66308 Federal Register / Vol. 79, No. 216 / Friday, November 7, 2014 / Rules and Regulations 

‘‘Creating a Federal Strategy to Promote 

the Health of Honey Bees and Other 

Pollinators’’ which directs EPA to assess 

the effect of pesticides on bee and other 

pollinator health and take action as 

appropriate. This exemption from the 

requirement of a tolerance is for a 

substance used as an inert ingredient in 

a pesticide formulation and as such is 

not itself a pesticide. However, under 

the strategy, the Agency will consider 

any available product specific data on 

bee toxicity during the product 

registration process. 

XI. 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 30, 2014. 

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 § 180.960, alphabetically add the 

following polymer to the table to read as 

follows: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

* * * * * 

Polymer CAS No. 

*******

2-Propenoic acid, 2-methyl-, phenylmethyl ester, polymer with 2-propenoic acid, peroxydisulfuric acid ([(HO)S(O)2]2O2) sodium salt (1:2)-initiated, compounds with diethanolamine, minimum number average molecular weight (in amu), 2,000 ........ 1574486–33–1 

* * * * * * * 

[FR Doc. 2014–26529 Filed 11–6–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0572; FRL–9917–14] 

FD&C Red No. 40; 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 FD&C Red No. 

40 when used as an inert ingredient as 

colorant in antimicrobial pesticide 

formulation in food-contact surface 

sanitizer products at a maximum level 

in the end-use concentration of 20 parts 

per million (ppm). Diversey 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 FD&C 

Red No. 40. 

DATES: This regulation is effective 

November 7, 2014. Objections and 

requests for hearings must be received 

on or before January 6, 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–2012–0572, 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 T. 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–2012–0572 in the subject line on 

the first page of your submission. All 


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objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before January 6, 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– 

2012–0572, 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 August 22, 

2012 (77 FR 50664) (FRL–9358–9), EPA 

issued a document pursuant to FFDCA 

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

the filing of a pesticide petition (PP 

1E7843) by Diversey Inc., 8310 16th 

Street, Sturtevant, Wisconsin 53177. 

The petition requested that 40 CFR 

180.940(a) be amended by establishing 

an exemption from the requirement of a 

tolerance for residues of FD&C Red No. 

40 (CAS No. 25956–17–6) when used as 

an inert ingredient (colorant) in foodcontact surface sanitizing solutions at a 

maximum level in the end-use 

concentration of 20 parts per million 

(ppm). That document referenced a 

summary of the petition prepared by 

Diversey Inc., the petitioner, which is 

available in the docket, EPA–HQ–OPP– 

2012–0572, at 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 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 FD&C Red No. 40 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with FD&C Red No. 40 is 

detailed in a May 9, 2014 Memorandum 

entitled ‘‘Decision Document for 

Petition Number 1E7843: FD&C Red No. 

40 (CAS Reg. No. 25956–17–6); Human 

Health Risk Assessment and Ecological 

Effects Assessment for Proposed 

Exemption from the Requirement of a 

Tolerance When Used as an Inert 

Ingredient in Pesticide Formulations’’ 

which is available in the docket for this 

rule, EPA–HQ–OPP–2012–0572. A 

summary of that assessment 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 is 

discussed in this unit. 

The European Food Safety Authority 

(EFSA) has conducted the most recent 

(2009) full review of the toxicology of 

FD&C Red No. 40. This document relied 

heavily on the earlier reviews (1980), 

conducted by the Joint FAO/WHO 

Expert Committee on Food Additives 

(JECFA) and the European Union 

Scientific Committee for Food (SCF) in 

1984 and 1989. These evaluations of 

FD&C Red No. 40 included reviews of 

an extensive set of toxicological data 

including genotoxicity, chronic toxicity, 

carcinogenicity, reproductive and 

developmental toxicity and metabolism. 

The available data demonstrated that no 

adverse effects were seen in studies at 

limit dose levels. 

Briefly, no compound related clinical 

signs of toxicity were observed when 

FD&C Red No. 40 (Allura Red AC) was 


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given to rats by gavage at doses varying 

from 215 to 10,000 milligrams/kilogram 

(mg/kg). It was not irritating to the skin 

of rabbits. Repeated dose toxicity 

studies were conducted in rats, dogs 

and pigs. No evidence of systemic 

toxicity was observed in rats fed FD&C 

Red No. 40 in the diet for six weeks at 

doses up to 2,595 mg/kg/day. The dog 

studies (two) were determined to be too 

limited to derive a NOAEL. No 

compound related effects were reported 

in pigs given gavage dose of 1,000 mg/ 

kg/day for 21 days and then increased 

to 1,500 mg/kg/day for an additional 54 

days. 

