Fenazaquin, 4-tert-butylphenethyl Quinazolin-4-yl Ether; Pesticide Import Tolerance, 44388-44393 [E7-15334]
Download as PDF
<![CDATA[
44388
Federal Register / Vol. 72, No. 152 / Wednesday, August 8, 2007 / Rules and Regulations
ebenthall on PRODPC61 with RULES
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of the 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 on the basis of a
petition under section 408(d) of the
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 6, 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
VerDate Aug<31>2005
15:29 Aug 07, 2007
Jkt 211001
Mandates Reform Act of 1995 (UMRA)
(Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0075; FRL–8141–3]
Fenazaquin, 4-tert-butylphenethyl
Quinazolin-4-yl Ether; Pesticide Import
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
import tolerances for residues of
fenazaquin, 4-tert-butylphenethyl
quinazolin-4-yl ether, in or on apple at
0.2 parts per million (ppm); in or on
pear at 0.2 ppm; in or on citrus fruit
group 10, except grapefruit, at 0.5 ppm;
and in or on citrus oil at 10 ppm. Gowan
Company requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective
August 8, 2007. Objections and requests
for hearings must be received on or
before October 9, 2007, and must be
filed in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
Dated: July 23, 2007.
OPP–2006–0075. To access the
Lois Rossi,
electronic docket, go to https://
Director, Registration Division, Office of
www.regulations.gov, select ‘‘Advanced
Pesticide Programs.
Search,’’ then ‘‘Docket Search.’’ Insert
I Therefore, 40 CFR chapter I is
the docket ID number where indicated
amended as follows:
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
PART 180—[AMENDED]
web site to view the docket index or
access available documents. All
I 1. The authority citation for part 180
documents in the docket are listed in
continues to read as follows:
the docket index available in
Authority: 21 U.S.C. 321(q), 346a and 371.
regulations.gov. Although listed in the
I 2. Section 180.464 is amended by
index, some information is not publicly
alphabetically adding the following
available, e.g., Confidential Business
commodities to the table in paragraph
Information (CBI) or other information
(a) to read as follows:
whose disclosure is restricted by statute.
Certain other material, such as
§ 180.464 Dimethenamid; tolerances for
copyrighted material, is not placed on
residues.
the Internet and will be publicly
(a) * * *
available only in hard copy form.
Publicly available docket materials are
Commodity
Parts per million
available in the electronic docket at
https://www.regulations.gov,or, if only
*
*
*
*
*
Grass, forage ..................
0.15 available in hard copy, at the OPP
Grass, hay ......................
2.5 Regulatory Public Docket in Rm. S–
Grass, seed screenings ..
0.01 4400, One Potomac Yard (South Bldg.),
Grass, straw ...................
0.01 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
[FR Doc. E7–15112 Filed 8–7–07; 8:45 am]
Facility telephone number is (703) 305–
BILLING CODE 6560–50–S
5805.
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
ADDRESSES:
E:\FR\FM\08AUR1.SGM
08AUR1
Federal Register / Vol. 72, No. 152 / Wednesday, August 8, 2007 / Rules and Regulations
Dan
Peacock, Registration Division, Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (703) 305–
5407; e-mail address:
peacock.dan@epa.gov.
FOR FURTHER INFORMATION CONTACT:
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),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 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 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
the person listed under FOR FURTHER
INFORMATION CONTACT.
ebenthall on PRODPC61 with RULES
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.
VerDate Aug<31>2005
15:29 Aug 07, 2007
Jkt 211001
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the 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–2006–0075 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 October 9, 2007.
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–2006–0075, 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. Petition for Tolerance
In the Federal Register of April 12,
2006 (71 FR 18736) (FRL–7775–5), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of an
import pesticide petition (PP 9E5059) by
Gowan Company, 370 S. Main Street,
Yuma, AZ 85364. The petition
requested that 40 CFR part 180 be
amended by establishing import
tolerances for residues of the
insecticide, fenazaquin, in or on apple
at 0.2 ppm; in or on pear at 0.2 ppm,
and in or on citrus fruits at 0.5 ppm.
