Escherichia coli, 20542-20546 [2011-8712]
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Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations
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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) (Pub. L.
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
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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).
Parts per
million
Commodity
*
*
*
*
Mango .....................................
Melon subgroup 9A ................
*
0.20
0.20
*
0.20
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
*
*
*
*
Papaya ....................................
Pepper/eggplant subgroup 8–
10B ......................................
0.20
*
*
*
*
Sapodilla .................................
Sapote, black ..........................
Sapote, mamey ......................
*
0.20
0.20
0.20
Dated: April 1, 2011.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
*
*
*
*
Squash/cucumber subgroup
9B ........................................
Star apple ...............................
*
Therefore, 40 CFR chapter I is
amended as follows:
*
*
*
*
Tea, dried * .............................
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 180.593 is amended by:
i. Revising the introductory text in
paragraph (a);
■ ii. Removing the commodities
‘‘Cucumber,’’ ‘‘Grape’’ and ‘‘Strawberry’’
from the table in paragraph (a);
■ iii. Revising the entry ‘‘Vegetable,
cucurbit subgroup 9A’’ to read ‘‘Melon
subgroup 9A’’ in the table; and
■ iv. Alphabetically adding the
following commodities to the table in
paragraph (a) to read as follows:
■
■
§ 180.593 Etoxazole; tolerances for
residues.
(a) General. Tolerances are
established for residues of etoxazole,
including its metabolites and
degradates, in or on the commodities in
the table below. Compliance with the
tolerance levels specified below is to be
determined by measuring only etoxazole
(2-(2,6-difluorophenyl)-4-[4-(1,1dimethylethyl)-2-ethoxyphenyl]-4,5dihydrooxazole) in or on the
commodity.
Parts per
million
Commodity
*
*
*
*
Avocado ..................................
Berry, low growing, subgroup
13–07G ...............................
Caneberry subgroup 13–07A
Canistel ...................................
*
*
*
*
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13–07F ......................
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*
0.20
0.50
1.5
0.20
*
0.50
*
*
*
0.02
0.20
*
15
*
* There are currently no U.S. registrations
for tea as of April 13, 2011.
*
*
*
*
*
[FR Doc. 2011–8550 Filed 4–12–11; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2010–0274; FRL–8868–4]
Escherichia coli O157:H7 Specific
Bacteriophages; Temporary Exemption
From the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
temporary exemption from the
requirement of a tolerance for residues
of lytic bacteriophages that are specific
to Escherichia coli O157:H7, sequence
negative for shiga toxins I and II, and
grown on atoxigenic host bacteria when
applied/used on food contact surfaces in
food processing plants in accordance
with the terms of Experimental Use
Permit (EUP) No. 74234–EUP–2.
Intralytix, Inc. submitted a petition to
EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting the
temporary tolerance exemption. This
regulation eliminates the need to
establish a maximum permissible level
for residues of lytic bacteriophages that
are specific to Escherichia coli O157:H7,
sequence negative for shiga toxins I and
II, and grown on atoxigenic host
bacteria. The temporary tolerance
exemption expires on April 1, 2013.
SUMMARY:
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This regulation is effective April
13, 2011. Objections and requests for
hearings must be received on or before
June 13, 2011, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
(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.
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2010–0274. 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:
Tracy Lantz, Antimicrobials Division
(7510P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–6415; e-mail address:
lantz.tracy@epa.gov.
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
www.gpoaccess.gov/ecfr.
DATES:
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
Industrial Classification System
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C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2010–0274 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 13, 2011. 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 that does not
contain any 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 a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2010–0274, 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
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for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Background and Statutory Findings
In the Federal Register of May 5, 2010
(75 FR 24692) (FRL–8820–7), 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 9G7585)
by Intralytix, Inc., 701 East Pratt Street,
Baltimore, MD 21202. The petition
requested that 40 CFR part 180 be
amended by establishing a temporary
exemption from the requirement of a
tolerance for residues of Escherichia coli
O157:H7 Specific Bacteriophages. This
notice referenced a summary of the
petition prepared by the petitioner
Intralytix, Inc., which is available in the
docket, https://www.regulations.gov.
There were no comments received in
response to the notice of filing.
