Standard #1
- State Interpretation of When Otherwise Approved vs. intent
of Food Code.
The county that I represent has a delegation agreement with the
State. Under the
delegation agreement the county is required to use the Food Code adopted by the
State. The county may develop Food Code provisions that are stricter than the
State. In 2001, the State adopted the 1999 FDA Food Code.
Recently the State has issued interpretations on several key provisions
within the Food Code. Most notably, Section 3-301.11 Preventing Contamination from Hands. The
State adopted the FDA Food Code language verbatim for this Section. Since that
time, however, the State has issued an interpretation on what is meant by “when
otherwise approved”. This interpretation is less stringent
then what FDA has provided as guidance in ANNEX 3 of the FDA Food
Code.
The States interpretation of “when otherwise approved” in essence states that if a facility is in compliance
with the hand wash provisions within the Food Code and has a system, such as SOPs, to
support this practice, then they meet the intent of “when otherwise approved”.
Question/Problem
My questions is this, if the Food Code adopted in the State specifically
meets the language in the FDA Food Code, does that meet the
intent of complying with this risk based
provision in Standard #1, or will the State’s interpretation
of the provision (and any other similar types of interpretations)
also have to be taken into account when
conducting the self-assessment?
Rationale: We believe that if the Food
Code language in the State (thus County) Code is verbatim to the
FDA Food Code language then our County meets the intent of
Standard #1 which is based on a provision by provision comparison
of Food Code requirements. If not, how will an auditor be
able to assess a jurisdictions compliance with Standard #1 without
knowing all the individual Food Code interpretations
that may have been issued by the State.
Clearinghouse Work Group Response
The jurisdiction has adopted the language in Section 3-301.11
verbatim. For this
specific provision, the jurisdiction is in compliance with the
assessment criteria contained in Standard No. 1.
The language of Standard No. 1, in both the ‘Requirement Summary’ and the
‘Description of Requirement’ states that a jurisdiction’s regulation, rule,
or ordinance must have a provision as least as stringent as the specified provisions of
the Food Code. According to the information provided, the jurisdiction has adopted
3-301.11 of the 1999 version verbatim. That meets the
stated requirement of Standard No. 1 for the item in question.
The language of 3-301.11 includes a phrase ‘Except . . . as otherwise
approved.” FDA originally anticipated that jurisdictions approving alternatives
to the ‘no bare hands contact with ready-to-eat foods’ provision would approve
those alternatives that could convincingly address the hazards of fecal/oral contamination
and would provide effective management controls to ensure protection of the food.
This phrase was intended to allow some flexibility for innovative ideas or advancing
technology that might not be foreseen. It was not anticipated that the phrase would
be used as a blanket approval for ‘business as usual.’
Later, FDA provided guidance in Annex 3 regarding the
kinds of criteria to be used when approving alternative controls
to ‘no bare hand contact.’ Standard No. 1
language does not include adherence to guidance or Annex 3 as a condition of meeting the
Standard. While the Work Group agrees that the jurisdiction is not meeting the
spirit of that provision of the Food Code, it has adopted the regulatory language
necessary to protect the public health, which was the goal of Standard 1. It is in
the implementation of the regulatory language where the failure occurs. This failure
to meet the spirit of the Code cannot be addressed through Standard No. 1.
This appears to be a gap in the Standards that was not foreseen and may well need to be
addressed. The Standards will doubtless evolve over time
with changes and/or additions as stakeholders gain experience and
knowledge through their use.
- Section 8-813.10 Petitions, Penalties, and Continuing Violations
The Statutes in the State do not provide the State and local health
jurisdictions the authority to enact or
administer civil penalties. The State and local jurisdictions
do have provisions for criminal penalties that are equivalent to
the FDA Food Code.
Question/Problem
Since criminal penalties are, in most instances, more punitive and stringent than civil
penalties, would jurisdictions operating under the limitations of the State statute
prohibiting the application of civil penalties by health authorities meet the intent of
the FDA Food Code?
Rationale: Since criminal penalties are more stringent then civil
penalties, we believe that jurisdictions that do not have authority to enact civil
penalties but incorporate criminal penalties at least equivalent to the FDA
Food Code meet
the intent of Standard #1.
Clearinghouse Work Group Response
The language of Standard No. 1 currently requires provisions
corresponding to all of the 15 identified Code provisions, which
includes both criminal and civil penalties. According to
the criteria established in Standard No. 1, the jurisdiction does
not meet the Standard.
The Work Group believes that in some circumstances criminal
penalties alone can provide the foundation for effective enforcement. The
Work Group is referring this question to the CFP Accreditation
Committee for their assessment of the criteria contained in
Standard 1, Appendix A, Table A-5.
