[Federal Register Volume 74, Number 46 (Wednesday, March 11, 2009)]
[Rules and Regulations]
[Pages 10494-10498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-5266]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0303; FRL-8400-2]


Bacillus Mycoides Isolate J; Temporary Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a temporary exemption from the 
requirement of a tolerance for residues of the Bacillus mycoides 
isolate J in or on pecans, potatoes, sugar beets, tomatoes, and peppers 
when used in accordance with good agricultural practices. Montana 
Microbial Products, submitted a petition to EPA under the Federal Food, 
Drug, and Cosmetic Act (FFDCA), requesting to amend the existing 
temporary tolerance exemption. This regulation eliminates the need to 
establish a maximum permissible level for residues of Bacillus mycoides 
isolate J in or on pecans, potatoes, sugar beets, tomatoes, and peppers 
on a time-limited basis. The temporary tolerance exemption expires on 
March 31, 2011.

[[Page 10495]]


DATES: This regulation is effective March 11, 2009. Objections and 
requests for hearings must be received on or before May 11, 2009, 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2005-0303. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Susanne Cerrelli, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8077; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Guidelines referenced in this 
document, go directly to the guideline at http://www.epa.gpo/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of 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. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. 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-2005-0303 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk on or before May 11, 2009.
    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 that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2005-0303, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of June 18, 2008 (73 FR 34734-34736) (FRL-
8366-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 8G7320) by Montana Microbial Products, 510 East Kent Ave., 
Missoula, MT 59801. The petition requested that 40 CFR part 180 be 
amended by establishing a temporary exemption from the requirement of a 
tolerance for residues of Bacillus mycoides isolate J. This notice 
included a summary of the petition prepared by the petitioner, Montana 
Microbial Products. There were no comments received in response to the 
notice of filing. The Agency has determined that the change sought by 
Montana Microbial products is actually a revision of Sec.  180.1269, 
rather than an amendment of the exemption. The exemption for the 
commodities listed in Sec.  180.1269 expired on December 31, 2007 and 
new exemptions for pecans, potatoes, tomatoes, and peppers based on the 
petition are being approved for a period that does not expire until 
March 31, 2011, based on the petition submitted by Montana Microbial 
Products. Therefore, the section is being revised to reflect these 
changes.
    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 section 408(c)(2)(B) of FFDCA, in 
establishing or maintaining in effect an exemption from the requirement 
of a

[[Page 10496]]

