolerance 
will be safe.

X. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption 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

[[Page 61125]]

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).

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 and pests, Reporting and 
recordkeeping requirements.

    Dated: October 1, 2015.
Susan Lewis,
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, add alphabetically the following polymer to the 
table to read as follows:


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

* * * * *

------------------------------------------------------------------------
                          Polymer                              CAS No.
------------------------------------------------------------------------
 
                                * * * * *
Cellulose carboxymethyl ether, potassium salt, minimum        54848-04-3
 number average molecular weight 9587 Daltons..............
 
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2015-25689 Filed 10-8-15; 8:45 am]
 BILLING CODE 6560-50-P



                                             61122                   Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations

                                             contain any unfunded mandate as                                     Representatives, and the Comptroller                                 PART 180—[AMENDED]
                                             described under Title II of the Unfunded                            General of the United States prior to
                                             Mandates Reform Act (UMRA) (2 U.S.C.                                publication of the rule in the Federal                               ■ 1. The authority citation for part 180
                                             1501 et seq.).                                                      Register. This action is not a ‘‘major                               continues to read as follows:
                                               This action does not involve any                                  rule’’ as defined by 5 U.S.C. 804(2).
                                                                                                                                                                                           Authority: 21 U.S.C. 321(q), 346a and 371.
                                             technical standards that would require                              List of Subjects in 40 CFR Part 180
                                             Agency consideration of voluntary                                                                                                        ■ 2. In § 180.910, add alphabetically the
                                             consensus standards pursuant to section                               Environmental protection,                                          inert ingredient to the table to read as
                                                                                                                 Administrative practice and procedure,
                                             12(d) of the National Technology                                                                                                         follows:
                                                                                                                 Agricultural commodities, Pesticides
                                             Transfer and Advancement Act
                                                                                                                 and pests, Reporting and recordkeeping                               § 180.910 Inert ingredients used pre- and
                                             (NTTAA) (15 U.S.C. 272 note).
                                                                                                                 requirements.                                                        post-harvest; exemptions from the
                                             VIII. Congressional Review Act                                        Dated: October 1, 2015.                                            requirement of a tolerance.
                                               Pursuant to the Congressional Review                              Susan Lewis,
                                             Act (5 U.S.C. 801 et seq.), EPA will                                Director, Registration Division, Office of
                                             submit a report containing this rule and                            Pesticide Programs.
                                             other required information to the U.S.                                Therefore, 40 CFR chapter I is
                                             Senate, the U.S. House of                                           amended as follows:

                                                                                                        Inert ingredients                                                                             Limits                         Uses


                                                      *                     *                  *                      *                                *                                                       *                           *
                                             Trans-1,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No. 29118–24–9) .......................................................                          ..............................   Propellant.

                                                          *                            *                            *                            *                            *                                *                           *



                                             ■ 3. In § 180.930 add alphabetically the                            § 180.930 Inert ingredients applied to
                                             inert ingredient to the table to read as                            animals; exemptions from the requirement
                                             follows:                                                            of a tolerance.

                                                                                                        Inert ingredients                                                                             Limits                         Uses


                                                      *                     *                  *                      *                                *                                                       *                           *
                                             Trans-1,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No. 29118–24–9) .......................................................                          ..............................   Propellant.

                                                          *                            *                            *                            *                            *                                *                           *



                                             ■ 4. In § 180.940(a), add alphabetically                            § 180.940 Tolerance exemptions for active
                                             the inert ingredient to the table to read                           and inert ingredients for use in
                                                                                                                 antimicrobial formulations (Food-contact
                                             as follows:
                                                                                                                 surface sanitizing solution).
                                                                                                                     (a) * * *

                                                                                                     Pesticide chemical                                                                        CAS Reg. No.                          Limits


                                                      *                     *                             *                                 *                                *                         *                                   *
                                             Trans-1,3,3,3-tetrafluoroprop-1-ene .......................................................................................................        29118–24–9                   None.

                                                          *                            *                            *                            *                            *                                *                           *



                                             *       *        *        *        *                                ENVIRONMENTAL PROTECTION                                             SUMMARY:   This regulation establishes an
                                             [FR Doc. 2015–25690 Filed 10–8–15; 8:45 am]                         AGENCY                                                               exemption from the requirement of a
                                             BILLING CODE 6560–50–P                                                                                                                   tolerance for residues of cellulose
                                                                                                                 40 CFR Part 180                                                      carboxymethyl ether, potassium salt;
                                                                                                                                                                                      when used as an inert ingredient in a
                                                                                                                 [EPA–HQ–OPP–2015–0482; FRL–9934–45]                                  pesticide chemical formulation. Spring
                                                                                                                                                                                      Trading Company on behalf of Lamberti
rmajette on DSK7SPTVN1PROD with RULES




                                                                                                                 Cellulose Carboxymethyl Ether,                                       USA, Incorporated submitted a petition
                                                                                                                 Potassium Salt; Tolerance Exemption                                  to EPA under the Federal Food, Drug,
                                                                                                                 AGENCY:  Environmental Protection                                    and Cosmetic Act (FFDCA), requesting
                                                                                                                 Agency (EPA).                                                        an exemption from the requirement of a
                                                                                                                                                                                      tolerance. This regulation eliminates the
                                                                                                                 ACTION: Final rule.
                                                                                                                                                                                      need to establish a maximum


                                        VerDate Sep<11>2014       15:01 Oct 08, 2015       Jkt 238001    PO 00000       Frm 00036     Fmt 4700       Sfmt 4700    E:\FR\FM\09OCR1.SGM             09OCR1


                                                                Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations                                        61123

