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QUESTIONS FOR THE RECORD
1) Who decided on behalf of FDA to defer major responsibility for this
matter to ATF?
circumstances arose today, would you handle the matter differently?
The division of responsibility between BATF and FDA concerning
imported wines contaminated with DEG was agreed to by John M.
Taylor, who was then the Director, Office of Compliance, Center for
Food Safety and Applied Nutrition, on behalf of FDA.
If the same
circumstances arose today, we would agree to the same division of
responsibility for the reasons stated in our written
2) You testify (on page 2) that FDA could not have acted as
efficiently as ATF in this matter. The GAO report was critical of ATF's handling of this matter. DO you disagree with the GAO'S conclusions in this regard?
Although we have not scrutinized BATF's activities to the
degree that GAO has, we have no reason to be critical of the way in
which BATF carried out its activities with regard to DEG.
3) Your testimony (on page 4) implies that you evaluate the health
risks in choosing your method of testing foods for contaminants, concentrating on those most likely to contain such residues. Don't you think ATF should have acted similarly in targeting the most highly-contaminated wines, rather than refusing to establish any priorities in this matter?
We believe that BATF acted reasonably in targeting all wines
containing DEG, regardless of amount. Even at the highest DEG levels found, the likelihood of harm to an individual is low
because of the excessive amounts of wine that probably would have
to be consumed over several days in order to produce a serious
At lesser DEG levels, steady heavy
consumption over much longer periods of time probably would be
needed to cause harm.
For these reasons, we do not think that
BATF acted improperly by striving to remove all wines containing
DEG without prioritizing among such wines, especially since DEG is
illegal in any amount.
4) You testified that ATF can withdraw the license of any wholesaler
who fails to report their findings of tests of possible contaminated wines. (Page 6) Yet GAO reports only 26 out of at least 175 importers even reported their findings. Do you know of any ATF action to suspend licenses of any of the others?
5) You indicate that on July 17, 1985, you provided BATF with a DEG
hazard evaluation. Was this evaluation in writing? If so, please make a copy available. Did you provide this information to GAO? Their report is critical of BATF for not obtaining such an evaluation. Can you account for this discrepancy? Did you provide a copy of this evaluation to GAO since their report was published?
Because we were anxious to respond to BATF quickly, the DEG
health hazard evaluation that we provided to BATF at that time
consisted of material prepared for internal FDA use coupled with
numerous telephone conversations between FDA and BATF staff. These
communications, both written and oral, continued into August. The
written documentation is submitted for the record.
We provided the written toxicological information an DEG to
GAO before their report was published. Because GAO had this
PDA prepared information and included its findings in their report,
we cannot explain why GAO would criticize BATF for not obtaining
such an evaluation. (Attached)
6) What is your opinion as to the best way to assure that
contaminated wines that could represent a public health hazard are identified and removed from the market?
We believe that the present system is fundamentally sound. We
have no major changes to recommend.
Additional Information an Diethylene Glycol - Wines (your IAR - 8/2/85)
As per as telephone conversation coday, further to my of August 6, we present brief specifts mowers to assist in your reply to several of the points raised in telegram of Dobassy Venna, Austria to Depe. of
Are there tolerance levels and for thresholds regarding crude or
Polyethylene Wycols, the poeme to DeG would be very low.
Yos! In the 198 sulfaniodde eld: episode, a saber of deaths and injures occurred as a result of patients cornosing the elite which used DEG as the solvent and vehicle. The DBG careed culate crystals in the kidneys and severe kidney derage. ?5 ml DOC OT
above was fatal in humans in about 307 of the cases of injury.
Yes. Studies done in rats show caelate cryscals in wrina at .48
level at only 0.085 of the diet
The media acceptable daily Incake (ADI) based on a roseffect
• 60 lg-pertan.
With my Auguse 6, 1985 m, have applied you with a postage of doua and Infocortion and liccature refamoes on our bondcity.
Cherla Koleoski, M.D.
Mo-effect Level (NEL) at 0.0852 (about 50 mg/kg b.v.)
Calvusy Klugor - (1939) Case studies of 1938 Sulfanilaide 011810
25 al DEG or above vas fatal to humans in about 30% of the cases.
Estripolation of DEG Tosicity co Humans:
ADI (Milau acceptable daily intake) based on NEL of 0.085%,
applylag a 500-lold ualety factor (because only ??5 day study and
one species), and for a 60 kg person is about 6 ag DEG.
Il one extrapolates directly from cac co a 60 kg man (using ao
safety factor), DEG is coxic to humans as follows: