Bacillus mycoides Isolate J; Time-Limited Exemption From the Requirement of a Tolerance, 24349-24353 [2013-09706]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 78, Number 80 (Thursday, April 25, 2013)]
[Rules and Regulations]
[Pages 24349-24353]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09706]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0397; FRL-9383-1]


Bacillus mycoides Isolate J; Time-Limited Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited exemption from the 
requirement of a tolerance for residues of Bacillus mycoides isolate J 
in or on potato, when used in accordance with the terms of the section 
18 emergency exemption. This action is in response to EPA's granting of 
an emergency exemption under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide 
on potato. The time-limited exemption from the requirement of a 
tolerance expires on December 31, 2015.

DATES: This regulation is effective April 25, 2013. Objections and 
requests for hearings must be received on or before June 24, 2013, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION section.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0397, 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), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Debra Rate, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0309; email address: rate.debra@epa.gov.

SUPPLEMENTARY INFORMATION: 

[[Page 24350]]

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at https://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this 
document electronically, please go to https://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 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-
2012-0397 in the subject line on the first page of your submission. All 
objections and requests for a hearing must be in writing, and must be 
received by the Hearing Clerk on or before June 24, 2013. 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-2012-0397, 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

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is 
establishing a time-limited exemption from the requirement of a 
tolerance for Bacillus mycoides isolate J, in or on potato. This time-
limited exemption from the requirement of a tolerance expires on 
December 31, 2015.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement of a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances and exemptions from the requirement of a 
tolerance can be established without providing notice or period for 
public comment. EPA does not intend for its actions on FIFRA section 18 
related time-limited tolerances or exemptions to set binding precedents 
for the application of FFDCA section 408 and the safety standard to 
other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to 
establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement of a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(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 requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue.* * 
*''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.
    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. Emergency Exemption for Bacillus mycoides isolate J on Potato and 
Exemption From the Requirement of a Tolerance

    The Montana Department of Agriculture requested a specific 
emergency exemption, for the use of the unregistered active ingredient 
(ai), Bacillus mycoides isolate J (BmJ), to control tuber infections 
caused by potato virus Y (PVY), on generation 1 (G1) and generation 2 
(G2) potatoes grown for certified seed potato stock. There are no 
registered alternatives to control PVY infections, only registered 
alternatives that inadequately control the aphids which vector the 
virus. The Montana Department of Agriculture, requested use for 2,675 
acres of seed potato.
    After having reviewed the submission, EPA determined that an 
emergency condition existed for this State, and that the criteria for 
approval of an emergency exemption were met. Accordingly, EPA 
authorized a specific exemption under FIFRA section 18 for the use of 
Bacillus mycoides isolate J on potato for control of PVY in Montana.

[[Page 24351]]

    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of Bacillus 
mycoides isolate J in or on potato. In doing so, EPA considered the 
safety standard in FFDCA section 408(b)(2), and EPA decided that the 
necessary exemption from the requirement of a tolerance under FFDCA 
section 408(l)(6) would be consistent with the safety standard and with 
FIFRA section 18. Consistent with the need to move quickly on the 
emergency exemption in order to address an urgent non-routine situation 
and to ensure that the resulting food is safe and lawful, EPA is 
issuing this exemption from the requirement of a tolerance without 
notice and opportunity for public comment as provided in FFDCA section 
408(l)(6). This time-limited exemption from the requirement of a 
tolerance expires on December 31, 2015. EPA will take action to revoke 
the time-limited exemption from the requirement of a tolerance earlier 
if any experience with, scientific data on, or other relevant 
information on this pesticide indicates that the residues are not safe.
    Because this time-limited exemption from the requirement of a 
tolerance is being approved under emergency conditions, EPA has not 
made any decisions about whether Bacillus mycoides isolate J meets 
FIFRA's registration requirements for use on potato or whether 
permanent tolerances or exemption from the requirement of a tolerance 
for this use would be appropriate. Under these circumstances, EPA does 
not believe that this time-limited exemption from the requirement of a 
tolerance serves as a basis for registration of Bacillus mycoides 
isolate J by a State for special local needs under FIFRA section 24(c). 
Nor does this tolerance by itself serve as the authority for persons in 
any State other than Montana to use this pesticide on the applicable 
crops under FIFRA section 18 absent the issuance of an emergency 
exemption applicable within that State. For additional information 
regarding the emergency exemption for Bacillus mycoides isolate J, 
consult the person listed under FOR FURTHER INFORMATION CONTACT.

