7 Regulatory Perspective in Translating Science into Policy. . .
81
the view that further review of the proposed levels would be necessary, but that
data may currently be limited. Some delegations were of the view that it would
be difficult to endorse the levels without some understanding on how the levels
had been reached in the CCFFP and supported the concern of the WHO with
regard to potentially high exposure to biotoxins. Because the Expert Consultation
had been unable to complete a risk assessment on brevetoxins due to the lack of
sufficient data, one delegate requested clarification on how the CCFFP had set
a level for this biotoxin. In reply, it was clarified that the CCFFP had agreed
to the level of 200 mouse units/kg in view of the knowledge resulting from the
existing history of regulatory programmes and the absence of human illness in
commercially harvested shellfish where these programmes were implemented. After
some discussion the CCCF agreed to provisionally endorse the proposed levels, with
the recommendation that the levels would require complete review in the coming
few years with a view to revising these levels where necessary, when more data
became available (Codex 2008a).
Salmonella in Bivalve Molluscs
The CCFFP, at the 29th session, discussed the sampling plans for Salmonella in
the draft Standard for Live and Raw Bivalve Molluscs. It was pointed out that the
criteria proposed for Salmonella was not based on a risk assessment as required in
the Principles for the Establishment and Application on Microbiological Criteria
for Foods and general requirements for Codex food safety standards. As a result,
it was proposed either to ask for a specific risk assessment in order to justify the
use of these criteria, or transfer to the Code of Practice. It was also pointed out
that when testing for Salmonella in the areas where the occurrence was known
to be high, the number of samples should be much higher (50 or 60) but that for
routine testing five samples could be used. A proposal was made to prepare a table
with the different sampling levels that could be used according to the prevalence of
Salmonella. The CCFFP agreed that the number of samples would depend on the
incidence of Salmonella but recognized that it was not possible to develop such a
table at this stage. After some further discussion, the CCFFP agreed to retain the
text referring to five samples, as mentioned above, and to ask for scientific advice
from FAO and WHO on the following question:
In the context of harvesting area monitoring for faecal contamination and lot contamination,
estimate the risk mitigation for Salmonella in bivalve molluscs when different sampling
plans and microbiological criteria are applied (Codex 2008b).
At the 30th session of the CCFFP, the Representative of FAO informed the
CCFFP that the estimation of risk mitigation required risk assessment and, since
there were currently no national or international risk assessments available for
Salmonella in bivalve molluscs, the FAO/WHO had requested Codex members
to provide data on sampling plans and Salmonella detection from their shellfish
81
the view that further review of the proposed levels would be necessary, but that
data may currently be limited. Some delegations were of the view that it would
be difficult to endorse the levels without some understanding on how the levels
had been reached in the CCFFP and supported the concern of the WHO with
regard to potentially high exposure to biotoxins. Because the Expert Consultation
had been unable to complete a risk assessment on brevetoxins due to the lack of
sufficient data, one delegate requested clarification on how the CCFFP had set
a level for this biotoxin. In reply, it was clarified that the CCFFP had agreed
to the level of 200 mouse units/kg in view of the knowledge resulting from the
existing history of regulatory programmes and the absence of human illness in
commercially harvested shellfish where these programmes were implemented. After
some discussion the CCCF agreed to provisionally endorse the proposed levels, with
the recommendation that the levels would require complete review in the coming
few years with a view to revising these levels where necessary, when more data
became available (Codex 2008a).
Salmonella in Bivalve Molluscs
The CCFFP, at the 29th session, discussed the sampling plans for Salmonella in
the draft Standard for Live and Raw Bivalve Molluscs. It was pointed out that the
criteria proposed for Salmonella was not based on a risk assessment as required in
the Principles for the Establishment and Application on Microbiological Criteria
for Foods and general requirements for Codex food safety standards. As a result,
it was proposed either to ask for a specific risk assessment in order to justify the
use of these criteria, or transfer to the Code of Practice. It was also pointed out
that when testing for Salmonella in the areas where the occurrence was known
to be high, the number of samples should be much higher (50 or 60) but that for
routine testing five samples could be used. A proposal was made to prepare a table
with the different sampling levels that could be used according to the prevalence of
Salmonella. The CCFFP agreed that the number of samples would depend on the
incidence of Salmonella but recognized that it was not possible to develop such a
table at this stage. After some further discussion, the CCFFP agreed to retain the
text referring to five samples, as mentioned above, and to ask for scientific advice
from FAO and WHO on the following question:
In the context of harvesting area monitoring for faecal contamination and lot contamination,
estimate the risk mitigation for Salmonella in bivalve molluscs when different sampling
plans and microbiological criteria are applied (Codex 2008b).
At the 30th session of the CCFFP, the Representative of FAO informed the
CCFFP that the estimation of risk mitigation required risk assessment and, since
there were currently no national or international risk assessments available for
Salmonella in bivalve molluscs, the FAO/WHO had requested Codex members
to provide data on sampling plans and Salmonella detection from their shellfish