54248 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Rules and Regulations 

§ 180.532 Cyprodinil; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

Acerola ........................................ 1.5 

* * * * * 

Artichoke, globe .......................... 4.0 

* * * * * 

Feijoa .......................................... 1.5 

* * * * * 

Fruit, stone, group 12–12 ........... 2.0 

* * * * * 

Guava ......................................... 1.5 

* * * * * 

Jaboticaba .................................. 1.5 

* * * * * 

Passionfruit ................................. 1.5 

* * * * * 

Pomegranate .............................. 10 

* * * * * 

Starfruit ....................................... 1.5 

* * * * * 

Wax jambu .................................. 1.5 

* * * * * 

[FR Doc. 2015–22031 Filed 9–8–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0143; FRL–9932–06] 

Propylene Glycol Monomethyl Ether; 

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 propylene 

glycol monomethyl ether (PGME; CAS 

No. 107–98–2) when used as an inert 

ingredient under 40 CFR 180.910 as a 

solvent in pesticide formulations which 

include pre-and post–harvest use on 

crops. Syngenta Crop Protection 

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 PGME. 

DATES: This regulation is effective 

September 9, 2015. Objections and 

requests for hearings must be received 

on or before November 9, 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–2015–0143, 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–2015–0143 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 9, 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– 

2015–0143, 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 April 6, 

2015 (80 FR 18327) (FRL–9924–00), 

EPA issued a document pursuant to 

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

announcing the filing of a pesticide 

petition inert ingredient (PP IN–10775) 

by Syngenta Crop Protection, P.O. Box 

18300, Greensboro, NC 27409, The 

petition requested that 40 CFR 180.910 

be amended by establishing an 


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exemption from the requirement of a 

tolerance for residues of PGME (CAS 

No. 107–98–2) when used as an inert 

ingredient as a solvent in pesticide 

formulations applied to pre- and post– 

harvest use on crops. That document 

referenced a summary of the petition 

prepared by Syngenta Crop Protection, 

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 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 PGME including 

exposure resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with PGME 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 PGME as well as the no-observedadverse-effect-level (NOAEL) and the 

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies are 

discussed in this unit. 

PGME exhibits low acute toxicity by 

the oral, dermal, and inhalation routes. 

PGME is not a skin sensitizer or skin 

irritant and was only slightly irritating 

to the eye. In repeat dose inhalation 

studies ranging from 11 days to six 

months in duration, NOAELs of 300 

parts per million (ppm) and higher were 

seen in rats, mice, rabbits, guinea pigs 

and monkeys. Effects observed included 

sedation, hepatic changes and a 

decrease in body weight gain. Oral 

NOAELs of 459.5 milligram/kilogram/

day (mg/kg/day) and 919 mg/kg/day 

were observed in rat studies lasting 13 

and 5 weeks, respectively. Observations 

included central nervous system (CNS) 

effects at very high doses (above limit 

dose of 1,000 mg/kg/day), enlarged 

livers and weight loss. In a reproduction 

study conducted via the inhalation 

route, offspring effects seen at 3,000 

ppm appear to be related to decreased 

maternal body weight and secondary to 

general toxicity and nutritional stress. 

Decreased maternal body weight was 

also noted at the next lower dose. 

NOAELs in this study were 300 ppm for 

adults and 1,000 ppm for offspring. 

Studies with rats, mice, and rabbits 

showed that PGME was not a 

developmental toxicant (two inhalation 

and three gavage studies). Weight-ofevidence indicates that PGME is not 

genotoxic or carcinogenic. In a 2-year 

bioassay, there were no statistically 

significant increases in any tumor type 

in rats and mice. 

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. 

No acute adverse effect level has been 

selected for PGME. The chronic NOAEL 

of 459.5 mg/kg/day was based on CNS 

effects at very high doses, enlarged 

livers and weight loss in a 13 week oral 

study in rats. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to PGME, EPA considered 


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exposure under the proposed exemption 

from the requirement of a tolerance. 

EPA assessed dietary exposures from 

PGME in food as follows: 

An acute dietary risk assessment was 

not conducted because no endpoint of 

concern following a single exposure was 

identified in the available studies. A 

chronic dietary exposure assessment 

was completed and performed using the 

Dietary Exposure Evaluation Model 

DEEM–FCIDTM, Version 3.16.which 

includes food consumption information 

from the U.S. Department of 

Agriculture’s National Health and 

Nutrition Examination Survey, ‘‘What 

We Eat In America’’, (NHANES/

WWEIA). This dietary survey was 

conducted from 2003 to 2008. In the 

absence of actual residue data, the inert 

ingredient evaluation is based on a 

highly conservative model that assumes 

that the residue level of the inert 

ingredient would be no higher than the 

highest established tolerance for an 

active ingredient on a given commodity. 

