Document ID: EPA-HQ-OPP-2015-0420-0003
Agency: epa
Document Type: Rule
Title: Exemptions from the Requirement of a Tolerance: Bacillus amyloliquefaciens strain PTA-4838
Posted Date: 2016-06-24T04:00Z

[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 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: 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 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.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