PDF of submission (without links)
August 24, 2009
FROM:
Fluoride Action Network
82 Judson Street
Canton NY 13617
Tel: 315-379-9200
Email: pesticides@fluoridealert.org]
TO:
Office of Pesticide Programs
Environmental Protection Agency
Special Review and Reregistration Division (7508P)
1200 Pennsylvania Ave., NW.
Washington, DC 20460-0001
RE: SULFURYL FLUORIDE
Docket ID. EPA-HQ-OPP-2009-0136
Registration Review; Pesticide Dockets Opened for Review and Comment; Closure of
the Terpineols Registration Review Case
Federal Register at
http://www.epa.gov/fedrgstr/EPA-PEST/2009/June/Day-24/p14735.htm
Hitherto we have been very comprehensive in our Objections, and having repeated our
case three times, without any response from the Office of Pesticide Programs (OPP), we
are not going in to ALL the issues as they have been presented in our submissions that
are listed below. However, we will recap a central argument that simply cannot be
denied, or obfuscated by the OPP: their manipulation of the reference dose for fluoride
to give a totally unacceptable level for infants.
It is extremely enigmatic, and a further cause for concern, that the OPP has opened a
Registration Review of Sulfuryl fluoride when it has yet to respond to multiple Objections
(submitted in 2004, 2005); a Petition to revoke all sulfuryl fluoride tolerances submitted
in 2006; two submissions of Consolidated Objections, both requested by EPA, submitted
in 2005 and 2006; in 2009 a submission of 23 published papers reporting an association
of decreased IQ in children and exposure to fluoride. The specifics are as follows:\
• 2002: The first Objection submitted by Fluoride Action Network on Dow
AgroSciences request for tolerances for an Experimental Use Permit
--Objection online at
http://www.fluoridealert.org/pesticides/sulfuryl.f.objections.apr02.htm
EPA responded to this Objection at the same time it issued the first-time tolerances for
sulfuryl fluoride, which were the highest residue tolerances for fluoride in the history of
the EPA, by stating
Because the tolerances that were objected to have now been revoked,
the objections are moot and are denied on that ground.
Ref: Federal Register, January 23, 2004, Sulfuryl Fluoride; Pesticide
Tolerance. http://www.epa.gov/fedrgstr/EPA-PEST/2004/January/Day-23/p1540.htm
EPA then stated,
EPA fully considered, however, all of the Fluoride Action Network's
objections as a part of today's action and has responded to each
significant objection lodged by the Fluoride Action Network.
Ref: Federal Register, January 23, 2004, Sulfuryl Fluoride; Pesticide
Tolerance .http://www.epa.gov/fedrgstr/EPA-PEST/2004/January/Day-23/p1540.htm
EPA’s responses to our 2002 Objections were seriously scientifically flawed. EPA’s
response was a waste of their time, and FAN’s, because they did not allow a resolution
of FAN’s Objections before the first-time tolerances were approved. More importantly,
the tolerances pose a threat to the public.
• 2004: Objections to first-time tolerances for the use of sulfuryl fluoride as a postharvest
fumigant submitted by the Fluoride Action Network and Beyond Pesticides.
(Attachment 2005.objections.pdf)
APPENDIXES (included separately as Attachments to 2004 Objections)
A. Summation of Data on Fluoride & Bone Damage (at Exposure Levels
Relevant to EPA’s Current MCL).
(Attachment 2004.appendix-a.pdf)
B. Fluoride & Bone Damage: Published Data.
(Attachment: 2004.appendix-b.pdf)
C. Translation of Chinese Fetal Bone Study.
(Attachment: 2004.appendix-c.pdf)
D. FAN’s response to EPA’s criticisms of submitted health studies.
(Attachment: 2004.appendix-d.pdf)
E. Translation of Bachinskii Paper.
(Attachment: 2004.appendix-e.pdf)
F. A comparison of a review of animal studies on fluoride’s reproductive
effects by Stan Freni (1994) and the DHHS (1991).
(Attachment: 2004.appendix-f.pdf)
G. Adverse Effects on Male Reproductive System
(Available at:
http://www.fluoridealert.org/pesticides/sf.comments.male.repro.htm
H. Adverse Effects on Brain.
(Available at:
http://www.fluoridealert.org/pesticides/sf.appendix.brain.htm
J. Fluoride Ingestion from Toothpaste.
(Attachment:: 2004.appendix-j.pdf)
K. Objections based on OPP failure to adhere to statutes and guidelines.
(Attachment: 2004.appendix-k.pdf)
1-L. Comparisons of Residue Tolerances: Final vs. Proposed.
