32034 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations 

Pesticide chemical CAS Reg. No. Limits 

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n-Butyl benzoate ................. 136–60–7 When ready for use, the end-use concentration is not to exceed 15,000 ppm. 

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* * * * * 

[FR Doc. 2015–13818 Filed 6–4–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0207; FRL–9927–66] 

Aluminum Sulfate; 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 aluminum 

sulfate (CAS Reg. No. 10043–01–3) 

under 40 CFR 180.940(a). This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of aluminum sulfate. 

DATES: This regulation is effective June 

5, 2015. Objections and requests for 

hearings must be received on or before 

August 4, 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–2012–0207, 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 Publishing 

Office’s e-CFR site at http://

www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under the Federal Food, Drug, and 

Cosmetic Act (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–2012–0207 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 August 4, 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– 

2012–0207, 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. Background and Statutory Findings 

In the Federal Register of May 2, 

2012, (77 FR 25954) (FRL–9346–1), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

tolerance petition (PP 1E7933) by 

Exponent Inc., 1150 Connecticut Ave. 

NW., Suite 1100, Washington, DC 

20036, on behalf of Ecolab, Inc., 370 N. 

Wabasha Street, St. Paul, MN 55102. 

The petition requested that 40 CFR part 

180.940(a) be amended by establishing 

an exemption from the requirement of a 

tolerance for residues of aluminum 

sulfate for use as an inert ingredient in 

antimicrobial pesticide formulations 

applied to food-contact surfaces in 

public eating places, dairy-processing 

equipment, and food-processing 

equipment and utensils at a maximum 

end use concentration not to exceed 50 

parts per million (ppm). That document 

referenced a summary of the petition 

prepared by the petitioner Exponent, 

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Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations 32035 

Inc., which is available in the docket, 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

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.’’ 

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. Pursuant to 

FFDCA section 408(c)(2)(B), in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

408(b)(2)(C), which 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 performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

Consistent with FFDCA section 

408(b)(2)(D), EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability and the 

relationship of this information 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. The 

nature of the toxic effects caused by 

aluminum sulfate is discussed in this 

unit. 

The acute oral toxicity of aluminum 

sulfate is low. The acute oral lethal dose 

(LD)50 in male rats is >5,000 milligram/ 

kilogram (mg/kg). No acute dermal or 

inhalation toxicity studies are available 

on aluminum sulfate. It is not a dermal 

irritant and is minimally irritating to the 

eyes. No skin sensitization studies are 

available. 

The points of departure (PODs) used 

for the chronic and short-term risk 

assessments for aluminum sulfate were 

based on an Organization for Economic 

Cooperation and Development (OECD) 

Guideline 416, 2-generation rat oral 

reproduction study with aluminum 

sulfate (equivalent to OCSPP 

Harmonized Test Guideline 870.3800) 

in which the lowest-observed-adverseeffect level (LOAEL) was 188 milligram/ 

kilogram/day (mg/kg/day) (equivalent to 

37 mg aluminum (Al)/kg/day) based on 

decreased body weight from pups and 

parents and delay in vaginal opening. 

The no-observed-adverse-effect level 

(NOAEL) was 41 mg/kg/day aluminum 

sulfate (equivalent to 8.06 mg Al/kg/

day. 

Apart from the 2-generation rat oral 

reproduction study described above, 

limited data are available on aluminum 

sulfate. However, since ingested 

aluminum sulfate will readily dissociate 

in the stomach to aluminum (as will 

many other aluminum compounds), 

toxicology data on aluminum 

compounds as well as aluminum sulfate 

are considered in determining the 

acceptability and completeness of the 

toxicological data relevant to aluminum 

sulfate. 

