1. That there be an endorsement of the principle of a single sanitation standard for all shellfish sold or harvested in the United States;

2. That each State be recommended to examine how it controis the problem of sports harvesting and that each coastal State be urged to take necessary steps to prevent or discourage the harvesting of shellfish from contaminated or toxic areas; and

3. That the Public Health Service be requested to prepare a yearly report on the status of this problem and that the resulting report be made available to interested organizations, such as ASTHO, CSSE, ASMFC, etc., and the States.

Mr. Trygg indicated the above as delinated by Mr. Jensen was now open for comment and that although they were in essence very similar to the previous ones discussed it would be desirable to have a record of the group opinion.

Mr. Bennett raised a question as to whether use of the word "sold" in the first item implied interest in the boats or equipment used in sports harvesting or whether the application referred to the location of harvesting.

Mr. Jensen indicated the most important word here was "harvesting" and it was not intended to indicate interest in the methods and equipment used for sports harvesting. Mr. Bennett indicated that in that event the State of New York was in accord with Mr. Jensen's proposal.

An unidentified voice among the Workshop participants suggested that the words "sold or" be removed from the first item as a person engaged in sports harvesting was obstensibly not harvesting for sale.

Mr. Jensen agreed to removal of the words "sold or" from the item.

The Chairman, Mr. Trygg, indicated that the record would show the removal of the two words "sold or."

Mr. Pringle raised the point that this would give any person the opportunity to pick oysters out of polluted water. Mr. Jensen said this is almost a God-given right in some States, and that the custom goes back to the days of colonial settlement. Mr. Pringle suggested that the item might be changed to read "prohibition of taking for any purposes" as it is part of the State Health Departments duty to prevent people from making themselves sick. Mr. Jensen indicated this was his view and he thought it was of no business of the Cooperative Program as such, but it is something we have an obligation to bring to the attention of the appropriate interest groups.

Mr. McIntyre commented in reply to Mr. Pringle's point that he worked in one State where the State prohibited harvesting for commercial purposes from polluted waters and the Fish and Wildlife Service of the same State advertised that particular place as excellent for sports harvesting of shellfish. Mr. Pringle replied that in the State of South Carolina, it is the State Board of Health that declares what lands are open or closed, that commercial fisheries lease land, and that the State Board of Health declares closed areas.

Mr. Trygg pointed out that he did not understand some of the discussion as it seemed to him the Workshop as a group should be interested in anything that is good for industry over-all and that he, as State Sanitary Engineer wanted standards covering harvesting to be just as rigid in his State, for his people, as it is for others harvesting shellfish to be shipped. He then called for a show of hands from those who were in favor of the last three principles delineated by Mr. Jensen, and subsequently, a show of hands of those not in favor. He then indicated that since there were no hands raised in opposition to the proposal that the record showed that some participants abstained from voting and apparently had no feeling in regard to the matter.

Report on "Bacteriological Criteria for Shellfish Growing Areas" by William J. Beck
Director Northwest Shellfish Sanitation Laboratory. Purdy. Washington

Mr. Beck's paper was presented by Mr. C. B. Kelly. It summarized the data collected by the States and the Public Health Service regarding the use of the fecal

coliform test in evaluating growing areas and presented a proposed fecal coliform standard for use as an alternate to the present growing area water standard. The proposed fecal coliform standard would be used as an alternate to sub Item c, Section B, page 13 of Part 1 of the 1962 Revised Shellfish Sanitation Manual worded as follows:

Suggested Change. Page 13. Item 3 Approved Areas:

It is proposed that a new sub-item (d) be added after Item c which would read as follows:

Agencies not desiring to use the above shellfish growing water standard may alternately use the following:

The fecal coliform median MPN of the water does not exceed 7.8 per 100 ml. and not more than 10 percent of the samples exceed a fecal coliform MPN of 33 per 100 ml, (or 46 per 100 ml where a 3-tube decimal dilution test is used) in those portions of the area most probably exposed to fecal contamination during the most unfavorable hydrographic and pollution conditions. (Note: Under no circumstances should these standards be used to usurp sanitary surveys and other criteria for approved areas as outlined in Sanitation of Shellfish Growing Areas, Part 1, Section C.) (Mr. Beck's complete paper is included as Appendix S of these Proceedings.)