In chronic studies, no dye-related 

anomalies were noted in terms of 

survival, or gross and histopathology of 

major organs and the skin in mice 

treated dermally with FD&C Red No. 40 

with a 5% test solution twice weekly for 

20 months. A moderate growth 

depression was observed in both sexes 

of rat fed at the highest dose level of 

2,595 mg/kg/day for 92 weeks. No 

compound-related effects were observed 

regarding appearance, behavior, 

survival, organ weights, clinical 

laboratory studies, or gross and 

histopathology in rats. 

FD&C Red No. 40 was evaluated for 

its mutagenic activity in adequate range 

of in vivo and in vitro mutagenicity 

assays. Overall, it gave a negative 

response for mutagenicity in in vivo and 

in vitro assays except Comet assay. 

EFSA Panel considered this finding in 

the light of negative carcinogenicity 

studies, and determined that the 

biological significance of the Comet 

assay results is uncertain. 

As summarized by EFSA, no evidence 

of carcinogenicity was observed in male 

rats at doses up to 2,595 mg/kg/day and 

2,829 mg/kg/day in female rats; and in 

mice at dose levels up to 7,422 mg/kg/ 

day in males and 8,304 mg/kg/day in 

females. 

Relevant reproductive and 

developmental toxicity studies are 

summarized in the EFSA document. In 

a multi-generation reproduction study 

in rats at a dietary levels of 0, 0.37, 0.72, 

1.39 or 5.19% (equivalent to 0, 185, 360, 

695 and 2,595 mg/kg bw/day), no 

treatment related adverse effects were 

observed in the parental animals. Only 

slight growth retardation was observed 

at the high dose levels in F1 and F2

pups. The NOAEL for offspring toxicity 

was 695 mg/kg/day and the LOAEL was 

2,595 mg/kg/day. No reproductive or 

developmental toxicity was seen at high 

doses in three chronic studies in rats 

and mice in which these parameters 

were evaluated concurrently. Rats 

(group number not reported) were 

exposed up to 10% of FD&C Red No. 40 

in the diet (calculated doses of 0, 1,250, 

2,500 and 5,000 mg/kg/day). Litter 

mortality was increased between 22–24 

days of age at a concentration of 10% in 

the diet. Significantly decreased 

running wheel activity was observed in 

all exposed groups. Increased open-field 

rearing was observed in the two highest 

dose groups. The LOAEL was 

determined to be 1,250 mg/kg/day; a 

NOAEL could not be determined from 

this study. No neurobehavioral effects 

were observed in mice administered 

1.68% FD&C Red No. 40 via diet 

(equivalent to 2,400 mg/kg/day) for 2- 

generations. Teratology studies in rats 

and rabbits showed no evidence of 

adverse effects at doses up to 200 mg/ 

kg/day administered via gavage during 

gestation days (GD) 0–19 in rats, and at 

doses up to 700 mg/kg/day administered 

via gavage during GD 6–18 in rabbits. In 

rats (group number not reported) dosed 

with FD&C Red No. 40 up to 0.7% in 

drinking water (equivalent to 939 mg/kg 

bw/day) during GDs, on GD 0–20 a 

significant increase in the incidence of 

fetuses with reduced ossification of the 

hyoid was observed at the highest dose 

level. No other fetal malformations were 

observed. The NOAEL from this study 

was determined to be 546 mg/kg/day. 

In rats fed 5.19% FD&C Red No. 40 in 

the diet, only 0.1% and 29% of the 

unmetabolized dye was found to be 

excreted in the urine and feces, 

respectively. Several metabolites, 

possibly resulting from azo-reduction in 

the gastrointestinal tract (two identified 

as aromatic amines, p-cresidine sulfnic 

acid being the major one), were also 

found in the feces and urine. Finally, 

significant retention in the washed 

intestines of rat was observed, probably 

due to adhesion to the intestinal wall. 

B. Toxicological Points of Departure/

Levels of Concern 

Based on the low potential hazard, 

toxicological endpoints of concern have 

not been identified for FD&C Red No. 

