Mandipropamid; Pesticide Tolerance, 2812-2816 [E8-677]
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[FR Doc. E8–683 Filed 1–15–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0461; FRL–8346–6]
Mandipropamid; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
tolerance for residues of
mandipropamid, 4-chloro-N-[2-[3methoxy-4-(2propynyloxy)phenyl]ethyl]-alpha-(2propynyloxy)-benzeneacetamide in or
on Brassica, head and stem, subgroup
5A; Brassica, leafy greens, subgroup 5B;
vegetable, cucurbit, group 9; vegetable,
fruiting, group 8; okra; vegetable, leafy
except brassica, group 4; vegetable,
tuberous and corm, subgroup 1C; grape;
grape, raisin; onion, dry bulb; onion,
green; and potato, wet peel. Syngenta
Crop Protection Inc. requested this
tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective
January 16, 2008. Objections and
requests for hearings must be received
on or before March 17, 2008, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2007–0461. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
regulations.gov. Although listed in the
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SUMMARY:
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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.
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.
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1.6
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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 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–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 March 17, 2008.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
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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’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.
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ADDRESSES.
II. Petition for Tolerance
In the Federal Register of July 25,
2007 (72 FR 40877) (FRL–8137–1) and
October 31, 2007 (72 FR 61637) (FRL
8154-8) EPA issued notices pursuant to
section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of
pesticide petitions (PP7F7184 and
6F7057) by Syngenta Crop Protection
Inc., P.O. Box 18300, Greensboro, NC
27419. The petition (6F7057) requested
that 40 CFR part 180 be amended by
establishing tolerances for residues of
the fungicide mandipropamid, 4-chloroN-[2-[3-methoxy-4-(2propynyloxy)phenyl]ethyl]-alpha-(2propynyloxy)-benzeneacetamide, in or
on Brassica, head and stem, Subgroup
5A at 3 parts per million (ppm);
Brassica, leafy greens, subgroup 5B at 30
ppm; vegetable, cucurbit, group 9 at .3
ppm; vegetable, fruiting, group 8 at 1
ppm; vegetable, leafy except Brassica,
group 4 at 20 ppm; vegetable, tuberous
and corm, subgroup 1C at 0.01 ppm;
grape at 2 ppm; grape, raisin at 4 ppm;
onion, dry bulb at 0.05 ppm; onion,
green at 4 ppm; and tomato paste at 1.3
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.
Comments were received on the notice
of filing. EPA’s response to these
comments is discussed in Unit IV.B..
Based upon review of the data
supporting the petition, EPA has
recommended the inclusion of okra in
Crop Group 8 (Vegetable, Fruiting).
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However, a separate tolerance for okra
must be listed in the 40 CFR 180.637,
until the new crop group regulation is
published. A tolerance for tomato paste
was requested. However, the maximum
expected residue in tomato paste and
puree resulting from the proposed use
will be covered by the recommended
tolerance for vegetable, fruiting, crop
group 8. A separate tolerance is being
established for potato, wet peel, even
though it was not requested. The
maximum expected residue in potato,
wet peel resulting from the proposed
use is 0.03 ppm which was calculated
by multiplying the HAFT of <0.01 ppm
by the observed concentration factor of
>3x. Potatoes have a separate tolerance
under the vegetable, tuberous and corm
subgroup 1C.
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....’’ These provisions
were added to FFDCA by the Food
Quality Protection Act (FQPA) of 1996.
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for the petitioned-for
tolerance for residues of
mandipropamid on Brassica, head and
stem, subgroup 5A at 3 ppm; Brassica,
leafy greens, subgroup 5B at 25 ppm;
vegetable, cucurbit, group 9 at 0.6 ppm;
vegetable, fruiting, group 8 at 1 ppm;
okra at 1.0 ppm; vegetable, leafy except
Brassica, group 4 at 20 ppm; vegetable,
tuberous and corm, subgroup 1C at 0.01
ppm; grape at 1.4 ppm; grape, raisin at
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3 ppm; onion, dry bulb at 0.05 ppm;
onion, green at 4 ppm; and okra at 1
ppm and potato, wet peel at 0.03 ppm.
