United States Environmental Protection Agency
Washington DC 20460
Office of Prevention, Pesticides
and Toxic Substances
[Undated: received June 4, 2005. EPA informed
FAN that the letter should have been dated June 2, 2005]
Fluoride Action Network
82 Judson Street
Canton, New York 13617
Jay Feldman
Executive Director
Beyond Pesticides/National Coalition Against the Misuse of
Pesticides
701 E Street, SE
Washington, DC 2003
Re: Objections and Request for a Hearing
Concerning Sulfuryl Fluoride Tolerances
Dears Sirs and Madam:
This letter relates to the objections and request
for a hearing that were filed by the Fluoride Action Network
("FAN") and Beyond Pesticides/National Coalition
Against the Misuse of Pesticides [For the sake of brevity
the objecting parties are referred to throughout the balance
of this letter as "FAN."] with EPA on March 23,
2004, in regard to the establishment of various pesticide
tolerances for sulfuryl fluoride under section 408 of the
Federal Food, Drug, and Cosmetic Act ("FFDCA"),
§ 346a. In your Objection/Hearing Request, you listed
numerous issues on which you seek an administrative hearing.
Although EPA is still considering whether to grant your hearing
request, EPA can identify, at this point, several issues included
in the hearing request that either appear not to meet regulatory
requirements or are not even phrased as issues but rather
as questions to EPA. The purpose of this letter is
(1) to provide you with notice of the issues
we have preliminarily determined not to meet the requirements
for a hearing so that you may cure any deficiency, if you
so choose;
(2) to alert you to the requirement to submit
reports and articles relied upon in your hearing request;
and
(3) to provide answers to questions you have
raised. We ask that you respond to this letter within 90
days from receipt.
Pursuant to section 408(g)(2) of the FFDCA,
any person may file an objection to EPA establishment of a
pesticide tolerance, so long as that objection is filed within
60 days of issuance of the tolerance, and request a public
evidentiary hearing on the objection. EPA regulations prescribe
the form and manner of hearing requests. According to 40 C.F.R.
§ 178.27, hearing requests must:
(1) be submitted in conjunction with an objection
to a tolerance;
(2) include a statement of the factual issues
on which a hearing is requested and the requestor's contentions
on these issues;
(3) include a copy of any report, article,
survey, or other written document upon which the objector
relies to justify an evidentiary hearing;
(4) include a summary of any evidence not
covered by paragraph (3); and
(5) include a discussion of the relationship
between the factual issues and the relief requested by the
objection.
EPA is directed to hold an evidentiary hearing
"if and to the extent [EPA] determines that such a public
hearing is necessary to receive factual evidence relevant
to material issues of fact raised by the objections."
21 U.S.C. § 346a(g)(2)(B). EPA regulations further describe
those issues that are appropriate for review at a public evidentiary
hearing. According to 40 C.F.R. § 178.32(b), a
hearing will only be granted if the material submitted by
the requestor shows that all of the following three conditions
are met:
(1) There is genuine and substantial issue
of fact for resolution at a hearing. An
evidentiary hearing will not be granted on issues of policy
or law.
(2) 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 requetor, taking into account uncontested
claims or facts to the contrary. An evidentiary hearing
will not be granted on the basis of mere allegations, denials,
or general descriptions of positions and contentions, nor
if the Administrator concludes that the data and information
submitted, even if accurate, would be insufficient to justify
the factual determinations urged.
(3) Resolution of the
factual issue(s) in the manner sought by the person requesting
the hearing would be adequate to justify the action requested.
An evidentiary hearing will not be granted on factual issues
that are not determinative with respect to the action requested.
For example, a hearing will not be granted if the Administrator
concludes that the action would be the same even if the
factual issues were resolved in the manner sought.
