Return to
Index
Page
List
of All Tolerances for Sulfuryl Fluoride
• See also: EPA's
response to Public Comments
http://www.epa.gov/fedrgstr/EPA-PEST/2005/July/Day-15/p13982.htm
[Federal Register: July 15, 2005 (Volume 70, Number 135)]
[Rules and Regulations]
[Page 40899-40908]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jy05-11]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0174; FRL-7723-7]
Sulfuryl fluoride; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
sulfuryl fluoride and of fluoride anion in or on commodities in
food
processing facilities. Dow AgroSciences LLC requested this tolerance
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended
by
the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective July 15, 2005. Objections
and
requests for hearings must be received on or before September 13,
2005.
ADDRESSES: To submit a written objection or hearing request follow
the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under
docket
identification (ID) number OPP-2005-0174. All documents in
the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket .
Although
listed in the index, some information is not publicly available,
i.e.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed
on
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S.
Bell St., Arlington, VA. This docket facility is open from 8:30
a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The docket
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Daniel Kenny, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection
Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7546; e-mail address: kenny.dan@epa.gov .
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
• 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 provides
a guide for readers regarding entities likely to be affected by
this
action. Other types of entities not listed in this unit could also
be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have
any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET ( http://www.epa.gov/edocket/ ), you
may
access this Federal Register document electronically through the
EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/ . A frequently updated electronic version of 40 CFR part
180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/
.
To access the OPPTS Harmonized Guidelines referenced in this
document, go directly to the guidelines at
http://www.epa.gov/opptsfrs/home/guidelin.htm.
II. Background and Statutory Findings
In the Federal Register of March 4, 2005 (70 FR 10621) (FRL-7701-
8), 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
3F6573) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis,
IN
46268. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the fumigant sulfuryl fluoride,
and of fluoride anion (also referred to as ``fluoride'' in this
document), from the fumigation use of sulfuryl fluoride in food
processing facilities, as follows:
1. The petition requested that 40 CFR 180.145 be amended by
establishing tolerances for residues of fluoride in or on the following
raw agricultural commodities (RAC): Animal feed at 130 parts per
million (ppm); beef, meat at 40 ppm; cheese, postharvest at 5 ppm;
cocoa bean, postharvest at 12 ppm; coconut, postharvest at 40 ppm;
coffee, postharvest at 12 ppm; cottonseed, postharvest at 13 ppm;
egg
at 850 ppm; ginger, postharvest at 13 ppm; grain, cereal, forage,
fodder and straw group 16, postharvest at 130 ppm; grass, forage,
fodder and hay group 17, postharvest at 130 ppm; ham at 20 ppm;
herbs
and spices group 19, postharvest at 50 ppm; milk at 3 ppm; nut,
pine,
postharvest at 10 ppm; other processed food at 70 ppm; peanut,
postharvest at 13 ppm; rice flour, postharvest at 98 ppm; and
vegetable, legume, group 06, postharvest at 6 ppm. As a result of
the
residue data, and in order to provide more adequate coverage of
all
commodities that may be involved in the use of sulfuryl fluoride
in
food processing facilities, the proposed tolerances were subsequently
revised to tolerances for residues of fluoride in or on all processed
food commodities where a separate tolerance is not already established
at 70 ppm; cattle, meat, dried at 40 ppm; cheese at 5.0 ppm; cocoa
bean, postharvest at 20 ppm; coconut, postharvest at 40 ppm; coffee,
postharvest at 15 ppm; cottonseed, postharvest at 70 ppm; eggs,
dried
at 900 ppm; ginger, postharvest at 70 ppm; ham at 20 ppm; herbs
and
spices, group 19 postharvest at 70 ppm; milk, powdered at 5.0 ppm;
nut,
pine, postharvest at 20 ppm; peanut, postharvest at 15 ppm; rice,
flour, postharvest at 45 ppm; and vegetables, legume, group 6,
postharvest at 70 ppm.
[[Page 40900]]
2. The petition requested that 40 CFR 180.575 be amended by
establishing tolerances for residues of sulfuryl fluoride in or
on the
following RACs: Animal feed at 2.0 ppm; beef, meat at 0.01 ppm;
cheese,
postharvest at 0.5 ppm; cocoa bean, postharvest at 0.8 ppm; coconut,
post harvest at 1.0 ppm; coffee, postharvest at 0.8 ppm; cottonseed,
postharvest at 0.2 ppm; egg at 0.7 ppm; ginger, postharvest at 0.2
ppm;
grain, cereal, forage, fodder and straw group 16, postharvest at
2.0
ppm; grass, forage, fodder and hay group 17, postharvest at 2.0
ppm;
ham at 0.01 ppm; herbs and spices group 19, postharvest at 0.3 ppm;
milk at 1.5 ppm; nut, pine, postharvest at 3.0 ppm; other processed
food at 1.2 ppm; peanut, postharvest at 0.2 ppm; rice flour,
postharvest at 0.08 ppm; and vegetable, legume, group 06, postharvest
at 0.02 ppm. As a result of the residue data, and in order to provide
more adequate coverage of all commodities that may be involved in
the
use of sulfuryl fluoride in food processing facilities, the proposed
tolerances were subsequently revised to a tolerance for residues
of
sulfuryl fluoride in or on all processed food commodities where
a
separate tolerance is not already established at 2.0 ppm; cattle,
meat,
dried at 0.01 ppm; cheese at 2.0 ppm; cocoa bean, postharvest at
0.2
ppm; coconut, postharvest at 1.0 ppm; coffee, postharvest at 1.0
ppm;
cottonseed, postharvest at 0.5 ppm; eggs, dried at 1.0 ppm; ginger,
postharvest at 0.5 ppm; ham at 0.02 ppm; herbs and spices, group
19
postharvest at 0.5 ppm; milk, powdered at 2.0 ppm; nut, pine,
postharvest at 0.2 ppm; peanut, postharvest at 0.5 ppm; rice, flour,
postharvest at 0.05 ppm; and vegetables, legume, group 6, postharvest
at 0.5 ppm.
