82_FR_39701 82 FR 39541 - Potassium Salts of Naphthalenesulfonic Acids Formaldehyde Condensates; Exemption From the Requirement of a Tolerance

82 FR 39541 - Potassium Salts of Naphthalenesulfonic Acids Formaldehyde Condensates; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 160 (August 21, 2017)

Page Range39541-39544
FR Document2017-17631

This regulation establishes an exemption from the requirement of a tolerance for residues of naphthalenesulfonic acids formaldehyde condensates, potassium salts (CAS Reg. No. 67828-14-2) when used as an inert ingredient (surfactant and related adjuvant of surfactants) applied to growing crops and raw agricultural commodities after harvest by amending an existing exemption for similar substances. Monsanto Company submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting this amendment. This regulation eliminates the need to establish a maximum permissible level for residues of naphthalenesulfonic acids formaldehyde condensates, potassium salts, when used consistent with the terms.

Federal Register, Volume 82 Issue 160 (Monday, August 21, 2017)
[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)]
[Rules and Regulations]
[Pages 39541-39544]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-17631]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0500; FRL-9964-21]


Potassium Salts of Naphthalenesulfonic Acids Formaldehyde 
Condensates; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of naphthalenesulfonic acids formaldehyde 
condensates, potassium salts (CAS Reg. No. 67828-14-2) when used as an 
inert ingredient (surfactant and related adjuvant of surfactants) 
applied to growing crops and raw agricultural commodities after harvest 
by amending an existing exemption for similar substances. Monsanto 
Company submitted a petition to EPA under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), requesting this amendment. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of naphthalenesulfonic acids formaldehyde condensates, 
potassium salts, when used consistent with the terms.

DATES: This regulation is effective August 21, 2017. Objections and 
requests for hearings must be received on or before October 20, 2017, 
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-2016-0500, 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: Michael Goodis, 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).

[[Page 39542]]

     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. How 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-2016-0500 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 
October 20, 2017. 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-2016-0500, 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. Petition for Exemption

    In the Federal Register of October 18, 2016 (81 FR 71668) (FRL-
9952-19), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
10965) by Monsanto Company, 1300 I (Eye) Street NW., Washington, DC 
20005. The petition requested that the existing exemption for residues 
of mono-, di-, and trimethylnapthalenesulfonic acids and 
napthalenesulfonic acids formaldehyde condensates, ammonium and sodium 
salts (CAS Reg. Nos. 9008-63-3, 9069-80-1, 9084-06-4, 36290-04-7, 
91078-68-1, 141959-43-5, 68425-94-5) in 40 CFR 180.910 be amended to 
also exempt residues of the potassium salts (CAS Reg. No. 67828-14-2) 
when used as an inert ingredient (i.e., as a surfactant or related 
adjuvant of surfactants) in pesticide formulations applied to growing 
crops or raw agricultural commodities after harvest. That document 
referenced a summary of the petition prepared by Monsanto Company, the 
petitioner, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing. 
EPA's response to that comment is discussed in Unit V.C.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    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 tolerance is ``safe.'' Section 408(b)(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 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 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 . . . .''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for naphthalenesulfonic acids 
formaldehyde condensate potassium salt including exposure resulting 
from the exemption established by this action. EPA's assessment of 
exposures and risks associated with naphthalenesulfonic acids 
formaldehyde condensate potassium salt follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of

[[Page 39543]]

the studies 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 Federal Register of October 7, 2009 (74 FR 51470) (FRL-8439-
1), EPA established an exemption from the requirement of a tolerance 
for the sodium and ammonium salts of naphthalenesulfonate formaldehyde 
condensates (SANFC). In the preamble to that rule, EPA concluded that 
there were no adverse effects observed in the available database. 
Naphthalenesulfonic acids formaldehyde condensate potassium salt 
differs from sodium and ammonium salts of naphthalenesulfonate 
formaldehyde condensates, only in the counterion (i.e., potassium 
versus sodium and ammomium) and would all share the same toxicity 
profile.
    Specific information on the studies received and the nature of the 
adverse effects caused by naphthalenesulfonic acids formaldehyde 
condensate potassium salt as well as the no-observed-adverse-effect-
level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from 
the toxicity studies are discussed in the final rule published in the 
Federal Register of October 7, 2009 (74 FR 51470) (FRL-8439-1).

