This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated April 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[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]
[Page 270]
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.
123.5 Current good manufacturing practice.
123.6 Hazard analysis and Hazard Analysis Critical Control Point
(HACCP) plan.
123.7 Corrective actions.
123.8 Verification.
123.9 Records.
123.10 Training.
123.11 Sanitation control procedures.
123.12 Special requirements for imported products.
Subpart B--Smoked and Smoke-Flavored Fishery Products
123.15 General.
123.16 Process controls.
Subpart C--Raw Molluscan Shellfish
123.20 General.
123.28 Source controls.
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.
[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.
[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: 21CFR123.5]
[Page 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. 123.5 Current good manufacturing practice.
(a) Part 110 of this chapter applies in determining whether the
facilities, methods, practices, and controls used to process fish and
fishery products are safe, and whether these products have been
processed under sanitary conditions.
(b) The purpose of this part is to set forth requirements specific
to the processing of fish and fishery products.
[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: 21CFR123.6]
[Page 271-273]
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. 123.6 Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan.
(a) Hazard analysis. Every processor shall conduct, or have
conducted for it, a hazard analysis to determine whether there are food
safety hazards that are reasonably likely to occur for each kind of fish
and fishery product processed by that processor and to identify the
preventive measures that the processor can apply to control those
hazards. Such food safety hazards can be introduced both within and
outside the processing plant environment, including food safety hazards
that can occur before, during, and after harvest. A food safety hazard
that is reasonably likely to occur is one for which a prudent processor
would establish controls because experience, illness data, scientific
reports, or other information provide a basis to conclude that there is
a reasonable possibility that it will occur in the particular type of
fish or fishery product being processed in the absence of those
controls.
(b) The HACCP plan. Every processor shall have and implement a
written HACCP plan whenever a hazard analysis reveals one or more food
safety hazards that are reasonably likely to occur, as described in
paragraph (a) of this section. A HACCP plan shall be specific to:
(1) Each location where fish and fishery products are processed by
that processor; and
(2) Each kind of fish and fishery product processed by the
processor. The
[[Page 272]]
plan may group kinds of fish and fishery products together, or group
kinds of production methods together, if the food safety hazards,
critical control points, critical limits, and procedures required to be
identified and performed in paragraph (c) of this section are identical
for all fish and fishery products so grouped or for all production
methods so grouped.
(c) The contents of the HACCP plan. The HACCP plan shall, at a
minimum:
(1) List the food safety hazards that are reasonably likely to
occur, as identified in accordance with paragraph (a) of this section,
and that thus must be controlled for each fish and fishery product.
Consideration should be given to whether any food safety hazards are
reasonably likely to occur as a result of the following:
(i) Natural toxins;
(ii) Microbiological contamination;
(iii) Chemical contamination;
(iv) Pesticides;
(v) Drug residues;
(vi) Decomposition in scombroid toxin-forming species or in any
other species where a food safety hazard has been associated with
decomposition;
(vii) Parasites, where the processor has knowledge or has reason to
know that the parasite-containing fish or fishery product will be
consumed without a process sufficient to kill the parasites, or where
the processor represents, labels, or intends for the product to be so
consumed;
(viii) Unapproved use of direct or indirect food or color additives;
and
(ix) Physical hazards;
(2) List the critical control points for each of the identified food
safety hazards, including as appropriate:
(i) Critical control points designed to control food safety hazards
that could be introduced in the processing plant environment; and
(ii) Critical control points designed to control food safety hazards
introduced outside the processing plant environment, including food
safety hazards that occur before, during, and after harvest;
(3) List the critical limits that must be met at each of the
critical control points;
(4) List the procedures, and frequency thereof, that will be used to
monitor each of the critical control points to ensure compliance with
the critical limits;
(5) Include any corrective action plans that have been developed in
accordance with Sec. 123.7(b), to be followed in response to deviations
from critical limits at critical control points;
(6) List the verification procedures, and frequency thereof, that
the processor will use in accordance with Sec. 123.8(a);
(7) Provide for a recordkeeping system that documents the monitoring
of the critical control points. The records shall contain the actual
values and observations obtained during monitoring.
