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Report on Regulatory Problems on Non-Cortified Imports of Shellfish:

Mr. C. S. Brinsfield, Chiof, Division of Food Control, Maryland State Department of Health presented a report on Regulatory Problems on Non-Certified Imports. Mr. Brinsfield indicated that before starting on his prepared paper he would like to make ono statement. This was to the offect that no cases of hepatitis had ever been attributed to Maryland shellfish. Mr. Brinsfield went on to say that some growing areas in Maryland were not opened when their 1964-65 season began on September 1, pending results of their double-check to make certain that these growing areas were satisfactory. As of the time he was speaking Mr. Brinsfield indicated 80% of Maryland's growing areas were open and that this percentage would increase as they continued their doublechecking. He further indicated Maryland for several years had been suggesting that numerical shellfish ratings of individual plants be published on the Public Health Service certification list.

With regard to Regulatory Problems on Non-Certified Imports of shellfish, Mr. Brinsfield indicated that on learning from Mr. Jensen that there was the possibility of non-certified oysters from outside the U.S.A. being imported into Maryland, he was shocked to learn the Public Health Service had no control over imported shellfish under the Cooperative Shellfish Sanitation Program. Mr. Brinsfield learned it was the duty of the U. S. Food and Drug Administration to sample imported oysters unless they came in under the Cooperative Program. Mr. Brinsfield indicated ho visited the Food and Drug Administration concerning the problem and was informed their laws only provided for an objective examination, that several se i zures had been made at border custom points, that some shipments had passed FDA objective examinations, and that FDA records show thay sample approximately 1% of the foods entering the United States.

Mr. Brinsfield said he then held a series of conferences with the segment of the U. S. industry planning to use the imports and it was stated that the company in question would consider them unfit for sale in any of their stores in the U.s. if not good enough for sale in Maryland. This example was used by Mr. Brinsfield as indicating that the vast majority of industry members will cooperate if properly informed of the quality of foods they are buying and selling. Mr. Brinsfield also cited the example of his action informing adjacent States about the problem which ultimately led to sei zure of impor tod oysters, and stressed the importance of cooperation among States on such matters. Mr. Brinsfield pointed out that probably ne i ther the PHS nor FDA could keep out oysters to which had been added monosodium glutamate and other seasoning by calling the product oyster stew. Although such products would be subject to FDA objective examination, they would not be subject to control under the Cooperative Program. It was stressed that States receiving shellfish should possess information relative to the growing area, harvesting practices, in-plant protocol inclusive of sanitation, in-transit handling, etc. It was further pointed out that objective examinations do not ordinarly detect-toxigenic strains, staphylococci, hepatitis virus, or de teriation caused by enzyme reactions.

Mr. Brinsfield quoted from a law which the Maryland legislature had passed, and which took effect June 1, 1964, as the method Maryland had used to control the problem of imports. In essence the Maryland law (refor to Appendix P for details, on the law) prohibits the importation into the State of shellfish from sources that have not been certified for interstate shipment through the U. S. Public Health Service. Mr. Brinsfield pointed out that the Maryland law covers all types of shellfish rather than only raw or frozen shellfish. Mr. Brinsfield also described what Maryland is doing in connection with "oyster roasts" where row shellfish are served on the half shell. (Mr. Brinsfield's statement is included as Appendix p of these proceedings.)

Mr. Richard Howell, Delaware Department of Health, commented that Delaware had a similar problem on imports from a foreign country and had solved it by regulation rather than by a change in the law. He also pointed out that although neither PHS or FDA controlled imports the actual legal basis for all food programs rests with the States. He said the States should recognize the problem and take adequate steps.

Mr. Brinsfield proposed that the Workshop consider inclusion of all edible types of shellfish and or portions of shellfish under the National Shellfish Sanitation Program

Mr. Brinsfield's proposal and the subsequent discussion actually took place at the Thursday afternoon session (Nov. 19, 1964) but is inserted at this point of the Proceedings for reasons of continuity.

instead of the present restriction to raw and frozen shellfish, regardless of whether mixed with seasoning or other food ingredients. He explained the above by saying it should be clearly understood that the certification shall not apply to the seasoning or other food ingredients but would only apply to the oyster, clam, or mussel or segments thereof that would be in the final product. Mr. Brinsfield further requested that the Public Health Service consult with the Food and Drug Administration regarding the practicability of labeling such foods to indicate that the shellfish in it were produced and processed under the sanitation requirements of the National Shellfish Sanitation Program.