B. Toxicological Points of Departure/Levels of Concern

    Based on the low potential hazard and the lack of a hazard endpoint 
for these compounds, EPA determined that a quantitative risk assessment 
is not appropriate.

C. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA 
to consider available information concerning exposures from the 
pesticide residue in food and all other nonoccupational exposures, 
including drinking water from ground water or surface water and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses).
    No hazard was identified for the acute and chronic dietary 
assessment (food and drinking water), or for the short term, 
intermediate-term, and long-term residential assessments, and 
therefore, no quantitative aggregate exposure assessments were 
performed. The Agency qualitatively assessed exposure as follows. When 
used in pesticide formulations applied to growing crops and raw 
agricultural commodities after harvest, there may be exposure from 
residues in or on food and from residues ending up in drinking water 
from use on growing crops. The SANFC inerts are used as disperants, 
defoamers and emulsifiers in pesticide formulations. These surfactants 
have a wide range of industrial uses as well as serving as emulsifiers 
in personal care products and in food contact packaging; therefore, EPA 
concludes that exposure from these sources is also likely.

D. 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 naphthalenesulfonic acids formaldehyde condensate 
potassium salt to share a common mechanism of toxicity with any other 
substances, and naphthalenesulfonic acids formaldehyde condensate 
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 naphthalenesulfonic acids formaldehyde 
condensate 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.

E. Determination of Safety

    Based on all available information, EPA concludes that there is a 
reasonable certainty that no harm will result to the general population 
or to infants and children from aggregate exposure to residues of the 
potassium salt of naphthalenesulfonic acids formaldehyde condensates, 
when used as inert ingredients in pesticide formulations applied to 
growing crops and raw agricultural commodities after harvest.

V. Other Considerations

A. Analytical Enforcement Methodology

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

B. Response to Comments

    One comment was received for a notice of filing offering 
suggestions on how to move away from using synthetic chemicals as 
pesticides. This comment is not specifically directed at today's 
tolerance exemption action nor does it include any information for the 
Agency to consider in making its safety determination for this 
exemption.

VI. Conclusions

    Therefore, the existing exemption from the requirement of a 
tolerance in 40 CFR 180.910 for residues of mono-, di-, and 
trimethylnapthalenesulfonic acids and napthalenesulfonic acids 
formaldehyde condensates, ammonium and sodium salts is amended to 
include potassium salts (specifically, naphthalenesulfonic acids 
formaldehyde condensate potassium salt (CAS Reg. No. 67828-14-2)) when 
used as an inert ingredient (surfactant and related adjuvant of 
surfactant) in pesticide formulations applied to growing crops and raw 
agricultural commodities after harvest.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of 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 exemption in this 
final rule, do not require the issuance of a proposed rule,

[[Page 39544]]

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).

VIII. 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: July 18, 2017.
Donna S. Davis,
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.  180.910, revise the existing entry for ``Mono-, di-, and 
trimethylnapthalenesulfonic acids and napthalenesulfonic acids 
formaldehyde condensates, ammonium and sodium salts (CAS Reg. Nos. 
9008-63-3, 9069-80-1, 9084-06-4, 36290-04-7, 91078-68-1, 141959-43-5, 
68425-94-5)'' to read as follows:


Sec.  180.910  Inert ingredients used pre- and post-harvest; exemption 
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
         Inert ingredients              Limits              Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Mono-, di-, and                     ..............  Surfactants, related
 trimethylnaphthalenesulfonic                        adjuvants of
 acids and naphthalenesulfonic                       surfactants
 acids formaldehyde condensates,
 ammonium, sodium and potassium
 salts (CAS Reg. Nos. 9008-63-3,
 9069-80-1, 9084-06-4, 36290-04-7,
 91078-68-1, 141959-43-5, 68425-94-
 5, 67828-14-2).
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2017-17631 Filed 8-18-17; 8:45 am]
 BILLING CODE 6560-50-P



                                                                   Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Rules and Regulations                                                                         39541