40 C.F.R. § 178.32(b)(1b) - (3).
As noted above, several of the issues for which
a hearing is requested are framed as questions to EPA, not
as disputed matters of fact. The purpose of a hearing is to
resolve genuine and substantial issues of fact that are disputed
by the parties, not to discover if such issues exist. To clarify
whether a disputed factual issue exists, EPA has attempted
below to answer FAN's questions with this letter. In its reply,
FAN can indicate whether it believes there is a disputed matter
with regard to the issue that meets the criteria for a hearing
stated above. In addition to answering FAN's questions, EPA
has also identified those issues that, while presented as
a disputed matter, appear not to be appropriate for a hearing
either because they do not concern a genuine and substantial
issue of fact or because FAN has not shown that there is a
reasonable possibility that available evidence identified
by the FAN would, if established, resolve one or more such
issues in FAN's favor. Finally, EPA also calls to FAN's attention
the requirement in 40 C.F.R. § 178.27(c) that the requestor
of a hearing submit a copy of "any report, article, survey,
or other written document" upon which the requestor relies.
To date, no determination has been made that
a hearing is appropriate as to any issue. These matters are
still under consideration.
FAN Questions
1. Use of Fluoride as an Inert Ingredient.
(FAN Objection No. 8). FAN has stated that sodium fluoride
is approved for use in pesticides as a "List 4-B Inert."
FAN has identified 198 pesticides that have tolerances on
commodities that may be treated with sulfuryl fluoride and
asks:
(a) Is sodium fluoride approved for use as a
List 4-B inert in any or all of these 198 pesticides?
EPA Response: Sodium fluoride is not an approved
inert ingredient in any pesticide product containing the 198
pesticides listed by FAN. Sodium fluoride does appear as an
impurity in two pesticide products and exposure to fluoride
as a result of use of these pesticide products has been taken
into account by the aggregate exposure assessment for sulfuryl
fluoride. Because issues involving impurities may involve
Confidential Business Information (CBI), EPA cannot release
any more information without ascertaining whether any CBI
claims are involved.
(b) Has EPA caluclated the levels of fluoride
that may result in food from use of sodium fluoride as a List
4-B inert?
EPA response: See response to (a) above.
(c) Has EPA ever tested crops treated with pesticide
containing sodium fluoride as a List 4-B inert ingredient
for fluoride residues?
EPA Response: See response to (a) above.
(d) Has EPA ever tested crops treated with cryolite
for fluoride residues? If so, has EPA released the results
to the public?
EPA Response: EPA has extensive data on fluoride
residues resulting from treatment of crops with cryolite.
Cryolite residues on crops are measured as fluoride and these
levels of fluoride are used in estimating aggregate fluoride
exposure. These issues are discussed in the following enclosed
memoranda. [See
Enclosures 1 at pp. 18-26 and
pp. 45-48; 2 at pp. 4-13; 3
at pp. 7-10; and 4 at pp. 26-28].
(e) Does EPA know whether fluoride residues
can result from fluorinated pesticides (FAN identifies 31
of the 198 pesticides as fluorinated)?
EPA Response: Generally speaking, EPA believes
that fluoride residues are unlikely to result from the use
of fluorinated pesticides due to the nature of the covalent
carbon-fluorine bond that occurs in most fluorinated pesticide
molecules. A review of the metabolism studies that have been
submitted for the fluorinated pesticides in question would
be required to definitively determine whether or not residues
of fluoride per se might result from the use of fluorinated
pesticides. Further data review would be required to then
determine if any fluoride residues occur at biologically significant
levels. As a screen to estimate the exposure to fluoride that
may occur from fluorinated pesticides, scientists in the Health
Effects Division of the Office of Pesticide Programs ("OPP")
have searched the toxicology databases in OPP for references
to a finding of fluorosis. The only compounds for which fluorosis
is noted are sulfuryl fluoride and cryolite. Since toxicology
studies typically include exposure levels that are far in
excess of that which would be experienced by humans, EPA is
confident that the lack of findings of fluorosis provides
strong evidence that any fluoride residues occurring from
the use of these pesticides are insignificant in comparison
to exposure from sulfuryl fluoride or cryolite. The fungicide
tolyfluanid provides an example of this. Studies with tolyfluanid
show that fluoride may be released during the metabolism of
the parent compound and toxicology studies show that fluoride
levels do, in fact, increase in the teeth and bones of test
organisms. However, the increase is well below levels that
are known to cause fluorosis. Fluorosis was looked for in
these studies and was not observed (Joint FAO/WHO Meeting
on Pesticide Residues, 2002 - Tolyfluanid). If FAN has further
questions regarding potential fluoride exposure from fluorinated
pesticides, EPA can make available metabolism studies for
these pesticides.
