Sulfuryl fluoride; Pesticide Tolerance, 40899-40908 [05-13982]
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Federal Register / Vol. 70, No. 135 / Friday, July 15, 2005 / Rules and Regulations
17. Section 80.604 is amended by
removing and reserving paragraph(d)(5).
I 18. Section 80.613 is amended by
revising paragraph (a)(1) introductory
text to read as follows:
I
§ 80.613 What defenses apply to persons
deemed liable for a violation of a prohibited
act under this subpart?
(a) * * *
(1) Any person deemed liable for a
violation of a prohibition under
§ 80.612(a)(1)(i), (a)(1)(iii), (a)(2), or
(a)(3), will not be deemed in violation
if the person demonstrates all of the
following, as applicable:
*
*
*
*
*
[FR Doc. 05–13781 Filed 7–14–05; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2005–0174; FRL–7723–7]
Sulfuryl fluoride; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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
https://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.,
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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
(https://www.epa.gov/edocket/), you may
access this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 180 is available at E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr/. To access the
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40899
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines athttps://www.epa.gpo/
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.
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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
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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;
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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 noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (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
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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
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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
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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. 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 fooduse 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),
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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
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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 overestimation 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
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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 × 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
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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 nonoccupational, 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
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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 https://www.epa.gov/
pesticides/cumulative/.
D. Safety Factor for Infants and
Children
1. In general. Section 408 of FFDCA
provides that EPA shall apply an
additional tenfold margin of safety for
infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the 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
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40903
quantitative nor qualitative evidence of
increased susceptability of fetuses to in
utero; exposure to sulfuryl fluoride was
observed. In the sulfuryl fluoride 2generation 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
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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 longterm 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, intermediateterm, 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
cPAD, mg/
kg/day
Population Subgroup
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
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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
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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:
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TABLE 2.–ESTIMATED AGGREGATE EXPOSURE TO FLUORIDE ANION BY SOURCE
From Sulfuryl Fluoride mg/kg/
day
From Cryolite mg/kg/
day
Background
Food 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
Population Subgroup
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
Water mg/
kg/day
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
Tooth-paste
mg/kg/day
Air mg/kg/
day
Total mg/kg/
day
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
Total Allowable Exposure in mg/
day under
MCL
Total
Flouride Exposure, mg/
kg/day
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
Population Subgroup
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Body
Weight, kg
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Total Fluoride Exposure, mg/
day
15JYR1
Risk, % of
Allowable
Exposure
under MCL
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TABLE 3.–AGGREGATE EXPOSURE AND RISK ESTIMATES FOR SKELETAL FLUOROSIS RELYING ON MCL—Continued
Total Allowable Exposure in mg/
day under
MCL
Total
Flouride Exposure, mg/
kg/day
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
Population Subgroup
Body
Weight, kg
Total Fluoride Exposure, mg/
day
Risk, % of
Allowable
Exposure
under MCL
TABLE 4.—AGGREGATE EXPOSURE AND RISK ESTIMATES FOR SKELETAL FLUOROSIS BASED ON ANALYSIS BY THE
INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES
IOM-selected
NOAEL,
mg/day
Population Subgroup
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
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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 intermediateterm 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
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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;
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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
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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 email 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.
PO 00000
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40907
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,
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40908
Federal Register / Vol. 70, No. 135 / Friday, July 15, 2005 / Rules and Regulations
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the
Agency has determined that this action
will not have a substantial direct effect
on States, on the relationship between
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive Order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this rule
does not have any ‘‘tribal implications’’
as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive Order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
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VIII. Congressional Review Act
Commodity
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
Dated: July 1, 2005
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
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.
3. Section 180.145 is amended by
adding alphabetically the following
commodities to the table in paragraph
(a)(3) to read as follows:
I
§ 180.145 Flourine compounds; tolerances
for residues.