EPA’s assessment of exposures and risks
associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the adverse effects caused
by mandipropamid as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found in the docket established
by this action, which is described under
ADDRESSES, and is identified as
‘‘Mandipropamid: Human Health Risk
Assessment for Proposed Uses’’ 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 (UFs) 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 UFs. Short-, 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 UFs 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
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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/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for mandipropamid used for
human risk assessment is shown in
Table 1 of this unit.
TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR MANDIPROPAMID FOR USE IN DIETARY HUMAN RISK
ASSESSMENT
Exposure/Scenario
Point of Departure
Uncertainty/FQPA
Safety Factors
RfD, PAD, Level of
Concern for Risk
Assessment
Study and Toxicological Effects
Acute Dietary (General Population, including Infants and
Children)
N/A
N/A
N/A
No appropriate endpoint was identified.
Acute
Dietary(Females
years of age)
N/A
N/A
N/A
No appropriate endpoint was identified.
NOAEL = 5 mg/kg/
day
UFA = 10X .............
UFH = 10X
FQPA SF = 1X
Chronic RfD = 0.05
mg/kg/day
cPAD = 0.05 mg/
kg/day
Chronic toxicity – dogs
LOAEL = 40 mg/kg/day, based on evidence of liver toxicity (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).
13-49
Chronic Dietary (All Populations)
Cancer
‘‘Not Likely to be Carcinogenic to Humans.’’
No treatment-related tumors observed in carcinogenicity studies in rats and mice. A cancer risk assessment is not needed.
NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from
animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF =
FQPA Safety Factor. PAD = population adjusted dose (c = chronic). RfD = reference dose. N/A = not applicable.
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to mandipropamid, EPA
considered exposure under the
petitioned-for tolerances. 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, or 1998;
CSFII. As to residue levels in food, EPA
relied upon tolerance level residues and
percent crop treated (PCT) information
for all commodities A unrefined chronic
exposure assessment that assumes 100%
crop treated was conducted for the
proposed Section 3 uses of
mandipropamid. The DEEM analysis
incorporates estimates of drinking water
concentrations from the Environmental
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Fate and Effects Division directly into
the analysis. The chronic dietary
exposure analysis for mandipropamid
results in dietary risk estimates for food
and water that are below the Agency’s
level of concern for chronic dietary
exposure.
iii. Cancer. There were no treatmentrelated tumors observed in
carcinogenicity studies in rats and mice.
Mandipropamid is classified as not
likely to be a human carcinogen.
Therefore, a cancer dietary exposure
assessment was not performed.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring data to complete a
comprehensive dietary exposure
analysis and risk assessment for
mandipropamid in drinking water.
Because the Agency does not have
comprehensive monitoring data,
drinking water concentration estimates
are made by reliance on simulation or
modeling taking into account data on
the environmental fate 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.
Based on the First Index Reservoir
Screening Tool (FIRST), and Screening
Concentration in Ground Water (SCI-
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GROW) models, the estimated
environmental concentrations (EECs) of
mandipropamid for acute exposures are
estimated to be 25.2 parts per billion
(ppb) for surface water and 0.05 ppb for
ground water. The EECs for the aquatic
degradates SYN500003 and SYN504851
are estimated to be 2.32 and 8.99 ppb for
surface water and 0.6 and 1.7 ppb for
ground water. The combined level of
mandipropamid and the degradates in
surface water is 36.5 ppb.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
chronic dietary risk assessment, the
acute water concentration of value 36.5
ppb was used to conservatively 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
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 FFDCA
requires that, when considering whether
to establish, modify, or revoke a
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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
mandipropamid and 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 not assumed that
mandipropamid 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 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. 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 UFs and/or special FQPA
safety factors, as appropriate.
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 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 toxicological database for
mandipropamid is complete.
ii. The toxicity data showed no
increase in qualitative or quantitative
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susceptibility in fetuses and pups with
in utero and post-natal exposure.
iii. The toxicity data indicates that
there are no neurotoxic effects.
iv. The dietary food exposure
assessment is based on tolerance-level
residues and assumes 100% crop treated
for all commodities, which results in
very high-end estimates of dietary
exposure.
v. The dietary drinking water
assessment is based on values generated
by model and associated modeling
parameters which are designed to
provide conservative, health protective,
high-end estimates of water
concentrations.
vi. No residential uses are proposed at
this time.
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 UFs. For linear cancer risks,
EPA calculates the probability of
additional cancer cases given aggregate
exposure. Short-, intermediate-, and
long-term risks are evaluated by
comparing aggregate exposure to the
LOC to ensure that the MOE called for
by the product of all applicable UFs is
not exceeded.
