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fqpa food additives, infant child, pesticides (fwd)
Teige Davidson
Tufts University
School of Nutrition Science & Policy
Agriculture, Food & Environment Program
---------- Forwarded message ----------
Date: Thu, 17 Apr 1997 08:54:15 -0400 (EDT)
From: Teige Davidson <tdavidso@emerald.tufts.edu>
To: Molly Anderson <manderso@emerald.tufts.edu>
Subject: fqpa food additives, infant child, pesticides
Hi Molly and Saneters
I posted a question concerning indirect food additives and pesticides and
if both were regulated by the FQPA, specifically in regards to infants
and children and the ten fold safety rule that will be applied to them.
Well I received no responses from any of you out there, so I have some
documents for you to check out.
I have three FQPA documents off the web
two are summaries
www.pestlaw.com/law/hr1627a.html (I was there last night, a good summary)
http://thomas.loc.gov/cgq-bin/bdquery/z?d104:hr01627:@@@l (10/9/96)
one is like what you gave me a copy off
www.pestlaw.com/law/hr1627.html
I did searches on the document for the tenfold clause. I tediously
searched for "ten" and "10"
It only appears twice. Examples of what it says specifically in
regard to infants and children are included below. It clearly does not
ammend the safety standards concerning infants and children for food
additives. Only pesticide chemicals and residues and other means of
exposure. I suggest you look at the summary. It helps to make this clear
(see pestlaw.com/law/hr1627a.html) It states that the ammendments to the
Fed food drug and cosmetic act is specific to "pesticide chemical". No
mention of indirect food additives either. If it did say anything about
indirect food additive or food additves itwould surely be clearly stated
in the law which I also tediously looked at. You can search for "food
additive" in the bill, it comes up a few times but it doesn't seem to
apply to anyything but pesticides in these cases.
Thus I would like to know if the Delaney clause is still in effect for
food additives and indirect food additives, i.e. the FDA interpretation
which appears in the CFR or I am dreaming this whole thing and the FQPA is
an all inclusive standard which looks at all chemicals in regards to
infants and children who are at increased risk? AM I WRONG? I am no lawyer
but it if the law stated anything about indirect food additives, it would
probabley spend an additional 50 pages talking about this.
If you are curious why I am interested in this it is because I am looking
at indirect food additives i.e. the kind of food additives that get into
your food and are not supposed to be there like plasticizers which
migrated from containers and wrappings into food. Phthalates have been
implicated as having reproductive effects in rats and mice (Phthalates are
plasticizers commonly found in PVC) and other compounds such as
Bisphenol-A a monomer in polycarbonate has been found to leach from
laquers inside cans into food and also has been implicated as being
estrogenic by the in vitro breast cancer cell assays.
(C) Exposure of infants and children.--In establishing, modifying, leaving
in effect, or revoking a tolerance or exemption for a pesticide chemical
residue, the Administrator-- (i) shall assess the risk of the pesticide
chemical residue based on-- (I) available information about consumption
patterns among infants and children that are likely to result in
disproportionately high consumption of foods containing or bearing such
residue among infants and children in comparison to the general
population; (II) available information concerning the special
susceptibility of infants and children to the pesticide chemical
residues, including neurological differences between infants and children
and adults, and effects of in utero exposure to pesticide chemicals; and
(III) available information concerning the cumulative effects on infants
and children of such residues and other substances that have a common
mechanism of toxicity; and (ii) shall-- (I) ensure that there is a
reasonable certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue; and (II) <<NOTE:
Publication.>> publish a specific determination regarding the safety of
the pesticide chemical residue for infants and children.
The other part says
Section 408 (21 U.S.C. 346a) is amended to read as follows:
about two pages into this section
(I) Use of the pesticide chemical that produces the residue protects
consumers from adverse effects on health that would pose a greater risk
than the dietary risk from the residue. (II) Use of the pesticide chemical
that produces the residue is necessary to avoid a significant disruption
in domestic production of an adequate, wholesome, and economical food
supply. (iv) Conditions regarding risk.--For purposes of clause (ii), the
conditions described in this clause with respect to a tolerance for an
eligible pesticide chemical residue are the following: (I) The yearly risk
associated with the nonthreshold effect from aggregate exposure to the
residue does not exceed 10 times the yearly risk that would be allowed
under subparagraph (A) for such effect. (II) The tolerance is limited so
as to ensure that the risk over a lifetime associated with the
nonthreshold effect from aggregate exposure to the residue is not greater
than twice the lifetime risk that would be allowed under subparagraph (A)
for such effect.
Teige Davidson
Tufts University
School of Nutrition Science & Policy
Agriculture, Food & Environment Program