82 FR 19001 - Bacillus simplex strain BU288; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 78 (April 25, 2017)
Federal Register Volume 82, Issue 78 (April 25, 2017)
| Page Range | 19001-19005 | |
| FR Document | 2017-08249 |
[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)] [Rules and Regulations] [Pages 19001-19005] From the Federal Register Online [www.thefederalregister.org] [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 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] 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
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this action alter the relationships or § 180.693 Benzobicyclon; tolerances for ADDRESSES: The docket for this action,
distribution of power and residues. identified by docket identification (ID)
responsibilities established by Congress (a) General. [Reserved] number EPA–HQ–OPP–2016–0123, is
in the preemption provisions of FFDCA (b) Section 18 emergency exemptions. available at http://www.regulations.gov
section 408(n)(4). As such, the Agency [Reserved] or at the Office of Pesticide Programs
has determined that this action will not (c) Tolerances with regional Regulatory Public Docket (OPP Docket)
have a substantial direct effect on States registrations. Tolerances with regional in the Environmental Protection Agency
or tribal governments, on the registration, as defined in § 180.1(l), are Docket Center (EPA/DC), EPA West
relationship between the national established for residues of the herbicide Bldg., Rm. 3334, 1301 Constitution Ave.
government and the States or tribal benzobicyclon, including its metabolites NW., Washington, DC 20460–0001. The
governments, or on the distribution of and degradates, in or on the commodity Public Reading Room is open from 8:30
power and responsibilities among the in the table below. Compliance with the a.m. to 4:30 p.m., Monday through
various levels of government or between tolerance levels specified below is to be Friday, excluding legal holidays. The
the Federal Government and Indian determined by measuring only telephone number for the Public
tribes. Thus, the Agency has determined benzobicyclon, 3-[2-chloro-4- Reading Room is (202) 566–1744, and
that Executive Order 13132, entitled (methylsulfonyl)benzoyl]-4- the telephone number for the OPP
‘‘Federalism’’ (64 FR 43255, August 10, (phenylthio)bicyclo-[3.2.1]oct-3-en-2- Docket is (703) 305–5805. Please review
1999) and Executive Order 13175, one), in or on the following raw the visitor instructions and additional
entitled ‘‘Consultation and Coordination agricultural commodities: information about the docket available
with Indian Tribal Governments’’ (65 FR at http://www.epa.gov/dockets.
Parts per
67249, November 9, 2000) do not apply Commodity FOR FURTHER INFORMATION CONTACT:
million
to this action. In addition, this action Michael Goodis, Registration Division
does not impose any enforceable duty or Rice, grain ............................ 0.01 (7505P), Office of Pesticide Programs,
contain any unfunded mandate as Environmental Protection Agency, 1200
described under Title II of the Unfunded (d) Indirect or inadvertent residues. Pennsylvania Ave. NW., Washington,
Mandates Reform Act (UMRA) (2 U.S.C. [Reserved] DC 20460–0001; telephone number:
1501 et seq.). [FR Doc. 2017–08357 Filed 4–24–17; 8:45 am] (703) 305–7090; email address:
This action does not involve any BILLING CODE 6560–50–P RDFRNotices@epa.gov.
technical standards that would require SUPPLEMENTARY INFORMATION:
Agency consideration of voluntary
consensus standards pursuant to section ENVIRONMENTAL PROTECTION I. General Information
12(d) of the National Technology AGENCY A. Does this action apply to me?
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note). 40 CFR Part 180 You may be potentially affected by
this action if you are an agricultural
[EPA–HQ–OPP–2016–0123; FRL–9960–61]
VII. Congressional Review Act producer, food manufacturer, or
Pursuant to the Congressional Review Bacillus simplex strain BU288; pesticide manufacturer. The following
Act (5 U.S.C. 801 et seq.), EPA will Exemption From the Requirement of a list of North American Industrial
submit a report containing this rule and Tolerance Classification System (NAICS) codes is
other required information to the U.S. not intended to be exhaustive, but rather
AGENCY: Environmental Protection provides a guide to help readers
Senate, the U.S. House of Agency (EPA).
