April 19, 2005.
Comments submitted to EPA on Dow AgroSciences petition
to establish
Fluoride and Sulfuryl fluoride tolerances for a large number (over
600) of raw and processed foods.
(Federal
Register, March 4, 2005)
Submitted by
Ellen Connett
Director, Fluoride Action Network Pesticide Project
82 Judson Street, Canton NY 13617
Tel: 3415-379-9200. Email: pesticides@fluoridealert.org
1. FLUORIDE:
1.1 EPA identified fluoride as the major toxicological endpoint
of concern for exposure to sulfuryl fluoride.
1.2 The issue of approving fluoride tolerances is significant
because fluoride bio-accumulates in the human body, wildlife,
and fish, and it persists in soil.
1.3 The fluoride tolerances EPA approved on January 23, 2004,
are the highest ever allowed in EPA’s history.
1.4 EPA has not responded to the Objections and the Request for
a Hearing submitted by Fluoride Action Network and Beyond Pesticides
on March 24, 2004 (Docket No. OPP-2003-0373) to the first-time
use of sulfuryl fluoride as a food fumigant. (Objections available
at: http://www.fluoridealert.org/epa-sf.htm).
1.5 Among the many substantive issues that FAN and Beyond Pesticides
raised was the unprecedented decision by EPA to allow an acceptable
dosage of fluoride for infants (0.571 mg/kg bodyweight/day) which
is five times higher than for adults (0.114 mg/kg/day). This decision
runs counter to EPA’s mandate under the Food Quality Protection
Act (FQPA) to set standards that are more protective
of children, not less.
2. Which States have Approved the Use
of Sulfuryl Fluoride as a Fumigant on Food Commodities since EPA’s
Final Rule of January 23, 2004?
2.1 Certain states have approved the use of sulfuryl fluoride
as a food fumigant. This is quite an offensive action for EPA
to have allowed to occur in light of the fact that EPA has not
responded to the Objections and Request for Hearing submitted
by FAN and Beyond Pesticides.
2.2 Would EPA please explain its rationale for allowing the use
of sulfuryl fluoride as a food fumigant before they responded
to the Objections and a Request for a Hearing on their Final Rule.
Were there no acceptable alternatives available?
2.3 There is no centralized list available to the public for
the states which have approved the use of sulfuryl fluoride on
food commodities. We request that EPA provide the name of each
state that approved its use and to identify the food commodities
that it has been used on in both 2004 and 2005. Further, we ask
EPA to identify the food commodities that are for export markets.
2.4 Have there been any reported adverse reactions to the workers
involved in using sulfuryl fluroide as a food fumigant in these
states? If so, could EPA please provide the details.
2.5 Have there been any reported incidents in the use of sulfuryl
fluoride as a fumigant on food? If so, could EPA please provide
the details.
2.6 Has any testing for fluoride levels in the workers using
sulfuryl fluoride as a food fumigant been performed? If so, could
EPA please provide the details.
2.6.1 What levels of fluoride in blood and/or urine in workers
using sulfuryl fluoride as a food fumigant would trigger EPA’s
concern?
2.7 Does EPA have information that identifies the makeup of the
workforce using sulfuryl fluoride on food commodities? For example
-- the percentage of migrant farm workers in these states?
-- the percentage of workers with health insurance?
-- the percentage of workers belonging to a union?
3. DOW’S Petition of March 4, 2005:
3.1 The information provided in DOW's petition offers no response
to our substantive objections submitted on March 24, 2004. In
fact, several statements that DOW makes in its petition are issues
that we commented on in the Objections.
3.2 Dow is petitioning a fluoride tolerance for “Egg”
at 850 ppm. This tolerance is approximately seven times higher
than any fluoride tolerance approved or petitioned.
3.2.1 Dow states that “The highest fluoride levels were
754 ppm in powdered eggs.” Why is DOW requesting such a
significant increase in the tolerance for egg – from 754
ppm to 850 ppm?
3.2.2 Would EPA identify for the public the exact uses, or intended
uses, of these eggs (for example, baby food, processed food, bakeries,
restaurants, animal feed, List 4 Inerts, food to foreign countries,
non-food products, etc.) and the population subsets that will
be most exposed to these eggs (prisons, schools, military bases,
organic consumers, export market, etc.). EPA might consider this
request unreasonable; however, because fluoride accumulates in
the body, people have the right to know where they can expect
to find this intolerable level of fluoride in their food.
3.2.3 If a person ate 1 powdered egg, what would be the milligrams
of fluoride consumed?