That notice included a summary of the petition prepared by Dow
AgroSciences LLC, the registrant. The Agency received 19 sets of
written comments on this notice. In general, the comments addressed
either procedural issues concerning the process of establishing
tolerance levels for sulfuryl fluoride and total fluoride or addressed
issues concerning the human health and other consequences that would
result from the use of sulfuryl fluoride and increased human exposure
to fluorides. In addition, numerous questions and requests for
additional information were raised concerning issues related to
EPA's
human health risk assessment process and to possible secondary fluoride
exposures. Most of the comments and questions relate to fluoride
exposure and fluoride toxicology. The Agency
has separately reviewed
these comments and concludes that the information contained within
does
not support adopting a change in EPA's current evaluation of the
adverse health effects of fluoride. The
Agency has prepared a detailed
response to the public comments regarding the establishment of
tolerances for sulfuryl fluoride and for fluoride anion on food
resulting from the application of sulfuryl fluoride as a fumigant
in
food processing facilities. This document has been made part of
the
public docket
OPP-2005-0067 for this regulatory action.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or
on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there
is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and
in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that
there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue.
. .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion
of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances in the Federal Register of November
26,
1997 (62 FR 62961) (FRL-5754-7).
III. Aggregate Risk Assessment and Determination
of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed
the
available scientific data and other relevant information in support
of
this action. EPA has sufficient data to assess the hazards of and
to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of sulfuryl fluoride
on all processed food commodities where a separate tolerance is
not
already established at 2.0 ppm; cattle, meat, dried at 0.01 ppm;
cheese
at 2.0 ppm; cocoa bean, postharvest at 0.2 ppm; coconut, postharvest
at
1.0 ppm; coffee, postharvest at 1.0 ppm; cottonseed, postharvest
at 0.5
ppm; eggs, dried at 1.0 ppm; ginger, postharvest at 0.5 ppm; ham
at
0.02 ppm; herbs and spices, group 19 postharvest at 0.5 ppm; milk,
powdered at 2.0 ppm; nut, pine, postharvest at 0.2 ppm; peanut,
postharvest at 0.5 ppm; rice, flour, postharvest at 0.05 ppm; and
vegetables, legume, group 6, postharvest at 0.5 ppm, and residues
for
fluoride anion on all processed food commodities where a separate
tolerance is not already established at 70 ppm; cattle, meat, dried
at
40 ppm; cheese at 5.0 ppm; cocoa bean, postharvest at 20 ppm; coconut,
postharvest at 40 ppm; coffee, postharvest at 15 ppm; cottonseed,
postharvest at 70 ppm; eggs, dried at 900 ppm; ginger, postharvest
at
70 ppm; ham at 20 ppm; herbs and spices, group 19 postharvest at
70
ppm; milk, powdered at 5.0 ppm; nut, pine, postharvest at 20 ppm;
peanut, postharvest at 15 ppm; rice, flour, postharvest at 45 ppm;
and
vegetables, legume, group 6, postharvest at 70 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. Since residues of concern for sulfuryl
fluoride are sulfuryl
fluoride, per se, and fluoride anion, the Agency assessed the human
health risk associated with both sulfuryl fluoride and fluoride
anion
in connection with this action. Due to the different toxicological
effects elicited by these two chemicals, their risks have been assessed
separately. The nature of the toxic effects caused by sulfuryl fluoride
and by fluoride anion as well as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from
the
toxicity studies reviewed are discussed in the Federal Register
of
January
23, 2004 (69 FR 3240) (FRL-7342-1).
B. Toxicological Endpoints
The dose at which the NOAEL from the toxicology study identified
as
appropriate for use in risk assessment is used to estimate the
toxicological level of concern (LOC). However, the lowest dose at
which
adverse effects of concern are identified (the LOAEL) is sometimes
used
for risk assessment if no NOAEL was achieved in the toxicology study
[[Page 40901]]
selected. An uncertainty factor (UF) is applied to reflect
uncertainties inherent in the extrapolation from laboratory animal
data
to humans and in the variations in sensitivity among members of
the
human population as well as other unknowns. An UF of 100 is routinely
used, 10X to account for interspecies differences and 10X for
intraspecies differences.
Three other types of safety or UFs may be used: ``Traditional
UFs,'' the ``special FQPA safety factor,'' and the ``default FQPA
safety factor.'' By the term ``traditional UF,'' EPA is referring
to
those additional UFs used prior to FQPA passage to account for database
deficiencies. These traditional UFs have been incorporated by the
FQPA
into the additional safety factor for the protection of infants
and
children. The term ``special FQPA safety factor'' refers to those
safety factors that are deemed necessary for the protection of infants
and children primarily as a result of the FQPA. The ``default FQPA
safety factor'' is the additional 10X safety factor that is mandated
by
the statute unless it is decided that there are reliable data to
choose
a different additional factor (potentially a traditional UF or a
special FQPA safety factor).
For dietary risk assessment (other than cancer) the Agency uses
the
UF to calculate an acute or chronic reference dose (aRfD or cRfD)
where
the RfD is equal to the NOAEL divided by an UF of 100 to account
for
interspecies and intraspecies differences and any traditional UFs
deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety
factor
or the default FQPA safety factor is used, this additional factor
is
applied to the RfD by dividing the RfD by such additional factor.
The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF
(10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL
to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated
and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The
Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk). An example of how such a probability risk is expressed
would be to describe the risk as one in one hundred thousand (1
x
10-5), one in a million (1 x 10-6), or one in ten
million (1 x 10-7). Under certain specific circumstances,
MOE calculations will be used for the carcinogenic risk assessment.
In
this non-linear approach, a ``point of departure'' is identified
below
which carcinogenic effects are not expected. The point of departure
is
typically a NOAEL based on an endpoint related to cancer effects
though
it may be a different value derived from the dose response curve.