Representatives, and the Comptroller determine whether this document
ACTION: Final rule. applies to them. Potentially affected
General of the United States prior to
publication of the rule in the Federal entities may include:
SUMMARY: This regulation establishes an • Crop production (NAICS code 111).
Register. This action is not a ‘‘major exemption from the requirement of a • Animal production (NAICS code
rule’’ as defined by 5 U.S.C. 804(2). tolerance for residues of Bacillus 112).
List of Subjects in 40 CFR Part 180 simplex strain BU288 when used as an • Food manufacturing (NAICS code
inert ingredient (emulsifier) in pesticide 311).
Environmental protection, formulations applied to growing crops • Pesticide manufacturing (NAICS
Administrative practice and procedure, and raw agricultural commodities. code 32532).
Agricultural commodities, Pesticides BASF Corporation submitted a petition
and pests, Reporting and recordkeeping to EPA under the Federal Food, Drug, B. How can I get electronic access to
requirements. and Cosmetic Act (FFDCA), requesting other related information?
Dated: April 5, 2017, establishment of an exemption from the You may access a frequently updated
Michael Goodis,
requirement of a tolerance. This electronic version of 40 CFR part 180
regulation eliminates the need to through the Government Printing
Director, Registration Division, Office of
Pesticide Programs.
establish a maximum permissible level Office’s e-CFR site at http://
for residues of Bacillus simplex strain www.ecfr.gov/cgi-bin/text-
Therefore, 40 CFR chapter I is BU288 when used in accordance with idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
amended as follows: approved conditions. 40tab_02.tpl.
asabaliauskas on DSK3SPTVN1PROD with RULES
DATES: This regulation is effective April
PART 180—[AMENDED] C. How can I file an objection or hearing
25, 2017. Objections and requests for
hearings must be received on or before request?
■ 1. The authority citation for part 180
continues to read as follows: June 26, 2017, and must be filed in Under FFDCA section 408(g), 21
accordance with the instructions U.S.C. 346a, any person may file an
Authority: 21 U.S.C. 321(q), 346a and 371. provided in 40 CFR part 178 (see also objection to any aspect of this regulation
■ 2. Add § 180.693 to subpart C to read Unit I.C. of the SUPPLEMENTARY and may also request a hearing on those
as follows: INFORMATION). objections. You must file your objection
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minimal ocular irritation was observed evaluating the risk posed by human surface disinfection on walls, floors,
during the 24-hr treatment period, with exposure to the pesticide. For hazards tables). It is possible that Bacillus
clearance by 48 hours. that have a threshold below which there simplex strain BU288 may be used as an
A primary dermal irritation study was is no appreciable risk, the toxicological inert ingredient in pesticide products
conducted for Bacillus simplex strain POD is used as the basis for derivation that may result in residential exposures,
BU288 on rabbits. Very slight erythema of reference values for risk assessment. although no residential uses are
was observed, with clearance by 24 PODs are developed based on a careful currently proposed. A residential
hours. analysis of the doses in each exposure assessment was not conducted
In an acute intravenous toxicity and toxicological study to determine the because no endpoint of concern
infectivity study with Bacillus simplex dose at which no adverse effects are following a single or repeat dose
strain BU288 in rats the test substance observed (the NOAEL) and the lowest exposure was identified in the available
Bacillus simplex strain BU288 was dose at which adverse effects of concern studies.
determined to be non-toxic at a dose of are identified (the LOAEL). Uncertainty/ 3. Cumulative effects from substances
1.0 x 109 CFU (colony forming units). safety factors are used in conjunction with a common mechanism of toxicity.