2. Corn Grits Tolerance Level. (FAN Objection
No. 8). Is the 15.0 ppm tolerance for sulfuryl fluoride on "corn,
field, grits, postharvest" an error?
Response: The tolerance petition requested a tolerance
for processed corn, field, grits at 0.01 ppm. Upon re-examination
of the data, it is apparent that the 15.0 ppm tolerance value
is an error. The residue study lists a maximum residue of 14.4
ppb (parts per billion). [See
Enclosures 5 at p 9;
6 at p 9; and 7 at p. 9]
This value was mistakenly carried forward in the review process
as 14.4 ppm. The data support a tolerance of 0.02 ppm
and the tolerance for corn, field, grits will be corrected as
part of EPA's response to the objections filed by FAN. [See
Enclosure 5].
3. Sorghum Grain Tolerance. (FAN Objection
No. 8). Will sulfuryl fluoride be used on "Sorghum, grain"
only, or will it be used also on the category: "Sorghum,
grain, grain?"
Response: The tolerance regulation is imprecise
here and will be corrected as part of EPA's response to the
objections filed by FAN. Grain sorghum (or sorghum, grain) is
the overall crop under EPA's commodity definitions. Grain sorghum
is divided into four raw agricultural commodities: forage (sorghum,
grain, forage); aspirated grain fractions (sorghum, grain, aspirated
grain fractions); stover (sorghum, grain, stover); and grain
(sorghum, grain, grain) [See Enclosure
8 at p. 30, Table 1]. Sulfuryl
fluoride is only registered as a fumigant on the commodity grain
produced from grain sorghum and thus the tolerance should have
read "sorghum, grain, grain." [See
Enclosure 9, Proposed Label at
p. 5].
4. Use of Cryolite on Grapes. (FAN Objection
No. 9). How many times can various cryolite products be applied
to grapes?
Response: The label allows up to 5 applications
per year and states that the total application rate cannot exceed
20 lb ai/A/year. The maximum single application rate is 9.6
lb ai/A. [See
Enclosure 10 at p. 8].
5. Cryolite Grape Tolerance and Multiple Cryolite
Applications. (FAN Objection No. 9). Does each application
of cryolite to grapes have an individual tolerance of 7 ppm
or is 7 ppm the legal limit no matter how many applications
of cryolite?
Response: The legal limit for cryolite on raisins
is 7 ppm. Although EPA through use of crop field residue trials
considered the number of applications and application amount,
as specified on the label, in approving the tolerance level,
the established level defines what amount of residue may remain
in food regardless of what application pattern is followed.
6. Use of Sulfuryl Fluoride on Raisins.
(FAN Objection No. 9). How many times can sulfuryl fluoride
be applied to raisins?
Response: The label permits sequential fumigations
but limits the maximum cumulative dosage to 1500 oz-h/1000 cu
ft. If fumigations are made with the commodity under reduced
pressure, the total rate cannot exceed 200 mg hr/L (200 oz hr/1000
ft3). [See
Enclosure 9, Proposed Label at
pp. 6 and 10].
7. Total Fluoride Residue on Raisins. (FAN
Objection No. 9). What is the total fluoride residue that EPA
has calculated for raisins? If fluoride residues on grapes from
cryolite can be 7 ppm, residues would be expected to be 2X to
6X greater.
Response: The current tolerance for cryolite on
grapes is 7 ppm. 40 CF.R. § 180.145. That tolerance would
apply to raisins produced from treated grapes. See 21
U.S.C. § 346a(a)(2). In the Reregistration Eligibility
Decision (RED) for cryolite, EPA determined that fluoride residues
from cryolite did have the potential to concentrate in raisins
produced from cryolite-treated grapes [See
Enclosure 1 at p. 26]. The
RED found the concentration factor to be 10X and recommended
a raisin tolerance of 55 ppm. EPA's current view is that this
concentration factor is in error because it exceeds the maximum
theoretical concentration factor in producing raisins of 4.5X.
Maximum theoretical concentration factors are calculated by
dividing the mass of the processed product into the mass of
the raw agricultural commodity. Assuming that all of the pesticide
on the treated raw agricultural commodity remains in the processed
food, the actual degree of concentration of the pesticide in
the processed food cannot be higher than the maximum theoretical
concentration factor. EPA plans to correct the cryolite tolerances
in the future.
