Gentamicin; Pesticide Tolerance for Emergency Exemptions, 44157-44162 [E8-17337]
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Federal Register / Vol. 73, No. 147 / Wednesday, July 30, 2008 / Rules and Regulations
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97% of applied 1-MCP was bound
rapidly and tightly to the surfaces of
four different soil types, and that no 1MCP was detected in the soil leachates.
This study indicates that 1-MCP has
extremely low mobility in the soil and
that it is highly unlikely that it will
move into ground water. Modeling of
potential runoff into surface waters
using the generic expected
environmental concentration (GENEEC)
2, shows that the maximum potential
concentration of 1-MCP in surface
waters following runoff would not
exceed approximately 25 ppb.
With regard to the potential exposure
and effects on human health as a result
of the newly approved usage of 1-MCP
in pre-harvest treatments, the applicant
submitted extensive guideline animal
studies. These studies were conducted
using doses much greater than any
measured or estimated environmental
concentration of 1-MCP following
applications at the maximum allowable
label rate. EPA reviews of these studies
concluded that 1-MCP has no adverse
effects on any animal organism tested.
These reviews are discussed in detail in
the April 9, 2008 Federal Register
document (73 FR 19147).
Furthermore, based on the nature of
residue studies (D339988, MRIDs
47088611–12 & 47108203, field residue
studies demonstrate that environmental
concentrations of 1-MCP will be
extremely low following applications at
the maximum allowable product label
use rate. When the product was applied
to apple trees at the maximum product
label use rate 0.28 lbs (121.4 g) 1-MCP/
acre, 1-MCP residues ranged from 3 to
4 parts per billion (ppb) on apple fruits,
at 3 to 7 days post-treatment; 212 to 379
ppb on apple leaves at 3 to 30 days posttreatment; and 17 ppb in the upper 2
centimeter of soil below the tree at 1 day
post-treatment
The Agency does not expect any
human health concerns or negative
effect on non-target organisms including
endangered species, from exposure to
residues of 1-MCP when applied or used
as directed on the label and in
accordance with good agricultural
practices.
III. Why is this Correction Issued as a
Final Rule?
Section 553 of the Administrative
Procedure Act (APA), 5 U.S.C.
553(b)(B), provides that, when an
Agency for good cause finds that notice
and public procedure are impracticable,
unnecessary or contrary to the public
interest, the Agency may issue a final
rule without providing notice and an
opportunity for public comment. EPA
has determined that there is good cause
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for making today’s technical correction
final without prior proposal and
opportunity for comment, because EPA
is merely responding to comments that
were not addressed in the previously
published final rule. The comments
received and reviewed do not affect
EPA’s decision for establishing an
amendment to the tolerance exemption
for the use 1-MCP for pre-harvest
treatment. EPA finds that this
constitutes good cause under 5 U.S.C.
553(b)(B).
IV. Do Any of the Statutory and
Executive Order Reviews Apply to this
Action?
No. The applicable statutory and
Executive order reviews were included
in the April 8, 2008 Federal Register
document. This document is a technical
correction and as such no new reviews
are applicable.
V. 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: July 23, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
[FR Doc. E8–17478 Filed 7–29–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0234; FRL–8370–8]
Gentamicin; Pesticide Tolerance for
Emergency Exemptions
Environmental Protection
Agency (EPA).
AGENCY:
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ACTION:
44157
Final rule.
SUMMARY: This regulation establishes a
time-limited tolerance for residues of
gentamicin in or on apples. This action
is in response to EPA’s granting of an
emergency exemption under section 18
of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA)
authorizing use of the pesticide on
apples. This regulation establishes a
maximum permissible level for residues
of gentamicin in this food commodity.
The time-limited tolerance expires and
is revoked on December 31, 2010.
DATES: This regulation is effective July
30, 2008. Objections and requests for
hearings must be received on or before
September 29, 2008, 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–2006–0234. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
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 either in the electronic docket
at https://www.regulations.gov, or, if only
available in hard copy, at the Office of
Pesticide Programs (OPP) Regulatory
Public Docket in Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are
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:
Andrew Ertman, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9367; e-mail address:
ertman.andrew@epa.gov.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 73, No. 147 / Wednesday, July 30, 2008 / Rules and Regulations
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.
