U.S. Food & Drug Administration
Center for
Food
Safety &
Applied
Nutrition
FISH AND FISHERIES PRODUCTS
HAZARDS AND CONTROLS GUIDE
Second Edition, January 1998
|
The Third Edition of this guidance issued in
June 2001. Below is an earlier version.
CHAPTER 1
INTRODUCTION
Status
This is the second edition of the Food and Drug Administrations's (FDA) "Fish and Fishery
Products Hazards and Controls Guide." This Guide relates to FDA's final
regulations (21 CFR 123) that require processors of fish and fishery
products to develop and implement Hazard Analysis Critical Control Point (HACCP) systems for
their operations. Those final regulations were published in the
Federal Register on December 18, 1995
and became effective on December 18, 1997.
The codified portion of the regulations is included in
Appendix 7.
FDA intends to revise and reissue this Guide from time to time as the state of knowledge
advances relative to fish and fishery products hazards and controls. The
agency will accept public
comment on this second edition of the Guide for consideration in drafting the third
edition. Such comments must be received within ninety days of the publication of a Notice of
Availability for this Guide in the Federal Register. Comments
received after that date will be considered for subsequent editions.
Comments should be submitted to:
U.S. Food and Drug Administration
Dockets Management Branch
Room 1-23
12420 Parklawn Drive
Rockville, MD 20857
Comments should be identified with Docket Number 93N-0195.
This Guide is being issued as a companion document to "HACCP: Hazard Analysis Critical
Control Point Training Curriculum," which was developed by the Seafood HACCP Alliance for
Training and Education. The Alliance is an organization of federal and state regulators, including
FDA, academia, and the seafood industry. FDA encourages processors of fish and fishery
products to use the two documents together in the development of a HACCP system. Copies of
the training document may be obtained from:
North Carolina Sea Grant
North Carolina State University
Box 8605
Raleigh, NC 27695
Purpose
The primary purpose of this Guide is to assist processors of fish and fishery products in the
development of their HACCP plans. Processors of fish and fishery products will find information
in this Guide that will help them identify hazards that are associated with their products, and
help them formulate control strategies.
Another purpose of this Guide is to help consumers and the public generally to understand
commercial seafood safety in terms of hazards and their controls. This Guide does not specifically
address safe handling practices by consumers or by retail establishments, although many of the
concepts contained in this Guide are applicable to both.
This Guide is also intended to serve as a tool to be used by federal and State regulatory
officials in
the evaluation of HACCP plans for fish and fishery products.
Scope and Limitations
The controls and practices provided in this Guide are recommendations and
guidance to the fish and fishery products industry. This Guide provides
information that would likely result in a HACCP plan that is acceptable
to FDA. However, it is in no way a binding set of requirements.
Processors may choose to use other control measures, as long as they
provide an equivalent level of assurance of safety for the product.
The information contained in the tables in Chapter 3 and in Steps 10 and 11 in Chapters 4-20
provide guidance for determining which hazards are "reasonably likely to occur" in particular fish
and fishery products under ordinary circumstances. The tables should not be used separately for
this purpose. The tables list potential hazards for specific species and finished product types.
This information must be combined with the information in the subsequent chapters to determine
the likelihood of occurrence.
This Guide is not a substitute for the performance of a Hazard Analysis by a processor of
fish and fishery products, as required by FDA's regulations.
Hazards not covered by this Guide may be relevant to certain
products under certain circumstances. In particular, processors should be alert to new or
emerging problems (e.g., the occurrence of natural toxins in fish not previously associated with
that toxin).
This Guide covers safety hazards associated with fish and fishery products only. It does not
cover most hazards associated with non-fishery ingredients (e.g.,
Salmonella enteritidis in
raw eggs, allergic response to peanuts).
However, where such hazards are presented by a fishery product that
contains non-fishery ingredients,
control must be included in the HACCP plan. Processors may use the principles
included in this guide as assistance in developing appropriate controls for these hazards.
This Guide does not cover the hazard associated with the formation of
Clostridium botulinum
toxin in low acid canned foods (LACF) or shelf-stable
acidified foods. Mandatory controls for this hazard are
contained in the LACF regulation (21 CFR 113) and the acidified foods regulation (21 CFR 114).
Such controls need not be included in HACCP plans for these products.
This Guide does not cover the sanitation controls required by the Seafood HACCP regulation.
However, the maintenance of a sanitation monitoring program is an
essential prerequisite to the development of a HACCP program. If
necessary sanitation controls are not included in a prerequisite
sanitation monitoring program, they must be included in the HACCP plan.