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the exemption is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of FFDCA
defines ‘‘safe ’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Pursuant to
section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an
exemption from the requirement of a
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
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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.
Phages are naturally occurring viruses
infecting bacteria. They are found in soil
and water and in association with plants
and animals, including humans.
Bacteriophages are obligate parasites of
bacteria, which means they attach to,
infect, and reproduce in bacteria. Phages
are host-specific for bacteria, with
specific bacteriophages attacking only
one bacterial species and most
frequently only one strain within a
bacterial species. As such, phages do
not attack other beneficial bacteria. In
addition, there is no evidence for
bacteriophages infecting any other life
form, including humans, except
bacteria. Thus, non-target organisms,
such as mammals, birds, fish, plants,
and other wildlife, are not affected by
exposure to bacteriophages. Humans
and other animals commonly consume
bacteriophages as they are abundantly
found in water, on plant surfaces, and
in foods such as ground beef, pork
sausage, chicken, oysters, cheese, fresh
mushrooms, and lettuce. In addition,
phages are common commensals of the
human gut and likely play an important
role in regulating populations of various
bacteria in the gastrointestinal tract. As
cited in public literature, phages have
been used for more than 80 years as
therapeutic agents with no ill effects
and are active against bacteria that cause
many infections and human diseases.
Since bacteriophage do not infect
humans, there is not a human health
risk concern from the bacteriophages
themselves. The potential concerns for
human health risk from bacteriophages
relate to their interaction with the
bacteria they infect. If bacteriophage do
not lyse (i.e., break open) the bacterial
cell they infect, there is a possibility the
cell will survive the infection and
incorporate any DNA carried by the
bacteriophage in its genome (i.e.
lysogenize). If genes for shigatoxins I
and II, often associated with pathogenic
strains of Escherichia coli O157:H7, are
carried by a lysogenized bacteriophage
into an atoxigenic Escherichia coli,
there is a possibility, in theory, to
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convert a commensal and harmless
bacterium into a pathogen. This
theoretical risk is handled in three ways
for this tolerance exemption: (1) Only
lytic bacteriophage are used; (2)
bacteriophage covered by this tolerance
exemption are DNA sequenced to
ensure they do not have the ability to
convey shigatoxins I and II; and (3) host
bacteria used to grow bacteriophage also
are atoxigenic in that they do not carry
DNA sequences capable of shigatoxin
production.
To address the infectivity and toxicity
endpoints for oral, pulmonary, and
injection exposures, the petitioner
provided publicly available information
documenting a lack of mammalian
toxicity or infectivity associated with
bacteriophages due to the specificity of
bacteriophages attachment and attack to
a narrow range of bacterial strains. As a
result, the public literature
demonstrates that phages pose little to
no risk to humans even with the known
wide exposure in food and the
environment.
Based on the published literature and
information submitted in accordance
with the Tier I toxicology data
requirements set forth in 40 CFR
158.2140(c), the Tier II and Tier III
toxicology data requirements also set
forth therein were not triggered and,
therefore, not required in connection
with this action.
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).
one study found Escherichia coli and
coliphages in 11 of 12 foods purchased
at retail markets. In this study, 10
purchases of each of the 12 foods were
made. All 10 of the fresh ground beef
purchases were contaminated with
Escherichia coli, and all 10 contained
coliphages. In addition to ground beef,
Escherichia coli and coliphages were
found in chicken, fresh pork, fresh
oyster, fresh mushrooms, lettuce,
chicken pot pie, biscuit dough, deli loaf,
deli roasted turkey, and package roasted
chicken. Another example of phages in
food has been Propionibacterium
freundenreichii phage found in
concentrations as high as 1.4 × 106/gm
of swiss cheese.
The use of the bacteriophages covered
by this tolerance in food processing
plants on food contact surfaces could
result in some residues of these
bacteriophages on food. The Agency
anticipates that food coming into
contact with these surfaces could get
residues of the phages on them and
foods with Escherichia coli O157:H7
may end up with more phages on them
as the bacteriophages covered by this
tolerance exemption infect the bacteria
and produce progeny.
2. Drinking water exposure. The
Escherichia coli bacteriophages covered
by this tolerance exemption are not
intended for use in drinking water, nor
are the approved uses likely to result in
these bacteriophages reaching surface
water or ground water that might be
used as drinking water. Use sites are
only for food processing facilities.
