81 FR 41219 - Bacillus Amyloliquefaciens Strain PTA-4838; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 122 (June 24, 2016)
Federal Register Volume 81, Issue 122 (June 24, 2016)
| Page Range | 41219-41222 | |
| FR Document | 2016-15006 |
[Federal Register Volume 81, Number 122 (Friday, June 24, 2016)] [Rules and Regulations] [Pages 41219-41222] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-15006] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0420; FRL-9946-62] Bacillus Amyloliquefaciens Strain PTA-4838; 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 the Bacillus amyloliquefaciens strain PTA-4838 on all food commodities when applied or used as a fungicide, nematocide, or plant growth regulator. LidoChem, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus amyloliquefaciens strain PTA-4838. DATES: This regulation is effective June 24, 2016. Objections and requests for hearings must be received on or before August 23, 2016, 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-2015-0420, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Robert McNally, Director, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305- 7090; email address: [email protected]. 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 [[Page 41220]] 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 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-2015-0420 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 23, 2016. 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-2015-0420, 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.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. II. Background and Statutory Findings In the Federal Register of August 26, 2015 ([80] FR 51759) (FRL- 9931-74), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP [4F8317]) by LidoChem, Inc., 20 Village Ct., Hazlet, NJ 07730. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Bacillus amyloliquefaciens strain PTA-4838. That document referenced a summary of the petition prepared by the petitioner LidoChem, Inc., which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require 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. . . .'' Additionally, FFDCA section 408(b)(2)(D) requires that the Agency consider ``available information concerning the cumulative effects of a particular pesticide's residues'' and ``other substances that have a common mechanism of toxicity.'' EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. III. Toxicological Profile Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability, and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Bacillus amyloliquefaciens is a gram positive non-pathogenic bacterium which is commonly found in the air, water, soil, and on plants. Bacillus amyloliquefaciens is ubiquitous in the environment, especially in soils and agricultural environments all over the world. Bacillus amyloliquefaciens was previously classified as Bacillus subtilis var. amyloliquefaciens. (Ref 1). B. subtilis var. amyloliquefaciens is used to produce proteolytic enzymes for laundry detergents, is used in broiler feed as a probiotic, and produces chitinase, protease, and lipases which suppress fungi and nematodes. It has also been reported as having plant growth regulator activity. Bacillus subtilis sp. are known to cause spoilage in dough, and are rarely found to cause food poisoning (Ref. 2). Between 1990-1996 ten different foods have been associated with B. subtilis foodborne illness outbreaks, other infrequent cases have been reported as well (Ref. 3), but no reported foodborne illnesses have been associated with Bacillus amyloliquefaciens or Bacillus amyloliquefaciens PTA-4838. Bacillus amyloliquefaciens infections have only been associated with amylosin producing strains and presence of other pathogens isolated from indoor dust in water damaged buildings (Ref. 3), and infections have not been associated with any dietary consumption. The production of amylosin has not been reported with Bacillus amyloliquefaciens PTA-4838 strain, and the acute pulmonary toxicity pathogenicity studies show no signs of toxicity or pathogenicity for this strain. [[Page 41221]] Thus, Bacillus amyloliquefaciens PTA-4838 strain is not considered a risk for infection. Acute oral, pulmonary, and injection toxicity/pathogenicity testing of Bacillus amyloliquefaciens strain PTA-4838 has shown that it is not toxic or pathogenic. Specific information on the studies received and other available information concerning potential effects of Bacillus amyloliquefaciens strain PTA-4838 can be found at http://www.regulations.gov in the document titled ``Registration Decision for the New Active Ingredient Bacillus amyloliquefaciens strain PTA-4838'' in this docket ID number EPA-HQ-OPP-2015-0420. (Ref. 4). As no adverse