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Malnu toric affect (increased oxalate excretion)

My be seen at 6 DECIdey (about 5.5 al).

Orylate crystals

may be seen at about 13 DEG/de, (about 11 .1).

Calvary and Kluapp stated (1939) that Mo My be more susceptible

chan other species, which wy uske above levels of DEG even more

toxic to huacas. Their opinion was based on 25 al of DEG being

fatal ja sove people and on the pathological findings from the 1933

sulfonilande clixir episode.

Diethylene Glycol is not allowed as a direct tood additive in 21 CTR

Food Additive Regulations.

It may occur as a contenidaat liaired to lov

levels in tone echylene oxide condensates le.f. polyethylene glycol) wend as food additives. However, any purposefuély added DEG co food is

not authorized by the regulations and any such soported food would be

considered illeus.

Charla J. Kokoski, HIF-156

Mr. BARNARD. Mr. Taylor, likewise in our letter of invitation of April 16, we included a couple of questions on page 3 of our letter which FDA did not answer. I would appreciate it if you all would It is question 8, the FDA's assessment of BATF's sampling, testing, removal procedures and recommendations for changes. If you would submit those, we would appreciate it very much.

[The information follows:)

RESPONSE TO QUESTION 8 IN SUBCOMMITTEE'S LETTER OF INVITATION

DATED APRIL 16, 1986

8.

FDA 's Assessment of BATF's sampling, testing, and removal
procedures and recommendations for changes:

a.

Pursuant to the GAO's recommendations (made in the context of future FDA-BATF consultations), please determine and report to the subcommittee whether the actions taken by BATF in sampling, testing, and removing contaminated wines from the marketplace were adequate, in FDA's view, to protect the public health and safety.

The existence of DEG in imported wines presented a problem that

clearly warranted a Federal response, but did not pose a serious

public health emergency. It appears to us that BATF's activities

under the circumstances were adequate to protect the public health

and safety. As we testified, we know of no injuries or deaths in

the United States that have been attributed to DEG in imported

wines.

b. Also, arsuant to GAO's recommendation, please suggest appropriate policies and procedures which BATF should consider implementing to redress any deficiencies at any stage. (Recent information developed by the subcommittee indicates that BATF still lacks a followup system to verify sufficient testing and adequate removal of the methanol contaminated wines.)

We have no suggestions at this time, but as we testified, the

two agencies are exploring the merits of developing a formal

agreement to address the responsibilities of each agency whenever

joint jurisdiction is involved. During the course of these

discussions, the two agencies will review their past responses to

contamination problems in alcoholic beverages and the GAO report

findings to determine if changes are needed.

62-011 O - 86 - 5

Mr. BARNARD. Mr. Taylor, thank you very much for your witnessing today. I am sure you have provided very important information for our hearing. Thank you very much.

Our next witnesses will be a panel: Mr. John Martini, who repre sents the New York Wine Council; and Mr. Richard H. Naylor, the Wine Grape Growers of America.

I might state to the others we asked to stay, we have no further need of the previous witnesses, if you feel inclined to leave this very exciting testimony.

Mr. Martini, we appreciate you and Mr. Naylor for being with us today. It will be interesting to complete this study to know what the American wine producers have to do to comply with the regulations. So, we will hear from you, Mr. Martini, first, and then Mr. Naylor. Your entire testimony will be included in the record in the event you would like to summarize.

STATEMENT OF JOHN H. MARTINI, PRESIDENT, NEW YORK STATE

WINE GRAPE GROWERS, INC.
Mr. MARTINI. Thank you, sir. I will try to go quickly.

My name is John Martini, and I am a farmer, a grower of grapes and other fruit, on a farm that I share with my wife and children in the Finger Lakes region of New York State. I also serve as president of the New York State Wine Grape Growers, Inc. I was employed at the New York Agricultural Experiment Station in Geneva, NY, for 9 years, working in the analytical section of the food science department. I am here today to tell the committee what I have to do as a grape farmer to assure that the American consumer receives high quality fruit and wines, free from contaminating spray materials.

There was a time, unfortunately, when spray materials were applied almost willy-nilly. If some was good, then lots was better. Times have changed: We became aware of the effects that even minute amounts of chemicals can have on the lifecycles of beneficial organisms as well as those we sought to eradicate. We also became more acutely aware of the effect these residues might have on the human organism. State and Federal agencies sought to balance the consumer demand for low cost, blemishless fruits, and vegetables with the health concerns that chemical residues might present to those consumers.

In New York, I am required to register and be tested for a permit to buy the chemicals that I might use on my farm. The same scenario takes place in other States, as well. We use training manuals—I brought one with me. I don't have this memorized, and I don't think any farmer does. It provides us information, and we use these training manuals to cover all aspects of the use and disposal of pesticides. We are tested on the contents of these manuals. The test is what you might consider an open book test. Upon satisfactory

Mr. BARNARD. Is that State or Federal, Mr. Martini?

Mr. MARTINI. This is State. For my State permit, I have it. I am not sure what the Federal extent is. It does come through the EPA. Mr. BARNARD. Of course, the FDA recognizes the State of New York, California, and others. That is an effort on the part of the State?

Mr. MARTINI. This is an effort on the part of the State, supported by the Federal-EPA, I believe.

We receive the appropriate permit for the crops we raise. If I take this test, and I grow grapes and fruit, it doesn't give me a permit to use chemicals on corn and oats or beef and pigs. I would have to take another series of tests to get a permit to use chemicals there. Every 3 years, our permit has to be renewed; and every 6 years we are retested and recertified. The permit does not allow us to spray as we please and use materials at our whim. By law, it is illegal to use a pesticide for uses other than those stated on the label.

I have a sample label from a herbicide here. It has instructions where we can use it, where we can't. Label instructions also pro vide methods of container disposal, relative toxicity, compatible materials and dosage rates for various conditions. Another part of label recommendations stipulates days-to-harvest time periods which restrict application of those materials if the crop will be harvested before the time period allows.

The companies that produce the spray materials we use must spend considerable sums of money to get their products approved for use on a particular crop. If it is considered safe on apples, that does not give the material an approval for use on grapes. As users of pesticides, we are responsible for the effects that they may have on our neighbor's crops, and we must keep records of what and how much we use and when we use it.

We talked about the records BATF requires of processors. In theory, it is possible to trace a contaminated product if it does exist in a domestic wine-to my knowledge, none has ever existed-back to the grapes and vineyard they were raised in. Here is a sample of my 1983 chemical spray sheets, the amount, the blocks I sprayed them on.

The State agricultural colleges and cooperative extension provide information on recommended materials and dosages for pests that might be a problem in producing good quality fruit. There was a time when most growers sprayed on a schedule. This was done because most materials we use are considered protective rather than eradicative. For example, the presence of sulfur powder on the foliage and fruit of the grape can prevent powdery mildew; once powdery mildew starts, no amount of sulfur will serve to eradicate it. Because of safety and economics, more growers are now applying chemicals on the basis of need. Insects can be monitored and sprays applied if they seem to be getting out of hand.

Integrated pest management is a federally funded program to encourage the use of a multipronged attack on the pests that would destroy our crops. These include not only chemical means but also biological and cultural practices. It also means that we may accept some damage in our crops in an effort to reduce residues. It is not cheaper, but it is safer. Unfortunately, the IPM program apparently will be dropped this year because of Federal budget cutbacks.

The EPA, and in New York the department of environmental conservation, constantly monitor the chemicals we are allowed to

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