B. Other Non-Occupational Exposure
Since Escherichia coli bacteriophages
subject to this tolerance exemption are
only intended to be applied to food
contact surfaces in food processing
plants, the potential for nonoccupational, non-dietary exposures
(i.e., dermal and inhalation exposures)
to these phages by the general
A. Dietary Exposure
population, including infants and
1. Food. All phages, including those at children, is highly unlikely.
issue in this action, are similar in nature
V. Cumulative Effects From Substances
in that they are host-specific, attacking
With a Common Mechanism of Toxicity
only bacteria. Published literature
submitted by the registrant, and other
Section 408(b)(2)(D)(v) of FFDCA
publically available literature, indicate
requires that, when considering whether
that humans are exposed to phages
to establish, modify, or revoke a
daily, and these phages are commonly
tolerance, the Agency consider
found in humans, having no known
‘‘available information’’ concerning the
adverse effects. Indeed, humans and
cumulative effects of a particular
other animals routinely consume phages pesticide’s residues and ‘‘other
when they eat food such as raw produce substances that have a common
and cheese. For example, it is reported
mechanism of toxicity.’’
that 1,000 (103) to 5 × 105 phages can
EPA has not found lytic
bacteriophages that are specific to
be isolated routinely per gram (g) of
Escherichia coli O157:H7, sequence
high quality cheese. Pathogenic
negative for shiga toxins I and II, and
microorganisms are often found in
foods; therefore, it is not surprising that grown on atoxigenic host bacteria to
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share a common mechanism of toxicity
with any other substances. Moreover,
bacteriophage that meet these
conditions do not appear to produce a
toxic metabolite produced by other
substances. Therefore, for the purposes
of this action, EPA has assumed that
lytic bacteriophages that are specific to
Escherichia coli O157:H7, sequence
negative for shiga toxins I and II, and
grown on atoxigenic host bacteria do not
have a common mechanism of toxicity
with other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s Web site at
https://www.epa.gov/pesticides/
cumulative.
lytic bacteriophages that are specific to
Escherichia coli O157:H7, sequence
negative for shiga toxins I and II, and
grown on atoxigenic host bacteria are
non-toxic to mammals, including
infants and children. Because there are
no threshold effects of concern to
infants, children, and adults when lytic
bacteriophages that are specific to
Escherichia coli O157:H7, sequence
negative for shiga toxins I and II, and
grown on atoxigenic host bacteria are
used as labeled, 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.
VI. Determination of Safety for U.S.
Population, Infants and Children
An analytical method is not required
for enforcement purposes since the
Agency is establishing an exemption
from the requirement of a tolerance
without any numerical limitation.
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A. U.S. Population
Based on the fact that bacteriophages
are host-specific and do not cause harm
to human health, except in theoretical
instances that the Agency is avoiding
through its conditions on this
exemption, there is reasonable certainty
that no harm will result to the U.S.
population, including infants and
children, from aggregate exposure to
residues of lytic bacteriophages that are
specific to Escherichia coli O157:H7,
sequence negative for shiga toxins I and
II, and grown on atoxigenic host
bacteria. This includes all anticipated
dietary exposures and all other
exposures for which there is reliable
information.
B. Infants and Children
FFDCA section 408 (b)(2)(C) provides
that EPA shall apply an additional
tenfold margin of exposure (MOE) for
infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the data base on
toxicity and exposure, unless EPA
determines that a different MOE will be
safe for children. MOEs, which are often
referred to as uncertainty (safety)
factors, are incorporated into EPA risk
assessments either directly, or through
the use of a MOE analysis or by using
uncertainty factors in calculating a dose
level that poses no appreciable risk. As
previously mentioned in the
toxicological profile, humans, including
infants and children, have been exposed
to phages generally through food and
water, where they are commonly found,
and through decades of therapeutic use,
with no known or reported adverse
effects. Based on all available
information, the Agency concludes that
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VII. Other Considerations
A. Analytical Enforcement Methodology
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint U.N.