effects have been observed in the available data for Bacillus amyloliquefaciens strain PTA-4838, the Agency has not identified any points of departure for conducting a quantitative assessment of Bacillus amyloliquefaciens strain PTA-4838. Consequently, the Agency conducted a qualitative assessment. IV. Aggregate Exposures In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). A. Dietary Exposure 1. Food. Bacillus amyloliquefaciens is ubiquitous in the environment, especially in soils and agricultural environments, so dietary exposure to background levels of the naturally occurring microbe are already occurring. B. subtilis and B. amyloliquefaciens are considered GRAS food additives and the FDA has estimated that dietary exposure of B. subtilis and B. amyloliquefaciens by the U.S. population is 200 mg/day (Ref. 5). Similar Bacillus subtilis strains are used in the production of food grade products and in fermented foods in Japan and Thailand. Dietary exposure via crop residues from pesticidal uses will be much lower based on maximum application rates. Further, the product containing Bacillus amyloliquefaciens PTA-4848 is not toxic or pathogenic and is not expected to cause adverse health effects, and has not been connected to any illnesses. 2. Drinking water exposure. Bacillus amyloliquefaciens is naturally present in soils; therefore, Bacillus amyloliquefaciens may occur in surface water and possibly groundwater. According to the World Health Organization, Bacillus species are often detected in drinking water even after going through acceptable water treatment processes, mostly because the spores are resistant to municipal water treatment measures. Should this microbial pesticide be present, no adverse effects are expected from exposure to Bacillus amyloliquefaciens through drinking water (Ref. 6), based on the results outlined in the Toxicological Profile Section. B. Other Non-Occupational Exposure The pesticide use of Bacillus amyloliquefaciens PTA-4838 except during application right before harvest, as proposed, does not increase in a significant way the potential for non-dietary, non-occupational exposure to its residues for the general population, including infants and children, because Bacillus amyloliquefaciens is ubiquitous in the environment and because populations have been previously exposed to background levels of the microbe. Children are not expected to have any incidental exposure at levels above what they are naturally exposed to already. Human exposure to Bacillus subtilis and Bacillus amyloliquefaciens in food grade products or fermented foods have not resulted in any reports of infection. As previously mentioned Bacillus subtilis and Bacillus amyloliquefaciens dietary exposure is reported as 200 mg/per person per day in the U.S. (Ref. 5). Any additional exposure to Bacillus amyloliquefaciens PTA-4838 resulting from residues from pesticidal use and residential homeowner applications will not result in additional aggregate non occupational risk, since no acute oral, pulmonary, and injection toxicity or pathogenicity hazard exists. V. 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.'' B. amyloliquefaciens strain PTA-4838 does not share a common mechanism of toxicity with any other substances, since it is not toxic via the oral, dermal, or inhalation routes of exposure. For the purposes of this tolerance action, therefore, EPA has assumed that Bacillus amyloliquefaciens strain PTA-4838 does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative. VI. Determination of Safety for U.S. Population, Infants and Children A. U.S. Population Although there is likely to be dietary and non-occupational exposure to Bacillus amyloliquefaciens strain PTA-4838, the Agency concludes that there is reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Bacillus amyloliquefaciens strain PTA-4838 because of the lack of any toxicity, infectivity, and pathogenicity of this microbe. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. B. Infants and Children FFDCA section 408(b)(2)(C) provides that the 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 the EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor. In applying this provision, the EPA either retains the default value of 10X or uses a different additional safety factor when reliable data available to the EPA support the choice of a different factor. As discussed above, EPA has concluded that Bacillus amyloliquefaciens strain PTA-4838 is not toxic, pathogenic, or infective to mammals, including infants and children. Because there are no threshold levels of concern to infants, children, and adults when Bacillus amyloliquefaciens strain PTA-4838 is used according to label directions and good agricultural practices, EPA concludes that no additional margin of safety is necessary to protect infants and children. VII. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption [[Page 41222]] from the requirement of a tolerance without any numerical limitation. VIII. Conclusions Therefore, an exemption is established for residues of Bacillus amyloliquefaciens strain PTA-4838 on all food commodities. IX. References 1. Priest, F., Goodfellow, M., Shute, L., and Berkeley, R. 1987. ``Bacillus amyloliquefaciens sp. nom., nom. rev.'' International Journal of Systematic Bacteriology. 37: 69-71. http://ijs.sgmjournals.org/content/37/1/69.full.pdf. 2. https://microbewiki.kenyon.edu/index.php/Bacillus_subtilis. 3. Apetroaie[hyphen]Constantin, C., et al. (2009). ``Bacillus subtilis and B. mojavensis strains connected to food poisoning produce the heat stable toxin amylosin.'' Journal of Applied Microbiology 106(6): 1976-1985. 4. Registration Decision for the New Active Ingredient Bacillus amyloliquefaciens strain PTA-4838, http://www.regulations.gov. Docket No. EPA-HQ-OPP-2015-0420. 5. http://www.fda.gov/ohrms/dockets/98fr/042399a.txt. 6. https://www.thefederalregister.org/fdsys/pkg/FR-2012-01-06/pdf/2011-33846.pdf, Federal Register (77 FR 745, January 6, 2012). X. Statutory and Executive Order Reviews This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). XI. 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: June 1, 2016. Jack E. Housenger, Director, 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. Section 180.1336 is added to subpart D to read as follows: Sec. 180.1336 Bacillus amyloliquefaciens strain PTA-4838; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of Bacillus amyloliquefaciens strain PTA-4838 in or on all food commodities. [FR Doc. 2016-15006 Filed 6-23-16; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 81, No. 122 / Friday, June 24, 2016 / Rules and Regulations 41219
TABLE 1—Continued
Location: All waters of Charles River between the Longfellow Bridge and the Harvard Bridge within the following
points (NAD 83):
42°21.7′ N., 071°04.8′ W.
42°21.7′ N., 071°04.3′ W.
42°22.2′ N., 071°07.3′ W.
42°22.1′ N., 070°07.4′ W.
This notice is issued under authority 412–221–0807, email amyloliquefaciens strain PTA–4838 on
of 33 CFR 165.118 and 5 U.S.C. 552 (a). Jennifer.L.Haggins@uscg.mil. all food commodities when applied or
In addition to this notice in the Federal SUPPLEMENTARY INFORMATION: The Coast used as a fungicide, nematocide, or
Register, the Coast Guard will provide Guard will enforce the Safety Zone for plant growth regulator. LidoChem, Inc.
notification of these enforcement the annual Wheeling Heritage Port submitted a petition to EPA under the
periods via the Local Notice to Mariners Sternwheel Festival Fireworks listed in Federal Food, Drug, and Cosmetic Act
and Broadcast Notice to Mariners. 33 CFR 165.801 Table 1, Sector Ohio (FFDCA), requesting an exemption from
Dated: June 10, 2016. Valley, No. 60, from 10 p.m. to 11:30 the requirement of a tolerance. This
C.C. Gelzer, p.m. on September 17, 2016. This safety regulation eliminates the need to
zone extends from mile 90.2 to 90.7 on establish a maximum permissible level
Captain, U.S. Coast Guard, Captain of the
Port Boston. the Ohio River in Wheeling, WV. This for residues of Bacillus
action is being taken to provide for the amyloliquefaciens strain PTA–4838.
[FR Doc. 2016–14783 Filed 6–23–16; 8:45 am]
safety of life on navigable waterways DATES: This regulation is effective June
BILLING CODE 9110–04–P
during the fireworks display. Entry into 24, 2016. Objections and requests for
the safety zone is prohibited unless hearings must be received on or before
DEPARTMENT OF HOMELAND authorized by the COTP or a designated August 23, 2016, and must be filed in
SECURITY representative. Persons or vessels accordance with the instructions
desiring to enter into or passage through provided in 40 CFR part 178 (see also
Coast Guard the safety zone must request permission Unit I.C. of the SUPPLEMENTARY
from the COTP or a designated INFORMATION).
33 CFR Part 165 representative. If permission is granted, ADDRESSES: The docket for this action,
[Docket No. USCG–2016–0388] all persons and vessels shall comply identified by docket identification (ID)
with the instructions of the COTP or number EPA–HQ–OPP–2015–0420, is
Eighth Coast Guard District Annual designated representative. available at http://www.regulations.gov
Safety Zones; Wheeling Heritage Port This notice of enforcement is issued or at the Office of Pesticide Programs
Festival; Ohio River Mile 90.2 to 90.7; under authority of 33 CFR 165.801 and Regulatory Public Docket (OPP Docket)
Wheeling, WV 5 U.S.C. 552(a). In addition to this in the Environmental Protection Agency
notice of enforcement in the Federal Docket Center (EPA/DC), West William
AGENCY: Coast Guard, DHS.