It is the agency's intent to provide guidance on the development of sanitation
standard operating processes and sanitation monitoring programs in the
future.
This Guide does not describe corrective action or verification records, because these records are
not required to be listed in the HACCP plan. Nonetheless, such records must be maintained,
where applicable. Likewise, it does not recount the specific requirements for the
content of records that are set out in § 123.9(a).
This Guide does not cover verification activities such as
reassessment of the HACCP plan and/or the hazard analysis and review of consumer complaints,
that are mandated by § 123.8.
The Guide also does not provide specific guidance to importers of fish and fishery products for
the development of required importer verification procedures. However, the information
contained in the text, and, in particular, in
Appendix 5,
should prove useful for this purpose.
Additionally, it is the agency's intent to provide more specific guidance for importers, either in
future editions of this Guide, or in a separate guidance document.
Changes in this Edition
Following is a summary of the most significant
changes in this edition of the Guide:
- The following species are now listed in Table 3-1
(Potential Vertebrate Species Related Hazards),
with relevant potential hazards identified:
- Alligator;
- Frog;
- Herring roe;
- Scomberomorus cavalla (under "spanish
mackerel");
- Microstomus kitt and Microstomus pacificus
(under "sole or flounder");
- Pandalus jordani (under "shrimp" or
"pink shrimp");
- The following are no longer listed in Table 3-1
(Potential Vertebrate Species Related Hazards) or
Table 3-2 (Potential Invertebrate Species Related
Hazards) as potential hazards for the indicated
species:
- histamine in atka mackerel;
- ciguatera fish poison in spanish mackerel,
except for Scomberomorus cavalla;
- pathogens in squid;
- Parasites and histamine are now listed as potential
hazards for Pristipomoides spp. (under "snapper")
in Table 3-1 (Potential Vertebrate Species Related
Hazards);
- Aquaculture drugs is now listed as a potential
hazard for lobster in Table 3-2 (Potential
Invertebrate Species Related Hazards);
- Hermetically sealed containers and product packed
in oil are now listed in the "package type" column
of Table 3-3 (Potential Process Related Hazards);
- The following are no longer listed in Table 3-3
(Potential Process Related Hazards) as potential
hazards:
- Pathogen survival through cooking for partially
cooked or uncooked prepared foods;
- Pathogen growth as a result of time/temperature
abuse for raw breaded fish, raw fish (except raw
molluscan shellfish, vacuum packaged, modified
atmosphere packaged, controlled atmosphere
packaged, and hermetically sealed fish, and fish
packed in oil);
- Pickled and salted fish are now specifically listed
in Table 3-3 (Potential Process Related Hazards);
- Pathogen growth as a result of temperature abuse is
now listed in Table 3-3 (Potential Process Related
Hazards) as a potential hazard for fermented,
acidified, pickled, salted, and low acid canned
foods;
- The first edition of this Guide indicated (Chapters
4 and 12) that FDA would update the Guide by
including advice on how to assess the significance
of a potential pathogen hazard in raw fishery
products that will be cooked by the consumer or
end user before consumption. This Guide now
indicates that FDA is not aware of any HACCP
controls that may exist internationally for the
control of pathogens in fish and fishery products
that are intended to be fully cooked by the
consumer or end user before consumption, other
than a rigorous sanitation regime as part of either a
prerequisite program or as part of HACCP itself.
The Seafood HACCP Regulation requires such a
regime. The proper application of sanitation
controls is essential because of the likelihood that
any pathogens that may be present in seafood
products are introduced through poor handling
practices (e.g. by the aquacultural producer, the
fisherman, or the processor).
FDA is interested in information regarding any
HACCP controls beyond sanitation that may be
both necessary and practical for the control of
pathogens in fish and fishery products that are
intended to be fully cooked by the consumer or end
user before consumption. However, the agency
makes no recommendations in this Guide and has
no specific expectations with regard to such
controls in processors' HACCP plans. The agency
plans to develop Good Manufacturing Practice
guidelines for harvest vessels and for aquaculture,
in an effort to minimize the likelihood that these
operations will contribute pathogens to fish and
fishery products.
