Isophorone; Exemption from the Requirement of a Tolerance, 45403-45408 [E6-12547]
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Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations
Regulatory Public Docket in Rm. S-4400,
One Potomac Yard (South Building),
2777 S. Crystal Drive, Arlington, VA.
The Docket Facility is open from 8:30
a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
telephone number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Kerry Leifer, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–8811; e;mail address:
leifer.kerry@epa.gov.
SUPPLEMENTARY INFORMATION:
[FR Doc. E6–12964 Filed 8–8–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0582; FRL–8082–1]
Isophorone; Exemption from the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation amends
existing exemption from the
requirement of a tolerance for residues
of isophorone (CAS Reg. No. 78–59–1)
to limit the use to beets, ginseng, rice,
spinach, sugar beets, and Swiss chard.
The Isophorone Task Group (ITG)
requested this revised exemption from
the requirement of a tolerance under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food
Quality Protection Act (FQPA) of 1996.
This regulatory action contributes
toward the Agency’s tolerance
reassessment requirements under
FFDCA section 408(q), as amended by
the FQPA of 1996. By law, EPA is
required by August 2006 to reassess the
tolerances that were in existence on
August 2, 1996. The regulatory action in
this document pertains to the revision of
one existing tolerance exemption which
is counted as a tolerance reassessment
toward the August 2006 review
deadline.
This regulation is effective
August 9, 2006. Objections and requests
for hearings must be received on or
before October 10, 2006, 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–2006–0582. All documents in the
docket are listed in the index for the
docket. 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
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ADDRESSES:
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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 111), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
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
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45403
electronic version of 40 CFR part 180
through the Government Printing
Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines at https://www.epa.gpo/
opptsfrs/home/guidelin.htm
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the FFDCA, as
amended by the 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–2006–0582 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 October 10, 2006.
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–2006–0582, 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 Building), 2777 S.
Crystal Drive, 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 telephone number is (703) 305–
5805.
II. Background and Statutory Findings
In the Federal Register of April 27,
2005 (70 FR 7951) (FRL–7710–1), EPA
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issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 4E6894) The
Isophorone Task Group (ITG) of the
Ketones Panel of the American
Chemistry Council, 1300 Wilson Blvd.,
Arlington, VA 22209. The petition
requested that 40 CFR 180.920 be
amended by limiting the existing
exemption from the requirement for
isophorone (CAS Reg. No. 78–59–1) to
rice, spinach, and sugar beets. That
notice included a summary of the
pesticide petition prepared by ITG, the
petitioner. Comments were received on
the notice of filing. EPA’s response to
these comments is discussed in Unit IV.
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. . . .’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. For
further discussion of the regulatory
requirements of section 408 of the
FFDCA and a complete description of
the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and
Determination of Safety
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. EPA has sufficient data to assess
the hazards of and to make a
determination on aggregate exposure,
consistent with section 408(b)(2) of
FFDCA, for an exemption from the
requirement of a tolerance for residues
of isophorone in or on beets, ginseng,
rice, spinach, sugar beets, and Swiss
chard. EPA’s assessment of exposures
and risks associated with establishing
the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. The nature of the
toxic effects caused by isophorone are
discussed in the following Table 1 as
well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
reviewed toxicity studies.
TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY
Guideline No.
Study Type
870.3100
Results
90–Day oral toxicity rodents (rats)
NOAEL = 233.8/>311.8 milligram/kilogram/
day (mg/kg/day) male/female.