To
estimate risk, a ratio of the point of departure to exposure
(MOEcancer = point of departure/exposures) is calculated.
In assessing the risks associated with exposure to fluoride, EPA
has relied on the toxicological assessment and Maximum Contaminant
Levels (MCLs) established by the Agency's Office of Water and the
hazard analysis performed by the Institute of Medicine of the National
Academy of Science. A MCL is an enforceable level that is set as
closely as feasible to the Maximum Contaminant Level Goal (MCLG)
of a
contaminant. The MCLG is the maximum level of a contaminant in drinking
water at which no known or anticipated adverse effect on the health
of
persons would occur, and which allows an adequate margin of safety.
MCL
goals are non-enforceable health goals. For fluoride, both the MCL
and
the MCLG have been set at 4.0 ppm (4 milligrams/liter (mg/L)). EPA
chose the MCL value to protect against cripplying skeletal fluorosis
effects that were only seen where there was daily consumption of
20 mg
or more of fluoride for 20 or more years. (50 FR 47142) (November
14,
1985). A 4 mg/L level in water is designed to limit total daily
exposure to approximately 8 milligrams day (mg/day).
The Institute of Medicine (IOM) examined
fluoride in 1997 and
recommended a NOAEL for use in evaluating the risk posed by fluoride
exposure. Its examination of the available data identified a NOAEL
of
10 mg/day as relates to fluoride intake and skeletal fluorosis.
The IOM
further pointed out that exposures of 10 or more years are required
to
develop this condition and therefore concluded that skeletal fluorosis
is not a concern for children under the age of 8. Their analysis
results in a tolerable upper intake level of 10 mg/day for children
age
8 and above and adults. In deriving a recommended upper limit for
exposure, the IOM used an UF of 1, noting that the NOAEL is derived
from human studies and that symptomatic skeletal fluorosis is not
observed at intakes of 10 mg/day. As noted in the general discussion
of
fluoride toxicity, the FQPA safety factor can also be reduced to
1X;
therefore, the safe dose level for skeletal fluorosis based on the
IOM
analysis is 10 mg/day.
A summary of the toxicological endpoints for sulfuryl fluoride
and
for fluoride anion used for use in human risk assessment is discussed
in Unit III.B. of the final rule published in the Federal Register
of
January
23, 2004 (69 FR 3240) (FRL-7342-1).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.575) for the residues of sulfuryl fluoride,
in
or on a variety of RACs. Tolerances currently exist for sulfuryl
fluoride on cereal grains, dried fruits, and tree nuts as a result
of
postharvest fumigation application to grain processing and storage
facilities. Tolerances have been established (40
CFR 180.145) for the
residues of fluoride, in or on a variety of RACs as a result of
applications of sulfuryl fluoride and cryolite on food. With this
action, tolerances are established in association with the use of
sulfuryl fluoride for the fumigation of dried beef, cheese, coffee,
cottonseed, cocoa bean, coconuts, coffee, powdered eggs, ginger,
ham,herbs and spices, powdered milk, pine nuts, peanuts, rice flour,
and legume vegetables for the control of insects, and all other
processed foods as a result of the treatment of areas and equipment
within food and feed processing plants with sulfuryl fluoride for
the
control of insects. The term food
and feed processing plant includes
those facilities specifically listed under the Food and Feed Processing
Plants subgroup within pesticide use site group
12 in Appendix A to 40
CFR part 158.
Note
from FAN.
Food
and feed processing plant includes:
http://www.setonresourcecenter.com/cfr/40CFR/P158_050.HTM
•
Food and feed processing plants
• Bakeries
• Bottlers
• Canneries
• Dairies, creameries, milk processing plants
• Feed mills, feed stores
• Fresh fruit packing and processing
• Meat processing
• Poultry processing
• Wineries, wine cellars
• Flour mills, machinery, warehouses, bins, elevators
• Egg processing
• Candy and confectionary plants
• Sugar processing, cane mills, etc.
• Cider mills
• Dry food products plants
• Tobacco processing
• Air treatment for processing and transportation
of foods
• Beverage processing
• Nut processing
• Cereal processing
• Seafood processing
• Vegetable oil processing
• Spice mills
• Vinegar processing
• Farinaceous processing (noodles, etc.)
• Mushroom processing
• Dried fruit processing
• Pickle processing
• Ice plants
• Chocolate processing
• Fruit juice processing
|
Risk assessments were conducted by EPA to assess dietary
exposures from sulfuryl fluoride and from fluoride anion in food
as
follows:
i. Acute exposure.
Acute dietary 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 toxicological endpoint attributable to a single exposure was
identified in the available toxicology studies on sulfuryl fluoride
or
the fluoride anion. Therefore, acute dietary
exposure assessments were
not conducted.
ii. Chronic exposure.
In conducting the chronic dietary risk
assessment, EPA used the Dietary Exposure Evaluation Model (DEEM)
software with the Food Commodity Intake Database (FCID),
[[Page 40902]]
which incorporates food consumption data as reported by respondents
in
the United States Department of Agriculture (USDA) 1994-1996 and
1998
Nationwide Continuing Surveys of Food Intake by Individuals (CSFII),
and accumulated exposure to the chemical for each commodity.
Due to the
potential for serial fumigation of a commodity or ingredient, first
as
part of a postharvest or grain mill fumigation and then again due
to
food processing facility fumigation, dietary exposure estimates
from
the previous assessment are combined with those from the current
assessment. The actual probability of this occurring is likely to
be
very small; therefore, this assumption results in an overestimate
of
exposure. The following assumptions were made for the chronic exposure
assessments.
For sulfuryl fluoride, the chronic analysis used average residue
values from residue trials reflecting the maximum proposed use,
percent
market share estimates, and an estimate of the amount of yearly
production that might be within the processing facility during fumigation.
