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Table 4:
HACCP "Prerequisites" Side-By-Side
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FSIS |
FDA |
NACMCF |
CODEX |
9 CFR ?
416; Food Safety and
Inspection Service (FSIS). |
21 CFR ?
123; Food and Drug Administration (FDA). |
Adopted August 14, 1997,
by the National Advisory Committee on Microbiological Criteria for
Foods (NACMCF) as a revision of their 1992 adopted HACCP System
document. From the Journal of Food Protection, Volume 61, Number
9, 1998, pages 1246-1259, and as noted in the article, this
article may reproduced without permission. Tables, figures,
appendixes, references, and some introductory text portions are
not included in this comparison document. |
Adopted June
1997; Codex Alimentarius Commission and
the FAO/WHO Food Standards Programme, annex to CAC/RCP 1-1969,
Rev. 3. |
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| [FSIS
stated its views regarding the association of sanitation
procedures and HACCP n the preamble to the Pathogen Reduction/HACCP
final regulation (i.e., "[i]n a sense, the Sanitation SOP?s
are a prerequisite for HACCP"). FSIS further stated that
"[a] sanitation procedure that is incorporated into a
validated HACCP plan need not be duplicated in the Sanitation SOP?s"
(61 FR 38834, July 25, 1996). The following information is the
FSIS Sanitation SOP?s.]
**************
? 416 Sanitation standard
operating procedures.
? 416.11 General rules.
Each official establishment shall develop, implement, and
maintain written standard operating procedures for sanitation
(Sanitation SOP's) in accordance with the requirements of this
part. |
[The FDA
seafood HACCP regulations cross-reference the FDA Current Good
Manufacturing Practice (cGMP) regulations contained in 21 CFR
? 110, as well as specify sanitation requirements. Below,
the cGMP requirement found in the seafood HACCP regulations is
restated, along with the sanitation requirements].
**************
? 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. |
(Realigned
from page 1248, Guidelines for Application
of HACCP Principles, Introduction): HACCP is a management
system in which
food safety is addressed through the analysis and control of
biological, chemical, and physical hazards from raw material
production, procurement and handling, to manufacturing,
distribution and consumption of the finished product. For
successful implementation of a HACCP plan, management must be
strongly committed to the HACCP concept. A firm commitment to
HACCP by top management provides company employees with a sense of
the importance of producing safe food. HACCP is designed for use
in all segments of the food industry from growing, harvesting,
processing, manufacturing, distributing,
and merchandising to preparing food for consumption. Prerequisite
programs such as current Good Manufacturing Practices (cGMPs) are
an essential foundation for the
development and implementation of successful HACCP plans. Food
safety systems based on the HACCP principles have been
successfully applied in food processing plants, retail food
stores, and food service operations. The seven principles of HACCP
have been universally accepted by government agencies,
trade associations and the food industry around the world. The
following guidelines will facilitate the development and
implementation of effective HACCP plans. While the specific
application of HACCP to manufacturing facilities is emphasized
here, these guidelines should be applied as appropriate to each
segment of the food industry under consideration.
Prerequisite Programs
The production of safe food products requires that the HACCP
system be built upon a solid foundation of prerequisite programs.
Examples of common prerequisite programs are listed in Appendix A.
Each segment of the food industry must provide the conditions
necessary to protect food while it is under their control. This
has traditionally been accomplished through the application of
cGMPs. These conditions and practices are now considered to be
prerequisite to the development and implementation of effective
HACCP plans. Prerequisite programs provide the basic environmental
and operating conditions that are necessary for the production of
safe, wholesome food. Many of the conditions and practices are
specified in federal, state and local regulations and guidelines
(e.g., cGMPs and Food Code).
The Codex Alimentarius General Principles of Food Hygiene describe
the basic conditions and practices expected for foods intended for
international trade. In addition to the requirements specified in
regulations, industry often adopts policies and procedures that
are specific to their operations. Many of these
are proprietary. While prerequisite programs may impact upon the
safety of a
food, they also are concerned with ensuring that foods are
wholesome and suitable for consumption (Appendix A). HACCP plans
are narrower in scope, being limited to ensuring food is safe to
consume. The
existence and effectiveness
of prerequisite programs should be assessed during the design and
implementation of each HACCP plan. All prerequisite
programs should be documented and regularly audited.Prerequisite
programs are established and managed separately from the HACCP
plan. Certain aspects, however, of a prerequisite program may be
incorporated into a HACCP plan. For example, many establishments
have preventive maintenance procedures for processing equipment to
avoid unexpected equipment failure and loss of production. During
the development of a HACCP plan, the HACCP team may decide that
the routine maintenance and calibration of an oven should be
included in the plan as an activity of verification. This would
further ensure that all the food in the
oven is cooked to the minimum internal temperature that is
necessary for food safety.
Realigned from page 1254, Appendix A: Examples of Common
Prerequisite Programs
The production of safe food products requires that the
HACCP system be built on a
solid foundation of prerequisite programs. Each segment of the
food industry must provide the conditions necessary to protect
food while it is under their
control. This has traditionally been accomplished through the
application of cGMPs. These conditions and practices are
now considered to be
prerequisite to the development and implementation of effective
HACCP plans. Prerequisite programs provide the basic environmental
and operating conditions that are necessary for the production of
safe, wholesome food. Common prerequisite programs may include but
are not limited to:
Facilities.
The establishment should be located, constructed, and
maintained according to
sanitary design principles. There should be linear product flow
and traffic control to minimize cross-contamination from raw to
cooked materials.
Supplier Control.
Each facility should assure
that its suppliers have in place effective GMP and food safety
programs. These may be the subject of continuing supplier
guarantee and supplier HACCP system verification.
