Bacillus Amyloliquefaciens Strain PTA-4838; Exemption From the Requirement of a Tolerance, 41219-41222 [2016-15006]
Download as PDF
<![CDATA[
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
of 33 CFR 165.118 and 5 U.S.C. 552 (a).
In addition to this notice in the Federal
Register, the Coast Guard will provide
notification of these enforcement
periods via the Local Notice to Mariners
and Broadcast Notice to Mariners.
Dated: June 10, 2016.
C.C. Gelzer,
Captain, U.S. Coast Guard, Captain of the
Port Boston.
[FR Doc. 2016–14783 Filed 6–23–16; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2016–0388]
Eighth Coast Guard District Annual
Safety Zones; Wheeling Heritage Port
Festival; Ohio River Mile 90.2 to 90.7;
Wheeling, WV
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
ACTION:
The Coast Guard will enforce
a safety zone for the Wheeling Heritage
Port Festival Fireworks on the Ohio
River, in Wheeling, WV from mile 90.2
to 90.7, extending the entire width of
the river on September 17, 2016. This
zone is needed to protect vessels
transiting the area and event spectators
from the hazards associated with a
barge-based fireworks display. During
the enforcement period, entry into,
transiting, or anchoring in the safety
zone is prohibited to all vessels not
registered with the sponsor as
participants or official patrol vessels,
unless specifically authorized by the
Captain of the Port (COTP) Pittsburgh or
a designated representative.
DATES: The regulations in 33 CFR
165.801 Table 1, Sector Ohio Valley, No.
60, will be enforced from 10 p.m. until
11:30 p.m., on September 17, 2016.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this notice of
enforcement, call or email MST1
Jennifer Haggins, Marine Safety Unit
Pittsburgh, U.S. Coast Guard; telephone
sradovich on DSK3GDR082PROD with RULES
SUMMARY:
VerDate Sep<11>2014
16:19 Jun 23, 2016
Jkt 238001
412–221–0807, email
Jennifer.L.Haggins@uscg.mil.
SUPPLEMENTARY INFORMATION: The Coast
Guard will enforce the Safety Zone for
the annual Wheeling Heritage Port
Sternwheel Festival Fireworks listed in
33 CFR 165.801 Table 1, Sector Ohio
Valley, No. 60, from 10 p.m. to 11:30
p.m. on September 17, 2016. This safety
zone extends from mile 90.2 to 90.7 on
the Ohio River in Wheeling, WV. This
action is being taken to provide for the
safety of life on navigable waterways
during the fireworks display. Entry into
the safety zone is prohibited unless
authorized by the COTP or a designated
representative. Persons or vessels
desiring to enter into or passage through
the safety zone must request permission
from the COTP or a designated
representative. If permission is granted,
all persons and vessels shall comply
with the instructions of the COTP or
designated representative.
This notice of enforcement is issued
under authority of 33 CFR 165.801 and
5 U.S.C. 552(a). In addition to this
notice of enforcement in the Federal
Register, the Coast Guard will provide
the maritime community with advance
notification of this enforcement period
via Local Notice to Mariners and
updates via Marine Information
Broadcasts.
L. Mcclain, Jr.,
Commander, U.S. Coast Guard, Captain of
the Port Pittsburgh.
[FR Doc. 2016–14900 Filed 6–23–16; 8:45 am]
BILLING CODE 9110–04–P
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
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of the Bacillus
SUMMARY:
PO 00000
Frm 00049
Fmt 4700
Sfmt 4700
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 https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), 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 https://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:
BPPDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
E:\FR\FM\24JNR1.SGM
24JNR1
41220
Federal Register / Vol. 81, No. 122 / Friday, June 24, 2016 / Rules and Regulations
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).
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
B. How can I get electronic access to
other related information?
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,
https://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
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
sradovich on DSK3GDR082PROD with RULES
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: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
VerDate Sep<11>2014
16:19 Jun 23, 2016
Jkt 238001
II. Background and Statutory Findings
PO 00000
Frm 00050
Fmt 4700
Sfmt 4700
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.
E:\FR\FM\24JNR1.SGM
24JNR1
Federal Register / Vol. 81, No. 122 / Friday, June 24, 2016 / Rules and Regulations
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 https://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.
sradovich on DSK3GDR082PROD with RULES
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 nonoccupational 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.
VerDate Sep<11>2014
16:19 Jun 23, 2016
Jkt 238001
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 nondietary, 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
PO 00000
Frm 00051
Fmt 4700
Sfmt 4700
41221
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 https://
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
E:\FR\FM\24JNR1.SGM
24JNR1
41222
Federal Register / Vol. 81, No. 122 / Friday, June 24, 2016 / Rules and Regulations
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
sradovich on DSK3GDR082PROD with RULES
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. https://
ijs.sgmjournals.org/content/37/1/
69.full.pdf.
2. https://microbewiki.kenyon.edu/
index.php/Bacillus_subtilis.
3. Apetroaie-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, https://
www.regulations.gov. Docket No. EPA–
HQ–OPP–2015–0420.
5. https://www.fda.gov/ohrms/dockets/98fr/
042399a.txt.
6. https://www.gpo.gov/fdsys/pkg/FR-201201-06/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
VerDate Sep<11>2014
16:19 Jun 23, 2016
Jkt 238001
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:
PO 00000
Frm 00052
Fmt 4700
Sfmt 4700
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1336 is added to
subpart D to read as follows:
■
§ 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
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 271 and 272
[EPA–R08–RCRA–2016–0131; FRL 9947–
04–Region 8]
South Dakota: Final Authorization of
State Hazardous Waste Management
Program Revisions and Incorporation
by Reference
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
AGENCY:
The State of South Dakota has
applied to the Environmental Protection
Agency (EPA) for Final authorization of
the changes to its hazardous waste
program under the Resource
Conservation and Recovery Act (RCRA).
The EPA has determined that these
changes satisfy all requirements needed
to qualify for final authorization, and is
authorizing the State’s changes through
this direct final action. The EPA uses
the regulations entitled ‘‘Approved State
Hazardous Waste Management
Programs’’ to provide notice of the
authorization status of State programs
and to incorporate by reference those
provisions of State statutes and
regulations that will be subject to the
EPA’s inspection and enforcement. This
rule also codifies in the regulations the
approval of South Dakota’s hazardous
waste management program and
incorporates by reference authorized
provisions of the State’s regulations.
DATES: This rule is effective on August
23, 2016 unless the EPA receives
adverse written comment by July 25,
2016. The incorporation by reference of
certain publications listed in the rule is
approved by the Director of the Federal
Register as of August 23, 2016. If the
EPA receives adverse comment, it will
publish a timely withdrawal of this
SUMMARY:
E:\FR\FM\24JNR1.SGM
24JNR1
]]>Agencies
[Federal Register Volume 81, Number 122 (Friday, June 24, 2016)]
[Rules and Regulations]
[Pages 41219-41222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), 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 https://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: BPPDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial
[[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 https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection 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: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://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, https://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 https://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 https://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. https://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, https://www.regulations.gov.
Docket No. EPA-HQ-OPP-2015-0420.
5. https://www.fda.gov/ohrms/dockets/98fr/042399a.txt.
6. https://www.gpo.gov/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
