CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]

[Title 21, Volume 2]

[CITE: 21CFR123]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION

PART 123 FISH AND FISHERY PRODUCTS

Subpart C - Raw Molluscan Shellfish

Sec. 123.20 General.

This subpart augments subpart A of this part by setting forth specific requirements for processing fresh or frozen molluscan shellfish, where such processing does not include a treatment that ensures the destruction of vegetative cells of microorganisms of public health concern.

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 § 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 § 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 § 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.

Authority: 21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e, 381, 393; 42 U.S.C. 241, 241l, 264.
Source: 60 FR 65197, Dec. 18, 1995, unless otherwise noted.