U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Seafood Presentation, September 1996
Seafood HACCP Implementation Timeline
Presentation
The Seafood HACCP Regulation becomes effective on December 18, 1997. What
happens in the meantime?
I'd like to break that time period into three segments:
Phase I
What should the seafood industry be doing?
- Look at your prerequisite programs
- Sanitation
- Do you or your employees need training in sanitation or GMP's? -- If so,
such training is often
available from Sea Grant, Cooperative Extension, Trade Associations, Private
Consultants, and State and local health authorities.
- Does your facility meet the requirements of the Good Manufacturing Practice
regulations (21
CFR 110)? -- If not, make the necessary improvements in equipment, facilities, or
procedures.
- Do you have written sanitation procedures (what the regulation calls SSOPs)?
-- These are not
required by the regulation but are invaluable in meeting its intent. If you
don't have them you will
benefit from developing them. Again, the intent of the SSOPs should be to meet
the standards specified in the GMPs.
- Do you have an organized system in place to monitor your facility's
sanitation conditions and
practices? -- If not, you need to develop one. It is not reasonable to expect
that the level of
sanitation in your facility can be consistently held to a high standard if you
do not make a
concerted effort to keep an eye on the conditions and practices.
- Do you have a system in place that ensures that sanitation deficiencies are
corrected? - This is
critical to making improvements in the overall sanitary condition of your
facility. If you don't have such a system in place you should develop one.
- Do you have a recordkeeping system in place to document your sanitation
monitoring and
correction efforts? -- If not, you should develop one. This will help you audit
your firm's
sanitation program, and will ultimately be a required system under the Seafood
HACCP regulation.
- Product Coding
- Does your firm have a system of product coding? If so, is it suitable for a
HACCP program?
- While there is no regulatory requirement for product coding of seafood
products, other than low
acid canned foods, coding serves a valuable function in a HACCP program.
The period that is
covered by a product code will often determine the quantity of product that will
need to be
subjected to a corrective action when there is a critical limit deviation.
- Recall Plan
- Does your firm have a recall plan?
- While there is no regulatory requirement for a
recall plan, such plans also serve a valuable
function in a HACCP program. It may be necessary
to recall product involved in a critical limit
deviation, especially when record review uncovers
a problem not detected during monitoring.
What will FDA be doing?
- Working with the Seafood HACCP Alliance to finalize the
training materials. (Completed July 1996)
- Certain HACCP functions must be performed by a trained
individual.
- While there is some flexibility in this requirement,
for most of you the easiest way to comply with this
requirement will be to have one or more of your
employees trained.
- There are no restrictions on who can deliver the
training, but the course must be at least equivalent to
a standardized curriculum that is recognized by FDA.
- To develop such a curriculum, the Seafood HACCP
Alliance was formed. It consists of FDA, NMFS, the
Association of Food and Drug Officials, which is a
professional organization of state and federal food
regulators, trade associations, including NFI and NFPA,
and academia, especially the Sea Grant program.
- The primary functions of the Alliance are to develop
the standardized curriculum and to set up a system of
instructors to deliver the course in a standardized
way.
- Development of the training materials is almost
completed, and the Alliance is in the process of
recruiting and screening potential trainers.
- Redrafting the guidelines that are intended to help seafood
processors with the details of developing appropriate HACCP
systems. We call the guidelines the Fish and Fishery
Products Hazards and Controls Guide. It is scheduled to be
available in June. More on the Guide later in this talk.
Phase II
- Alliance train-the-trainer courses started in July 1996. As
I mentioned earlier, the Alliance will be screening
potential trainers from those who have expressed an interest
to the Association of Food and Drug Officials representative
in their area. The Association has five regional
affiliates, one for every part of the country, that focus on
local issues. The trainers will be selected based on their
knowledge of HACCP and their capabilities as an instructor.
Additionally, they should be willing to perform training for
the Alliance at no cost or on a cost recovery basis, thereby
facilitating the Alliance's goal of low cost training for
the seafood industry and for seafood regulators. There will
be at least two train-the-trainer courses in each of the
five AFDO affiliate regions. This should accommodate at
least 300 trainers, at no cost to the trainer except their
travel expenses.
- Industry and regulator training by Alliance-trained trainers
will also begin in July, to be performed by the first wave
of trained instructors. Students are to include industry
members and State and FDA regulators. Training will be
sanctioned by the appropriate AFDO regional affiliate, and
certificates will be issued by the AFDO national office.