Implicit in this assumption is that there 

would be similar rates of degradation 

between the active and inert ingredient 

(if any) and that the concentration of 

inert ingredient in the scenarios leading 

to these highest of tolerances would be 

no higher than the concentration of the 

active ingredient. The model assumes 

100 percent crop treated (PCT) for all 

crops and that every food eaten by a 

person each day has tolerance-level 

residues. A complete description of the 

general approach taken to assess inert 

ingredient risks in the absence of 

residue data is contained in the 

memorandum entitled ‘‘Alkyl Amines 

Polyalkoxylates (Cluster 4): Acute and 

Chronic Aggregate (Food and Drinking 

Water) Dietary Exposure and Risk 

Assessments for the Inerts’’ (D361707, S. 

Piper, 2/25/09) and can be found at 

http://www.regulations.gov in docket ID 

number EPA–HQ–OPP–2008–0738. 

2. Dietary exposure from drinking 

water. For the purpose of the screening 

level dietary risk assessment to support 

this request for an exemption from the 

requirement of a tolerance for PGME, a 

conservative drinking water 

concentration value of 100 parts per 

billion (ppb) based on screening level 

modeling was used to assess the 

contribution to drinking water for the 

chronic dietary risk assessments for 

parent compound. These values were 

directly entered into the dietary 

exposure model. 

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). The highest exposures to 

consumers are likely to be associated 

with the use of paints and varnishes that 

contain PGME with some small dermal 

exposures possible. Inhalation 

exposures to relatively high 

concentrations of PGME are believed to 

be self-limiting due to the irritant effects 

of the chemical. Based on this 

residential exposure assessment, 

exposure to PGME would be low (less 

than 2 mg/kg/day). This level of 

exposure would be two orders of 

magnitude below that which would be 

of concern for PGME. 

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, 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 PGME to share a 

common mechanism of toxicity with 

any other substances, and PGME does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that PGME 

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 (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 

Food Quality Protection Act Safety 

Factor (FQPA 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. 

2. Prenatal and postnatal sensitivity. 

Studies in laboratory animals indicate 

that PGME is not a developmental 

toxicant when administered via 

inhalation or ingestion. Developmental 

studies conducted in rats and rabbits 

with PGME administered via inhalation 

showed no developmental toxicity in 

the rabbit and developmental delays 

(delayed sternebral ossification) in the 

rat but only in the presence of maternal 

toxicity. In oral developmental studies 

in rats, mice, and rabbits, 

developmental delays were seen only in 

the rat fetuses at the highest dose tested. 

3. Conclusion. Based on this 

information there is no concern for 

increased sensitivity to infants and 

children to PGME when used as an inert 

ingredient in pesticide formulations. For 

the same reason, a safety factor analysis 

has not been used to assess risk to 

PGME and, therefore, the additional 

safety factor for the protection of infants 

and children is also unnecessary. 

EPA has determined that reliable data 

show the safety of infants and children 

would be adequately protected if the 

FQPA SF were reduced to 1X. That 

decision is based on the following 

findings: 

i. The toxicity database for PGME is 

complete. 

ii. There is a clinical signs of 

neurotoxicity observed at very high oral 

doses. However, there are no concern at 

this time because the clinical signs were 

observed at or above limit doses. 

Therefore there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that PGME 

results in increased susceptibility in in 

utero rats or rabbits in the prenatal 

developmental studies or in young rats 

in the 2-generation reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100% CT and 

model estimates from the use of PGME 

in pesticidal formulations resulting in 

chronic dietary exposure estimates for 

food and drinking water below the 

Agency’s level of concern. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to PGME in 

drinking water. EPA used similarly 

conservative assumptions to assess 

postapplication exposure of children as 

well as incidental oral exposure of 

toddlers. These assessments will not 

underestimate the exposure and risks 

posed by PGME. 