In addition to assessing the exposure to sulfuryl fluoride in food,
EPA included quantitative estimates of fluoride
exposure from residues
in foods from the use of sulfuryl fluoride and/or cryolite, background
levels in foods, and consumption of fluoride-containing water. Also
addressed quantitatively are exposure from the use of fluoridated
toothpaste and inhalation of fluoride from the atmosphere. For each
of
these pathways of exposure, residue estimates are conservative to
moderately conservative in nature. After assessing
these pathways of
exposure, drinking water and background levels in food are the
principal sources of dietary exposure to fluoride.
iii. Cancer.
Sulfuryl fluoride has been classified as ``not likely
to be carcinogenic to humans'' and there is
no evidence showing an
increased risk of cancer following exposure to fluoride. Therefore,
EPA
has not conducted an assessment of cancer risk from dietary exposures
for either sulfuryl fluoride or fluoride anion.
iv. Anticipated residue and percent crop
treated (PCT) information.
Section 408(b)(2)(E) of the 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 chemicals that
have been
measured in food.
If EPA relies on such information, EPA must pursuant
to section 408(f)(1) require 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. Following
the initial data submission, EPA is authorized to require similar
data
on a time frame it deems appropriate. For
the present action, EPA will
issue such data call-ins for information relating to anticipated
residues as are required by FFDCA section 408(b)(2)(E) and authorized
under FFDCA section 408(f)(1). Such data call-ins will be required
to
be submitted no later than 5 years from the date of issuance of
this
tolerance.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if the Agency can make the following findings: Condition
1,
that the data used are reliable and provide a valid basis to show
what
percentage of the food derived from such crop is likely to contain
such
pesticide residue; condition 2, that
the exposure estimate does not
underestimate exposure for any significant subpopulation group;
and
condition 3, if data are available
on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition,
the
Agency must provide for periodic evaluation of any estimates used.
To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to
submit
data on PCT.
The Agency used PCT information as follows:
EPA has estimated that 40% of the commodities
for which an
individual, specific tolerance is established by this action will
be
fumigated with sulfuryl fluoride. The
exceptions are cocoa beans
and
ham, which were estimated at 100%. Sulfuryl fluoride
is intended to be
used as a methyl bromide alternative that is used to target pests
in
commodities and food processing facilities. Usage
information indicates
that an estimated 20 to 40% of the fumigated commodity market is
fumigated using methyl bromide. Assuming full market penetration
by
sulfuryl fluoride, and using the upper bound percentage and applying
it
to the entire U.S. market as opposed to only the fumigated market,
EPA
believes that 40% PCT is a highly conservative over-estimation of
actual potential usage of sulfuryl fluoride for these commodities.
For processed
foods that may be present while fumigating areas
and
equipment within food processing facilities (i.e., the commodities
covered by the catchall provision in the tolerance ``all processed
foods not otherwise listed''), EPA has estimated the percentage
of food
processing facilities that will likely be fumigated, the frequency
of
fumigation, as well as the extent of a given facility's production
that
would be exposed during fumigation. Of the
processing facilities in the
U.S., it is estimated that approximately 40% would receive sulfuryl
fluoride fumigation with, on average, 2.5 fumigations per year.
Approximately one day's worth of production could be stored on-site
and
the facilities typically operate over 300 days per year. Assuming
3
fumigations per year, that gives a percent commodity treated estimate
of 0.4 x 3 / 300 = 0.004. For this assessment,
it was assumed that rice
mills could be fumigated 6 times per
year, yielding a factor of 0.008.
Since commodities would be exposed in their ``final'' form, processing
factors were not used in this assessment. In the case of milk
and egg,
only dried food forms were included
in the analysis since that is the
form that would be present in the processing facility.
The Agency believes that the three conditions listed in this Unit
have been met. With respect to condition 1,
EPA finds that the PCT
information described in this document for sulfuryl fluoride used
in
food processing facilities is reliable and has a valid basis. Sulfuryl
fluoride is a postharvest fumigant in food processing facilities
that
will replace methyl bromide uses for which the Agency has good
information about the actual amounts used. It is also possible that
sulfuryl fluoride could replace other fumigant products for which
there
are also use data available, although not as refined as for methyl
bromide. This has been considered when making the percent crop treated
estimates which are considered to be conservative, i.e., estimating
the
upper range of the in food processing facilities that will likely
be
treated with sulfuryl fluoride. As to conditions
2 and 3, regional
consumption information and consumption information for significant
subpopulations is taken into account through EPA's computer-based
model
for evaluating the exposure of significant subpopulations including
several regional groups. Use of this consumption information in
EPA's
risk assessment process ensures that EPA's exposure estimate does
not
understate exposure for any significant subpopulation group and
allows
the Agency to be reasonably certain that no regional population
is
exposed to residue levels higher than those estimated by the Agency.
Other than the data available through national food consumption
surveys, EPA does not
[[Page 40903]]
have available information on the regional
consumption of food to which
sulfuryl fluoride may be applied in a particular area.
2. Dietary exposure from drinking water.
The Agency has determined
that, because of the use pattern and physicochemical characteristics
of
sulfuryl fluoride, neither residues of sulfuryl fluoride nor of
inorganic fluoride are expected to reach surface water or ground
water
due to the postharvest fumigation (an indoor use) of the commodities
listed in Unit II. Residues of fluoride anion may be in drinking
water
due to intentional fluoridation. The nature of fluoride residues
in
drinking water and fluoride exposure estimates are discussed in
the
Federal
Register of January 23, 2004 (69 FR 3240) (FRL-7342-1).
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).
Sulfuryl fluoride is currently registered
for use on the following
residential non-dietary sites: Fumigation of residential sites for
termites. The risk assessment was conducted using the following
residential exposure assumptions:
Sulfuryl fluoride is registered for fumigation of domestic
structures. Exposure could occur when residents re-occupy a fumigated
home; however, the label for the sulfuryl fluoride product that
is used
for fumigation of domestic structures (Vikane) restricts reentry
to the
residence until the measured levels of sulfuryl fluoride are very
low.