LOAEL = 102.5 (M)/not established (F) mg/
kg/day based on M decrease in body
weight
90–Day oral toxicity study in nonrodents
(dogs)
NOAEL = 150 mg/kg/day higest dose tested
(HDT)
LOAEL = cannot be established
870.3700
Prenatal developmental (inhalation) in rodents (mice)
Maternal NOAEL = 50 ppm
LOAEL = 115 ppm based on decreased gestation day 18 body weight, corrected for
uterine weight
Developmental NOAEL = >115 ppm
Developmental LOAEL = cannot be established
870.3700
Prenatal developmental (inhalation) in rodents (rats)
Maternal NOAEL = 25 ppm
LOAEL = 50 ppm based on increased incidence of clinical signs (alopecia, ano-genital and cervical staining)
Developmental NOAEL = 115 ppm HDT
Developmental LOAEL = cannot be established
870.4200
Carcinogenicity (rats)
NOAEL = 250/500 mg/kg/day (M/F)
LOAEL = 500 (M)/not established (F) based
on M = increased incidence of preputial
gland carcinoma
870.4200
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870.3150
Carcinogenicity (mice)
NOAEL = 500 mg/kg/day HDT
LOAEL = cannot be established
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Isophorone was evaluated as part of
the International Programme on
Chemical Safety (ICPS). The IPCS is a
joint venture of the United Nations
Environment Programme, the
International Labour Organisation, and
the World Health Organization. The
main objective of the IPCS is to carry
out and disseminate evaluations of the
effects of chemicals on human health
and the quality of the environment.
The ICPS Environmental Health
Criteria monograph for isophorone
critically evaluated the available
toxicity data on isophorone, which
included a consideration of the studies
summarized in Table 1 as well as other
available toxicity data on isophorone.
As part of the human health risk
assessment of isophorone, the ICPS
monograph states that ‘‘limited studies
in rats and mice indicate that
isophorone does not affect fertility nor
does it cause developmental toxicity in
experimental animals.’’ Additionally in
summarizing the results of genotoxicity
testing, the ICPS further concluded that
‘‘the weight of evidence of all
mutagenicity data supports the
contention that isophorone is not a
potent DNA-reactive compound.’’
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the NOAEL from the toxicology
study identified as appropriate for use
in risk assessment is used to estimate
the toxicological level of concern (LOC).
However, the LOAEL are identified is
sometimes used for risk assessment if no
NOAEL was achieved in the toxicology
45405
study selected. An uncertainty factor
(UF) is applied to reflect 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.
The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify nonthreshold hazards such as cancer. The
Q* approach assumes that any amount
of exposure will lead to some degree of
cancer risk, estimates risk in terms of
the probability of occurrence of
additional cancer cases.
A summary of the toxicological
endpoints for isophorone used for
human risk assessment is shown in the
following Table 2:
TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR ISOPHORONE FOR USE IN HUMAN RISK ASSESSMENT
Exposure/Scenario
Chronic dietary (all populations).
Special FQPA SF = 1 ........
cPAD = chronic RfD
Special FQPA SF = 0.2
mg/kg/day
Cancer (oral, dermal, inhalation).
Dose Used in Risk Assessment,
Interspecies and Intraspecies and
any Traditional UF
Special FQPA SF and Level of
Concern for Risk Assessment
Study and Toxicological Effects
NOAEL = 150 mg/kg/day
UF = 1.000
Chronic RfD = 0.2 mg/kg/day
90–Day oral dog toxicity study. No
toxicity was seen at the HDT
NOAEL = 250 mg/kg/day
NA
Increased incidence of preputial
gland carcinomas in male rats
Toxicology and Carcinogenesis
Study of Isophorone in F344/N
Rats
Classification: Under the 1986 cancer classification scheme, isophorone was classified as Group C- Possible
Human Carcinogen, with a linear low-dose extrapolation approach and a 3/4s interspecies scaling factor for
human risk. The upper bound estimate of unit risk, Q1* is 6.08 x 10-4 in human equivalents
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. An exemption from the
requirement of a tolerances has been
established (40 CFR 180.40 CFR site) for
the residues of isophorone, in or on
beet, ginseng, rice, spinach, sugar beet
and Swiss chard commodities. Risk
assessments were conducted by EPA to
assess dietary exposures from
isophorone in food as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1–day or single
exposure.
Option 1. No such effects were
identified in the toxicological studies
for isophorone; therefore, a quantitative
acute dietary exposure assessment is
unnecessary.
