Mandipropamid; Pesticide Tolerances, 33165-33170 [E9-16369]
Download as PDF
<![CDATA[
Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
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 1, 2009.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office
of Pesticide Programs.
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.564 is amended in
paragraph (a) by revising the
introductory text and by alphabetically
adding the following commodities to the
table to read as follows:
■
§180.564 Indoxacarb; tolerances for
residues.
(a) General. Tolerances are
established for residues of indoxacarb,
including its metabolites and
degradates, in or on the commodities in
the table below. Compliance with the
tolerance levels specified below is to be
determined by measuring only
indoxacarb, (S)-methyl 7-chloro-2,5dihydro-2-[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]
amino]carbonyl]indeno[1,2-e][1,3,4]
[oxadiazine-4a(3H)-carboxylate, and its
R-enantiomer, (R)-methyl 7-chloro-2,5dihydro-2-[[(methoxycarbonyl)[4(trifluoromethoxy)phenyl]amino]
carbonyl]indeno[1,2e][1,3,4][oxadiazine-4a(3H)-carboxylate.
Therefore, 40 CFR chapter I is
amended as follows:
■
Commodity
Parts per million
*
*
*
*
*
Beet, garden, roots ..............................................................................................................................................................
Beet, garden, tops ...............................................................................................................................................................
Bushberry subgroup 13–07B ...............................................................................................................................................
*
*
*
*
*
*
*
*
*
*
[FR Doc. E9–16368 Filed 7–9–09; 8:45 am]
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0461; FRL–8422–5]
Mandipropamid; Pesticide Tolerances
erowe on DSK5CLS3C1PROD with RULES
AGENCY: Environmental Protection
Agency (EPA).
ACTION:
Final rule.
SUMMARY: This regulation establishes a
tolerance for residues of
mandipropamid in or on hops, dried
cones. Syngenta Crop Protection, Inc.
requested this tolerance under the
VerDate Nov<24>2008
14:18 Jul 09, 2009
Jkt 217001
Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective July
10, 2009. Objections and requests for
hearings must be received on or before
September 8, 2009, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
BILLING CODE 6560–50–S
33165
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2007–0461. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
ADDRESSES:
PO 00000
Frm 00027
Fmt 4700
Sfmt 4700
0.30
6.0
1.5
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT: Rose
Mary Kearns, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5611; e-mail address:
kearns.rosemary@epa.gov.
E:\FR\FM\10JYR1.SGM
10JYR1
33166
Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
erowe on DSK5CLS3C1PROD with RULES
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing electronically
available documents at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
cite at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. 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–2007–0461 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
as required by 40 CFR part 178 on or
before September 8, 2009.
In addition to filing an objection or
hearing request with the Hearing Clerk
VerDate Nov<24>2008
14:18 Jul 09, 2009
Jkt 217001
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–2007–0461, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of June 13,
2008, (73 FR 33814) (FRL–8367–3), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 8F7342) by
Syngenta Crop Protection, Inc., 410
Swing Road, P.O. Box 18300,
Greensboro, NC 27419. The petition
requested that 40 CFR 180.637 be
amended by establishing tolerances for
residues of the fungicide
mandipropamid [4-chloro-N-[2-[3methoxy-4-(2propynyloxy)phenyl]ethyl]-a-(2propynyloxy)-benzeneacetamide],
regulated chemical, in or on hops, at 50
parts per million (ppm). That notice
referenced a summary of the petition
prepared by Syngenta Crop Protection,
Inc, the registrant, which is available to
the public in the docket, 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
changed the requested commodity
‘‘hops’’ to ‘‘hop, dried cones.’’ The
reason for this change is explained in
Unit IV.C.
PO 00000
Frm 00028
Fmt 4700
Sfmt 4700
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue....’’
Consistent with section 408(b)(2)(D)
of FFDCA, and the factors specified in
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 for the petitioned-for
tolerances for residues of
mandipropamid on hop, dried cones at
50 ppm. EPA’s assessment of exposures
and risks associated with establishing
tolerances 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.
Mandipropamid has low or minimal
acute toxicity via the oral, dermal, and
inhalation routes of exposure. It is
minimally irritating to the eye and nonirritating to the skin. It is also negative
for skin sensitization.