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
44389
That notice referenced a summary of the
petition prepared by Gowan Company,
the registrant, which is available to the
public in the docket, under docket
identification (ID) number EPA–HQ–
OPP–2006–0075–0002 at https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
Based upon review of the data
supporting the petition, EPA has
modified Gowan Company’s request for
tolerances as follows. This regulation
establishes import tolerances for
residues of fenazaquin in or on apple at
0.2 ppm; in or on pear at 0.2 ppm; in
or on citrus fruit group 10, except
grapefruit, at 0.5 ppm; and in or on
citrus oil at 10 ppm. The reason for the
addition of a tolerance for citrus oil at
10 ppm is explained in Unit V.
(Conclusions).
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of the 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 the 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 the 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. . . .’’ These
provisions were added to the FFDCA by
the Food Quality Protection Act (FQPA)
of 1996.
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
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 for
the petitioned–for import tolerances for
residues of Fenazaquin in or on apple at
0.2 ppm; in or on pear at 0.2 ppm; in
or on citrus fruit group 10, except
grapefruit, at 0.5 ppm; and in or on
citrus oil at 10 ppm. EPA’s assessment
of exposures and risks associated with
establishing the tolerance follows.
E:\FR\FM\08AUR1.SGM
08AUR1
44390
Federal Register / Vol. 72, No. 152 / Wednesday, August 8, 2007 / Rules and Regulations
A. Toxicological Profile
B. Toxicological Endpoints
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. Specific
information on the studies received and
the nature of the adverse effects caused
by Fenazaquin as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at https://
www.regulations.gov. The referenced
document (Fenazaquin: PP# 9E5059.
Tolerances on apples, pears and citrus
fruits exported to the U.S. HED Risk
Assessment) is available in the docket
established by this action, which is
described under ADDRESSES, and is
identified as docket ID No. EPA–HQ–
OPP–2006–0075–0004 in that docket.
For hazards that have a threshold
below which there is no appreciable
risk, the toxicological level of concern
(LOC) is derived from the highest dose
at which no adverse effects 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 of concern are
identified (the LOAEL) is sometimes
used for risk assessment. Uncertainty/
safety factors (UF) are used in
conjunction with the LOC 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 risks by comparing
aggregate 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 LOC by all
applicable uncertainty/safety factors.
Short-term, intermediate-term, and longterm risks are evaluated by comparing
aggregate exposure to the LOC to ensure
that the margin of exposure (MOE)
called for by the product of all
applicable uncertainty/safety factors is
not exceeded.
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk and
estimates risk in terms of the probability
of occurrence of additional adverse
cases. Generally, cancer risks are
considered non-threshold. 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/fedrgstr/EPA–PEST/1997/
November/Day–26/p30948.htm.
A summary of the toxicological
endpoints for Fenazaquin used for
human risk assessment is shown in
Table 1 below of this unit and in docket
ID number EPA–HQ–OPP–2007–0075–
0004 in an alternate format.
TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FENAZAQUIN FOR USE IN HUMAN RISK ASSESSMENT
Exposure/Scenario
Dose used in risk assessment, interspecies and
intraspecies and any traditional FQPA, SF
Special FQPA SF and
level of concern for risk assessment UF
Study and toxicological effects
NOAEL = 10 mg/kg/day SF =
100
Acute RfD = 0.1 mg/kg/day
Special FQPA SF = 1 x
aPAD = acute
RfD = 0.1 mg/kg/day
Rat developmental toxicity
LOAEL = 40 mg/kg/day based on findings (as
early as GD 6–9) of decreased body weight
gain, food intake, and food efficiency.
Chronic dietary (all populations)
NOAEL= 5 mg/kg/day
SF = 100
Chronic RfD = 0.05 mg/kg/
day
Special FQPA
SF = 1 x
cPAD = chronic
RfD = 0.05 mg/kg/day
Rat two-generation toxicity study
LOAEL = 25 mg/kg/day based on excessive
salivation and decreased body weight/weight
gain and food intake.
Short-term, intermediate-term,
and long-term incidential oral
(1-30 days; 1-6 months)
(Residential)
These exposure scenarios
do not apply to this risk assessment because there
are no proposed registered
residential uses of
fenazaquin.