Register, the Coast Guard will provide Jefferson Clinton Bldg., Rm. 3334, 1301
ACTION: Notice of enforcement of the maritime community with advance Constitution Ave. NW., Washington, DC
regulation. notification of this enforcement period 20460–0001. The Public Reading Room
SUMMARY: The Coast Guard will enforce via Local Notice to Mariners and is open from 8:30 a.m. to 4:30 p.m.,
a safety zone for the Wheeling Heritage updates via Marine Information Monday through Friday, excluding legal
Port Festival Fireworks on the Ohio Broadcasts. holidays. The telephone number for the
River, in Wheeling, WV from mile 90.2 Public Reading Room is (202) 566–1744,
L. Mcclain, Jr.,
to 90.7, extending the entire width of and the telephone number for the OPP
Commander, U.S. Coast Guard, Captain of Docket is (703) 305–5805. Please review
the river on September 17, 2016. This the Port Pittsburgh.
zone is needed to protect vessels the visitor instructions and additional
[FR Doc. 2016–14900 Filed 6–23–16; 8:45 am]
transiting the area and event spectators information about the docket available
BILLING CODE 9110–04–P at http://www.epa.gov/dockets.
from the hazards associated with a
barge-based fireworks display. During FOR FURTHER INFORMATION CONTACT:
the enforcement period, entry into, Robert McNally, Director, Biopesticides
transiting, or anchoring in the safety ENVIRONMENTAL PROTECTION and Pollution Prevention Division
zone is prohibited to all vessels not AGENCY (7511P), Office of Pesticide Programs,
registered with the sponsor as Environmental Protection Agency, 1200
40 CFR Part 180 Pennsylvania Ave. NW., Washington,
participants or official patrol vessels,
unless specifically authorized by the [EPA–HQ–OPP–2015–0420; FRL–9946–62] DC 20460–0001; main telephone
Captain of the Port (COTP) Pittsburgh or number: (703) 305–7090; email address:
a designated representative. Bacillus Amyloliquefaciens Strain BPPDFRNotices@epa.gov.
DATES: The regulations in 33 CFR
PTA–4838; Exemption From the SUPPLEMENTARY INFORMATION:
165.801 Table 1, Sector Ohio Valley, No. Requirement of a Tolerance
I. General Information
sradovich on DSK3GDR082PROD with RULES
60, will be enforced from 10 p.m. until AGENCY: Environmental Protection
11:30 p.m., on September 17, 2016. Agency (EPA). A. Does this action apply to me?
FOR FURTHER INFORMATION CONTACT: If ACTION: Final rule. You may be potentially affected by
you have questions about this notice of this action if you are an agricultural
enforcement, call or email MST1 SUMMARY: This regulation establishes an producer, food manufacturer, or
Jennifer Haggins, Marine Safety Unit exemption from the requirement of a pesticide manufacturer. The following
Pittsburgh, U.S. Coast Guard; telephone tolerance for residues of the Bacillus list of North American Industrial
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Classification System (NAICS) codes is DC), (28221T), 1200 Pennsylvania Ave. residues’’ and ‘‘other substances that
not intended to be exhaustive, but rather NW., Washington, DC 20460–0001. have a common mechanism of toxicity.’’
provides a guide to help readers • Hand Delivery: To make special EPA performs a number of analyses to
determine whether this document arrangements for hand delivery or determine the risks from aggregate
applies to them. Potentially affected delivery of boxed information, please exposure to pesticide residues. First,
entities may include: follow the instructions at http:// EPA determines the toxicity of
• Crop production (NAICS code 111). www.epa.gov/dockets/contacts.html. pesticides. Second, EPA examines
• Animal production (NAICS code Additional instructions on exposure to the pesticide through food,
112). commenting or visiting the docket, drinking water, and through other
• Food manufacturing (NAICS code along with more information about exposures that occur as a result of
311). dockets generally, is available at http:// pesticide use in residential settings.