Food and Agriculture Organization/
World Health Organization food
standards program, and it is recognized
as an international food safety
standards-setting organization in trade
agreements to which the United States
is a party. EPA may establish a tolerance
that is different from a Codex MRL;
however, FFDCA section 408(b)(4)
requires that EPA explain the reasons
for departing from the Codex level.
The Codex has not established a MRL
for lytic bacteriophages that are specific
to Escherichia coli O157:H7, sequence
negative for shiga toxins I and II, and
grown on atoxigenic host bacteria.
C. Revisions to Petitioned-for Tolerances
In its petition PP 9G7585, Intralytix
requested that the Agency establish a
tolerance exemption for residues of
Escherichia coli O157:H7 specific
bacteriophages. The Agency is
narrowing the scope of the tolerance
exemption to residues of lytic
bacteriophages that are specific to
Escherichia coli O157:H7, sequence
negative for shiga toxins I and II, and
grown on atoxigenic host bacteria
because that is the category of
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20545
bacteriophages for which the Agency
can make a safety finding.
VIII. Conclusion
The Agency concludes that there is a
reasonable certainty that no harm will
result to the U.S. population, including
infants and children, from aggregate
exposure to residues of lytic
bacteriophages that are specific to
Escherichia coli O157:H7, sequence
negative for shiga toxins I and II, and
grown on atoxigenic host bacteria,
including all anticipated dietary
exposures and all other exposures for
which there is reliable information,
when used according to label directions,
as a microbial on food contact surfaces
in food processing plants. Therefore, a
temporary exemption is established for
residues of lytic bacteriophages that are
specific to Escherichia coli O157:H7,
sequence negative for shiga toxins I and
II, and grown on atoxigenic host
bacteria.
IX. 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
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,
E:\FR\FM\13APR1.SGM
13APR1
20546
Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations
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) (Pub. L. 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).
X. 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).
emcdonald on DSK2BSOYB1PROD with RULES
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 5, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is
amended as follows:
VerDate Mar<15>2010
21:27 Apr 12, 2011
Jkt 223001
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. Add § 180.1301 to subpart D to read
as follows:
■
§ 180.1301 Escherichia coli O157:H7
specific bacteriophages; temporary
exemption from the requirement of a
tolerance.
A temporary exemption from the
requirement of a tolerance is established
for residues of lytic bacteriophages that
are specific to Escherichia coli O157:H7,
sequence negative for shiga toxins I and
II, and grown on atoxigenic host bacteria
when used/applied on food contact
surfaces in food processing plants in
accordance with the terms of
Experimental Use Permit (EUP) No.
74234–EUP–2. This temporary
exemption expires on April 1, 2013.
[FR Doc. 2011–8712 Filed 4–12–11; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 300
[EPA–HQ–SFUND–1983–0002; FRL–9291–6]
National Oil and Hazardous Substance
Pollution Contingency Plan; National
Priorities List: Deletion of the
Spiegelberg Landfill Superfund Site
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
AGENCY:
The U.S. Environmental
Protection Agency (EPA) Region 5 is
publishing a direct final Notice of
Deletion of the Spiegelberg Landfill
Superfund Site (Site), located in Green
Oak Township, Michigan from the
National Priorities List (NPL). The NPL,
promulgated pursuant to Section 105 of
the Comprehensive Environmental
Response, Compensation, and Liability
Act (CERCLA) of 1980, as amended, is
an appendix to the National Oil and
Hazardous Substances Pollution
Contingency Plan (NCP). This direct
final deletion is being published by EPA
with the concurrence of the State of
Michigan through the Michigan
Department of Environmental Quality
(MDEQ), because EPA has determined
that all appropriate response actions
under CERCLA have been completed.
However, this deletion does not
preclude future actions under
Superfund.
DATES: This direct final deletion is
effective June 13, 2011 unless EPA
SUMMARY:
PO 00000
Frm 00058
Fmt 4700
Sfmt 4700
receives adverse comments by May 13,
2011. If adverse comments are received,
EPA will publish a timely withdrawal of
the direct final deletion in the Federal
Register informing the public that the
deletion will not take effect.
ADDRESSES: Submit your comments,
identified by Docket ID no. EPA–HQ–
SFUND–1983–0002, by one of the
following methods:
• https://www.regulations.gov: Follow
on-line instructions for submitting
comments.