The Agency has determined, based on the available
exposure data
supporting the Vikane registration and the Vikane label restriction
on
reentry, that there is negligible exposure to sulfuryl fluoride
from
home fumigation.
Fluoride exposure may also occur from non-dietary sources,
including incidental ingestion of
toothpaste and inhalation of airborne
fluoride. Other non-dietary exposures may occur;
however, the Agency
has included only exposure from toothpaste and the air in its
quantitative assessment due to lack of data indicating that other
sources of exposure are significant. The nature of non-dietary
exposures to fluoride and non-dietary exposure estimates are discussed
in the Federal Register of January 23, 2004 (69 FR 3240) (FRL-7342-1).
4. Cumulative effects from substances with
a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that,
when
considering whether to establish, modify, or revoke a tolerance,
the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA
has not made
a common mechanism of toxicity finding as to sulfuryl fluoride and
any
other substances and sulfuryl fluoride 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 sulfuryl fluoride
has a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals
have a
common mechanism of toxicity and to evaluate the cumulative effects
of
such chemicals, see the policy statements released by EPA's Office
of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have
a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children
in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the 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. Margins of safety
are
incorporated into EPA risk assessments either directly through use
of a
MOE analysis or through using UF (safety) in calculating a dose
level
that poses no appreciable risk to humans. In applying this provision,
EPA either retains the default value of 10X when reliable data do
not
support the choice of a different factor, or, if reliable data are
available, EPA uses a different additional safety factor value based
on
the use of traditional uncertainty factors and/or special FQPA safety
factors, as appropriate.
2. Prenatal and postnatal sensitivity.
In the sulfuryl fluoride
developmental toxicity study in rats, neither quantitative
nor
qualitative evidence of increased susceptibility of fetuses to in
utero
exposure to sulfuryl fluoride was observed. In the sulfuryl fluoride
developmental study in rabbits, neither quantitative nor qualitative
evidence of increased susceptability of fetuses to in utero; exposure
to sulfuryl fluoride was observed. In the sulfuryl fluoride 2-
generation reproductive study in rats, neither quantitative nor
qualitative evidence of increased susceptability of fetuses to sulfuryl
fluoride was observed.
A very large body of information regarding the toxicology of
fluoride is available in the open literature.
A complete review or re-
presentation of that information is beyond the scope of this
assessment. For a comprehensive review of the toxicology
of fluoride,
the reader is referred to publications by the World Health Organization
(2002), the National Research Council
(1993), the Medical Research
Council (1992), and the Department
of Health and Human Services (Draft
Document 1993). In conducting the assessment
for fluoride, the Agency
has used the toxicological assessment and Maximum Contaminant Level
Goals (MCLGs) established by the Agency's Office of Water. The MCLG
was
established in 1986 and is based on an LOAEL of 20 mg/day, a safety
factor of 2.5, and an adult drinking water intake of 2 L/day. The
use
of a safety factor of 2.5 ensures public health criteria while still
allowing sufficient concentration of fluoride in water to realize
its
beneficial effects in protecting against dental caries.
3. Conclusion. The
toxicity database for sulfuryl fluoride is
complete with the exception of a developmental neurotoxicity (DNT)
study in rats. The exposure data are sufficiently complete
or are
estimated based on data that reasonably accounts for potential
exposures. Based on the available evidence,
the Agency is requiring an
inhalation DNT study in rats (OPPTS Harmonized Guideline 870.6300)
as a
condition of registration in order to more clearly and fully
characterize the potential for neurotoxic effects in young animals.
The Agency has determined that a 10X FQPA safety factor in the form
of a database (UFDB) is needed to account for the lack of the DNT
study
since the available data provide no basis to support reduction or
removal of the default 10X factor. The following points were considered
in this determination.
The current regulatory dose for chronic dietary risk assessment
is
the NOAEL of 8.5 milligrams/kilogram/day (mg/kg/day) (30 ppm; 0.13
mg/
L) selected from a 90-day inhalation toxicity study in rabbits.
This
dose is also used for intermediate-term and long-term inhalation
exposure risk assessments. The current dose for the short-term
inhalation exposure risk
[[Page 40904]]
assessment is the NOAEL of 30 mg/kg day (100 ppm; 0.42 mg/L) from
a 2-
week inhalation toxicity study in rabbits. In addition, after
considering the dose levels used in the neurotoxicity studies and
in
the 2-generation reproduction study, it is assumed
that the DNT study
with sulfuryl fluoride will be conducted at dose levels similar
to
those used in the 2-generation reproduction study (0, 5, 20, 150
ppm;
0, 0.02, 0.08, 0.6 mg/L). It is considered possible that the results
of
the DNT study could impact the endpoint selection for risk assessments
because the lowest dose that may be tested in the DNT (5 ppm or
0.02
mg/L), based on the Agency's dose analysis, could become an effect
level which would necessitate an additional factor resulting in
doses
which would then be lower than the current doses used for chronic
dietary (8.5 mg/kg/day), intermediate, and long-term inhalation
(30 ppm
or 0.13 mg/L) and short-term inhalation (100 ppm or 0.42 mg/L) risk
assessments.
Given these circumstances, the Agency does
not have sufficient
reliable data justifying selection of an additional safety factor
for
the protection of infants and children lower than the default value
of
10X. Therefore, a UFDB of 10X will be applied to repeated dose exposure
scenarios (i.e. chronic RfD, and residential short-term, intermediate-
term, and long-term inhalation) to account for the lack of the DNT
study with sulfuryl fluoride.
Given the wealth of reliable human data on
fluoride, EPA believes
no additional safety factor for the protection of children is necessary
(1X). Relying on the extensive data bearing on skeletal fluorosis,
EPA's Office of Water reduced the traditional intraspecies safety
factor to 2.5X. This is reasonable, especially given that the NAS
has
recommended that a safe dose for fluoride should be set using no
intraspecies safety factor or any other safety factor.