Liver toxicity was the primary effect
and was observed in rats, mice, and
dogs. In the 24–month rat study,
nephrotoxicity was observed in males
only. The lack of liver toxicity in this
long-term study was probably due to the
lower doses when compared with the
90–day study. In a 90–day rat study,
there was slight hepatotoxicity in both
E:\FR\FM\10JYR1.SGM
10JYR1
erowe on DSK5CLS3C1PROD with RULES
Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations
sexes; there was the suggestion of effects
on the liver in the 90–day mouse study
in which increased liver weights in both
sexes and microscopic pathology were
observed. In the 90–day dog study liver
effects included increased cholesterol,
increased liver weights and liver
enzymes (alkaline phosphatase activity,
alanine aminotransferase) and increased
pigment in hepatocytes and Kupffer
cells in both sexes. Additionally,
centrilobular hepatocyte vacuolation in
females was observed. In the combined
chronic/carcinogenicity rat study, no
effects on the liver were noted at doses
up to and including the highest dose
tested (HDT) of 61/70 mg/kg/day (M/F);
however, increased nephrotoxicity
occurred in males. No liver effects were
observed in the mouse carcinogenicity
study at doses up to 223/285 mg/kg/day
(M/F). The following effects on the liver
were present in the 1–year dog study:
Increased incidence and severity of
microscopic pigment in the liver and
increased alkaline phosphatase activity
in both sexes, as well as increased
alanine aminotransferase activity in
males. Therefore, effects on the liver of
rats, mice and dogs appear within 90–
days (also in the 1–year dog study);
whereas, in the 24–month rat study,
only nephrotoxicity was observed and,
in the 18–month mouse study, only
decreased body weight and food
utilization was noted.
There was no evidence of
teratogenicity or indications of
increased neonatal sensitivity in the
developmental and reproduction
toxicity studies. In the rat and rabbit
developmental toxicity studies, there
were no treatment-related maternal or
developmental effects observed up to
the limit dose of 1,000 mg/kg/day. In the
2-generation rat reproduction study, the
only parental/systemic effects were
decreased body weights, body weight
gains, food consumption and food
utilization in males. No effects on
reproduction were observed at any dose.
Offspring effects were decreased pup
body weights in both sexes, but this
effect occurred at doses which also
caused effects in parental animals.
Dermal exposure to mandipropamid
for 28–days in the rat did not result in
systemic or dermal toxicity up to the
limit dose of 1000 mg/kg/day. There
was no evidence of developmental
effects, neurotoxicity, mutagenicity or
carcinogenicity after exposure to
mandipropamid.
Specific information on the studies
received and the nature of the adverse
effects caused by mandipropamid as
well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
VerDate Nov<24>2008
14:18 Jul 09, 2009
Jkt 217001
toxicity studies are discussed in the
final rule published in the Federal
Register of January 16, 2008, (73 FR
2812) (FRL–8346–6).
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, a toxicological point of departure
(POD) is identified as the basis for
derivation of reference values for risk
assessment. The POD may be defined as
the highest dose at which no adverse
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) or a Benchmark Dose
(BMD) approach is sometimes used for
risk assessment. Uncertainty/safety
factors (UFs) are used in conjunction
with the POD to take into account
uncertainties inherent in the
extrapolation from laboratory animal
data to humans and in the variations in
sensitivity among members of the
human population as well as other
unknowns. Safety is assessed for acute
and chronic dietary risks by comparing
aggregate food and water exposure to
the pesticide to the acute population
adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The
aPAD and cPAD are calculated by
dividing the POD by all applicable UFs.
Aggregate short-, intermediate-, and
chronic-term risks are evaluated by
comparing food, water, and residential
exposure to the POD to ensure that the
margin of exposure (MOE) called for by
the product of all applicable UFs is not
exceeded. This latter value is referred to
as the Level of Concern (LOC).
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk. Thus,
the Agency estimates risk in terms of the
probability of an occurrence of the
adverse effect greater than that expected
in a lifetime. For more information on
the general principles EPA uses in risk
characterization and a complete
description of the risk assessment
process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological
endpoints for mandipropamid used for
human risk assessment is discussed in
Unit III.B. of the final rule published in
the Federal Register of January 16,
2008.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to mandipropamid, EPA
considered exposure under the
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
33167
petitioned-for tolerance as well as all
existing mandipropamid tolerances in
(40 CFR 180.637). EPA assessed dietary
exposures from mandipropamid 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.