Aluminum compounds have been 

evaluated by the Agency for Toxic 

Substances and Disease Registry 

(ASTDR, 2008) and as part of the 

toxicological profile of aluminum, 

ASTDR notes that ‘‘There is a rather 

extensive database on the oral toxicity 

of aluminum in animals. These studies 

clearly identify the nervous system as 

the most sensitive target of aluminum 

toxicity and most of the animal studies 

have focused on neurotoxicity and 

neurodevelopmental toxicity. Other 

adverse effects that have been observed 

in animals orally exposed to aluminum 

include impaired erythropoiesis in rats 

exposed to 230 mg Al/kg/day and 

higher; erythrocyte damage (as 

evidenced by decreases in hemoglobin, 

hematocrit, and erythrocyte osmotic 

fragility, and altered erythrocyte 

morphology) in rats exposed to 230 mg 

Al/kg/day and higher; increased 

susceptibility to infection in mouse 

dams exposed to 155 mg Al/kg/day; 

delays in pup maturation following 

exposure of rats to 53 mg Al/kg/day; and 

decreases in pup body weight gain in 

rats and mice exposed to 103 mg Al/kg/ 

day and higher. Oral studies in rats and 

mice have not found significant 

histopathological changes in the brain 

under typical exposure conditions; 

however, altered myelination was found 

in the spinal cord of mouse pups 

exposed to 330 mg Al/kg/day on 

gestation day 1 through postnatal day 

35. Overt signs of neurotoxicity are 

rarely reported at the doses tested in the 

available animal studies (≤330mg Al/kg/ 

day for bioavailable aluminum 

compounds); rather, exposure to these 

doses is associated with subtle 

neurological effects detected with 

neurobehavioral performance tests. 

Significant alterations in motor 

function, sensory function, and 

cognitive function have been detected 

following exposure to adult or weanling 

rats and mice or following gestation 

and/or lactation exposure of rats and 

mice to aluminum lactate, aluminum 

nitrate, and aluminum chloride. The 

most consistently affected performance 

tests were forelimb and/or hindlimb 

grip strength, spontaneous motor 

activity, thermal sensitivity, and startle 

responsiveness. Significant impairments 

in cognitive function have been 

observed in some studies, although this 

has not been found in other studies even 

at higher doses. Adverse neurological 

effects have been observed in rats and 

mice at doses of 100–200 mg Al/kg/day 

and neurodevelopmental effects have 

been observed in rats and mice at doses 

of 103–330 mg Al/kg/day.’’ 

There are no available carcinogenicity 

studies with aluminum sulfate; 

however, in a cancer study with 

aluminum potassium sulfate, there were 

no exposure-related increased 

incidences of tumors, other proliferative 

lesions, or non-neoplastic lesions in 

B6C3F1 mice that ingested ≤979 mg Al/ 

kg/day as aluminum potassium sulfate 

in the diet for 20 months. Based on this 

information, aluminum sulfate is not 

expected to be a carcinogen. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by aluminum sulfate as 

well as the NOAEL and the LOAEL from 

the toxicity studies are discussed in 

‘‘Aluminum Sulfate: Human Health Risk 

Assessment and Ecological Effects 

Assessment for Proposed Exemption 

from the Requirement for a Tolerance 

When Used as an Inert Ingredient in 

Antimicrobial Pesticide Formulations 

Applied to Food-Contact Surfaces’’ in 

docket ID number EPA–HQ–OPP–2012– 

0267. 

A. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological 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 

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32036 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations 

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 

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. 

A summary of the toxicological 

endpoints for aluminum sulfate used for 

human risk assessment is discussed 

below: 

Acute Dietary Endpoint. No 

appropriate endpoint was identified 

from any of the aluminum sulfate 

studies in the database, including 

developmental toxicity studies in the 

rat. Consequently, EPA determined that 

there was no basis for selecting a dose 

and endpoint for an acute POD for the 

general population or females 13–49 

years old. 

Chronic Dietary Endpoint. A 2- 

generation reproduction study of 

aluminum sulfate in rats was considered 

critical in establishing the POD for 

chronic dietary risk assessment. The 

study supports a NOAEL of 41 mg/kg/ 

day and a LOAEL of 188 mg/kg/day for 

decreased body weight in parents and 

pups and a delay in vaginal opening and 

should be used as the POD for all 

durations and exposure scenarios. An 

uncertainty factor (UF) of 100X (10X for 

interspecies extrapolation and 10X for 

intraspecies variation) is applied to 

obtain a chronic reference dose (cRfD) of 

0.41 mg/kg/day. The Food Quality 

Protection Act (FQPA) factor is reduced 

to 1X. The chronic population adjusted 

dose (cPAD) is 0.41 mg/kg/day. This 

cPAD is protective of potential 

neurotoxicological effects of aluminum 

compounds. 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Exposures to aluminum 

sulfate can occur following ingestion of 

foods with residues from food-contact 

surface sanitizing solutions for public 

eating places, treated dairy- and foodprocessing equipment and utensils as 

well as pre-harvest crop uses. In 

evaluating dietary exposure to 

aluminum sulfate, EPA considered 

exposure under the requested 

exemption from the requirement of a 

tolerance as well as exposures from 

existing uses of aluminum sulfate under 

the extant exemption from the 

requirement of a tolerance under 40 CFR 

180.920. EPA assessed dietary 

exposures from aluminum sulfate in 

food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide 

chemical, if a toxicological study has 

indicated the possibility of an effect of 

concern occurring as a result of a 1-day 

or single exposure. No such effects were 

identified in the toxicological studies 

for aluminum sulfate; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. The chronic 

dietary exposure assessment for this 

inert ingredient utilizes the Dietary 

Exposure Evaluation Model Food 

Commodity Intake Database (DEEM– 

FCID), Version 3.16, EPA, 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. 

Additionally, a dietary exposure 

assessment of aluminum sulfate 

resulting from the requested use in 

antimicrobial food-contact surface 

sanitizing solutions was conservatively 

assumed that 100% of the diet results 

from food treated with food-contact 

surface sanitizers and that 100% of the 

sanitizing solution is transferred into 

food. A highly conservative model 

based on FDA assumptions regarding 

transfer of food contact sanitizing 

solution residues to food is utilized. 

The dietary exposure values derived 

from both the conservative model used 

to estimate residues from application to 

growing crops are combined with the 

exposures estimated from the 

antimicrobial food-contact sanitizer 

uses. 

iii Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that aluminum sulfate is not 

expected to pose a cancer risk to 

humans. Therefore, a dietary exposure 

assessment for the purpose of assessing 

cancer risk is unnecessary. 

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 aluminum 

sulfate, 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 assessment of 

aluminum sulfate. This value was 

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). 

There are no registered pesticide 

products containing aluminum sulfate 

as an inert ingredient for any specific 

use patterns that would result in 

residential exposure. 

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 aluminum sulfate 

to share a common mechanism of 

toxicity with any other substances, and 

aluminum sulfate does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that aluminum sulfate does not 

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Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations 32037 

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. 

C. 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. 

In a 2-generation reproduction toxicity 

study, there was no evidence of 

increased susceptibility of infants and 

children to aluminum sulfate. In this 

study, the offspring and parental 

toxicity NOAEL was 41 mg/kg/day 

based on decreased weight gain in 

offspring, decreased body weight in 

parental animals, and a delay in vaginal 

opening seen at the LOAEL of 188 mg/ 

kg/day. 

3. Conclusion. 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 aluminum 

sulfate includes a 2-generation 

reproduction study, as well as chronic/ 

carcinogenicity studies, mutagenicity 

studies, neurotoxicity studies and 

developmental neurotoxicity studies on 

other related aluminum compounds. 

The Agency concludes that for this 

ingredient, the results of these studies 

provide a reliable basis for assessing the 

range of potential effects to infants and 

children, such that the Agency has 

determined that no additional data are 

necessary at this time to evaluate effects 

to infants and children. 

ii. There are available data on 

neurotoxicity and developmental 

neurotoxicity on aluminum compounds. 

The point of departure selected for risk 

assessment is based on a 2-generation 

rat reproductive toxicity study with 

aluminum sulfate, in which adverse 

effects were identified at dose levels 

below the dose levels at which 

neurotoxic effects or developmental 

neurotoxicological effects were observed 

and is therefore protective of those 

effects; no additional UFs are required 

to account for neurotoxicity. 

iii. There is no evidence of increased 

susceptibility due to pre-or post-natal 

exposure to aluminum in infants and 

children. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

residues equivalent to the highest 

established tolerance-level residues for 

every food commodity. EPA made 

conservative (protective) assumptions 

utilizing a 100 ppb default value in the 

ground and surface water modeling 

used to assess exposure to aluminum 

sulfate in drinking water. In addition, 

highly conservative assumptions were 

utilized in assessing exposures to 

aluminum sulfate resulting from the 

proposed use in food-contact surface 

antimicrobial pesticide formulations. 

