Bacillus simplex strain BU288; Exemption From the Requirement of a Tolerance, 19001-19005 [2017-08249]
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Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Rules and Regulations
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).
§ 180.693
residues.
VII. Congressional Review Act
[EPA–HQ–OPP–2016–0123; FRL–9960–61]
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).
Bacillus simplex strain BU288;
Exemption From the Requirement of a
Tolerance
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: April 5, 2017,
Michael Goodis,
Director, Registration Division, Office of
Pesticide Programs.
asabaliauskas on DSK3SPTVN1PROD with RULES
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. Add § 180.693 to subpart C to read
as follows:
■
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Benzobicyclon; tolerances for
(a) General. [Reserved]
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. Tolerances with regional
registration, as defined in § 180.1(l), are
established for residues of the herbicide
benzobicyclon, including its metabolites
and degradates, in or on the commodity
in the table below. Compliance with the
tolerance levels specified below is to be
determined by measuring only
benzobicyclon, 3-[2-chloro-4(methylsulfonyl)benzoyl]-4(phenylthio)bicyclo-[3.2.1]oct-3-en-2one), in or on the following raw
agricultural commodities:
Commodity
Parts per
million
Rice, grain ............................
0.01
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. 2017–08357 Filed 4–24–17; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of Bacillus
simplex strain BU288 when used as an
inert ingredient (emulsifier) in pesticide
formulations applied to growing crops
and raw agricultural commodities.
BASF Corporation submitted a petition
to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), requesting
establishment of an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of Bacillus simplex strain
BU288 when used in accordance with
approved conditions.
DATES: This regulation is effective April
25, 2017. Objections and requests for
hearings must be received on or before
June 26, 2017, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
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19001
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2016–0123, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West
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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
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asabaliauskas on DSK3SPTVN1PROD with RULES
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–2016–0123 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 June 26, 2017. 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–
2016–0123, by one of the following
methods:
• Federal eRulemaking Portal: https://
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 https://
www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Petition for Exemption
In the Federal Register of May 19,
2016 (81 FR 31581) (FRL–9946–02),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide
petition (PP IN–10891) by BASF
Corporation, 26 Davis Drive, Research
Triangle Park, NC 27709. The petition
requested that 40 CFR 180.910 be
amended by establishing an exemption
from the requirement of a tolerance for
residues of Bacillus simplex strain
BU288 when used as an inert ingredient
(emulsifier) in pesticide formulations
applied to growing crops or raw
agricultural commodities after harvest.
That document referenced a summary of
the petition prepared by BASF
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Corporation, the petitioner, which is
available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients
that are not active ingredients as defined
in 40 CFR 153.125 and include, but are
not limited to, the following types of
ingredients (except when they have a
pesticidal efficacy of their own):
Solvents such as alcohols and
hydrocarbons; surfactants such as
polyoxyethylene polymers and fatty
acids; carriers such as clay and
diatomaceous earth; thickeners such as
carrageenan and modified cellulose;
wetting, spreading, and dispersing
agents; propellants in aerosol
dispensers; microencapsulating agents;
and emulsifiers. The term ‘‘inert’’ is not
intended to imply nontoxicity; the
ingredient may or may not be
chemically active. Generally, EPA has
exempted inert ingredients from the
requirement of a tolerance based on the
low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and
Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the 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. Section
408(c)(2)(B) of the FFDCA requires EPA
to take into account the factors found in
subparagraphs (b)(2)(C) and (b)(2)(D) in
establishing an exemption. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be clearly
demonstrated that the risks from
aggregate exposure to pesticide
chemical residues under reasonably
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foreseeable circumstances will pose no
appreciable risks to human health. In
order to determine the risks from
aggregate exposure to pesticide inert
ingredients, the Agency considers the
toxicity of the inert in conjunction with
possible exposure to residues of the
inert ingredient through food, drinking
water, and through other exposures that
occur as a result of pesticide use in
residential settings. If EPA is able to
determine that a finite tolerance is not
necessary to ensure that there is a
reasonable certainty that no harm will
result from aggregate exposure to the
inert ingredient, an exemption from the
requirement of a tolerance may be
established.
