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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

testimony.

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

toxicologic reaction.

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?

No.

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.

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Subject

Additional Information an Diethylene Glycol - Wines (your IAR - 8/2/85)

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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

State.

Are there tolerance levels and for thresholds regarding crude or
acuco corappelon of DC in humana?"
There are nu tolerancer. DBG to not allored for direct addition to
Polyechylene Glycol, the Food Cheesecakes coches de les compactador
Toome linde of not core than 0.25% ethyla glycol ad dethylene
glycol, individually or combined. At the use levels of

Polyethylene Wycols, the poeme to DeG would be very low.
"5. Has Intocication with DG ever occurred in the CS?"

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.
"S. Are daca available of taascological animal rests with DG7"

Yes. Studies done in rats show caelate cryscals in wrina at .48
& 27 DEC in the diet for 225 days, salate excretion in wine &c
0.172 of diet, and a no-effect

level at only 0.085 of the diet
(about 50 mg DEG per kg b.v. of rats). Another study 10 rats for
2 years showed bladder stones at 17 and bladder coats and stones
at" 27 and 47 DEI in the diet.
Direct extrapolation with no margina of safety or safety factor
applied would mean a mantan codc offect (increased alate
excretion) ay be seen at 6 pm DEG/ day, ad culata ayicals in
kidory way be seen at 12 P DEG/day. However, abe han sy be
more cusceptible to traicity to Dea than other specie bered an
fatalicius seen at 25 ml Doc or above and pathological findings
from the 1938 culfanilamide elixis episode.

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The media acceptable daily Incake (ADI) based on a roseffect
level of 0.0852 in rats, oplying a 500-fold ufety factor (because
only 3 225 day study and are speciaal, would be about 6 og Deg for

• 60 lg-pertan.
"9. fery addicional Information on DC would be highly appreciated."

With my Auguse 6, 1985 m, have applied you with a postage of doua and Infocortion and liccature refamoes on our bondcity.

a

Cherla Koleoski, M.D.

MT-100 (Floc)
HT-150 (Blumenthal)
HT-152 (Larde, Shibico)
HY-1%
11-334
MT-450

Chokonkt::RD:8/8/85:187-156:472-5767
F/1:8/13/83: Doct125:DLEKULL19

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Mo-effect Level (NEL) at 0.0852 (about 50 mg/kg b.v.)

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Calvusy Klugor - (1939) Case studies of 1938 Sulfanilaide 011810

episode.

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:

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