1. Acute risk. No acute dietary
endpoint based on effects attributable to
a single dose could be identified based
on the toxicology data currently
available for mandipropamid. Therefore,
mandipropamid is not expected to pose
an acute risk.
2. Chronic risk. There are no
residential uses proposed or registered
for mandipropamid, and therefore
aggregate risk is equal to that from
consumption of food and water. Chronic
aggregate risk estimates associated with
exposure to mandipropamid residues in
food and water do not exceed the
Agency’s level of concern. For
mandipropamid, the chronic dietary
exposure estimate was 22% of the cPAD
for the U.S. population and was 30% of
the cPAD for the highest exposed
population subgroup, children 1-2 years
of age.
3. Short-term and intermediate-term
risk. Short and intermediate-term
dermal exposures and risks were not
assessed for mandipropamid, since
mandipropamid is not registered for use
on any sites that would result in
residential exposure.
4. Aggregate cancer risk for U.S.
population. Aggregate cancer risk was
not assessed because mandipropamid is
not likely to be carcinogenic in humans.
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5. 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
Analytical Method RAM 415/01 Residue
Analytical Method for the
Determination of Mandipropamid in
Crop Samples. Final Determination by
LC/MS/MS and the Analytical Method
Development and Validation (German S19) for the determination of residues of
MA Mandipropamid in or on Plant
Matrices is available to enforce the
tolerance expression. The method may
be requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no specific CODEX,
Canadian or Mexican maximum residue
limits (MRLs) for mandipropamid.
C. General Response to Comments
Several comments were received from
a private citizen objecting to
establishment of tolerances. The agency
has received similar comments from this
commenter on numerous previous
occasions. Refer to Federal Register 70
FR 37686 (June 30, 2005), 70 FR 1354
(January 7, 2005), 69 FR 63096-63098
(October 29, 2004) for the Agency’s
response to these objections. In
addition, the commenter noted several
adverse effects seen in animal
toxicology studies with mandipropamid
and claims because of these effects no
tolerance should be approved. EPA has
found, however, that there is reasonable
certainty of no harm to humans after
considering these toxicological studies
and the exposure levels of humans to
mandipropamid.
V. Conclusion
Therefore, the tolerances are
established for residues of
mandipropamid, 4-chloro-N-[2-[3methoxy-4-(2propynyloxy)phenyl]ethyl]-alpha-(2propynyloxy)-benzeneacetamide, in or
on Brassica, head and stem, subgroup
5A at 3 ppm; Brassica, leafy greens,
subgroup 5B at 25 ppm; vegetable,
cucurbit, group 9 at 0.6 ppm; vegetable,
fruiting, group 8 at 1.0 ppm; okra at 1.0
ppm; vegetable, leafy, except Brassica,
group 4 at 20 ppm; vegetable, tuberous
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and corm, subgroup 1C at 0.01 ppm;
grape at 1.4 ppm; grape, raisin at 3.0
ppm; onion, dry bulb at 0.05 ppm;
onion, green at 4 ppm; and potato, wet
peel at 0.03 ppm. A tolerance for tomato
paste is not being established because
residue expected will be covered by the
vegetable, fruiting crop group 8.
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,
VerDate Aug<31>2005
15:01 Jan 15, 2008
Jkt 214001
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
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).
Commodity
Parts per million
Brassica, head and stem,
subgroup 5A ................
Brassica, leafy greens,
subgroup 5B ................
Vegetable, cucurbit,
group 9 ........................
Vegetable, fruiting, group
8 ..................................
Vegetable, leafy except
Brassica, group 4 ........
Vegetable, tuberous and
corm, subgroup 1C .....
Grape ..............................
Grape, raisin ...................
Okra ................................
Onion, dry bulb ...............
Onion, green ...................
Potato, wet peel ..............
3
25
0.6
1.0
20
0.01
1.4
3.0
1.0
0.05
4
0.03
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent tolerances.
[Reserved]
[FR Doc. E8–677 Filed 1–15–08; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 64
List of Subjects in 40 CFR Part 180
[Docket No. FEMA–8007]
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Suspension of Community Eligibility
Dated: January 8, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.