• Pesticide manufacturing (NAICS www.epa.gov/dockets. III. Toxicological Profile
code 32532). Consistent with FFDCA section
II. Background and Statutory Findings
B. How can I get electronic access to 408(b)(2)(D), EPA has reviewed the
In the Federal Register of August 26,
other related information? available scientific data and other
2015 ([80] FR 51759) (FRL–9931–74),
relevant information in support of this
You may access a frequently updated EPA issued a document pursuant to
action and considered its validity,
electronic version of 40 CFR part 180 FFDCA section 408(d)(3), 21 U.S.C. completeness and reliability, and the
through the Government Printing 346a(d)(3), announcing the filing of a relationship of this information to
Office’s e-CFR site at http:// pesticide tolerance petition (PP human risk. EPA has also considered
www.ecfr.gov/cgi-bin/text- [4F8317]) by LidoChem, Inc., 20 Village available information concerning the
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Ct., Hazlet, NJ 07730. The petition variability of the sensitivities of major
40tab_02.tpl. requested that 40 CFR part 180 be identifiable subgroups of consumers,
amended by establishing an exemption including infants and children.
C. How can I file an objection or hearing
from the requirement of a tolerance for Bacillus amyloliquefaciens is a gram
request?
residues of Bacillus amyloliquefaciens positive non-pathogenic bacterium
Under FFDCA section 408(g), 21 strain PTA–4838. That document which is commonly found in the air,
U.S.C. 346a, any person may file an referenced a summary of the petition water, soil, and on plants. Bacillus
objection to any aspect of this regulation prepared by the petitioner LidoChem, amyloliquefaciens is ubiquitous in the
and may also request a hearing on those Inc., which is available in the docket, environment, especially in soils and
objections. You must file your objection http://www.regulations.gov. There were agricultural environments all over the
or request a hearing on this regulation no comments received in response to world.
in accordance with the instructions the notice of filing. Bacillus amyloliquefaciens was
provided in 40 CFR part 178. To ensure Section 408(c)(2)(A)(i) of FFDCA previously classified as Bacillus subtilis
proper receipt by EPA, you must allows EPA to establish an exemption var. amyloliquefaciens. (Ref 1). B.
identify docket ID number EPA–HQ– from the requirement for a tolerance (the subtilis var. amyloliquefaciens is used to
OPP–2015–0420 in the subject line on legal limit for a pesticide chemical produce proteolytic enzymes for
the first page of your submission. All residue in or on a food) only if EPA laundry detergents, is used in broiler
objections and requests for a hearing determines that the exemption is ‘‘safe.’’ feed as a probiotic, and produces
must be in writing, and must be Section 408(c)(2)(A)(ii) of FFDCA chitinase, protease, and lipases which
received by the Hearing Clerk on or defines ‘‘safe’’ to mean that ‘‘there is a suppress fungi and nematodes. It has
before August 23, 2016. Addresses for reasonable certainty that no harm will also been reported as having plant
mail and hand delivery of objections result from aggregate exposure to the growth regulator activity. Bacillus
and hearing requests are provided in 40 pesticide chemical residue, including subtilis sp. are known to cause spoilage
CFR 178.25(b). all anticipated dietary exposures and all in dough, and are rarely found to cause
In addition to filing an objection or other exposures for which there is food poisoning (Ref. 2).
hearing request with the Hearing Clerk reliable information.’’ This includes Between 1990–1996 ten different
as described in 40 CFR part 178, please exposure through drinking water and in foods have been associated with B.