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ii. Chronic exposure.—Option 2. In
conducting the chronic dietary exposure
assessment EPA used the Dietary
Exposure Evaluation Model software
with the Food Commodity Intake
Database (DEEM-FCIDTM), which
incorporates food consumption data as
reported by respondents in the United
States Department of Agriculture
(USDA) 1994–1996 and 1998
Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII), and
accumulated exposure to the chemical
for each commodity. The following
assumptions were made for the chronic
exposure assessments: The assessment
was based on a screening level dietary
assessment that assumed residues of
isophorone in beet, ginseng, rice,
spinach, sugar beet and Swiss chard
commodities corresponding to the
highest established active ingredient
tolerance level residues for those
commodities and 100% crop treated.
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The highest established tolerance level
active ingredient residue level is chosen
as ‘‘worst-case’’ chronic exposure
scenario as it would be highly unlikely
that residues of isophorone in the
above-listed crops would be at such
levels.
iii. Cancer. The assessment assumed
residues of isophorone in beet, ginseng,
rice, spinach, sugar beet and Swiss
chard commodities corresponding to the
highest established active ingredient
tolerance level residues for those
commodities and 100% crop treated.
The highest established tolerance level
active ingredient residue level is chosen
as ‘‘worst-case’’ cancer exposure
scenario as it would be highly unlikely
that residues of isophorone in the
above-listed crops would be at such
levels.
2. Dietary exposure from drinking
water. Monitoring exposure data are
utilized to complete a dietary exposure
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analysis and risk assessment for
isophorone in drinking water. The
estimated drinking water concentration
(EDWC) of isophorone of 10 µg/L
utilized for the purposes of this
tolerance action is a value equivalent to
the highest measured concentration of
isophorone in drinking water sources in
monitoring studies used by EPA to
establish ambient water quality criteria
for isophorone. (EPA 440/5–80–056;
NTIS PB81–11767).
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).
Since the use of isophorone is limited
to pesticide productswhich are not
registered for use on any sites that
would result in residential exposure, no
residential exposures are expected and
a residential exposure assessment has
not been conducted
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the 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.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
isophorone and any other substances
and isophorone does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
not assumed that isophorone has 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.
D. Safety Factor for Infants and
Children
1. In general. Section 408 of FFDCA
provides that EPA shall apply an
additional tenfold margin of safety for
infants and children in the case of
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threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the data base on
toxicity and exposure unless EPA
determines based on reliable data that a
different margin of safety will be safe for
infants and children. Margins of safety
are incorporated into EPA risk
assessments either directly through use
of a MOE analysis or through using
uncertainty (safety) factors in
calculating a dose level that poses no
appreciable risk to humans. In applying
this provision, EPA either retains the
default value of 10X when reliable data
do not support the choice of a different
factor, or, if reliable data are available,
EPA uses a different additional safety
factor value based on the use of
traditional uncertainty factors and/or
special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity.
There was no evidence of increased
prenatal or postnatal susceptibility of
isophorone following in utero exposure
to rats and mice.
3. Conclusion. There is an adequate
toxicity database for the selection of
doses and endpoints for use in risk
assessment for isophorone. Exposure
data are complete or are estimated based
on data that reasonably account for
potential exposures. The use of the IRIS
chronic reference dose (cRfD) utilizes an
additional 10X UF beyond the
traditional UFs for intraspecies
variability and interspecies
extrapolation of 100X . This is
protective of any potential concerns for
increased susceptibility of infants and
children to isophorone. The additional
10X uncertainty factor incorporated into
the IRIS RfD is based on the use of a
subchronic toxicity study, which, given
the lack of increased pre-natal and
postnatal susceptibility of isophorone,
would address any potential concerns
for increased susceptibility of infants
and children to isophorone, therefore
the FQPA factor is removed.
E. Aggregate Risks and Determination of
Safety
1. Acute risk. As there were no toxic
effects attributable to a single dose, an
endpoint of concern was not identified
to quantitate acute dietary risk to the
general population or to the
subpopulation females 13-50 years old.
