Bacillus Mycoides Isolate J; Temporary Exemption From the Requirement of a Tolerance, 10494-10498 [E9-5266]
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10494
Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Rules and Regulations
existing petitions for which a Notice of
Filing had been published, the Agency
would attempt to conform these
petitions to the rule. Therefore,
consistent with this rule, EPA is
establishing a tolerance on low growing
berry, except strawberry, subgroup 13–
07H. EPA concludes it is reasonable to
establish the tolerance on the newly
created subgroup, since the individual
commodities for which tolerances were
requested are identical to those which
comprise low growing berry, except
strawberry, subgroup 13–07H.
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V. Conclusion
Therefore, a tolerance is established
for residues of chlorimuron-ethyl, ethyl
2-[[[[(4-chloro-6-methoxypyrimidin-2yl)
amino]carbonyl]sulfonyl]benzoate], in
or on berry, low growing, except
strawberry, subgroup 13–07H at 0.02
ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
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
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
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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).
VII. 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: February 24, 2009.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
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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 180.429 is revised to read
as follows:
■
§ 180.429 Chlorimuron ethyl; tolerances
for residues.
(a) General. Tolerances are
established for residues of the herbicide
chlorimuron ethyl, ethyl 2-[[[[(4-chloro6-methoxypyrimidin-2yl)
amino]carbonyl]sulfonyl]benzoate], in
or on the following raw agricultural
commodities:
Commodity
Parts per million
Berry, low growing, except strawberry, subgroup 13–07H .............
Peanut ............................
Soybean ..........................
0.02
0.02
0.05
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. E9–5192 Filed 3–10–09; 8:45 am]
BILLING CODE 6560–50–S
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.
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.
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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).
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 https://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
https://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:
cerrelli.susanne@epa.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
I. General Information
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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
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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 https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://
www.gpoaccess.gov/ecfr. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guideline at https://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: https://
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
PO 00000
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10495
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 § 180.1269, rather than an
amendment of the exemption. The
exemption for the commodities listed in
§ 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
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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.
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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
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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,
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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 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
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
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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.
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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
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10497
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
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Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Rules and Regulations
rwilkins on PROD1PC63 with RULES
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
VerDate Nov<24>2008
16:30 Mar 10, 2009
Jkt 217001
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.
Therefore, 40 CFR chapter I is revised
as follows:
■
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 180.1269 is revised to read
as follows:
■
§ 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
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0617; FRL–8397–2]
2-Propenoic acid, polymer with α-[4(ethenyloxy) butyl]-w-hydroxypoly
(oxy-1,2-ethanediyl) and 1,2propanediol mono-2-propenoate,
potassium sodium salt; Tolerance
Exemption
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes an
exemption from the requirement of a
tolerance for residues of 2-Propenoic
PO 00000
Frm 00044
Fmt 4700
Sfmt 4700
acid, polymer with a-[4-(ethenyloxy)
butyl]-w-hydroxypoly (oxy-1,2ethanediyl) and 1,2-propanediol mono2-propenoate, potassium sodium salt;
(CAS Reg. No. 518026–64–7); when
used as an inert ingredient in a pesticide
chemical formulation. BASF
Corporation 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 2propenoic acid, polymer with a-[4(ethenyloxy) butyl]-w-hydroxypoly (oxy1,2-ethanediyl) and 1,2-propanediol
mono-2-propenoate, potassium sodium
salt on food or feed commodities.
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–2008–0617. All documents in the
docket are listed in the docket index
available at https://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
https://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:
Alganesh Debesai, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–8353; e-mail address:
debesai.alganesh@epa.gov.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 74, Number 46 (Wednesday, March 11, 2009)]
[Rules and Regulations]
[Pages 10494-10498]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5266]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://
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 https://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: cerrelli.susanne@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.
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
https://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at https://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 https://www.gpoaccess.gov/
ecfr. To access the OPPTS Harmonized Guidelines referenced in this
document, go directly to the guideline at https://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: https://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
