52990 Federal Register / Vol. 79, No. 172 / Friday, September 5, 2014 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0073; FRL–9914–18] 

Sulfuric Acid; 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 sulfuric acid 

(CAS Reg. No. 7664–93–9), when used 

as an inert ingredient, in antimicrobial 

formulations, on food-contact surfaces 

in public eating places, dairy-processing 

equipment, and food-processing 

equipment and utensils. Exponent, Inc., 

on behalf of Ecolab, Inc., submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of sulfuric 

acid. 

DATES: This regulation is effective 

September 5, 2014. Objections and 

requests for hearings must be received 

on or before November 4, 2014 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–2014–0073, 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: Lois 

Rossi, 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). 

• 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/textidx?&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–2014–0073 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 November 4, 2014. 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– 

2014–0073, 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 February 

25, 2014 (79 FR 10458) (FRL–9906–77), 

EPA issued a document pursuant to 

FFDCA section 408, 21 U.S.C. 346a, 

announcing the filing of a pesticide 

petition (PP IN–10654) by Exponent, 

Inc. (1150 Connecticut Ave. NW., 

Washington, DC 20036), on behalf of 

Ecolab, Inc., 370 N. Wasbasha St., St. 

Paul, MN 55102. The petition requested 

that 40 CFR 180.940 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of sulfuric acid (CAS Reg. No. 7664–93– 

9) when used as an inert ingredient in 

antimicrobial formulations applied on 

food-contact surfaces in public eating 

places, dairy-processing equipment, and 

food-processing equipment and utensils 

up to 600 parts per million (ppm) in end 

use formulations. That document 

referenced a summary of the petition 

prepared by Exponent, Inc., on behalf of 

Ecolab, Inc., the petitioner, which is 

available in the docket, http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

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 


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Federal Register / Vol. 79, No. 172 / Friday, September 5, 2014 / Rules and Regulations 52991 

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 sulfuric acid 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with sulfuric acid 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 

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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by sulfuric acid as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

are discussed in this unit. 

In formulating a pesticide product, an 

acidic chemical such as sulfuric acid 

serves a specific purpose, that of a 

neutralizing agent or a pH adjuster. 

During the manufacture of a pesticide 

product (or, in fact, many industrial 

chemicals), it may be necessary to adjust 

the pH of the product. An acid functions 

as a neutralizing agent when the 

hydrogen ion (H+ 1) combines with the 

hydroxy (OH-) in a basic solution to 

form a molecule of water. Small 

amounts of the hydrogen ion would be 

added to the solution to lower the pH 

until a neutral pH is reached. After the 

pH adjustment is performed and the 

neutralization reaction occurs, sulfuric 

acid is no longer present. The reaction 

products that are then present are the 

sulfate (II) negatively charged ion and 

water. 

Alternatively, it might be necessary to 

have a pesticide product maintain an 

acidic pH; thus, the sulfuric acid would 

be added during the manufacturing 

process to deliberately lower the pH, 

which would mean an excess of the 

hydrogen ion. Such products are not 

likely to be sold to the residential 

market. 

As a chemical class, acids are 

significantly different from many of the 

chemicals regulated as inert ingredients 

in pesticide products. First, acids are 

highly corrosive. Due to this property, 

toxicity testing can only be performed 

on very diluted solutions. Therefore, 

toxicity studies performed with 

undiluted (concentrated) sulfuric acid 

are not available. Second, acids are 

highly reactive, and therefore are not 

expected to be persistent in the food 

supply, the environment, or in water 

resources. Sulfuric acid would be 

expected to dissociate and immediately 

react with both plant and animal 

materials. 

Chemically, an acid is a substance 

that yields a hydrogen (H+1) ion when 

dissolved in water. The increase of the 

concentration of the H+ 1 ion reduces 

the pH. It is the hydrogen ion that is 

highly reactive, thus displaying the 

corrosive characteristic. The 

consequences of acute exposure to acids 

are well understood; they are corrosive 

to the eyes, the skin, and the respiratory 

tract. The hazard of any acidic chemical 

derives directly from and is due to these 

irritation and acidic effects. 