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B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket 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 pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the Federal
Food, Drug, and Cosmetic Act (FFDCA),
as amended by the Food Quality
Protection Act of 1996 (FQPA), 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–2006–0234 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
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mailed or delivered to the Hearing Clerk
on or before September 29, 2008.
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–2006–0234, 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’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.
tolerance on its own initiative, i.e.,
without having received any petition
from an outside party.
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. * * *’’
Section 18 of FIFRA authorizes EPA
to exempt any Federal or State agency
from any provision of FIFRA, if EPA
determines that ‘‘emergency conditions
exist which require such exemption.’’
EPA has established regulations
governing such emergency exemptions
in 40 CFR part 166.
II. Background and Statutory Findings
EPA, on its own initiative, in
accordance with sections 408(e) and
408(l)(6) of FFDCA, 21 U.S.C. 346a(e)
and 346a(1)(6), is establishing a timelimited tolerance for residues of the
agricultural antibiotic gentamicin, in or
on apples at 0.10 parts per million
(ppm). This time-limited tolerance
expires and is revoked on December 31,
2010. EPA will publish a document in
the Federal Register to remove the
revoked tolerances from the CFR.
Section 408(l)(6) of FFDCA requires
EPA to establish a time-limited
tolerance or exemption from the
requirement for a tolerance for pesticide
chemical residues in food that will
result from the use of a pesticide under
an emergency exemption granted by
EPA under section 18 of FIFRA. Such
tolerances can be established without
providing notice or period for public
comment. EPA does not intend for its
actions on section 18 related timelimited tolerances to set binding
precedents for the application of section
408 of FFDCA and the new safety
standard to other tolerances and
exemptions. Section 408(e) of FFDCA
allows EPA to establish a tolerance or an
exemption from the requirement of a
III. Emergency Exemption for
Gentamicin on Apples and FFDCA
Tolerances
The State of Michigan requested the
use of gentamicin on apples due to the
development of resistance of fire blight
to the pesticide streptomycin and the
lack of viable control options. After
having reviewed the submission, EPA
determined that emergency conditions
exist for this State, and that the criteria
for an emergency exemption are met.
EPA has authorized under FIFRA
section 18 the use of gentamicin on
apples for control of fire blight in
Michigan.
As part of its evaluation of the
emergency exemption application, EPA
assessed the potential risks presented by
residues of gentamicin in or on apples.
In doing so, EPA considered the safety
standard in section 408(b)(2) of FFDCA,
and EPA decided that the necessary
tolerance under section 408(l)(6) of
FFDCA would be consistent with the
safety standard and with FIFRA section
18. Consistent with the need to move
quickly on the emergency exemption in
order to address an urgent non-routine
situation and to ensure that the resulting
food is safe and lawful, EPA is issuing
this tolerance without notice and
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opportunity for public comment as
provided in section 408(l)(6) of FFDCA.
Although this time-limited tolerance
expires and is revoked on December 31,
2010, under section 408(l)(5) of FFDCA,
residues of the pesticide not in excess
of the amount specified in the tolerance
remaining in or on apples after that date
will not be unlawful, provided the
pesticide was applied in a manner that
was lawful under FIFRA, and the
residues do not exceed a level that was
authorized by this time-limited
tolerance at the time of that application.
EPA will take action to revoke this timelimited tolerance earlier if any
experience with, scientific data on, or
other relevant information on this
pesticide indicate that the residues are
not safe.
Because this time-limited tolerance is
being approved under emergency
conditions, EPA has not made any
decisions about whether gentamicin
meets FIFRA’s registration requirements
for use on apples or whether a
permanent tolerance for this use would
be appropriate. Under these
circumstances, EPA does not believe
that this time-limited tolerance decision
serves as a basis for registration of
gentamicin by a State for special local
needs under FIFRA section 24(c). Nor
does this tolerance serve as the basis for
persons in any State other than
Michigan to use this pesticide on this
crop under FIFRA section 18 absent the
issuance of an emergency exemption
applicable within that State. For
additional information regarding the
emergency exemption for gentamicin,
contact the Agency’s Registration
Division at the address provided under
FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
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result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with the factors specified
in FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure expected as a result
of this emergency exemption request
and the time-limited tolerance for
residues of gentamicin on apples at 0.10
ppm. EPA’s assessment of exposures
and risks associated with establishing
time-limited tolerances follows.
A. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, a toxicological point of departure
(POD) is identified as the basis for
derivation of reference values for risk
assessment. The POD may be defined as
the highest dose at which no adverse
effect are observed (the NOAEL) in the
toxicology study identified as
appropriate for use in risk assessment.
However, if a NOAEL cannot be
determined, the lowest dose at which
adverse effects are observed of concern
are identified (the LOAEL) or a
Benchmark Dose (BMD) approach is
sometimes used for risk assessment.
Uncertainty/safety factors (UFs) are
used in conjunction with the POD to
take into account uncertainties inherent
in the extrapolation from laboratory
animal data to humans and in the
variations in sensitivity among members
of the human population as well as
other unknowns. Safety is assessed for
acute and chronic dietary risks by
comparing aggregate food and water
exposure to the pesticide to the acute
population adjusted dose (aPAD) and
chronic population adjusted dose
(cPAD). The aPAD and cPAD are
calculated by dividing the POD by all
applicable UFs. Aggregate short-term,
intermediate-term, and chronic-term
risks are evaluated by comparing food,
water, and residential exposure to the
POD to ensure that the margin of
exposure (MOE) called for by the
product of all applicable UFs is not
exceeded. This latter value is referred to
as the Level of Concern (LOC).
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk. Thus,
the Agency estimates risk in terms of the
probability of an occurrence of the
adverse effect greater than that expected
in a lifetime. For more information on
the general principles EPA uses in risk
characterization and a complete
description of the risk assessment
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process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological
endpoints for gentamicin used for
human risk assessment can be found at
https://www.regulations.gov in the
document registration #06MI01.
‘‘Section 18 Emergency Exemption for
the application of Gentamicin Sulfate to
Apples. Human-Health Risk
Assessment’’ pages 25–26 in docket ID
number EPA–HQ–OPP–2006–0234.
B. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to gentamicin, EPA considered
exposure under the time-limited
tolerance established by this action.
EPA assessed dietary exposures from
gentamicin in food as follows:
i. Acute exposure. No such effects
were identified in the toxicological
studies for gentamicin; therefore, a
quantitative acute dietary exposure
assessment is unnecessary.
ii. Chronic exposure. A Tier 1 chronic
dietary-exposure assessment was
conducted using the established/
recommended tolerances for all food
commodities, 100% crop treated
information for all proposed and
existing uses, and DEEMTM Version 7.81
default processing factors for some
processed commodities. Drinking water
was incorporated directly into the
dietary assessment using the EDWC
generated by GENEEC2.
iii. Cancer. A cancer dietary exposure
assessment was not performed for
gentamicin because gentamicin is not
likely to be carcinogenic to humans.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for gentamicin. Tolerance level residues
and/or 100% CT were assumed for all
food commodities.
2. Dietary exposure from drinking
water.The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for gentamicin in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of gentamicin.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www.epa.gov/oppefed1/models/
water/index.htm.
A Tier I Generic Expected
Environmental Concentration
(GENEEC2) screening model was used
to determine estimated surface water
concentrations of gentamicin following
3 applications to apples.
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Based on the GENEEC2 model
described above, the highest estimated
drinking water concentration (EDWC) of
gentamicin for chronic exposure is
estimated to be 45.08 ppb for ground
water and surface water. Modeled
estimates of drinking water
concentrations were directly entered
into the dietary exposure model (DEEM
Version 7.81). The modeled exposure
scenario was conservative, as compared
to the section 18 use pattern.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Gentamicin is not registered for any
specific use patterns that would result
in residential exposure.
4. 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 gentamicin to
share a common mechanism of toxicity
with any other substances, and
gentamicin does not appear to produce
a toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that gentamicin does not have
a common mechanism of toxicity with
other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see the policy statements
released by EPA’s Office of Pesticide
Programs concerning common
mechanism determinations and
procedures for cumulating effects from
substances found to have a common
mechanism on EPA’s website at https://
www.epa.gov/pesticides/cumulative.
C. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
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FQPA safety factor (SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
additional SF when reliable data
available to EPA support the choice of
a different factor.
2. Prenatal and postnatal sensitivity.
Based on data reviewed by the Agency,
there is no evidence of increased
susceptibility in the developmental
studies in rats, rabbits, mice, and guinea
pigs. Furthermore, there is no evidence
in increased susceptibility in the 2generation reproduction study in rats. In
all studies, gentamicin was tested
parentrally, which is very conservative
since about 1% of the oral dose is
absorbed. The doses tested in these
studies are 100-fold higher than the
hypothetical oral dose. Therefore, there
is no residual uncertainty for prenatal
and/or postnatal susceptibility
3. Conclusion. EPA has determined
that reliable data show that the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for gentamicin
is complete.
ii. There is no indication that
gentamicin is a neurotoxic chemical and
there is no need for a developmental
neurotoxicity study or additional UFs to
account for neurotoxicity.
iii. There is no evidence that
gentamicin results in increased
susceptibility in the developmental
studies in rats, rabbits, mice, and guinea
pigs. There is no evidence of increased
susceptibility in the 2-generation
reproduction study in rats.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 PCT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground water and surface water
modeling used to assess exposure to
gentamicin in drinking water. These
assessments will not underestimate the
exposure and risks posed by gentamicin.
D. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic pesticide exposures are safe by
comparing aggregate exposure estimates
to the aPAD and cPAD. The aPAD and
cPAD represent the highest safe
exposures, taking into account all
appropriate SFs. EPA calculates the
aPAD and cPAD by dividing the POD by
all applicable UFs. For linear cancer
risks, EPA calculates the probability of
additional cancer cases given the
estimated aggregate exposure. Shortterm, intermediate-term, and chronic-
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term risks are evaluated by comparing
the estimated aggregate food, water, and
residential exposure to the POD to
ensure that the MOE called for by the
product of all applicable UFs is not
exceeded.
1. Acute risk. An acute aggregate risk
assessment takes into account exposure
estimates from acute dietary
consumption of food and drinking
water. No adverse effect resulting from
a single-oral exposure was identified,
therefore, no acute dietary endpoint was
selected. Therefore, gentamicin is not
expected to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to gentamicin from food
and water will utilize 1% of the cPAD
for the U.S. population, 4% of the cPAD
for all infants less than 1 year old, and
3% of the cPAD for children 1-2 years
old. All other population subgroups
utilize 2% or less of the cPAD. There are
no residential uses for gentamicin that
result in chronic residential exposure to
gentamicin.
3. Short-term and intermediate-term
risk. Short-term and intermediate-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level).
Gentamicin is not registered for any
use patterns that would result in
residential exposure. Therefore, the
short-term aggregate risk is the sum of
the risk from exposure to gentamicin
through food and water and will not be
greater than the chronic aggregate risk.
4. Aggregate cancer risk for U.S.
population. Gentamicin is not likely to
be carcinogenic to humans and is
therefore not expected to pose a cancer
risk.
5. Pharmaceutical aggregate risk.
Section 408 of the FFDCA requires EPA
to consider potential sources of
exposure to a pesticide and related
substances in addition to the dietary
sources expected to result from a
pesticide use subject to the tolerance. In
order to determine whether to maintain
a pesticide tolerance, EPA must
‘‘determine that there is a reasonable
certainty of no harm.’’ Under FFDCA
section 505, the Food and Drug
Administration (FDA) reviews human
drugs for safety and effectiveness and
may approve a drug notwithstanding the
possibility that some users may
experience adverse side effects. EPA
does not believe that, for purposes of the
section 408 dietary risk assessment, it is
compelled to treat a pharmaceutical
user the same as a non-user, or to
assume that combined exposures to
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Federal Register / Vol. 73, No. 147 / Wednesday, July 30, 2008 / Rules and Regulations
pesticide and pharmaceutical residues
that lead to a physiological effect in the
user constitutes ‘‘harm’’ under the
meaning of section 408 of the FFDCA.