3.3 Dow states
“The comparative results of fluoride residues in commodities
fumigated under
packaged versus open fumigation conditions indicate that the
packaging
in most cases does function as a barrier that isolates the contents
of
the package from external SF atmospheres or at least attenuates
the
inner-package concentration of SF to which the commodities are
exposed.”
3.3.1 The high levels of fluoride recorded in eggs (754 ppm)
were reported from “open fumigation (non-packaged)”
conditions. Has the packaging that provided a barrier for fluoride
levels been tested for fluoride levels?
3.3.2 Will the packaging materials fumigated with sulfuryl fluoride
need to be treated as a hazardous waste when they are disposed?
3.3.3 There are many scenarios in which some people might reuse
retail packing materials. For example, they may use them to store
food or allow their children to play with, etc. What are the fluoride
levels a young child would receive in hand-to-mouth exposure after
they handle a food package fumigated with sulfuryl fluoride?
3.3.3 Dow states, “Most of the finished food products were
fumigated in their retail packaging.” What is the estimated
quantity of the packaging to be fumigated with sulfuryl fluoride
on a yearly basis?
3.3.4 What is the major expected route of disposal of this packaging?
Is it reused? Is it sent to an incinerator? Is it sent to landfill?
3.3.5 What percentage of this packaging will be incinerated on
a yearly basis? Has EPA calculated the levels and the fate of
the fluoride emissions when disposed by incineration on a yearly
basis? If it has, would EPA please provide the details.
3.3.6 Several states allow “burn barrels” or “open
burning” of garbage. For example, New York State allows
“open burning” in communities with a population less
than 20,000 people. (EPA has estimated that this is a major source
of dioxin entering the US environment.) What are the levels of
fluoride emissions estimated to be from “burn barrels”
when retail packaging fumigated with sulfuryl fluoride is burned?
3.4 Are there any circumstances that EPA knows of when food commodities
can be fumigated more than once with sulfuryl fluoride? If so,
would EPA please explain.
3.5 Is chloropicrin added to sulfuryl fluoride when it is used
as a food fumigant? If it is, would EPA give the details.
3.6 Dow states, “1. Acute toxicity. The acute LC50 for
sulfuryl fluoride is 642 ppm 1,088 milligram/kilogram body weight
(mg/kg/bwt) for CD-1 mice exposed for four hours.” Is this
oral or inhalation exposure? Is this the most sensitive acute
toxicity data available? Is the mouse the most sensitive species
for acute toxicity data?
3.6.1 EPA needs to present all acute toxicity data. For example,
“The oral LD50 for sulfuryl fluoride in rats and guinea
pigs is 100 mg/kg. The 4-hour inhalation LC50 in rats is approximately
5 mg/L. The 1-hour LC50 is 12 to 15 mg/L in rats.” Ref:
Kidd, H. and James, D. R., Eds. The Agrochemicals Handbook, Third
Edition. Royal Society of Chemistry Information Services, Cambridge,
UK, 1991 (As Updated).10-2.
3.7 Dow states, “There is no evidence from any studies
to suggest that sulfuryl fluoride or fluoride are endocrine disrupters.”
3.7.1 FAN finds this statement to be false and misleading.
3.7.2 The pineal gland is part of the endocrine system. In the
1990s, Jennifer Luke discovered that the pineal gland is a major
site of fluoride accumulation within the body - with higher concentrations
of fluoride than either teeth or bone. Luke's studies indicate
that the accumulation of fluoride in the pineal gland can reduce
the gland's synthesis of melatonin, a hormone that helps regulate
the onset of puberty. Fluoride-treated animals were found to have
reduced levels of circulating melatonin and an earlier onset puberty
than untreated animals. Luke concluded:
"The safety of the use of fluorides ultimately rests on
the assumption that the developing enamel organ is most sensitive
to the toxic effects of fluoride. The results from this study
suggest that the pinealocytes may be as susceptible to fluoride
as the developing enamel organ"
Luke also states:
"It is remarkable that the pineal gland has never been
analysed separately for F because it has several features which
suggest that it could accumuate F. It has the highest calcium
concentration of any normal soft tissue in the body because
it calcifies physiologically in the from of hydroxyapatite (HA).
It has a high metabolic activitity coupled with a very profuse
blood supply: two factors favouring the deposition of F in mineralizing
tissues. The fact that the pineal is outside the blood-brain
barrier suggests that pineal HA could sequester F from the bloodstreatm
if it has the same strong affinity for F as HA in the other
mineralizing tissues (page 1).