E. Aggregate Risks and Determination of Safety
1. Acute risk.
No toxicological endpoint attributable to a single
exposure was identified in the available toxicology studies for
either
sulfuryl fluoride and/or fluoride; therefore, no acute risk is expected
from exposure to these compounds.
2. Chronic risk. Using the exposure
assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to sulfuryl
fluoride from food will utilize 2.4% of the cPAD for the U.S.
population, 5.3% of the cPAD for infants less than 1 year of age,
and
3.3% of the cPAD for children 6-12 years of age. There are no
residential uses for sulfuryl fluoride that result in chronic
residential exposure to sulfuryl fluoride. In addition, as discussed
above, residues of sulfuryl fluoride will not occur in drinking
water.
Therefore, drinking water does not contribute to aggregate exposure,
leaving residues in or on food as the only quantifiable exposure
pathway for estimating aggregate risks. Estimated chronic dietary
risks
represent chronic aggregate risks, and are no more than 2.4% of
the
cPAD for the U.S. population or any subgroup. Therefore, EPA does
not
expect the aggregate exposure to exceed 100% of the cPAD, as shown
in
the following Table 1:
Table
1.-Aggregate Risk Assessment for Chronic Exposure to Sulfuryl
Fluoride |
Population
Subgroup |
cPAD, mg/kg/
day |
Estimated
Exposure (Current Request), mg/kg/day |
Estimated
Exposure (Previous Estimate), mg/kg/day |
Estimated
Exposure (Total), mg/ kg/day |
Risk, %cPAD |
U. S. population |
0.003 |
0.000070 |
0.000003 |
0.000073 |
2.4 |
All infants
(< 1 year) |
0.003 |
0.000156
|
0.000002
|
0.000158
|
5.3 |
Children (1-2 years) |
0.003 |
0.000236 |
0.000004 |
0.000240
|
8.0 |
Children
(3-5 years) |
0.003 |
0.000178 |
0.000004 |
0.000182 |
6.1 |
Children
(6-12 years) |
0.003 |
0.000096 |
0.000003 |
0.000099 |
3.3 |
Youth (13-19
years) |
0.003 |
0.000052 |
0.000001 |
0.000053 |
1.8 |
Adults
(20-49 years) |
0.003 |
0.000056 |
0.000003 |
0.000059 |
2.0 |
Adults
(50+ years) |
0.003 |
0.000046 |
0.000004 |
0.000050 |
1.7 |
Females
(13-49 years) |
0.003 |
0.000052 |
0.000003 |
0.000055 |
1.8 |
As discussed previously in this Unit, to assess aggregate risk for
fluoride, EPA included quantitative estimates of dietary exposure
from
background levels of fluoride in food, fluoride in water, fluoride
from
the pesticidal food uses of cryolite and sulfuryl fluoride, non-dietary
exposure from the use of fluoridated toothpaste, and non-dietary
exposure from fluoride residues in air. For each of these pathways
of
exposure, residue estimates are conservative to moderately conservative
in nature. Total estimated aggregate exposures were calculated for
the
U.S. population and each subgroup and are shown in the following
Table 2:
[[Page 40905]]
Table
2.-Estimated Aggregate Exposure to Fluoride Anion by Source
|
Population
Subgroup |
From Sulfuryl
Fluoride mg/kg/ day |
From Cryolite
mg/kg/
day |
Back-ground
Food mg/kg/ day |
Water mg/kg/
day |
Tooth-paste
mg/kg/ day |
Air mg/kg/
day |
Total mg/kg/
day |
U.S. population
|
0.0093
|
0.0007
|
0.0068
|
0.0269 |
0.0043
|
0.0006
|
0.049 |
All infants
(< 1 year) |
0.0114 |
0.0010
|
0.0093 |
0.1424
|
0.0429
|
0.0019
|
0.209 |
Children
(1-2 years) |
0.0231
|
0.0033
|
0.0175
|
0.0407 |
0.0231
|
0.0020
|
0.110 |
Children
(3-5 years) |
0.0204 |
0.0021 |
0.0149 |
0.0338
|
0.0136 |
0.0012 |
0.086 |
Children
(6-12 years) |
0.0130
|
0.0009 |
0.0094 |
0.0227
|
0.0075 |
0.0007 |
0.054 |
Youth
(13-19 years) |
0.0078
|
0.0003
|
0.0062
|
0.0176
|
0.0050 |
0.0007
|
0.038 |
Adults
(20-49 years) |
0.0078
|
0.0004
|
0.0057 |
0.0252
|
0.0043 |
0.0006 |
0.044 |
Adults
(50+ years) |
0.0072 |
0.0005
|
0.0050
|
0.0256
|
0.0043
|
0.0006
|
0.043 |
Females
(13-49 years) |
0.0073
|
0.0005 |
0.0054
|
0.0238
|
0.0049
|
0.0006
|
0.043 |
In a prior tolerance action involving sulfuryl fluoride, aggregate
exposure estimates expressed in milligrams per kilogram of body
weight
per day were then compared to the MCL for the U.S. population and
each
subgroup. Because the MCL was expressed in terms of an allowable
level
of fluoride in milligrams per liter of water, EPA converted the
MCL
into a reference dose-type number relying on standard age group
body
weights and water consumption figures. The
IOM's conclusion that
exposures to fluoride must continue for at least 10 years has convinced
EPA that its prior risk assessment approach using the MCL to calculate
a reference dose-type number mischaracterizes the risk by focusing
attention on daily or yearly exposure rather than looking at total
exposure over a 10-year period. In fact, the
MCL, itself, was based on
a concern that fluoride could cause skeletal fluorosis if there
was
exposure at a 20 mg/day level over a period of 20 years. Setting
the
MCL at 4 mg/L was based on the conclusion that value would limit
exposure to 8 mg/day (assuming 2 liters of water consumed per day)
over
the long-term and would therefore, provide an adequate margin of
exposure. Accordingly, in this action, EPA has characterized the
risk
by comparing total exposure for various age groups to the value
deemed
safe in choosing the MCL (8 mg/day) and identifying the 10-year
span
most likely to produce the highest exposure. Because the MCL was
based
on the finding that exposures over 8 mg/day would have to occur
for 20
years or more, EPA believes it is appropriate to use the 8 mg/day
figure to evaluate exposure for all populations subgroups, including
infants and children. Nonetheless, out of an abundance of caution,
and
because the EPA document establishing the MCL value did not
specifically address the level of exposure in children that could
contribute to crippling skeletal fluorosis later in life, EPA has
also
evaluated children's exposure to fluoride by comparing it to the
expected exposure under the MCL for children of 4 mg/day (assuming
consumption of 1 liter of water a day).