                                             permissible level for residues of                       through the Government Printing                       petition (PP IN–10821) filed by Spring
                                             cellulose carboxymethyl ether,                          Office’s e-CFR site at http://                        Trading Company (203 Dogwood Trail
                                             potassium salt on food or feed                          www.ecfr.gov/cgi-bin/text-                            Magnolia, Texas 77354) on behalf of
                                             commodities.                                            idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                  Lamberti USA, Incorporated, 161
                                             DATES:  This regulation is effective                    40tab_02.tpl.                                         Washington Street Eight Tower Bridge,
                                             October 9, 2015. Objections and                                                                               Suite 1000 Conshohocken, PA 19428.
                                                                                                     C. Can I file an objection or hearing
                                                                                                                                                           The petition requested that 40 CFR
                                             requests for hearings must be received                  request?
                                                                                                                                                           180.960 be amended by establishing an
                                             on or before December 8, 2015, and                        Under FFDCA section 408(g), 21                      exemption from the requirement of a
                                             must be filed in accordance with the                    U.S.C. 346a, any person may file an                   tolerance for residues of cellulose
                                             instructions provided in 40 CFR part                    objection to any aspect of this regulation            carboxymethyl ether, potassium salt;
                                             178 (see also Unit I.C. of the                          and may also request a hearing on those               CAS Reg. No. 54848–04–3. That
                                             SUPPLEMENTARY INFORMATION).                             objections. You must file your objection              document included a summary of the
                                             ADDRESSES: The docket for this action,                  or request a hearing on this regulation               petition prepared by the petitioner and
                                             identified by docket identification (ID)                in accordance with the instructions                   solicited comments on the petitioner’s
                                             number EPA–HQ–OPP–2015–0482, is                         provided in 40 CFR part 178. To ensure                request. The Agency did not receive any
                                             available at http://www.regulations.gov                 proper receipt by EPA, you must                       comments.
                                             or at the Office of Pesticide Programs                  identify docket ID number EPA–HQ–                        Section 408(c)(2)(A)(i) of FFDCA
                                             Regulatory Public Docket (OPP Docket)                   OPP–2015–0482 in the subject line on                  allows EPA to establish an exemption
                                             in the Environmental Protection Agency                  the first page of your submission. All                from the requirement for a tolerance (the
                                             Docket Center (EPA/DC), West William                    objections and requests for a hearing                 legal limit for a pesticide chemical
                                             Jefferson Clinton Bldg., Rm. 3334, 1301                 must be in writing, and must be                       residue in or on a food) only if EPA
                                             Constitution Ave. NW., Washington, DC                   received by the Hearing Clerk on or                   determines that the exemption is ‘‘safe.’’
                                             20460–0001. The Public Reading Room                     before December 8, 2015. Addresses for                Section 408(c)(2)(A)(ii) of FFDCA
                                             is open from 8:30 a.m. to 4:30 p.m.,                    mail and hand delivery of objections                  defines ‘‘safe’’ to mean that ‘‘there is a
                                             Monday through Friday, excluding legal                  and hearing requests are provided in 40               reasonable certainty that no harm will
                                             holidays. The telephone number for the                  CFR 178.25(b).                                        result from aggregate exposure to the
                                             Public Reading Room is (202) 566–1744,                    In addition to filing an objection or               pesticide chemical residue, including
                                             and the telephone number for the OPP                    hearing request with the Hearing Clerk                all anticipated dietary exposures and all
                                             Docket is (703) 305–5805. Please review                 as described in 40 CFR part 178, please               other exposures for which there is
                                             the visitor instructions and additional                 submit a copy of the filing (excluding                reliable information.’’ This includes
                                             information about the docket available                  any Confidential Business Information                 exposure through drinking water and
                                             at http://www.epa.gov/dockets.                          (CBI)) for inclusion in the public docket.            use in residential settings, but does not
                                             FOR FURTHER INFORMATION CONTACT:                        Information not marked confidential                   include occupational exposure. Section
