[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR123.3]

[Page 270-271]
 
                        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 A--General Provisions
 
Sec. 123.3  Definitions.


    The definitions and interpretations of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act (the act) and in part 110 of this 
chapter are applicable to such terms when used in this part, except 
where they are herein redefined. The following definitions shall also 
apply:
    (a) Certification number means a unique combination of letters and 
numbers assigned by a shellfish control authority to a molluscan 
shellfish processor.
    (b) Critical control point means a point, step, or procedure in a 
food process at which control can be applied, and a food safety hazard 
can as a result be prevented, eliminated, or reduced to acceptable 
levels.
    (c) Critical limit means the maximum or minimum value to which a 
physical, biological, or chemical parameter must be controlled at a 
critical control point to prevent, eliminate, or reduce to an acceptable 
level the occurrence of the identified food safety hazard.
    (d) Fish means fresh or saltwater finfish, crustaceans, other forms 
of aquatic animal life (including, but not limited to, alligator, frog, 
aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of 
such animals) other than birds or mammals, and all mollusks, where such 
animal life is intended for human consumption.
    (e) Fishery product means any human food product in which fish is a 
characterizing ingredient.
    (f) Food safety hazard means any biological, chemical, or physical 
property that may cause a food to be unsafe for human consumption.
    (g) Importer means either the U.S. owner or consignee at the time of 
entry into the United States, or the U.S. agent or representative of the 
foreign owner or consignee at the time of entry into the United States, 
who is responsible for ensuring that goods being offered for entry into 
the United States are in compliance with all laws affecting the 
importation. For the purposes of this definition, ordinarily the 
importer is not the custom house broker, the freight forwarder, the 
carrier, or the steamship representative.
    (h) Molluscan shellfish means any edible species of fresh or frozen 
oysters, clams, mussels, or scallops, or edible portions of such 
species, except when the product consists entirely of the shucked 
adductor muscle.
    (i) Preventive measure means physical, chemical, or other factors 
that can be used to control an identified food safety hazard.
    (j) Process-monitoring instrument means an instrument or device used 
to indicate conditions during processing at a critical control point.
    (k)(1) Processing means, with respect to fish or fishery products: 
Handling, storing, preparing, heading, eviscerating, shucking, freezing, 
changing into different market forms, manufacturing, preserving, 
packing, labeling, dockside unloading, or holding.
    (2) The regulations in this part do not apply to:

[[Page 271]]

    (i) Harvesting or transporting fish or fishery products, without 
otherwise engaging in processing.
    (ii) Practices such as heading, eviscerating, or freezing intended 
solely to prepare a fish for holding on board a harvest vessel.
    (iii) The operation of a retail establishment.
    (l) Processor means any person engaged in commercial, custom, or 
institutional processing of fish or fishery products, either in the 
United States or in a foreign country. A processing includes any person 
engaged in the production of foods that are to be used in market or 
consumer tests.
    (m) Scombroid toxin-forming species means tuna, bluefish, mahi mahi, 
and other species, whether or not in the family Scombridae, in which 
significant levels of histamine may be produced in the fish flesh by 
decarboxylation of free histidine as a result of exposure of the fish 
after capture to temperatures that permit the growth of mesophilic 
bacteria.
    (n) Shall is used to state mandatory requirements.
    (o) Shellfish control authority means a Federal, State, or foreign 
agency, or sovereign tribal government, legally responsible for the 
administration of a program that includes activities such as 
classification of molluscan shellfish growing areas, enforcement of 
molluscan shellfish harvesting controls, and certification of molluscan 
shellfish processors.
    (p) Shellstock means raw, in-shell molluscan shellfish.
    (q) Should is used to state recommended or advisory procedures or to 
identify recommended equipment.
    (r) Shucked shellfish means molluscan shellfish that have one or 
both shells removed.
    (s) Smoked or smoke-flavored fishery products means the finished 
food prepared by:
    (1) Treating fish with salt (sodium chloride), and
    (2) Subjecting it to the direct action of smoke from burning wood, 
sawdust, or similar material and/or imparting to it the flavor of smoke 
by a means such as immersing it in a solution of wood smoke.
    (t) Tag means a record of harvesting information attached to a 
container of shellstock by the harvester or processor.