No acute risk is expected from exposure
to isophorone
2. Chronic risk. The chronic dietary
exposure analysis is based on a
screening level dietary assessment that
assumed residues of isophorone in
beets, ginseng, rice, spinach, sugar beet
and Swiss chard commodities
corresponding to the highest established
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active ingredient tolerance level
residues for those commodities and
100% crop treated Even with these
highly conservative assumptions, the
risk estimates are well below the
Agency’s level of concern. Using the
exposure assumptions described in this
unit for chronic exposure, EPA has
concluded that exposure to isophorone
from food and drinking water will
utilize 1.8% of the chronic population
adjusted dose (cPAD) for the U.S.
population, and 4.4% of the cPAD for
non-nursing infants, the most highly
exposed population subgroup. Based on
the use pattern, chronic residential
exposure to residues of isophorone is
not expected. Drinking water was
incorporated directly into the dietary
assessment using the concentration for
drinking water given in unit III.C.2.
3. Aggregate cancer risk for U.S.
population. A non-threshold (Q1*)
approach is used to estimate estimate
cancer risk. The upper bound estimate
of lifetime cancer risk for the U.S
population is 2.14 x 10-6. This value is
derived by multiplying the upper bound
estimate of unit risk, 6.08 x 10-4 by the
chronic dietary exposure (food +
drinking water) for the U.S. general
population (0.003520 mg/kg/day).
Drinking water was incorporated
directly into the dietary assessment
using the concentration for drinking
water given in unit III.C.2. Since this
upper bound estimate of cancer risk is
based on a very conservative exposure
estimate, and is within the range of one
in one million cancer risk that is
typically considered to not be a concern.
EPA therefore concludes that
isophorone is not expected to pose a
carcinogenic risk to humans. If
applicable, insert text. There is no
boilerplate for this section.
4. 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, and to infants and children
from aggregate exposure to isophorone
residues.
IV. 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
There are currently no Codex
Maximum Residue Limits for
isophorone
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C. Response to Comments
Ten comments were received
regarding petition PP 4E6894. One
comment, from B. Sachau, regarded
general opposition to Agency approval
of tolerances and exemptions other than
zero, and general opposition to any
residue left on a treated crop. The
Agency finds that this comment
contained no scientific data or evidence
to rebut the Agency’s conclusion that
there is a reasonable certainty that no
harm will result from aggregate
exposure to isophorone including all
anticipated dietary exposures and other
exposures for which there is reliable
information. This comment, as well as
prior similar comments from B. Sachau
have been responded to by the Agency
on several occasions. For example,
(October 29, 2004, 69 FR 63083),
(January 7, 2005, 70 FR 1349), and (June
30, 2005, 70 FR 37683. The other nine
comments regarded the use of
isophorone in desmedipham and
phenmedipham formulations for use on
beets, Swiss chard and ginseng. These
uses are either part of existing section
24(c) registrations or section 18
emergency exemptions, with each of the
commentors requesting that these
commodities be included in the
reassessment of the isophorone
tolerance exemption. The Agency agrees
that these commodities should be
included in the tolerance exemption
expression for isophorone and has
included these commodities in the
aggregrate risk assessment and safety
determination provided in Unit III.
V. Conclusion
Therefore, an exemption from the
requirement of a tolerance is established
for residues of the inert ingredient
isophorone, in or on beets, ginseng, rice,
spinach, sugar beets, and Swiss chard.
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VI. 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 rule has
been exempted from review under
Executive Order 12866 due to its lack of
significance, 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). This final rule does not
contain any information collections
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subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or 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). 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), or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
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). 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 In addition, the
Agency has determined that this action
will not have a substantial direct effect
on States, on the relationship between
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this rule
does not have any ‘‘tribal implications’’
PO 00000
Frm 00045
Fmt 4700
Sfmt 4700
45407
as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, 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 28, 2006.
Lois Rossi,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
E:\FR\FM\09AUR1.SGM
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45408
Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations
2. Section 180.920 is amended in the
table by removing the entry Isophorone.
I Section 180.1270 is added to subpart
D to read as follows:
I
§ 180.1270 Isophorone; exemption from
the requirement of a tolerance.
Isophorone (CAS Reg. No. 78–59–1) is
exempt from the requirement of a
tolerance when used as an inert
ingredient in pesticide formulations
applied to beets, ginseng, rice, spinach,
sugar beets, and Swiss chard.