Mr. Hope inquired of Mr. Kelly whether the 24 hour incubation period should be used in the test for fecal coliform organisms. Mr. Kelly explained that one of the recommendations made by Mr. Beck was that the 24 hour incubation be accepted. He further pointed out that the 24 hour incubation period is recommended for the fecal coliform test of fresh water by the Water Supply and Pollution Laboratory at the Sanitary Engineering Center in Cincinnati.

Mr. Goggins pointed out that Maine was one of the States from which no fecal coliform data was received. The Department of Sea and Shore Fisheries has taken over full responsibility of evaluating growing areas in Maine and have accumulated some data since the last Workshop. This data tentatively indicates Maine could not meet the 7.8 E.C. fecal coliform standards. However they would go along with this as a supplementary test and discuss the failure at the next Workshop.

Dr. Tennant indicated they had been running this test in Canada for some time. However, they have not yet had the chance to analyze the data accumulated in the last 10 years or so in the light of the new proposed standard. He felt that for certain areas, it will be somewhat too severe. He believed that in certain areas it would not relate to the former standard of 70. It was indicated that if one refers to table 2, it will be noted that the median of the incidence of fecal coliform types, is likely to range from 11 percent to almost 100 percent. The new standard seems to demand that if the area is to meet the old standard of 70 for the total group and the new standard of 7.8 fecal coliforms, the incidence would only be approximately 11 percent. We know that in some areas it is almost 100 percent and that in some of these areas they would be unable to meet the new standard.

Mr. Trygg commented that perhaps the Workshop ought to have a clarification of the terminology at this point. He pointed out that the test being talked about is the fecal coliform test and not the E. Coli test.

Mr. Jensen indicated that he was having difficulty with some of the statistics in the proposal. Under the existing coliform standard of median 70 and the 90 percentile of 230 there is a statistical relationship between the two, in that 230 is approximately at the 95% confidence limit of the 70. The same relationship does not seem to hold in the two figures which Mr. Beck has given. Mr. Jensen wondered whether the figure 33 was the upper 95% confidence limit of 7.8.

Mr. Kelly remarked that this was checked out since we were sensitive to the need for holding to this relationship. The figure 33 is closer to the 95 percentile upper limit of 7.8 than is 23, the next lower MPN in the table. He said it was preferable to err in the area of greater public health protection.

Mr. Trygg commented that he had spent some time prior to the morning session with Mr. Kelly in reviewing past surveys in view of the new standards and found themselves in somewhat of an untenable position and had prepared maps and reports of their

growing areas. As an illustration he held up a map showing plotted points on a regular survey and plotted points in red in evaluating the fecal coliform proposed standards. He noted there were six areas which would not comply with the proposed standard. Mr. Trygg emphasized that Louisiana has a lot of coastal and swampy area away from population centers with no pollution other than that from wild life. It was indicated that he and Mr. Kelly had come up with the term "supplementary" and he inquired of Mr. Kelly if in presenting the new standard orally he meant acceptance as a supplementary method rather than an alternate method.

Mr. Kelly indicated that whether it should be considered as "supplementary" or "alternate" was part of the discussion.

Mr. Trygg then indicated the question before the group was whether to accept the proposed standards as supplementary to the present standards with the thought that perhaps at the next Workshop they could be made a true alternate standard.

Mr. Carpenter indicated he thought the Workshop should note the difference between an alternate and supplementary standard. Mr. Trygg indicated a more fundamental decision is whether it should be included in the Manual, and then whether it would be "alternate" or supplementary. An unidentified person speaking from among the participants suggested that if there was going to be a change in the Manual, that it be an "alternate" rather than "supplementary."

Mr. Bellis commented that he thought that all can recognize the value of looking into the fecal coliform test, but at this point in time do we really want to change the Manual or do we want to accept this on an interim basis as a supplementary test? It would seem to him more practical than going through the formality of changing the Manual.