                                              Subpart PP—South Carolina                                             ■  B. Revise Regulation No. 62.2,                               § 52.2120   Identification of plan.
                                                                                                                    ■  C. Under Regulation No. 62.3, revise                         *       *    *        *      *
                                              ■ 2. Section 52.2120(c) is amended by:                                the entry for ‘‘Section I,’’ and
                                              ■ A. Under Regulation No. 62.1 revise                                 ■ D. Under Regulation No. 62.6, revise
                                                                                                                                                                                        (c) * * *
                                              the entries for ‘‘Section I,’’ ‘‘Section IV,’’                        ‘‘Section I’’ and ‘‘Section III’’.
                                              and ‘‘Section V,’’                                                       The revisions read as follows:

                                                                                               AIR POLLUTION CONTROL REGULATIONS FOR SOUTH CAROLINA
                                                                                                                                                                       State            EPA
                                               State citation                                           Title/subject                                                                                     Federal Register Notice
                                                                                                                                                                   effective date   approval date


                                                        *                          *                                 *                                 *                       *                      *                      *
                                              Section I .......    Definitions .................................................................................        6/24/2016        8/21/2017     [Insert citation of publication].

                                                       *                        *                                *                                 *                           *                      *                      *
                                              Section IV .....     Source Tests ............................................................................            6/27/2014        8/21/2017     [Insert citation of publication].

                                                       *                        *                             *                                 *                              *                      *                      *
                                              Section V ......     Credible Evidence ....................................................................               6/27/2014        8/21/2017     [Insert citation of publication].

                                                       *                          *                      *                                 *                                   *                      *                      *
                                              Regulation           Prohibition of Open Burning .....................................................                   12/27/2013        8/21/2017     [Insert citation of publication].
                                                No. 62.2.

                                                        *                       *                                *                                 *                           *                      *                      *
                                              Section I .......    Episode Criteria ........................................................................            4/26/2013        8/21/2017     [Insert citation of publication].

                                                        *                      *                   *                  *                                                        *                      *                      *
                                              Section I .......    Control of Fugitive Particulate Matter in Non-Attainment                                            11/27/2015        8/21/2017     [Insert citation of publication].
                                                                     Areas.

                                                        *                        *                     *                        *                                              *                      *                      *
                                              Section III .....    Control of Fugitive Particulate Matter Statewide .....................                              12/27/2013        8/21/2017     [Insert citation of publication].

                                                         *                             *                                *                              *                       *                      *                      *



                                              *      *       *        *         *                                   submitted a petition to EPA under the                           and the telephone number for the OPP
                                              [FR Doc. 2017–17240 Filed 8–18–17; 8:45 am]                           Federal Food, Drug, and Cosmetic Act                            Docket is (703) 305–5805. Please review
                                              BILLING CODE 6560–50–P                                                (FFDCA), requesting this amendment.                             the visitor instructions and additional
                                                                                                                    This regulation eliminates the need to                          information about the docket available
                                                                                                                    establish a maximum permissible level                           at http://www.epa.gov/dockets.
                                              ENVIRONMENTAL PROTECTION                                              for residues of naphthalenesulfonic                             FOR FURTHER INFORMATION CONTACT:
                                              AGENCY                                                                acids formaldehyde condensates,                                 Michael Goodis, Registration Division
                                                                                                                    potassium salts, when used consistent                           (7505P), Office of Pesticide Programs,
                                              40 CFR Part 180                                                       with the terms.                                                 Environmental Protection Agency, 1200
                                              [EPA–HQ–OPP–2016–0500; FRL–9964–21]                                   DATES: This regulation is effective                             Pennsylvania Ave. NW., Washington,
                                                                                                                    August 21, 2017. Objections and                                 DC 20460–0001; main telephone
                                              Potassium Salts of                                                    requests for hearings must be received                          number: (703) 305–7090; email address:
                                              Naphthalenesulfonic Acids                                             on or before October 20, 2017, and must                         RDFRNotices@epa.gov.
                                              Formaldehyde Condensates;                                             be filed in accordance with the
                                              Exemption From the Requirement of a                                                                                                   SUPPLEMENTARY INFORMATION:
                                                                                                                    instructions provided in 40 CFR part
                                              Tolerance                                                             178 (see also Unit I.C. of the                                  I. General Information
                                              AGENCY:  Environmental Protection                                     SUPPLEMENTARY INFORMATION).
                                                                                                                                                                                    A. Does this action apply to me?
                                              Agency (EPA).                                                         ADDRESSES: The docket for this action,
                                                                                                                    identified by docket identification (ID)                           You may be potentially affected by
                                              ACTION: Final rule.
                                                                                                                    number EPA–HQ–OPP–2016–0500, is                                 this action if you are an agricultural
                                              SUMMARY:   This regulation establishes an                             available at http://www.regulations.gov                         producer, food manufacturer, or
                                              exemption from the requirement of a                                   or at the Office of Pesticide Programs                          pesticide manufacturer. The following
                                              tolerance for residues of                                             Regulatory Public Docket (OPP Docket)                           list of North American Industrial
                                              naphthalenesulfonic acids                                             in the Environmental Protection Agency                          Classification System (NAICS) codes is
                                              formaldehyde condensates, potassium                                   Docket Center (EPA/DC), West William                            not intended to be exhaustive, but rather
sradovich on DSK3GMQ082PROD with RULES