40. 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. JEFCA and EFSA 

established the acceptable daily intake 

(ADI) of 0–7 mg/kg/day based on the 

NOAEL of 695 mg/kg/day derived from 

a reproductive toxicity study in rats, 

which revealed slight growth 

suppression observed mainly at the high 

test levels of 2,595 mg/kg/day in F1 and 

F2 pups and from a teratogenicity study 

in rats which revealed lower body 

weights and growth rates at the highest 

dose level of 2,595 mg/kg/day but not at 

695 mg/kg bw/day. Since adverse effects 

in these two studies were observed at 

2.5 times the limit dose of 1,000 mg/kg/ 

day; EPA concluded that it is not 

warranted to conduct a quantitative risk 

assessment. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses and drinking water. Dietary 

exposure (food and drinking water) to 

FD&C Red No. 40 can occur following 

ingestion of foods with residues from 

food-contact surface sanitizing solutions 

for public eating places, treated dairyand food-processing equipment and 

utensils; pre- and post-harvest crop uses 

and as a direct food additives. In 

addition, dietary exposures to FD&C 

Red No. 40 can occur as a result of its 

use as a color additive in foods. 

However, EPA did not conduct a 

quantitative dietary exposure 

assessment since no endpoint of 

concern for risk assessment has been 

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). 

FD&C Red No. 40 is used as an inert 

ingredient in agricultural pesticide 

products that could result in short- and 

intermediate-term residential exposure. 

Residential exposure can occur via 

dermal and inhalation routes of 

exposure to residential applicator. 

Dermal and inhalation exposure can 

occur from the use of consumer 

products and foods/food additives 

containing FD&C Red No. 40. Since an 

endpoint for risk assessment was not 

identified, a quantitative residential 

exposure assessment for FD&C Red No. 

40 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 FD&C Red No. 40 

to share a common mechanism of 

toxicity with any other substances, and 

FD&C Red No. 40 does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that FD&C Red No. 40 does not 

have a common mechanism of toxicity 


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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 (10X) 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 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

At this time, there is no concern for 

potential sensitivity to infants and 

children resulting from exposures to 

FD&C Red No. 40. There is no reported 

quantitative or qualitative evidence of 

increased susceptibility of rat fetuses to 

in utero exposure to FD&C Red No. 40 

in developmental toxicity studies in 

rats. No quantitative or qualitative 

evidence of increased susceptibility has 

been reported following the pre/ 

postnatal exposure to rats in 2- 

generation reproduction toxicity studies 

in rats. Given the lack of adverse 

toxicological effects at limit dose levels, 

a safety factor analysis has not been 

used to assess the risk. For these reasons 

the additional tenfold safety factor is 

unnecessary. 

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 FD&C 

Red No. 40 because of its low toxicity 

based on animal studies showing 

toxicity at or above the limit dose of 

1,000 mg/kg/day. Taking into 

consideration all available information 

on FD&C Red No. 40, EPA has 

determined that there is a reasonable 

certainty that no harm to any population 

subgroup, including infants and 

children, will result from aggregate 

exposure to FD&C Red No. 40 under 

reasonably foreseeable circumstances. 

Therefore, the establishment of an 

exemption from tolerance under 40 CFR 

180.940(a) for residues of FD&C Red No. 

40 when used as an inert ingredient 

(colorant) in pesticide formulations 

applied to food contact surfaces in 

public eating places, dairy processing 

equipment and food processing 

equipment and utensils up to 20 ppm in 

antimicrobial pesticide formulations is 

safe under FFDCA section 408. 

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. EPA 

is establishing a limitation on the 

amount of FD&C Red No. 40 that may 

be used in pesticide formulations. 

The limitation will be enforced 

through the pesticide registration 

process under the Federal Insecticide, 

Fungicide, and Rodenticide Act 

(FIFRA), 7 U.S.C. 136 et seq. EPA will 

not register any food-contact surface 

antimicrobial pesticide for sale or 

distribution with concentrations of 

FD&C Red No. 40 exceeding 20 ppm in 

the end use formulation. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.940(a) for FD&C Red 

No. 40 (CAS No. 25956–17–6) when 

used as an inert ingredient (colorant) in 

pesticide formulations applied to foodcontact surfaces in public eating places, 

dairy-processing equipment and foodprocessing equipment and utensils up to 

20 ppm in end use formulation. 

VII. Statutory and Executive Order 

Reviews 

This final rule 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 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 exemption 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 


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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 30, 2014. 

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, the table in paragraph 

(a) is amended by alphabetically adding 

an entry for ‘‘FD&C Red No. 40’’ before 

the entry for ‘‘FD&C Yellow No. 5’’ 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 

*******

FD&C Red No. 40 ...................................................................... 25956–17–6 When ready for use, the end-use concentration is not to exceed 20 ppm. 