submit a copy of the filing (excluding residential settings, but does not include subtilis foodborne illness outbreaks,
any Confidential Business Information occupational exposure. Pursuant to other infrequent cases have been
(CBI)) for inclusion in the public docket. FFDCA section 408(c)(2)(B), in reported as well (Ref. 3), but no reported
Information not marked confidential establishing or maintaining in effect an foodborne illnesses have been
pursuant to 40 CFR part 2 may be exemption from the requirement of a associated with Bacillus
disclosed publicly by EPA without prior tolerance, EPA must take into account amyloliquefaciens or Bacillus
notice. Submit the non-CBI copy of your the factors set forth in FFDCA section amyloliquefaciens PTA–4838. Bacillus
objection or hearing request, identified 408(b)(2)(C), which require EPA to give amyloliquefaciens infections have only
by docket ID number EPA–HQ–OPP– special consideration to exposure of been associated with amylosin
2015–0420, by one of the following infants and children to the pesticide producing strains and presence of other
methods: chemical residue in establishing a pathogens isolated from indoor dust in
• Federal eRulemaking Portal: http:// tolerance and to ‘‘ensure that there is a water damaged buildings (Ref. 3), and
www.regulations.gov. Follow the online reasonable certainty that no harm will infections have not been associated with
sradovich on DSK3GDR082PROD with RULES
instructions for submitting comments. result to infants and children from any dietary consumption. The
Do not submit electronically any aggregate exposure to the pesticide production of amylosin has not been
information you consider to be CBI or chemical residue. . . .’’ Additionally, reported with Bacillus
other information whose disclosure is FFDCA section 408(b)(2)(D) requires amyloliquefaciens PTA–4838 strain, and
restricted by statute. that the Agency consider ‘‘available the acute pulmonary toxicity
• Mail: OPP Docket, Environmental information concerning the cumulative pathogenicity studies show no signs of
Protection Agency Docket Center (EPA/ effects of a particular pesticide’s toxicity or pathogenicity for this strain.
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![41222 Federal Register / Vol. 81, No. 122 / Friday, June 24, 2016 / Rules and Regulations
from the requirement of a tolerance under FFDCA section 408(d), such as PART 180—[AMENDED]
without any numerical limitation. the exemption in this final rule, do not
require the issuance of a proposed rule, ■ 1. The authority citation for part 180
VIII. Conclusions continues to read as follows:
the requirements of the Regulatory
Therefore, an exemption is Flexibility Act (RFA) (5 U.S.C. 601 et Authority: 21 U.S.C. 321(q), 346a and 371.
established for residues of Bacillus seq.), do not apply.
amyloliquefaciens strain PTA–4838 on ■ 2. Section 180.1336 is added to
This action directly regulates growers, subpart D to read as follows:
all food commodities. food processors, food handlers, and food
IX. References retailers, not States or tribes, nor does § 180.1336 Bacillus amyloliquefaciens
this action alter the relationships or strain PTA–4838; exemption from the
1. Priest, F., Goodfellow, M., Shute, L., and requirement of a tolerance.
Berkeley, R. 1987. ‘‘Bacillus
distribution of power and
responsibilities established by Congress An exemption from the requirement
amyloliquefaciens sp. nom., nom. rev.’’
International Journal of Systematic in the preemption provisions of FFDCA of a tolerance is established for residues
Bacteriology. 37: 69–71. http:// section 408(n)(4). As such, the Agency of Bacillus amyloliquefaciens strain
ijs.sgmjournals.org/content/37/1/ has determined that this action will not PTA–4838 in or on all food
69.full.pdf. have a substantial direct effect on States commodities.
2. https://microbewiki.kenyon.edu/ or tribal governments, on the [FR Doc. 2016–15006 Filed 6–23–16; 8:45 am]
index.php/Bacillus_subtilis.
3. Apetroaie-Constantin, C., et al. (2009).
relationship between the national BILLING CODE 6560–50–P
‘‘Bacillus subtilis and B. mojavensis government and the States or tribal
strains connected to food poisoning governments, or on the distribution of
produce the heat stable toxin amylosin.’’ power and responsibilities among the ENVIRONMENTAL PROTECTION
Journal of Applied Microbiology 106(6): various levels of government or between AGENCY
1976–1985. the Federal Government and Indian
4. Registration Decision for the New Active tribes. Thus, the Agency has determined 40 CFR Parts 271 and 272
Ingredient Bacillus amyloliquefaciens that Executive Order 13132, entitled [EPA–R08–RCRA–2016–0131; FRL 9947–
strain PTA–4838, http://
www.regulations.gov. Docket No. EPA– ‘‘Federalism’’ (64 FR 43255, August 10, 04–Region 8]
HQ–OPP–2015–0420. 1999) and Executive Order 13175,
5. http://www.fda.gov/ohrms/dockets/98fr/ entitled ‘‘Consultation and Coordination South Dakota: Final Authorization of
042399a.txt. with Indian Tribal Governments’’ (65 FR State Hazardous Waste Management
6. https://www.gpo.gov/fdsys/pkg/FR-2012- 67249, November 9, 2000) do not apply Program Revisions and Incorporation
01-06/pdf/2011-33846.pdf, Federal to this action. In addition, this action by Reference
Register (77 FR 745, January 6, 2012). does not impose any enforceable duty or AGENCY: Environmental Protection