WORKSHOP PROPOSAL

By

Mr. Carroll Brinsfield
Maryland State Dept. of Health

Proposal:

That all edible types of oysters, clams, or mussels
and--or portions of these species be included in the
Cooperative Program for the Certification of
Interstato Shellfish Shippers, regardless of whether
mixed with seasoning or other food ingredients;
provided however, that Cooperative Program require-
ments would not apply to the seasoning or other food
ingredients, but only to the oysters, clams, or mussels,
or to segments thereof as used in the final product
itself, and; that the Public Health Service consult
with the Food and Drug Administration regarding the
practicality of labeling such foods to indicate that
the shellfish contained therein were produced and pro-
cessed under the sanitation requirements of the
National Shellfish Sanitation Program.

Action:

After discussion by Workshop participants in which it
was reaffirmed that the proposal did not pertain to
ingredients such as "breeding materials," but only to
shellfish meats, the Workshop unam inously adopted
Mr. Brinsfield's proposal.

Mr. Jensen commented that from the standpoint of the Public Health Service he could foresee no difficulties with Mr. Brinsfield's proposal and thought it would help avoid some of the very unpleasant situations that have been encountered.

Mr. Fisher inquired if the proposal also included breaded oysters. Mr. Brinsfield replied 'yes'', but pointed out that it would be the meat of the breaded oysters and not the breaded oyster per se. Mr. Fisher then indicated they had an oyster breading operation in indiana and inquired whether it would be under the Certification Program. Mr. Brinsfield replied ''no', it would only apply to the shellfish themselves, i.e. the oysters, would have to be from a certified source. Mr. Fisher indicated Indiana already had that and it appeared that Indiana and Maryland were ahead of some of the other States.

Mr. Jensen indicated they were also ahead of the Public Health Service and inquired if there were any others who wished to comment. There being no response, he indicated Mr. Brinsfield's proposal would be considered as adopted by the Workshop and would be so recorded.

It being 5:20 p.m. the Chairman, Mr. Dana Wallace, announced that Mr. Felsings paper on imports would be held over until the following morning ant that the Workshop was adjourned, and would reconvenc at 9:30 a.m. the next day.

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The Workshop reconvened at 9:30 a.m. on November 18, 1964 with Mr. John Trygg, Director, Division of Public Health Engineering, Louisiana State Board of Health, as Chairman. The Chairman introduced Mr. William A. Felsing, San Francisco Regional Office, Public Health Service, to speak on the subject of Shellfish Imports.

Report on Shellfish Imports

Mr. Felsing noted the prevalent increased interest of foreign countries in exporting fishery products into the United States to bolster their national economies through international trade. It was pointed out however that imported fresh and frozen oysters and clams represented less than 0.1% of the total fishery imports of this country, but that recent expressions of interest of foreign countries desiring to market their bivalve shellfish in this country would tend to indicate that there will be more and more shellfish imported during the years immediately ahead. Even though present imports are a small fraction of the total fishery products entering the United States, their associated potential public health significance is far greater than the statistical amounts of imports would indicate. Concern over the sanitary quality of fresh and frozen shellfish imports is not a new problem but stems from the concept that "control of source" or prevention of harvesting from areas of unsatisfactory quality is the most important aspect of protection of the public. Mr. Felsing pointed out that while the objective examinations of the Food and Drug Administration are of value, they cannot provide complete evidence as to the sanitary conditions under which the shellfish were produced, and cannot be relied upon as a total substitute for the "control of source" sanitary controls required by the Cooperative Program. The Public Health Service, therefore, cannot recommend the sale of fresh or frozen foreign shellfish produced outside the provisions of the Cooperative Program although such shellfish may have been legally admitted into this country. State action is presently the only truly effective means of controlling importation of non-certified foreign shellfish.

