[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR123.28]

[Page 277-278]
 
                        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.
    (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

[[Page 278]]

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.