                                              salts (CAS Reg. No. 67828–14–2) when                                  Jefferson Clinton Bldg., Rm. 3334, 1301                         provides a guide to help readers
                                              used as an inert ingredient (surfactant                               Constitution Ave. NW., Washington, DC                           determine whether this document
                                              and related adjuvant of surfactants)                                  20460–0001. The Public Reading Room                             applies to them. Potentially affected
                                              applied to growing crops and raw                                      is open from 8:30 a.m. to 4:30 p.m.,                            entities may include:
                                              agricultural commodities after harvest                                Monday through Friday, excluding legal                             • Crop production (NAICS code 111).
                                              by amending an existing exemption for                                 holidays. The telephone number for the                             • Animal production (NAICS code
                                              similar substances. Monsanto Company                                  Public Reading Room is (202) 566–1744,                          112).


                                         VerDate Sep<11>2014      16:12 Aug 18, 2017        Jkt 241001      PO 00000        Frm 00051       Fmt 4700       Sfmt 4700   E:\FR\FM\21AUR1.SGM   21AUR1


                                              39542             Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Rules and Regulations

                                                • Food manufacturing (NAICS code                      dockets generally, is available at http://            determines that the tolerance is ‘‘safe.’’
                                              311).                                                   www.epa.gov/dockets.                                  Section 408(b)(2)(A)(ii) of FFDCA
                                                • Pesticide manufacturing (NAICS                                                                            defines ‘‘safe’’ to mean that ‘‘there is a
                                                                                                      II. Petition for Exemption
                                              code 32532).                                                                                                  reasonable certainty that no harm will
                                                                                                         In the Federal Register of October 18,             result from aggregate exposure to the
                                              B. How can I get electronic access to                   2016 (81 FR 71668) (FRL–9952–19),                     pesticide chemical residue, including
                                              other related information?                              EPA issued a document pursuant to                     all anticipated dietary exposures and all
                                                You may access a frequently updated                   FFDCA section 408, 21 U.S.C. 346a,                    other exposures for which there is
                                              electronic version of 40 CFR part 180                   announcing the filing of a pesticide                  reliable information.’’ This includes
                                              through the Government Printing                         petition (PP IN–10965) by Monsanto                    exposure through drinking water and in
                                              Office’s e-CFR site at http://                          Company, 1300 I (Eye) Street NW.,                     residential settings, but does not include
                                              www.ecfr.gov/cgi-bin/text-idx?&c=                       Washington, DC 20005. The petition                    occupational exposure. Section
                                              ecfr&tpl=/ecfrbrowse/Title40/40tab_                     requested that the existing exemption                 408(b)(2)(C) of FFDCA requires EPA to
                                              02.tpl.                                                 for residues of mono-, di-, and                       give special consideration to exposure
                                                                                                      trimethylnapthalenesulfonic acids and                 of infants and children to the pesticide
                                              C. How can I file an objection or hearing               napthalenesulfonic acids formaldehyde
                                              request?                                                                                                      chemical residue in establishing a
                                                                                                      condensates, ammonium and sodium                      tolerance and to ‘‘ensure that there is a
                                                Under FFDCA section 408(g), 21                        salts (CAS Reg. Nos. 9008–63–3, 9069–                 reasonable certainty that no harm will
                                              U.S.C. 346a, any person may file an                     80–1, 9084–06–4, 36290–04–7, 91078–                   result to infants and children from
                                              objection to any aspect of this regulation              68–1, 141959–43–5, 68425–94–5) in 40                  aggregate exposure to the pesticide
                                              and may also request a hearing on those                 CFR 180.910 be amended to also exempt                 chemical residue . . . .’’
                                              objections. You must file your objection                residues of the potassium salts (CAS                     EPA establishes exemptions from the
                                              or request a hearing on this regulation                 Reg. No. 67828–14–2) when used as an                  requirement of a tolerance only in those
                                              in accordance with the instructions                     inert ingredient (i.e., as a surfactant or            cases where it can be clearly
                                              provided in 40 CFR part 178. To ensure                  related adjuvant of surfactants) in                   demonstrated that the risks from
                                              proper receipt by EPA, you must                         pesticide formulations applied to                     aggregate exposure to pesticide
                                              identify docket ID number EPA–HQ–                       growing crops or raw agricultural                     chemical residues under reasonably
                                              OPP–2016–0500 in the subject line on                    commodities after harvest. That                       foreseeable circumstances will pose no
                                              the first page of your submission. All                  document referenced a summary of the                  appreciable risks to human health. In
                                              objections and requests for a hearing                   petition prepared by Monsanto                         order to determine the risks from