The current agreements with the governments of Canada and Japan worked out through the Department of State were explained by Mr. Felsing whereby certain of their shellfish shippers are currently listed on the Public Health Service list of certified shippers. It was indicated that constituents of the Republic of South Korea, Franch, Venezuela, Australia, New Zealand, American Somoa, and Iceland have indicated an interest at one time or another in sending shellfish into the United States.

It was pointed out that enactment of Federal legislation for control of the public health aspects of non-certified shellfish imports would appear to offer the most promising solution to the problem. However, Bills introduced at the second and first sessions of the 86th and 87 th Congress, respectively, were not passed although interest in the field continues. The Oyster Institute of North America, the Conference of State Sanitary Engineers, and the Association of State and Territorial Health Officers have all endorsed the principle of Federal legislation as providing a mechanism for controlling the sanitary quality of imported shellfish, however, the Department of Health Education and Welfare has not at this time taken a formal position on the matter. in the absence of specific legislation, the Public Health Service will continue to consider the extension of the sanitary provisions of the Cooperative Program to other countries wherever technically possible, and with due regard to the limitations of available fiscal and personnel resources. State and local health agencies must necessarily retain the responsibility of permitting or denying the sale of shellfish imported from those countries not extended Shellfish Sanitation agreements. Mr. Felsing also presented tables of imports on clams and oysters covering the calender year 1960 through 1964. (Mr. Felsing's complete paper is included as Appendix l of these proceedings.)

Mr. J. Richards Nelson commented that it would appear that one of the prices we pay for the fact that the Shellfish Sanitation Program is a voluntary program is that foreign shellfish can come in produced under conditions which we would not accept or certify in this country. He questioned whether or not the price of asking that our voluntary program be made a matter of law was worth the cost of doing it but indicated it would seem to him as a layman, not a lawyer, that if we were operating under a law saying that operators had to be certified by the U.S.P.H.S. for interstate for interstate shipment, that this would take care of the foreign import situation. He asked whether that was a logical conclusion or an over simplification of the problem.

Mr. Jensen explained that under the General Agreements on Tariffs and Trades, that would be the only way the problem could be resolved. Under agreements with other nations we cannot have higher standards or use our sanitation standards as a barrier to legitimate foreign trade. However, if we were operating the national program under a law in which our interstate shippers were required to meet certain standards, then these same standards could also be applied through law to shellfish which might come in from outside the United States. Apparently the only solution to a problem of this kind is in law. The other solution is the one we have used in the past, and this is a negotiated agreement with each country. Although it has worked with Canada and Japan, each country presents a whole new set of problems and we have no real guidance as to how we should proceed in a new situation. Recent discussions with State Department representatives on some of these problems had led him to believe the State Department would probably favor legislation which would clarify the rules under which shellfish might be imported and that the present situation is rather difficult to explain to representatives of foreign governments. Mr. Jensen said it was also a difficult problem for the States to handle as Mr. Brinsfield had pointed out earlier and it almost becomes a game for an impor ter to try to find a community or a State in which their product might be sold.

Mr. Trygg indicated he hesitated to ask the Workshop for endorsement of legislation to control foreign imports since such legislation, in his opinion, would perhaps end the cooperative program, but it might be in order to present the question to this workshop since the previous Workshop had gone on record as favoring legislation.

Mr. Jensen then indicated the 1961 Workshop did not exactly endorse the principle of legislation but had requested the Federal government to investigate the problem of controlling imports, and they adopted a resolution in those terms.

Mr. Trygg pointed out that the Conference of State Sanitary Engineers, of which he is a member, has in its charges for this year to review their statement of policy of 1963 to determine the possible effects of Federal regulation on the present State Public Health Service Industry Cooperative Shellfish Sanitation Program.

Mr. Morgan asked whether such a law would terminate the voluntary relationship with the Public Health Service.

Mr. Trygg indicated this possibility exists and was the reason he hesitated to get into such a discussion, because he felt Workshop participants were not sure of it and that he felt it was a topic which needs more clarification before the Workshop could take action, but that he would go along with whatever the group wants to do. He further indicated it appears that if we have legislation for imports we must have legislation of a similar nature for our own industry.