SUMMARY: This rule identifies
communities, where the sale of flood
insurance has been authorized under
the National Flood Insurance Program
(NFIP), that are scheduled for
suspension on the effective dates listed
within this rule because of
noncompliance with the floodplain
management requirements of the
program. If the Federal Emergency
Management Agency (FEMA) receives
documentation that the community has
adopted the required floodplain
management measures prior to the
effective suspension date given in this
rule, the suspension will not occur and
a notice of this will be provided by
publication in the Federal Register on a
subsequent date.
DATES: Effective Dates: The effective
date of each community’s scheduled
suspension is the third date (‘‘Susp.’’)
listed in the third column of the
following tables.
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 180.637 is added to read as
follows:
I
§ 180.637 Mandipropamid; tolerances for
residues.
(a) General. Tolerances are
established for residues of the fungicide
mandipropamid, 4-chloro-N-[2-(3methoxy-4-(2-propynyloxy)phenyl]
ethyl]-alpha-(2-propynyloxy)benzeneacetamide in or on the
following commodities.
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
Federal Emergency
Management Agency, DHS.
ACTION: Final rule.
AGENCY:
E:\FR\FM\16JAR1.SGM
16JAR1
Agencies
[Federal Register Volume 73, Number 11 (Wednesday, January 16, 2008)]
[Rules and Regulations]
[Pages 2812-2816]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-677]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0461; FRL-8346-6]
Mandipropamid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
mandipropamid, 4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-
alpha-(2-propynyloxy)-benzeneacetamide in or on Brassica, head and
stem, subgroup 5A; Brassica, leafy greens, subgroup 5B; vegetable,
cucurbit, group 9; vegetable, fruiting, group 8; okra; vegetable, leafy
except brassica, group 4; vegetable, tuberous and corm, subgroup 1C;
grape; grape, raisin; onion, dry bulb; onion, green; and potato, wet
peel. Syngenta Crop Protection Inc. requested this tolerance under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective January 16, 2008. Objections and
requests for hearings must be received on or before March 17, 2008, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0461. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available 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.
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 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-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 March 17, 2008.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in
[[Page 2813]]
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'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 July 25, 2007 (72 FR 40877) (FRL-8137-1)
and October 31, 2007 (72 FR 61637) (FRL 8154-8) EPA issued notices
pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3),
announcing the filing of pesticide petitions (PP7F7184 and 6F7057) by
Syngenta Crop Protection Inc., P.O. Box 18300, Greensboro, NC 27419.
The petition (6F7057) requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the fungicide mandipropamid, 4-
chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-alpha-(2-
propynyloxy)-benzeneacetamide, in or on Brassica, head and stem,
Subgroup 5A at 3 parts per million (ppm); Brassica, leafy greens,
subgroup 5B at 30 ppm; vegetable, cucurbit, group 9 at .3 ppm;
vegetable, fruiting, group 8 at 1 ppm; vegetable, leafy except
Brassica, group 4 at 20 ppm; vegetable, tuberous and corm, subgroup 1C
at 0.01 ppm; grape at 2 ppm; grape, raisin at 4 ppm; onion, dry bulb at
0.05 ppm; onion, green at 4 ppm; and tomato paste at 1.3 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. Comments were received on the
notice of filing. EPA's response to these comments is discussed in Unit
IV.B..
Based upon review of the data supporting the petition, EPA has
recommended the inclusion of okra in Crop Group 8 (Vegetable,
Fruiting). However, a separate tolerance for okra must be listed in the
40 CFR 180.637, until the new crop group regulation is published. A
tolerance for tomato paste was requested. However, the maximum expected
residue in tomato paste and puree resulting from the proposed use will
be covered by the recommended tolerance for vegetable, fruiting, crop
group 8. A separate tolerance is being established for potato, wet
peel, even though it was not requested. The maximum expected residue in
potato, wet peel resulting from the proposed use is 0.03 ppm which was
calculated by multiplying the HAFT of <0.01 ppm by the observed
concentration factor of >3x. Potatoes have a separate tolerance under
the vegetable, tuberous and corm subgroup 1C.