Consistent with FFDCA section
408(c)(2)(A), and the factors referenced
in FFDCA section 408(c)(2)(B), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for Bacillus simplex
strain BU288, including exposure
resulting from the exemption
established by this action. EPA’s
assessment of exposures and risks
associated with Bacillus simplex strain
BU288 follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered their
validity, completeness, and reliability as
well as the relationship of the results of
the studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the adverse effects caused
by Bacillus simplex strain BU288 as
well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies are discussed in this
unit.
In an acute oral toxicity study of
Bacillus simplex strain BU288 in rats
the acute oral Lethal Dose (LD)50 was
estimated to be greater than 5,000
milligrams/kilogram (mg/kg).
In an acute dermal toxicity study of
Bacillus simplex strain BU288 in rats,
the LD50 was determined to be greater
than 5,050 mg/kg.
In an acute inhalation toxicity study
of Bacillus simplex strain BU288 in rats,
the acute inhalation Lethal
Concentration (LC)50 is greater than 2.14
mg/Liter (L).
In an acute ocular irritation study of
Bacillus simplex strain BU288 in rats,
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minimal ocular irritation was observed
during the 24-hr treatment period, with
clearance by 48 hours.
A primary dermal irritation study was
conducted for Bacillus simplex strain
BU288 on rabbits. Very slight erythema
was observed, with clearance by 24
hours.
In an acute intravenous toxicity and
infectivity study with Bacillus simplex
strain BU288 in rats the test substance
Bacillus simplex strain BU288 was
determined to be non-toxic at a dose of
1.0 x 109 CFU (colony forming units).
There are no chronic toxicity studies
available for Bacillus simplex strain
BU288. Bacillus simplex and other
closely related endospore-forming
Bacillus species are ubiquitous in the
environment. There are no reports of
any potential human health or
ecological hazards caused by Bacillus
simplex strain BU288.
Based on the results of the Tier I
testing, the Agency does not require any
additional testing on potential
subchronic or chronic toxicity. The
absence of acute toxicity or
pathogenicity in laboratory animals
indicates that it is unlikely that the
strain produces recognized toxins,
enzymes, or virulence factors normally
associated with mammalian
invasiveness or toxicity. The results of
in vivo toxicity testing identified no
potential human health hazard
following oral exposure to Bacillus
simplex strain BU288. There are no
reports of ecological or human health
hazards caused by Bacillus simplex
strain BU288. The absence of acute
toxicity or pathogenicity in laboratory
animals demonstrates the overall benign
nature of this strain. The acute studies
also cover chronic endpoints because
the pathogenicity/infectivity studies are
of longer duration, typically at least 21days. This longer duration allows for the
expression of possible toxicities
associated with the microbe as well as
ensuring that the microbe is recognized
and cleared by the immune system of
the exposed rodent. The information
provided by the identification of the
microbe and its potential hazards, both
toxin production and possible clinical
history, along with results of the
infectivity/pathogenicity studies
provide a basis for stating that Bacillus
simplex strain BU288 is not expected to
result in any subchronic or chronic,
including cancer, toxicity.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
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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 no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD) and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. [For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.]
Due to the lack of hazard associated
with Bacillus simplex strain BU288
based on the available data, no points of
departure were identified for assessing
risk.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to Bacillus simplex strain
BU288, EPA considered exposure under
the proposed exemption from the
requirement of a tolerance. EPA
assessed dietary exposures from
Bacillus simplex strain BU288 in food as
follows:
Acute and chronic dietary
assessments take into account exposure
estimates from dietary consumption of
food and drinking water. Because no
adverse effects attributable to a single or
repeat exposures to Bacillus simplex
strain BU288 were seen in the toxicity
databases, quantitative dietary risk
assessments are not appropriate. Due to
expected use of Bacillus simplex strain
BU288 in pesticide formulations
applied to growing crops and raw
agricultural commodities after harvest,
it is reasonable to expect that there will
be some exposure to these substances
from their use in pesticide products.
2. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., textiles (clothing and dapers),
carpets, swimming pools, and hard
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19003
surface disinfection on walls, floors,
tables). It is possible that Bacillus
simplex strain BU288 may be used as an
inert ingredient in pesticide products
that may result in residential exposures,
although no residential uses are
currently proposed. A residential
exposure assessment was not conducted
because no endpoint of concern
following a single or repeat dose
exposure was identified in the available
studies.
3. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
Because Bacillus simplex strain
BU288 does not have a toxic mode of
action or a mechanism of toxicity, this
provision does not apply.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
Because there are no threshold effects
associated with Bacillus simplex strain
BU288, EPA conducted a qualitative
assessment. As part of that assessment,
the Agency did not use safety factors for
assessing risk, and no additional safety
factor is needed for assessing risk to
infants and children. Based on an
assessment of Bacillus simplex strain
BU288, EPA has concluded that there
are no toxicological endpoints of
concern for the U.S. population,
including infants and children.
E. Aggregate Risks and Determination of
Safety
Based on the available data indicating
a lack of toxicity associated with
Bacillus simplex strain BU288, EPA
concludes that there is a reasonable
certainty that no harm will result to the
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general population, or to infants and
children from aggregate exposure to
Bacillus simplex strain BU288 residues.
V. 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.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180.910 for residues of
Bacillus simplex strain BU288 when
used as an inert ingredient (emulsifier)
in pesticide formulations applied to
growing crops and raw agricultural
commodities after harvest.
VII. Statutory and Executive Order
Reviews
This final rule establishes an
exemption from the requirement of a
tolerance under FFDCA section 408(d)
in response to a petition submitted to
the Agency. The Office of Management
and Budget (OMB) has exempted these
types of actions from review under
Executive Order 12866, entitled
‘‘Regulatory Planning and Review’’ (58
FR 51735, October 4, 1993). Because
this final rule has been exempted from
review under Executive Order 12866,
this final rule is not subject to Executive
Order 13211, entitled ‘‘Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled ‘‘Protection of Children from
Environmental Health Risks and Safety
Risks’’ (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et
seq.), nor does it require any special
considerations under Executive Order
12898, entitled ‘‘Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the exemption in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
Inert ingredients
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
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: March 28, 2017.
Michael Goodis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.910, alphabetically add the
following inert ingredient to the table to
read as follows:
■
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
Limits
Uses
*
*
*
*
*
Bacillus simplex strain BU288 ................................................................ ........................................................
*
*
*
*
*
Emulsifier.
*
*
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Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 423
[EPA–HQ–OW–2009–0819; FRL–9961–67–
OW]
RIN 2040–AF14
Postponement of Certain Compliance
Dates for Effluent Limitations
Guidelines and Standards for the
Steam Electric Power Generating Point
Source Category
Environmental Protection
Agency (EPA).
ACTION: Notification; postponement of
compliance dates.
AGENCY:
By a letter dated April 12,
2017, the Administrator announced the
EPA decision to reconsider the final rule
that amends the effluent limitations
guidelines and standards for the steam
electric point source category under the
Clean Water Act (‘‘CWA’’), published in
the Federal Register on November 3,
2015. These regulations have been
challenged in the U.S. Court of Appeals
for the Fifth Circuit, Southwestern
Electric Power Co., et al. v. EPA, No. 15–
60821. The EPA is postponing these
compliance dates pending judicial
review.
SUMMARY:
April 25, 2017.
EPA has established a
docket for the Rule amending 40 CFR
part 423 under Docket ID No. EPA–HQ–
OW–2009–0819. All documents in the
docket are listed on the https://
www.regulations.gov Web site.
FOR FURTHER INFORMATION CONTACT: For
technical information, contact Ronald
Jordan, United States Environmental
Protection Agency, Engineering and
Analysis Division; telephone number:
(202) 564–1003; email address:
jordan.ronald@epa.gov. For information
related to NPDES permitting of these
facilities, contact Sean Ramach at (202)
564–2865, email address: ramach.sean@
epa.gov.
Electronic copies of this document
and related materials are available on
EPA’s Web site at https://www.epa.gov/
eg/steam-electric-power-generatingeffluent-guidelines-2015-final-rule.
