[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]
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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.
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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 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), 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 http://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: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/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: 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.htm. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of 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, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the 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 http://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]
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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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.
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Inert ingredients Limits Uses
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* * * * * * *
Bacillus simplex strain BU288... .................. Emulsifier.
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[FR Doc. 2017-08249 Filed 4-24-17; 8:45 am]
BILLING CODE 6560-50-P