* * * * * * * 

* * * * * 

[FR Doc. 2014–26526 Filed 11–6–14; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 15 

[DA 14–1507] 

Unlicensed Personal Communications 

Services Devices in the 1920–1930 

MHz Band 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the 

Commission revises its rules. The 

practical effect of this decision is that 

applicants for certification of 

Unlicensed Personal Communications 

Service (UPCS) devices will no longer 

be required to be members of UTAM, 

Inc. (UTAM). 

DATES: Effective November 7, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Patrick Forster, Senior Engineer, (202) 

418–7061, Policy and Rules Division, 

Office of Engineering and Technology, 

(202) 418–2290, Patrick.Forster@fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Order 

adopted October 20, 2014, and released 

October 20, 2014, DA 14–1507. The full 

text of this document is available on the 

Commission’s Internet site at 

www.fcc.gov. It is also available for 

inspection and copying during regular 

business hours in the FCC Reference 

Center (Room CY–A257), 445 12th 

Street SW., Washington, DC 20554. The 

full text of this document also may be 

purchased from the Commission’s 

duplication contractor, Best Copy and 

Printing Inc., Portals II, 445 12th St. 

SW., Room CY–B402, Washington, DC 

20554; telephone (202) 488–5300; fax 

(202) 488–5563; email FCC@

BCPIWEB.COM. 

Summary of the Order 

1. The Order revises part 15 subpart 

D of the Commission’s rules to remove 

and reserve § 15.307. As a result of this 

decision, applicants for certification of 

Unlicensed Personal Communications 

Service (UPCS) devices will no longer 

be required to be members of UTAM, 

Inc. (UTAM). The Commission took the 

action to eliminate the rule without 

notice and comment procedures 

pursuant to section 553(b)(b) of the 

Administrative Procedures Act (5 U.S.C. 

553(b)(B)). 

2. Section 15.307 has served, along 

with other Commission actions, to 

ensure that UTAM is reimbursed for the 

costs it incurred in clearing the 1910– 

1930 MHz band of incumbent 

microwave licensees. In a letter 

submitted to the Commission, UTAM 

indicated that this objective had been 

met. The Commission agreed, and 

concluded that the rule no longer served 

its intended purpose. Moreover, because 

UTAM’s board of directors had 

proposed to its membership a plan of 

dissolution and cessation of all 

corporate activities, the Commission 

anticipated that it would soon become 

impossible for UPCS device 

manufacturers to satisfy § 15.307’s 

membership requirement. 

3. In 1993, the Commission 

reallocated the 1910–1930 MHz band 

from the Private Operational Fixed 

Microwave Service (POFS) to UPCS use. 

As part of this reallocation, the 

Commission designated UTAM to 

manage the transition of the 1910–1930 

MHz band from POFS to UPCS use. 

Under the relocation funding plan 

approved by the Commission, UTAM 

would pay to relocate or agree to share 

the costs to relocate incumbent services 

in the band, and future UPCS device 

manufacturers would reimburse UTAM 

for their share of the incurred costs. The 

UPCS device manufacturers would 

reimburse UTAM via a fee for each 

device sold (which UTAM subsequently 

eliminated), as well as a membership fee 

set by UTAM. To ensure that UTAM 

received this reimbursement, the 

Commission required—via § 15.307— 

that each application for certification of 

UPCS equipment be accompanied by an 

affidavit from UTAM certifying that the 

applicant was a member of UTAM. 

4. In 2004, the Commission redesignated the 1910–1915 MHz and 

1915–1920 MHz bands from UPCS use 

to Broadband PCS and Advanced 

Wireless Service (AWS) operations, 

respectively. As part of the 1910–1915 

MHz band re-designation, the 

Commission determined that UTAM 

was entitled to a reimbursement from 

Nextel Communications, Inc. (the 1910– 

1915 MHz band licensee) for 25 

percent—on a pro rata basis—of the 

total relocation costs it had incurred in 

clearing the 1910–1930 MHz band of 

incumbent microwave stations. In 2007, 

Sprint Nextel Corp. (successor to 

Nextel), reimbursed UTAM for these 

costs. 

5. Similarly, as part of the 1915–1920 

MHz band re-designation, the 

Commission determined that UTAM 

was entitled to a reimbursement from 

the future AWS licensee(s) in the 1915– 

1920 MHz AWS–2 band for 25 

percent—on a pro rata basis—of the 

total relocation costs it had incurred in 


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