As Table 3 shows, each of the age groups's exposure is well below
the exposure value deemed safe by the MCL and the highest exposure
over
a 10-year period is for adults and their exposure is likely to be
no
greater than 38% of the safe level. Even when it is assumed that
the
maximum exposure for infants, children, and youths should be 4 mg/day,
the highest 10-year period, which would be for the ages of 2-12,
would
only increase to 50% of the safe level. EPA conducted the same exercise
using the IOM safe level of 10 mg/day. Although the IOM did not
suggest
that skeletal fluorosis could be a problem for children under the
age
of 8, neither did IOM state that exposure under the age of 8 could
contribute to skeletal fluorosis later in life. Accordingly, as
a
conservative measure, EPA evaluated children under the age of 8
under
the 10 mg/day exposure level as well. EPA did not conduct an
alternative evaluation assuming a lower acceptable exposure level
for
children in relying on the IOM analysis because the IOM clearly
applied
its safe exposure level of 10 mg/day to children and adults. The
results using the IOM safe level of 10 mg/day are presented in Table
4.
It shows that exposure during the highest 10-year period is 31%
of the
safe dose.
Table
3.-Aggregate Exposure and Risk Estimates for Skeletal Fluorosis
Relying on MCL |
Population
Subgroup |
Total Allowable
Exposure in mg/day under MCL |
Total Fluoride
Exposure, mg/kg/day |
Body Weight,
kg |
Total Fluoride
Exposure, mg/day |
Risk, %
of
Allowable Exposure under MCL |
U. S. population
(total) |
8 |
0.049 |
70.0000 |
3.399 |
43 |
All infants
(< 1 year) |
8 |
0.209 |
7.0000 |
1.462 |
18 |
Children
(1-2 years) |
8 |
0.110 |
13.0000
|
1.427 |
18 |
Children
(3-5 years) |
8 |
0.086 |
22.0000
|
1.891 |
24 |
Children
(6-12 years) |
8 |
0.054 |
40.0000
|
2.168 |
27 |
Youth (13-19
years) |
8 |
0.038 |
60.0000 |
2.254 |
28 |
Adults
(20-49 years) |
8 |
0.044 |
70.0000 |
3.077 |
39 |
Adults
(50+ years) |
8 |
0.043 |
70.0000 |
3.022 |
38 |
Females
(13-49 years) |
8 |
0.043 |
61.0000 |
2.595 |
32 |
[[Page 40906]]
Table
4.--Aggregate Exposure and Risk Estimates for Skeletal Fluorosis
Based on Analysis by the Institute of Medicine of the National
Academies |
Population
Subgroup |
IOM- selected
NOAEL, mg/ day |
Total Fluoride
Exposure, mg/kg/day |
Body Weight,
kg |
Total Fluoride
Exposure, mg/day |
Risk, %
of IOM- selected NOAEL |
U. S. population
(total) |
10 |
0.049 |
70 |
3.399 |
34 |
Infants
(< 1 year) |
10 |
0.209 |
7 |
1.462 |
15 |
Children
(1-2 years) |
10 |
0.110
|
13 |
1.427 |
14 |
Children
(3-5 years) |
10 |
0.086 |
22 |
1.891 |
19 |
Children
(6-12 years) |
10 |
0.054
|
40 |
2.168 |
22 |
Youth (13-19
years) |
10 |
0.038
|
60 |
2.254 |
23 |
Adults
(20-49 years) |
10 |
0.044 |
70 |
3.077
|
31 |
Adults
(50+ years) |
10 |
0.043 |
70 |
3.022 |
30 |
Females
(13-49 years) |
10 |
0.043 |
61 |
2.595 |
26 |
3. Short-term risk. Short-term aggregate
exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Sulfuryl fluoride is not registered for use
on any sites that would
result in residential exposure. Therefore, the aggregate
risk is the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
Residential exposure could occur with fluoride
anion. However, as
stated above, the endpoint of concern for fluoride anion has been
identified as crippling skeletal fluorosis, which is a chronic effect.
Therefore, fluoride anion is not expected
to pose a short-term risk.
4. Intermediate-term risk. Intermediate-term
aggregate exposure
takes into account residential exposure plus chronic exposure to
food
and water (considered to be a background exposure level).
Sulfuryl fluoride is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is
the
sum of the risk from food and water, which do not exceed the Agency's
level of concern.
Residential exposure could occur with fluoride anion. However, as
stated above, the endpoint of concern for fluoride anion has been
identified as crippling skeletal fluorosis, which is a chronic effect.
Therefore, fluoride anion is not expected
to pose an intermediate-term risk.
5. Aggregate cancer risk for U.S. population.
Sulfuryl fluoride has
been classified as ``not likely to be carcinogenic to humans'' and
there is no evidence showing an increased
risk of cancer following
exposure to fluoride. Therefore, EPA
has not conducted an aggregate
assessment of cancer risk for either sulfuryl fluoride or fluoride
anion.
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, and to infants and children from aggregate
exposure to sulfuryl fluoride and fluoride anion residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology is available to enforce the
tolerance expression. The method may be requested
from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905;
e-mail
address: residuemethods@epa.gov.