(Available at: http://www.fluoridealert.org/pesticides/sf.comparisons.htm
• 2005: Objections to an expansion of sulfuryl fluoride tolerances. These
Objections were submitted by the Fluoride Action Network (FAN), Beyond Pesticides,
and the Environmental Working Group. (Attachment: 2005.objections.pdf)
TABLES (included separately as Attachments to 2005 Submission)
1. Sulfuryl Fluoride: Brain effects from animal studies.
(Attachment: 2005.table.1.brain.pdf)
2. Sulfuryl Fluoride: Thyroid, Adrenal Cortex, Heart, Kidney, Lung effects
from animal studies.
(Attachment: 2005.table.2.sf.non-brain.pdf)
3. Fluoride Studies on Brain effects.
(Attachment: 2005.table.3.brain.studies.pdf)
4. Fluoride Studies on IQ and Behavioral effects.
(Attachment: 2005.table.4.iq.behav.pdf)
5. Fluoride Studies on G-Proteins.
(Attachment: 2005.table.5.g-proteins.pdf)
6. Fluoride Studies on Male Reproductive System effects
(Atachment: 2005.table.6.male.repro.pdf)
• 2005: Supplementary Objection and Request for Hearing submitted in
September by Chris Neurath of Fluoride Action Network.
(Attachment: 2005.supplemental.obj.neurath.pdf)
• 2005: Consolidated Objections, submitted at EPA’s request, by Paul Connett,
Director, Fluoride Action Network; Richard Wiles, Sr. Vice President, Environmental
Working Group; and Jay Feldman, Executive Director, Beyond Pesticides.
(Attachment: 2005.1st.consolidated.pdf)
• 2006: Petition to revoke all sulfuryl tolerances submitted by Perry Wallace, Esq.,
on behalf of the Environmental Working Group, FAN, and Beyond Pesticides.
(Attachment: 2006.petition.revoke.pdf)
• 2006: Second Consolidated Objections, submitted, at EPA’s request, by Perry
Wallace, Esq., on behalf of the Environmental Working Group, FAN, and Beyond
Pesticides.
(Attachment: 2006.2nd.consolidated.pdf)
• 2007: Memorandum. Legal Standard for Grant of Hearings on Objections under
Federal Food, Drug, and Cosmetic Act Section 408, submitted at EPA’s request, by
Perry Wallace, Esq., on behalf of the Environmental Working Group, FAN, and Beyond
Pesticides. January.
(Attachment: 2007.memorandum.pdf)
• 2009: Submission of 23 published papers that found an association of
decreased IQ in children with exposure to fluoride. Perry Wallace, Esq., submitted
these papers to EPA’s Office of Pesticides on behalf of FAN, EWG, and Beyond
Pesticides.
(See http://fluoridealert.org/iq.studies.html for access to pdf copies of these studies.)
FAN has not received any serious response from the OPP to all these submissions -
which have now occupied us for over 7 years – while the use of sulfuryl fluoride -despite
our scientifically valid objections- continues to be used and continues to add to the overexposure
to fluoride of the American people, especially infants and young children.
Incredibly, despite the failure of the OPP in this respect, they now seek to expand the
use of sulfuryl fluoride still further. In addition to the use of hundreds of foodstuffs in
warehouses and processing plants (to which we have objected), Dow AgroSciences
requests to use if for pre-plant soil fumigant use.
We will make some comments here but we do so with little confidence that they will be
treated with a scientific response - or any response at all. One wonders why on earth
the EPA puts the public through these time-consuming and expensive exercises if it
does not seem to make a scrap of difference to their regulatory behavior. Can we be
excused for suspecting that the EPA’s OPP is more interested in protecting the interest
of Dow AgroSciences than it is in protecting either the public health or its reputation?
• 2009: Fluoride Action Network comment to US EPA on Dow AgroSciences
request for pre-plant soil fumigant use.
(Attachment: 2009.fan.comment.pdf)
A brief history of the OPP’s three risk assessments for fluoride residues and
FAN’s interventions.
Since Dow AgroSciences first sought a temporary use permit for two foods (walnuts and
raisins) in 2001, the Fluoride Action Network (FAN) along with the Environmental
Working group (EWG) and Beyond Pesticides (BP) have argued that the use of this
fumigant for this purpose should be denied because people, especially infants, are
already exceeding the reference dose (0.114 mg/kg/day) for its major breakdown
product (the fluoride ion) which it has previously used for fluoride in the case of cryolite.
Rather than concede this point, the OPP responded by changing the reference dose
after the FAN, EWG and BP interventions. It has done this twice.