IV. 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. The nature of the toxic effects caused by 
Bacillus mycoides isolate J, are discussed in this unit. Refer to risk 
assessments in docket number EPA-HQ-OPP-2005-0303 with the titles: (1) 
BPPD Review of Product Chemistry and Toxicity/Pathogenicity Data 
Submitted by Montana Microbial Products, for EUP of BmjJ WP, which 
contains Bacillus mycoides isolate J and (2) Ecological Risk Assessment 
for Bacillus mycoides Isolate J, for additional information.
    The stomach is a hostile environment for most microbes, as most 
oral exposure to microbes, leads to inactivation by stomach acids, 
proteases, and subsequently bile salts (Ref. 1). In contrast, a 
pulmonary exposure study provides those microbes that are capable of 
infecting mammals with the greatest opportunity to express infectivity 
by directing them into the lungs, from where they may enter the 
bloodstream and other organs. Therefore, a microbe that does not show 
significant infectivity in a pulmonary exposure study, presents 
negligible risk via oral exposure.
    An Acute Pulmonary Toxicity/Pathogenicity study (OPPTS 885.3150) in 
rats which were dosed intratracheally with Bacillus mycoides isolate J 
at 1.1 x 10\8\ cfu/animal, did not show complete clearance from all 
organs during the study's 35-day length. The test substance, however, 
did show a pattern of clearance in most organs. This is similar to what 
has been observed with other spore forming bacteria. Differential heat 
treatment of tissue samples showed that most of the recovered organisms 
were spores which are quiescent forms of this bacterium. Spores 
routinely take long periods to be cleared from pulmonary exposures 
(Ref. 2). Bacteria form spores when conditions do not support growth, 
so the predominance of spores among the Bacillus mycoides isolate J 
recovered from animal tissue, therefore indicates little infectivity. 
No treated animals died and there were no signs in the animals of 
toxicity or pathogenicity.
    Associated with the manufacture of Bacillus mycoides isolate J, as 
well as all exposures during the previous experimental use permits, 
more than 20 people have worked with Bacillus mycoides isolate J for 
over 8 years, and no adverse effects or incidents of hypersensitivity 
reaction have been reported associated with Bacillus mycoides isolate J 
in the routine use of the experimental product.
    Given the ubiquitous nature of this bacterium on plants, in soil, 
water, air, and decomposing plant tissue (Ref. 3), the lack of reported 
human pathogenicity, along with the lack of mortality of the test 
animals, and the absence of overt signs of toxicity or pathogenicity in 
the animals during the course of this pulmonary study, there is not 
expected to be an increase in dietary exposure or threshold effects of 
concern to infants and children when Bacillus mycoides isolate J is 
used as a foliar treatment on seed potatoes.
    This finding is consistent with a previously granted food-use 
experimental use permit (82761-EUP-2), where the Agency granted 
requests for waivers for Acute Oral Toxicity and Pathogenicity (OPPTS 
885.3050); Acute Injection Toxicity and Pathogenicity (OPPTS 885.3200); 
Acute Oral Toxicity (OPPTS 870.1100); Acute Inhalation Toxicity (OPPTS 
870.1300) mammalian studies for Bacillus mycoides isolate J, based on 
the following:
    1. Bacillus mycoides is not reported as a human pathogen, or as a 
cause of foodborne illness, food spoilage, or plant diseases, and does 
not persist on plant surfaces. Due to the ubiquitous level of Bacillus 
mycoides present in agricultural soils, there has been long term human 
exposure to Bacillus mycoides in crops and to residual Bacillus 
mycoides cells or spores in food crops (Ref. 3). No toxicity, 
infectivity, or pathogenicity of Bacillus mycoides in humans was 
reported in numerous searched citations.
    2. Bacillus mycoides is readily differentiable from other Bacillus 
cereus group organisms in production batches (including Bacillus 
thuringiensis, Bacillus pseudomycoides, Bacillus anthracis, Bacillus 
cereus, and Bacillus weihenstephanensis) and well defined quality 
control procedures are established to keep contaminants from 
fermentation batches during the production of Bacillus mycoides isolate 
J.
    3. In connection with the manufacture of Bacillus mycoides isolate 
J, no adverse effects or incidents of hypersensitivity reaction have 
been reported associated with Bacillus mycoides isolate J in the 
routine use of the experimental product in a laboratory setting. Any 
such effects would be subject to the reporting requirements of 40 CFR 
166.32(a) and guidelines for reporting Hypersensitivity Incidents 
(OPPTS 885.3400).

V. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA 
to consider available information concerning exposures from the 
pesticide residue in food and all other non-

[[Page 24352]]

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

    The authorized section 18 emergency exemption is not expected to 
result in increased dietary exposures of Bacillus mycoides isolate J to 
the general population based on the following:
    1. Food. The section 18 emergency exemption is for foliar 
application on plants, grown from first and second generation seed 
potatoes grown for seed stock. Only a small fraction of seed potatoes 
collected from treated plants may enter the food chain as livestock 
feed. The quantity of Bacillus mycoides isolate J applied to plant 
foliage, 7.5 x 10\11\ spores/acre per application, is small compared to 
the natural background levels of Bacillus mycoides.
    In agricultural soils, Bacillus mycoides typically occurs at about 
10\5\ spores per gram. In persistence studies, performed on a variety 
of crops (including peppers, potatoes, and sugar beets), the titer of 
Bacillus mycoides isolate J applied to the foliage typically declines 
from 10\6\ spores/cm\2\ to between 100 and 1,000 spores/cm\2\ over a 2-
week period. Specifically in potatoes, spores applied to foliage will 
not directly contact tubers. Tubers are exposed to natural soil 
concentrations of Bacillus mycoides that exceed the quantity of 
Bacillus mycoides isolate J spores applied to potato foliage (Ref. 3).
    2. Drinking water exposure. According to the World Health 
Organization, Bacillus species are often detected in drinking water 
even after going through acceptable water treatment processes, largely 
because the spores are resistant to these disinfection processes (Ref. 
4). Should this microbial pesticide be present, no adverse effects are 
expected from exposure to Bacillus mycoides through drinking water, 
based on the results of toxicity studies described in Unit IV.

B. Other Non-Occupational Exposure

    Natural background levels of Bacillus mycoides are reported to 
typically occur at about 10\5\ spores per gram in agricultural soils. 
Use of Bacillus mycoides isolate J pursuant to the section 18 emergency 
exemption is not likely to result in increased exposure in the general 
population because the 2,675 treated acres are not accessible to the 
general population.

VI. Cumulative Effects

    Pursuant to section 408(b)(2)(D)(v) of FFDCA, EPA has considered 
available information on the cumulative effects of such residues and 
other substances that have a common mechanism of toxicity. These 
considerations included the cumulative effects on infants and children 
of such residues and other substances with a common method of toxicity. 
Because there is no indication of mammalian toxicity or pathogenicity 
resulting from exposure to Bacillus mycoides isolate J, we conclude 
that there are no cumulative effects for this bacterium.