tolerance, EPA must take into account the factors set forth in section 
408(b)(2)(C) of FFDCA, 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, section 408(b)(2)(D) of FFDCA 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 section 408(b)(2)(D) of FFDCA, 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.
    An Acute Pulmonary Toxicity/Pathogenicity study (OPPTS 885.3150) in 
rats which were dosed intratracheally with Bacillus mycoides isolate J 
at 1.1 x 108 cfu/animal, was reviewed and found to be 
supplemental because a clear pattern of clearance from all organs was 
not demonstrated during the study's 35-day length. The test substance, 
however, did show a pattern of clearance in some organs. Differential 
heat treatment of tissue samples had suggested that most of the 
recovered organisms were spores. No treated animals died nor were there 
signs in the animals of toxicity or pathogenicity. Given the ubiquitous 
nature of this spore forming bacterium which is found on plants, in 
soil, water, air and decomposing plant tissue, 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, issuance of the Experimental Use Permit (EUP) can be 
justified provided there are instructions for appropriate respiratory 
protection for the applicators specified on the product label.
    The Agency has granted the 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 Dermal Toxicity (OPPTS 870.1200); Acute Inhalation 
Toxicity (OPPTS 870.1300) mammalian studies for Bacillus mycoides 
isolate ``J'' for this experimental-use permit (82761-EUP-2), based on 
the following submitted rationale:
    1. Personnel who worked with BmJ, more than 20 people over 8 years, 
have not reported any exposure effects in routine use of the 
experimental product.
    2. Exposure to BmJ will be limited by supervision and label 
mandated protective equipment.
    3. B. 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 B. mycoides 
present in agricultural soils, there has been long term human exposure 
to B. mycoides in crops and to residual B. mycoides cells or spores in 
food crops. No toxicity, infectivity or pathogenicity of B. mycoides in 
humans was reported in numerous searched citations.
    4. B. mycoides is readily differentiable from other B. cereus group 
organisms in production batches (including Bacillus thuringiensis, 
Bacillus pseudomycoides, Bacillus anthracis, Bacillus cereus, and 
Bacillus weihenstephanensis) and well defined quality control 
procedures keep contaminants from fermentation batches. B. mycoides is 
a member of the closely related group of Bacillus species which 
includes B. anthracis and B. cereus strains known to cause food 
poisoning as well as the widely used microbial pesticide B. 
thuringiensis. As part of a well recognized screening procedure used 
for quality control of B. thuringiensis and B. cereus, similar 
procedures shall be required for B. mycoides.
    The Agency has granted the requests for waivers for the studies 
Primary Eye Irritation (OPPTS 870.2400) and Primary Dermal Irritation 
(OPPTS 870.2500). The registrant had provided the following rationales 
for the requests with which the EPA agrees:
    1. Personnel who worked with Bacillus mycoides isolate J for 2 to 7 
years showed no eye or dermal exposure effects.
    2. Eye or dermal exposure to Bacillus mycoides isolate J will be 
limited by supervision and protective equipment. If eye or dermal 
exposure did, however, occur, the spores will rinse out of the eye with 
water or wash off the skin with soap and water because spores are 
hydrophilic.
    3. Bacillus mycoides isolate J is not recorded as a human pathogen. 
Due to the ubiquitous presence of Bacillus mycoides isolate J in 
agricultural soils, there has been long term human exposure to Bacillus 
mycoides isolate J in crops and to residual Bacillus mycoides isolate J 
cells or spores in food crops. No toxicity or pathogenicity of Bacillus 
mycoides isolate J in humans has been reported in numerous searched 
citations.
    In connection with the requirement for reporting Hypersensitivity 
Incidents (OPPTS 885.3400), the Registrant has notified the Agency that 
no recorded or reported adverse hypersensitivity reaction to Bacillus 
mycoides isolate J has occurred during the period of 2 years in which 
the substance has been handled in a laboratory setting.

IV. 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-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 proposed EUP is not expected to result in increased dietary 
exposures of Bacillus mycoides isolate J to the general population.
    1. Food. The experimental program will include five crops, pecans, 
potatoes, sugar beets, tomatoes and peppers. The quantity of BmJ 
applied to plant foliage, 7.5 x 1011 spores/acre per 
application in typical applications to a maximum of 3.75 x 
1012 spores per acre in pecan trees, is small compared to 
the natural background levels of Bacillus mycoides. In agricultural 
soils B. mycoides typically occurs at about 105 spores per 
gram and the titer of Bacillus mycoides isolate J applied to the 
foliage typically declines from 106 spores/cm2 to 
between 100 and 1,000 spores/cm2 over a 2-week period. In 
pecans, spores applied as foliage spray will also contact nutshells, 
however spores would be removed when shells are removed prior to any 
human consumption. In potatoes, spores applied to foliage will not 
directly contact tubers. Tubers are exposed to natural soil 
concentrations of Bacillus that exceed the quantity of Bacillus 
mycoides isolate J spores

[[Page 10497]]