Sulfuric acid is a strong acid. It is also 

a commonly used chemical. It has been 

used for years, and therefore, there is a 

significant body of existing publicly 

available information. 

• Solutions of sulfuric acid greater 

than 10% are severely corrosive by all 

routes of exposure. 

• Solutions of sulfuric acid of less 

than 10% are strong irritants. 

• There is sufficient evidence that 

occupational exposure to stronginorganic-acid mists containing sulfuric 

acid is carcinogenic (International 

Agency for Research on Cancer). 

• There were no significant 

developmental or reproductive effects in 

mice or rabbits exposed to 20 milligram/ 

cubic meter (mg/m3) sulfuric acid 

aerosols 7 hours per day on gestation 

days 6 to 15 (Agency for Toxic 

Substances and Disease (ATSDR)). 

In fact, available data for sulfuric acid 

indicates that the acute oral and dermal 

toxicity of sulfuric acid is moderate; the 

acute inhalation lethal concentration 

(LC50) is 18 mg/m3 in guinea pigs; and 

that sulfuric acid is corrosive to the eyes 

and skin in rabbits. 

However, as noted above, exposure to 

sulfuric acid in pesticide products as an 

inert ingredient would be in the role of 

a pH adjuster, that is, a liquid form, not 

a mist. As an inert ingredient small 

amounts of sulfuric acid are 

incorporated in a pesticide product to 

lower the pH. After the pH adjustment 

is performed, the sulfuric acid would be 

neutralized, and therefore no longer 

present. It is recognized that sulfuric 

acid must be used and applied 

according to good manufacturing or 

good agricultural practices. 

There are no available information on 

sulfuric acid indicative of a human 

health hazard from the ingestion of food 

directly treated with sulfuric acid. In 

fact, sulfuric acid would not be present 

in consumed foods. The small amounts 

of acids that might be added to a food 

during processing react rapidly with a 

food substance. Thus, the exposure is 

actually to sulfate residues. 

In aqueous environments, sulfuric 

acid will rapidly dissociate into sulfate 

ions and hydrogen protons. The sulfate 


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52992 Federal Register / Vol. 79, No. 172 / Friday, September 5, 2014 / Rules and Regulations 

anion, which is a normal constituent in 

the body, predominantly resulting from 

the body’s metabolism of sulfurcontaining food sources such as foods 

containing the essential amino acids 

cysteine and methionine, will enter the 

body electrolyte pool. Sulfate anions are 

vital components in a number of human 

biosynthetic pathways such as cartilage 

production and the formation of 

pancreatic digestive enzymes. 

Additionally, the sulfate anion is also an 

important conjugate in the Phase II 

conjugation/elimination of oxidized 

(OH) aromatic ring metabolites and for 

hydroxyl steroid hormones, such as 

estrogen, where it acts as a transport 

agent to target organ tissue receptors. 

Following ingestion, sulfate anions are 

predominantly not absorbed from the 

gastrointestinal tract and are excreted 

unchanged in urine. Therefore, the 

sulfate anion is unlikely to pose 

significant toxicity. 

The sulfate residues (resulting from 

the use of sulfuric acid) are of minimal 

toxicity. In fact, calcium, sodium, 

magnesium, and potassium sulfates 

have been previously classified as List 

4A, chemical substances of minimal 

risk. Various sulfate chemicals have 

uses as direct food additives. The 

human body metabolizes sulfate 

through well-understood pathways. It is 

a necessary human nutrient. There are 

no significant adverse effects, to the 

general public or any population 

subgroup from consumption of residues 

of sulfuric acid (actually the neutralized 

form which is the sulfate ion in 

solution) resulting from pesticide 

product uses. 

Sulfuric acid was not mutagenic in 

the Ames Test. It caused chromosomal 

aberrations in a non-bacterial test in 

vitro. However, it is well known that the 

aberrations were a consequence of 

reduced pH. 