                                             Susan Lewis, Registration Division                      pursuant to 40 CFR part 2 may be                      408(b)(2)(C) of FFDCA requires EPA to
                                             (7505P), Office of Pesticide Programs,                  disclosed publicly by EPA without prior               give special consideration to exposure
                                             Environmental Protection Agency, 1200                   notice. Submit the non-CBI copy of your               of infants and children to the pesticide
                                             Pennsylvania Ave. NW., Washington,                      objection or hearing request, identified              chemical residue in establishing an
                                             DC 20460–0001; main telephone                           by docket ID number EPA–HQ–OPP–                       exemption from the requirement of a
                                             number: (703) 305–7090; email address:                  2015–0482, by one of the following                    tolerance and to ‘‘ensure that there is a
                                             RDFRNotices@epa.gov.                                    methods.                                              reasonable certainty that no harm will
                                                                                                       • Federal eRulemaking Portal: http://               result to infants and children from
                                             SUPPLEMENTARY INFORMATION:
                                                                                                     www.regulations.gov. Follow the online                aggregate exposure to the pesticide
                                             I. General Information                                  instructions for submitting comments.                 chemical residue. . .’’ and specifies
                                                                                                     Do not submit electronically any                      factors EPA is to consider in
                                             A. Does this action apply to me?
                                                                                                     information you consider to be CBI or                 establishing an exemption.
                                                You may be potentially affected by                   other information whose disclosure is
                                             this action if you are an agricultural                                                                        III. Risk Assessment and Statutory
                                                                                                     restricted by statute.
                                             producer, food manufacturer, or                           • Mail: OPP Docket, Environmental                   Findings
                                             pesticide manufacturer. The following                   Protection Agency Docket Center (EPA/                    EPA establishes exemptions from the
                                             list of North American Industrial                       DC), (28221T), 1200 Pennsylvania Ave.                 requirement of a tolerance only in those
                                             Classification System (NAICS) codes is                  NW., Washington, DC 20460–0001.                       cases where it can be shown that the
                                             not intended to be exhaustive, but rather                 • Hand Delivery: To make special                    risks from aggregate exposure to
                                             provides a guide to help readers                        arrangements for hand delivery or                     pesticide chemical residues under
                                             determine whether this document                         delivery of boxed information, please                 reasonably foreseeable circumstances
                                             applies to them. Potentially affected                   follow the instructions at http://                    will pose no appreciable risks to human
                                             entities may include:                                   www.epa.gov/dockets/contacts.html.                    health. In order to determine the risks
                                                • Crop production (NAICS code 111).                  Additional instructions on commenting                 from aggregate exposure to pesticide
                                                • Animal production (NAICS code                      or visiting the docket, along with more               inert ingredients, the Agency considers
                                             112).                                                   information about dockets generally, is               the toxicity of the inert in conjunction
                                                • Food manufacturing (NAICS code                     available at http://www.epa.gov/                      with possible exposure to residues of
                                             311).                                                   dockets.                                              the inert ingredient through food,
                                                • Pesticide manufacturing (NAICS                                                                           drinking water, and through other
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                                             code 32532).                                            II. Background and Statutory Findings                 exposures that occur as a result of
                                                                                                        In the Federal Register of August 26,              pesticide use in residential settings. If
                                             B. How can I get electronic access to                   2015 (80 FR 51759) (FRL–9931–74),                     EPA is able to determine that a finite
                                             other related information?                              EPA issued a document pursuant to                     tolerance is not necessary to ensure that
                                               You may access a frequently updated                   FFDCA section 408, 21 U.S.C. 346a,                    there is a reasonable certainty that no
                                             electronic version of 40 CFR part 180                   announcing the receipt of a pesticide                 harm will result from aggregate