- The following changes have been made to Chapter
4 for consistency with 1997 Interstate Shellfish
Sanitation Conference actions:
- The use of raw consumption warnings on tags on
molluscan shellfish shellstock containers is now
recommended;
- Controls relative to the identification of the
harvester, the harvester's license, the approval
status of the harvest waters, and time-of-harvest
to time-of-refrigeration are now only
recommended for the primary processor (Note:
Similar changes in Chapters 6 and 9);
- The freezing recommendations for parasite control
contained in Chapter 5 have been changed as
follows:
- The -4°F (-20°C) freeze now refers to either
internal (product) or external (ambient)
temperature;
- The -31°F (-35°C) freeze now refers to internal
temperature;
- Chapter 5 now indicates that the parasite hazard
may not need to be considered a significant hazard
at retorting steps and other heating steps for
parasite-containing species if the step is
exceptionally lethal to the parasites (e.g. to the
extent that significant under processing would still
result in a safe product relative to parasites);
- The evisceration recommendations for PSP and
ASP control in fin fish or crustaceans in Chapter 6
have been changed as follows:
- Evisceration within 24 hours is no longer urged;
- The hazard is no longer identified as significant
if you eviscerate the finished product;
- The histamine control recommendations contained
in Chapter 7 have been changed as follows:
- Additional information is provided about the
mechanisms of histamine formation;
- Two control strategy examples are now provided
for receipt by the primary processor: one based
on harvest vessel records, sensory examination of
the fish, and checks on the cooling media and
internal temperature of the fish; and the other
based on histamine testing, sensory examination
of the fish, and checks on the cooling media and
internal temperature of the fish;
- New on-board cooling recommendations are
included:
- For fish other than tuna above 20 lbs., if the
fish have not been exposed to temperatures
above 83°F (28.3°C), the fish should be placed
in refrigerated sea water or brine at 50°F (10°)
or less within 9 hours of death, or placed in ice
within 12 hours of death;
- For tuna above 20 lbs, or if the fish have been
exposed to temperatures above 83°F (28.3°C),
the internal temperature of the fish should be
brought to 50°F (10°C) or less within 6 hours
of death;
- Recognition is included that fish that have been
handled particularly well on-board the harvest
vessel may be able to safely withstand somewhat
more exposure than four hours at temperatures
above 40°F (4.4°C) during post-harvest handling;
- The sample size recommended for histamine
analysis when such analysis is used as a
monitoring tool is one fish per ton if the fish are
greater than or equal to 20 lbs. each, or two fish
per ton if the fish are smaller than 20 lbs.;
- The recommendations relative to histamine
analysis as a corrective action have been
changed;
- Cooking (e.g. canned tuna "precooking") and
post cooking steps are now identified as unlikely
critical control points if sanitation practices are
sufficient to prevent recontamination with
enzyme-forming bacteria;
- Another corrective action option is included for
receipt by the secondary processor -- hold
pending evaluation of total time/temperature
exposure;
- Documentation of prior 24-week frozen storage
is now recommended, if you rely on this measure
for extended in-plant processing time at
unrefrigerated temperatures;
- The environmental chemical contaminants and
pesticides control recommendations contained in
Chapter 9 have been changed as follows:
- Making sure that incoming fish have not been
harvested from waters that are under certain (not
all) consumption advisories is now recommended
if you are the primary processor of a fish with
this hazard;
- Evidence of producer participation in a third-party
audited Quality Assurance Program is now
included as a control strategy example for this
hazard;
- Another verification option is now included for
use in combination with supplier's certificates -- quarterly
testing;
- Methyl mercury is now included in Table 9-1
(Environmental Chemical Contaminant and
Pesticide Tolerances, Action Levels, and
Guidance Levels);
- Another corrective action option is now included
in the event that supplier's certification is
missing -- testing;
- Receiving records are now recommended to be
used in combination with supplier's certificates,
if you choose that control approach;
- The aquaculture drugs control recommendations
contained in Chapter 11 have been changed as
follows:
- Evidence of producer participation in a third-party
audited Quality Assurance Program is now
included as a control strategy example for this
hazard;
- Another verification option is now included for
use in combination with supplier's certificates -- quarterly
testing;
- Aquaculture drugs is now identified as a
significant hazard in lobster pounds and a control
strategy example is provided;
- Cautions are now provided for the use of rapid
analytical methods for aquaculture drug
screening;
- The recommended frequency of on-farm visits to
check drug usage practices, if you choose that
control approach, is now once per year;
- Receiving records are now recommended to be
used in combination with supplier's certificates,
if you choose that control approach;
- The recommendations for the control of pathogen
growth and toxin formation as a result of time/temperature abuse contained in
Chapter 12 have
been changed as follows:
- Safe time limits for exposure of microbiologically
sensitive products are now based on
product internal temperature, rather than ambient