There are no chronic toxicity studies with the POD to calculate a safe Section 408(b)(2)(D)(v) of FFDCA
available for Bacillus simplex strain exposure level—generally referred to as requires that, when considering whether
BU288. Bacillus simplex and other a population-adjusted dose (PAD) or a to establish, modify, or revoke a
closely related endospore-forming reference dose (RfD) and a safe margin tolerance, the Agency consider
Bacillus species are ubiquitous in the of exposure (MOE). For non-threshold ‘‘available information’’ concerning the
environment. There are no reports of risks, the Agency assumes that any cumulative effects of a particular
any potential human health or amount of exposure will lead to some pesticide’s residues and ‘‘other
ecological hazards caused by Bacillus degree of risk. Thus, the Agency substances that have a common
simplex strain BU288. estimates risk in terms of the probability mechanism of toxicity.’’
Based on the results of the Tier I of an occurrence of the adverse effect Because Bacillus simplex strain
testing, the Agency does not require any expected in a lifetime. [For more BU288 does not have a toxic mode of
additional testing on potential information on the general principles action or a mechanism of toxicity, this
subchronic or chronic toxicity. The EPA uses in risk characterization and a provision does not apply.
absence of acute toxicity or complete description of the risk
pathogenicity in laboratory animals D. Safety Factor for Infants and
assessment process, see http:// Children
indicates that it is unlikely that the www.epa.gov/pesticides/factsheets/
strain produces recognized toxins, riskassess.htm.] 1. In general. Section 408(b)(2)(C) of
enzymes, or virulence factors normally Due to the lack of hazard associated FFDCA provides that EPA shall apply
associated with mammalian with Bacillus simplex strain BU288 an additional tenfold (10X) margin of
invasiveness or toxicity. The results of based on the available data, no points of safety for infants and children in the
in vivo toxicity testing identified no departure were identified for assessing case of threshold effects to account for
potential human health hazard risk. prenatal and postnatal toxicity and the
following oral exposure to Bacillus completeness of the database on toxicity
simplex strain BU288. There are no C. Exposure Assessment and exposure unless EPA determines
reports of ecological or human health 1. Dietary exposure from food and based on reliable data that a different
hazards caused by Bacillus simplex feed uses. In evaluating dietary margin of safety will be safe for infants
strain BU288. The absence of acute exposure to Bacillus simplex strain and children. This additional margin of
toxicity or pathogenicity in laboratory BU288, EPA considered exposure under safety is commonly referred to as the
animals demonstrates the overall benign the proposed exemption from the FQPA Safety Factor (SF). In applying
nature of this strain. The acute studies requirement of a tolerance. EPA this provision, EPA either retains the
also cover chronic endpoints because assessed dietary exposures from default value of 10X, or uses a different
the pathogenicity/infectivity studies are Bacillus simplex strain BU288 in food as additional safety factor when reliable
of longer duration, typically at least 21- follows: data available to EPA support the choice
days. This longer duration allows for the Acute and chronic dietary of a different factor.
expression of possible toxicities assessments take into account exposure Because there are no threshold effects
associated with the microbe as well as estimates from dietary consumption of associated with Bacillus simplex strain
ensuring that the microbe is recognized food and drinking water. Because no BU288, EPA conducted a qualitative
and cleared by the immune system of adverse effects attributable to a single or assessment. As part of that assessment,
the exposed rodent. The information repeat exposures to Bacillus simplex the Agency did not use safety factors for
provided by the identification of the strain BU288 were seen in the toxicity assessing risk, and no additional safety
microbe and its potential hazards, both databases, quantitative dietary risk factor is needed for assessing risk to
toxin production and possible clinical assessments are not appropriate. Due to infants and children. Based on an
history, along with results of the expected use of Bacillus simplex strain assessment of Bacillus simplex strain
infectivity/pathogenicity studies BU288 in pesticide formulations BU288, EPA has concluded that there
provide a basis for stating that Bacillus applied to growing crops and raw are no toxicological endpoints of
simplex strain BU288 is not expected to agricultural commodities after harvest, concern for the U.S. population,
result in any subchronic or chronic, it is reasonable to expect that there will including infants and children.