"After a half a century of the prophylactic use of fluorides
in dentistry, we now know that fluoride readily accumulates
in the human pineal gland. In fact, the aged pineal contains
more fluoride than any other normal soft tissue... However,
the pineal gland is unique in that it can be classified as a
soft or as a mineralizing tissue. In terms of mineralized tissue,
the mean fluoride concentration in the pineal calcification
was equivalent to that in severely fluorosed bone and more than
four times higher than in corresponding bone ash, i.e., 8,900
± 7,700 vs. 2,040 ± 1,100 mg/kg, respectively.
The calcification in two of the 11 pineals analysed in this
study contained extremely high levels of fluoride: 21,800 and
20,500 mg/kg (page 167)."
Ref: The Effect of Fluoride on the Physiology of the Pineal
Gland. Jennifer Anne Luke, 1997. A dissertation submitted to
the School of Biological Sciences, University of Surrey, in
fulfillment of the requirements for the Degree of Doctor of
Philosophy. See excerpts of Luke’s thesis at: http://www.fluoridealert.org/health/pineal/luke-1997.html
3.7.3 The fact that fluoride's impact on the pineal gland was
never studied, or even considered, before the 1990s, highlights
a major gap in knowledge underpinning current policies on fluoride
and health.
3.8 There is a substantive body of published papers that detail
fluoride's adverse effects on the male reproductive system. The
predominant effect reported is fluoride's potential to affect
male fertility. See a 2004 submission to the National Research
Council on a list of studies that document reproductive effects
at http://www.fluoridealert.org/pesticides/nrc.male.repro.april.2004.htm
3.9 Dow is requesting a tolerance for “Processed Food.”
Would EPA provide a definition of “Processed Food”
and also provide examples so that the public will know more definitively
what this term covers.
3.10 On April 1, 2005, the Federal
Register published an extension to the comment period on Dow’s
petition. I was told that the extension was due to a request from
“stakeholders.” Would EPA please identify who the
stakeholders were that made this request, and the reasons they
provided for the comment period extension.
3.11 Would EPA please explain to the public why sulfuryl fluoride
will not be an ozone depleter. Also, will EPA make accessible
the atmospheric test protocol for sulfuryl fluoride.
4. EPA Needs to Clarify the Food Commodities
with Approved and Petitioned Fluoride Tolerances that Can Be Used
as List 4 Inerts
4.1 EPA’s List 4 Inerts contain a long list of chemicals
and food commodities that are used as “other ingredients”
in pesticide formulations. The List 4 Inerts are also allowed
for use in organic agriculture in the US Department of Agriculture’s
National Organic Program. For example, both “sodium fluoride”
and “cheese” are included as List 4B Inerts.
4.2 Ellen Connett, on behalf of FAN, contacted the National Organic
Program in early April 2005 for clarification on the food commodities
with tolerances for sulfuryl fluoride (approved and petitioned)
that can be used as List 4 Inerts. Connett was told that this
question had to be submitted to EPA.
[Note for clarification - not included in comments:
The major concern is the very high levels of fluoride that are
allowed in or on food commodities resulting from fumigation
with sulfuryl fluoride. Added to this concern is that several
of the food commodities approved for fumigation with sulfuryl
fluoride are also on EPA's List 4 Inerts. The problem is compounded
by the fact that EPA does not allow the public the-right-to-know
how the majority of "inerts" are used in agriculture.
EPA is obligated to respond to comments it receives on pesticide
petitions. We expect to learn the identify of the food commodities
with high fluoride residues that are eligible for List 4. Most
inerts are chemicals. The inclusion of food commodities in List
4 has not been examined by public interest groups. We need to
understand if food commodities with high fluoride content included
in the List 4 Inerts will inadvertently increase our exposure
to fluoride when we buy organic food.
For example: "Eggs (raw and processed forms)" is
a List 4B inert. While Dow reported fluoride levels of 754 ppm
in "powdered eggs" from "open fumigation"
with sulfuryl fluoride, it is petitioning EPA for an incredibly
high fluoride tolerance of 850 ppm. While it seems logical that
"powdered eggs" would be eligible for the List 4B
category, we need EPA to confirm it. Then we have to learn how
Egg is used as a List 4 Inert in organic agriculture. --See:
fluoride
tolerances associated with sulfuryl fluoride; List
4A Inerts; List
4B Inerts; EPA's
explanation of the Inert Lists.]