These assessments will not 

underestimate the exposure and risks 

posed by aluminum sulfate. 

D. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

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, 

therefore, an acute dietary exposure 

assessment was not conducted. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to aluminum 

sulfate from food and water will utilize 

6.7% of the cPAD for children 1–2 years 

old, the population group receiving the 

greatest exposure. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). A short-term/

intermediate-term adverse effect was 

identified; however, aluminum sulfate 

is not used as inert ingredient in any 

pesticide product registered for any use 

patterns that would result in short-term 

or intermediate-term residential 

exposure. Because there is no short-term 

or intermediate-term residential 

exposure and chronic dietary exposure 

has already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess short-term risk), no further 

assessment of short-term risk is 

necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short-term risk for aluminum 

sulfate. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in a rodent 

carcinogenicity study with aluminum 

potassium sulfate, aluminum sulfate is 

not expected to pose a cancer risk to 

humans. 

5. 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 aluminum 

sulfate residues. 

VII. 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 aluminum sulfate that may be 

used in food-contact surface 

antimicrobial applications. That 

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 foodcontact surface antimicrobial 

applications for sale or distribution that 

contains greater than 50 ppm of 

aluminum sulfate by weight. 

VIII. Conclusion 

Therefore, an exemption is 

established for residues of aluminum 

sulfate for use as an inert ingredient in 

antimicrobial pesticide formulations 

applied to food-contact surfaces in 

public eating places, dairy-processing 

equipment, and food-processing 

equipment and utensils at a maximum 

end use concentration not to exceed 50 

ppm. 

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32038 Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations 

IX. Statutory and Executive Order 

Reviews 

This action establishes an exemption 

from the requirement of a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the exemption in this final rule, do not 

require the issuance of a proposed rule, 

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). 

X. 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: May 29, 2015. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.940, add alphabetically the 

following inert ingredient to the table in 

paragraph (a) 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 

*******

Aluminum sulfate ....................................... 10043–01–3 When ready for use, the end-use concentration is not to exceed 50 ppm. 

*******

* * * * * 

[FR Doc. 2015–13821 Filed 6–4–15; 8:45 am] 

BILLING CODE 6560–50–P 

COMMITTEE FOR PURCHASE FROM 

PEOPLE WHO ARE BLIND OR 

SEVERELY DISABLED 

41 CFR Part 51–6 

Military Resale Commodities 

AGENCY: Committee for Purchase From 

People Who Are Blind or Severely 

Disabled. 

ACTION: Final rule. 

SUMMARY: The Committee for Purchase 

From People Who Are Blind or Severely 

Disabled (the Committee) has in its 

procurement program nonprofit 

agencies that sell products to military 

commissary stores for resale. The items 

sold are assigned to specific number 

series so that the nonprofit agencies, the 

Committee, and the military stores may 

identify the specific products. The 

number series are only used for 

identification of specific products sold 

in the military stores. These product 

numbers are internal only to the 

Committee, the nonprofit agencies, and 

the military commissaries. This rule 

adds additional number series to the 

authorized series so that replacement 

products may have their own unique 

identifying numbers. 

DATES: Effective June 5, 2015. 

ADDRESSES: Committee for Purchase 

From People Who Are Blind or Severely 

Disabled, 1401 S. Clark Street, Suite 

715, Arlington, Virginia 22202–4149. 

FOR FURTHER INFORMATION CONTACT: 

Barry S. Lineback, Telephone: (703) 

603–7740, Fax: (703) 603–0655, or email 

CMTEFedReg@AbilityOne.gov. 

SUPPLEMENTARY INFORMATION: The 

Committee’s regulation at 41 CFR 51– 

6.4, Military Resale Commodities, 

requires military commissary stores and 

other military resale outlets to stock 

mstockstill on DSK4VPTVN1PROD with RULES