(d) Signing and dating the HACCP plan. (1) The HACCP plan shall be
signed and dated, either by the most responsible individual onsite at
the processing facility or by a higher level official of the processor.
This signature shall signify that the HACCP plan has been accepted for
implementation by the firm.
(2) The HACCP plan shall be dated and signed:
(i) Upon initial acceptance;
(ii) Upon any modification; and
(iii) Upon verification of the plan in accordance with
Sec. 123.8(a)(1).
(e) Products subject to other regulations. For fish and fishery
products that are subject to the requirements of part 113 or 114 of this
chapter, the HACCP plan need not list the food safety hazard associated
with the formation of Clostridium botulinum toxin in the finished,
hermetically sealed container, nor list the controls to prevent that
food safety hazard. A HACCP plan for such fish and fishery products
shall address any other food safety hazards that are reasonably likely
to occur.
(f) Sanitation. Sanitation controls may be included in the HACCP
plan. However, to the extent that they are monitored in accordance with
Sec. 123.11(b) they need not be included in the HACCP plan, and vice
versa.
(g) Legal basis. Failure of a processor to have and implement a
HACCP plan that complies with this section whenever a HACCP plan is
necessary, otherwise operate in accordance with the requirements of this
part, shall render the fish or fishery products of that processor
adulterated under section
[[Page 273]]
402(a)(4) of the act. Whether a processor's actions are consistent with
ensuring the safety of food will be determined through an evaluation of
the processors overall implementation of its HACCP plan, if one is
required.
[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: 21CFR123.7]
[Page 273]
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. 123.7 Corrective actions.
(a) Whenever a deviation from a critical limit occurs, a processor
shall take corrective action either by:
(1) Following a corrective action plan that is appropriate for the
particular deviation, or
(2) Following the procedures in paragraph (c) of this section.
(b) Processors may develop written corrective action plans, which
become part of their HACCP plans in accordance with Sec. 123.6(c)(5), by
which they predetermine the corrective actions that they will take
whenever there is a deviation from a critical limit. A corrective action
plan that is appropriate for a particular deviation is one that
describes the steps to be taken and assigns responsibility for taking
those steps, to ensure that:
(1) No product enters commerce that is either injurious to health or
is otherwise adulterated as a result of the deviation; and
(2) The cause of the deviation is corrected.
(c) When a deviation from a critical limit occurs and the processor
does not have a corrective action plan that is appropriate for that
deviation, the processor shall:
(1) Segregate and hold the affected product, at least until the
requirements of paragraphs (c)(2) and (c)(3) of this section are met;
(2) Perform or obtain a review to determine the acceptability of the
affected product for distribution. The review shall be performed by an
individual or individuals who have adequate training or experience to
perform such a review. Adequate training may or may not include training
in accordance with Sec. 123.10;
(3) Take corrective action, when necessary, with respect to the
affected product to ensure that no product enters commerce that is
either injurious to health or is otherwise adulterated as a result of
the deviation;
(4) Take corrective action, when necessary, to correct the cause of
the deviation;
(5) Perform or obtain timely reassessment by an individual or
individuals who have been trained in accordance with Sec. 123.10, to
determine whether the HACCP plan needs to be modified to reduce the risk
of recurrence of the deviation, and modify the HACCP plan as necessary.
(d) All corrective actions taken in accordance with this section
shall be fully documented in records that are subject to verification in
accordance with Sec. 123.8(a)(3)(ii) and the recordkeeping requirements
of Sec. 123.9.
[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: 21CFR123.8]
[Page 273-274]
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. 123.8 Verification.
(a) Overall verification. Every processor shall verify that the
HACCP plan is adequate to control food safety hazards that are
reasonably likely to occur, and that the plan is being effectively
implemented. Verification shall include, at a minimum:
(1) Reassessment of the HACCP plan. A reassessment of the adequacy
of the HACCP plan whenever any changes occur that could affect the
hazard analysis or alter the HACCP plan in any way or at least annually.