• E-mail: Howard Caine, Remedial
Project Manager, at
caine.howard@epa.gov or Cheryl Allen,
Community Involvement Coordinator, at
allen.cheryl@epa.gov.
• Fax: Gladys Beard, Deletion Process
Manager, at (312) 697–2077.
• Mail: Howard Caine, Remedial
Project Manager, U.S. Environmental
Protection Agency (SR–6J), 77 W.
Jackson Boulevard, Chicago, IL 60604,
(312) 353–9685; or Cheryl Allen,
Community Involvement Coordinator,
U.S. Environmental Protection Agency
(SI–7J), 77 W. Jackson Boulevard,
Chicago, IL 60604, (312) 353–6196 or
(800) 621–8431.
• Hand delivery: Cheryl Allen,
Community Involvement Coordinator,
U.S. Environmental Protection Agency
(SI–7J), 77 West Jackson Boulevard,
Chicago, IL 60604. Such deliveries are
only accepted during the docket’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information. The
normal business hours are Monday
through Friday, 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.
Instructions: Direct your comments to
Docket ID no. EPA–HQ–SFUND–1983–
0002. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through https://
www.regulations.gov or e-mail. The
https://www.regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through https://
www.regulations.gov, your e-mail
address will be automatically captured
and included as part of the comment
E:\FR\FM\13APR1.SGM
13APR1
]]>Agencies
[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Rules and Regulations]
[Pages 20542-20546]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8712]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0274; FRL-8868-4]
Escherichia coli O157:H7 Specific Bacteriophages; 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 lytic bacteriophages that
are specific to Escherichia coli O157:H7, sequence negative for shiga
toxins I and II, and grown on atoxigenic host bacteria when applied/
used on food contact surfaces in food processing plants in accordance
with the terms of Experimental Use Permit (EUP) No. 74234-EUP-2.
Intralytix, Inc. submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting the temporary tolerance
exemption. This regulation eliminates the need to establish a maximum
permissible level for residues of lytic bacteriophages that are
specific to Escherichia coli O157:H7, sequence negative for shiga
toxins I and II, and grown on atoxigenic host bacteria. The temporary
tolerance exemption expires on April 1, 2013.
[[Page 20543]]
DATES: This regulation is effective April 13, 2011. Objections and
requests for hearings must be received on or before June 13, 2011, 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-2010-0274. 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: Tracy Lantz, Antimicrobials Division
(7510P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-6415; e-mail address: lantz.tracy@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 get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at https://www.gpoaccess.gov/ecfr.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2010-0274 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 13, 2011. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0274, 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 May 5, 2010 (75 FR 24692) (FRL-8820-7),
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
9G7585) by Intralytix, Inc., 701 East Pratt Street, Baltimore, MD
21202. The petition requested that 40 CFR part 180 be amended by
establishing a temporary exemption from the requirement of a tolerance
for residues of Escherichia coli O157:H7 Specific Bacteriophages. This
notice referenced a summary of the petition prepared by the petitioner
Intralytix, Inc., which is available in the docket, https://www.regulations.gov. There were no comments received in response to the
notice of filing.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe '' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a 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
[[Page 20544]]
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.
Phages are naturally occurring viruses infecting bacteria. They are
found in soil and water and in association with plants and animals,
including humans. Bacteriophages are obligate parasites of bacteria,
which means they attach to, infect, and reproduce in bacteria. Phages
are host-specific for bacteria, with specific bacteriophages attacking
only one bacterial species and most frequently only one strain within a
bacterial species. As such, phages do not attack other beneficial
bacteria. In addition, there is no evidence for bacteriophages
infecting any other life form, including humans, except bacteria. Thus,
non-target organisms, such as mammals, birds, fish, plants, and other
wildlife, are not affected by exposure to bacteriophages. Humans and
other animals commonly consume bacteriophages as they are abundantly
found in water, on plant surfaces, and in foods such as ground beef,
pork sausage, chicken, oysters, cheese, fresh mushrooms, and lettuce.
In addition, phages are common commensals of the human gut and likely
play an important role in regulating populations of various bacteria in
the gastrointestinal tract. As cited in public literature, phages have
been used for more than 80 years as therapeutic agents with no ill
effects and are active against bacteria that cause many infections and
human diseases.