No such effects were identified in the
toxicological studies for
mandipropamid; therefore, a
quantitative acute dietary exposure
assessment is unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 1994–1996 and 1998
CSFII. As to residue levels in food, EPA
used tolerance level residues and
assumed 100 percent of all crops are
treated 100 percent crop treated (PCT).
iii. Cancer. EPA has determined that
mandipropamid classified as ‘‘not likely
to be carcinogenic to humans’’ based on
the absence of treatment-related
increases in tumors in rat and mouse
carcinogenicity studies. Therefore, there
is no cancer risk associated with the
proposed use of mandipropamid.
iv. Anticipated residue and PCT
information. EPA did not use
anticipated residue and/or PCT
information in the dietary assessment
for mandipropamid. Tolerance level
residues and/or 100 PCT were assumed
for all food commodities.
Section 408(b)(2)(E) of FFDCA
authorizes EPA to use available data and
information on the anticipated residue
levels of pesticide residues in food and
the actual levels of pesticide residues
that have been measured in food. If EPA
relies on such information, EPA must
require pursuant to FFDCA section
408(f)(1) that data be provided 5 years
after the tolerance is established,
modified, or left in effect, demonstrating
that the levels in food are not above the
levels anticipated. For the present
action, EPA will issue such data call-ins
as are required by FFDCA section
408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be
required to be submitted no later than
5 years from the date of issuance of
these tolerances.
EPA did not use PCT information in
assessing dietary exposure to
mandipropamid.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for mandipropamid in drinking water.
These simulation models take into
E:\FR\FM\10JYR1.SGM
10JYR1
erowe on DSK5CLS3C1PROD with RULES
33168
Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations
account data on the physical, chemical,
and fate/transport characteristics of
mandipropamid. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
The Agency used the FIRST (Version
1.1.0) model for estimation of surface
water and the Screening Concentration
in Ground Water (SCI–GROW, Version
2.3) model, for estimation of ground
water to determine estimated drinking
water concentrations (EDWC) of
mandipropamid.
For chronic exposures for non-cancer
assessment the EDWCs are estimated to
be 36.5 ppb for surface water and 2.4
ppb for ground water.
Modeled estimates of surface water
drinking water concentrations were
directly entered into the dietary
exposure model.
For chronic dietary risk assessment,
the water concentration of value 36.5
ppb was used to assess the contribution
to drinking water.
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).
Mandipropamid is not registered for
any specific use patterns that would
result in residential exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found mandipropamid to
share a common mechanism of toxicity
with any other substances, and
mandipropamid does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that mandipropamid does not
have a common mechanism of toxicity
with other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(c) of
FFDCA provides that EPA shall apply
VerDate Nov<24>2008
14:18 Jul 09, 2009
Jkt 217001
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA safety factor (SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
There is no evidence (quantitative or
qualitative) of increased susceptibility
and no residual uncertainties with
regard to prenatal toxicity following in
utero exposure to rats or rabbits
(developmental studies) and pre and/or
post-natal exposures to rats
(reproduction study).
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for
mandipropamid is not complete because
an immunotoxicity study is required.
Despite this data gap, EPA has
concluded that the database is adequate
to assess the pre- and postnatal toxicity
of mandipropamid and that there is no
need for an additional database
uncertainty factor to account for the
missing study.
EPA began requiring functional
immunotoxicity testing of all food and
nonfood use pesticides on December 26,
2007. This study is not yet available for
mandipropamid. EPA has evaluated the
available mandipropamid toxicity
studies for evidence of potential
immunotoxicity, including hematology,
gross organ weights for spleen and
thymus, clinical chemistry and
histopathology, to determine if an
additional database uncertainty factor is
needed to account for potential
immunotoxicity. The overall weight of
evidence suggests that mandipropamid
does not directly target the immune
system. Therefore, the Agency does not
believe that conducting a functional
immunotoxicity study will result in a
lower POD than the currently selected
for overall risk assessment, and
therefore, a database uncertainty (UFDB)
is not needed to account for the lack of
this study.
ii. There is no indication that
mandipropamid is a neurotoxic
chemical and there is no need for a
developmental neurotoxicity study or
PO 00000
Frm 00030
Fmt 4700
Sfmt 4700
additional UFs to account for
neurotoxicity.
iii. There is no evidence that
mandipropamid results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2–generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 PCT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to
mandipropamid in drinking water.
