0354 21cfr123

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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§ 123.15

21 CFR Ch. I (4–1–06 Edition)

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 § 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
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.

Subpart B—Smoked and SmokeFlavored Fishery Products
§ 123.15

General.

This subpart augments subpart A of
this part by setting forth specific requirements for processing smoked and
smoke-flavored fishery products.
§ 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.

Subpart C—Raw Molluscan
Shellfish
§ 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.
§ 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.

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