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Mr. Woodfield recalled that at the last Workshop there had been considerable discussion of interim standards, and that the industry relied generally on technical people to provide a standard which industry can operate by and have their merchandise received on a satisfactory basis, rather than on a conditional or unconditional basis. He therefore favored acceptance of the proposal based on the confidence he had in the evaluation of the work accomplished during the three preceeding years.

Mr. Sarraf commented that during the year 1963-644, Pennsylvania was credited with having 195 cases of shellfish-associated hepatitis. He then indicated he would like to have some guarantees, that if we do set the standard at 78, or whatever, that we can be reasonably sure that the people consuming these products will not get sick. He inquired if any work had been done to correlate this number with disease transmission. Mr. Kelly replied that the proposed standard is applied to a product which is handled under the strict regulations of the Cooperative Program. Further that both the States and the Public Health Service have been working and collecting data for years and that the products have gone through commercial channels and people have not gotten sick. Additionally, we cannot operate with any standard that is at all dangerous because by the time the examination is completed the product is consumed. Mr. Kelly mentioned that although there have been cases of hepatitis, no one can say that they did not come from illegal sources since the cases of which we have good knowledge involved violations of program requirements.

Mr. McGinnes stated that the industry would like to see a standard established to which all States could subscribe so that there would be no difficulties in shipping to the various States. He indicated that he ships to six different States at the present time and hoped agreement on a standard could be reached at the Workshop. It was indicated he supported the proposal as written.

Mr. Bennett indicated that New York State had done some recent sampling in their area based on the new proposed standard (230 fecal coliform and 500,000 total plate count). Whenever they had samples exceeding the above, the shipping States had investigated and had reported back some discrepency or irregularity in that the plant was not following the Manual requirements. Therefore, based on their experience they were willing to go along with the proposal although New York would use a higher standard for their own production.

Mrs. Wallace commented that under seasonal and geographical variations which exist in the industry, the industry group believes the proposed standards to be acceptable, safe, and that the industry could live with them.

Mr. Trygg asked for a show of hands for the against the proposal, most votes appeared to be in favor of the proposal, but since the vote indicated no clear or decisive agreement, he called on Mr. Jensen to resolve the matter.

Mr. Jensen pointed out that the standards under discussion were not arrived at hurriedly and that the original work started 10-15 years ago as a result of some problems the Canadians had with very high counts in shellfish shipped into Canada from the United States. He stated every possible avenue had been investigated, that the two values, the 230 fecal coliform and the 500,000 plate count, were realistic in terms of what is currently being produced in the United States; and that there has been substantial improvements in the bacteriological quality of the products as a result of using the interim standards. He mentioned that Mr. Bennett had indicated New York used more stringent bacteriological standards for their own products, but that it should be remembered that their product can be marketed very soon after it is harvested and removed from the water. It is known from experience that New York standards could not be met on the Gulf Coast and that there is no use in establishing a set of standards that shellfish could not meet to begin with. It should be recognized that there has to be some element of compromise if the standard is to apply over a broad geographic area and that the standards are intended to apply only to shellfish that have been produced under the Cooperative Program in which shellfish are safe to eat when they are removed from the water. Further, standards serve the purpose, first, to reflect the refrigeration practices from the time they leave the shipper, and we feel these standards do this; secondly, they provide a clue to any gross errors that might have occured in the original classification of areas, and again we feel that these standards would be effective and safe. If it turns our that gross errors have been made, after 15 years study, we can come back in 2 years and make the necessary revisions. Insofar as the Public Health Service is concerned, Mr. Jensen said, it recommended the adoption of the standards, pointing out however that the individual States can establish much higher standards if they wish.

Mr. Trygg stated that it appeared that the Workshop had arrived at a point where the majority would like to adopt the proposed standards, but that there were a few who wanted to retain the 78 - 100,000 standard. He indicated that as to the legality of the standard, it would be up to each individual State to decide for themselves which standard they would enforce.

Inasmuch as the matter does not involve a change in the Shellfish Sanitation Manual it was therefore resolved by Mr. Trygg that the majority would use the proposed standard but there might be a very few who would use the previous inter im suggested standard of 78 - 100,000. (Refer to page 190 of 1961 Proceedings Shellfish Sanitation Workshop)

At 12:40 p.m. Mr. Trygg recessed the meeting for lunch.

