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

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,’’ 

■ 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: 

§ 52.2120 Identification of plan. 

* * * * * 

(c) * * * 

AIR POLLUTION CONTROL REGULATIONS FOR SOUTH CAROLINA

State citation Title/subject State 

effective date 

EPA 

approval date Federal Register Notice 

*******

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 

No. 62.2.

Prohibition of Open Burning ..................................................... 12/27/2013 8/21/2017 [Insert citation of publication]. 

*******

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

*******

Section I ....... Control of Fugitive Particulate Matter in Non-Attainment 

Areas.

11/27/2015 8/21/2017 [Insert citation of publication]. 

*******

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

*******

* * * * * 

[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 

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: 

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). 


sradovich on DSK3GMQ082PROD with RULES
39542 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Rules and Regulations 

• 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 


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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 

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). 

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, 


sradovich on DSK3GMQ082PROD with RULES
39544 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Rules and Regulations 

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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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 Limits Uses 

*******

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).

........................ Surfactants, related adjuvants of 

surfactants 

* * * * * * * 

[FR Doc. 2017–17631 Filed 8–18–17; 8:45 am] 

BILLING CODE 6560–50–P 


sradovich on DSK3GMQ082PROD with RULES