The cost of the courses should be less than $50 -- including
approximately $15 for the training materials and $5-10 for
certificate processing and registration. Travel and per
diem costs are expected to be minimal as plans are to site
the courses as close as possible to the industry.
- HACCP training will also be available from other sources, as
it has been in the past. For example the National Marine
Fisheries Service and the Food Processors Institute of NFPA
have been and will continue to offer HACCP courses. Both
organizations have committed to reviewing their existing
courses and modifying them, as necessary, to ensure
consistency with the Alliance course. If need be, past
attenders will be updated so that they will not need to be
fully retrained.
Phase III: 1997
What should the seafood industry be doing?
- Developing, pilot testing, evaluating, and modifying their
HACCP plans.
What will FDA be doing?
- After having attended the Alliance courses in Summer and
Fall of 1996, federal and state regulators will be attending
training in HACCP auditing skills, probably via satellite
down-links, in early 1997. These courses will prepare them
for conducting HACCP-based inspections.
- FDA, and possibly states, will start conducting voluntary
HACCP reviews at seafood processing facilities. During a
routine inspection, if a processor is willing to provide
access to his or her HACCP plans and records, the inspector
will review the documents and the firm's operations on a
nonregulatory basis and provide comments on the extent to
which the processor's HACCP program meets the requirements
of the regulation. It is likely that the inspector will
leave a nonregulatory "report card" that identifies any
problems that the inspector noted in the processor's HACCP
program. This will give the processor the benefit of input
into his or her HACCP plan, and will give the inspector
practice at performing HACCP-based inspections.
December 18, 1997 and Beyond
Some commonly asked questions about HACCP implementation
- What happens if FDA determines that my plan is not
acceptable?
The regulation provides that failure to have an adequate
plan or to comply with the other requirements of the
regulation renders the food adulterated. However, in
deciding what if any regulatory action to take when
noncompliance is documented, FDA will look at the likelihood
that the deficiency could lead to a public health problem.
Minor violations that are not likely to affect public health
will likely result in verbal or written notification to
plant management by the inspector. A range of other
regulatory options, including warning letters, seizure,
injunction, and prosecution are available for dealing with
more serious violations, that have a significant potential
to affect the public health.
- Will FDA take the same regulatory action when an inspector
encounters a clerical error or some other type of technical
error in a HACCP record as when he or she finds that a
processor does not have controls in place for a food safety
hazard?
Not likely. There are a number of reviews through which any
recommendation for a regulatory action must go -- from the
inspector's supervisor through agency legal counsel. At
each step the merits of the individual case are reviewed.
However, it is safe to say that the agency has neither the
interest nor the resource to pursue regulatory action
against a processor simply for the existance of clerical-type recordkeeping
errors. Having said this, I must explain
that the agency does take HACCP records seriously and will
be looking to see that they are honestly and consistently
completed.
- Will HACCP plans be preapproved by FDA?
No, it would be impractical for FDA to preapprove HACCP
plans, and modifications to HACCP plans. HACCP plans are
unique documents that reflect the operation of a single
processor. Thus, the adequacy of a plan can really only be
determined by going to the plant and matching the plan to
the plant. This can best be done during routine in-plant
inspections. However, we recognize that the seafood
industry needs to know what sort of plan will be acceptable
to the agency. We are convinced that the combination of the
Hazards and Controls Guide and the Alliance training
materials will adequately prepare processors for plan
development.
- Will the first inspection of a processor's HACCP plan be
regulatory?
Yes. Because the effective date of the regulation was
delayed from one year after publication of the final rule to
two years after publication, we believe that processors
should be ready for inspection by December 1997.
Additionally, if processors make their HACCP plans and
programs available to inspectors between now and December
1997, they will be reviewed on a nonregulatory basis, as I
explained earlier.
- Will FDA inspectors be evaluating the adequacy of processor
HACCP plans or just looking to see that they are being
consistently implemented?
FDA inspectors will be doing both. Many already have
significant training in HACCP, and they will be receiving
more before the effective date of the regulation. However,
it is important to note that an inspector's observations do
not represent the final opinion of the agency, and are
subject to legal and scientific review. In the case of
anticipated regulatory action, final decisions about the
adequacy of a HACCP plan will be made by agency experts.
- What is the status of the Hazards and Controls Guide?
The Guide is intended to be a compilation of the best
available information on the subject of hazards and controls
in seafood processing. It will contain FDA's
recommendations on the hazards that it believes are
reasonably likely to occur in specific species and finished
product forms under ordinary circumstances. The Guide will
not be a binding set of requirements, and processors will be
free to select control options that are not included in the
Guide as long as they provide an equivalent level of safety
assurance. FDA and state regulators will be given training
that will enable them to evaluate the adequacy of controls
other than those contained in the Guide.