Wednesday Afternoon

November 18, 1964

Mr. Robert Brown, Chairman

The Workshop reconvened at 1:40 pom. in the afternoon on November 18, 1964, with Mr. Robert Brown, Chief, Bureau of Environmental Hygiene, Maryland State Department of Health as Chairman. Mr. Brown called on Mr. Jensen for a word of summary concerning the morning session.

Mr. Jensen indicated that rather than leave the matter of bacteriological standards unresolved, he would prefer to have the record show that it appears to be the general concensus of the group that the standards as recommended in Mr. Kelly's paper would be acceptable. He would also want the record to show that at least two of the receiving States, Indiana and Pennsylvania have strong reservations regarding the use of these standards.

Mr. Brown asked the Workshop participants if there was any question concerning Mr. Jensen's summary statement. There being none, Mr. Brown introduced the next speaker, Dr. Ar thur F. Novak, Professor and Chairman, Department of Food Science and Technology, Louisiana State University, who spoke extempor anously on the subject, "Initial Survey on Clostridium Botulinum Toxin, Type E".

Initial Survey on Clostridium Botulinum. Type E:

Dr. Novak indicated that, under a grant from the U.S. Atomic Energy Commission there have been collected approximately 800 to 1,000 samples of mud, oysters, and shrimp from the Gulf area. To date investigators had been unable to isolate but one Clostridium from mud in the intercoas tal waterway and it was not Clostridium botulinum. Ne i ther had they been able to isolate one Clostridium botulinum from Gulf oysters or shrimp, nor had they found any type E. Toxin. They were currently looking into the possibility of determining whether or not any virus are associated with Gulf shrimp and oysters. He further indicated they had searched most of the health records from the Gulf States and have not been able to find one case of botulism attributed to Gulf Coast shellfish. (Dr. Novaks complete extemper aneous remarks are included as Appendix U of these Proceedings.)

At the conclusion of Dr. Novak's remarks, Mr. Brown introduced Mr. Somers B. Pringle, Shellfish Section, Division of Sanitary Engineering, South Carolina State Board of Health, to speak on the subject of "Study of Hot Dip Process".

Heat

Shock Method of Preparation of Oysters for Shucking:

Mr. Pringle first rey i ewed the field and Laboratory Studies on Heat Shock Method of Preparation of Oysters for Shucking conducted by the Shellfish section of the South Carolina State Board of Health in cooperation with the PHS Gulf Coast Shellfish Sanitation Research Center. Thirty-two lots of shellfish meats and process waters collected and examined during various stages of the commercial process. The bacterial content of the immersion waters was found to be consistently low. Viable coliform organisms were recovered in only 2 of 31 samples tested. Viable fecal coliforms were recovered in only 1 of the 31 samples. The 35°C plate count ranged from 5 to 3000 organisms per milliliter. Tables on densities of coliform, fecal coliform, and plante counts, of oyster meats, during the cold shucking v.s. the heat shucking were presented. It was concluded from

the studies that the heat-shock me thod shows a reduction in the bacteriological parameters which are used in assessing the bacterial qual tiy. (Mr. Pringle's complete paper on Field and Laboratory Studies on Heat-Shock Method of Preparation of Oysters for Shucking is included in these Proceedings in Appendix V.)

Mr. Pringle then reviewed the Economic and conservation Aspects of the Shock Immersion Process in Commercial Handling of Shellfish in South Carolina. He related the costs, yields, and economic benefits, derived from 4 plants using heat-shock method and presented a table of Economic Phases of "'Shock" Shucking as well as a questionaire form used in collecting the information. (Mr. Pringle's complete paper on the Economic and Conservation Aspects of the ''Shock" immersion Process in Commercial Handling of Shellfish in South Carolina is included in these Proceedings in Appendix V.)

In conclusion, Mr. Pringle presented to the Workshop a proposal that an Appendix D be inser ted in Part 11 of the Shellfish Sanitation Manual which would specify the sani tary measures which should be required of those plants using the heat-shock me thod of preparation of oysters for shucking. As part of the proposal he presented a document for Workshop discussion and action entitled Appendix D, Heat Shock Method of Preparation of Oysters for Shucking, which contained 8 items of sanitation requirements, complete with Public Health explanation, and with Satisfactory Compliance sub-i tems. (The ''Appendix D" Manual inclusion as proposed by Mr. Pringle is included in these Proceedings in Appendix V.)