temperature, with a recommendation that you
may need to study fluctuations in your product's
internal temperature under normal operating
conditions if you chose to apply these limits to
the monitoring of ambient temperature;
- Control of cooling after a cook step is no longer
urged before the product is significantly handled,
if you cook the product sufficiently to kill
Clostridium perfringens and
Bacillus cereus,
cool the product in the same container in which
it was cooked, and strictly adhere to good
sanitation practices;
- Another corrective action option is now included
in the event that transit time/temperature controls
are inadequate at time of receipt -- hold the
product and evaluated it based on its total
time/temperature exposure;
- Another version of a sample portion of a HACCP
plan for the time/temperature control strategy
example is provided, typical of the East coast
blue crab processing technique;
- Information is now provided about the
significance of Clostridium perfringens and
Bacillus cereus;
- The recommendations for the control of
Clostridium botulinum toxin formation contained
in Chapter 13 have been changed as follows:
- C. botulinum toxin formation is now identified as
a significant hazard in products that are packaged
in hermetically sealed containers or in oil, even if
they have not been hot smoked or vacuum
packaged;
- A control strategy example is now provided for
refrigerated "pickled" fish and similar products
that are not subject to 21 CFR 114 (the acidified
foods regulations);
- Control recommendations are now included for
the prevention of C. botulinum toxin formation
during processing, in addition to the prior
recommendations relative to storage. The
sample portion of a HACCP plan for vacuum
packaged, hot-smoked salmon included in Table
13-1 now lists cooling after smoking and in-process
refrigerated storage as critical control
points;
- The recommended storage critical limit for
products that have been processed to control
C. botulinum type E and nonproteolytic types B
and F is 50°F (10°C) rather than 38°F (3.3°C);
- Corrective action options are now included in the
event that finished product samples show that the
water phase salt level and/or nitrite level is below
the critical limit, if you chose that control
approach;
- Scientific process establishment is now
recommended for brining, dry salting, drying,
pickling, and formulation steps when they are
critical in the prevention of this hazard, unless
you select finished product analysis as your
control strategy;
- Quarterly finished product testing is now
recommended as a verification procedure for
smoked, smoke-flavored, salted, and "pickled"
and similar products;
- Another corrective action option is now included in
the event that the critical limits for Staphylococcus
aureus toxin formation in hydrated batter mixes,
contained in Chapter 15, are not met -- test for the
toxin in the hydrated batter mix;
- Additional information is now included in Chapter
16 for the establishment for minimum cooking
processes;
- Another corrective action option is now included in
the event that the container sealing critical limits
established for the prevention of recontamination
after pasteurization, contained in Chapter 18, are
not met -- repack the product;
- The recommended monitoring frequencies for the
control of food and color additives, contained in
Chapter 19, have been changed as follows:
- Monitoring of prelabeled packaging material is
now recommended at the rate of one label from
each pallet;
- Monitoring of on-site computer generated labels
is now recommended to be daily;
- The flow of the CCP Decision Tree contained in
Appendix 3 is corrected;
- A number of changes have been made to the
Limiting Conditions for Pathogen Growth
information contained in
Table A-1 (Appendix 4)
including the addition of information on
Clostridium perfringens and Bacillus cereus, and
the separation of information on Staphylococcus
aureus into information on growth and information
on toxin formation.
- The Time/Temperature Guidance for Controlling
Pathogen Growth and Toxin Formation in Seafoods
contained in
Table A-2 (Appendix 4)
are now based
on product internal temperature, rather than
ambient temperature;
- The following changes have been made to Table A-3
(Appendix 5), FDA & EPA Guidance Levels:
- Mouse lethality is no longer referred to with
respect to
Vibrio vulnificus pathogenicity;
- The tolerance for oxytetracycline is now 2.0
ppm;
- A zero tolerance for unapproved drugs, except
under special circumstances, is now listed;
- The methyl mercury action level of 1.0 ppm is now listed;
- Numerous additional references are now included
in the Bibliography, and a number of the original references are corrected.
In addition to using the above listing to direct you to
relevant changes in this Guide, you should carefully
review the chapters that are applicable to your product and process.
Additional copies
Single copies of this Guide may be obtained as long as supplies last
from FDA district offices and from:
U.S. Food and Drug Administration
Office of Seafood
200 C St., S.W.
Washington, D.C. 20204
202-418-3133
Multiple copies may be obtained from:
National Technical Information Service
U.S. Department of Commerce
703-487-4650
This guide is also available electronically at:
http://www.fda.gov
Select "foods;" then select "seafood;" then select "HACCP."
Hazard Guide 2nd Edition Table of Contents
Chapters:
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Appendices:
A1
A2
A3
A4
A5
A6
A7
The Third Edition of this guidance issued in
June 2001. Above is an earlier version.
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