[FR Doc. E6–12547 Filed 8–8–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0253; FRL–8082–3]
Inert Ingredient; Revocation of the
Tolerance Exemption for Mono- and
Bis-(1H, 1H, 2H, 2H-perfluoroalkyl)
Phosphates Where the Alkyl Group is
Even Numbered and in the C6-C12
Range
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: EPA is revoking, under the
Federal Food, Drug, and Cosmetic Act
(FFDCA) section 408(e)(1), the existing
exemption from the requirement of a
tolerance for residues of the inert
ingredient ‘‘Mono- and bis-(1H, 1H, 2H,
2H-perfluoroalkyl) phosphates where
the alkyl group is even numbered and
in the C6-C12 range’’ under 40 CFR
180.920. The regulatory action
contributes toward the Agency’s
tolerance reassessment requirements
under FFDCA section 408(q), as
amended by the Food Quality Protection
Act (FQPA) of 1996. By law, EPA is
required by August 2006 to reassess the
tolerances that were in existence on
August 2, 1996. This regulatory action
counts as a tolerance reassessment
toward the August 2006 review
deadline.
DATES:
This rule is effective February 9,
2008.
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0253. All documents in the
docket are listed in the index for the
docket. 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
jlentini on PROD1PC65 with RULES
ADDRESSES:
VerDate Aug<31>2005
16:38 Aug 08, 2006
Jkt 208001
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 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:
Karen Angulo, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 306–0404; e-mail address:
angulo.karen@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. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
Unit II. 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
PO 00000
Frm 00046
Fmt 4700
Sfmt 4700
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 FFDCA, as
amended by the 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–2006–0253 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 October 10, 2006.
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–2006–0253, 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 Building), 2777 S.
Crystal Drive, 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
A. What Action is the Agency Taking?
In evaluating the tolerance exemption
under 40 CFR 180.920 for ‘‘Mono- and
E:\FR\FM\09AUR1.SGM
09AUR1
]]>Agencies
[Federal Register Volume 71, Number 153 (Wednesday, August 9, 2006)]
[Rules and Regulations]
[Pages 45403-45408]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12547]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0582; FRL-8082-1]
Isophorone; Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation amends existing exemption from the requirement
of a tolerance for residues of isophorone (CAS Reg. No. 78-59-1) to
limit the use to beets, ginseng, rice, spinach, sugar beets, and Swiss
chard. The Isophorone Task Group (ITG) requested this revised exemption
from the requirement of a tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act
(FQPA) of 1996. This regulatory action contributes toward the Agency's
tolerance reassessment requirements under FFDCA section 408(q), as
amended by the FQPA of 1996. By law, EPA is required by August 2006 to
reassess the tolerances that were in existence on August 2, 1996. The
regulatory action in this document pertains to the revision of one
existing tolerance exemption which is counted as a tolerance
reassessment toward the August 2006 review deadline.
DATES: This regulation is effective August 9, 2006. Objections and
requests for hearings must be received on or before October 10, 2006,
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-2006-0582. All documents in the
docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Kerry Leifer, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8811; e;mail address: leifer.kerry@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 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
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. To access the OPPTS Harmonized Guidelines
referenced in this document, go directly to the guidelines at https://
www.epa.gpo/opptsfrs/home/guidelin.htm
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the 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-2006-0582 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 October 10, 2006.
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-2006-0582, 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
Building), 2777 S. Crystal Drive, 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 telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of April 27, 2005 (70 FR 7951) (FRL-7710-
1), EPA
[[Page 45404]]
issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 4E6894)
The Isophorone Task Group (ITG) of the Ketones Panel of the American
Chemistry Council, 1300 Wilson Blvd., Arlington, VA 22209. The petition
requested that 40 CFR 180.920 be amended by limiting the existing
exemption from the requirement for isophorone (CAS Reg. No. 78-59-1) to
rice, spinach, and sugar beets. That notice included a summary of the
pesticide petition prepared by ITG, the petitioner. Comments were
received on the notice of filing. EPA's response to these comments is
discussed in Unit IV.
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. . .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and Determination of Safety
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. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for an exemption from the requirement of a
tolerance for residues of isophorone in or on beets, ginseng, rice,
spinach, sugar beets, and Swiss chard. EPA's assessment of exposures
and risks associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by isophorone are
discussed in the following Table 1 as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the reviewed toxicity studies.
Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL = 233.8/
toxicity rodents >311.8 milligram/
(rats) kilogram/day (mg/
kg/day) male/
female.
------------------------------------------------------------------------
LOAEL = 102.5 (M)/
not established
(F) mg/kg/day
based on M
decrease in body
weight
------------------------------------------------------------------------
870.3150 90-Day oral NOAEL = 150 mg/kg/
toxicity study in day higest dose
nonrodents (dogs) tested (HDT)
LOAEL = cannot be
established
------------------------------------------------------------------------
870.3700 Prenatal Maternal NOAEL =
developmental 50 ppm
(inhalation) in LOAEL = 115 ppm
rodents (mice) based on
decreased
gestation day 18
body weight,
corrected for
uterine weight
Developmental
NOAEL = >115 ppm
Developmental
LOAEL = cannot be
established
------------------------------------------------------------------------
870.3700 Prenatal Maternal NOAEL =
developmental 25 ppm
(inhalation) in LOAEL = 50 ppm
rodents (rats) based on
increased
incidence of
clinical signs
(alopecia, ano-
genital and
cervical
staining)
Developmental
NOAEL = 115 ppm
HDT
Developmental
LOAEL = cannot be
established
------------------------------------------------------------------------
870.4200 Carcinogenicity NOAEL = 250/500 mg/
(rats) kg/day (M/F)
LOAEL = 500 (M)/
not established
(F) based on M =
increased
incidence of
preputial gland
carcinoma
------------------------------------------------------------------------
870.4200 Carcinogenicity NOAEL = 500 mg/kg/
(mice) day HDT
LOAEL = cannot be
established
------------------------------------------------------------------------
[[Page 45405]]
Isophorone was evaluated as part of the International Programme on
Chemical Safety (ICPS). The IPCS is a joint venture of the United
Nations Environment Programme, the International Labour Organisation,
and the World Health Organization. The main objective of the IPCS is to
carry out and disseminate evaluations of the effects of chemicals on
human health and the quality of the environment.
The ICPS Environmental Health Criteria monograph for isophorone
critically evaluated the available toxicity data on isophorone, which
included a consideration of the studies summarized in Table 1 as well
as other available toxicity data on isophorone. As part of the human
health risk assessment of isophorone, the ICPS monograph states that
``limited studies in rats and mice indicate that isophorone does not
affect fertility nor does it cause developmental toxicity in
experimental animals.'' Additionally in summarizing the results of
genotoxicity testing, the ICPS further concluded that ``the weight of
evidence of all mutagenicity data supports the contention that
isophorone is not a potent DNA-reactive compound.''
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the NOAEL from the toxicology study identified as
appropriate for use in risk assessment is used to estimate the
toxicological level of concern (LOC). However, the LOAEL are identified
is sometimes used for risk assessment if no NOAEL was achieved in the
toxicology study selected. An uncertainty factor (UF) is applied to
reflect 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.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases.
A summary of the toxicological endpoints for isophorone used for
human risk assessment is shown in the following Table 2:
Table 2.--Summary of Toxicological Dose and Endpoints for isophorone for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment, Special FQPA SF and
Exposure/Scenario Interspecies and Level of Concern for Study and Toxicological
Intraspecies and any Risk Assessment Effects
Traditional UF
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations).... NOAEL = 150 mg/kg/day
UF = 1.000.............
Chronic RfD = 0.2 mg/kg/
day.