Since bacteriophage do not infect humans, there is not a human
health risk concern from the bacteriophages themselves. The potential
concerns for human health risk from bacteriophages relate to their
interaction with the bacteria they infect. If bacteriophage do not lyse
(i.e., break open) the bacterial cell they infect, there is a
possibility the cell will survive the infection and incorporate any DNA
carried by the bacteriophage in its genome (i.e. lysogenize). If genes
for shigatoxins I and II, often associated with pathogenic strains of
Escherichia coli O157:H7, are carried by a lysogenized bacteriophage
into an atoxigenic Escherichia coli, there is a possibility, in theory,
to convert a commensal and harmless bacterium into a pathogen. This
theoretical risk is handled in three ways for this tolerance exemption:
(1) Only lytic bacteriophage are used; (2) bacteriophage covered by
this tolerance exemption are DNA sequenced to ensure they do not have
the ability to convey shigatoxins I and II; and (3) host bacteria used
to grow bacteriophage also are atoxigenic in that they do not carry DNA
sequences capable of shigatoxin production.
To address the infectivity and toxicity endpoints for oral,
pulmonary, and injection exposures, the petitioner provided publicly
available information documenting a lack of mammalian toxicity or
infectivity associated with bacteriophages due to the specificity of
bacteriophages attachment and attack to a narrow range of bacterial
strains. As a result, the public literature demonstrates that phages
pose little to no risk to humans even with the known wide exposure in
food and the environment.
Based on the published literature and information submitted in
accordance with the Tier I toxicology data requirements set forth in 40
CFR 158.2140(c), the Tier II and Tier III toxicology data requirements
also set forth therein were not triggered and, therefore, not required
in connection with this action.
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
1. Food. All phages, including those at issue in this action, are
similar in nature in that they are host-specific, attacking only
bacteria. Published literature submitted by the registrant, and other
publically available literature, indicate that humans are exposed to
phages daily, and these phages are commonly found in humans, having no
known adverse effects. Indeed, humans and other animals routinely
consume phages when they eat food such as raw produce and cheese. For
example, it is reported that 1,000 (10\3\) to 5 x 10\5\ phages can be
isolated routinely per gram (g) of high quality cheese. Pathogenic
microorganisms are often found in foods; therefore, it is not
surprising that one study found Escherichia coli and coliphages in 11
of 12 foods purchased at retail markets. In this study, 10 purchases of
each of the 12 foods were made. All 10 of the fresh ground beef
purchases were contaminated with Escherichia coli, and all 10 contained
coliphages. In addition to ground beef, Escherichia coli and coliphages
were found in chicken, fresh pork, fresh oyster, fresh mushrooms,
lettuce, chicken pot pie, biscuit dough, deli loaf, deli roasted
turkey, and package roasted chicken. Another example of phages in food
has been Propionibacterium freundenreichii phage found in
concentrations as high as 1.4 x 10\6\/gm of swiss cheese.
The use of the bacteriophages covered by this tolerance in food
processing plants on food contact surfaces could result in some
residues of these bacteriophages on food. The Agency anticipates that
food coming into contact with these surfaces could get residues of the
phages on them and foods with Escherichia coli O157:H7 may end up with
more phages on them as the bacteriophages covered by this tolerance
exemption infect the bacteria and produce progeny.
2. Drinking water exposure. The Escherichia coli bacteriophages
covered by this tolerance exemption are not intended for use in
drinking water, nor are the approved uses likely to result in these
bacteriophages reaching surface water or ground water that might be
used as drinking water. Use sites are only for food processing
facilities.
B. Other Non-Occupational Exposure
Since Escherichia coli bacteriophages subject to this tolerance
exemption are only intended to be applied to food contact surfaces in
food processing plants, the potential for non-occupational, non-dietary
exposures (i.e., dermal and inhalation exposures) to these phages by
the general population, including infants and children, is highly
unlikely.
V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA has not found lytic bacteriophages that are specific to
Escherichia coli O157:H7, sequence negative for shiga toxins I and II,
and grown on atoxigenic host bacteria to
[[Page 20545]]
share a common mechanism of toxicity with any other substances.