Such changes may include changes in the following: Raw materials or
source of raw materials, product formulation, processing methods or
systems, finished product distribution systems, or the intended use or
consumers of the finished product. The reassessment shall be performed
by an individual or individuals who have been trained in accordance with
Sec. 123.10. The HACCP plan shall be modified immediately whenever a
reassessment reveals that the plan is no longer adequate to fully meet
the requirements of Sec. 123.6(c).
(2) Ongoing verification activities. Ongoing verification activities
including:
(i) A review of any consumer complaints that have been received by
the processor to determine whether they relate to the performance of
critical control points or reveal the existence of unidentified critical
control points;
(ii) The calibration of process-monitoring instruments; and,
(iii) At the option of the processor, the performing of periodic
end-product or in-process testing.
[[Page 274]]
(3) Records review. A review, including signing and dating, by an
individual who has been trained in accordance with Sec. 123.10, of the
records that document:
(i) The monitoring of critical control points. The purpose of this
review shall be, at a minimum, to ensure that the records are complete
and to verify that they document values that are within the critical
limits. This review shall occur within 1 week of the day that the
records are made;
(ii) The taking of corrective actions. The purpose of this review
shall be, at a minimum, to ensure that the records are complete and to
verify that appropriate corrective actions were taken in accordance with
Sec. 123.7. This review shall occur within 1 week of the day that the
records are made; and
(iii) The calibrating of any process control instruments used at
critical control points and the performing of any periodic end-product
or in-process testing that is part of the processor's verification
activities. The purpose of these reviews shall be, at a minimum, to
ensure that the records are complete, and that these activities occurred
in accordance with the processor's written procedures. These reviews
shall occur within a reasonable time after the records are made.
(b) Corrective actions. Processors shall immediately follow the
procedures in Sec. 123.7 whenever any verification procedure, including
the review of a consumer complaint, reveals the need to take a
corrective action.
(c) Reassessment of the hazard analysis. Whenever a processor does
not have a HACCP plan because a hazard analysis has revealed no food
safety hazards that are reasonably likely to occur, the processor shall
reassess the adequacy of that hazard analysis whenever there are any
changes that could reasonably affect whether a food safety hazard now
exists. Such changes may include, but are not limited to changes in: Raw
materials or source of raw materials, product formulation, processing
methods or systems, finished product distribution systems, or the
intended use or consumers of the finished product. The reassessment
shall be performed by an individual or individuals who have been trained
in accordance with Sec. 123.10.
(d) Recordkeeping. The calibration of process-monitoring
instruments, and the performing of any periodic end-product and in-
process testing, in accordance with paragraphs (a)(2)(ii) through (iii)
of this section shall be documented in records that are subject to the
recordkeeping requirements of Sec. 123.9.
[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: 21CFR123.9]
[Page 274-275]
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. 123.9 Records.
(a) General requirements. All records required by this part shall
include:
(1) The name and location of the processor or importer;
(2) The date and time of the activity that the record reflects;
(3) The signature or initials of the person performing the
operation; and
(4) Where appropriate, the identity of the product and the
production code, if any. Processing and other information shall be
entered on records at the time that it is observed.
(b) Record retention. (1) All records required by this part shall be
retained at the processing facility or importer's place of business in
the United States for at least 1 year after the date they were prepared
in the case of refrigerated products and for at least 2 years after the
date they were prepared in the case of frozen, preserved, or shelf-
stable products.
(2) Records that relate to the general adequacy of equipment or
processes being used by a processor, including the results of scientific
studies and evaluations, shall be retained at the processing facility or
the importer's place of business in the United States for at least 2
years after their applicability to the product being produced at the
facility.
(3) If the processing facility is closed for a prolonged period
between seasonal packs, or if record storage capacity is limited on a
processing vessel or at a remote processing site, the records may be
transferred to some other reasonably accessible location at the end of
the seasonal pack but shall be immediately returned for official review
upon demand.
