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Discussion: We propose to simplify the definition as the previous inclusion of references to processed food and to crabs, shrimp, or lobsters appears to unduly complicate the definition.

Shellfish. --All edible species of oysters, clams, or mussels, either shucked or in the shell, fresh or frozen.

Recommendation: That the workshop endorse the above-proposed definition of
shellfish.

Mr. Hollis inquired whether there was any intention or need to include mollusks such as snails and conch in this definition.

Mr. Silva indicated that historically the program had confined itself to clams, oysters, and mussels, because these animals are frequently eaten raw, and it was the intent of the Public Health Service to make the definitions in both parts of the Manual the same.

In the absence of further discussion the proposed change was accepted.

2.

Suggested Change, Page 4, Section A. "Satisfactory Compliance. "Sub-item
la of item 1: That the first sentence of sub-i tem (a) be changed to
read:

a.

Classify all actual or potential shellfish growing areas
as to their suitability for shellfish harvesting on the
basis of sanitary quality as defined in Section C of this
Manual, and to make compensatory changes in the related
Public-Health Explanation and Satisfactory Compliance
portions of the item as well as other items which contain
similar wording and intent.

Discussion: It has been pointed out by several States that it should not be necessary to classify waters which for biological reasons will not support shellfish production. Accordingly, the above-suggested change requires classification of actual or potential shellfish-growing areas rather than all coastal waters.

Recommendation: That the Workshop endorse the above change.

The suggested change was adopted without discussion.

3.

Suggested Change, Page 6, Section A, Item 2. Sub-i tem (e) of "Satisfactory
Compliance'': That the words "and inspection" be deleted from sub-i tem (e).
This sub-i tem would then read as follows:

e.

The following records are kept of shellfish sanitation activities
as required in Sections, C, D, & E, Part 1 of this Manual, and
when monthly summaries of State patrol activities are forwarded
to the Public Health Service Regional Office.

Discussion: The monthly summaries of plant inspections forwarded by the
States to the Public Health Service Regional Offices have not been useful

Recommendation: That the Workshop endorse the above revision.

The suggested change was adopted without discussion.

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Suggested Change. Page 9. Section c. Item 1. Sub-item (a) of "Satisfactory
Compliance'': That the word "pesticides" be inserted after the word 'was tes"
in the second sentence of sub-i tem (a) which would then be changed to read
as follows:

A comprehensive sanitary survey shall include evaluation of all sources
of actual or potential pollution on the estuary and its tributaries,
and the distance of such sources from the growing areas; effectiveness
and reliability of sewage treatment works; the presence of industrial

was tes, pesticides, or radionuclides which would cause a public-health hazard to the consumer of the shellfish; and the effect of wind, stream flow, and tidal currents in distributing polluting materials over the growing areas.

Discussion: The increased use of herbicides, insecticides, and other chemicals for predator control, constitutes a potential hazard to shellfish growing waters which regulatory authorities have to consider in conducting sanitary surveys of growing areas. It is necessary that the word "pesticides" be included in this sentence to provide Manual coverage of the practice.

Recommendation: That the word "pesticides" be inserted in the above section.

Mr. Boschetti indicated that he knew laboratory tests could determine DDT levels but inquired what levels should be established in determining whether growing areas should be closed or remain open.

Mr. Silva indicated that the intent was to require evaluation of the presence of pesticides in the same manner one would evaluate the presence of industrial was tes or radionuclides in growing areas.

Mr. Jensen indicated that the Public Health Service does not have a good answer for the levels or tolerances in growing areas because the Food and Drug Administration establishes acceptable tolerance levels in foods. Officially, the Public Health Service has brought the problem to the attention of the Food and Drug Administration. The problem will be resolved in one way or another in the near future. He pointed out that the proposed change was not inconsistent, but is saying that we recognize that the presence of pesticides in shellfish may be a public health hazard. Our research centers have been doing a great deal of pesticide analysis work and it is known that minute quantities of pesticides are found in some of the growing areas. Mr. Jensen agreed that this information may not provide a good answer, but he indicated that a solution to the problem would be worked out with FDA.

Mr. Brinsfield pointed out that in the case of milk, FDA was not interested in how much pesticide was in the feed or in the water, but how much there was in the milk. He thought FDA would not be interested primarily in how much pesticide was in the shellfish growing water, but how much was in the seafood.

Mr. Boschetti indicated that under the proposed change he still has to evaluate the significance of the presence of pesticides in growing waters and said the change provided no basis on which he could make an evaluation. He suggested deletion of this proposal for this reason.

Mr. Allen indicated that he agreed with Mr. Boschetti inasmuch as we had a hot potato, that we did not know what to do with. We know about the critical situation in Louisiana where they have pesticides in growing areas." He said that unless someone could tell him how much was too much, especially since a great deal of it seemed to be run-off from agricultural areas, he felt the proposal should be dropped for awhile.

Mr. Jensen disagreed with Mr. Allen as to pesticides in shellfish. He pointed out that we have information on the levels of pesticides in their growing areas and in the shellfish, and that this information has been made available to the FDA. Without moni toring, there could only be speculation as to the actual pesticide level, and the possible hazard to public health. Mr. Jensen expressed the view that he was certain a realistic tolerance level both for waters and shellfish would be established.

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Mr. Harrison indicated he agreed with those who opposed the insertion of the word as it did not seem to him to be practical since we had no standards or basis of fact to judge the areas.

Mr. Trygg pointed out that they all should be monitoring for pesticides because if they did not they might be placed in a very embarrassing situation.

Mr. Boschetti said he did not object to the subject being in the Manual but objected to it being in that portion which directed the States to evaluate. "If you are going to test for pesticides, he said, you have to evaluate." He confessed he did not know how to evaluate some of these substances,

Mr. Gruble spoke on behalf of the West Coast industry and indicated they would like to see the proposal included as they had been faced with spraying of lands by various State agencies and have always come up with the fact that no adequate record of levels of pesticides in growing areas was available. He believed that someone ought to start mon i toring these waters and have the record in hand before the industry finds itself out of business.

Mr. Jensen explained that in putting the proposal in the Manual, we are not putting it in as a set of quality standards but saying that data should be collected to establish facts upon which a decision can be made as to whether the growing area is acceptable. Ignoring the problem and hoping it will go away is totally unsatisfactory. He said that by putting a single word in the manual, attention is focussed on the problem, and a reason provided to the States for doing it.

Mr. Brown asked for a showing of hands for and against the proposal. He also announced that although there were a few opposing the proposal, since the predominant sentiment was favorable, the proposal was therefore deemed accepted.

IDENTIFICATION PROPOSAL

5. Suggested Change, Page 1, Section Co Item li That a new sub-i tem (d) be inserted

after sub-Item (c) which would be worded as follows:

d. The State agency having primary responsibility for this element of the

Cooperative Program develops a system for identification of growing
areas.

Discussion: Experience has indicated that it is highly desirable that records
and tags should contain information as to the growing area source of shell stock.
The first step in attaining this achievement is for each State to develop a
growing area identification system.

Recommendation: That the Workshop endorse the addition of the above sub-i tem to
Section C, i tem 1, page 9.

Mr. Hobbs inquired whether a number system or common name system for identification should be used for each growing area. "If it meant either, he said, it would be acceptable to Maryland."

Mr. Silva indicated that a previous proposal submitted to the States had permitted only a numerical system, but that this had been changed in order to permit the States the necessary latitude in using either.

In the absence of further discussion the proposal was accepted.

6. Suggested Change, Page 11. Section C. Last Sentence of Item li

That the words 'within one year" be inserted between the word 'made" and the
word "if" in the last sentence of item 1, page 11. Further, that the word
"detrimental" be inserted between the words "significant" and "change."

A resurvey should be made within one year if the reappraisal shows a signnificant detrimental change.

Discussion: The present wording indicates a resurvey should be made if the reappraisal shows a significant change, but does not indicate any time element. It is our belief that a year's time should be established for a resurvey if one is indicated to be necessary by the reappraisal.

Recommendation: That the Workshop endorse the above insertion of the words
'within one year" and the word "detrimental" in the last sentence of item 1.

The proposal was adopted without further comment.

7. Suggested Change. Page 11, Section Co Item 2: That a footnote be added to i tem 2

indicating that some States may wish to use other terms in describing classification of areas. Accordingly the following wording for the footnote is proposed:

*States may use other terms or terminology in describing area
classification; provided, that the classification terms used
are consistent with the intent and meaning of the words
"approved," "conditionally approved," "restricted," or
"prohibited."

Discussion: One State has indicated they do not like the term "conditionally
approved areas." We have no objection to any State using other terms in
describing the classification in sub-i tem (a).

Recommendation: That the Workshop endorse the above footnote.

The proposal was adopted without further comment.

8. Suggested Change, Page 13. Section c. Item 3: That the word 'besticides"

be inserted after the word "radionuclides" in the first paragraph of this
i tem. Further, that the words 'whenever the sanitary survey indicates the need"
be substituted for the words "insofar as possible" in the next to last line of
the paragraph. The first paragraph would then read:

3. Approved Areas.-- Growing areas may be designated as approved when: (a) the

sanitary survey indicates that pathogenic micro-organisms, radionuclides, pesticides, and/or harmful industrial was tes do not reach the area in dangerous concentration, and (b) this is verified by laboratory findings whenever the sanitary survey indicates the need. Shellfish may be taken from such areas for direct marketing.