Moreover, bacteriophage that meet these conditions do not appear to
produce a toxic metabolite produced by other substances. Therefore, for
the purposes of this action, EPA has assumed that lytic bacteriophages
that are specific to Escherichia coli O157:H7, sequence negative for
shiga toxins I and II, and grown on atoxigenic host bacteria do not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at https://www.epa.gov/pesticides/cumulative.
VI. Determination of Safety for U.S. Population, Infants and Children
A. U.S. Population
Based on the fact that bacteriophages are host-specific and do not
cause harm to human health, except in theoretical instances that the
Agency is avoiding through its conditions on this exemption, there is
reasonable certainty that no harm will result to the U.S. population,
including infants and children, from aggregate exposure to residues of
lytic bacteriophages that are specific to Escherichia coli O157:H7,
sequence negative for shiga toxins I and II, and grown on atoxigenic
host bacteria. This includes all anticipated dietary exposures and all
other exposures for which there is reliable information.
B. Infants and Children
FFDCA section 408 (b)(2)(C) provides that EPA shall apply an
additional tenfold margin of exposure (MOE) for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and
exposure, unless EPA determines that a different MOE will be safe for
children. MOEs, which are often referred to as uncertainty (safety)
factors, are incorporated into EPA risk assessments either directly, or
through the use of a MOE analysis or by using uncertainty factors in
calculating a dose level that poses no appreciable risk. As previously
mentioned in the toxicological profile, humans, including infants and
children, have been exposed to phages generally through food and water,
where they are commonly found, and through decades of therapeutic use,
with no known or reported adverse effects. Based on all available
information, the Agency concludes that lytic bacteriophages that are
specific to Escherichia coli O157:H7, sequence negative for shiga
toxins I and II, and grown on atoxigenic host bacteria are non-toxic to
mammals, including infants and children. Because there are no threshold
effects of concern to infants, children, and adults when lytic
bacteriophages that are specific to Escherichia coli O157:H7, sequence
negative for shiga toxins I and II, and grown on atoxigenic host
bacteria are used as labeled, 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. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for lytic bacteriophages that
are specific to Escherichia coli O157:H7, sequence negative for shiga
toxins I and II, and grown on atoxigenic host bacteria.
C. Revisions to Petitioned-for Tolerances
In its petition PP 9G7585, Intralytix requested that the Agency
establish a tolerance exemption for residues of Escherichia coli
O157:H7 specific bacteriophages. The Agency is narrowing the scope of
the tolerance exemption to residues of lytic bacteriophages that are
specific to Escherichia coli O157:H7, sequence negative for shiga
toxins I and II, and grown on atoxigenic host bacteria because that is
the category of bacteriophages for which the Agency can make a safety
finding.
VIII. Conclusion
The Agency concludes that there is a reasonable certainty that no
harm will result to the U.S. population, including infants and
children, from aggregate exposure to residues of lytic bacteriophages
that are specific to Escherichia coli O157:H7, sequence negative for
shiga toxins I and II, and grown on atoxigenic host bacteria, including
all anticipated dietary exposures and all other exposures for which
there is reliable information, when used according to label directions,
as a microbial on food contact surfaces in food processing plants.
Therefore, a temporary exemption is established for residues of lytic
bacteriophages that are specific to Escherichia coli O157:H7, sequence
negative for shiga toxins I and II, and grown on atoxigenic host
bacteria.
IX. 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 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,
[[Page 20546]]
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) (Pub. L. 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).
X. 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: April 5, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 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. Add Sec. 180.1301 to subpart D to read as follows:
Sec. 180.1301 Escherichia coli O157:H7 specific bacteriophages;
temporary exemption from the requirement of a tolerance.
A temporary exemption from the requirement of a tolerance is
established for residues of lytic bacteriophages that are specific to
Escherichia coli O157:H7, sequence negative for shiga toxins I and II,
and grown on atoxigenic host bacteria when used/applied on food contact
surfaces in food processing plants in accordance with the terms of
Experimental Use Permit (EUP) No. 74234-EUP-2. This temporary exemption
expires on April 1, 2013.
[FR Doc. 2011-8712 Filed 4-12-11; 8:45 am]
BILLING CODE 6560-50-P