VII. Determination of Safety for U.S. Population, Infants, and Children

    The Agency has determined that there is reasonable certainty that 
no harm will result to the U.S. population from exposure to residues of 
Bacillus mycoides isolate J in connection with the section 18 emergency 
exemption. This determination includes all anticipated dietary 
exposures and other non-occupational exposures for which there is 
reliable information. Oral ingestion of the Bacillus mycoides isolate J 
organism on potatoes treated under the section 18 emergency exemption 
is unlikely because the portion of the potato plant that is treated is 
not intended for human or livestock consumption.
    Data submitted in a pulmonary toxicity/pathogenicity study 
performed at doses several orders of magnitude above expected exposure 
revealed no signs of overt toxicity or pathogenicity in the test 
animals. The pulmonary exposure route is more sensitive than an oral 
exposure study which has the various inactivation processes discussed 
in Unit IV. The results of an extensive literature search, which 
included numerous citations of the test organism, yielded no reports of 
its pathogenicity for mammals (Ref. 5).
    Section 408(b)(2)(C) of FFDCA provides that EPA shall assess the 
available information about consumption patterns among infants and 
children, special susceptibility of infants and children to pesticide 
chemical residues, and the cumulative effects on infants and children 
of the residues and other substances with a common mechanism of 
toxicity. In addition, section 408(b)(2)(C) of FFDCA also provides that 
EPA shall apply an additional tenfold 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 unless EPA 
determines that a different margin will be safe for infants and 
children. In the absence of specific studies showing that infants and 
children are not at risk, the Agency has retained a 10X safety factor 
to account for gaps in the database for Bacillus mycoides isolate J. In 
this instance, however, based on all available information, the Agency 
concludes that Bacillus mycoides isolate J presents no oral toxicity 
effects of concern. Thus, there are no threshold effects of concern to 
infants and children when Bacillus mycoides isolate J is used in 
accordance with the authorized section 18 use directions.

VIII. Other Considerations

A. Endocrine Disruptors

    The pesticidal active ingredient, Bacillus mycoides isolate J is 
not known to exert an influence on the endocrine system.

B. Analytical Method(s)

    Analytical methods for Bacillus mycoides isolate J that are 
sufficient to justify the issuance of the section 18 emergency 
exemption have been submitted to the Agency. An enforcement analytical 
method is not required to support an exemption from the requirement of 
a tolerance.

C. Codex Maximum Residue Level

    No codex maximum residue levels exist for the microbial Bacillus 
mycoides isolate J.

IX. Conclusion

    Therefore, a time-limited exemption from the requirement of a 
tolerance is established for residues of Bacillus mycoides isolate J, 
in or on potatoes. This time-limited exemption from the requirement of 
a tolerance expires on December 31, 2015.

X. References

1. Martinsen, T.C., Bergh, K. & Waldrum, H.L., (2005) Gastric Juice: 
A Barrier Against Infectious Diseases, Basic and Clinical 
Pharmacology and Toxicology, vol. 96: 94-102.
2. USEPA. Prevention, Pesticides and Toxic Substances. 
Reregistration Eligibility Decision (RED) Bacillus thuringiensis. 
EPA738-R-98-004. March 1998.
3. Ludwig, W., Schleiffer, Whitman, W.H. (2009) Class I: Bacilli, 
class. nov., in ``Bergey's Manual of Systematic Bacteriology'', 2nd 
Edition, Volume 3, The Firmicutes, P. DeVos, G.M. Garrity, D. Jones, 
N.R.Krieg, W. Ludwig, K.H. Schleiffer, & W.B. Whitman (eds.) 
Springer Publishing.
4. World Health Organization, Guidelines for Drinking-Water Quality. 
(2011) Fourth Edition.
5. Logan, N.A. & Turnbull, P.C.B. (2003) Bacillus and other 
Endospore-forming Bacteria, Chap 32. in ``Manual of Clinical

[[Page 24353]]

Microbiology'' 8th edition, P.R.Murray, E.J. Baron, J.H. Jorgensen, 
M.A. Pfaller & R.H. Yolken (eds), ASM Press.

XI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA sections 408(e) 
and 408(l)(6). The Office of Management and Budget (OMB) has exempted 
these types of actions from review under Executive Order 12866, 
entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 
1993). Because this final rule has been exempted from review under 
Executive Order 12866, this final rule is not subject to Executive 
Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established in accordance 
with FFDCA sections 408(e) and 408(l)(6), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA (15 U.S.C. 272 note).

XII. 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: April 12, 2013.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:


    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Revise Sec.  180.1269 to read as follows:


Sec.  180.1269  Bacillus mycoides isolate J; exemption from the 
requirement of a tolerance.

    Bacillus mycoides isolate J is temporarily exempt from the 
requirement of a tolerance when used as a fungicide on potatoes in 
accordance with a valid Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) section 18 emergency exemption. This temporary exemption 
from the requirement of a tolerance expires and is revoked on December 
31, 2015.

[FR Doc. 2013-09706 Filed 4-24-13; 8:45 am]
BILLING CODE 6560-50-P