Mr. Brinsfield inquired if the oysters used in the bacteriological examinations were washed in the laboratory, as it has been their experience that lower bacteriological results were obtained on shellstock when washed in the laboratory than when taken from their own liquor. Mr. Kelly indicated that all samples were examined in accordance with APHA recommended procedures.

Mr. Caldwell indicated he basically agreed with Mr. Pringle's proposal but that the wording relative to "found in one State" was questionable as they had a cluster-type oyster in North Carolina which were being used and that they would like to review the proposal before it was incorporated as Appendix 0 in the Manual. Mr. Pringle indicated the terminology was merely pointing out that there was some investigative work going on in one State as it was known that North Carolina was using the process, as well as possibly Florida. Mr. Caldwell agreed that the proposal was basically good but he thought the time and temperature relationships used in North Carolina were different from those contained in the proposal and he would like to have time to discuss this with the North Carolina industry people. Mr. Pringle suggested that perhaps the PHS might conduct research with North Carolina based on the time factors used in North Carolina. He indicated that when South Carolina first investigated the problem there was no control of the process at all. They had attempted making the process more sophisticated in refinement by doing experimental work, and had arrived at a 150 degree temperature. Mr. Pringle asked Mr. Caldwell if he put any of his plants using the process on the certified list of shellfish shippers. Mr. Salley indicated such plants were evaluated by the PHS in making the North Carolina program evaluations.

Mr. Keys asked Mr. Caldwell whether the oysters picked in the North Carolina process were construed as being fresh oysters or cooked oysters. Mr. Caldwell said they had discussed this with the North Carolina Department of Agriculture and they were waiting to see what the Workshop was going to do. Mr. Caldwell indicated there is very little change in the appearance of the oyster. A small difference in pH has been noted; the enzymes are altered with the heat process; and the oyster might have a milky cast. There is a certain section in North Carolina where these oysters are preferred to the cold-shucked oyster. It also has helped the economy of the area. They felt in North Carolina that if there was a temperature in excess of 143°F. it helped lower the pathogenic content of the product. As the detention time is increased and as the temperature is increased, there is produced a safer product.

Mr. Pringle said that he had no objection to the movement of North Carolina heat shocked oysters into South Carolina in interstate commerce, and was merely asking that South Carolina heat-shocked oysters be allowed to also move in interstate commerce based on the provisions of the proposed Appendix D.

Mr. Allen commented that it seemed to him Mr. Pringle has developed and followed through on a process that has been in use for several years, he has gone to considerable lengths to show that the product is as safe as conventionally shucked oysters; and if it is accepted by the Public Health Service then certainly the product should be acceptable to the Workshop.

Mr. McGinnis inquired if the oyster shucked was considered a fresh oyster. Mr. Pringle replied that the oyster was shucked as you would shuck any other oyster; and that in the work where investigations were made on the physical characteristics of the oyster, at the Shellfish Sanitation Research Center in Narragansett, was unable to detect any indications of physical change, this was contained in their report.

Mr. Jensen said that it was obvious that the Public Health Service was in complete agreement with Mr. Pringle's proposal, that the standards should be included as an Appendix to Part 11 of the Manual. Mr. Pringle then pointed out that his paper was really a product of the Public Health Service and they had allowed him the previlege of presenting it.

Mr. Harrison inquired whether anyone from the Public Health Service had approached the Food and Drug Administration as to proper labeling for the product. Mr. Pringle replied that the question had been posed to Dr. Slocum during the 1961 Workshop but that he had been unable to provide a definite answer at that time. Mr. Kelly then requested Dr. Russell to comment on this point.

Dr. Russell indicated that one of the problems they were concerned with was whether the oyster was raw or cooked and not whether it was a live oyster. It was indicated the Shellfish Research Center conducted some studies with heart beat, cilia movement, deactivation of enzymes, etc., under the conditions proposed--which was up to 150°F. for a period of three minutes, plus or minus 30 seconds , --and that the oyster did not appear to be like a cooked oyster and that they cons i dered it to be a raw oyster. Dr. Russell further indicated the FDA would probably have a rather difficult time themselves making a decision. Up to the temperatures (150°F.) that were used, the oyster was considered as a raw oyster. Going to 160°F Ewould be some thing else, but we are not asking for 160°, as we are only asking for 150° F. as the maximum.