These assessments will not
underestimate the exposure and risks
posed by mandipropamid.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic pesticide exposures are safe by
comparing aggregate exposure estimates
to the aPAD and cPAD. The aPAD and
cPAD represent the highest safe
exposures, taking into account all
appropriate SFs. EPA calculates the
aPAD and cPAD by dividing the POD by
all applicable UFs. For linear cancer
risks, EPA calculates the probability of
additional cancer cases given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the POD to
ensure that the MOE called for by the
product of all applicable UFs is not
exceeded.
1. Acute risk. An acute aggregate risk
assessment takes into account exposure
estimates from acute dietary
consumption of food and drinking
water. No adverse effect resulting from
a single-oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, mandipropamid is
not expected to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to
mandipropamid from food and water
will utilize 30% of the cPAD for
(children 1–2 years of age) the
population group receiving the greatest
exposure. There are no residential uses
for mandipropamid.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level).
Mandipropamid is not registered for
any use patterns that would result in
E:\FR\FM\10JYR1.SGM
10JYR1
Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations
residential exposure. Therefore, a shortterm aggregate risk assessment was not
needed.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Mandipropamid is not registered for
any use patterns that would result in
intermediate-term residential exposure.
Therefore, an intermediate-term
aggregate risk was not needed.
5. Aggregate cancer risk for U.S.
population. Based on the absence of
treatment-related increases in tumors in
rat and mouse carcinogenicity studies
with mandipropamid, EPA concludes
that mandipropamid does not pose a
cancer risk.
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
mandipropamid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(liquid chromatography with tandem
mass spectrometry (LC/MS/MS)) is
available to enforce tolerances for
mandipropamid. The method may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no specific Codex,
Canadian, or Mexican maximum residue
limits (MRLs) for mandipropamid.
C. Revisions to Petitioned-For
Tolerances
EPA changed the requested
commodity ‘‘hops’’ to ‘‘hop, dried
cones’’ to harmonize with accepted
tolerance terminology.
erowe on DSK5CLS3C1PROD with RULES
V. Conclusion
Therefore, tolerances are established
for residues of mandipropamid, [4chloro-N-[2-[3-methoxy-4-(2propynyloxy)phenyl]ethyl]-a-(2propynyloxy)-benzeneacetamide in or
on hop, dried cones at 50 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: June 23, 2009.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.637 is amended by
alphabetically adding the following
commodity to the table in paragraph (a)
to read as follows:
■
§180.637 Mandipropamid; tolerances for
residues.
(a) General. * * *
Commodity
Parts per million
*
*
*
*
*
Hop, dried cones .................................................................................................................................................................
*
*
*
*
*
VerDate Nov<24>2008
14:18 Jul 09, 2009
Jkt 217001
PO 00000
Frm 00031
Fmt 4700
33169
Sfmt 4700
E:\FR\FM\10JYR1.SGM
10JYR1
50
33170
*
*
Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations
*
*
*
[FR Doc. E9–16369 Filed 7–9–09; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 622
[Docket No. 040205043–4043–01]
RIN 0648–XO54
Fisheries of the Caribbean, Gulf of
Mexico, and South Atlantic; Snapper–
grouper Fishery of the South Atlantic;
Closure of the 2009 Commercial
Fishery for Golden Tilefish in the
South Atlantic
AGENCY: National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; closure.
erowe on DSK5CLS3C1PROD with RULES
SUMMARY: NMFS closes the commercial
fishery for golden tilefish in the
exclusive economic zone (EEZ) of the
South Atlantic. In addition, for a person
on board a vessel for which a Federal
commercial or charter vessel/headboat
permit for the South Atlantic Snapper–
Grouper Fishery has been issued, the
provisions of the closure (restriction to
the bag and possession limits and
prohibition of sale or purchase) apply
regardless of whether the golden tilefish
are harvested in state waters or the
South Atlantic EEZ. NMFS has
determined that the quota for the
commercial fishery for golden tilefish
will have been reached by July 15, 2009.
This closure is necessary to protect the
golden tilefish resource.
DATES: Closure is effective 12:01 a.m.,
local time, July 15, 2009, through
December 31, 2009.
FOR FURTHER INFORMATION CONTACT:
Catherine Bruger, telephone 727–824–
5305, fax 727–824–5308, e–mail
Catherine.Bruger@noaa.gov.