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                                             61124              Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations

                                             exposure to the inert ingredient, an                    polymer to be considered low risk under               infants and children in the case of
                                             exemption from the requirement of a                     40 CFR 723.250. Based on its                          threshold effects to account for prenatal
                                             tolerance may be established.                           conformance to the criteria in this unit,             and postnatal toxicity and the
                                               Consistent with FFDCA section                         no mammalian toxicity is anticipated                  completeness of the data base unless
                                             408(b)(2)(D), EPA has reviewed the                      from dietary, inhalation, or dermal                   EPA concludes that a different margin of
                                             available scientific data and other                     exposure to cellulose carboxymethyl                   safety will be safe for infants and
                                             relevant information in support of this                 ether, potassium salt.                                children. Due to the expected low
                                             action and considered its validity,                                                                           toxicity of cellulose carboxymethyl
                                                                                                     IV. Aggregate Exposures
                                             completeness and reliability and the                                                                          ether, potassium salt, EPA has not used
                                             relationship of this information to                       For the purposes of assessing                       a safety factor analysis to assess the risk.
                                             human risk. EPA has also considered                     potential exposure under this                         For the same reasons the additional
                                             available information concerning the                    exemption, EPA considered that                        tenfold safety factor is unnecessary.
                                             variability of the sensitivities of major               cellulose carboxymethyl ether,
                                                                                                     potassium salt could be present in all                VII. Determination of Safety
                                             identifiable subgroups of consumers,
                                             including infants and children. In the                  raw and processed agricultural                          Based on the conformance to the
                                             case of certain chemical substances that                commodities and drinking water, and                   criteria used to identify a low-risk
                                             are defined as polymers, the Agency has                 that non-occupational non-dietary                     polymer, EPA concludes that there is a
                                             established a set of criteria to identify               exposure was possible. The number                     reasonable certainty of no harm to the
                                             categories of polymers expected to                      average MW of cellulose carboxymethyl                 U.S. population, including infants and
                                             present minimal or no risk. The                         ether, potassium salt is 9587 daltons.                children, from aggregate exposure to
                                             definition of a polymer is given in 40                  Generally, a polymer of this size would               residues of cellulose carboxymethyl
                                             CFR 723.250(b) and the exclusion                        be poorly absorbed through the intact                 ether, potassium salt.
                                             criteria for identifying these low-risk                 gastrointestinal tract or through intact              VIII. Other Considerations
                                             polymers are described in 40 CFR                        human skin. Since cellulose
                                             723.250(d). cellulose carboxymethyl                     carboxymethyl ether, potassium salt                   A. Existing Exemptions From a
                                             ether, potassium salt conforms to the                   conform to the criteria that identify a               Tolerance
                                             definition of a polymer given in 40 CFR                 low-risk polymer, there are no concerns                  There are no existing exemptions
                                             723.250(b) and meets the following                      for risks associated with any potential               from a tolerance for cellulose
                                             criteria that are used to identify low-risk             exposure scenarios that are reasonably                carboxymethyl ether, potassium salt
                                             polymers.                                               foreseeable. The Agency has determined                polymers.
                                               1. The polymer is not a cationic                      that a tolerance is not necessary to
                                                                                                     protect the public health.                            B. Analytical Enforcement Methodology
                                             polymer nor is it reasonably anticipated
                                             to become a cationic polymer in a                                                                                An analytical method is not required
                                                                                                     V. Cumulative Effects From Substances
                                             natural aquatic environment.                                                                                  for enforcement purposes since the
                                                                                                     With a Common Mechanism of Toxicity
                                               2. The polymer does contain as an                                                                           Agency is establishing an exemption
                                             integral part of its composition the                       Section 408(b)(2)(D)(v) of FFDCA                   from the requirement of a tolerance
                                             atomic elements carbon, hydrogen, and                   requires that, when considering whether               without any numerical limitation.
                                             oxygen.                                                 to establish, modify, or revoke a
                                                                                                     tolerance, the Agency consider                        IX. Conclusion
                                               3. The polymer does not contain as an
                                             integral part of its composition, except                ‘‘available information’’ concerning the                 Accordingly, EPA finds that
                                             as impurities, any element other than                   cumulative effects of a particular                    exempting residues of cellulose
                                             those listed in 40 CFR 723.250(d)(2)(ii).               pesticide’s residues and ‘‘other                      carboxymethyl ether, potassium salt
                                               4. The polymer is neither designed                    substances that have a common                         from the requirement of a tolerance will
                                             nor can it be reasonably anticipated to                 mechanism of toxicity.’’                              be safe.
                                             substantially degrade, decompose, or                       EPA has not found cellulose
                                                                                                                                                           X. Statutory and Executive Order
                                             depolymerize.                                           carboxymethyl ether, potassium salt to
                                                                                                                                                           Reviews
                                               5. The polymer is manufactured or                     share a common mechanism of toxicity
                                             imported from monomers and/or                           with any other substances, and cellulose                 This action establishes a tolerance
                                             reactants that are already included on                  carboxymethyl ether, potassium salt                   exemption under FFDCA section 408(d)
                                             the TSCA Chemical Substance                             does not appear to produce a toxic                    in response to a petition submitted to
                                             Inventory or manufactured under an                      metabolite produced by other                          the Agency. The Office of Management
                                             applicable TSCA section 5 exemption.                    substances. For the purposes of this                  and Budget (OMB) has exempted these
                                               6. The polymer is not a water                         tolerance action, therefore, EPA has                  types of actions from review under
                                             absorbing polymer with a number                         assumed that cellulose carboxymethyl                  Executive Order 12866, entitled
                                             average molecular weight (MW) greater                   ether, potassium salt does not have a                 ‘‘Regulatory Planning and Review’’ (58
                                             than or equal to 10,000 daltons.                        common mechanism of toxicity with                     FR 51735, October 4, 1993). Because
                                               Additionally, the polymer also meets                  other substances. For information                     this action has been exempted from
                                             as required the following exemption                     regarding EPA’s efforts to determine                  review under Executive Order 12866,
                                             criteria specified in 40 CFR 723.250(e).                which chemicals have a common                         this action is not subject to Executive
                                               7. The polymer’s number average MW                    mechanism of toxicity and to evaluate                 Order 13211, entitled ‘‘Actions
                                             of 9587 is greater than 1,000 and less                  the cumulative effects of such                        Concerning Regulations That
                                             than 10,000 daltons. The polymer                        chemicals, see EPA’s Web site at http://              Significantly Affect Energy Supply,
                                                                                                                                                           Distribution, or Use’’ (66 FR 28355, May
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                                             contains less than 10% oligomeric                       www.epa.gov/pesticides/cumulative.
                                             material below MW 500 and less than                                                                           22, 2001) or Executive Order 13045,
                                             25% oligomeric material below MW                        VI. Additional Safety Factor for the                  entitled ‘‘Protection of Children from
                                             1,000, and the polymer does not contain                 Protection of Infants and Children                    Environmental Health Risks and Safety
                                             any reactive functional groups.                           Section 408(b)(2)(C) of FFDCA                       Risks’’ (62 FR 19885, April 23, 1997).
                                               Thus, cellulose carboxymethyl ether,                  provides that EPA shall apply an                      This action does not contain any
                                             potassium salt meets the criteria for a                 additional tenfold margin of safety for               information collections subject to OMB


