Document ID: EPA-HQ-OPP-2016-0123-0003
Agency: epa
Document Type: Rule
Title: Tolerance Exemptions: Bacillus simplex strain BU288
Posted Date: 2017-04-25T04:00Z

[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: 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 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]

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
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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