Short-term, intermediate-term,
and long-term dermal (1-30
days; 1-6 months) (Residential)
These exposure scenarios
do not apply to this risk assessment because there
are no proposed registered
residential or occupational
uses of fenazaquin.
Short-term, intermediate-term,
long-term inhalation (1-30
days; 1-6 months) (Residential)
ebenthall on PRODPC61 with RULES
Acute dietary (general population including infants and
children)
These exposure scenarios
do not apply to this risk assessment because there
are no proposed registered
residential or occupational
uses of fenazaquin.
VerDate Aug<31>2005
15:29 Aug 07, 2007
Jkt 211001
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
E:\FR\FM\08AUR1.SGM
08AUR1
Federal Register / Vol. 72, No. 152 / Wednesday, August 8, 2007 / Rules and Regulations
44391
TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FENAZAQUIN FOR USE IN HUMAN RISK
ASSESSMENT—Continued
Exposure/Scenario
ebenthall on PRODPC61 with RULES
Cancer (oral, dermal, inhalation)
Dose used in risk assessment, interspecies and
intraspecies and any traditional FQPA, SF
15:29 Aug 07, 2007
Study and toxicological effects
A quantitative exposure assessment for cancer risk
was not performed because fenazaquin has
been classified as ‘‘Not
likely to be Carcinogenic to
Humans’’ and is not expected to pose a cancer
risk.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to fenazaquin, EPA considered
exposure under the petitioned-for
tolerances as well as a tolerance in or on
citrus oil. EPA assessed dietary
exposures from Fenazaquin 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 one–day or
single exposure. In estimating acute
dietary exposure, EPA used food
consumption information from the
United States Department of Agriculture
(USDA) 1998 Nationwide Continuing
Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food,
EPA assumed all foods for which there
are tolerances were treated and contain
tolerance-level residues. Percent Crop
Treated (PCT) and anticipated residues
were not used.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 1998 CSFII. As to
residue levels in food, EPA assumed all
foods for which there are tolerances
were treated and contain tolerance-level
residues. Percent Crop Treated (PCT)
and anticipated residues were not used.
iii. Cancer. A quantitative exposure
assessment for cancer risk was not
performed because fenazaquin has been
classified as ‘‘Not likely to be
Carcinogenic to Humans’’ and is not
expected to pose a cancer risk.
iv. Anticipated residue and PCT
information.PCT and anticipated
residues were not used.
2. Dietary exposure from drinking
water. Because the import tolerances in
this Final Rule do not involve current or
proposed registered uses of Fenazaquin
in the United States, EPA does not
anticipate dietary exposure from
VerDate Aug<31>2005
Special FQPA SF and
level of concern for risk assessment UF
Jkt 211001
drinking water. Therefore, EPA has not
assessed such exposure in this
document.
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).
Fenazaquin is not registered for use
on any sites that would result in
residential exposure.
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
fenazaquin and any other substances
and fenazaquin 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 fenazaquin 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 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 (10X) tenfold margin of safety
for infants and children in the case of
threshold effects to account for prenatal
PO 00000
Frm 00025
Fmt 4700
Sfmt 4700
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. This additional
margin of safety is commonly referred to
as the FQPA safety factor. 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 FQPA
safety factor value based on the use of
traditional uncertainty/safety factors
and/or special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity.
There are no qualitative or quantitative
prenatal or postnatal susceptibility
issues based on available data from two
developmental toxicity studies and a
two-generation reproduction toxicity
study.
3. Conclusion. EPA has determined
that reliable data show that it would be
safe for infants and children to reduce
the FQPA safety factor to 1X. That
decision is based on the following
findings:
i. The toxicity database for fenazaquin
is complete.
ii. There is no need for a
developmental neurotoxicity study or
additional uncertainty factors to account
for neurotoxicity.
iii. There is no evidence that
fenazaquin results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the two-generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100% CT and
tolerance-level residues.
v. There is no potential for dietary
drinking water exposure and there are
no residential uses.
E:\FR\FM\08AUR1.SGM
08AUR1
44392
Federal Register / Vol. 72, No. 152 / Wednesday, August 8, 2007 / Rules and Regulations
ebenthall on PRODPC61 with RULES
By using these screening-level
assessments, acute and chronic
exposures/risks will not be
underestimated.
