[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: 21CFR123.3]
[Page 275-276]
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.
[[Page 276]]
(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:
(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.
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