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                                                                Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations                                                     61125

                                             approval under the Paperwork                            List of Subjects in 40 CFR Part 180                               (FFDCA), requesting an amendment to
                                             Reduction Act (PRA) (44 U.S.C. 3501 et                    Environmental protection,                                       an existing exemption from the
                                             seq.), nor does it require any special                  Administrative practice and procedure,                            requirement of a tolerance. This
                                             considerations under Executive Order                    Agricultural commodities, Pesticides                              regulation eliminates the need to
                                             12898, entitled ‘‘Federal Actions to                    and pests, Reporting and recordkeeping                            establish a maximum permissible level
                                             Address Environmental Justice in                        requirements.                                                     for residues of dimethyl sulfoxide.
                                             Minority Populations and Low-Income                                                                                       DATES: This regulation is effective
                                                                                                       Dated: October 1, 2015.
                                             Populations’’ (59 FR 7629, February 16,                                                                                   October 9, 2015. Objections and
                                             1994).                                                  Susan Lewis,
                                                                                                     Director, Registration Division, Office of                        requests for hearings must be received
                                                Since tolerances and exemptions that                 Pesticide Programs.                                               on or before December 8, 2015, and
                                             are established on the basis of a petition                                                                                must be filed in accordance with the
                                                                                                       Therefore, 40 CFR chapter I is
                                             under FFDCA section 408(d), such as                                                                                       instructions provided in 40 CFR part
                                                                                                     amended as follows:
                                             the tolerance in this final rule, do not                                                                                  178 (see also Unit I.C. of the
                                             require the issuance of a proposed rule,                PART 180—[AMENDED]                                                SUPPLEMENTARY INFORMATION).
                                             the requirements of the Regulatory
                                                                                                                                                                       ADDRESSES:    The docket for this action,
                                             Flexibility Act (RFA) (5 U.S.C. 601 et                  ■ 1. The authority citation for part 180                          identified by docket identification (ID)
                                             seq.), do not apply.                                    continues to read as follows:                                     number EPA–HQ–OPP–2014–0630, is
                                                This action directly regulates growers,                  Authority: 21 U.S.C. 321(q), 346a and 371.                    available at http://www.regulations.gov
                                             food processors, food handlers, and food                ■ 2. In § 180.960, add alphabetically the                         or at the Office of Pesticide Programs
                                             retailers, not States or tribes, nor does               following polymer to the table to read as                         Regulatory Public Docket (OPP Docket)
                                             this action alter the relationships or                  follows:                                                          in the Environmental Protection Agency
                                             distribution of power and                                                                                                 Docket Center (EPA/DC), West William
                                             responsibilities established by Congress                § 180.960 Polymers; exemptions from the                           Jefferson Clinton Bldg., Rm. 3334, 1301
                                             in the preemption provisions of FFDCA                   requirement of a tolerance.                                       Constitution Ave. NW., Washington, DC
                                             section 408(n)(4). As such, the Agency                  *           *     *           *          *                        20460–0001. The Public Reading Room
                                             has determined that this action will not                                                                                  is open from 8:30 a.m. to 4:30 p.m.,
                                             have a substantial direct effect on States                               Polymer                              CAS No.     Monday through Friday, excluding legal
                                             or tribal governments, on the                                                                                             holidays. The telephone number for the
                                             relationship between the national                                                                                         Public Reading Room is (202) 566–1744,
                                                                                                        *         *        *            *       *
                                             government and the States or tribal                     Cellulose carboxymethyl ether,
                                                                                                                                                                       and the telephone number for the OPP
                                             governments, or on the distribution of                    potassium salt, minimum                                         Docket is (703) 305–5805. Please review
                                             power and responsibilities among the                      number average molecular                                        the visitor instructions and additional
                                             various levels of government or between                   weight 9587 Daltons ............. 54848–04–3                    information about the docket available