E. Aggregate Risks and Determination of
Safety
Safety is assessed for acute and
chronic risks by comparing aggregate
exposure to the pesticide to the aPAD
and cPAD. The aPAD and cPAD are
calculated by dividing the LOC by all
applicable uncertainty/safety factors.
For linear cancer risks, EPA calculates
the probability of additional cancer
cases given aggregate exposure. Shortterm, intermediate, and long-term risks
are evaluated by comparing aggregate
exposure to the LOC to ensure that the
margin of exposure (MOE) called for by
the product of all applicable
uncertainty/safety factors is not
exceeded.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food to fenazaquin will
occupy 48% of the aPAD for the
population group (children, 1-2 years
old) receiving the greatest exposure.
There is no acute dietary exposure from
water.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to fenazaquin from food
will utilize 25% of the cPAD for the
population group (children, 1-2 years
old) receiving the greatest exposure.
Because the tolerances being established
in this Final Rule are for uses outside of
the United States, there is no acute
dietary exposure from water. There are
no residential uses for Fenazaquin that
result in chronic residential exposure to
Fenazaquin.
3. Short-term risk. Short-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Fenazaquin is not registered for use
on any sites that would result in
residential exposure. Also, because the
tolerances being established in this
Final Rule are for uses outside of the
United States, there is no acute dietary
exposure from water. Therefore, the
aggregate risk is the sum of the risk from
food, which does not exceed the
Agency’s level of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level).
Fenazaquin is not registered for use
on any sites that would result in
VerDate Aug<31>2005
15:29 Aug 07, 2007
Jkt 211001
residential exposure. Also, because the
tolerances being established in this final
rule are for uses outside of the United
States, there is no chronic dietary
exposure from water. Therefore, the
aggregate risk is the sum of the risk from
food, which does not exceed the
Agency’s level of concern.
5. Aggregate cancer risk for U.S.
population. Fenazaquin is not expected
to pose a cancer risk based on negative
cancer findings in two adequate rodent
carcinogenicity studies.
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 fenazaquin
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(gas chromatography) is available to
enforce the tolerance expression, using
the existing Food and Drug
Administration (FDA) Multiresidue
Methods in the Pesticide Analytical
Manual (PAM), Vol I, available from
https://www.cfsan.fda.gov/~lrd/
pestadd.html.
B. International Residue Limits
There are no established or proposed
Canadian, Mexican or Codex MRLs for
residues of fenazaquin in plant
commodities.
C. Response to Comments
The Agency did not receive any
comments to this request for import
tolerances for fenazaquin.
V. Conclusion
Therefore, the Agency is establishing
import tolerances for residues of
Fenazaquin in or on apple at 0.2 parts
per million (ppm); in or on pear at 0.2
ppm; in or on citrus fruit group 10,
except grapefruit, at 0.5 ppm; and in or
on citrus oil at 10 ppm. The original
petition did not request the
establishment of a tolerance in or on
citrus oil at 10 ppm. However, the
Agency added this tolerance for the
following reason. Separate tolerances
are not required for apple and orange
juice as residues do not concentrate in
these commodities. However, the citrus
processing studies indicate that
fenazaquin residues concentrate on
average by 25x in citrus oil and thus
residues in citrus oil could exceed the
tolerance for citrus fruits. Based on the
25x processing factor and residue data
on fenazaquin levels in or on oranges,
a tolerance of 10 ppm would be
appropriate for citrus oil.
PO 00000
Frm 00026
Fmt 4700
Sfmt 4700
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, 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 on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 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
E:\FR\FM\08AUR1.SGM
08AUR1
Federal Register / Vol. 72, No. 152 / Wednesday, August 8, 2007 / Rules and Regulations
Mandates Reform Act of 1995 (UMRA)
(Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: July 26, 2007.
Debra Edwards,
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.
2. Section 180.632 is added to read as
follows:
I
§ 180.632 Fenazaquin; import tolerances
for residues.
(a) General. Import tolerances are
established for residues of the
insecticide and miticide, fenazaquin, 4tert-butylphenethyl quinazolin-4-yl
ether, in or on raw agricultural
commodities as follows:
ebenthall on PRODPC61 with RULES
Commodity
Parts per million
(d) Indirect or inadvertent residues.