Neither a neurotoxicity nor an 

immunotoxicity study was available for 

review. However, any sulfuric acid 

absorbed into the body would be in the 

form of inorganic sulfate, which is 

indistinguishable from endogenous 

sulfate. As a normal body constituent, 

sulfate is unlikely to be neurotoxic or 

immunotoxic. 

B. Toxicological Points of Departure/

Levels of Concern 

Based on the low potential hazard, 

toxicological endpoints of concern have 

not been identified for sulfuric acid. 

Thus, due to its low potential hazard 

and lack of hazard endpoint, the Agency 

has determined that a quantitative risk 

assessment using safety factors applied 

to a point of departure protective of an 

identified hazard endpoint is not 

appropriate. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses and drinking water. In 

evaluating dietary exposure to sulfuric 

acid, EPA considered exposure under 

the proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from sulfuric 

acid in food as follows: 

Dietary exposure (food and drinking 

water) to sulfuric acid can occur 

following ingestion of foods with 

residues from food-contact surface 

sanitizing solutions for public eating 

places, treated dairy- and foodprocessing equipment and utensils; preand post-harvest crop uses and as a 

direct food additives. However, a 

quantitative dietary exposure 

assessment was not conducted since an 

endpoint for risk assessment was not 

identified. 

2. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

Residential (dermal and inhalation) 

exposure are not expected from the 

current requested use pattern. However, 

residential (dermal and inhalation) 

exposure can occur from the use of 

consumer products containing sulfuric 

acid (i.e., stain remover, drain 

solutions). Since an endpoint for risk 

assessment was not identified, a 

quantitative residential exposure 

assessment for sulfuric acid was not 

conducted. 

3. 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 sulfuric acid to 

share a common mechanism of toxicity 

with any other substances, and sulfuric 

acid does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that sulfuric acid 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. 

D. Safety Factor for Infants and 

Children 

Section 408(b)(2)(C) of FFDCA 

provides that EPA shall apply an 

additional tenfold (10×) margin of safety 

for infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10×, or uses a different 

additional SF when reliable data 

available to EPA support the choice of 

a different factor. 

As part of its qualitative assessment, 

the Agency did not use SFs for assessing 

risk, and no additional SF is needed for 

assessing risk to infants and children. 

Based on an assessment of sulfuric acid 

and its chemical properties, EPA has 

concluded that there are no 

toxicological endpoints of concern for 

the U.S. population, including infants 

and children. 

E. Aggregate Risks and Determination of 

Safety 

In examining aggregate exposure, EPA 

takes into account the available and 

reliable information concerning 

exposures to pesticide residues in food 

and drinking water, and nonoccupational pesticide exposures. 

Dietary (food and drinking water) and 

non-dietary (residential) exposures of 

concern are not anticipated for sulfuric 

acid because it dissociates to ions in 

water, these ions are essential 

components in the human metabolic 

processes and there are no toxicity 

issues. In addition, it is currently 

exempted from the requirement of a 

tolerance (with limitations) under 40 

CFR 180.940(b) and (c); 40 CFR 180.910 

and 40 CFR 180.1019. Further, the Food 

and Drug Administration (FDA) 

considers sulfuric acid as generally 

recognized as safe (GRAS) for use in 

foods and drinking water. Taking into 

consideration all available information 

on sulfuric acid up to 600 ppm, EPA has 

determined that there is a reasonable 

certainty that no harm to any population 

subgroup will result from aggregate 

exposure to sulfuric acid under 

reasonable foreseeable circumstances. 

Therefore, the establishment of an 

exemption from tolerance under 40 CFR 


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Federal Register / Vol. 79, No. 172 / Friday, September 5, 2014 / Rules and Regulations 52993 

180.940 for residues of sulfuric acid 

when used as an inert ingredient in 

pesticide formulations on food contact 

surfaces in public eating places, dairy 

processing equipment and food 

processing equipment and utensils up to 

600 ppm in antimicrobial formulations, 

is safe under FFDCA section 408. 

V. Other Considerations 

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. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.940 for sulfuric acid 

(CAS Reg. No. 7664–93–9) when used as 

an inert ingredient in microbial 

formulations applied on food-contact 

surfaces in public eating places, dairyprocessing equipment and foodprocessing equipment and utensils up to 

600 ppm. 

Paragraph (b) of 40 CFR 180.940 

contains an entry exempting residues of 

sulfuric acid in antimicrobial 

formulations applied to dairyprocessing equipment and foodprocessing equipment and utensils up to 

288 ppm, and paragraph (c) of 40 CFR 

180.940 contains an entry exempting 

residues of sulfuric acid in 

antimicrobial formulations applied to 

food-processing equipment and utensils 

at concentrations not to exceed 228 

ppm. Because EPA is establishing an 

exemption for residues of sulfuric acid 

in paragraph (a) of 40 CFR 180.940, 

which would exempt residues of 

sulfuric acid in antimicrobial 

formulations applied to food-contact 

surfaces in public eating places, dairyprocessing equipment, and foodprocessing equipment and utensils at 

concentrations not to exceed 600 ppm, 

this exemption supersedes the current 

exemptions in paragraphs (b) and (c) of 

40 CFR 180.940. To avoid confusion 

caused by inconsistency between the 

paragraphs and because all residues 

covered under 40 CFR 180.940(b) and 

(c) would also be covered under 40 CFR 

180.940(a), EPA is removing the entries 

for sulfuric acid (CAS Reg. No. 7664– 

93–9) in 40 CFR 180.940(b) and (c). 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes 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 final rule 

has been exempted from review under 

Executive Order 12866, this final rule 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 final rule 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 tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This final rule 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 final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(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 of 1995 

(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: August 25, 2014. 

Lois Rossi, 

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 § 180.940: 

■ a. Alphabetically add the following 

inert ingredient to the table in paragraph 

(a). 

■ b. Remove the entries for sulfuric acid 

(CAS Reg. No. 7664–93–9) from the 

tables in paragraphs (b) and (c). 

The addition reads as follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 


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52994 Federal Register / Vol. 79, No. 172 / Friday, September 5, 2014 / Rules and Regulations 

Pesticide chemical CAS Reg. No. Uses 

*******

Sulfuric acid .......................... 7664–93–9 ......................... Food-contact surfaces in public eating places, dairy-processing equipment, and 

food-processing equipment and utensils in antimicrobial formulations. Not to exceed 600 ppm. 

* * * * * * * 

* * * * * 

[FR Doc. 2014–21109 Filed 9–4–14; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Parts 146, 147, 148, 155, and 

156 

[CMS–9941–F] 

RIN 0938–AS32 

Patient Protection and Affordable Care 

Act; Annual Eligibility 

Redeterminations for Exchange 

Participation and Insurance 

Affordability Programs; Health 

Insurance Issuer Standards Under the 

Affordable Care Act, Including 

Standards Related to Exchanges 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule. 

SUMMARY: This final rule specifies 

additional options for annual eligibility 

redeterminations and renewal and reenrollment notice requirements for 

qualified health plans offered through 

the Exchange, beginning with annual 

redeterminations for coverage for benefit 

year 2015. This final rule provides 

additional flexibility for Exchanges, 

including the ability to propose unique 

approaches that meet the specific needs 

of their state, while streamlining the 

consumer experience. 

DATES: These regulations are effective 

on October 6, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Jacob Ackerman, (301) 492–4179, for 

questions regarding parts 146 through 

148. Christine Hammer, (301) 492–4431, 

for questions regarding part 155. 

Spencer Manasse, (301) 492–5141, for 

questions regarding part 156. 

SUPPLEMENTARY INFORMATION: This 

Federal Register document is also 

available from the Federal Register 

online database through Federal Digital 

System (FDsys), a service of the U.S. 

Government Printing Office. This 

database can be accessed via the 

internet at http://www.gpo.gov/fdsys. 