                                              must be in writing, and must be                         Company, the petitioner, which is                     aggregate exposure to pesticide inert
                                              received by the Hearing Clerk on or                     available in the docket, http://                      ingredients, the Agency considers the
                                              before October 20, 2017. Addresses for                  www.regulations.gov. One comment was                  toxicity of the inert in conjunction with
                                              mail and hand delivery of objections                    received on the notice of filing. EPA’s               possible exposure to residues of the
                                              and hearing requests are provided in 40                 response to that comment is discussed                 inert ingredient through food, drinking
                                              CFR 178.25(b).                                          in Unit V.C.                                          water, and through other exposures that
                                                In addition to filing an objection or                                                                       occur as a result of pesticide use in
                                              hearing request with the Hearing Clerk                  III. Inert Ingredient Definition
                                                                                                                                                            residential settings. If EPA is able to
                                              as described in 40 CFR part 178, please                    Inert ingredients are all ingredients              determine that a finite tolerance is not
                                              submit a copy of the filing (excluding                  that are not active ingredients as defined            necessary to ensure that there is a
                                              any Confidential Business Information                   in 40 CFR 153.125 and include, but are                reasonable certainty that no harm will
                                              (CBI)) for inclusion in the public docket.              not limited to, the following types of                result from aggregate exposure to the
                                              Information not marked confidential                     ingredients (except when they have a                  inert ingredient, an exemption from the
                                              pursuant to 40 CFR part 2 may be                        pesticidal efficacy of their own):                    requirement of a tolerance may be
                                              disclosed publicly by EPA without prior                 Solvents such as alcohols and                         established.
                                              notice. Submit the non-CBI copy of your                 hydrocarbons; surfactants such as                        Consistent with FFDCA section
                                              objection or hearing request, identified                polyoxyethylene polymers and fatty                    408(c)(2)(A), and the factors specified in
                                              by docket ID number EPA–HQ–OPP–                         acids; carriers such as clay and                      FFDCA section 408(c)(2)(B), EPA has
                                              2016–0500, by one of the following                      diatomaceous earth; thickeners such as                reviewed the available scientific data
                                              methods:                                                carrageenan and modified cellulose;                   and other relevant information in
                                                • Federal eRulemaking Portal: http://                 wetting, spreading, and dispersing                    support of this action. EPA has
                                              www.regulations.gov. Follow the online                  agents; propellants in aerosol                        sufficient data to assess the hazards of
                                              instructions for submitting comments.                   dispensers; microencapsulating agents;                and to make a determination on
                                              Do not submit electronically any                        and emulsifiers. The term ‘‘inert’’ is not            aggregate exposure for
                                              information you consider to be CBI or                   intended to imply nontoxicity; the                    naphthalenesulfonic acids
                                              other information whose disclosure is                   ingredient may or may not be                          formaldehyde condensate potassium
                                              restricted by statute.                                  chemically active. Generally, EPA has                 salt including exposure resulting from
                                                • Mail: OPP Docket, Environmental                     exempted inert ingredients from the                   the exemption established by this
                                              Protection Agency Docket Center (EPA/                   requirement of a tolerance based on the               action. EPA’s assessment of exposures
                                              DC), (28221T), 1200 Pennsylvania Ave.                   low toxicity of the individual inert                  and risks associated with
                                              NW., Washington, DC 20460–0001.                         ingredients.                                          naphthalenesulfonic acids
                                                • Hand Delivery: To make special                                                                            formaldehyde condensate potassium
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                                              arrangements for hand delivery or                       IV. Aggregate Risk Assessment and
                                                                                                                                                            salt follows.
                                              delivery of boxed information, please                   Determination of Safety
                                              follow the instructions at http://                         Section 408(c)(2)(A)(i) of FFDCA                   A. Toxicological Profile
                                              www.epa.gov/dockets/contacts.html.                      allows EPA to establish an exemption                    EPA has evaluated the available
                                                Additional instructions on                            from the requirement for a tolerance (the             toxicity data and considered their
                                              commenting or visiting the docket,                      legal limit for a pesticide chemical                  validity, completeness, and reliability as
                                              along with more information about                       residue in or on a food) only if EPA                  well as the relationship of the results of