VerDate Nov<24>2008
14:18 Jul 09, 2009
The
snapper–grouper fishery of the South
Atlantic is managed under the Fishery
Management Plan for the Snapper–
Grouper Fishery of the South Atlantic
Region (FMP). The FMP was prepared
by the South Atlantic Fishery
Management Council and is
implemented under the authority of the
Magnuson–Stevens Fishery
Conservation and Management Act
(Magnuson–Stevens Act) by regulations
at 50 CFR part 622. Those regulations,
found at 50 CFR 622.42(e)(2), set the
commercial quota for golden tilefish in
the South Atlantic at 295,000 lb
(133,810 kg) for the current fishing year,
January 1 through December 31, 2009.
Under 50 CFR 622.43(a), NMFS is
required to close the commercial fishery
for a species or species group when the
quota for that species or species group
is reached, or is projected to be reached,
by filing a notification to that effect with
the Office of the Federal Register. Based
on current statistics, NMFS has
determined that the available
commercial quota of 295,000 lb (133,810
kg) for golden tilefish will be reached on
or before July 15, 2009. Accordingly,
NMFS is closing the commercial fishery
for golden tilefish in the South Atlantic
EEZ from 12:01 a.m., local time, on July
15, 2009, through December 31, 2009.
During the closure, the applicable bag
and possession limits specified in 50
CFR 622.39(d)(1)(ii) and (d)(2),
respectively, apply to all harvest or
possession of golden tilefish in or from
the South Atlantic EEZ, and the sale or
purchase of golden tilefish taken from
the EEZ is prohibited. In addition, for a
person on board a vessel for which a
Federal commercial or charter vessel/
headboat permit for the South Atlantic
Snapper–Grouper Fishery has been
issued, those provisions of the closure
for golden tilefish apply regardless of
whether the fish are harvested in state
waters or the South Atlantic EEZ. The
operator of a vessel with golden tilefish
in excess of the bag or possession limit
aboard must have landed such golden
tilefish prior to 12:01 a.m., local time,
SUPPLEMENTARY INFORMATION:
Jkt 217001
PO 00000
Frm 00032
Fmt 4700
Sfmt 4700
July 15, 2009, and all sale or purchase
of golden tilefish must occur prior to
12:01 a.m., local time, July 15, 2009.
The prohibition on sale or purchase
does not apply to sale or purchase of
golden tilefish that were harvested,
landed ashore, and sold prior to 12:01
a.m., local time, July 15, 2009, and were
held in cold storage by a dealer or
processor.
Classification
This action responds to the best
available information recently obtained
from the fishery. The Assistant
Administrator for Fisheries, NOAA,
(AA), finds good cause to waive the
requirement to provide prior notice and
opportunity for public comment
pursuant to the authority set forth at 5
U.S.C. 553(b)(B) as such prior notice
and opportunity for public comment is
unnecessary and contrary to the public
interest. Such procedures would be
unnecessary because the rule itself has
already been subject to notice and
comment, and all that remains is to
notify the public of the closure.
Allowing prior notice and opportunity
for public comment is contrary to the
public interest because of the need to
immediately implement this action to
protect the fishery since the capacity of
the fishing fleet allows for rapid harvest
of the quota. Prior notice and
opportunity for public comment would
require time and would potentially
result in a harvest well in excess of the
established quota.
For the aforementioned reasons, the
AA also finds good cause to waive the
30-day delay in the effectiveness of this
action under 5 U.S.C. 553(d)(3).
This action is taken under 50 CFR
622.43(a) and is exempt from review
under Executive Order 12866.
Authority: 16 U.S.C. 1801 et seq.
Dated: July 7, 2009.
Kristen C. Koch,
Acting Director, Office of Sustainable
Fisheries, National Marine Fisheries Service.
[FR Doc. E9–16378 Filed 7–7–09; 8:45 am]
BILLING CODE 3510–22–S
E:\FR\FM\10JYR1.SGM
10JYR1
]]>Agencies
[Federal Register Volume 74, Number 131 (Friday, July 10, 2009)]
[Rules and Regulations]
[Pages 33165-33170]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16369]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0461; FRL-8422-5]
Mandipropamid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
mandipropamid in or on hops, dried cones. Syngenta Crop Protection,
Inc. requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective July 10, 2009. Objections and
requests for hearings must be received on or before September 8, 2009,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0461. All documents in the
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Rose Mary Kearns, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5611; e-mail address:
kearns.rosemary@epa.gov.