                                             the Federal Government and Indian                                                                                         at http://www.epa.gov/dockets.
                                             tribes. Thus, the Agency has determined                       *               *              *           *          *
                                                                                                                                                                       FOR FURTHER INFORMATION CONTACT:
                                             that Executive Order 13132, entitled                    [FR Doc. 2015–25689 Filed 10–8–15; 8:45 am]                       Susan Lewis, Registration Division
                                             ‘‘Federalism’’ (64 FR 43255, August 10,                                                                                   (7505P), Office of Pesticide Programs,
                                                                                                     BILLING CODE 6560–50–P
                                             1999) and Executive Order 13175,                                                                                          Environmental Protection Agency, 1200
                                             entitled ‘‘Consultation and Coordination                                                                                  Pennsylvania Ave. NW., Washington,
                                             with Indian Tribal Governments’’ (65 FR                 ENVIRONMENTAL PROTECTION                                          DC 20460–0001; main telephone
                                             67249, November 9, 2000) do not apply                   AGENCY                                                            number: (703) 305–7090; email address:
                                             to this action. In addition, this action                                                                                  RDFRNotices@epa.gov.
                                             does not impose any enforceable duty or                 40 CFR Part 180
                                             contain any unfunded mandate as                                                                                           SUPPLEMENTARY INFORMATION:
                                                                                                     [EPA–HQ–OPP–2014–0630; FRL–9934–17]
                                             described under Title II of the Unfunded                                                                                  I. General Information
                                             Mandates Reform Act (UMRA) (2 U.S.C.                    Dimethyl Sulfoxide; Exemption From
                                             1501 et seq.).                                                                                                            A. Does this action apply to me?
                                                                                                     the Requirement of a Tolerance
                                                This action does not involve any                                                                                          You may be potentially affected by
                                                                                                     AGENCY:  Environmental Protection
                                             technical standards that would require                                                                                    this action if you are an agricultural
                                                                                                     Agency (EPA).
                                             Agency consideration of voluntary                                                                                         producer, food manufacturer, or
                                             consensus standards pursuant to section                 ACTION: Final rule.
                                                                                                                                                                       pesticide manufacturer. The following
                                             12(d) of the National Technology                        SUMMARY:   This regulation amends the                             list of North American Industrial
                                             Transfer and Advancement Act                            exemption from the requirement of a                               Classification System (NAICS) codes is
                                             (NTTAA) (15 U.S.C. 272 note).                           tolerance for residues of dimethyl                                not intended to be exhaustive, but rather
                                                                                                     sulfoxide (CAS Reg. No. 67–68–5) when                             provides a guide to help readers
                                             XI. Congressional Review Act
                                                                                                     used as an inert ingredient (solvent, co-                         determine whether this document
                                               Pursuant to the Congressional Review                  solvent) in pesticide formulations                                applies to them. Potentially affected
                                             Act (5 U.S.C. 801 et seq.), EPA will                    applied to growing crops (pre-emergent                            entities may include:
                                             submit a report containing this rule and                use only) to include use after the crop                              • Crop production (NAICS code 111).
                                             other required information to the U.S.                  emerges from the soil but before harvest
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                                                                                                                                                                          • Animal production (NAICS code
                                             Senate, the U.S. House of                               provided that the potential for increased                         112).
                                             Representatives, and the Comptroller                    residues of the formulation’s active
                                             General of the United States prior to                   ingredient(s) in or on food commodities                              • Food manufacturing (NAICS code
                                             publication of the rule in the Federal                  has been assessed. ISK BioSciences                                311).
                                             Register. This action is not a ‘‘major                  submitted a petition to EPA under the                                • Pesticide manufacturing (NAICS
                                             rule’’ as defined by 5 U.S.C. 804(2).                   Federal Food, Drug, and Cosmetic Act                              code 32532).


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Document Created: 2015-12-15 08:34:22
Document Modified: 2015-12-15 08:34:22
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 October 9, 2015. Objections and requests for hearings must be received on or before December 8, 2015, 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 Citation80 FR 61122 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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