- Local/county Jurisdictions Operating Under State Regulations
The State of West Virginia has adopted the 1999 Food Code, but deleted the Consumer
Advisory. The State Code is used throughout the State. We are two local
jurisdictions in the State. Currently, it is possible that we might be able to
promulgate a local rule that adds the consumer advisory to our county rules; however, that
option may be taken away soon.
Question/Problem
Will we be able to meet Standard #1?
Rationale: Unless we are able to enact separate provisions, we will not be able
to ever meet Standard #1.
Clearinghouse Work Group Response
For the initial listing, a jurisdiction’s regulation must contain at least 9 of the
11 risk factor controls and interventions. For the initial self- assessment, it is
possible to meet the criteria in Standard No. 1 without the consumer advisory
provision. By the second audit, however, the regulatory foundation
must meet all 11 of the 11 risk factor controls and interventions.
As a local jurisdiction, you must promulgate a local rule
to include the Consumer Advisory in order to get credit for that
item or work toward getting the State’s
regulation changed to include it.
- Asterisks in Appendix A of Standard #1
Annex A that accompanies Standard 1 is confusing in that there is no explanation
of the superscripts (asterisks) that appear on some of the line items. What
do these mean in terms of meeting the Standard?
Question/Problem
The Program Standard 1, Appendix A needs more clarity pertaining to
superscripts and line items. Please explain. We recommend that FDA provide
information to assist the user by including information from the Food
Code,
preface 8 (VIII – IX), in the Program Standards Appendix.
Clearinghouse Workgroup Response
The Workgroup believes that the issue involves the asterisks attached
to some of the Food Code tag lines that appear in the Appendix A
for Standard 1. The asterisks represent the Food Code convention that indicates
a ‘critical
item.’ The asterisks have no relevance to the Standard itself and
do not signify relative importance of one item over another. All
of the risk factors and interventions carry equal weight in the attainment
of
the Standard. This should be resolved, however, if it creates confusion
on the part of jurisdictions conducting self-assessment. The Clearinghouse
will recommend to FDA that a note explaining the asterisks be added
to Appendix A or that the asterisks be removed from the Appendix A for
Standard
1 entirely since they have no relative meaning in Standard 1.
- Access to the Food Code
Question/Problem:
Evaluating a program against Standard 1 requires access to FDA Food
Code. We recommend FDA provide sufficient number of Food Code copies
to jurisdictions when enrolling in the Program Standards.
Clearinghouse Workgroup Response
While the Clearinghouse acknowledges that the Code is
available free-of-charge on the FDA web site and is for sale through the National
Technical
Services Center, FDA does make limited distribution to jurisdictions
through its Regional Specialists. It seems reasonable that one
copy could be made available to each of the enrolled jurisdictions,
and the Clearinghouse will forward that recommendation to FDA.
You should also know that FDA’s Division of Federal Relations
will soon be distributing a CD-ROM set that includes many resource
documents, including the Code.
- Phase-in Period for Meeting the Risk Factors/Interventions in
Standard #1
This Standard currently requires that a jurisdiction have all 11
of the 11 risk factors/interventions provisions after two self-assessment
cycles, essentially six years
Question/Problem
We believe this requirement to meet all eleven of the risk factors/interventions
after six years is too stringent. More flexibility to reach compliance
is needed.
Recommendation: We recommend that the Clearinghouse extend the phase-in
time for compliance with the risk factors and interventions to:
9 of 11 in three years ( one assessment cycle);
9 of 11 in six years (two assessment cycles; and
11 of 11 in nine years (three assessment cycles).
Clearinghouse Workgroup Response
This issue involves extending the period for compliance with all
eleven of the risk factors and interventions from two assessment cycles
(six years) to three assessment cycles (nine years). Since this is a
request for a change in the Standard, the Clearinghouse will recommend
that this issue be referred to the CFP Standards Committee for deliberation.
- Requirement to have all Code sections under each heading to meet
the Standard.
Under the risk factor/intervention category “Approve Source,” there
are 18 identified Food Code sections. A jurisdiction’s regulation
must address each of these in order to meet the Standard for that risk
factor.
Question/Problem
Currently some jurisdictions have not included wild mushrooms in
their code and, therefore, are unable to meet the requirement for approved
source.
Recommendation: We recommend that a formula be developed for each major
intervention/risk factor in table A of Appendix A to allow for flexibility
in meeting this standard. So, if a jurisdiction meets 17 of the 18 Code provisions in the "Approved Source" section, the intent of the
Risk Factor would be met.
Clearinghouse Workgroup Response
While there may be some merit to the recommendation, the Workgroup
foresees an extremely complicated process for determining achievement.
Careful consideration will need to be made about whether any overall
national benefit will result from the increased complexity, given that
there is already a phase-in time for meeting all of the risk factors
and interventions. The Clearinghouse Workgroup is referring this issue
to the FDA Steering Committee for consideration.