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....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the petitioned-for tolerance
for residues of mandipropamid on Brassica, head and stem, subgroup 5A
at 3 ppm; Brassica, leafy greens, subgroup 5B at 25 ppm; vegetable,
cucurbit, group 9 at 0.6 ppm; vegetable, fruiting, group 8 at 1 ppm;
okra at 1.0 ppm; vegetable, leafy except Brassica, group 4 at 20 ppm;
vegetable, tuberous and corm, subgroup 1C at 0.01 ppm; grape at 1.4
ppm; grape, raisin at 3 ppm; onion, dry bulb at 0.05 ppm; onion, green
at 4 ppm; and okra at 1 ppm and potato, wet peel at 0.03 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. 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 can be found in the
docket established by this action, which is described under ADDRESSES,
and is identified as ``Mandipropamid: Human Health Risk Assessment for
Proposed Uses'' 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 (UFs)
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 UFs. Short-, 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
UFs 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
[[Page 2814]]
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/pesticides/
factsheets/riskassess.htm.
A summary of the toxicological endpoints for mandipropamid used for
human risk assessment is shown in Table 1 of this unit.
Table 1.--Summary of Toxicological Dose and Endpoints for Mandipropamid for Use in Dietary Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
RfD, PAD, Level of Study and
Exposure/Scenario Point of Departure Uncertainty/FQPA Concern for Risk Toxicological
Safety Factors Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General N/A N/A N/A No appropriate
Population, including Infants endpoint was
and Children) identified.
----------------------------------------------------------------------------------------------------------------
Acute Dietary(Females 13-49 N/A N/A N/A No appropriate
years of age) endpoint was
identified.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All NOAEL = 5 mg/kg/ UFA = 10X......... Chronic RfD = 0.05 Chronic toxicity -
Populations) day UFH = 10X......... mg/kg/day dogs
FQPA SF = 1X...... cPAD = 0.05 mg/kg/ LOAEL = 40 mg/kg/
day. day, based on
evidence of liver
toxicity
(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).
----------------------------------------------------------------------------------------------------------------
Cancer ``Not Likely to be Carcinogenic to Humans.''
No treatment-related tumors observed in carcinogenicity studies in rats and
mice. A cancer risk assessment is not needed.
----------------------------------------------------------------------------------------------------------------
NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose
(c = chronic). RfD = reference dose. N/A = not applicable.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to mandipropamid, EPA considered exposure under the
petitioned-for tolerances. 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,
or 1998; CSFII. As to residue levels in food, EPA relied upon tolerance
level residues and percent crop treated (PCT) information for all
commodities A unrefined chronic exposure assessment that assumes 100%
crop treated was conducted for the proposed Section 3 uses of
mandipropamid. The DEEM analysis incorporates estimates of drinking
water concentrations from the Environmental Fate and Effects Division
directly into the analysis. The chronic dietary exposure analysis for
mandipropamid results in dietary risk estimates for food and water that
are below the Agency's level of concern for chronic dietary exposure.
iii. Cancer. There were no treatment-related tumors observed in
carcinogenicity studies in rats and mice. Mandipropamid is classified
as not likely to be a human carcinogen. Therefore, a cancer dietary
exposure assessment was not performed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for mandipropamid in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the environmental
fate 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.
Based on the First Index Reservoir Screening Tool (FIRST), and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated environmental concentrations (EECs) of mandipropamid for
acute exposures are estimated to be 25.2 parts per billion (ppb) for
surface water and 0.05 ppb for ground water. The EECs for the aquatic
degradates SYN500003 and SYN504851 are estimated to be 2.32 and 8.99
ppb for surface water and 0.6 and 1.7 ppb for ground water. The
combined level of mandipropamid and the degradates in surface water is
36.5 ppb.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the acute water concentration of value 36.5 ppb was used to
conservatively 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 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 FFDCA requires that, when
considering whether to establish, modify, or revoke a
[[Page 2815]]
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 mandipropamid and 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 not assumed that mandipropamid 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 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. 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 UFs and/or special
FQPA safety factors, as appropriate.
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 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 toxicological database for mandipropamid is complete.
ii. The toxicity data showed no increase in qualitative or
quantitative susceptibility in fetuses and pups with in utero and post-
natal exposure.
iii. The toxicity data indicates that there are no neurotoxic
effects.
iv. The dietary food exposure assessment is based on tolerance-
level residues and assumes 100% crop treated for all commodities, which
results in very high-end estimates of dietary exposure.
v. The dietary drinking water assessment is based on values
generated by model and associated modeling parameters which are
designed to provide conservative, health protective, high-end estimates
of water concentrations.
vi. No residential uses are proposed at this time.