The Chairman, Mr. Brown, asked for a show of hands of those in favor and those against the proposal. He then indicated it was his reading of the show of hands that a fairly subs tan tual approval of those voting were in favor of the proposal by Mr. Pringle although he noted there were a number abstaining from voting.

Mr. Brown then introduced Mr. James Silva, PHS, to present the Proposed Changes in Part 1 of the Shellfish Sanitation Manual for cons i deration by the Workshop.

Proposed Changes in Part 1 of the Manual:

Mr. Silva directed the attention of the Workshop participants to a mimeographed sheet forwarded with the packet of informational materials sent to all participants in advance of the Workshop and which was entitled, "FOREWARD, A Declaration of Principles". (The complete Foreword is included in these proceedings as Appendix W.)

Mr. Silva indicated that when Parts 1 and 11 of the Shellfish Sanitation Manual are revised after the workshop, the Public Health Service is proposing that a Foreword, as worded in Appendix W, be inserted in Parts 1 and 11. Mr. Silva then, in order to conserve time, read the three "principles" on Page 2 of the proposed Foreword which are as follows:

1. Shellfish are a renewable natural resource of significant economical value

to many coastal communities, and should be treated as are other natural
resources such as forest, water and agricultural lands.

2. Shellfish culture and harvesting represents a beneficial use of water in

the es tuaries. This use should be recognized by State and Federal agencies in planning and carrying out pollution prevention and abatement programs

and in comprehensive planning for the use of these areas. 3. The goals of the National Shellfish Sanitation Program are: (1) the con

tinued safe use of this natural resource and (2) active encouragement of water quality programs which will preserve all possible coastal areas for this beneficial use.

Mr. Brown then indicated that the question before the workshop was approval of a Foreword for the Shellfish Sanitation Manual.

Mr. Bower indicated he was not too happy with certain wording of item one although he went along with the intent of the proposal. Specifically he objected to the words 'which should be treated as are other natural resources such as forest, water and agricultural lands," because he noted, since we have not taken care of our water, we do not want the shellfish industry treated as our water resources had been treated. He indicated also that as much weight should be given to this resource, as is given to our other natural resources.

Mr. Jensen suggested that item one be reworded as follows:

''Shellfish are a renewable, manageable resource of significant economic value to the commun i ty and should be managed as carefully as are other natural resources."

Mr. Bower agreed.

Mr. Gregory asked whether shellfish were not treated as a natureal resource by the States and should we think of natural resource management from the State level or think of it as a concept of national management

Mr. Jensen pointed out that even though they may be thought of as a natural resource in some States, this would not hold everywhere. He cited as an example, that Mr. Goggins had indicated there were over 46,000 acres closed in Maine which was like saying that 46,000 acres of forest land were allowed to burn. He pointed out that although they may be managed as a natural resource, he doubted they had been managed in the same way forest agencies, both State and Federal, manage forest resources.

Mr. Gregory indicated this was an acceptable idea.

Mrs. Wallace said that in her opening remarks at the beginning of thw Workshop the industry recommended this be adopted.

Mr. Brown then asked if there were any further objections which had not been resolved by the above named change in wording to be considered. There being no response he inquired if there was nay objection from anyone as to including the revised Foreword in the Manual. There veing no objection declared, he indicated it would be included in the next Manual revision.

Mr. Silva presented the next series of proposals as follows:*

PART 1

SANITATION OF SHELLFISH GROWING AREAS

1.

Suggested Change. Definition of the Word ''Shellfish" in Parts 1 and 11
of the Manual: The definition of 'shellfish" differs in Parts and 11
of the Manual, and they should be identical.

The definition in Part 1 is presently stated as follows:

Shellfish.--All edible species of oysters, clams, or mussels.
Shellfish products which contain any material other thant the
meats and/or shell liquor of oysters, clams, or mussels will
be regarded as a 'processed food" and will not be included
in the Cooperative Program.

The definition in Part 11 is presently worded as follows:

Shellfish. --All edible species of oysters, clams, or mussels,
either shucked or in the shell, fresh or frozen. (For the
purpose of this Manual, the term does not include crabs, shrimp,
or lobsters.)

(The complete paper from which Mr. Silva's presentation was made is included in these proceedings as Appendix X.)

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