[Reserved]
Current Regulations and Rulemaking
History
[FR Doc. E7–15334 Filed 8–7–07; 8:45 am]
The Jobs for Veterans Act (‘‘JVA’’),
(Pub. L. 107–288, 116 Stat. 2033), was
signed by the President on November 2,
2002. Section 2(b)(1) of the JVA
amended the affirmative action
provisions of the Vietnam Era Veterans’
Readjustment Assistance Act of 1974, as
amended, 38 U.S.C. 4212, (‘‘VEVRAA’’).
Section 2(b)(3) of the JVA made the
amendments applicable to Government
contracts entered into on or after
December 1, 2003.
Prior to amendment by the JVA, the
affirmative action provisions of
VEVRAA required parties holding
Government contracts or subcontracts of
$25,000 or more to ‘‘take affirmative
action to employ and advance in
employment qualified special disabled
veterans, veterans of the Vietnam era,
recently separated veterans, and any
other veterans who served on active
duty during a war or in a campaign or
expedition for which a campaign badge
has been authorized.’’ OFCCP has
adopted the term ‘‘other protected
veteran’’ to refer to ‘‘veterans who
served on active duty during a war or
in a campaign or expedition for which
a campaign badge has been authorized.’’
In addition, prior to amendment,
VEVRAA required that the Secretary
promulgate regulations requiring
contractors ‘‘to list immediately with
the appropriate local employment
service office all of its employment
openings, except that the contractor may
exclude openings for executive and top
management positions, positions which
are to be filled from within the
contractor’s organization, and positions
lasting three days or less.’’
The JVA amendments made three
significant changes to the affirmative
action provisions of VEVRAA. First,
section 2(b)(1) of the JVA increased the
coverage threshold from a contract of
$25,000 or more to a contract of
$100,000 or more.
Second, the JVA amendments
changed the categories of covered
veterans under VEVRAA. The JVA
eliminated the category of Vietnam era
veterans from coverage under VEVRAA.
However, many Vietnam era veterans
may remain covered in other categories.
The JVA added as a new category of
covered veterans—those ‘‘veterans who,
while serving on active duty in the
Armed Forces, participated in a United
States military operation for which an
Armed Forces service medal was
awarded pursuant to Executive Order
12985.’’ The JVA expanded the coverage
of veterans with disabilities. Prior to
amendment by the JVA, VEVRAA
BILLING CODE 6560–50–S
DEPARTMENT OF LABOR
Office of Federal Contract Compliance
Programs
41 CFR Part 60–300
RIN 1215–AB46
Affirmative Action and
Nondiscrimination Obligations of
Contractors and Subcontractors
Regarding Disabled Veterans, Recently
Separated Veterans, Other Protected
Veterans, and Armed Forces Service
Medal Veterans
Office of Federal Contract
Compliance Programs, Labor.
AGENCY:
ACTION:
Final rule.
SUMMARY: The Office of Federal Contract
Compliance Programs (OFCCP) is
publishing a new set of regulations to
implement the amendments to the
affirmative action provisions of the
Vietnam Era Veterans’ Readjustment
Assistance Act of 1974 (‘‘VEVRAA’’)
that were made by the Jobs for Veterans
Act (‘‘JVA’’) enacted in 2002. The JVA
amendments raised the threshold dollar
amount of the Government contracts
that are subject to the affirmative action
provisions of VEVRAA, changed the
categories of veterans protected by the
law, and changed the manner in which
the mandatory job listing requirement is
to be implemented. The final
regulations published today apply only
to covered Government contracts
entered into or modified on or after
December 1, 2003. The existing
VEVRAA implementing regulations
found in 41 CFR part 60–250 will
continue to apply to Government
contracts entered into before December
1, 2003.
Effective Date: These regulations
are effective September 7, 2007.
DATES:
FOR FURTHER INFORMATION CONTACT:
Lynn A. Clements, Acting Director,
Division of Policy, Planning, and
Program Development, Office of Federal
0.5 Contract Compliance Programs, 200
0.2 Constitution Avenue, NW., Room
N3422, Washington, DC. 20210.