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 


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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. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, PGME is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to PGME from 

food and water will utilize 15.4% of the 

cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

this unit, regarding residential use 

patterns, chronic residential exposure to 

residues of PGME is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

PGME may be used as an inert 

ingredient in pesticide products that are 

registered for uses that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

PGME. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures are below EPA’s 

level of concern for PGME based on 

highly conservative assumptions made 

regarding residential and dietary 

exposures to PGME as described in Unit 

IV. Section C. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

PGME may be used as an inert 

ingredient in pesticide products that are 

registered for uses that could result in 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

PGME. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined intermediate-term food, 

water, and residential exposures are 

below EPA’s level of concern for PGME 

based on highly conservative 

assumptions made regarding residential 

and dietary exposures to PGME as 

described in Unit IV. Section C. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

PGME is not expected to pose a cancer 

risk to humans. 

6. Determination of safety. Based on 

these risk assessments, 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 PGME 

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 PGME. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 for PGME (CAS 

No. 107–98–2) when used as an inert 

ingredient (as a solvent) in pesticide 

formulations applied to crops, postharvest. 

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 

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 


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54252 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Rules and Regulations 

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: August 17, 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 § 180.910, add alphabetically the 

following inert ingredient to the table to 

read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Propylene glycol monomethyl ether (CAS No. 107–98–2) .............................................. none ............................................................ solvent. 

* * * * * * * 

[FR Doc. 2015–22030 Filed 9–8–15; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 76 

[MB Docket No. 15–53; FCC 15–62] 

Concerning Effective Competition; 

Implementation of Section 111 of the 

STELA Reauthorization Act 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: In this document, the Federal 

Communications Commission 

(Commission) announces that the Office 

of Management and Budget (OMB) has 

approved, for a period of three years, the 

information collection requirements 

associated with the Commission’s 

Report and Order, MB Docket No. 15– 

53, FCC 15–62. This document is 

consistent with the Report and Order, 

which stated that the Commission 

would publish a document in the 

Federal Register announcing OMB 

approval and the effective date of the 

requirements. 

DATES: The rule amendments and FCC 

Form 328, published at 80 FR 38001, 

July 2, 2015 are effective on September 

9, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Cathy Williams, Cathy.Williams@

fcc.gov, (202) 418–2918. 

SUPPLEMENTARY INFORMATION: This 

document announces that, on August 

25, 2015, OMB approved the 

information collection requirements 

contained in the Commission’s Report 

and Order, FCC 15–62, published at 80 

FR 38001, July 2, 2015. The OMB 

Control Numbers 3060–0550 and 3060– 

0560. The Commission publishes this 

document as an announcement of the 

effective date of the requirements. If you 

have any comments on the burden 

estimates listed below, or how the 

Commission can improve the 

collections and reduce any burdens 

caused thereby, please contact Cathy 

Williams, Federal Communications 

Commission, Room 1–C823, 445 12th 

Street SW., Washington, DC 20554. 

Please include the OMB Control 

Numbers, 3060–0550 and 3060–0560 in 

your correspondence. The Commission 

will also accept your comments via 

email at PRA@fcc.gov. 

To request materials in accessible 

formats for people with disabilities 

(Braille, large print, electronic files, 

audio format), send an email to fcc504@

fcc.gov or call the Consumer and 

Governmental Affairs Bureau at (202) 

418–0530 (voice), (202) 418–0432 

(TTY). 

Synopsis 

As required by the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507), 

the FCC is notifying the public that it 

received OMB approval on August 25, 

2015, 2015, for the information 

collection requirements contained 

under OMB control numbers 3060–0550 

and 3060–0560, and FCC Form 328. 

Under 5 CFR part 1320, an agency 

may not conduct or sponsor a collection 

of information unless it displays a 

current, valid OMB Control Number. No 

person shall be subject to any penalty 

for failing to comply with a collection 

of information subject to the Paperwork 

Reduction Act that does not display a 

current, valid OMB Control Number. 

The OMB Control Numbers are 3060– 

0550 and 3060–0560. 

The foregoing notice is required by 

the Paperwork Reduction Act of 1995, 

Public Law 104–13, October 1, 1995, 

and 44 U.S.C. 3507. 

The total annual reporting burdens 

and costs for the respondents are as 

follows: 

OMB Control Number: 3060–0550. 

OMB Approval Date: August 25, 2015. 

OMB Expiration Date: August 31, 

2018. 

Title: Local Franchising Authority 

Certification, FCC Form 328; Section 

76.910, Franchising Authority 

Certification. 

Form No.: FCC Form 328. 

Respondents: State, local or tribal 

governments; Businesses or other forprofit entities. 

Number of Respondents and 

Responses: 7 respondents; 13 responses. 

Estimated Time per Response: 2 

hours. 

Frequency of Response: One-time 

reporting requirement; Third party 

disclosure requirement. 

Obligation to Respond: Required to 

obtain or retain benefits. The statutory 


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