Additionally, EPA did not include the higher levels
of fluoride that may be in raisins as a result of treatment
with cryolite in the fluoride risk assessment prepared for the
sulfuryl fluoride tolerance action. [See
Enclosure 4 at p. 27, Table 4.2.1.3].
To correct this error, EPA has recalculated exposure expected
from fluoride from cryolite in raisins using a residue level
for raisins that reflects both the concentration of fluoride
that may occur upon drying (4.5X) and the removal that results
from washing (0.3X). [See
Enclosure 11 at p. 7]. This
reanalysis yields chronic dietary exposure estimates for fluoride
from cryolite that are, at most, 6.7% higher for all population
subgroups. [See
Enclosures 3 & 11 (compare
results in Table 8 of each memorandum)]
8. Fluoride Residues on "Dried Fruits."
(FAN Objection No. 9). Do the following fruits fall into the
category of "Dried fruit (except raisin)": apricot,
blackberry, blueberry, boysenberry, cherry, sweet and tart,
cranberry, dewberry, kiwi fruit, loganberry, melon, nectarine,
peach, plum, prune, dried, raspberry, strawberry, youngberry,
figs, dates? Are there any others? (These fruits have fluoride
residue tolerances of 7 ppm on the RAC, except kiwi fruit which
is 15 ppm from the use of cryolite.) Has EPA calculated total
fluoride residues from both cryolite and sulfuryl fluoride?
Has EPA taken into account that fluoride residues on dried fruit
would concentrate between 2X and 6X?
Response: Any commodity that meets the common
meaning of the term "fruit" and has been dried would
qualify under EPA regulations as a "dried fruit."
In conducting its dietary exposure assessment, the Agency included
residues for all dried fruit commodities in the dietary exposure
modeling software. These are the commodities with reported consumption
in the Continuing Surveys of Food Intakes by Individuals (CSFII)
and include apricot, cranberry, currant, raisin, peach, and
plum. [See
Response in No. 9 infra
for further information concerning the CSFII]. Since
this food survey is designed to be a comprehensive examination
of food consumption, the fact that a particular food form is
not captured in the survey suggests that consumption of the
food form is, at most, a very minor component of the diet.
Further, EPA calculated fluoride residues resulting
from use of cryolite and sulfuryl fluoride. [See
Enclosure 2 at 20-29]. As
to potential concentrations of fluoride in dried fruit from
treatment of the raw commodity with cryolite, EPA included concentration
factors of 6X for dried apricots, 7X for dried peaches, and
5X for dried plums (prunes). [See
Enclosure 11 at p. 9, Table 3].
No concentration factors were used for the dried commodities
cranberry and currant. Concentration factors were not available
for these two commodities. Within the CSFII database for the
general U.S. population, dried cranberry accounts for less than
0.3% of the total dried fruits consumption and dried currant
for less than 0.02%. In terms of the total diet, these percentages
of consumption would be significantly less than that. Given
the low consumption of these dried froms, EPA believes that
the lack of a processing factor for them does not result in
any meaningful effect on the estimation exposure to fluoride.
For sulfuryl fluoride the application is to the
dried fruit, not the fruit prior to drying, so concentration
is not an issue.
9. High End Consumers of Dried Fruit. (FAN
Objection No. 9). Has EPA factored into its assessment high
end users of dried fruit such as outdoor enthusiasts and school
children?
Response: In conducting its dietary assessment,
the Agency has used the Food Commodity Intake Database version
of the Dietary Exposure Evaluation Model (DEEM-FCID). This model
uses the food consumption information contained in the CSFII
databases from surveys conducted in 1994, 1995, 1996, and 1998.
That survey is under the administration of the U.S. Dept. of
Agriculture, Agricultural Research Service. The surveys included
a target population of noninstitutionalized individuals from
all 50 states and the District of Columbia. The 1994-96 and
1998 data are based on the reported food consumption of more
than 20,000 individuals. The CSFII is designed to be representative
of the United States population including major identifiable
population subgroups. The dietary modeling software uses the
demographic and residues in food commodities to derive estimates
of dietary exposure for various population subgroups. For more
information on the CSFII program, see http://www.barc.usda.gov/ghnrc/foodsurvey/
Issues Not Appearing to Meet the Substantive
Requirements for a Hearing Request
The following issues in the FAN objections do
not appear to meet the requirements for an administrative hearing.