First, the OPP raised the reference dose for infants by a factor of 5, to 0.571 mg/kg/day
(making it five times the reference dose for an adult).
Second, after another FAN, EWG and BP intervention, it raised the reference dose for
infants still higher - to 1.14 mg/kg/day - which made it ten times higher than the
reference dose for adults. (i.e. the original reference dose used by OPP for fluoride
residues from cryolite use).
There is no other example in EPA’s regulation of pesticides or pesticide residues, where
a reference dose has been set HIGHER for an infant than an adult. Not only is it
blatantly absurd from a toxicological point of view (infants are considered to be more
sensitive than adults to toxics, not less so), but it is also a clear violation of the Food
Quality and Protection Act (FQPA), which requires that an extra margin of safety be
applied to protect infants.
With the latest application by Dow AgroSciences to extend the use of sulfuryl fluoride
as a soil fumigant (Federal Register, June 10, 2009, Docket ID EPA-HQ-OPP-2009-
0298. Available at http://www.epa.gov/fedrgstr/EPA-PEST/2009/June/Day-10/p13475.htm)
time to growing food (not just to post harvest food in warehouses and
processing plants), the OPP continues to nurture the fiction that infants are ten times
more tolerant of fluoride than adults. They didn’t spend much time on this, merely
mentioning in passing that 8 mg/day of fluoride was safe for everyone. They add that
the Water Division is reviewing the MCLG for fluoride (4 ppm), which was the starting
point for all three of their health risk assessments for fluoride. The major focus of their
latest health risk assessment was on the sulfuryl fluoride itself
However, claiming to wait for the EPA Water Division to come up with a new MCLG, is
completely disingenuous, since this cannot rescue their bogus manipulations of the
reference dose, but instead make their starting point, and hence final reference dose
even lower, which ever of the three manipulations they choose to use. In turn this will put
even more people over the reference dose, making further exposure to fluoride for the
use of sulfuryl fluoride unacceptable.
The OPP knows that the 2006 National Research Council of the National Academies
report, Fluoride in Drinking Water: A Scientific Review of EPA's Standards (requested by
the EPA Office of Drinking Water to review the MCLG for fluoride) concluded that the
MCLG of 4 ppm was unprotective of health and recommended that the water division
perform a new risk assessment to determine a new value. The new value for the MCLG
can only be lower than 4 ppm, since the NRC showed that the end point on which it is
based - namely crippling skeletal fluorosis - was not the most sensitive end point of
concern when considering fluoride’s damage to bone. The NRC concluded that earlier
symptoms, when fluoride accumulates in the bone and joints, which are similar to
arthritis, should be considered an end point of concern. The NRC also stated that the
EPA’s Office of Drinking Water MCLG of 4 ppm fluoride was not protective of bone
fractures.
Re-examination of the OPP’s fiction on the reference dose for the fluoride ion for
infants.
In its third health risk assessment the OPP used the following reasoning. As with the
previous two risk assessments, the OPP started with the derivation of the MCLG of 4
ppm. This has several key steps.
Step 1. The assumption that the only health end point of concern was
crippling skeletal fluorosis.
Step 2. The assumption that the LOAEL at which this occurs is 20 mg
per day
Step 3. The assumption that a safety factor of 2.5 would be protective for
all adults from this end point. Thus 20 mg/day divided by 2.5 gives a safe
daily dose for adults of 8 mg/day.
At this point the normal and traditional way of determining what a safe dose would be for
any other age range (and thereby range of bodyweigth) is to divide this safe daily dose
for adults by an adult’s body weight (70 kg) to derive a safe REFERENCE DOSE of
0.114 mg/kg/day. This reference dose can then be used to back-calculate the safe daily
dose for any other age range, by multiplying by the average weight for the age range in
question. For an infant the weight is taken as 7 kg, thus a safe dose would compute for
them: 0.114 mg/kg/day x 7kg = 0.8 mg/day.
That’s the traditional way – taking into account the difference in bodyweight for each age
range. In the OPP’s third assessment, the results which we have challenged but appear
to have been carried over in this current risk assessment for sulfuryl fluoride BY
DEFAULT, the OPP abandoned this traditional way – and toxicologically defendable way
– and instead said that if 8 mg/day was safe for adults then it was safe for everyone
regardless of age or bodyweight! This is clearly a preposterous suggestion and makes
as much sense as saying that, if 2000 mg of aspirin is safe for an adult, it would also be
safe for 7 kg infant!
By assuming that 8 mg per day was safe for everyone regardless of age or bodyweight,
it allowed the OPP to produce an outrageously high reference dose for a 7 kg infant of
1.14 mg/kg/day: 8 mg/day divided by 7k bodyweight = 1.14 mg/kg bodyweight/day.