Specifications.
There should be written specifications for all ingredients,
products, and packaging materials.
Production Equipment.
All equipment should be
constructed and installed
according to sanitary design principles. Preventive
maintenance and calibration schedules should be
established and documented.
Cleaning and Sanitation.
All procedures for cleaning
and sanitation of the equipment and the facility should be written
and followed. A master sanitation schedule should be in place.
Personal Hygiene.
All employees and other
persons who enter the
manufacturing plant should follow the requirements for
personal hygiene.
Training.
All employees should receive documented training in
personal hygiene, GMP,
cleaning and sanitation procedures, personal safety,
and their role in the HACCP program.
Chemical Control.
Documented procedures must
be in place to ensure the
segregation and proper use
of nonfood chemicals in the
plant. These include cleaning chemicals, fumigants, and pesticides
or baits used in or around the plant.
Receiving, Storage, and Shipping.
All raw materials and products should be stored under
sanitary conditions and the proper environmental conditions such
as temperature and humidity to
assure their safety and wholesomeness.
Traceability and Recall.
All raw materials and products should be lot-coded and a
recall system should be in place so that rapid and complete traces
and recalls can be done when a
product retrieval is necessary.
Pest Control.
Effective pest control should be in place.
Other examples of prerequisite programs might include
quality assurance procedures; standard
operating procedures for
sanitation, processes, product formulations, and recipes; glass
control; procedures for receiving, storage, and shipping;
labeling; and employee food and ingredient handling practices. |
Guidelines
for the
application of the HACCP system.
Prior to application of HACCP to any sector of the food chain,
that sector should be operating according to the Codex General
Principles of Food Hygiene, the appropriate Codex Codes of
Practice, and appropriate food safety legislation. Management
commitment is necessary for implementation of an effective HACCP
system. During hazard identification, evaluation, and subsequent
operations in designing and applying HACCP systems, consideration
must be given to the impact of raw materials, ingredients, food
manufacturing practices, role of manufacturing processes to
control hazards, likely end-use of the product, categories of
consumers of concern, and epidemiological evidence relative to
food safety. The intent of the HACCP system is to focus control at
CCPs. Redesign of the operation should be considered if a hazard
which must be controlled is identified but no CCPs are found.
HACCP should be applied to each specific operation separately.
CCPs
identified in any given example in any Codex Code of Hygienic
Practice might not be the only ones identified for a specific
application or might be of a different nature. The HACCP
application should be reviewed and necessary changes made when any
modification is made in the product, process, or any step. It is
important when applying HACCP to be flexible where appropriate,
given the context of the application taking into account the
nature and the size of the operation. |
?
416.12 Development of
Sanitation SOP's.
(a) The Sanitation SOP's
shall describe all procedures an official establishment will
conduct
daily, before and during operations, sufficient to prevent direct
contamination or adulteration of
product(s).
? 416.13 Implementation of
SOP's.
(a) Each official establishment shall conduct the
pre-operational
procedures in the Sanitation SOP's before the start of operations.
(b) Each official establishment shall conduct
all other procedures in the
Sanitation SOP's at the frequencies specified.
(c) Each official establishment shall monitor
daily the implementation of
the procedures in the Sanitation SOP's.
? 416.14 Maintenance of
Sanitation SOP's.
Each official establishment shall routinely evaluate
the effectiveness of the Sanitation SOP's
and the
procedures therein in preventing direct contamination
or adulteration of product(s) and shall
revise both as necessary to keep them effective
and current with respect to changes in facilities,
equipment, utensils, operations, or
personnel.
? 416.15 Corrective Actions.
(a) Each official establishment shall take appropriate
corrective action(s) when either the establishment or FSIS
determines that the establishment's Sanitation SOP's or the
procedures specified therein, or the implementation or maintenance
of the Sanitation SOP's, may have
failed to prevent direct contamination or adulteration of
product(s).
(b) Corrective actions include procedures to ensure appropriate
disposition of product(s) that may be contaminated, restore
sanitary conditions, and prevent the recurrence of direct
contamination or adulteration of product(s), including appropriate
reevaluation and modification of the Sanitation SOP's and the
procedures specified therein or appropriate improvements in the
execution of the Sanitation SOP's or the procedures specified
therein.
? 416.16 Recordkeeping requirements.
(a) Each official establishment shall maintain daily records
sufficient to document the implementation and monitoring of the
Sanitation SOP's and any corrective actions taken.
The establishment employee(s) specified in the Sanitation SOP's as
being responsible for the implementation and monitoring of the
procedure(s) specified in the Sanitation SOP's shall authenticate
these records with his or her initials and the date.
(b) Records required by this part may be maintained on
computers provided the establishment implements appropriate
controls to
ensure the integrity of the electronic data.
(c) Records required by this part shall
be maintained for at least 6 months and made accessible available
to FSIS. All such records
shall be maintained at the official establishment for 48 hours
following completion, after which they may be maintained off-site
provided such records can be made available to FSIS within 24
hours of request.
? 416.17 Agency
verification.
FSIS shall verify the adequacy and effectiveness of the
Sanitation SOP's and the procedures specified therein by
determining that they meet the requirements of this part. Such
verification may include:
( a) Reviewing the Sanitation SOP's;
(b) Reviewing the daily records documenting the implementation
of the Sanitation SOP's and the procedures specified therein and
any corrective actions taken or required to be taken; and
(c) Direct observation of the implementation of the Sanitation
SOP's and the procedures specified therein and any corrective
actions
taken or required to be taken; and
(d) Direct observation or testing to
assess the sanitary conditions in the establishment. |
? 123.6(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 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.
? 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 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.
?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 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.
? 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.
? 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 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. |
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