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                                                                Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Rules and Regulations                                         39543

                                              the studies to human risk. EPA has also                 ending up in drinking water from use on               B. Response to Comments
                                              considered available information                        growing crops. The SANFC inerts are                      One comment was received for a
                                              concerning the variability of the                       used as disperants, defoamers and                     notice of filing offering suggestions on
                                              sensitivities of major identifiable                     emulsifiers in pesticide formulations.                how to move away from using synthetic
                                              subgroups of consumers, including                       These surfactants have a wide range of                chemicals as pesticides. This comment
                                              infants and children.                                   industrial uses as well as serving as                 is not specifically directed at today’s
                                                 In the Federal Register of October 7,                emulsifiers in personal care products                 tolerance exemption action nor does it
                                              2009 (74 FR 51470) (FRL–8439–1), EPA                    and in food contact packaging;                        include any information for the Agency
                                              established an exemption from the                       therefore, EPA concludes that exposure                to consider in making its safety
                                              requirement of a tolerance for the                      from these sources is also likely.
                                              sodium and ammonium salts of                                                                                  determination for this exemption.
                                              naphthalenesulfonate formaldehyde                       D. Cumulative Effects From Substances                 VI. Conclusions
                                              condensates (SANFC). In the preamble                    With a Common Mechanism of Toxicity
                                                                                                                                                               Therefore, the existing exemption
                                              to that rule, EPA concluded that there
                                                                                                         Section 408(b)(2)(D)(v) of FFDCA                   from the requirement of a tolerance in
                                              were no adverse effects observed in the
                                                                                                      requires that, when considering whether               40 CFR 180.910 for residues of mono-,
                                              available database. Naphthalenesulfonic
                                                                                                      to establish, modify, or revoke a                     di-, and trimethylnapthalenesulfonic
                                              acids formaldehyde condensate
                                                                                                      tolerance, the Agency consider                        acids and napthalenesulfonic acids
                                              potassium salt differs from sodium and
                                                                                                      ‘‘available information’’ concerning the              formaldehyde condensates, ammonium
                                              ammonium salts of
                                                                                                      cumulative effects of a particular                    and sodium salts is amended to include
                                              naphthalenesulfonate formaldehyde
                                                                                                      pesticide’s residues and ‘‘other                      potassium salts (specifically,
                                              condensates, only in the counterion
                                                                                                      substances that have a common                         naphthalenesulfonic acids
                                              (i.e., potassium versus sodium and
                                                                                                      mechanism of toxicity.’’                              formaldehyde condensate potassium
                                              ammomium) and would all share the
                                                                                                                                                            salt (CAS Reg. No. 67828–14–2)) when
                                              same toxicity profile.                                     EPA has not found
                                                 Specific information on the studies                                                                        used as an inert ingredient (surfactant
                                                                                                      naphthalenesulfonic acids
                                              received and the nature of the adverse                                                                        and related adjuvant of surfactant) in
                                                                                                      formaldehyde condensate potassium
                                              effects caused by naphthalenesulfonic                                                                         pesticide formulations applied to
                                                                                                      salt to share a common mechanism of
                                              acids formaldehyde condensate                                                                                 growing crops and raw agricultural
                                                                                                      toxicity with any other substances, and
                                              potassium salt as well as the no-                                                                             commodities after harvest.
                                                                                                      naphthalenesulfonic acids
                                              observed-adverse-effect-level (NOAEL)                   formaldehyde condensate potassium                     VII. Statutory and Executive Order
                                              and the lowest-observed-adverse-effect-                 salt does not appear to produce a toxic               Reviews