(c) Official review. All records required by this part and all plans
and procedures required by this part shall
[[Page 275]]
be available for official review and copying at reasonable times.
(d) Public disclosure. (1) Subject to the limitations in paragraph
(d)(2) of this section, all plans and records required by this part are
not available for public disclosure unless they have been previously
disclosed to the public as defined in Sec. 20.81 of this chapter or they
relate to a product or ingredient that has been abandoned and they no
longer represent a trade secret or confidential commercial or financial
information as defined in Sec. 20.61 of this chapter.
(2) However, these records and plans may be subject to disclosure to
the extent that they are otherwise publicly available, or that
disclosure could not reasonably be expected to cause a competitive
hardship, such as generic-type HACCP plans that reflect standard
industry practices.
(e) Tags. Tags as defined in Sec. 123.3(t) are not subject to the
requirements of this section unless they are used to fulfill the
requirements of Sec. 123.28(c).
(f) Records maintained on computers. The maintenance of records on
computers is acceptable, provided that appropriate controls are
implemented to ensure the integrity of the electronic data and
signatures.
[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: 21CFR123.10]
[Page 275]
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. 123.10 Training.
At a minimum, the following functions shall be performed by an
individual who has successfully completed training in the application of
HACCP principles to fish and fishery product processing at least
equivalent to that received under standardized curriculum recognized as
adequate by the U.S. Food and Drug Administration or who is otherwise
qualified through job experience to perform these functions. Job
experience will qualify an individual to perform these functions if it
has provided knowledge at least equivalent to that provided through the
standardized curriculum.
(a) Developing a HACCP plan, which could include adapting a model or
generic-type HACCP plan, that is appropriate for a specific processor,
in order to meet the requirements of Sec. 123.6(b);
(b) Reassessing and modifying the HACCP plan in accordance with the
corrective action procedures specified in Sec. 123.7(c)(5), the HACCP
plan in accordance with the verification activities specified in
Sec. 123.8(a)(1), and the hazard analysis in accordance with the
verification activities specified in Sec. 123.8(c); and
(c) Performing the record review required by Sec. 123.8(a)(3); The
trained individual need not be an employee of the processor.
[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: 21CFR123.11]
[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. 123.11 Sanitation control procedures.
(a) Sanitation SOP. Each processor should have and implement a
written sanitation standard operating procedure (herein referred to as
SSOP) or similar document that is specific to each location where fish
and fishery products are produced. The SSOP should specify how the
processor will meet those sanitation conditions and practices that are
to be monitored in accordance with paragraph (b) of this section.
(b) Sanitation monitoring. Each processor shall monitor the
conditions and practices during processing with sufficient frequency to
ensure, at a minimum, conformance with those conditions and practices
specified in part 110 of this chapter that are both appropriate to the
plant and the food being processed and relate to the following:
(1) Safety of the water that comes into contact with food or food
contact surfaces, or is used in the manufacture of ice;
(2) Condition and cleanliness of food contact surfaces, including
utensils, gloves, and outer garments;
(3) Prevention of cross-contamination from insanitary objects to
food, food packaging material, and other food contact surfaces,
including utensils, gloves, and outer garments, and from raw product to
cooked product;
(4) Maintenance of hand washing, hand sanitizing, and toilet
facilities;
(5) Protection of food, food packaging material, and food contact
surfaces from adulteration with lubricants, fuel, pesticides, cleaning
compounds, sanitizing agents, condensate, and other chemical, physical,
and biological contaminants;
(6) Proper labeling, storage, and use of toxic compounds;
(7) Control of employee health conditions that could result in the
microbiological contamination of food, food
[[Page 276]]
packaging materials, and food contact surfaces; and
(8) Exclusion of pests from the food plant.
The processor shall correct in a timely manner, those conditions and
practices that are not met.
(c) Sanitation control records. Each processor shall maintain
sanitation control records that, at a minimum, document the monitoring
and corrections prescribed by paragraph (b) of this section. These
records are subject to the requirements of Sec. 123.9.