We have explained below the reason for this conclusion as to
each of the issues. Unless you can explain why these issues
are proper for resolution in a hearing, EPA intends to deny
a hearing with regard to them. EPA's identification in this
letter of various issues that do not appear to meet the requirements
for a hearing does not preclude EPA from determining that other
issues in FAN's objections have similar flaws. Nor does the
identification of particular flaws below preclude EPA from determining
that the issues listed below have additional flaws not identified
here.
Issue 1. EPA has failed to consider reasonable
alternatives to Dow's use of sulfuryl fluoride. (FAN Objection
No. 7).
FAN argues that there are other safer alternatives
to methyl bromide than sulfuryl fluroide. FAN aserts that
other countries have ended use of methyl bromide and adopted
use of safer fumigants such as steam and carbon dioxide rather
than sulfuryl fluroide. FAN notes that EPA's website identifies
alternatives to methyl bromide other than sulfuryl fluoride.
EPA Response: As EPA's regulations make clear,
"an evidentiary hearing will not be granted on factural
issues that are not determinative with respect to the action
requrested." 40 C.F.R. § 178.32(b)(3). Whether or
not there are safer fumigants than sulfuryl fluoride is not
a relevant issue in determining whether it was proper for
EPA to establishe the sulfuryl tolerances that are subect
of FAN's objections. Subject only to a narrow exception not
applicable to sulfuryl fluoride, section 408 establishes a
risk-only standard for the approval of tolerances. To establish
a tolerance EPA must determine that the tolerance poses a
reasonable certainty of no harm. 21 U.S.C. § 346a(b)(2)(A).
Section 408 does not allow EPA to deny
tolerances to pesticides that meet this safety standard if
other, even-safer pesticides are available. Accordingly,
even if FAN could prove that there are
safer fumigants than sulfuryl fluoride that are equally efficacious,
that showing would not be determinative of FAN's request for
a revocation of the sulfuryl fluoride tolerances.
Issue 2. Sulfuryl fluoride poses an unacceptable
risk to workers. (FAN Objection No. 7).
FAN asserts that the acute toxicity of sulfuryl
fluoride poses an unacceptable risk to workers. FAN claims
that sulfuryl fluoride can damage workers' brains. FAN states
that EPA has no regulatory function to assess the risk to
workers but urges EPA to work with other agencies to regulate
sulfuryl fluoride.
Response: This issue is not appropriate for
a hearing because it also is not determinative of the action
requested. Section 408 specifically dictates that occupational
exposures to pesticides are not a proper consideration in
making a decision on the safety of a tolerance. 21 U.S.C.
§ 346a(b)(2)(D)(vi). FAN, however, is incorrect to claim
that EPA has no regulatory authority with regard to workers
exposed to pesticides. Under the Federal Insecticide, Fungicide,
and Rodenticide Act ("FIFRA"), 7 U.S.C. § 136
et seq., EPA is charged with taking into account "the
economic, social, and environmental costs" of pesticides.
One of the potential costs of pesticides is harm to pesticide
handlers and applicators from occupational exposure to pesticides.
Risks to pesticide handlers and applicators are routinely
considered during the pesticide registration process under
FIFRA and were considered in approving the sulfuryl fluoride
registration. [See Enclosure 4,
pp. 38-40]
Issue 3. It is confusing to have pistachio in
a separate category from "nut, tree, group." (FAN
Objection No. 8.)
Response: This issue is not proper for a hearing
because it is not an appropriate objection to the sulfuryl
fluroide tolerance rulemaking. The exclusion of pistachio
from the Crop Group 14 - Tree Nuts is based on a long-existing
regulation. See 40 C.F.R. § 180.41. The existing
crop group regulation may not be challenged through a procedure
allowing an administrative review of a separate current action
(i.e. the establishment of the sulfuryl fluoride tolerances).
In any event, EPA does not believe its crop group regulations
are confusing. Crop groups have been established by EPA to
facilitate the establishment of tolerances for related crops
that have similar proposed or registered pesticide application
patterns. The regulation defining Crop Group 14 - Tree Nuts
clearly does not list pistachio as one of the included crops.