4.3 Therefore, we request EPA to identify each of the food commodities
that have fluoride tolerances, and those petitioned by Dow on
March 4, 2005, which can be used as List 4 Inerts.
4.4 Specifically, which of the following commodities petitioned
by Dow on March 4, 2005, for fluoride tolerances, are eligible
for inclusion as a List 4 Inert?
-- Animal feed
-- Beef, meat
-- Cheese, post harvest
-- Cocoa bean, post harvest
-- Coconut, post harvest
-- Coffee, post harvest
-- Cottonseed, post harvest
-- Egg
-- Flour, post harvest
-- Ginger, post harvest
-- Ham
-- Milk
-- Nut, pine, post harvest
-- Other processed food
-- Peanut, post-harvest
-- Rice flour, post harvest
-- Grain, cereal, forage, fodder and straw group 16, post harvest
This group includes 50 commodities.
Do any of these commodities qualify as a List 4 Inert?
-- Grass, forage, fodder and hay group 17, post harvest
This group includes 360 commodities.
Do any of these commodities qualify as a List 4 Inert?
-- Herbs and spices group 19, post harvest
This group includes 135 commodities.
Do any of these commodities qualify as a List 4 Inert?
-- Vegetable, legume, group 06, post harvest
This group includes 57 commodities.
Do any of these commodities qualify as a List 4 Inert?
4.5 EPA needs to identify the specific List 4 “category”
for any or all of the above food commodities. For example,
4.5.1 Which of the above would be included in the List 4A Inert
category: "Commonly consumed food commodities conforming
to 40 CFR 180.950(a)"
4.5.2 Herbs and Spices, Group 19. Is Group 19 included in the
List 4A Inert Category: "Commonly consumed food commodities
conforming to 40 CFR 180.950(a)"
4.5.3 Egg. Which List 4 B Inert category would this come under:
-- "Eggs (raw and processed forms)"
-- "Egg white"
4.5.4 Would “Cottonseed, post harvest” be included
in the List 4A Inert category “Cottonseed meal”
4.5.5 Peanut, post-harvest. Which category in List 4B Inerts
would this be included in:
-- "Peanut meal"
-- "Peanut shells"
-- "Peanuts (raw and processed forms)"
4.5.6 Cocoa bean, post harvest. Would this commodity be included
in the List 4A Inert category: "Cocoa" ?
4.5.7 Coffee, post harvest. Would this commodity be included
in the List 4A Inert category: "Coffee grinds" ?
4.5.8 Cheese, post harvest. "Cheese" is a 4B Inert.
4.5.9 Milk. Which category in List 4B Inerts would this be included
in:
-- "Milk (raw and processed forms)"
-- "Milk, hydrolyzed"
4.6 Specifically, which of the following commodities with approved
fluoride tolerances (Final
Rule, January 23, 2004) are eligible for inclusion as a List
4 Inert?
-- Barley, bran, postharvest
-- Barley, flour, postharvest
-- Barley, grain, postharvest
-- Barley, pearled, postharvest
-- Corn, aspirated grain fractions, postharvest
-- Corn, field, flour, postharvest
-- Corn, field, grain, postharvest
-- Corn, field, grits, postharvest
-- Corn pop, grain, postharvest
-- Fruit, dried, postharvest
-- Fruit, dried , postharvest (other than raisin)
-- Grape, raisin, postharvest
-- Millet, grain, postharvest
-- Oat, flour, postharvest
-- Oat, grain, postharvest
-- Oat, rolled, postharvest
-- Pistachio, postharvest
-- Rice, bran, postharvest
-- Rice, grain, postharvest
-- Rice, hulls, postharvest
-- Rice, polished, postharvest
-- Rice, polished, postharvest
-- Sorghum, grain, postharvest
-- Triticale, grain, postharvest
-- Wheat, bran, postharvest
-- Wheat, flour, postharvest
-- Wheat, germ, postharvest
-- Wheat, grain, postharvest
-- Wheat, shorts, postharvest
-- Wheat, milled byproducts, postharvest
Nut, tree, group 14, postharvest. This group includes:
- almond
- almond, hulls
- beechnut
- butternut
- cashew
- chestnut
- chinquapin
- filbert
- nut, brazil
- nut, hickory
- nut, macadamia
- nutmeat, processed, except peanut
- nuts • pecan
- pistachio
- walnut
4.6.1 EPA needs to identify the specific List 4 “category”
for any or all of the above food commodities.
-- end --
•• See EPA's
July 14, 2005, response
to comments.