Copies of this notification are also
available at https://www.regulations.gov.
SUPPLEMENTARY INFORMATION:
DATES:
asabaliauskas on DSK3SPTVN1PROD with RULES
ADDRESSES:
I. Background
On November 3, 2015, the EPA issued
a final rule amending 40 CFR part 423,
the effluent limitations guidelines and
standards for the steam electric power
generating point source category, under
VerDate Sep<11>2014
17:26 Apr 24, 2017
Jkt 241001
Sections 301, 304, 306, 307, 308, 402,
and 501 of the CWA (33 U.S.C. 1311,
1314, 1316, 1317, 1318, 1342, and
1361). The amendments addressed and
contained limitations and standards on
various wastestreams at steam electric
power plants: Fly ash transport water,
bottom ash transport water, flue gas
mercury control wastewater, flue gas
desulfurization (‘‘FGD’’) wastewater,
gasification wastewater, and combustion
residual leachate. Collectively, this
rulemaking is known as the ‘‘Effluent
Limitations Guidelines and Standards
for the Steam Electric Power Generating
Point Source Category’’ (‘‘Rule’’). For
further information on the Rule, see 80
FR 67838 (Nov. 3, 2015).
EPA received seven petitions for
review of the Rule. The United States
Judicial Panel on Multi-District
Litigation issued an order on December
8, 2015, consolidating all of the
petitions in the U.S. Court of Appeals
for the Fifth Circuit. Petitioners have
filed their briefs, and EPA’s brief is
currently due by May 4, 2017.
In a letter dated March 24, 2017, the
Utility Water Act Group (‘‘UWAG’’) 1
submitted a petition for reconsideration
of the Rule and requested that EPA
suspend the Rule’s approaching
deadlines. In a letter dated April 5,
2017, the Small Business
Administration Office of Advocacy also
petitioned the EPA for reconsideration
of the Rule. The petitions raise wideranging and sweeping objections to the
Rule, some of which overlap with the
claims in the ongoing litigation
challenging the Rule in the U.S. Court
of Appeals for the Fifth Circuit.2 The
UWAG petition also points to new data,
claiming that plants burning
subbituminous and bituminous coal
cannot comply with the Rule’s
limitations and standards for FGD
wastewater through use of EPA’s model
technology. The UWAG petition says
that a pilot study has been conducted at
the Pleasant Prairie plant that supports
petitioner’s request, and that a final
report on the pilot study ‘‘is likely to
[be] publish[ed] . . . within the next
few weeks.’’ Moreover, the petitions say
that new data have been collected by
American Electric Power that
‘‘illustrate[ ] that variability in
wastewater management can also
impact performance at bituminous
1 UWAG is a voluntary, ad hoc, unincorporated
group of 163 individual energy companies and
three national trade associations of energy
companies: Edison Electric Institute, the National
Rural Electric Cooperative Association, and the
American Public Power Association.
2 A copy of each petition is included in the docket
for this rule, Docket ID No. EPA–HQ–OW–2009–
0819.
PO 00000
Frm 00031
Fmt 4700
Sfmt 4700
19005
plants such that additional technologies
beyond EPA’s model technology will be
needed to achieve the limits.’’ EPA
wishes to review these data.
In an April 12, 2017 letter to those
who submitted the reconsideration
petitions, the Administrator announced
his decision to reconsider the Rule (a
copy of this letter is included in the
docket for the Rule). As explained in
that letter, after considering the
objections raised in the reconsideration
petitions, the Administrator determined
that it is appropriate and in the public
interest to reconsider the Rule. Under
Section 705 of the APA
(‘‘Administrative Procedure Act’’), 5
U.S.C. 705, and when justice so
requires, an Agency may postpone the
effective date of action taken by it
pending judicial review. The earliest
compliance dates for the new, and more
stringent, best available technology
economically achievable effluent
limitations and pretreatment standards
is November 1, 2018, for each of the
following wastestreams: Fly ash
transport water, bottom ash transport
water, flue gas desulfurization
wastewater, flue gas mercury control
wastewater, and gasification
wastewater. These dates have not yet
passed, and they are within the meaning
of the term ‘‘effective date’’ as that term
is used in Section 705 of the APA. In
light of the capital expenditures that
facilities incurring costs under the Rule
will need to undertake in order to meet
the compliance deadlines for the new,
more stringent limitations and standards
in the Rule—which are as early as
November 1, 2018, for direct dischargers
and by November 1, 2018, for indirect
dischargers—the Agency finds that
justice requires it to postpone the
compliance dates of the Rule that have
not yet passed, pending judicial review.