40 C.F.R. § 180.41(b)(14). A pesticide tolerance established
for the Tree Nuts Crop Group plainly only authorizes pesticide
residues on the tree nuts listed in 40 C.F.R. § 180.41(b)(14).
A pesticide tolerance established for the Tree Nuts Crop Group
plainly only authorizes pesticide residues on the tree nuts
listed in 40 C.F.R. § 180.41(b)(14). EPA is reviewing
the commodities included in the various crop groups in section
180.41 and may, in the future, amend Crop Group 14 to include
pistachio. Until such amendment is made, however, the regulation
is clear as to whether pistachio is covered.
Issue 4. EPA must withdraw tolerances for commodities
not addressed in Dow's petition. (FAN Objection No. 10).
FAN argues that because Dow's petition to establish
sulfuryl fluoride and fluoride tolerances on various commodities
did not specifically request tolerances on barley (bran),
barley (flour), barley (pearled), corn (aspirated grain fractions),
oat (flour), and oat (rolled), EPA was not permitted to establish
tolerances on these commodities.
EPA Response: Evidentiary hearings are for the
purpose of resolving genuine and substantial issues of fact.
Evidentiary hearings are not granted on legal issues such
as whether EPA's action on a petition may vary from the action
requested by the petitioner. See 40 C.F.R. § 178.32(b)(1).
There are no disputed facts here. Dow's petition did not request
tolerances on the six commodities listed above. Dow did, however,
request tolerances on the main raw agricultural commodities
associated with each of the six commodities - barley (grain),
corn (grain), and oat (grain). Under FFDCA section 408(d)(4)(A)(I),
EPA is authorized in issuing a tolerance regulation in reponse
to a petition to "vary [the regulation] from that sought
by the petition." Setting tolerances on subsidiary or
processed froms of a commodity when the petition has only
sought a tolerance on the underlying commodity falls well
within EPA's authority to vary from a petition in acting upon
it.
Issue 5. EPA must withdraw tolerances for commodities
where EPA excessively increased the value of the tolerance requested
in Dow's petition (FAN Objection No. 10).
In acting on Dow's petition, EPA set fluoride
tolerances for wheat (flour) and wheat (milled byproducts)
at 125 ppm and 130 ppm, respectively. Dow had petitioned for
tolerances of 10 ppm on wheat (flour) and 35 ppm on wheat
(milled byproducts). FAN contends these increases are excessive
but provides no explanation as to why that is the case.
EPA Response: EPA's regulations make clear that
"[a]n evidentiary hearing will not be granted on the
basis of mere allegations, denials, or general descriptions
of positions and contentions . . . ." 40 C.F.R. §
178.32(b)(2). FAN's hearing request regarding this issue is
unsupported by any factual allegations. As such, EPA does
not believe a hearing is appropriate. By way of explanation,
EPA would note that it varied the level of the tolerances
for these two commodities from the level requested by Dow
based on residue data showing that the higher values were
needed to legalize levels that could result from intended
use. [See
Enclosures 5 and
7].
Issue 6. EPA has no statutory authority or guidance
to accept RfDs from other agencies or divisions in EPA. (FAN
Objections, Appendix G, p. 1).
FAN contends EPA's Office of Pesticide Programs
abrogated its responsibility to determine a RfD for fluoride
using its "own methodology" and instead relied on
an RfD from another division in EPA. FAN claims the Office
of Pesticide Programs has no "statutory authority or
internal guidance allowing it to take RfDs from other agencies
or divisions of the EPA."
Response: Evidentiary hearings are for the purpose
of resolving genuine and substantial issues of fact. Evidentiary
hearings are not granted on legal issues such as the scope
of EPA's statutory authority. See 40 C.F.R. §
178.32(b)(1).
Issue 7. EPA has short-circuited the risk assessment
process and FAN is requesting a hearing to correct this error.
(FAN Objections, Appendix G, p. 2).
FAN claims that the Office of Pesticide Programs
("OPP") short-circuited the risk assessment process
by relying on the Maximum Contaminant Limit (MCL) for fluoride
promulgated by EPA's Office of Water. FAN asserts that even
if OPP can legally rely on the MCL, a hearing is necessary
to give FAN "the opportunity to question the RfD, on
the same basis as if it had been prepared by OPP." FAN
states that "the requirement that OPP's methods and decision
be transparent cannot be waived just because the OPP used
the work of a different department."