Mr. Trygg suggested that those in the group who had not applied this standard to their growing areas should do so before accepting the standard. He further indicated that Louisiana had applied the new standards to their growing areas and he was not entirely satisfied with them.

Mr. Jensen suggested that the Workshop might be well advised to consider this meeting as endorsing Mr. Beck's proposal as a supplemental method which could be used, and that the Workshop not go through the formalities of making a change in the Manual at this time.

Mr. Gregory pointed out that we had had to change our interim standards for oysters several times so perhaps we should not be too hasty in adopting this proposal.

Mr. Trygg then asked for a show of hands regarding Mr. Jensen's proposal which would not change the Manual but which would use the suggested fecal coliform standard as a supplementary method for study purposes for the next year or several years. Mr. Trygg indicated the "ayes" have it as there was no response from the Workshop participants to the contrary.

Report on "Interim Bacteriological Criteria for Oysters"

Mr. C. B. Kelly, Chief, Research and Investigations Section, Shellfish Branch, Public Health Service, presented a prepared paper on the above subject which summarized the entensive tests on market oysters by the States and the Public Health Service and which included the following recommendations and proposal for adoption by the Workshop:

RECOMMENDATIONS

The following standards are recommended to be applied to all shucked oysters at the wholesale level as received in interstate shipment. Except for four changes, the standards are the same as the current interim criteria for shucked Eastern oysters. The first two changes are suggested to accomplish uniformity with the recommended criteria for shellfish growing areas. The third change would more accurately define the technique for bacteria counts and the fourth would convert the numerical expressions of density to currently accepted terms. The changes are:

1. Substitute "fecal coliforms" for "E. coli."

2.

3.

Revise the definition of the fecal coliform group.
Change the incubation period from 48 to 24 hours and

stipulate the conditions for use of 45.5°C. air incubation.

Substitute 'plate count per gram" for "total bacteria per ml."

4. Substitute "MPN per 100 grams" for "MPM per 100 ml."

Accordingly, it is the recommendation of the Public Health Service that the Workshop adopt the following proposed standard for shucked oysters:

Bacteriological Standards for Shucked Oysters at the Wholesale Market Level

Satisfactory

*

Fecal coliform density of not more than 230 MPN per 100 grams and 35°C. plate counts of not more than 500,000 per gram will constitute a conditional sample and may be subject to rejection by the State shellfish regulatory authority. If these concentrations are found in two successive samples from the same shipper, the State regulatory authority at the source will be requested to supply information to the receiving State concerning the status of operation of this shipper. Future shipments to receiving markets by the shipper concerned will depend upon satisfactory operationsl reports by the shellfish regulatory authorities at the point of origin.

Mr. Kelly's complete paper is included as Appendix T of these Proceedings.

At the conclusion of Mr. Kelly's presentation, Mr. Trygg, the Chairman, indicated the discussion was now open for comments from the floor.

Mr. Fisher said that he had previously discussed this recommendation and proposal with Mr. Kelly and that it was the view in Indiana that the proposal constituted a relaxation of the bacteriological standards for oysters. He mentioned that in Indiana it had been found that the industry can meet the original MPN of 78 and a plate count of 100,000 because last year's sampling showed a much higher percentage of satisfactory samples than the year before. He believed that 78 MPN for the fecal Coliform and the 100,000 standard plate count is a true criteria of a satisfactory sample and that they would continue to take action on samples on a similar basis as they did in 1962. Mr. Kelly, in continuing the discussion, pointed out that 78 was not the only figure mentioned in the 1962 standard. Also, 230 was mentioned and was acceptable if it did not violate the frequency established.

Mr. Sarraf indicated he concurred with Mr. Fisher's remark to the extent that they had carried out an extensive sampling program in Pennsylvania for the past two years and found that the shippers shipping into their State were able to meet the 78 fecal coliform density. He then posed a question: "Assuming we set a 78 or 230, or 500 or any other figure, are we saying then that if we do meet these standards you will not get sick from eating these shellfish?" He indicated that as far as Pennsylvania is concerned, it was believed there, they would go along with Indiana in saying they would accept shellfish having the fecal coliform density of 78, and not 230.