(b) Section is emergency exempotions. Telephone: (202) 693–0102 (voice) or
[Reserved]
(202) 693–1337 (TTY).
(c) Tolerances with regional
registration. [Reserved]
SUPPLEMENTARY INFORMATION:
Apple ...............................
Citrus Oil .........................
Fruit, Citrus, Group 10,
except Grapefruit ........
Pear ................................
VerDate Aug<31>2005
15:29 Aug 07, 2007
0.2
10
Jkt 211001
44393
PO 00000
Frm 00027
Fmt 4700
Sfmt 4700
E:\FR\FM\08AUR1.SGM
08AUR1
]]>Agencies
[Federal Register Volume 72, Number 152 (Wednesday, August 8, 2007)]
[Rules and Regulations]
[Pages 44388-44393]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15334]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0075; FRL-8141-3]
Fenazaquin, 4-tert-butylphenethyl Quinazolin-4-yl Ether;
Pesticide Import Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes import tolerances for residues of
fenazaquin, 4-tert-butylphenethyl quinazolin-4-yl ether, in or on apple
at 0.2 parts per million (ppm); in or on pear at 0.2 ppm; in or on
citrus fruit group 10, except grapefruit, at 0.5 ppm; and in or on
citrus oil at 10 ppm. Gowan Company requested these tolerances under
the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective August 8, 2007. Objections and
requests for hearings must be received on or before October 9, 2007,
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-2006-0075. 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 web site 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 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.
[[Page 44389]]
FOR FURTHER INFORMATION CONTACT: Dan Peacock, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-5407; e-mail address: peacock.dan@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), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 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 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 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 the 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-2006-0075 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 October 9, 2007.
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-2006-0075, 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. Petition for Tolerance
In the Federal Register of April 12, 2006 (71 FR 18736) (FRL-7775-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of an import pesticide
petition (PP 9E5059) by Gowan Company, 370 S. Main Street, Yuma, AZ
85364. The petition requested that 40 CFR part 180 be amended by
establishing import tolerances for residues of the insecticide,
fenazaquin, in or on apple at 0.2 ppm; in or on pear at 0.2 ppm, and in
or on citrus fruits at 0.5 ppm. That notice referenced a summary of the
petition prepared by Gowan Company, the registrant, which is available
to the public in the docket, under docket identification (ID) number
EPA-HQ-OPP-2006-0075-0002 at https://www.regulations.gov. There were no
comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
modified Gowan Company's request for tolerances as follows. This
regulation establishes import tolerances for residues of fenazaquin in
or on apple at 0.2 ppm; in or on pear at 0.2 ppm; in or on citrus fruit
group 10, except grapefruit, at 0.5 ppm; and in or on citrus oil at 10
ppm. The reason for the addition of a tolerance for citrus oil at 10
ppm is explained in Unit V. (Conclusions).
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of the 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 the 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 the 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. . .
.'' These provisions were added to the FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in 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 for the petitioned-for import
tolerances for residues of Fenazaquin in or on apple at 0.2 ppm; in or
on pear at 0.2 ppm; in or on citrus fruit group 10, except grapefruit,
at 0.5 ppm; and in or on citrus oil at 10 ppm. EPA's assessment of
exposures and risks associated with establishing the tolerance follows.
[[Page 44390]]
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. Specific information on the studies received and the nature
of the adverse effects caused by Fenazaquin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://
www.regulations.gov. The referenced document (Fenazaquin: PP
9E5059. Tolerances on apples, pears and citrus fruits exported to the
U.S. HED Risk Assessment) is available in the docket established by
this action, which is described under ADDRESSES, and is identified as
docket ID No. EPA-HQ-OPP-2006-0075-0004 in that docket.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects 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 of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UF) are
used in conjunction with the LOC 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
risks by comparing aggregate 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 LOC by all
applicable uncertainty/safety factors. Short-term, intermediate-term,
and long-term risks are evaluated by comparing aggregate exposure to
the LOC to ensure that the margin of exposure (MOE) called for by the
product of all applicable uncertainty/safety factors is not exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
A summary of the toxicological endpoints for Fenazaquin used for
human risk assessment is shown in Table 1 below of this unit and in
docket ID number EPA-HQ-OPP-2007-0075-0004 in an alternate format.