X. Statutory and Executive Order contain any unfunded mandate as Agency (EPA).
Reviews described under Title II of the Unfunded ACTION: Direct final rule.
This action establishes an exemption Mandates Reform Act (UMRA) (2 U.S.C.
from the requirement of a tolerance 1501 et seq.). SUMMARY: The State of South Dakota has
under FFDCA section 408(d) in This action does not involve any applied to the Environmental Protection
response to a petition submitted to the technical standards that would require Agency (EPA) for Final authorization of
Agency. The Office of Management and Agency consideration of voluntary the changes to its hazardous waste
Budget (OMB) has exempted these types consensus standards pursuant to section program under the Resource
of actions from review under Executive 12(d) of the National Technology Conservation and Recovery Act (RCRA).
Order 12866, entitled ‘‘Regulatory Transfer and Advancement Act The EPA has determined that these
Planning and Review’’ (58 FR 51735, (NTTAA) (15 U.S.C. 272 note). changes satisfy all requirements needed
October 4, 1993). Because this action to qualify for final authorization, and is
XI. Congressional Review Act authorizing the State’s changes through
has been exempted from review under
Executive Order 12866, this action is Pursuant to the Congressional Review this direct final action. The EPA uses
not subject to Executive Order 13211, Act (5 U.S.C. 801 et seq.), EPA will the regulations entitled ‘‘Approved State
entitled ‘‘Actions Concerning submit a report containing this rule and Hazardous Waste Management
Regulations That Significantly Affect other required information to the U.S. Programs’’ to provide notice of the
Energy Supply, Distribution, or Use’’ (66 Senate, the U.S. House of authorization status of State programs
FR 28355, May 22, 2001) or Executive Representatives, and the Comptroller and to incorporate by reference those
Order 13045, entitled ‘‘Protection of General of the United States prior to provisions of State statutes and
Children from Environmental Health publication of the rule in the Federal regulations that will be subject to the
Risks and Safety Risks’’ (62 FR 19885, Register. This action is not a ‘‘major EPA’s inspection and enforcement. This
April 23, 1997). This action does not rule’’ as defined by 5 U.S.C. 804(2). rule also codifies in the regulations the
contain any information collections approval of South Dakota’s hazardous
List of Subjects in 40 CFR Part 180 waste management program and
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44 Environmental protection, incorporates by reference authorized
U.S.C. 3501 et seq., nor does it require Administrative practice and procedure, provisions of the State’s regulations.
any special considerations under Agricultural commodities, Pesticides DATES: This rule is effective on August
Executive Order 12898, entitled and pests, Reporting and recordkeeping 23, 2016 unless the EPA receives
sradovich on DSK3GDR082PROD with RULES
‘‘Federal Actions to Address requirements. adverse written comment by July 25,
Environmental Justice in Minority Dated: June 1, 2016. 2016. The incorporation by reference of
Populations and Low-Income Jack E. Housenger,
certain publications listed in the rule is
Populations’’ (59 FR 7629, February 16, approved by the Director of the Federal
Director, Office of Pesticide Programs.
1994). Register as of August 23, 2016. If the
Since tolerances and exemptions that Therefore, 40 CFR chapter I is EPA receives adverse comment, it will
are established on the basis of a petition amended as follows: publish a timely withdrawal of this
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Document Created: 2016-06-24 00:52:52
Document Modified: 2016-06-24 00:52:52
| 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 June 24, 2016. Objections and requests for hearings must be received on or before August 23, 2016, 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 | Robert McNally, Director, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305- | |
| FR Citation | 81 FR 41219 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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