Special FQPA SF = 1.................. 90-Day oral dog
cPAD = chronic RfD................... toxicity study. No
Special FQPA SF = 0.2 mg/kg/day...... toxicity was seen at
the HDT
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation).... NOAEL = 250 mg/kg/day NA Increased incidence of
preputial gland
carcinomas in male
rats Toxicology and
Carcinogenesis Study
of Isophorone in F344/
N Rats
----------------------------------------------------------------------------------------------------------------
Classification: Under the 1986 cancer classification scheme, isophorone
was classified as Group C- Possible Human Carcinogen, with a linear low-
dose extrapolation approach and a 3/4s interspecies scaling factor for
human risk. The upper bound estimate of unit risk, Q1* is 6.08 x 10-4 in
human equivalents
----------------------------------------------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. An exemption from the
requirement of a tolerances has been established (40 CFR 180.40 CFR
site) for the residues of isophorone, in or on beet, ginseng, rice,
spinach, sugar beet and Swiss chard commodities. Risk assessments were
conducted by EPA to assess dietary exposures from isophorone in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
Option 1. No such effects were identified in the toxicological
studies for isophorone; therefore, a quantitative acute dietary
exposure assessment is unnecessary.
ii. Chronic exposure.--Option 2. In conducting the chronic dietary
exposure assessment EPA used the Dietary Exposure Evaluation Model
software with the Food Commodity Intake Database (DEEM-
FCIDTM), which incorporates food consumption data as
reported by respondents in the United States Department of Agriculture
(USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake
by Individuals (CSFII), and accumulated exposure to the chemical for
each commodity. The following assumptions were made for the chronic
exposure assessments: The assessment was based on a screening level
dietary assessment that assumed residues of isophorone in beet,
ginseng, rice, spinach, sugar beet and Swiss chard commodities
corresponding to the highest established active ingredient tolerance
level residues for those commodities and 100% crop treated. The highest
established tolerance level active ingredient residue level is chosen
as ``worst-case'' chronic exposure scenario as it would be highly
unlikely that residues of isophorone in the above-listed crops would be
at such levels.
iii. Cancer. The assessment assumed residues of isophorone in beet,
ginseng, rice, spinach, sugar beet and Swiss chard commodities
corresponding to the highest established active ingredient tolerance
level residues for those commodities and 100% crop treated. The highest
established tolerance level active ingredient residue level is chosen
as ``worst-case'' cancer exposure scenario as it would be highly
unlikely that residues of isophorone in the above-listed crops would be
at such levels.
2. Dietary exposure from drinking water. Monitoring exposure data
are utilized to complete a dietary exposure
[[Page 45406]]
analysis and risk assessment for isophorone in drinking water. The
estimated drinking water concentration (EDWC) of isophorone of 10
[mu]g/L utilized for the purposes of this tolerance action is a value
equivalent to the highest measured concentration of isophorone in
drinking water sources in monitoring studies used by EPA to establish
ambient water quality criteria for isophorone. (EPA 440/5-80-056; NTIS
PB81-11767).
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).
Since the use of isophorone is limited to pesticide productswhich
are not registered for use on any sites that would result in
residential exposure, no residential exposures are expected and a
residential exposure assessment has not been conducted
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to isophorone and any other
substances and isophorone does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that isophorone has 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.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There was no evidence of
increased prenatal or postnatal susceptibility of isophorone following
in utero exposure to rats and mice.
3. Conclusion. There is an adequate toxicity database for the
selection of doses and endpoints for use in risk assessment for
isophorone. Exposure data are complete or are estimated based on data
that reasonably account for potential exposures. The use of the IRIS
chronic reference dose (cRfD) utilizes an additional 10X UF beyond the
traditional UFs for intraspecies variability and interspecies
extrapolation of 100X . This is protective of any potential concerns
for increased susceptibility of infants and children to isophorone. The
additional 10X uncertainty factor incorporated into the IRIS RfD is
based on the use of a subchronic toxicity study, which, given the lack
of increased pre-natal and postnatal susceptibility of isophorone,
would address any potential concerns for increased susceptibility of
infants and children to isophorone, therefore the FQPA factor is
removed.