                                              level (LOAEL) from the toxicity studies                 metabolite produced by other                             This action establishes an exemption
                                              are discussed in the final rule published               substances. For the purposes of this                  from the requirement of a tolerance
                                              in the Federal Register of October 7,                   tolerance action, therefore, EPA has                  under FFDCA section 408(d) in
                                              2009 (74 FR 51470) (FRL–8439–1).                        assumed that naphthalenesulfonic acids                response to a petition submitted to the
                                              B. Toxicological Points of Departure/                   formaldehyde condensate potassium                     Agency. The Office of Management and
                                              Levels of Concern                                       salt does not have a common                           Budget (OMB) has exempted these types
                                                                                                      mechanism of toxicity with other                      of actions from review under Executive
                                                Based on the low potential hazard and
                                                                                                      substances. For information regarding                 Order 12866, entitled ‘‘Regulatory
                                              the lack of a hazard endpoint for these
                                                                                                      EPA’s efforts to determine which                      Planning and Review’’ (58 FR 51735,
                                              compounds, EPA determined that a
                                                                                                      chemicals have a common mechanism                     October 4, 1993). Because this action
                                              quantitative risk assessment is not
                                                                                                      of toxicity and to evaluate the                       has been exempted from review under
                                              appropriate.
                                                                                                      cumulative effects of such chemicals,                 Executive Order 12866, this action is
                                              C. Aggregate Exposures                                  see EPA’s Web site at http://                         not subject to Executive Order 13211,
                                                In examining aggregate exposure,                      www.epa.gov/pesticides/cumulative.                    entitled ‘‘Actions Concerning
                                              section 408 of FFDCA directs EPA to                     E. Determination of Safety                            Regulations That Significantly Affect
                                              consider available information                                                                                Energy Supply, Distribution, or Use’’ (66
                                              concerning exposures from the pesticide                   Based on all available information,                 FR 28355, May 22, 2001) or Executive
                                              residue in food and all other                           EPA concludes that there is a reasonable              Order 13045, entitled ‘‘Protection of
                                              nonoccupational exposures, including                    certainty that no harm will result to the             Children from Environmental Health
                                              drinking water from ground water or                     general population or to infants and                  Risks and Safety Risks’’ (62 FR 19885,
                                              surface water and exposure through                      children from aggregate exposure to                   April 23, 1997). This action does not
                                              pesticide use in gardens, lawns, or                     residues of the potassium salt of                     contain any information collections
                                              buildings (residential and other indoor                 naphthalenesulfonic acids                             subject to OMB approval under the
                                              uses).                                                  formaldehyde condensates, when used                   Paperwork Reduction Act (PRA) (44
                                                No hazard was identified for the acute                as inert ingredients in pesticide                     U.S.C. 3501 et seq.), nor does it require
                                              and chronic dietary assessment (food                    formulations applied to growing crops                 any special considerations under
                                              and drinking water), or for the short                   and raw agricultural commodities after                Executive Order 12898, entitled
                                              term, intermediate-term, and long-term                  harvest.                                              ‘‘Federal Actions to Address
                                              residential assessments, and therefore,                                                                       Environmental Justice in Minority
                                              no quantitative aggregate exposure                      V. Other Considerations                               Populations and Low-Income
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                                              assessments were performed. The                         A. Analytical Enforcement Methodology                 Populations’’ (59 FR 7629, February 16,
                                              Agency qualitatively assessed exposure                                                                        1994).
                                              as follows. When used in pesticide                        An analytical method is not required                   Since tolerances and exemptions that
                                              formulations applied to growing crops                   for enforcement purposes since the                    are established on the basis of a petition
                                              and raw agricultural commodities after                  Agency is establishing an exemption                   under FFDCA section 408(d), such as
                                              harvest, there may be exposure from                     from the requirement of a tolerance                   the exemption in this final rule, do not
                                              residues in or on food and from residues                without any numerical limitation.                     require the issuance of a proposed rule,


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                                              39544             Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Rules and Regulations

