62462 Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Rules and Regulations 

comments in a subsequent final action 

based on the proposal. If we do not 

receive timely adverse comments, the 

direct final approval will be effective 

without further notice on December 15, 

2015. 

V. Statutory and Executive Order 

Reviews 

Under the CAA, the Administrator is 

required to approve a SIP submission 

that complies with the provisions of the 

Act and applicable Federal regulations. 

42 U.S.C. 7410(k); 40 CFR 52.02(a). 

Thus, in reviewing SIP submissions, the 

EPA’s role is to approve state choices, 

provided that they meet the criteria of 

the Clean Air Act. Accordingly, this 

action merely approves state law as 

meeting Federal requirements and does 

not impose additional requirements 

beyond those imposed by state law. For 

that reason, this action: 

• Is not a significant regulatory action 

subject to review by the Office of 

Management and Budget under 

Executive Orders 12866 (58 FR 51735, 

October 4, 1993) and 13563 (76 FR 3821, 

January 21, 2011); 

• does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• does not provide the EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, the SIP is not approved 

to apply on any Indian reservation land 

or in any other area where the EPA or 

an Indian tribe has demonstrated that a 

tribe has jurisdiction. In those areas of 

Indian country, the rule does not have 

tribal implications and will not impose 

substantial direct costs on tribal 

governments or preempt tribal law as 

specified by Executive Order 13175 (65 

FR 67249, November 9, 2000). 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. The EPA will 

submit a report containing this action 

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. A major rule cannot take effect 

until 60 days after it is published in the 

Federal Register. This action is not a 

‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by December 15, 

2015. Filing a petition for 

reconsideration by the Administrator of 

this final rule does not affect the finality 

of this action for the purposes of judicial 

review nor does it extend the time 

within which a petition for judicial 

review may be filed, and shall not 

postpone the effectiveness of such rule 

or action. Parties with objections to this 

direct final rule are encouraged to file a 

comment in response to the parallel 

notice of proposed rulemaking for this 

action published in the Proposed Rules 

section of today’s Federal Register, 

rather than file an immediate petition 

for judicial review of this direct final 

rule, so that the EPA can withdraw this 

direct final rule and address the 

comment in the proposed rulemaking. 

This action may not be challenged later 

in proceedings to enforce its 

requirements (see section 307(b)(2)). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Ozone, Reporting and recordkeeping 

requirements, Volatile organic 

compounds. 

Dated: September 25, 2015. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

Part 52, Chapter I, Title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for Part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart D—Arizona 

■ 2. Section 52.120 is amended by 

adding paragraph (c)(172) to read as 

follows: 

§ 52.120 Identification of plan. 

* * * * * 

(c) * * * 

(172) The following plan was 

submitted July 2, 2014, by the 

Governor’s designee. 

(i) [Reserved] 

(ii) Additional materials. 

(A) Arizona Department of 

Environmental Quality (ADEQ). 

(1) MAG 2014 Eight-Hour Ozone 

Plan—Submittal of Marginal Area 

Requirements for the Maricopa 

Nonattainment Area (June 2014), 

excluding: 

(i) Sections titled ‘‘A Nonattainment 

Area Preconstruction Permit Program— 

CAA section 182(a)(2)(C),’’ ‘‘New Source 

Review—CAA, Title I, Part D,’’ and 

‘‘Offset Requirements: 1:1 to 1 (Ratio of 

Total Emission Reductions of Volatile 

Organic Compounds to Total Increased 

Emissions)—CAA Section 182(a)(4)’’ on 

pages 8 and 9 and section titled ‘‘Meet 

Transportation Conformity 

Requirements—CAA Section 176(c)’’ on 

pages 10 and 11. 

(ii) Appendices A and B. 

[FR Doc. 2015–26023 Filed 10–15–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0363; FRL–9933–98] 

2-Propen-1-Aminium, N,N-Dimethyl-NPropenyl-, Chloride, Homopolymer; 

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 


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Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Rules and Regulations 62463 

tolerance for residues of 2-propen-1- 

aminium, N,N-dimethyl-N-propenyl-, 

chloride, homopolymer (PolyDADMAC, 

CAS No. 26062–79–3) when used as an 

inert ingredient under 40 CFR 

180.940(a) as a dispersing aid in food 

contact surface sanitizing solutions at 

less than 0.6% by weight in the final 

product. Scientific & Regulatory 

Solutions, L.L.C., on behalf of SNF, 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 

PolyDADMAC. 