Table 1.--Summary of Toxicological Dose and Endpoints for Fenazaquin 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 UF effects
traditional FQPA, SF
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population NOAEL = 10 mg/kg/day SF Special FQPA SF = 1 x Rat developmental
including infants and children) = 100 aPAD = acute........... toxicity
Acute RfD = 0.1 mg/kg/ RfD = 0.1 mg/kg/day.... LOAEL = 40 mg/kg/day
day. based on findings (as
early as GD 6-9) of
decreased body weight
gain, food intake, and
food efficiency.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations) NOAEL= 5 mg/kg/day Special FQPA Rat two-generation
SF = 100............... SF = 1 x............... toxicity study
Chronic RfD = 0.05 mg/ cPAD = chronic......... LOAEL = 25 mg/kg/day
kg/day. RfD = 0.05 mg/kg/day... based on excessive
salivation and
decreased body weight/
weight gain and food
intake.
----------------------------------------------------------------------------------------------------------------
Short-term, intermediate-term, and These exposure
long-term incidential oral (1-30 scenarios do not apply
days; 1-6 months) (Residential) to this risk
assessment because
there are no proposed
registered residential
uses of fenazaquin.
----------------------------------------------------------------------------------------------------------------
Short-term, intermediate-term, and These exposure
long-term dermal (1-30 days; 1-6 scenarios do not apply
months) (Residential) to this risk
assessment because
there are no proposed
registered residential
or occupational uses
of fenazaquin.
----------------------------------------------------------------------------------------------------------------
Short-term, intermediate-term, long- These exposure
term inhalation (1-30 days; 1-6 scenarios do not apply
months) (Residential) to this risk
assessment because
there are no proposed
registered residential
or occupational uses
of fenazaquin.
----------------------------------------------------------------------------------------------------------------
[[Page 44391]]
Cancer (oral, dermal, inhalation) A quantitative exposure
assessment for cancer
risk was not performed
because fenazaquin has
been classified as
``Not likely to be
Carcinogenic to
Humans'' and is not
expected to pose a
cancer risk.
----------------------------------------------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fenazaquin, EPA considered exposure under the petitioned-
for tolerances as well as a tolerance in or on citrus oil. EPA assessed
dietary exposures from Fenazaquin 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 one-day or single exposure. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) 1998 Nationwide Continuing
Surveys of Food Intake by Individuals (CSFII). As to residue levels in
food, EPA assumed all foods for which there are tolerances were treated
and contain tolerance-level residues. Percent Crop Treated (PCT) and
anticipated residues were not used.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1998 CSFII.
As to residue levels in food, EPA assumed all foods for which there are
tolerances were treated and contain tolerance-level residues. Percent
Crop Treated (PCT) and anticipated residues were not used.
iii. Cancer. A quantitative exposure assessment for cancer risk was
not performed because fenazaquin has been classified as ``Not likely to
be Carcinogenic to Humans'' and is not expected to pose a cancer risk.
iv. Anticipated residue and PCT information.PCT and anticipated
residues were not used.
2. Dietary exposure from drinking water. Because the import
tolerances in this Final Rule do not involve current or proposed
registered uses of Fenazaquin in the United States, EPA does not
anticipate dietary exposure from drinking water. Therefore, EPA has not
assessed such exposure in this document.
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).
Fenazaquin is not registered for use on any sites that would
result in residential exposure.
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 fenazaquin and any other
substances and fenazaquin 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 fenazaquin 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
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 (10X) 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. This additional margin of
safety is commonly referred to as the FQPA safety factor. 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 FQPA
safety factor value based on the use of traditional uncertainty/safety
factors and/or special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There are no qualitative or
quantitative prenatal or postnatal susceptibility issues based on
available data from two developmental toxicity studies and a two-
generation reproduction toxicity study.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
i. The toxicity database for fenazaquin is complete.
ii. There is no need for a developmental neurotoxicity study or
additional uncertainty factors to account for neurotoxicity.
iii. There is no evidence that fenazaquin results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the two-generation
reproduction study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues.
v. There is no potential for dietary drinking water exposure and
there are no residential uses.