Mr. Nelson asked whether, even if we had Federal legislation, the program could not continue to operate very much as it presently does.

Mr. Morgan pointed out that the industry believed it had an excellent relationship with the Public Health Service, other Federal agencies, and the State agencies in the past, and that he for one would not like to see this relationship terminated by a law that does not include a voluntary arrangement.

Mr. Trygg on noting the lack of further response from the Workshop participants on Federal legislation, indicated that it appeared that the group has not made up its mind and that in view of this the Workshop should proceed with the next topic on the Agenda.

Report on Control of Sport Harvesting and Intrastate Sale:

Mr. Eugene Jensen presented a paper on the Control of Sport Harvesting and Intrastate Sale. Mr. Jensen's paper is included as Appendix R of these proceedings. Specifically Mr. Jensen presented the following four points pertaining to "intrastate" sale for endorsement by the Workshop:

1. Re-endorsement by the Workshop of the concept of a single sanitation

standard for all shellfish:

2.

That the Workshop request other interested groups, such as CSSE and
ASTHO, to endorse the need for uniform standards:

3. That intrastate shippers not be considered in the PHS evaluation

of State programs; and
4. A joint PHS State progress report should be submitted at the next

Workshop relative to the progress made in eliminating dual standards.

At the conclusion of the presentation of the above four points the Chairman, Mr. Trygg, indicated that action by the Workshop was needed. He therefore asked for comments on the above four points.

Mr. Jensen asked specifically that Mr. Girard comment.

Mr. Girard replied that the Washington group absolutely refused to talk on the issue. He explained that they refused to do so because any shellfish which will not be going into interstate commerce is not a responsibility of the Cooperative Program and therefore is not a concern of the Workshop. Accordingly, he could not comment or recommend it to the Workshop.

Mr. Bennett indicated the New York State Department of Conservation had a system of licensing whereby a different price is charged for interstate shippers than for intrastate. However, New York maintains the exact same standards for the interstate shipper as the intrastate shipper. New York is quite in favor of endorsing the above four points and sees no reason why we should have dual standards, and has no intention of entertaining such a program.

Mr. Nelson pointed out that as an industry member he could see no reason for not endorsing Mr. Jensen's recommendations as he thought they were entirely logical. He further said that after all, what we are talking about is a sanitary program that assures the consumer a good product, and he could not see that it makes any difference whether it crosses State lines or not, it should have the same basic qualities.

Mr. D'Alfonso of the Louisiana State Board of Health asked 'What is the purpose of having Intrastate shippers? An intrastate shipper might sell to an interstate shipper who in turn sells his oysters in interstate commerce. Is he cons i dered a certified dealer in doing so, with a dual set of standards? Is it a small operator that just wants to sell locally, and if he gets a larger order, can he sell to an interstate shipper?"

Mr. Trygg indicated that the word "intrastate" concerns itself strictly within the State, and any time it gets involved with an out of State program it becomes the interstate program.

Mr. D. Alfonso pointed out that "intrastate" oysters could get into interstate commerce.

Mr. Jensen agreed there was always this possibility. However, if the State feels they can keep the two separate and there is no evidence in our review of the State program that there is any shipment between the two dealers then we would have to accept the two classes. It was explained that he agreed with Mr. Girard that the problem is not the business of the Cooperative Program as such but that essentially what the above points do is to ask the health agencies in the United States to evaluate what they are doing now to ascertain if really adequate protection is being provided their own consumers and to tourists who may visit the area.

Mr. Trygg requested a show of hands of those for and against the above four points delineated by Mr. Jensen. Mr. Trygg then indicated that the show of hands indicated the majority were in favor of the concepts as given by Mr. Jensen.

Mr. Jensen then indicated that we must recognize that there are a few States who will abstain from any participation in these concepts for various reasons and that this would be reflected in the Proceedings.

Mr. Jensen then continued with his prepared paper and specifically presented the following three points, pertaining to sports harvesting, for endorsement by the Workshop:

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