Table of Contents 

I. Background 

A. Legislative Overview 

B. Stakeholder Consultation and Input 

C. Structure of the Final Rule 

II. Provisions of the Proposed Regulations 

and Analysis and Responses to Public 

Comments 

A. Part 146—Requirements for the Group 

Health Insurance Market; Subpart E— 

Provisions Applicable to Only Health 

Insurance Issuers 

B. Part 147—Health Insurance Reform 

Requirements for the Group and 

Individual Health Insurance Markets 

C. Part 148—Requirements for the 

Individual Health Insurance Market; 

Subpart B—Requirements Relating to 

Access and Renewability of Coverage 

D. Part 155—Exchange Establishment 

Standards and Other Related Standards 

Under the Affordable Care Act; Subpart 

D—Exchange Functions in the 

Individual Market: Eligibility 

Determinations for Exchange 

Participation and Insurance Affordability 

Programs 

E. Part 156—Health Insurance Issuer 

Standards Under the Affordable Care 

Act, Including Standards Related to 

Exchanges; Subpart M—Qualified Health 

Plan Issuer Responsibilities 

III. Collection of Information Requirements 

IV. Regulatory Impact Statement 

I. Background 

A. Legislative Overview 

The Patient Protection and Affordable 

Care Act (Pub. L. 111–148) was enacted 

on March 23, 2010. The Health Care and 

Education Reconciliation Act of 2010 

(Pub. L. 111–152), which amended and 

revised several provisions of the Patient 

Protection and Affordable Care Act, was 

enacted on March 30, 2010. In this final 

rule, we refer to the two statutes 

collectively as the ‘‘Affordable Care 

Act.’’ Subtitles A and C of Title I of the 

Affordable Care Act reorganized, 

amended, and added to the provisions 

of part A of Title XXVII of the Public 

Health Service Act (PHS Act) relating to 

group health plans and health insurance 

issuers in the group and individual 

markets. 

Starting on October 1, 2013 for 

coverage starting as soon as January 1, 

2014, qualified individuals and 

qualified employers have been able to 

purchase qualified health plans 

(QHPs)—private health insurance that 

has been certified as meeting certain 

standards—through competitive 

marketplaces called Exchanges or 

Health Insurance Marketplaces. The 

word ‘‘Exchanges’’ refers to both State 

Exchanges, also called State-based 

Exchanges, and Federally-facilitated 

Exchanges (FFEs). In this final rule, we 

use the terms ‘‘State Exchange’’ or 

‘‘FFE’’ when we are referring to a 

particular type of Exchange. When we 

refer to ‘‘FFEs,’’ we are also referring to 

State Partnership Exchanges, which are 

a form of FFE. 

Section 1411(f)(1)(B) of the Affordable 

Care Act directs the Secretary of Health 

and Human Services (the Secretary) to 

establish procedures to redetermine the 

eligibility of individuals on a periodic 

basis in appropriate circumstances. 

Section 1321(a) of the Affordable Care 

Act provides authority for the Secretary 

to establish standards and regulations to 

implement the statutory requirements 

related to Exchanges, QHPs and other 

components of Title I of the Affordable 

Care Act. Section 2703 of the PHS Act, 

as added by the Affordable Care Act, 

and sections 2712 and 2741 of the PHS 

Act, as added by the Health Insurance 

Portability and Accountability Act of 

1996, require health insurance issuers in 

the group and individual markets to 

guarantee the renewability of coverage 

unless an exception applies. 

B. Stakeholder Consultation and Input 

The Department of Health and Human 

Services (HHS) has consulted with 

stakeholders on a number of policies 

related to the operation of Exchanges, 

including eligibility redetermination. 

HHS has held a number of listening 

sessions with consumers, providers, 

employers, health plans, and State 

representatives to gather public input. 

HHS consulted with stakeholders 

through regular meetings with the 

National Association of Insurance 

Commissioners (NAIC), regular contact 

with states through the Exchange grant 

process, meetings with the CMS Tribal 

Technical Advisory Group and an All 

Tribes Call on July 21, 2014 with tribal 

leaders and representatives, health 

insurance issuers, trade groups, 

consumer advocates, employers, and 


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