[[Page 33166]]
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
https://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at https://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. 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-2007-0461 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before September 8, 2009.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0461, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of June 13, 2008, (73 FR 33814) (FRL-8367-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8F7342) by Syngenta Crop Protection, Inc., 410 Swing Road, P.O. Box
18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.637
be amended by establishing tolerances for residues of the fungicide
mandipropamid [4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-
a-(2-propynyloxy)-benzeneacetamide], regulated chemical, in or on hops,
at 50 parts per million (ppm). That notice referenced a summary of the
petition prepared by Syngenta Crop Protection, Inc, the registrant,
which is available to the public in the docket, 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
changed the requested commodity ``hops'' to ``hop, dried cones.'' The
reason for this change is explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in 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 for the petitioned-for
tolerances for residues of mandipropamid on hop, dried cones at 50 ppm.
EPA's assessment of exposures and risks associated with establishing
tolerances 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.
Mandipropamid has low or minimal acute toxicity via the oral,
dermal, and inhalation routes of exposure. It is minimally irritating
to the eye and non-irritating to the skin. It is also negative for skin
sensitization.
Liver toxicity was the primary effect and was observed in rats,
mice, and dogs. In the 24-month rat study, nephrotoxicity was observed
in males only. The lack of liver toxicity in this long-term study was
probably due to the lower doses when compared with the 90-day study. In
a 90-day rat study, there was slight hepatotoxicity in both
[[Page 33167]]
sexes; there was the suggestion of effects on the liver in the 90-day
mouse study in which increased liver weights in both sexes and
microscopic pathology were observed. In the 90-day dog study liver
effects included increased cholesterol, increased liver weights and
liver enzymes (alkaline phosphatase activity, alanine aminotransferase)
and increased pigment in hepatocytes and Kupffer cells in both sexes.
Additionally, centrilobular hepatocyte vacuolation in females was
observed. In the combined chronic/carcinogenicity rat study, no effects
on the liver were noted at doses up to and including the highest dose
tested (HDT) of 61/70 mg/kg/day (M/F); however, increased
nephrotoxicity occurred in males. No liver effects were observed in the
mouse carcinogenicity study at doses up to 223/285 mg/kg/day (M/F). The
following effects on the liver were present in the 1-year dog study:
Increased incidence and severity of microscopic pigment in the liver
and increased alkaline phosphatase activity in both sexes, as well as
increased alanine aminotransferase activity in males. Therefore,
effects on the liver of rats, mice and dogs appear within 90-days (also
in the 1-year dog study); whereas, in the 24-month rat study, only
nephrotoxicity was observed and, in the 18-month mouse study, only
decreased body weight and food utilization was noted.
There was no evidence of teratogenicity or indications of increased
neonatal sensitivity in the developmental and reproduction toxicity
studies. In the rat and rabbit developmental toxicity studies, there
were no treatment-related maternal or developmental effects observed up
to the limit dose of 1,000 mg/kg/day. In the 2-generation rat
reproduction study, the only parental/systemic effects were decreased
body weights, body weight gains, food consumption and food utilization
in males. No effects on reproduction were observed at any dose.
Offspring effects were decreased pup body weights in both sexes, but
this effect occurred at doses which also caused effects in parental
animals.
Dermal exposure to mandipropamid for 28-days in the rat did not
result in systemic or dermal toxicity up to the limit dose of 1000 mg/
kg/day. There was no evidence of developmental effects, neurotoxicity,
mutagenicity or carcinogenicity after exposure to mandipropamid.
Specific information on the studies received and the nature of the
adverse effects caused by mandipropamid as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule
published in the Federal Register of January 16, 2008, (73 FR 2812)
(FRL-8346-6).
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse 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) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for mandipropamid used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of January 16, 2008.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to mandipropamid, EPA considered exposure under the
petitioned-for tolerance as well as all existing mandipropamid
tolerances in (40 CFR 180.637). EPA assessed dietary exposures from
mandipropamid 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.