DATES: This regulation is effective 

October 16, 2015. Objections and 

requests for hearings must be received 

on or before December 15, 2015, 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–2015–0363, 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: 

Susan Lewis, 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–2015–0363 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 December 15, 2015. 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– 

2015–0363, 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 July 17, 

2015 (80 FR 42462) (FRL–9929–13), 

EPA issued a document pursuant to 

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

announcing the filing of a pesticide 

petition (PP IN–10750) by Scientific & 

Regulatory Solutions, L.L.C., 3450 Old 

Washington Rd #303, Waldorf, MD 

20602 on behalf of SNF, Inc., 1 

Chemical Plant Road, Riceboro, GA 

31321. The petition requested that 40 

CFR 180.940(a) be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of PolyDADMAC, (CAS No. 26062–79– 

3) when used as an inert ingredient as 

a dispersing aid in pesticide 

formulations at less than 0.6% by 

weight. That document referenced a 

summary of the petition prepared by 

Scientific & Regulatory Solutions, 

L.L.C., on behalf of SNF, 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 

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 exemption is ‘‘safe.’’ 


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62464 Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Rules and Regulations 

Section 408(c)(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 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 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 PolyDADMAC 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with PolyDADMAC 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 PolyDADMAC 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. 

A single dose feeding study with rats 

classified PolyDADMAC as ‘‘slightly 

toxic’’ at a dose level of 5 milliliter/

kilogram (mL/kg) (approx. 2,000 

milligram/kilogram (mg/kg)). The 

results of two skin irritation studies 

performed with rabbits indicate that 

PolyDADMAC is not a skin irritant. In 

two eye irritation studies performed 

with PolyDADMAC on rabbits, the 

results indicate that the product was 

slightly irritating to the eyes and that 

the effects were totally reversed within 

72 hours following exposure. In an eye 

study performed with PolyDADMAC on 

cultured fibroblasts, the results indicate 

that PolyDADMAC is slightly irritating. 

In a teratology study performed with 

Sprague-Dawley rats, the administration 

of 600 milligram/kilogram/day (mg/kg/

day) of PolyDADMAC, and to a lesser 

extent, at the 450 and 150 mg/kg/day 

test groups, elicited a significant 

reduction in maternal food consumption 

during the first half of the dosing 

period. The NOAEL for PolyDADMAC 

on embryonic development is 600 mg/ 

kg/day. A multi-generational study 

performed with PolyDADMAC using 

Sprague-Dawley rats dosed with 0.375, 

12.5, and 125 mg/kg/day (oral gavage) 

showed no increase in reproductive 

failure, nor were there any effects upon 

the fertility index or any other F1 or F2 

generation parameters. The inferred 

NOAEL from the study was 125 mg/kg/ 

day. The two genotoxicity studies 

performed with PolyDADMAC were 

negative in both an Ames test and in a 

mouse micronucleus assay. There are no 

carcinogenicity studies available for 

PolyDADMAC. However, no significant 

systemic toxicity was observed in the 

teratology, multi-generational and 

mutagenicity toxicity studies. In the 

absence of significant systemic toxicity, 

and lack of mutagenicity concerns, 

PolyDADMAC is not likely to be 

carcinogenic. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which the NOAEL and the 

LOAEL are identified. Uncertainty/

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

PolyDADMAC is a large molecular 

weight chemical which satisfies all of 

the TSCA Polymer Exemption Rule 

except for its cationic properties. 

Generally, high molecular weight 

polymers are unlikely to be absorbed 

significantly through any route of 

exposure. In the case of PolyDADMAC, 

this is evidenced by: No systemic 

toxicity up to 600 mg/kg/day in the 

teratology study, no systemic toxicity in 

the multi-generational reproduction 

study up to 125 mg/kg/day, and low 

acute toxicity. Therefore, no adverse 

effect level endpoints have been 

selected for PolyDADMAC, and EPA 

concludes that it is not necessary to 

assess quantitative dietary risk or risk 

from exposure via dermal or inhalation. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to PolyDADMAC, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from 

PolyDADMAC in food as follows: Acute 

dietary assessments take into account 

exposure estimates from dietary 

consumption of food and drinking 

water. Chronic dietary assessments take 

into account dietary food and drinking 

water as well as food contact surface 

sanitation uses. In the case of 

PolyDADMAC, there are no current or 

proposed crop pesticidal uses; therefore 

oral exposures from that route 

(including exposure through drinking 

water) are not expected. Dietary 

exposure to PolyDADMAC can occur 

through its use in food contact 

sanitizing solutions. However, 

PolyDADMAC is a large molecular 

weight chemical which is unlikely to be 

absorbed significantly through any route 

of exposure and no endpoints have been 


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Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Rules and Regulations 62465 

selected for it. The Agency has not 

identified any concerns for 

carcinogenicity relating to 

PolyDADMAC; therefore, a cancer 

dietary exposure assessment was not 

performed. 

