[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]


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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.

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