B. International Residue Limits
There are no CODEX MRLs established for sulfuryl fluoride or
fluoride anion.
V. Conclusion
Therefore, the tolerance is established for residues of sulfuryl
fluoride in or on all processed food commodities where a separate
tolerance is not already established at 2.0 ppm; cattle, meat, dried
at
0.01 ppm; cheese at 2.0 ppm;
[[Page 40907]]
cocoa bean, postharvest at 0.2 ppm; coconut, postharvest at 1.0
ppm;
coffee, postharvest at 1.0 ppm; cottonseed, postharvest at 0.5 ppm;
eggs, dried at 1.0 ppm; ginger, postharvest at 0.5 ppm; ham at 0.02
ppm; herbs and spices, group 19 postharvest at 0.5 ppm; milk, powdered
at 2.0 ppm; nut, pine, postharvest at 0.2 ppm; peanut, postharvest
at
0.5 ppm; rice, flour, postharvest at 0.05 ppm; and vegetables, legume,
group 6, postharvest at 0.5 ppm. In addition, tolerances are estalished
for residues of fluoride anion in or on all processed food commodities
where a separate tolerance is not already established at 70 ppm;
cattle, meat, dried at 40 ppm; cheese at 5.0 ppm; cocoa bean,
postharvest at 20 ppm; coconut, postharvest at 40 ppm; coffee,
postharvest at 15 ppm; cottonseed, postharvest at 70 ppm; eggs,
dried
at 900 ppm; ginger, postharvest at 70 ppm; ham at 20 ppm; herbs
and
spices, group 19 postharvest at 70 ppm; milk, powdered at 5.0 ppm;
nut,
pine, postharvest at 20 ppm; peanut, postharvest at 15 ppm; rice,
flour, postharvest at 45 ppm; and vegetables, legume, group 6,
postharvest at 70 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also
request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear
in
40 CFR part 178. Although the procedures
in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA,
EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement
of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However,
the period
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection
or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this
unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2005-0174 in the subject line on the
first page of your submission. All requests must be in writing,
and
must be mailed or delivered to the Hearing Clerk on
or before September
13, 2005.
1. Filing the request. Your objection
must specify the specific
provisions in the regulation that you object to, and the grounds
for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on
which a
hearing is requested, the requestor's contentions on such issues,
and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of
that
information as CBI. Information so marked will not be disclosed
except
in accordance with procedures set forth in 40 CFR part 2. A copy
of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office
of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to
the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from
8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition
to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A.,
you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2005-0174, to: Public
Information and Records Integrity Branch, Information Resources
and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy
of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form
of
encryption. Copies of electronic objections and hearing requests
will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit
an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for
a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There
is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor
would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner
sought
by the requestor would be adequate to justify the action requested
(40
CFR 178.32).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office
of
Management and Budget (OMB) has exempted these types of actions
from
review under Executive Order 12866, entitled Regulatory Planning
and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack
of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy
Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule
does
not contain any information collections subject to OMB approval
under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described
under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public
Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental
Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action
does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of
1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in
this
final rule, do not require the issuance of a proposed rule,
[[Page 40908]]
the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C.
601
et seq.) do not apply. In addition, the Agency has determined that
this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or
on the
distribution of power and responsibilities among the various levels
of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA
to
develop an accountable process to ensure ``meaningful and timely
input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or
on the
distribution of power and responsibilities among the various levels
of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency
has
determined that this rule does not have any ``tribal implications''
as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (59 FR 22951, November
6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials
in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects
on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power
and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government
and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply
to
this rule.
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by
the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the
rule,
to each House of the Congress and to the Comptroller General of
the
United States. EPA will submit a report containing this rule and
other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States
prior
to publication of this final rule in the Federal Register. This
final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 1, 2005
Lois Rossi,
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.
• 3. Section 180.145 is amended by adding alphabetically the
following
commodities to the table in paragraph (a)(3) to read as follows:
Sec. 180.145 Flourine compounds; tolerances
for residues.
(a) * * *
(3) * * *
Commodity
|
Parts per
million |
All processed
food commodities not otherwise listed |
70 |
Cattle,
meat, dried |
40 |
Cheese |
5.0 |
Cocoa bean,
postharvest |
20 |
Coffee,
postharvest |
15 |
Coconut,
postharvest |
40 |
Cottonseed,
postharvest |
70 |
Eggs, dried
|
900 |
Ginger,
postharvest |
70 |
Ham |
20 |
Herbs and
spices, group 19, postharvest |
70 |
Milk, powdered |
5.0 |
Nut, pine,
postharvest |
20 |
Peanut,
postharvest |
15 |
Rice, flour,
postharvest |
45 |
Vegetables,
legume, group 6, postharvest |
70 |
• 5. Section 180.575 is amended by alphabetically adding
the following
commodities to the table in paragraph (a)(1) to read as follows:
Sec. 180.575 Sulfuryl fluoride; tolerances
for residues.
(a)(1) General. * * *
Commodity
|
Parts per
million |
All processed
food commodities not otherwise listed |
2.0 |
Cattle,
meat, dried |
0.01 |
Cheese |
2.0 |
Cocoa bean,
postharvest |
0.2 |
Coconut,
postharvest |
1.0 |
Coffee,
postharvest |
1.0 |
Cottonseed,
postharvest |
0.5 |
Eggs, dried
|
1.0 |
Ginger,
postharvest |
0.5 |
Ham |
0.02 |
Herbs and
spices, group 19, postharvest |
0.5 |
Milk, powdered |
2.0 |
Nut, pine,
postharvest |
0.2 |
Peanut,
postharvest |
0.5 |
Rice, flour,
postharvest |
0.05 |
Vegetables,
legume, group 6, postharvest |
0.5 |
* * * * *
[FR Doc. 05-13982 Filed 7-14-05; 8:45 am]
BILLING CODE 6560-50-S
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