0354 21cfr123

§ 123.10

21 CFR Ch. I (4–1–06 Edition)

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
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 § 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has been abandoned and they no longer
represent a trade secret or confidential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 § 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 § 123.3(t)
are not subject to the requirements of
this section unless they are used to fulfill the requirements of § 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.
§ 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 § 123.6(b);
(b) Reassessing and modifying the
HACCP plan in accordance with the
corrective action procedures specified
in § 123.7(c)(5), the HACCP plan in accordance with the verification activities specified in § 123.8(a)(1), and the
hazard analysis in accordance with the
verification activities specified in
§ 123.8(c); and
(c) Performing the record review required by § 123.8(a)(3); The trained individual need not be an employee of the
processor.
§ 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

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Food and Drug Administration, HHS

§ 123.12

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
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 § 123.9.
(d) Relationship to HACCP plan. Sanitation controls may be included in the
HACCP plan, required by § 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.
§ 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 func-

tioning 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

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