Response: This hearing request is faulty because
it seeks a hearing on legal issues (e.g., Can EPA waive steps
in the risk assessment process?) and as a means of gaining
information on the basis of EPA's decision. As noted above,
hearings are not granted on legal issues. Further, hearings
are granted for the purpose of resolving genuine, disputed
issues of fact; not for the purpose of investigating whether
disputed issues of fact exist.
Issue 8. EPA should protect 99.9 percent of the
public from chronic risks. (FAN Objections, Appendix G, pp.
4-6).
FAN claims that the FFDCA requires that EPA
protect at leat 99.9 percent of the population from chronic
risks of pesticides.
Response: This is a legal issue and as such,
is not appropriate for an evidentiary hearing. Further, EPA
would note that FAN appears to have misunderstood the purpose
in using population percentiles of exposure in estimating
risk. EPA does not use such percentiles as a means of defining
the percentage of the population that deserves protection
but rather as a way of estimating exposure for the overall
population and major identifiable subgroups taking into account
the degree of conservatism present in various exposure values
and risk assessment methodologies. [See
Enclosure 13].
Issue 9. EPA has failed to protect the following
subpopulations: (a) People with kidney disease such as diabetes
who drink lots of water; (b) People over 50 who excrete less
fluoride; (c) People who live in areas with water with naturally
high fluoride levels; (d) Nursing age infants; (e) Formula fed
infants; (f) People exposed occupationally; (g) Children who
swallow most of their toothpaste; (h) People who are given fluoride
dental products such as mouthwashes; (I) Athletes, and others,
who exercise more and consume more water; (j) People whose diets
include many high fluoride foods; (k) People living near active
volcanic areas; and (l) People who stockpile food. (FAN Objections,
Appendix G. pp 6-8).
FAN argues that each of these subgroups is likely
to have higher exposures. Except with regard to children swallowing
most of their toothpaste, FAN cites no data or reports to
support these allegations. As to chidren's exposure to toothpaste,
elsewhere in its hearing requet, FAN does reference studies
bearing on fluoride expsoure from toothpaste. It is not clear
as to whether these cited data address the amount of toothpaste
swallowed by children.
Compliance with the Requirement to Submit All
Written Material Relied Upon
EPA regulations make clear that for a hearing
request to be considered by the Agency, the request must "include
a copy of any report, article, survey, or other written document
(or the pertinent pages thereof) upon which the objector relies
to justify an evidetiary hearing, unless the document is an
EPA document that is routinely available to any member of the
public." 40 C.F.R. § 178.27(c). This requirement is
mandatory and failure to comply is grounds for denial of the
hearing request. Although FAN has attached copies of a few of
the reports on which it relies to justify its hearing request,
it cites to hundreds of other reports and documents that have
not been submitted. Until FAN submits copies of all these documents
EPA cannot proceed other than to deny the hearing request.
Conclusion
At the present time, EPA is still considering
whether to grant your hearing request. This letter, among other
things, describes various flaws in your hearing request which
may result in a denial of a hearing as to some or all of the
issues you have raised. If you wish to respond to this letter,
we request that that response be made 90 days from receipt.
Such response should be sent to EPA at:
Public Information and Records Integrity Branch,
Information Resources and Services Division (7502C)
Docket ID No. OPP-2003-0373
Offrice of Pesticide Programs
U.S. EPA
1200 Pennsylvania Ave., NW
Washington, DC 20460-0001
A copy should be sent to:
Jonathan Fleuchaus (2333A)
Office of General Counsel
U.S. EPA
1200 Pennsylvania Ave., NW
Washington, DC 20460-0001
If you have questions concerning this letter or
need additional time to prepare a response please contact Jonathan
Fleuchaus in EPA's Office of General Counsel. He can be reached
by telephone at (202) 564-5628 or by email at fleuchaus.jonathan@epa.gov
Sincerely
James J. Jones
Director, Office of Pesticide Programs
Enclosures:
1. U.S. EPA, Reregistration Eligibility Decision,
Cryolite (August 1996)
[Note: EPA sent FAN a hard copy.