There is no rational scientific defense for such a manipulation. The only conclusion is
that OPP was working backwards from what was needed to produce a risk assessment
that would allow them to approve Dow AgroSciences agenda for using sulfuryl fluoride
as an alternative to methyl bromide. In other words, OPP is violating scientific integrity
and betraying the public’s trust.
The OPP has failed to address the FAN, EWG and BP's challenge on these
manipulations in their latest attempt to expand the use of Dow AgroScience’s use of
sulfuryl fluoride and simply continued as if we had not intervened at all. This clearly
demonstrates a lack of good faith on their part. Why on earth should the OPP go through
the exercise of asking for public comment, not just once – but now FOUR TIMES - if they
are merely going to ignore well-argued and well-documented interventions by those
members of the public like ourselves who take the trouble to respond. Such behavior, in
our view, simply underlines the OPP's desire to follow Dow AgroSciences agenda at all
costs. The costs being in this case: the public’s health, the public’s trust, scientific
integrity and the mandates of the Food Quality and Protection Act.
Use of the Food and Nutrition Board's UL
There is one other tame argument that the OPP has used to justify its use of a 8 mg/day
as being safe for everyone and that is their claim that the Food and Nutrition Board of
the Institute of Medicine (IOM) 1997 report, Dietary Reference Intakes for Calcium,
Phosphorus, Magnesium, Vitamin D, and Fluoride used an upper tolerance level
(UL) value of 10 mg per day for a wide age range. However, this hurts their case rather
than helping it. The IOM did indeed come up with a UL of 10 mg/day* but did so only for
adults and children of 8 years and above. The value they used for children younger than
eight years, especially for infants, was much lower than this.
UL for Infants, 0 through 6 months - 0.7 mg/day
UL for Infants, 7 through 12 months - 0.9 mg/day
UL for Children, 1 through 3 years - 1.3 mg/day
UL for Children, 4 through 8 years - 2.2 mg/day
UL for Children and Adults > 8 years - 10 mg/day
If we consider just the UL for infants 0 through 6 months, and take the average
bodyweight for this age range of 7 kg, this translates to a reference dose of 0.1
mg/kg/day (0.7 mg /day divided by 7 kg bodyweight)
This is ELEVEN TIMES lower than the 1.14 mg/kg/day used by the OPP’s third and
latest health risk assessment.
*The IOM applied a totally unjustifiable safety factor of 1 (in their language an
uncertainty factor of 1) to the revised LOAEL for skeletal fluorosis of 10 mg/day
Evidence that children are being over-exposed to fluoride
Empirical evidence that many people – especially infants and children - are already
being over-exposed to fluoride comes in the form of the dental fluorosis rates in the US.
According to the Centers for Disease and Prevention (CDC) 32% of American children
have a condition called dental fluorosis (Surveillance for dental caries, dental sealant,
tooth retention, edentulism and enamel fluorosis --- United States 1988-1994 and 1992-
2002. MMWR. August 26, 2005 / 54(03);1-44.) This percentage has
increased by at least 9% since 1987. Dental fluorosis is well-accepted evidence that a
child has been over-exposed to fluoride before its permanent teeth have erupted.
According to the NRC (2006) review, several other tissues are impacted by ingested
fluoride.
It is simply inexcusable for the OPP to sanction a further increase in fluoride exposure to
the US population, and their notion that somehow infants are far more tolerant of fluoride
than adults, by using a bogus reference dose TEN times higher than adults, is a
dishonest attempt to obscure this truth.
Thus the OPP’s current health risk assessment for sulfuryl fluoride, is completely moot,
unless and until the OPP is able to demonstrate that the consumption of fluoride
residues that this fumigant leaves on food (and permitted by the OPP as tolerances),
when combined with existing exposures, will not exceed a genuine scientific reference
dose. This is something that they have failed to do, in three separate attempts, since
Dow AgroSciences first applied for the use of this fumigant on food in 2001. For how
long will the OPP continue to waste taxpayers’ money on prolonging this exercise?
Not only does the failure of the OPP to justify its use of a reference dose for fluoride at a
level ten times higher for infants than adults, violate the clear mandates of the FQPA,
and violate that need of government agencies to exercise scientific integrity in their
regulatory behavior as urged by President Obama, but it also continues to threaten the
health of millions of Americans every day this fumigant is used on the food supply.
We again request responses to all our arguments that have been submitted to EPA by
FAN, EWG, and Beyond Pesticides.
Sincerely,
Paul Connett, Director
Fluoride Action Network