- How will consumers know that HACCP is having any real effect
on the safety of seafood?
Many would expect that the best way to judge the success of
HACCP would be to look at the reported illness data.
However, because of serious under-reporting and skewed
reporting of one type of illness compared to another,
reported illness data would not a reliable means of judging
program success. FDA has been looking at other ways of
judging program success. At present we are considering
comparing the level of preventive controls in place for food
safety hazards after the effective date of the rule to those
in place before that date. We have survey data from a few
years back that gives us a good baseline against which to
compare. It is likely that future inspections will include
the collection of data that facilitates these comparisons.
More About the Guide
- The Seafood HACCP regulation is short as regulations go. It
takes up only about five pages in the Federal Register.
Essentially, it says processors must operate preventive
systems for safety that follow the seven principles and are
written down in something we call a HACCP plan. That's
pretty general. So to help industry with the details we are
developing a guideline in which we will explain what we know
about which seafood hazards are associated with which
species and products, and how these hazards can be
controlled. A fill in the blank HACCP plan will also be
included.
- We published a draft of the Guide in 1994 and asked for
public comment on it. We received hundreds of comments and
are in the process of evaluating them. The next step was
the publication of the first edition of the Guide in June
1996. We call it the first edition because we expect the
Guide to evolve with changes in the industry and the state
of scientific knowledge. We expect to periodically update
the Guide over time. As a result it is never too late to
comment on its contents. We will consider all comments
during the next update.
- The first edition of the Guide will be designed to be a
companion document to the Seafood HACCP Alliance training
course. The course will provide instruction on the theory
and mechanics of how to perform a hazard analysis and
develop a HACCP plan and an explanation of the regulation.
The Guide will give specific advice on how to control the
various food safety hazards associated with seafood. Both
will use the same model hazard analysis worksheet and HACCP
plan form. Copies of these are included in your information
packet.
- Like the draft Guide, the first edition will identify
hazards as species-related and process-related. You will be
able to look up the species of fish and finished product
form of the product of interest and find the potential
hazards associated with them.
- The first edition of the Guide will be designed to more
explicitly lead the reader through the hazard analysis and
HACCP plan development process. The process will be
essentially the same as taught in the Alliance course. The
Guide will walk you through a series of well defined steps
that ultimately lead to a completed HACCP plan. These steps
are summarized in a hand-out included in your information
packet.
Steps in developing a HACCP plan
- Preliminary steps
- Describe the food
- Describe the method of distribution and storage
- Identify the intended use and consumer
- Develop a flow diagram
- Hazard analysis worksheet
- Identify the potential species-related hazards
- Identify the potential process-related hazards
- Learn something about the potential hazards
- Determine which potential hazards are significant
- Identify the critical control points
- HACCP plan form
- Set the critical limits
- Establish monitoring procedures
- Establish corrective action procedures
- Establish a recordkeeping procedure
- Establish verification procedures
Finally, I'd like to close with a few comments on how I believe
HACCP presents an opportunity for a fundamental change in the
relationship between industry and FDA. Under FDA's traditional
food inspection programs there was little incentive for industry
to be forthcoming about its problems in discussions with FDA
representatives. In fact, many would believe that there has been
incentive to keep them concealed. They would argue that if FDA
caught wind of a problem, the agency's first reaction would be to
document the problem for potential legal action.
HACCP presents quite a different situation. It is true that
under HACCP a processor is obliged to document deviations from
critical limits. However, just as important is the requirement
that processors document their corrective actions. It is this
point that shifts the regulatory focus from those occasions when
problems occur to those occasions where a processor fails to take
corrective action when a problem occurs.
A well intentioned processor who properly develops and implements
a HACCP plan but still has occasions where product does not meet
the appropriate critical limit need not be concerned about an FDA
inspector finding those glitches. That is because the well
intentioned processor will recognize that such product represents
a potential health hazard and will subject the product to a
corrective action that eliminates the hazard or removes the
product from commerce. If this is done, the agency has no
regulatory interest in the product.
If you don't believe that the agency can behave in this manner,
you need only look at the low acid canned food program, in which
this has been the course of action for twenty years. By almost
all accounts that program has been a complete success, from the
prospective of the agency, the industry, and consumers.
In this era of reinvention of government, HACCP offers a real
opportunity.
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