Potassium Salts of Naphthalenesulfonic Acids Formaldehyde Condensates; Exemption From the Requirement of a Tolerance, 39541-39544 [2017-17631]
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39541
Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Rules and Regulations
§ 52.2120
B. Revise Regulation No. 62.2,
C. Under Regulation No. 62.3, revise
the entry for ‘‘Section I,’’ and
■ D. Under Regulation No. 62.6, revise
‘‘Section I’’ and ‘‘Section III’’.
The revisions read as follows:
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Subpart PP—South Carolina
2. Section 52.2120(c) is amended by:
A. Under Regulation No. 62.1 revise
the entries for ‘‘Section I,’’ ‘‘Section IV,’’
and ‘‘Section V,’’
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[FR Doc. 2017–17240 Filed 8–18–17; 8:45 am]
BILLING CODE 6560–50–P
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
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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
sradovich on DSK3GMQ082PROD with RULES
SUMMARY:
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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 https://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,
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Federal Register Notice
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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 https://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:
RDFRNotices@epa.gov.
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).
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Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Rules and Regulations
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
sradovich on DSK3GMQ082PROD with RULES
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 https://
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: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
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16:12 Aug 18, 2017
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dockets generally, is available at https://
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, https://
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
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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
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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 noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (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).
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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
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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.
B. Response to Comments
D. Cumulative Effects From Substances
With a Common Mechanism of Toxicity
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VI. Conclusions
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 https://
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.
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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.
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,
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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).
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]
1. The authority citation for part 180
continues to read as follows:
■
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
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 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:
■
§ 180.910 Inert ingredients used pre- and
post-harvest; exemption from the
requirement of a tolerance.
*
Inert ingredients
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Surfactants,
surfactants
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BILLING CODE 6560–50–P
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[FR Doc. 2017–17631 Filed 8–18–17; 8:45 am]
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Mono-, di-, and trimethylnaphthalenesulfonic acids and naphthalenesulfonic 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).
*
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Agencies
[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)]
[Rules and Regulations]
[Pages 39541-39544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17631]
-----------------------------------------------------------------------
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 https://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 https://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: RDFRNotices@epa.gov.
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 https://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: https://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 https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://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, https://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 https://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