2. Dietary exposure from drinking 

water. PolyDADMAC residues may be 

found in drinking water. However, since 

an endpoint of concern was not 

identified for the dietary assessment 

(food and drinking water), a quantitative 

dietary exposure risk assessment was 

not conducted. 

3. 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). 

While there are no current or 

proposed residential uses for 

PolyDADMAC, it is possible that 

PolyDADMAC may be used as an inert 

ingredient in pesticide products for 

which residential exposures may result. 

However, in the case of PolyDADMAC 

no applicable endpoints of concern for 

residential exposures have been 

identified and a quantitative exposure 

assessment from residential exposures 

was not performed. 

4. 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 or exemption from 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 PolyDADMAC to 

share a common mechanism of toxicity 

with any other substances, and 

PolyDADMAC does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that PolyDADMAC 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 

1. In general. 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 safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

Teratology and multi-generational 

studies in laboratory animals indicate 

that PolyDADMAC caused no increase 

in reproductive failure nor were there 

any PolyDADMAC related effects upon 

the fertility index or any other F1 or F2 

generation parameters (e.g., litter size, 

pup weight, fertility and parturition, 

reproductive indices such as mating 

index, fecundity index, male or female 

fertility indices, etc.). Finally, there was 

no remarkable pathology noted upon 

necropsy of any of the test animals. 

Neurotoxicity was not observed in a 

reproduction/developmental screening 

study in rats where neurotoxicity 

parameters were evaluated. 

3. Conclusion. Based on an 

assessment of PolyDADMAC, EPA has 

concluded that there are no 

toxicological endpoints of concern for 

the U.S. population, including infants 

and children, and has conducted a 

qualitative assessment. As part of its 

qualitative assessment, the Agency did 

not use safety factors for assessing risk, 

and no additional safety factor is needed 

for assessing risk to infants and 

children. 

E. Aggregate Risks and Determination of 

Safety 

Determination of safety section. EPA 

determines whether acute and chronic 

dietary pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the acute PAD (aPAD) and chronic 

PAD (cPAD). For linear cancer risks, 

EPA calculates the lifetime probability 

of acquiring cancer given the estimated 

aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

Based on the lack of any endpoints of 

concern, 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 PolyDADMAC residues. 

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. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nation Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for PolyDADMAC. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.940(a) for 

PolyDADMAC (CAS No. 26062–79–3) 

when used as an inert ingredient as a 

dispersing aid in food contact surface 

sanitizing solutions at less than 0.6% by 

weight in the final product. 

VII. Statutory and Executive Order 

Reviews 

This action 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 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 


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62466 Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Rules and Regulations 

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 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: October 7, 2015. 

Susan Lewis, 

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), add alphabetically 

the inert ingredient ‘‘2-propen-1- 

aminium, N,N-dimethyl-N-propenyl-, 

chloride, homopolymer (CAS No. 

26062–79–3)’’ to the table to read as 

follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

Pesticide chemical CAS Reg. No. Limits 

*******

2-propen-1-aminium, N,N-dimethyl-N-propenyl-, chloride, 

homopolymer.

26062–79–3 When ready for use, the end-use concentration is not to exceed 0.6%. 

*******

* * * * * 

[FR Doc. 2015–26297 Filed 10–15–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

46 CFR Parts 2, 5, 11, 107, 113, 114, 

117, 125, 159, 162, 175, and 180 

[Docket No. USCG–2015–0867] 

Shipping; Technical, Organizational, 

and Conforming Amendments 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: This final rule makes nonsubstantive technical, organizational, 

and conforming amendments to existing 

regulations throughout Title 46 of the 

Code of Federal Regulations. This rule 

will have no substantive effect on the 

regulated public. 

DATES: This final rule is effective 

October 16, 2015. 

ADDRESSES: Documents mentioned in 

this preamble as being available in the 

docket are part of docket USCG–2015– 

0867, which is available at http://

regulations.gov. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this final rule, 

call or email Mr. Paul Crissy, Coast 

Guard; telephone 202–372–1093, email 

Paul.H.Crissy@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

Table of Contents for Preamble 

I. Abbreviations 

II. Regulatory History 

III. Basis and Purpose 

IV. Discussion of the Rule 

V. Regulatory Analyses 

A. Regulatory Planning and Review 

B. Small Entities 

C. Assistance for Small Entities 

D. Collection of Information 

E. Federalism 

F. Unfunded Mandates Reform Act 

G. Taking of Private Property 

H. Civil Justice Reform 

I. Protection of Children 

J. Indian Tribal Governments 

K. Energy Effects 

L. Technical Standards 

M. Environment 

I. Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

E.O. Executive Order 

FR Federal Register 

OMB Office of Management and Budget 

Pub. L. Public Law 

§ Section symbol 

U.S.C. United States Code 


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