It is also available online at
http://www.epa.gov/oppsrrd1/REDs/0087.pdf]
2. U.S. EPA, Memorandum from David Soderberg to
Deborah McCall, Cryolite (List A). Summary of Issues on Tolerance
Reassessment, Including Reassessment of Tolerances on Stone
Fruits and Reassessment of the Time-Limited Tolerances for Potato
and Potato Waste, with a Revised Dietary Exposure Assessment
(December 18, 2001).
3. U.S. EPA, Memorandum from Michael Doherty and
David Soderberg to Michael Doherty, Chronic Dietary Exposure
Assessments for Sulfuryl Fluoride and Fluoride Anion, Addressing
the Section 3 Registration of Sulfuryl Fluoride on Stored Cereal
Grains, Grain Processing Facilities, Dried Fruits, and Tree
Nuts (January 13, 2004).
4. U.S. EPA, Memorandum from Michael Doherty to
Dennis McNeilly/Richard Keigwin, Human Health Risk Assessment
for Sulfuryl Fluoride and Fluoride Anion Addresing the Section
3 Registration of Sulfuryl Fluoride Post-Harvest Fumigation
of Stored Cereal Grains, Dried Fruits and Tree Nuts and Pest
Control in Grain Processing Facilities. PP#1F6312 (January
20, 2004).
[Note: This was attached to the
Docket of the January 23, 2004, Final Rule. Available
online at
http://www.fluorideaction.org/pesticides/sf.jan.20.2004.epa.docket.pdf]
5. U.S. EPA, Memorandum from Michael Doherty to
Dan Keny/Meredith Laws. PP#1F06312 - Sulfuryl Fluoride. Section
3 Registration for the Post-harvest Fumigation of Stored Cereal
Grains, Dried Fruits, and Tree Nuts, and Fumigation of Grain
Milling Establishments. Corrected Summary of Analytical Chemistry
and Residue Data (October 12, 2004).
6. U.S. EPA, Data Evaluation Report, Sulfuryl
Fluoride/078003 (October 14, 2004).
7. U.S. EPA, Memorandum from Michael Doherty to
Dennis McNeilly/Kerry Leifer. PP#1F06312 - Sulfuryl Fluoride.
Section 3 Registration for the Post-harvest Fumigation of Stored
Cereal Grains, Dried Fruits, and Tree Nuts, and Fumigation of
Grain Milling Establishments. Summary of Analytical Chemistry
and Residue Data (January 13, 2004).
8. EPA, Residue Chemistry Guidelines: OPPTS
860.1000 Background (August 1996).
9. EPA, Notice of Pesticide Registration, Profume
Gas Fumigant (Reg. No. 62719-376) (January 26, 2004).
10. Label, Kryocide (May 15, 2003).
[Note: EPA sent FAN a hard copy.
What EPA sent differs from the following label. Both have the
same Registration No. (4581-116). FAN is including the following
for information purposes only.
EPA Specimen Label at http://www.fluorideaction.org/pesticides/msds/cryolite.label.kryocide.epa.pdf
Material Safety Data Sheet at http://www.fluorideaction.org/pesticides/msds/cryolite.kryocide.pdf
]
11. U.S. EPA, Memorandum from Michael Doherty
to Michael Doherty, Corrected Chronic Dietary Exposure Assessments
for Sulfuryl Fluoride and Fluoride Anion, Addressing the Section
3 Registration of Sulfuryl Fluoride on Stored Cereal Grains,
Grain Processing Facilities, Dried Fruits, and Tree Nuts. PP#1F6312
(October 12, 2004).
12. U.S. EPA, Memorandum from Michael Doherty
to Dennis McNeilly/Richard Keigwin, Corrected Human Health
Risk Assessment for Sulfuryl Fluoride and Fluoride Anion Addressing
the Section 3 Registration of Sulfuryl Fluoride Post-Harvest
Fumigation of Stored Cereal Grains, Dried Fruits and Tree Nuts
and Pest Control in Grain Processing Facilities. PP#1F6312
(October 12, 2004).
13. Office of Pesticide Programs, U.S. EPA, Choosing
a Perrcentile of Acute Dietary Exposure As A Threshold of Regulatory
Concern (March 16, 2000).