asabaliauskas on DSK3SPTVN1PROD with RULES
including cancer, toxicity. be some exposure to these substances
from their use in pesticide products. E. Aggregate Risks and Determination of
B. Toxicological Points of Departure/ 2. From non-dietary exposure. The Safety
Levels of Concern term ‘‘residential exposure’’ is used in Based on the available data indicating
Once a pesticide’s toxicological this document to refer to non- a lack of toxicity associated with
profile is determined, EPA identifies occupational, non-dietary exposure Bacillus simplex strain BU288, EPA
toxicological points of departure (POD) (e.g., textiles (clothing and dapers), concludes that there is a reasonable
and levels of concern to use in carpets, swimming pools, and hard certainty that no harm will result to the
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![19004 Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Rules and Regulations
general population, or to infants and Reduction Act (PRA) (44 U.S.C. 3501 et This action does not involve any
children from aggregate exposure to seq.), nor does it require any special technical standards that would require
Bacillus simplex strain BU288 residues. considerations under Executive Order Agency consideration of voluntary
12898, entitled ‘‘Federal Actions to consensus standards pursuant to section
V. Analytical Enforcement Methodology
Address Environmental Justice in 12(d) of the National Technology
An analytical method is not required Minority Populations and Low-Income Transfer and Advancement Act of 1995
for enforcement purposes since the Populations’’ (59 FR 7629, February 16, (NTTAA) (15 U.S.C. 272 note).
Agency is establishing an exemption 1994).
from the requirement of a tolerance VIII. Congressional Review Act
Since tolerances and exemptions that
without any numerical limitation. are established on the basis of a petition Pursuant to the Congressional Review
VI. Conclusions under FFDCA section 408(d), such as Act (5 U.S.C. 801 et seq.), EPA will
the exemption in this final rule, do not submit a report containing this rule and
Therefore, an exemption from the other required information to the U.S.
require the issuance of a proposed rule,
requirement of a tolerance is established Senate, the U.S. House of
the requirements of the Regulatory
under 40 CFR 180.910 for residues of Representatives, and the Comptroller
Flexibility Act (RFA) (5 U.S.C. 601 et
Bacillus simplex strain BU288 when General of the United States prior to
seq.), do not apply.
used as an inert ingredient (emulsifier) publication of the rule in the Federal
in pesticide formulations applied to This final rule directly regulates
growers, food processors, food handlers, Register. This action is not a ‘‘major
growing crops and raw agricultural
and food retailers, not States or tribes, rule’’ as defined by 5 U.S.C. 804(2).
commodities after harvest.
nor does this action alter the List of Subjects in 40 CFR Part 180
VII. Statutory and Executive Order relationships or distribution of power
Reviews and responsibilities established by Environmental protection,
This final rule establishes an Congress in the preemption provisions Administrative practice and procedure,
exemption from the requirement of a of FFDCA section 408(n)(4). As such, Agricultural commodities, Pesticides
tolerance under FFDCA section 408(d) the Agency has determined that this and pests, Reporting and recordkeeping
in response to a petition submitted to action will not have a substantial direct requirements.
the Agency. The Office of Management effect on States or tribal governments, Dated: March 28, 2017.
and Budget (OMB) has exempted these on the relationship between the national Michael Goodis,
types of actions from review under government and the States or tribal
Director, Registration Division, Office of
Executive Order 12866, entitled governments, or on the distribution of Pesticide Programs.
‘‘Regulatory Planning and Review’’ (58 power and responsibilities among the
FR 51735, October 4, 1993). Because various levels of government or between Therefore, 40 CFR chapter I is
this final rule has been exempted from the Federal Government and Indian amended as follows:
review under Executive Order 12866, tribes. Thus, the Agency has determined
this final rule is not subject to Executive that Executive Order 13132, entitled PART 180—[AMENDED]
Order 13211, entitled ‘‘Actions ‘‘Federalism’’ (64 FR 43255, August 10,
Concerning Regulations That 1999) and Executive Order 13175, ■ 1. The authority citation for part 180
Significantly Affect Energy Supply, entitled ‘‘Consultation and Coordination continues to read as follows:
Distribution, or Use’’ (66 FR 28355, May with Indian Tribal Governments’’ (65 FR Authority: 21 U.S.C. 321(q), 346a and 371.