(a) * * *
(3) * * *
PO 00000
Frm 00030
Fmt 4700
Parts per million
70
*
*
40
5.0
20
40
15
*
*
*
70
900
*
*
*
*
*
*
*
20
*
*
*
*
*
*
*
*
*
*
*
*
15
45
70
*
*
*
*
5. Section 180.575 is amended by
alphabetically adding the following
commodities to the table in paragraph
(a)(1) to read as follows:
§ 180.575 Sulfuryl fluoride; tolerances for
residues.
*
*
All processed food
commodities not
otherwise listed
*
*
Cattle, meat, dried
Cheese .................
Cocoa bean,
postharvest ........
Coconut,
postharvest ........
Coffee, postharvest
*
*
Cottonseed,
postharvest ........
Eggs, dried ...........
*
*
Ginger,
postharvest ........
Ham ......................
Herbs and spices,
group 19,
postharvest ........
*
*
Milk, powdered .....
Nut, pine,
postharvest ........
*
*
Peanut,
postharvest ........
*
*
Rice, flour,
postharvest ........
*
*
Vegetables, legume, group 6,
postharvest ........
*
*
*
*
*
Parts per million
70
*
20
Sfmt 4700
*
5.0
Commodity
Therefore, 40 CFR chapter I is
amended as follows:
*
70
*
*
(a)(1) General.
I
All processed food
commodities not
otherwise listed
*
*
Cattle, meat, dried
Cheese .................
Cocoa bean,
postharvest ........
Coconut,
postharvest ........
Coffee, postharvest
*
*
Cottonseed,
postharvest ........
Eggs, dried ...........
*
*
Ginger,
postharvest ........
*
*
Ham ......................
Herbs and spices,
group 19,
postharvest ........
*
*
Milk, powdered .....
Nut, pine,
postharvest ........
*
*
Peanut,
postharvest ........
*
*
Rice, flour,
postharvest ........
*
*
Vegetables, legume, group 6,
postharvest ........
*
*
I
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Commodity
Parts per million
*
BILLING CODE 6560–50–S
2.0
*
*
*
0.01
2.0
0.2
1.0
1.0
*
*
*
0.5
1.0
*
*
*
0.5
0.02
0.5
*
*
*
2.0
0.2
*
*
*
*
*
*
*
*
*
*
*
*
0.5
0.05
0.5
*
[FR Doc. 05–13982 Filed 7–14–05; 8:45 am]
\\ALPHA3\E\FR\FM\15JYR1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 135 (Friday, July 15, 2005)]
[Rules and Regulations]
[Pages 40899-40908]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13982]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 (https://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.
To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines athttps://www.epa.gpo/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. 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 https://www.epa.gov/pesticides/
cumulative/.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the 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
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Exposure Exposure Estimated
Population Subgroup cPAD, mg/kg/ (Current (Previous Exposure Risk, %cPAD
day Request), Estimate), (Total), mg/
mg/kg/day mg/kg/day kg/day
----------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
From
Sulfuryl From Back-ground Water mg/kg/ Tooth-paste Air mg/kg/ Total mg/kg/
Population Subgroup Fluoride mg/ Cryolite mg/ Food mg/kg/ day mg/kg/day day day
kg/day kg/day 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
----------------------------------------------------------------------------------------------------------------
Total
Allowable Total Total Risk, % of
Population Subgroup Exposure in Flouride Body Fluoride Allowable
mg/day Exposure, Weight, kg Exposure, Exposure
under MCL mg/kg/day mg/day 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
----------------------------------------------------------------------------------------------------------------
[[Page 40906]]
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
----------------------------------------------------------------------------------------------------------------
Table 4.--Aggregate Exposure and Risk Estimates for Skeletal Fluorosis Based on Analysis by the Institute of
Medicine of the National Academies
----------------------------------------------------------------------------------------------------------------
IOM- Total Total Risk, % of
selected Fluoride Body Fluoride IOM-
Population Subgroup NOAEL, mg/ Exposure, Weight, kg Exposure, selected
day mg/kg/day mg/day 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;
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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 Admi