Rather, EPA believes the appropriate
way to consider the pharmaceutical use
of gentamicin in its risk assessment is to
examine the impact that the additional
nonoccupational pesticide exposures
would have to a pharmaceutical user
exposed to a related (or, in some cases,
the same) compound. Where the
additional pesticide exposure has no
more than a minimal impact on the
pharmaceutical user, EPA could make a
reasonable certainty of no harm finding
for the pesticide tolerances of that
compound under section 408 of the
FFDCA. If the potential impact on the
pharmaceutical user as a result of coexposure from pesticide use is more
than minimal, then EPA would not be
able to conclude that dietary residues
were safe, and would need to discuss
with FDA appropriate measures to
reduce exposure from one or both
sources.
The pesticidal exposure estimates
reflect the dietary dose from pesticidal
uses of gentamicin that a user treated
with a pharmaceutical gentamicin
product would receive in a reasonable
worst-case scenario. EPA’s pesticide
exposure assessment has taken into
consideration the appropriate
population, exposure route, and
exposure duration for comparison with
exposure to the pharmaceutical use of
gentamicin.
EPA estimates that the
pharmaceutical gentamicin exposure a
user is expected to receive from a
typical therapeutic dose (3–7.5
milligrams/kilogram/day (mg/kg/day)) is
2,400 to 6,000 times greater than the
estimated dietary exposure from the
pesticidal sources of gentamicin
(0.001229 mg/kg/day). Therefore,
because the pesticide exposure has no
more than a minimal impact on the total
dose to a pharmaceutical user, EPA
believes that there is a reasonable
certainty that the potential dietary
pesticide exposure will result in no
harm to a user being treated
therapeutically with gentamicin. FDA
has been made aware of EPA’s
conclusions regarding pesticide
exposure in users receiving treatment
with a pharmaceutical gentamicin drug
product.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children,
from aggregate exposure to gentamicin
residues.
VerDate Aug<31>2005
16:51 Jul 29, 2008
Jkt 214001
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
is available to enforce the tolerance
expression. The method may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no Codex maximum residue
limits (MRLs) for residues of gentamicin
on apples.
VI. Conclusion
Therefore, a time-limited tolerance is
established for residues of gentamicin
per se, in or on apple at 0.10 ppm. The
tolerance expires and is revoked on
December 31, 2010.
VII. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under sections 408(e) and 408(l)(6) 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 rule has been exempted
from review under Executive Order
12866, this rule is not subject to
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established in accordance with
sections 408(e) and 408(l)(6) 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,
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44161
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 rule. In addition, This 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).
VIII. 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: July 17, 2008.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
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Federal Register / Vol. 73, No. 147 / Wednesday, July 30, 2008 / Rules and Regulations
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
§ 180.642 Gentamicin; tolerances for
residues.
(a) General. [Reserved].
(b) Section 18 emergency exemptions.
Time-limited tolerances specified in the
following table are established for
residues of gentamicin in or on the
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.642 is added to read as
follows:
I
Commodity
Parts per million
Apple
[FR Doc. E8–17337 Filed 7–29–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0857; FRL–8370–7]
Cyfluthrin; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes a
tolerance for residues of cyfluthrin in or
on alfalfa, forage and revises the existing
tolerance for residues of cyfluthrin in or
on alfalfa, hay. Bayer CropScience
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
This regulation is effective July
30, 2008. Objections and requests for
hearings must be received on or before
September 29, 2008, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
DATES:
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0857. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
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.
ADDRESSES:
rwilkins on PROD1PC63 with RULES
Expiration/revocation date
0.10
(c) Tolerance with regional
restrictions. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
VerDate Aug<31>2005
specified agricultural commodities,
resulting from use of the pesticide
pursuant to FIFRA section 18
emergency exemptions. The tolerances
expire and are revoked on the date
specified in the following table.
16:51 Jul 29, 2008
Jkt 214001
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:
Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5218; e-mail address:
stanton.susan@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 those engaged in the
following activities:
• 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 to provide 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
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December 31, 2010
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket 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 EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s pilot
e-CFR site at https://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 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–2006–0857 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
as required by 40 CFR part 178 on or
before September 29, 2008.