See 80 FR 67838, 67863–67868 (Nov. 3,
2015) (discussion of costs of the Rule).
This will preserve the regulatory status
quo with respect to wastestreams
subject to the Rule’s new, and more
stringent, limitations and standards,
while the litigation is pending and the
reconsideration is underway. While
EPA is not making any concession of
error with respect to the rulemaking, the
far-ranging issues contained in the
reconsideration petitions warrant
careful and considerate review of the
Rule. EPA will also file a motion
requesting the Fifth Circuit to hold the
litigation challenging the Rule in
abeyance while the Agency reconsiders
the Rule, after which it will inform the
E:\FR\FM\25APR1.SGM
25APR1
]]>Agencies
[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Rules and Regulations]
[Pages 19001-19005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08249]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0123; FRL-9960-61]
Bacillus simplex strain BU288; 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 Bacillus simplex strain BU288 when used
as an inert ingredient (emulsifier) in pesticide formulations applied
to growing crops and raw agricultural commodities. BASF Corporation
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting establishment of an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of Bacillus simplex
strain BU288 when used in accordance with approved conditions.
DATES: This regulation is effective April 25, 2017. Objections and
requests for hearings must be received on or before June 26, 2017, 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-2016-0123, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West 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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection
[[Page 19002]]
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-2016-0123 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 June 26, 2017. 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-2016-0123, by one of
the following methods:
Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.htm. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of May 19, 2016 (81 FR 31581) (FRL-9946-
02), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-10891) by
BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709. The
petition requested that 40 CFR 180.910 be amended by establishing an
exemption from the requirement of a tolerance for residues of Bacillus
simplex strain BU288 when used as an inert ingredient (emulsifier) in
pesticide formulations applied to growing crops or raw agricultural
commodities after harvest. That document referenced a summary of the
petition prepared by BASF Corporation, the petitioner, which is
available in the docket, https://www.regulations.gov. There were no
comments received in response to the notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the 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. Section 408(c)(2)(B) of the FFDCA requires EPA
to take into account the factors found in subparagraphs (b)(2)(C) and
(b)(2)(D) in establishing an exemption. Section 408(b)(2)(C) of FFDCA
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
referenced in FFDCA section 408(c)(2)(B), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for Bacillus simplex strain
BU288, including exposure resulting from the exemption established by
this action. EPA's assessment of exposures and risks associated with
Bacillus simplex strain BU288 follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by Bacillus simplex strain BU288 as well
as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies are
discussed in this unit.
In an acute oral toxicity study of Bacillus simplex strain BU288 in
rats the acute oral Lethal Dose (LD)50 was estimated to be
greater than 5,000 milligrams/kilogram (mg/kg).
In an acute dermal toxicity study of Bacillus simplex strain BU288
in rats, the LD50 was determined to be greater than 5,050
mg/kg.
In an acute inhalation toxicity study of Bacillus simplex strain
BU288 in rats, the acute inhalation Lethal Concentration
(LC)50 is greater than 2.14 mg/Liter (L).
In an acute ocular irritation study of Bacillus simplex strain
BU288 in rats,
[[Page 19003]]
minimal ocular irritation was observed during the 24-hr treatment
period, with clearance by 48 hours.
A primary dermal irritation study was conducted for Bacillus
simplex strain BU288 on rabbits. Very slight erythema was observed,
with clearance by 24 hours.