22, 2001) or Executive Order 13045, 67249, November 9, 2000) do not apply
entitled ‘‘Protection of Children from to this final rule. In addition, this final ■ 2. In § 180.910, alphabetically add the
Environmental Health Risks and Safety rule does not impose any enforceable following inert ingredient to the table to
Risks’’ (62 FR 19885, April 23, 1997). duty or contain any unfunded mandate read as follows:
This final rule does not contain any as described under Title II of the § 180.910 Inert ingredients used pre- and
information collections subject to OMB Unfunded Mandates Reform Act of 1995 post-harvest; exemptions from the
approval under the Paperwork (UMRA) (2 U.S.C. 1501 et seq.). 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
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![Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Rules and Regulations 19005
ENVIRONMENTAL PROTECTION Sections 301, 304, 306, 307, 308, 402, plants such that additional technologies
AGENCY and 501 of the CWA (33 U.S.C. 1311, beyond EPA’s model technology will be
1314, 1316, 1317, 1318, 1342, and needed to achieve the limits.’’ EPA
40 CFR Part 423 1361). The amendments addressed and wishes to review these data.
contained limitations and standards on
[EPA–HQ–OW–2009–0819; FRL–9961–67– In an April 12, 2017 letter to those
OW]
various wastestreams at steam electric
who submitted the reconsideration
power plants: Fly ash transport water,
bottom ash transport water, flue gas petitions, the Administrator announced
RIN 2040–AF14
mercury control wastewater, flue gas his decision to reconsider the Rule (a
Postponement of Certain Compliance desulfurization (‘‘FGD’’) wastewater, copy of this letter is included in the
Dates for Effluent Limitations gasification wastewater, and combustion docket for the Rule). As explained in
Guidelines and Standards for the residual leachate. Collectively, this that letter, after considering the
Steam Electric Power Generating Point rulemaking is known as the ‘‘Effluent objections raised in the reconsideration
Source Category Limitations Guidelines and Standards petitions, the Administrator determined
for the Steam Electric Power Generating that it is appropriate and in the public
AGENCY: Environmental Protection
Point Source Category’’ (‘‘Rule’’). For interest to reconsider the Rule. Under
Agency (EPA).
further information on the Rule, see 80 Section 705 of the APA
ACTION: Notification; postponement of FR 67838 (Nov. 3, 2015). (‘‘Administrative Procedure Act’’), 5
compliance dates. EPA received seven petitions for U.S.C. 705, and when justice so
review of the Rule. The United States requires, an Agency may postpone the
SUMMARY: By a letter dated April 12,
Judicial Panel on Multi-District effective date of action taken by it
2017, the Administrator announced the
Litigation issued an order on December pending judicial review. The earliest
EPA decision to reconsider the final rule
8, 2015, consolidating all of the compliance dates for the new, and more
that amends the effluent limitations
petitions in the U.S. Court of Appeals stringent, best available technology
guidelines and standards for the steam
for the Fifth Circuit. Petitioners have economically achievable effluent
electric point source category under the
filed their briefs, and EPA’s brief is limitations and pretreatment standards
Clean Water Act (‘‘CWA’’), published in
currently due by May 4, 2017. is November 1, 2018, for each of the
the Federal Register on November 3, In a letter dated March 24, 2017, the
2015. These regulations have been Utility Water Act Group (‘‘UWAG’’) 1 following wastestreams: Fly ash
challenged in the U.S. Court of Appeals transport water, bottom ash transport
submitted a petition for reconsideration
for the Fifth Circuit, Southwestern water, flue gas desulfurization
of the Rule and requested that EPA
Electric Power Co., et al. v. EPA, No. 15– wastewater, flue gas mercury control
suspend the Rule’s approaching
60821. The EPA is postponing these wastewater, and gasification
deadlines. In a letter dated April 5,
compliance dates pending judicial wastewater. These dates have not yet
2017, the Small Business