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 this copy,
identified by docket ID number EPA–
HQ–OPP–2006–0857, 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),
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]]>Agencies
[Federal Register Volume 73, Number 147 (Wednesday, July 30, 2008)]
[Rules and Regulations]
[Pages 44157-44162]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17337]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0234; FRL-8370-8]
Gentamicin; Pesticide Tolerance for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a time-limited tolerance for
residues of gentamicin in or on apples. This action is in response to
EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing
use of the pesticide on apples. This regulation establishes a maximum
permissible level for residues of gentamicin in this food commodity.
The time-limited tolerance expires and is revoked on December 31, 2010.
DATES: This regulation is effective July 30, 2008. Objections and
requests for hearings must be received on or before September 29, 2008,
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-2006-0234. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in 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 either in the electronic docket at https://
www.regulations.gov, or, if only available in hard copy, at the Office
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are 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: Andrew Ertman, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9367; e-mail address: ertman.andrew@epa.gov.
SUPPLEMENTARY INFORMATION:
[[Page 44158]]
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 an electronic copy of this Federal
Register document through the electronic docket 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 pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA),
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-2006-0234 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 September 29, 2008.
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-2006-0234, 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'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
EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing a
time-limited tolerance for residues of the agricultural antibiotic
gentamicin, in or on apples at 0.10 parts per million (ppm). This time-
limited tolerance expires and is revoked on December 31, 2010. EPA will
publish a document in the Federal Register to remove the revoked
tolerances from the CFR.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related time-limited tolerances to set binding precedents
for the application of section 408 of FFDCA and the new safety standard
to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. * *
*''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Gentamicin on Apples and FFDCA Tolerances
The State of Michigan requested the use of gentamicin on apples due
to the development of resistance of fire blight to the pesticide
streptomycin and the lack of viable control options. After having
reviewed the submission, EPA determined that emergency conditions exist
for this State, and that the criteria for an emergency exemption are
met. EPA has authorized under FIFRA section 18 the use of gentamicin on
apples for control of fire blight in Michigan.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of gentamicin in
or on apples. In doing so, EPA considered the safety standard in
section 408(b)(2) of FFDCA, and EPA decided that the necessary
tolerance under section 408(l)(6) of FFDCA would be consistent with the
safety standard and with FIFRA section 18. Consistent with the need to
move quickly on the emergency exemption in order to address an urgent
non-routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing this tolerance without notice and
[[Page 44159]]
opportunity for public comment as provided in section 408(l)(6) of
FFDCA. Although this time-limited tolerance expires and is revoked on
December 31, 2010, under section 408(l)(5) of FFDCA, residues of the
pesticide not in excess of the amount specified in the tolerance
remaining in or on apples after that date will not be unlawful,
provided the pesticide was applied in a manner that was lawful under
FIFRA, and the residues do not exceed a level that was authorized by
this time-limited tolerance at the time of that application. EPA will
take action to revoke this time-limited tolerance earlier if any
experience with, scientific data on, or other relevant information on
this pesticide indicate that the residues are not safe.
Because this time-limited tolerance is being approved under
emergency conditions, EPA has not made any decisions about whether
gentamicin meets FIFRA's registration requirements for use on apples or
whether a permanent tolerance for this use would be appropriate. Under
these circumstances, EPA does not believe that this time-limited
tolerance decision serves as a basis for registration of gentamicin by
a State for special local needs under FIFRA section 24(c). Nor does
this tolerance serve as the basis for persons in any State other than
Michigan to use this pesticide on this crop under FIFRA section 18
absent the issuance of an emergency exemption applicable within that
State. For additional information regarding the emergency exemption for
gentamicin, contact the Agency's Registration Division at the address
provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with the factors specified in FFDCA section
408(b)(2)(D), EPA has reviewed the available scientific data and other
relevant information in support of this action. EPA has sufficient data
to assess the hazards of and to make a determination on aggregate
exposure expected as a result of this emergency exemption request and
the time-limited tolerance for residues of gentamicin on apples at 0.10
ppm. EPA's assessment of exposures and risks associated with
establishing time-limited tolerances follows.
A. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effect are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects
are observed of concern are identified (the LOAEL) or a Benchmark Dose
(BMD) approach is sometimes used for risk assessment. Uncertainty/
safety factors (UFs) are used in conjunction with the POD to take into
account uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. Safety is
assessed for acute and chronic dietary risks by comparing aggregate
food and water exposure to the pesticide to the acute population
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The
aPAD and cPAD are calculated by dividing the POD by all applicable UFs.
Aggregate short-term, intermediate-term, and chronic-term risks are
evaluated by comparing food, water, and residential exposure to the POD
to ensure that the margin of exposure (MOE) called for by the product
of all applicable UFs is not exceeded. This latter value is referred to
as the Level of Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for gentamicin used for
human risk assessment can be found at https://www.regulations.gov in the
document registration 06MI01. ``Section 18 Emergency Exemption
for the application of Gentamicin Sulfate to Apples. Human-Health Risk
Assessment'' pages 25-26 in docket ID number EPA-HQ-OPP-2006-0234.
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to gentamicin, EPA considered exposure under the time-limited
tolerance established by this action. EPA assessed dietary exposures
from gentamicin in food as follows:
i. Acute exposure. No such effects were identified in the
toxicological studies for gentamicin; therefore, a quantitative acute
dietary exposure assessment is unnecessary.
ii. Chronic exposure. A Tier 1 chronic dietary-exposure assessment
was conducted using the established/recommended tolerances for all food
commodities, 100% crop treated information for all proposed and
existing uses, and DEEMTM Version 7.81 default processing
factors for some processed commodities. Drinking water was incorporated
directly into the dietary assessment using the EDWC generated by
GENEEC2.
iii. Cancer. A cancer dietary exposure assessment was not performed
for gentamicin because gentamicin is not likely to be carcinogenic to
humans.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for gentamicin. Tolerance level residues and/or 100%
CT were assumed for all food commodities.
2. Dietary exposure from drinking water.The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for gentamicin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of gentamicin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
A Tier I Generic Expected Environmental Concentration (GENEEC2)
screening model was used to determine estimated surface water
concentrations of gentamicin following 3 applications to apples.
[[Page 44160]]
Based on the GENEEC2 model described above, the highest estimated
drinking water concentration (EDWC) of gentamicin for chronic exposure
is estimated to be 45.08 ppb for ground water and surface water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM Version 7.81). The
modeled exposure scenario was conservative, as compared to the section
18 use pattern.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Gentamicin is not registered for any specific use patterns that
would result in residential exposure.
4. 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 gentamicin to share a common mechanism of
toxicity with any other substances, and gentamicin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
gentamicin does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at https://
www.epa.gov/pesticides/cumulative.
C. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional SF when reliable data
available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. Based on data reviewed by
the Agency, there is no evidence of increased susceptibility in the
developmental studies in rats, rabbits, mice, and guinea pigs.
Furthermore, there is no evidence in increased susceptibility in the 2-
generation reproduction study in rats. In all studies, gentamicin was
tested parentrally, which is very conservative since about 1% of the
oral dose is absorbed. The doses tested in these studies are 100-fold
higher than the hypothetical oral dose. Therefore, there is no residual
uncertainty for prenatal and/or postnatal susceptibility
3. Conclusion. EPA has determined that reliable data show that the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for gentamicin is complete.
ii. There is no indication that gentamicin is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
iii. There is no evidence that gentamicin results in increased
susceptibility in the developmental studies in rats, rabbits, mice, and
guinea pigs. There is no evidence of increased susceptibility in the 2-
generation reproduction study in rats.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground water and surface water modeling
used to assess exposure to gentamicin in drinking water. These
assessments will not underestimate the exposure and risks posed by
gentamicin.
D. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-term, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the POD to ensure that the MOE
called for by the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified, therefore, no acute dietary endpoint was selected.
Therefore, gentamicin is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
gentamicin from food and water will utilize 1% of the cPAD for the U.S.
population, 4% of the cPAD for all infants less than 1 year old, and 3%
of the cPAD for children 1-2 years old. All other population subgroups
utilize 2% or less of the cPAD. There are no residential uses for
gentamicin that result in chronic residential exposure to gentamicin.
3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account short-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Gentamicin is not registered for any use patterns that would result
in residential exposure. Therefore, the short-term aggregate risk is
the sum of the risk from exposure to gentamicin through food and water
and will not be greater than the chronic aggregate risk.