E. Aggregate Risks and Determination of Safety
1. Acute risk. As there were no toxic effects attributable to a
single dose, an endpoint of concern was not identified to quantitate
acute dietary risk to the general population or to the subpopulation
females 13-50 years old. No acute risk is expected from exposure to
isophorone
2. Chronic risk. The chronic dietary exposure analysis is based on
a screening level dietary assessment that assumed residues of
isophorone in beets, ginseng, rice, spinach, sugar beet and Swiss chard
commodities corresponding to the highest established active ingredient
tolerance level residues for those commodities and 100% crop treated
Even with these highly conservative assumptions, the risk estimates are
well below the Agency's level of concern. Using the exposure
assumptions described in this unit for chronic exposure, EPA has
concluded that exposure to isophorone from food and drinking water will
utilize 1.8% of the chronic population adjusted dose (cPAD) for the
U.S. population, and 4.4% of the cPAD for non-nursing infants, the most
highly exposed population subgroup. Based on the use pattern, chronic
residential exposure to residues of isophorone is not expected.
Drinking water was incorporated directly into the dietary assessment
using the concentration for drinking water given in unit III.C.2.
3. Aggregate cancer risk for U.S. population. A non-threshold
(Q1*) approach is used to estimate estimate cancer risk. The
upper bound estimate of lifetime cancer risk for the U.S population is
2.14 x 10-6. This value is derived by multiplying the upper
bound estimate of unit risk, 6.08 x 10-4 by the chronic
dietary exposure (food + drinking water) for the U.S. general
population (0.003520 mg/kg/day). Drinking water was incorporated
directly into the dietary assessment using the concentration for
drinking water given in unit III.C.2. Since this upper bound estimate
of cancer risk is based on a very conservative exposure estimate, and
is within the range of one in one million cancer risk that is typically
considered to not be a concern. EPA therefore concludes that isophorone
is not expected to pose a carcinogenic risk to humans. If applicable,
insert text. There is no boilerplate for this section.
4. 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, and to infants and children from aggregate
exposure to isophorone residues.
IV. 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
There are currently no Codex Maximum Residue Limits for isophorone
[[Page 45407]]
C. Response to Comments
Ten comments were received regarding petition PP 4E6894. One
comment, from B. Sachau, regarded general opposition to Agency approval
of tolerances and exemptions other than zero, and general opposition to
any residue left on a treated crop. The Agency finds that this comment
contained no scientific data or evidence to rebut the Agency's
conclusion that there is a reasonable certainty that no harm will
result from aggregate exposure to isophorone including all anticipated
dietary exposures and other exposures for which there is reliable
information. This comment, as well as prior similar comments from B.
Sachau have been responded to by the Agency on several occasions. For
example, (October 29, 2004, 69 FR 63083), (January 7, 2005, 70 FR
1349), and (June 30, 2005, 70 FR 37683. The other nine comments
regarded the use of isophorone in desmedipham and phenmedipham
formulations for use on beets, Swiss chard and ginseng. These uses are
either part of existing section 24(c) registrations or section 18
emergency exemptions, with each of the commentors requesting that these
commodities be included in the reassessment of the isophorone tolerance
exemption. The Agency agrees that these commodities should be included
in the tolerance exemption expression for isophorone and has included
these commodities in the aggregrate risk assessment and safety
determination provided in Unit III.
V. Conclusion
Therefore, an exemption from the requirement of a tolerance is
established for residues of the inert ingredient isophorone, in or on
beets, ginseng, rice, spinach, sugar beets, and Swiss chard.
VI. 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 rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, 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). 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., or 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). 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), or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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 In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
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 28, 2006.
Lois Rossi,
Director, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
[[Page 45408]]
0
2. Section 180.920 is amended in the table by removing the entry
Isophorone.
0
Section 180.1270 is added to subpart D to read as follows:
Sec. 180.1270 Isophorone; exemption from the requirement of a
tolerance.
Isophorone (CAS Reg. No. 78-59-1) is exempt from the requirement of
a tolerance when used as an inert ingredient in pesticide formulations
applied to beets, ginseng, rice, spinach, sugar beets, and Swiss chard.
[FR Doc. E6-12547 Filed 8-8-06; 8:45 am]
BILLING CODE 6560-50-S