No such effects were identified in the toxicological studies for
mandipropamid; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA used tolerance level
residues and assumed 100 percent of all crops are treated 100 percent
crop treated (PCT).
iii. Cancer. EPA has determined that mandipropamid classified as
``not likely to be carcinogenic to humans'' based on the absence of
treatment-related increases in tumors in rat and mouse carcinogenicity
studies. Therefore, there is no cancer risk associated with the
proposed use of mandipropamid.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for mandipropamid. Tolerance level residues and/or 100 PCT were assumed
for all food commodities.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
EPA did not use PCT information in assessing dietary exposure to
mandipropamid.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for mandipropamid in drinking water. These simulation models
take into
[[Page 33168]]
account data on the physical, chemical, and fate/transport
characteristics of mandipropamid. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
The Agency used the FIRST (Version 1.1.0) model for estimation of
surface water and the Screening Concentration in Ground Water (SCI-
GROW, Version 2.3) model, for estimation of ground water to determine
estimated drinking water concentrations (EDWC) of mandipropamid.
For chronic exposures for non-cancer assessment the EDWCs are
estimated to be 36.5 ppb for surface water and 2.4 ppb for ground
water.
Modeled estimates of surface water drinking water concentrations
were directly entered into the dietary exposure model.
For chronic dietary risk assessment, the water concentration of
value 36.5 ppb was used to assess the contribution to drinking water.
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).
Mandipropamid is not registered for any specific use patterns that
would result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found mandipropamid to share a common mechanism of
toxicity with any other substances, and mandipropamid does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
mandipropamid does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. There is no evidence
(quantitative or qualitative) of increased susceptibility and no
residual uncertainties with regard to prenatal toxicity following in
utero exposure to rats or rabbits (developmental studies) and pre and/
or post-natal exposures to rats (reproduction study).
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for mandipropamid is not complete because
an immunotoxicity study is required. Despite this data gap, EPA has
concluded that the database is adequate to assess the pre- and
postnatal toxicity of mandipropamid and that there is no need for an
additional database uncertainty factor to account for the missing
study.
EPA began requiring functional immunotoxicity testing of all food
and nonfood use pesticides on December 26, 2007. This study is not yet
available for mandipropamid. EPA has evaluated the available
mandipropamid toxicity studies for evidence of potential
immunotoxicity, including hematology, gross organ weights for spleen
and thymus, clinical chemistry and histopathology, to determine if an
additional database uncertainty factor is needed to account for
potential immunotoxicity. The overall weight of evidence suggests that
mandipropamid does not directly target the immune system. Therefore,
the Agency does not believe that conducting a functional immunotoxicity
study will result in a lower POD than the currently selected for
overall risk assessment, and therefore, a database uncertainty (UFDB)
is not needed to account for the lack of this study.
ii. There is no indication that mandipropamid is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that mandipropamid results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to mandipropamid in drinking water. These
assessments will not underestimate the exposure and risks posed by
mandipropamid.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
mandipropamid is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
mandipropamid from food and water will utilize 30% of the cPAD for
(children 1-2 years of age) the population group receiving the greatest
exposure. There are no residential uses for mandipropamid.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Mandipropamid is not registered for any use patterns that would
result in
[[Page 33169]]
residential exposure. Therefore, a short-term aggregate risk assessment
was not needed.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Mandipropamid is not registered for any use patterns that would
result in intermediate-term residential exposure. Therefore, an
intermediate-term aggregate risk was not needed.
5. Aggregate cancer risk for U.S. population. Based on the absence
of treatment-related increases in tumors in rat and mouse
carcinogenicity studies with mandipropamid, EPA concludes that
mandipropamid does not pose a cancer risk.
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 mandipropamid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography with tandem
mass spectrometry (LC/MS/MS)) is available to enforce tolerances for
mandipropamid. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no specific Codex, Canadian, or Mexican maximum residue
limits (MRLs) for mandipropamid.
C. Revisions to Petitioned-For Tolerances
EPA changed the requested commodity ``hops'' to ``hop, dried
cones'' to harmonize with accepted tolerance terminology.
V. Conclusion
Therefore, tolerances are established for residues of
mandipropamid, [4-chloro-N-[2-[3-methoxy-4-(2-
propynyloxy)phenyl]ethyl]-a-(2-propynyloxy)-benzeneacetamide in or on
hop, dried cones at 50 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 23, 2009.
Daniel J. Rosenblatt,
Acting Director, Registration Division, 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 180.637 is amended by alphabetically adding the following
commodity to the table in paragraph (a) to read as follows:
Sec. 180.637 Mandipropamid; tolerances for residues.
(a) General. * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Hop, dried cones............................... 50
* * * * *
------------------------------------------------------------------------
[[Page 33170]]
* * * * *
[FR Doc. E9-16369 Filed 7-9-09; 8:45 am]
BILLING CODE 6560-50-S
