. 8.

authority over wholesalers and distributors. FDA has the toxicological

expertise and addressed the health issue in order to determine the

seriousness of the problem.

These were the most important factors in

determining the Federal regulatory response.

A chronology of our

activities is appended to this testimony.

FDA's analysis of the hazard posed by DEG in wine is based on both

human and animal data.

The human data show that acute levels of

exposure of about an ounce or more of DEG consumed each day for several

days can produce kidney failure leading to death. The animal data suggest that below this level, a maximum acceptable daily intake level

does exist where no harm is expected.

At certain levels in between,

the potential exists for the formation of kidney stones and kidney

damage from the consumption of DEG over varying periods of time,

depending on the level. However, given the amounts of DEG that have

been found, the types of wine involved, and the conservative nature of

our estimate of intake necessary to produce harm, we believe it unlikey

that any illnesses or deaths have or will occur. And, as I have

stated, FDA has not received any reports of illness or injury resulting

from this problem.


The recent discovery of high methanol levels in Italian wines is being

handled similarly by the two Agencies, although the situation is

slightly more complicated because methanol does appear naturally in wine. Methanol that occurs naturally is permissable as long as it is

- 9

not injurious to health.

FDA has recently advised BATF that levels of

methanol in wine exceeding the natural background level of 0.1 percent

by volume would pose a threat to the health of consumers.

I will be

happy to provide the Subcommittee with the full toxicological

evaluation upon which this guidance is based. Methanol levels above

the 0.1 percent background level usually indicate improper processing

or a deliberate addition of methanol to the wine.

Nitrosamines in Beer

The division of labor between FDA and BATF can differ substantially in

other situations because of the unique scientific and enforcement

issues involved. On one end of the spectrum, for example, FDA, again

in consultation with BATF, assumed full responsibility several years ago for regulating the levels of nitros amines in beer because FDA was

the Agency best equipped to deal with the problem. Nitrosamines are a

class of chemicals that includes some known carcinogens. Because they occur as a byproduct of manufacture without being purposefully added,

they are not food additives and thus not automatically illegal.

Whether their presence renders a product adulterated under our law

depends upon their toxicity, or lack of it.

When nitrosamines were first discovered in beer in the late 1970's,

we did not know why they were occurring, whether their presence was

unavo idable, or how toxic they were at various daily intake levels.

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Thus the issues, at least at that point, were primarily


It was soon determined that nitrosamines are formed during the drying

of the sprouted barley malt. Although they cannot be eliminated

entirely, they can be reduced to very low levels. Through

toxicological analysis, FDA was able to establish an "action level" for

nitrosamines that permits insignificant and unavoidable amounts.


also assumed responsibility for enforcing these levels, primarily because only FDA possessed the analytical capability to detect them

down to the parts per billion level.


Although several occurrences of alcoholic beverage contamination have

been discovered in the past several years, we are satisfied that in

each situation the Federal response has been quick and adequate for the

protection of the public health.

We have also found that the

relationship between FDA and BATF has worked well and without any

confusion. Given the close working relationship between the two

Agencies, the need for a written agreement between FDA and BATF has not

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merits of developing a formal agreement to address the division of

responsibilities whenever joint jurisdiction is involved.

This concludes my formal test imony.

I will be pleased to answer any

questions that you may have.


July 12, 1985 - FDA alerts BATF of DEG in Austrian wine based on State

Department telegram. July 15 - BATF advises FDA it is seeking additional information

from Austrian authorities.

BATF advises FDA that Austrian authorities assure them that no DEG contaminated wine was exported to the United States.

- FDA advises BATF it will analyze toxicological data.

July 17

- BATF alerts FDA that U.S. wine importer had found DEG

in his Austrian wine. BATF further advises FDA that it was deve loping a plan to identify and remove DEG contaminated Austrian wine from U.S. market.

- FDA provides DEG hazard evaluation to BATF

July 18

FDA and BATF meet and discuss information known on the
DEG problem. BATF advises it was initiating action:

to alert the U.S. wine (wholesalers and importers)
industry to quarantine all Austrian wines until
tested and found free of DEG;

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to alert customs to detain all shipments of Austrian
wine until tested and found free of DEG; and
to initiate recalls and issue publicity on all
Austrian wines found to contain DEG. (John M.
Taylor, Director, CFSAN Office of Compliance, FDA)

concurs with BATF action plan.
At BATF request, FDA reviews BATF analytical findings
to evaluate quality of confirmation findings. FDA
analyzes BATF samples confirming their findings.

Aug. - Sept.

Mr. BARNARD. Mr. Taylor, let me ask you some questions relative to the chronology of activities, set forth in your statement's appendix.

On July 18, you-I mean by that the FDA-concurred with BATF's action plan. What exactly was this action plan? In other words, what did FDA review and concur in?

Mr. TAYLOR. What we did was more or less a conversation of what we were going to do. It was not really, to my knowledge, an actual written document, but rather how we would handle the problem. Mr. Coker might have additional information on that, but it is my understanding that it was more or less a telephone conversation.

Mr. COKER. Well, what they proposed doing was, of course, to immediately notify the wholesalers and distributors in the country to stop further shipments of Austrian wine until they had been tested. That was one aspect.

The other aspect was the notification of Customs to detain all entries of Austrian wine.

And the third aspect was to release publicity any time DEG was found in wine.

Mr. BARNARD. Did you make any recommendations at that time on how they might conduct a nationwide recall and if so, what were they?

Mr. TAYLOR. No, we did not.
Mr. BARNARD. You did not make any suggestions to them.

The chronology statement also indicates that FDA reviewed BATF's analytical findings in August or September 1985, at the BATF's request. What actually did the FDA review at that time?

Mr. TAYLOR. They sent three of the samples where they had found DEG for us to do some additional analysis and confirmation to make sure that we had DEG present in the products. This was done by mass spectrometry and these results were furnished back to BATF. So it was really a confirmation of results they obtained.

Mr. BARNARD. What was the FDA opinion of the quality of the findings from BATF?

Mr. TAYLOR. We agreed with what they had found as far as the presence of DEG in the products.

Mr. BARNARD. You didn't find any problems with that analysis? Mr. TAYLOR. No.

Mr. BARNARD. Is the FDA at the present time testing any wines domestically or foreign on a routine and regular basis?

Mr. TAYLOR. Between the period of 1982 to 1985, I think we checked some 52 wines, both domestic and importers. These were primarily checked for pesticides and in some cases for fill.

As far as an unproved food additive, the answer is, no, we are not on a uniform program.

Mr. BARNARD. So, in other words, the contaminants you are testing for is not in the product itself, but how the product was developed; is that it?

Mr. TAYLOR. Well, the kinds of things we are testing for is maybe pesticide residues. Usually we do that on the grape rather than the wine.

You are asking whether we are testing for additives such as DEG; the answer is, no. One of the problems we have as was point

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