Document ID: EPA-HQ-OPP-2012-0207-0003
Agency: epa
Document Type: Rule
Title: Exemptions from the Requirement of a Tolerance: Aluminum sulfate
Posted Date: 2015-06-05T04:00Z

[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)]
[Rules and Regulations]
[Pages 32034-32038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13821]

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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.

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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/text-idx?&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,

[[Page 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-
adverse-effect 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

[[Page 32036]]

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 food-processing 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 non-occupational, 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

[[Page 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 food-contact 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.

[[Page 32038]]

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]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec.  180.940, add alphabetically the following inert ingredient 
to the table in paragraph (a) to read as follows:

Sec.  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