(d) Relationship to HACCP plan. Sanitation controls may be included
in the HACCP plan, required by Sec. 123.6(b). However, to the extent
that they are monitored in accordance with paragraph (b) of this section
they need not be included in the HACCP plan, and vice versa.
[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: 21CFR123.12]
[Page 276-277]
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. 123.12 Special requirements for imported products.
This section sets forth specific requirements for imported fish and
fishery products.
(a) Importer verification. Every importer of fish or fishery
products shall either:
(1) Obtain the fish or fishery product from a country that has an
active memorandum of understanding (MOU) or similar agreement with the
Food and Drug Administration, that covers the fish or fishery product
and documents the equivalency or compliance of the inspection system of
the foreign country with the U.S. system, accurately reflects the
current situation between the signing parties, and is functioning and
enforceable in its entirety; or
(2) Have and implement written verification procedures for ensuring
that the fish and fishery products that they offer for import into the
United States were processed in accordance with the requirements of this
part. The procedures shall list at a minimum:
(i) Product specifications that are designed to ensure that the
product is not adulterated under section 402 of the Federal Food, Drug,
and Cosmetic Act because it may be injurious to health or have been
processed under insanitary conditions, and,
(ii) Affirmative steps that may include any of the following:
(A) Obtaining from the foreign processor the HACCP and sanitation
monitoring records required by this part that relate to the specific lot
of fish or fishery products being offered for import;
(B) Obtaining either a continuing or lot-by-lot certificate from an
appropriate foreign government inspection authority or competent third
party certifying that the imported fish or fishery product is or was
processed in accordance with the requirements of this part;
(C) Regularly inspecting the foreign processor's facilities to
ensure that the imported fish or fishery product is being processed in
accordance with the requirements of this part;
(D) Maintaining on file a copy, in English, of the foreign
processor's HACCP plan, and a written guarantee from the foreign
processor that the imported fish or fishery product is processed in
accordance with the requirements of the part;
(E) Periodically testing the imported fish or fishery product, and
maintaining on file a copy, in English, of a written guarantee from the
foreign processor that the imported fish or fishery product is processed
in accordance with the requirements of this part or,
(F) Other such verification measures as appropriate that provide an
equivalent level of assurance of compliance with the requirements of
this part.
(b) Competent third party. An importer may hire a competent third
party to assist with or perform any or all of the verification
activities specified in paragraph (a)(2) of this section, including
writing the importer's verification procedures on the importer's behalf.
(c) Records. The importer shall maintain records, in English, that
document the performance and results of the affirmative steps specified
in paragraph (a)(2)(ii) of this section. These records shall be subject
to the applicable provisions of Sec. 123.9.
(d) Determination of compliance. There must be evidence that all
fish and fishery products offered for entry into the United States have
been processed under conditions that comply with this part. If
assurances do not exist that the
[[Page 277]]
imported fish or fishery product has been processed under conditions
that are equivalent to those required of domestic processors under this
part, the product will appear to be adulterated and will be denied
entry.
[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: 21CFR123.15]
[Page 277]
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 B--Smoked and Smoke-Flavored Fishery Products
Sec. 123.15 General.
This subpart augments subpart A of this part by setting forth
specific requirements for processing smoked and smoke-flavored fishery
products.
[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: 21CFR123.16]
[Page 277]
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 B--Smoked and Smoke-Flavored Fishery Products
Sec. 123.16 Process controls.
In order to meet the requirements of subpart A of this part,
processors of smoked and smoke-flavored fishery products, except those
subject to the requirements of part 113 or 114 of this chapter, shall
include in their HACCP plans how they are controlling the food safety
hazard associated with the formation of toxin by Clostridium botulinum
for at least as long as the shelf life of the product under normal and
moderate abuse conditions.
[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: 21CFR123.20]
[Page 277]
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. 123.20 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.
[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: 21CFR123.28]
[Page 277]
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 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.
[[Page 278]]
