[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR123.28]
[Page 282-283]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 123 FISH AND FISHERY PRODUCTS--Table of Contents
Subpart C Raw Molluscan Shellfish
Sec. 123.28 Source controls.
(a) In order to meet the requirements of subpart A of this part as
they apply to microbiological contamination, chemical contamination,
natural toxins, and related food safety hazards, processors shall
include in their HACCP plans how they are controlling the origin of the
molluscan shellfish they process to ensure that the conditions of
paragraphs (b), (c), and (d) of this section are met.
(b) Processors shall only process molluscan shellfish harvested from
growing waters approved for harvesting by a shellfish control authority.
In the case of molluscan shellfish harvested from U.S. Federal waters,
the requirements of this paragraph will be met so long as the shellfish
have not been harvested from waters that have been closed to harvesting
by an agency of the Federal government.
(c) To meet the requirements of paragraph (b) of this section,
processors who receive shellstock shall accept only shellstock from a
harvester that is in compliance with such licensure requirements as may
apply to the harvesting of molluscan shellfish or from a processor that
is certified by a shellfish control authority, and that has a tag
affixed to each container of shellstock. The tag shall bear, at a
minimum, the information required in Sec. 1240.60(b) of this chapter.
In place of the tag, bulk shellstock shipments may be accompanied by a
bill of lading or similar shipping document that contains the
information required in Sec. 1240.60(b) of this chapter. Processors
shall maintain records that document that all shellstock have met the
requirements of this section. These records shall document:
(1) The date of harvest;
(2) The location of harvest by State and site;
(3) The quantity and type of shellfish;
(4) The date of receipt by the processor; and
(5) The name of the harvester, the name or registration number of
the harvester's vessel, or an identification number issued to the
harvester by the shellfish control authority.
[[Page 283]]
(d) To meet the requirements of paragraph (b) of this section,
processors who receive shucked molluscan shellfish shall accept only
containers of shucked molluscan shellfish that bear a label that
complies with Sec. 1240.60(c) of this chapter. Processors shall
maintain records that document that all shucked molluscan shellfish have
met the requirements of this section. These records shall document:
(1) The date of receipt;
(2) The quantity and type of shellfish; and
(3) The name and certification number of the packer or repacker of
the product.
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