In an acute intravenous toxicity and infectivity study with
Bacillus simplex strain BU288 in rats the test substance Bacillus
simplex strain BU288 was determined to be non-toxic at a dose of 1.0 x
10\9\ CFU (colony forming units). There are no chronic toxicity studies
available for Bacillus simplex strain BU288. Bacillus simplex and other
closely related endospore-forming Bacillus species are ubiquitous in
the environment. There are no reports of any potential human health or
ecological hazards caused by Bacillus simplex strain BU288.
Based on the results of the Tier I testing, the Agency does not
require any additional testing on potential subchronic or chronic
toxicity. The absence of acute toxicity or pathogenicity in laboratory
animals indicates that it is unlikely that the strain produces
recognized toxins, enzymes, or virulence factors normally associated
with mammalian invasiveness or toxicity. The results of in vivo
toxicity testing identified no potential human health hazard following
oral exposure to Bacillus simplex strain BU288. There are no reports of
ecological or human health hazards caused by Bacillus simplex strain
BU288. The absence of acute toxicity or pathogenicity in laboratory
animals demonstrates the overall benign nature of this strain. The
acute studies also cover chronic endpoints because the pathogenicity/
infectivity studies are of longer duration, typically at least 21-days.
This longer duration allows for the expression of possible toxicities
associated with the microbe as well as ensuring that the microbe is
recognized and cleared by the immune system of the exposed rodent. The
information provided by the identification of the microbe and its
potential hazards, both toxin production and possible clinical history,
along with results of the infectivity/pathogenicity studies provide a
basis for stating that Bacillus simplex strain BU288 is not expected to
result in any subchronic or chronic, including cancer, toxicity.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD) and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. [For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.]
Due to the lack of hazard associated with Bacillus simplex strain
BU288 based on the available data, no points of departure were
identified for assessing risk.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to Bacillus simplex strain BU288, EPA considered exposure
under the proposed exemption from the requirement of a tolerance. EPA
assessed dietary exposures from Bacillus simplex strain BU288 in food
as follows:
Acute and chronic dietary assessments take into account exposure
estimates from dietary consumption of food and drinking water. Because
no adverse effects attributable to a single or repeat exposures to
Bacillus simplex strain BU288 were seen in the toxicity databases,
quantitative dietary risk assessments are not appropriate. Due to
expected use of Bacillus simplex strain BU288 in pesticide formulations
applied to growing crops and raw agricultural commodities after
harvest, it is reasonable to expect that there will be some exposure to
these substances from their use in pesticide products.
2. 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 dapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables). It is
possible that Bacillus simplex strain BU288 may be used as an inert
ingredient in pesticide products that may result in residential
exposures, although no residential uses are currently proposed. A
residential exposure assessment was not conducted because no endpoint
of concern following a single or repeat dose exposure was identified in
the available studies.
3. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Because Bacillus simplex strain BU288 does not have a toxic mode of
action or a mechanism of toxicity, this provision does not apply.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
Because there are no threshold effects associated with Bacillus
simplex strain BU288, EPA conducted a qualitative assessment. As part
of that assessment, the Agency did not use safety factors for assessing
risk, and no additional safety factor is needed for assessing risk to
infants and children. Based on an assessment of Bacillus simplex strain
BU288, EPA has concluded that there are no toxicological endpoints of
concern for the U.S. population, including infants and children.
E. Aggregate Risks and Determination of Safety
Based on the available data indicating a lack of toxicity
associated with Bacillus simplex strain BU288, EPA concludes that there
is a reasonable certainty that no harm will result to the
[[Page 19004]]
general population, or to infants and children from aggregate exposure
to Bacillus simplex strain BU288 residues.
V. 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.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 for residues of Bacillus simplex
strain BU288 when used as an inert ingredient (emulsifier) in pesticide
formulations applied to growing crops and raw agricultural commodities
after harvest.
VII. Statutory and Executive Order Reviews
This final rule establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this final rule has been exempted from review
under Executive Order 12866, this final rule is not subject to
Executive Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to 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: March 28, 2017.
Michael Goodis,
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. 180.910, alphabetically add the following inert ingredient
to the table to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Bacillus simplex strain BU288... .................. Emulsifier.
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2017-08249 Filed 4-24-17; 8:45 am]
BILLING CODE 6560-50-P