review. passed, and they are within the meaning
Administration Office of Advocacy also
DATES: April 25, 2017. petitioned the EPA for reconsideration of the term ‘‘effective date’’ as that term
ADDRESSES: EPA has established a of the Rule. The petitions raise wide- is used in Section 705 of the APA. In
docket for the Rule amending 40 CFR ranging and sweeping objections to the light of the capital expenditures that
part 423 under Docket ID No. EPA–HQ– Rule, some of which overlap with the facilities incurring costs under the Rule
OW–2009–0819. All documents in the claims in the ongoing litigation will need to undertake in order to meet
docket are listed on the http:// challenging the Rule in the U.S. Court the compliance deadlines for the new,
www.regulations.gov Web site. of Appeals for the Fifth Circuit.2 The more stringent limitations and standards
FOR FURTHER INFORMATION CONTACT: For UWAG petition also points to new data, in the Rule—which are as early as
technical information, contact Ronald claiming that plants burning November 1, 2018, for direct dischargers
Jordan, United States Environmental subbituminous and bituminous coal and by November 1, 2018, for indirect
Protection Agency, Engineering and cannot comply with the Rule’s dischargers—the Agency finds that
Analysis Division; telephone number: limitations and standards for FGD justice requires it to postpone the
(202) 564–1003; email address: wastewater through use of EPA’s model compliance dates of the Rule that have
jordan.ronald@epa.gov. For information technology. The UWAG petition says not yet passed, pending judicial review.
related to NPDES permitting of these that a pilot study has been conducted at See 80 FR 67838, 67863–67868 (Nov. 3,
facilities, contact Sean Ramach at (202) the Pleasant Prairie plant that supports 2015) (discussion of costs of the Rule).
564–2865, email address: ramach.sean@ petitioner’s request, and that a final
This will preserve the regulatory status
epa.gov. report on the pilot study ‘‘is likely to
quo with respect to wastestreams
Electronic copies of this document [be] publish[ed] . . . within the next
few weeks.’’ Moreover, the petitions say subject to the Rule’s new, and more
and related materials are available on stringent, limitations and standards,
EPA’s Web site at https://www.epa.gov/ that new data have been collected by
American Electric Power that while the litigation is pending and the
eg/steam-electric-power-generating- reconsideration is underway. While
effluent-guidelines-2015-final-rule. ‘‘illustrate[ ] that variability in
wastewater management can also EPA is not making any concession of
Copies of this notification are also error with respect to the rulemaking, the
available at http://www.regulations.gov. impact performance at bituminous
far-ranging issues contained in the
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SUPPLEMENTARY INFORMATION: 1 UWAG is a voluntary, ad hoc, unincorporated reconsideration petitions warrant
I. Background group of 163 individual energy companies and careful and considerate review of the
three national trade associations of energy
Rule. EPA will also file a motion
On November 3, 2015, the EPA issued companies: Edison Electric Institute, the National
Rural Electric Cooperative Association, and the requesting the Fifth Circuit to hold the
a final rule amending 40 CFR part 423,
American Public Power Association. litigation challenging the Rule in
the effluent limitations guidelines and 2 A copy of each petition is included in the docket
standards for the steam electric power abeyance while the Agency reconsiders
for this rule, Docket ID No. EPA–HQ–OW–2009–
generating point source category, under 0819.
the Rule, after which it will inform the
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Document Created: 2017-04-25 02:18:24
Document Modified: 2017-04-25 02:18:24
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| 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). | |
| Contact | Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone | |
| FR Citation | 82 FR 19001 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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