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 UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the MOE called for by the product of all applicable UFs is
not exceeded.
1. Acute risk. No acute dietary endpoint based on effects
attributable to a single dose could be identified based on the
toxicology data currently available for mandipropamid. Therefore,
mandipropamid is not expected to pose an acute risk.
2. Chronic risk. There are no residential uses proposed or
registered for mandipropamid, and therefore aggregate risk is equal to
that from consumption of food and water. Chronic aggregate risk
estimates associated with exposure to mandipropamid residues in food
and water do not exceed the Agency's level of concern. For
mandipropamid, the chronic dietary exposure estimate was 22% of the
cPAD for the U.S. population and was 30% of the cPAD for the highest
exposed population subgroup, children 1-2 years of age.
3. Short-term and intermediate-term risk. Short and intermediate-
term dermal exposures and risks were not assessed for mandipropamid,
since mandipropamid is not registered for use on any sites that would
result in residential exposure.
4. Aggregate cancer risk for U.S. population. Aggregate cancer risk
was not assessed because mandipropamid is not likely to be carcinogenic
in humans.
5. 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 Analytical Method RAM 415/01
Residue Analytical Method for the Determination of Mandipropamid in
Crop Samples. Final Determination by LC/MS/MS and the Analytical Method
Development and Validation (German S-19) for the determination of
residues of MA Mandipropamid in or on Plant Matrices is available to
enforce the tolerance expression. The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905;
e-mail address: residuemethods@epa.gov.
B. International Residue Limits
There are no specific CODEX, Canadian or Mexican maximum residue
limits (MRLs) for mandipropamid.
C. General Response to Comments
Several comments were received from a private citizen objecting to
establishment of tolerances. The agency has received similar comments
from this commenter on numerous previous occasions. Refer to Federal
Register 70 FR 37686 (June 30, 2005), 70 FR 1354 (January 7, 2005), 69
FR 63096-63098 (October 29, 2004) for the Agency's response to these
objections. In addition, the commenter noted several adverse effects
seen in animal toxicology studies with mandipropamid and claims because
of these effects no tolerance should be approved. EPA has found,
however, that there is reasonable certainty of no harm to humans after
considering these toxicological studies and the exposure levels of
humans to mandipropamid.
V. Conclusion
Therefore, the tolerances are established for residues of
mandipropamid, 4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-
alpha-(2-propynyloxy)-benzeneacetamide, in or on Brassica, head and
stem, subgroup 5A at 3 ppm; Brassica, leafy greens, subgroup 5B at 25
ppm; vegetable, cucurbit, group 9 at 0.6 ppm; vegetable, fruiting,
group 8 at 1.0 ppm; okra at 1.0 ppm; vegetable, leafy, except Brassica,
group 4 at 20 ppm; vegetable, tuberous
[[Page 2816]]
and corm, subgroup 1C at 0.01 ppm; grape at 1.4 ppm; grape, raisin at
3.0 ppm; onion, dry bulb at 0.05 ppm; onion, green at 4 ppm; and
potato, wet peel at 0.03 ppm. A tolerance for tomato paste is not being
established because residue expected will be covered by the vegetable,
fruiting crop group 8.
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 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: January 8, 2008.
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 180.637 is added to read as follows:
Sec. 180.637 Mandipropamid; tolerances for residues.
(a) General. Tolerances are established for residues of the
fungicide mandipropamid, 4-chloro-N-[2-(3-methoxy-4-(2-
propynyloxy)phenyl]ethyl]-alpha-(2-propynyloxy)-benzeneacetamide in or
on the following commodities.
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A................. 3
Brassica, leafy greens, subgroup 5B.................. 25
Vegetable, cucurbit, group 9......................... 0.6
Vegetable, fruiting, group 8......................... 1.0
Vegetable, leafy except Brassica, group 4............ 20
Vegetable, tuberous and corm, subgroup 1C............ 0.01
Grape................................................ 1.4
Grape, raisin........................................ 3.0
Okra................................................. 1.0
Onion, dry bulb...................................... 0.05
Onion, green......................................... 4
Potato, wet peel..................................... 0.03
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent tolerances. [Reserved]
[FR Doc. E8-677 Filed 1-15-08; 8:45 am]
BILLING CODE 6560-50-S