[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13821]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
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: [email protected].
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
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
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
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
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
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
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
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
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
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
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.
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.
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
Dated: May 29, 2015.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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
* * * * *
(a) * * *
Pesticide chemical CAS Reg. No. Limits
* * * * * * *
Aluminum sulfate............... 10043-01-3 When ready for use,
concentration is not
to exceed 50 ppm.
* * * * * * *
* * * * *
[FR Doc. 2015-13821 Filed 6-4-15; 8:45 am]
BILLING CODE 6560-50-P