Discussion: The increased use of herbicides, insecticides and other chemicals has
discussed in the previously recommended change No. 4; consequently, this change is
necessary as a follow-up on the previous recommendation. It is thought the words
'Whenever the sanitary survey indicates the need" is more definitive than the
words "insofar as possible." Co ensatory changes will be necessary in sub-item
(b) of the satisfactory compliance portion.

Recommendation: That the Workshop endorse the above additions.

After discussion of the proposal at some length, which was very similar to the discussion of item No. 4 above, the Workshop decided to withhold acceptance of this proposal until tolerance levels or standards were established.

Dr. Litsky requested that he be permitted to say a few words on the problem of pesticides. He stated that three years ago the cranberry growers of Massachusetts were 'clubbed" severely because of pesticide residuals and that all those present knew what happened to a great industry. He pointed out that although the States had indicated they did not object to the Federal government doing the work, he pleaded with the States to realize that it was not the Federal government's responsibility to direct State laboratories. He pointed out that mon i toring for pesticides is everyone's problem, including the shellfisheries industry, the States, and the Federal government. He urged that the States put pressure on their State universities to do research in this area, and on industry to put pressure on their States to mon i tor. He warned that if the States do not work with the Federal government in this, another cranberry fiasco may be a result.

9. Suggested Change, Page 13, Section Co Item 3: That the word ''or" be inserted at

the end of sub-item (c) and a new paragraph "id" be inserted after the present
sub-item (c) in accordance with Mr. Beck's proposal.

(Refer to Mr. William J. Beck's paper on Bacteriological Criteria for Shellfish Growing Waters for consideration of the proposal regarding an alternate bacteriological standard for growing waters.)

Mr. Silva explained that this item referred to the inclusion of an alternate growing area standard which had been discussed that morning, and it was decided that the use of this standard would be endorsed on a supplemental basis but would not be included as a change in the Manual. States would use it on a supplemental basis with their growing area evaluations but it would not be included as a standard in the Manual.

Mr. Pringle asked if he was correct in assuming it would not be used as an alternate, Mr. Silva replied in the affirmative.

There being no further comment, Mr. Brown indicated the above would be considered as reaffirming the previous action taken by the Workshop on this proposal. (Refer to the discussion under Mr. William J. Bock's paper on page 22.

10. Suggested Change, Page 18. the Heading, the First Sentence of Item 2. Sub-i tem

(a) of "Satisfactory Compliance" on Page 19. That the word "paralytic' be
deleted from the item wherever it is presently used. The heading would be changed
to read as follows:

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The State shellfish control agency shall regularly collect and assay repre• sentative samples of shellfish from growing areas where shellfish toxins are

likely to occur. Sub-i tem (a) of the Satisfactory Compliance portion on page 19 would be changed to read as follows:

a.

The State shellfish control agency collects and assays representative samples of shellfish for the presence of toxins from each suspected growing area during the harvesting season.

Discussion: The occurrence of toxins in Gulf State waters which may not be
related to the "Paralytic Shellfish Poison" of Northeast waters or Pacific
Coast waters indicates the need for a change in wording of this item so as to
include all and any forms of toxins which may appear in shellfish growing waters.

Recommendation: That the proposed change be endorsed by the Workshop.

The proposal was adopted without further comment.

11. Suggested Change, Page 20, Section De Item 1. Sub-item (b) of "Satisfactory

Compliance'': That the word "direct" in this sub-i tem be replaced by the word "continuous. This sentence would then read as follows:

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However, continuous supervision will not be necessary if relaying operations are carried out during a period when shellfish may not be marketed.

Discussion: It is desirable that all relaying operations be under the immediate supervision of the State shellfish control or patrol agency. However, it has been pointed out that where closed marketing seasons exist for some species in one State, they would have difficulty complying with this item if "direct supervision" were indicated, but could comply if the words "continuous supervision" were used.

Recommendation:

That the Workshop endorse the above change.

The proposal was adopted without further comment.

That the wording

12. Suggested Change, Page 20, Section D. Sub-item (c) of item 1:

of sub-i tem (c) be changed to read as follows:

C.

State permission to relay shellfish is given only to responsible
persons; responsibility to be determined by the past record of the
permit applicant.

The present wording of this sub-item is presented below:

C.

State permission to relay shellfish is given only to responsible
persons, unless the entire operation is under direct supervision
of the State. Responsibility shall, when possible, be determined by
the past record of the permit applicant. it is recommended that
applicants be required to post performance bonds.

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