[[Page 44392]]
By using these screening-level assessments, acute and chronic
exposures/risks will not be underestimated.
E. Aggregate Risks and Determination of Safety
Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable uncertainty/
safety factors. For linear cancer risks, EPA calculates the probability
of additional cancer cases given aggregate exposure. Short-term,
intermediate, and long-term risks are evaluated by comparing aggregate
exposure to the LOC to ensure that the margin of exposure (MOE) called
for by the product of all applicable uncertainty/safety factors is not
exceeded.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
fenazaquin will occupy 48% of the aPAD for the population group
(children, 1-2 years old) receiving the greatest exposure. There is no
acute dietary exposure from water.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
fenazaquin from food will utilize 25% of the cPAD for the population
group (children, 1-2 years old) receiving the greatest exposure.
Because the tolerances being established in this Final Rule are for
uses outside of the United States, there is no acute dietary exposure
from water. There are no residential uses for Fenazaquin that result in
chronic residential exposure to Fenazaquin.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Fenazaquin is not registered for use on any sites that would result
in residential exposure. Also, because the tolerances being established
in this Final Rule are for uses outside of the United States, there is
no acute dietary exposure from water. Therefore, the aggregate risk is
the sum of the risk from food, which does not exceed the Agency's level
of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Fenazaquin is not registered for use on any sites that would result
in residential exposure. Also, because the tolerances being established
in this final rule are for uses outside of the United States, there is
no chronic dietary exposure from water. Therefore, the aggregate risk
is the sum of the risk from food, which does not exceed the Agency's
level of concern.
5. Aggregate cancer risk for U.S. population. Fenazaquin is not
expected to pose a cancer risk based on negative cancer findings in two
adequate rodent carcinogenicity studies.
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 fenazaquin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography) is available
to enforce the tolerance expression, using the existing Food and Drug
Administration (FDA) Multiresidue Methods in the Pesticide Analytical
Manual (PAM), Vol I, available from https://www.cfsan.fda.gov/~lrd/
pestadd.html.
B. International Residue Limits
There are no established or proposed Canadian, Mexican or Codex
MRLs for residues of fenazaquin in plant commodities.
C. Response to Comments
The Agency did not receive any comments to this request for import
tolerances for fenazaquin.
V. Conclusion
Therefore, the Agency is establishing import tolerances for
residues of Fenazaquin in or on apple at 0.2 parts per million (ppm);
in or on pear at 0.2 ppm; in or on citrus fruit group 10, except
grapefruit, at 0.5 ppm; and in or on citrus oil at 10 ppm. The original
petition did not request the establishment of a tolerance in or on
citrus oil at 10 ppm. However, the Agency added this tolerance for the
following reason. Separate tolerances are not required for apple and
orange juice as residues do not concentrate in these commodities.
However, the citrus processing studies indicate that fenazaquin
residues concentrate on average by 25x in citrus oil and thus residues
in citrus oil could exceed the tolerance for citrus fruits. Based on
the 25x processing factor and residue data on fenazaquin levels in or
on oranges, a tolerance of 10 ppm would be appropriate for citrus oil.
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, 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 on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers and food retailers, not States or tribes, nor does this action
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of section
408(n)(4) of FFDCA. As such, the Agency has determined that this action
will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, the Agency has determined
that Executive Order 13132, entitled Federalism (64 FR 43255, August
10, 1999) and Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
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
[[Page 44393]]
Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 26, 2007.
Debra Edwards,
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.
0
2. Section 180.632 is added to read as follows:
Sec. 180.632 Fenazaquin; import tolerances for residues.
(a) General. Import tolerances are established for residues of the
insecticide and miticide, fenazaquin, 4-tert-butylphenethyl quinazolin-
4-yl ether, in or on raw agricultural commodities as follows:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Apple................................................ 0.2
Citrus Oil........................................... 10
Fruit, Citrus, Group 10, except Grapefruit........... 0.5
Pear................................................. 0.2
------------------------------------------------------------------------
(b) Section is emergency exempotions. [Reserved]
(c) Tolerances with regional registration. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E7-15334 Filed 8-7-07; 8:45 am]
BILLING CODE 6560-50-S