* Fecal coliform organisms are those which, on transfer to E. C. Medium from gas
positive presumptive broth tubes show production of gas after incubation in a
water bath at 44.5 C. 0.2 C. for 24 hours. Where air incubation is at
45.5°C. 0.2°C. utilized, comparative tests must be made to determine com-
parable time of incubation.

** Plate count is the number of bacteria determined by the "Standard Plate Count" procedure for shellfish described in the third edition of the APHA Recommended Procedures for the Bacteriological Examination of Sea Water and Shellfish.

Mr. Goggins stated he could not comment on oyster count results but in Maine they had been evaluating clams, both those shipped intrastate and those shipped out of State, for approximately eight months, and they had found a very confusing situation. He indicated that total plate counts had not been found useful. They did find a dramatic increase in coliform with what they thought was a breakdown in refrigeration. Clams fresh from the growing water had low coliform levels. When they reach the plant or market level they had extremely high coliforms with low total plate counts. He inquired if this might happen with oysters: Mr. Kelly indicated that there was the possibility that there might be a decrease in coliforms in the later stages of storage because of growth of competing micro-organisms.

Mr. Bellis indicated that when you come to the practical application of a standard, it did not appear to him that what had been proposed was truly a standard. "Granted that it is more or less a guideline, he said, it still does not specify anything unsatisfactory." Mr. Bellis suggested that the standard should specify what is unsatisfactory.

Mr. Kelly indicated he agreed with Mr. Bellis to a point but that we should remember that the proposed standard assumes that the products have been handled under the requirements of the certification program and that unless this assumption is made then we can not consider any numerical value. He felt that this point also answers the question about whether or not the standards preclude anyone getting sick. Further, although the title says conditional, it does allow for rejection of the product within the text of the conditional section.

Mr. D'Alfonso indicated that those in the Gulf area had had some problems with the interim standards. He remarked that the interim standards introduced in 1958 had been used to condemn their oysters when received in eastern markets. As a result the 1963 Gulf Coast Shellfish Conference requested that the interest of the 1958 interim standards be explained and they had gone on record to state that they preferred the fecal coliform test of 230. They found in 1962 that only sixty percent of their oysters could comply under the 230 standards. However, in 1963 and 1964 after improvements in some of their conditions they could comply in 92.5 percent of the shipments. Mr. D'Alfonso further remarked that he and his co-workers in the Gulf States believe that the 230 standard is more applicable in the Gulf States than the 78.

Mr. Girard commented that the interim standards applied only to eastern oysters, but as proposed at this time they would include the Pacific oyster and the Olympia oyster. He then stated that the data accumulated on the West Coast for the Pacific oyster is rather meager. The first time an extensive survey was made was in 1961-62, and there is no data at all for the Olympia oyster. He recommended that the Workshop endorse the standard as proposed by Mr. Kelly.

Mr. Howell indicated that he was in favor of the standard as proposed since our technology and our controls have not progressed to the point where we can effectively state a number and say that at this level it will cause illness.

Mr. Bellis questioned whether the standard being proposed had any true public health significance. He also pointed out that the decision as to whether the proposed standard was to be used or not was the State's.

Mr. Redman inquired if there really was a significant difference between an MPN of 78 and one of 230. Mr. Kelly replied that if we apply the confidence limits of .33 and 3.3 to 78 and 230 there is some overlapping, but there still is some significant difference.

Mr. Bower indicated that, although West Coast oyster-producers had some reservations about the proposal, they would go along with it as long as the word 'may" was used in the phrase, 'may be subject to rejection by the State shellfish regulatory authority."

Captain Chandler indicated the military was quite interested in acceptance of some type of standard since it procured and estimated million pounds a year. He said that although 78 is optimum, the military would go along with 230 if the Public Health Service feels it would provide ample protection.