                                              the requirements of the Regulatory                      contain any unfunded mandate as                              and pests, Reporting and recordkeeping
                                              Flexibility Act (RFA) (5 U.S.C. 601 et                  described under Title II of the Unfunded                     requirements.
                                              seq.), do not apply.                                    Mandates Reform Act (UMRA) (2 U.S.C.                            Dated: July 18, 2017.
                                                 This action directly regulates growers,              1501 et seq.).                                               Donna S. Davis,
                                              food processors, food handlers, and food                  This action does not involve any                           Acting Director, Registration Division, Office
                                              retailers, not States or tribes, nor does               technical standards that would require                       of Pesticide Programs.
                                              this action alter the relationships or                  Agency consideration of voluntary
                                              distribution of power and                                                                                              Therefore, 40 CFR chapter I is
                                                                                                      consensus standards pursuant to section
                                              responsibilities established by Congress                                                                             amended as follows:
                                                                                                      12(d) of the National Technology
                                              in the preemption provisions of FFDCA                   Transfer and Advancement Act
                                              section 408(n)(4). As such, the Agency                                                                               PART 180—[AMENDED]
                                                                                                      (NTTAA) (15 U.S.C. 272 note).
                                              has determined that this action will not
                                                                                                                                                                   ■ 1. The authority citation for part 180
                                              have a substantial direct effect on States              VIII. Congressional Review Act
                                                                                                                                                                   continues to read as follows:
                                              or tribal governments, on the
                                              relationship between the national                         Pursuant to the Congressional Review                           Authority: 21 U.S.C. 321(q), 346a and 371.
                                              government and the States or tribal                     Act (5 U.S.C. 801 et seq.), EPA will
                                                                                                      submit a report containing this rule and                     ■  2. In § 180.910, revise the existing
                                              governments, or on the distribution of                                                                               entry for ‘‘Mono-, di-, and
                                              power and responsibilities among the                    other required information to the U.S.
                                                                                                      Senate, the U.S. House of                                    trimethylnapthalenesulfonic acids and
                                              various levels of government or between                                                                              napthalenesulfonic acids formaldehyde
                                              the Federal Government and Indian                       Representatives, and the Comptroller
                                                                                                      General of the United States prior to                        condensates, ammonium and sodium
                                              tribes. Thus, the Agency has determined                                                                              salts (CAS Reg. Nos. 9008–63–3, 9069–
                                              that Executive Order 13132, entitled                    publication of the rule in the Federal
                                                                                                      Register. This action is not a ‘‘major                       80–1, 9084–06–4, 36290–04–7, 91078–
                                              ‘‘Federalism’’ (64 FR 43255, August 10,                                                                              68–1, 141959–43–5, 68425–94–5)’’ to
                                              1999) and Executive Order 13175,                        rule’’ as defined by 5 U.S.C. 804(2).
                                                                                                                                                                   read as follows:
                                              entitled ‘‘Consultation and Coordination                List of Subjects in 40 CFR Part 180
                                              with Indian Tribal Governments’’ (65 FR                                                                              § 180.910 Inert ingredients used pre- and
                                              67249, November 9, 2000) do not apply                    Environmental protection,                                   post-harvest; exemption from the
                                              to this action. In addition, this action                Administrative practice and procedure,                       requirement of a tolerance.
                                              does not impose any enforceable duty or                 Agricultural commodities, Pesticides                         *        *     *        *       *

                                                                                    Inert ingredients                                                  Limits                                    Uses


                                                      *                    *                    *                 *                                        *                         *                        *
                                              Mono-, di-, and trimethylnaphthalenesulfonic acids and naphthalenesulfonic acids                  ........................   Surfactants,        related   adjuvants   of
                                               formaldehyde condensates, ammonium, sodium and potassium salts (CAS Reg.                                                      surfactants
                                               Nos. 9008–63–3, 9069–80–1, 9084–06–4, 36290–04–7, 91078–68–1, 141959–
                                               43–5, 68425–94–5, 67828–14–2).

                                                        *                       *                       *                      *                          *                           *                      *



                                              [FR Doc. 2017–17631 Filed 8–18–17; 8:45 am]
                                              BILLING CODE 6560–50–P
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Document Created: 2017-08-19 00:44:50
Document Modified: 2017-08-19 00:44:50
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 August 21, 2017. Objections and requests for hearings must be received on or before October 20, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactMichael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation82 FR 39541 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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