4. Aggregate cancer risk for U.S. population. Gentamicin is not
likely to be carcinogenic to humans and is therefore not expected to
pose a cancer risk.
5. Pharmaceutical aggregate risk. Section 408 of the FFDCA requires
EPA to consider potential sources of exposure to a pesticide and
related substances in addition to the dietary sources expected to
result from a pesticide use subject to the tolerance. In order to
determine whether to maintain a pesticide tolerance, EPA must
``determine that there is a reasonable certainty of no harm.'' Under
FFDCA section 505, the Food and Drug Administration (FDA) reviews human
drugs for safety and effectiveness and may approve a drug
notwithstanding the possibility that some users may experience adverse
side effects. EPA does not believe that, for purposes of the section
408 dietary risk assessment, it is compelled to treat a pharmaceutical
user the same as a non-user, or to assume that combined exposures to
[[Page 44161]]
pesticide and pharmaceutical residues that lead to a physiological
effect in the user constitutes ``harm'' under the meaning of section
408 of the FFDCA. Rather, EPA believes the appropriate way to consider
the pharmaceutical use of gentamicin in its risk assessment is to
examine the impact that the additional nonoccupational pesticide
exposures would have to a pharmaceutical user exposed to a related (or,
in some cases, the same) compound. Where the additional pesticide
exposure has no more than a minimal impact on the pharmaceutical user,
EPA could make a reasonable certainty of no harm finding for the
pesticide tolerances of that compound under section 408 of the FFDCA.
If the potential impact on the pharmaceutical user as a result of co-
exposure from pesticide use is more than minimal, then EPA would not be
able to conclude that dietary residues were safe, and would need to
discuss with FDA appropriate measures to reduce exposure from one or
both sources.
The pesticidal exposure estimates reflect the dietary dose from
pesticidal uses of gentamicin that a user treated with a pharmaceutical
gentamicin product would receive in a reasonable worst-case scenario.
EPA's pesticide exposure assessment has taken into consideration the
appropriate population, exposure route, and exposure duration for
comparison with exposure to the pharmaceutical use of gentamicin.
EPA estimates that the pharmaceutical gentamicin exposure a user is
expected to receive from a typical therapeutic dose (3-7.5 milligrams/
kilogram/day (mg/kg/day)) is 2,400 to 6,000 times greater than the
estimated dietary exposure from the pesticidal sources of gentamicin
(0.001229 mg/kg/day). Therefore, because the pesticide exposure has no
more than a minimal impact on the total dose to a pharmaceutical user,
EPA believes that there is a reasonable certainty that the potential
dietary pesticide exposure will result in no harm to a user being
treated therapeutically with gentamicin. FDA has been made aware of
EPA's conclusions regarding pesticide exposure in users receiving
treatment with a pharmaceutical gentamicin drug product.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children, from aggregate
exposure to gentamicin residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology is available to enforce the
tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: residuemethods@epa.gov.
B. International Residue Limits
There are no Codex maximum residue limits (MRLs) for residues of
gentamicin on apples.
VI. Conclusion
Therefore, a time-limited tolerance is established for residues of
gentamicin per se, in or on apple at 0.10 ppm. The tolerance expires
and is revoked on December 31, 2010.
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under sections 408(e) and
408(l)(6) 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 rule
has been exempted from review under Executive Order 12866, this rule is
not subject to Executive Order 13211, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established in accordance
with sections 408(e) and 408(l)(6) 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 rule. In addition, This
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).
VIII. 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: July 17, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
[[Page 44162]]
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 180.642 is added to read as follows:
Sec. 180.642 Gentamicin; tolerances for residues.
(a) General. [Reserved].
(b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table are established for residues of
gentamicin in or on the specified agricultural commodities, resulting
from use of the pesticide pursuant to FIFRA section 18 emergency
exemptions. The tolerances expire and are revoked on the date specified
in the following table.
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
Apple 0.10 December 31, 2010
----------------------------------------------------------------------------------------------------------------
(c) Tolerance with regional restrictions. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E8-17337 Filed 7-29-08; 8:45 am]
BILLING CODE 6560-50-S