applied to potato foliage. Washing, peeling, and or cooking will remove 
or destroy any residual spores. Because the ordinary consumer 
encounters only the sugar produced from sugar beets, (in which the 
bacterium is not present), an increased dietary exposure is not 
foreseen from treated sugar beets. Residue of Bacillus mycoides isolate 
J applied to sugar beet foliage is not expected to carry through sugar 
beet processing to create a residue in refined sugar for human 
consumption. Application of Bacillus mycoides isolate J will create 
minimal residues on sugar beet foliage. Cattle fed sugar beet tops 
treated with Bacillus mycoides isolate J may have an exposure to a low 
level of Bacillus mycoides isolate J spores. Given the natural 
occurrence of B. mycoides, the exposure to applied Bacillus mycoides 
isolate J on sugar beet tops is not expected to represent a significant 
increase in natural exposure of cattle to B. mycoides. Nor is human 
exposure anticipated of Bacillus mycoides isolate J in meat or milk as 
a result of feeding sugar beet tops with Bacillus mycoides isolate J 
residue to cattle.
    In tomatoes and peppers, spores applied as foliage sprays may leave 
a Bacillus mycoides isolate J spore residue on the tomatoes or peppers. 
From persistence studies, discussed in Unit III., residues of Bacillus 
mycoides isolate J are expected to decline by more than 1,000-fold over 
a 2-week period. Washing harvested fruit will also further reduce or 
eliminate any Bacillus mycoides isolate J residue.
    2. Drinking water exposure. There is minimal to negligible risk 
that surface water and, thus, drinking water exposure would occur with 
the proposed EUP testing. The proposed test sites are at least one half 
mile from the nearest surface water. When spray drift or accidental 
application of Bacillus mycoides isolate J over surface water did 
occur, the concentration of Bacillus mycoides isolate J spores in the 
water had been found to be very low. For example an acre dose of 
Bacillus mycoides isolate J, 7.5 x 1011 spores to 100 square 
meters of surface water 1 meter deep, would result in a concentration 
of 750 spores per cc. of water as noted in the EPA ecological risk 
assessment for Bacillus mycoides isolate J which is based on data 
submitted by Montana Microbial Products.

B. Other Non-Occupational Exposure

    Natural background levels of Bacillus mycoides isolate J are 
reported to typically occur at about 105 spores per gram in 
agricultural soils.
    EPA concludes that dermal or inhalation exposure to Bacillus 
mycoides isolate J in the general population as a result of this EUP is 
not likely to occur, based on information submitted in pesticide 
tolerance petition 8G7320 indicating that the relevant EUP agricultural 
sites, which will not exceed 956 acres, are not accessible to 
individuals other than those conducting this EUP program.

V. 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 Bacillus mycoides isolate J, we conclude that there are 
no cumulative effects for this bacterium.

VI. 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 testing for the 
proposed EUP program. 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 crops treated under the proposed EUP is unlikely 
because: The portion of the pecans, potatoes, and sugar cane that is 
treated is not consumed by humans. The residues on peppers and tomatoes 
are readily removed by washing with water, and the U.S. population is 
already exposed to B. mycoides as a prevalent naturally occurring 
microbe in untreated soil. Data submitted in a pulmonary toxicity/
pathogenicity study revealed no signs of overt toxicity or 
pathogenicity in the test animals. The results of an extensive 
literature search, which included numerous citations of the test 
organism, yielded no reports of its pathogenicity for mammals. There 
will be no access to persons other than participants in the program to 
the test sites for the EUP. The participants in the EUP program are 
required to wear appropriate respiratory protection. 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, also referred to as 
margins of exposure (MOEs), 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 
MOE will be safe for infants and children. In this instance, based on 
all available information, the Agency concludes that there is a finding 
of no toxicity for Bacillus mycoides isolates J. Thus, there are no 
threshhold effects of concern to infants and children when the 
microbial is used as a fungicide. Accordingly, the Agency concludes 
that the additional MOE is not necessary to protect infants and 
children, and that not adding any additional MOE will be safe for 
infants and children.

VII. 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 an Experimental Use Permit (EUP) 
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.

VIII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from

[[Page 10498]]

Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997). This final rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq., nor does it require any special considerations 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance 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 section 408(n)(4) of FFDCA. 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) (Public Law 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

IX. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: January 14, 2009.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

0
Therefore, 40 CFR chapter I is revised 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 180.1269 is revised 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 pecans, 
potatoes, sugar beets, tomatoes, and peppers in accordance with the 
Experimental Use Permit 82761-EUP-2. This temporary exemption from the 
requirement of a tolerance expires and is revoked on March 31, 2011.
[FR Doc. E9-5266 Filed 3-10-09; 8:45 am]
BILLING CODE 6560-50-S