- Want Alternative Criteria for Demonstrating Control of Risk Factors
Question/Problem
Some local codes have adopted standards which control the risk
factors but still differ from the FDA Food Code. A jurisdiction
that has adopted 130F for hot holding may be adequately addressing
the risk factor and controlling the public health concern, but would
not meet the 135F requirement in the FDA Food Code. Another example
is with hand washing - suppose the requirement has a hand washing
provision but does not identify a time, such as 20 seconds. Does
this meet the intent of the risk factor?
Recommendation: We recommend a list of questions be developed for
each major intervention/risk factor so a jurisdiction that has different
language than the Food Code has guidance to determine if the intent
of the Code section is met without compromising it.
Clearinghouse Workgroup Response
Standard 1 is very specific in using the model Food Code as the
criteria for this Standard. Any attempt to try to interpret “adequate” control
of risk factors using something other than the Code would
be to invite debate on any number of issues without having a viable
means
of arriving at an authoritative final answer. The forum for debate
and for establishing what is acceptable in the ‘community
of practice’ is the Conference for Food Protection, which
represents the entire food safety community. In the example given
for hot holding of 130° F versus 135° F, the answer is very clear.
The Food Code in the future will require 135° F for hot
holding, so that anything less than that does not meet the intent
of the
Code; and, therefore, does not meet Standard 1.
The example of the omission of the 20-second time frame in the
handwash requirement can be overcome in some cases. Given the amount
of debate and attention that the handwash issue received in the
CFP during its last two sessions, the Food Code and those interpreting
it clearly intend that a 20-second minimum time be included as
a part
of the acceptable procedure. If the 20-second requirement is omitted
from a jurisdiction’s adopted regulation language, but the jurisdiction
establishes supplemental policies or standard operating procedures
that enable it to carry out the intent of the Code language, then
the Standard can be met.
The recommendation to develop a list of questions for each major
intervention and risk factor and to provide alternative language for
determining Code intent is not practical. Even to provide a list of
potential questions would be a daunting task. Additionally, trying
to provide alternative language that would meet the intent of the
Code would only further confuse matters and would compromise the criteria
for determining achievement of the Standard. While developing a list
of anticipated questions might not be practical, the Clearinghouse
will continue to respond to questions as they are submitted by jurisdictions.
It is hoped that this process for answering questions is beneficial
in providing guidance to those of you who are conducting your self-assessments.
- GRP Requirements Too Stringent
Question/Problem:
Too much emphasis is placed on GRP's. The 95% requirement is too stringent
and does not take into account language differences in local codes, which
may not have the same degree of specificity but shares the same intent.
Recommendation: We recommend that the Clearinghouse allow local justification
for variance of local codes from the FDA Food Code with the condition
that the risk factors are NOT compromised.
Clearinghouse Workgroup Response
It is too early to determine whether any of the Standards are too stringent
or too lenient since not enough information has been gathered from
the participants. There are currently more than 70 jurisdictions
enrolled and conducting self-evaluations for the first time based
on the criteria in the Standards. The number of participants grows
daily. Many jurisdictions are just beginning to complete the self-assessment
process. Any recommended changes to the Standards, made through the
CFP, should be made based on empirical data and should reflect the
best practices in the food safety community.
-
Compliance and Enforcement Code Sections
Our jurisdiction has adopted the Food Code, and we are working diligently
on our self-assessment process. We also have a very aggressive inspection
and follow-up inspection schedule that requires a follow-up whenever a
critical item is marked. Our problem is this, there are many items in the Food
Code that are designated as ‘critical,’ and yet failure
to comply are not likely to cause illness. An example is 2-401-11(B) – where
an employee is drinking from an open cup. In our jurisdiction, an inspector’s
marking this item requires a follow-up inspection. This is causing far
too many follow-up inspections and consuming resources unnecessarily. We
would like to change the designation in our regulation from a hard and
fast ‘critical’ to ‘swing” for about 28 items so
that we can continue to accurately record all violations without triggering
follow-up inspections for items that we judge to be non-critical and so
that we can maintain a consistent re-inspection policy.
Question/Problem
If we change the critical item designations in our regulation, do
we still meet Standard #1?
Rationale
We believe that we will still met Standard #1. Our regulatory language
is the same as the model Food Code, and we cannot find anything
in the Standard that requires identical designations or conventions
as the Food Code. The Standards, in general, focus on risk factors
and interventions, which are not identical to ‘critical’ items.
Clearinghouse Workgroup Response
You make some valid points. The Food Code definition of a ‘critical
item’ is “a provision of this Code, that, if in noncompliance,
is more likely than other violations to contribute to FOOD contamination,
illness, or environmental health HAZARD.” The Standards definition
of a ‘risk factor’ is “improper practices or procedures
stated below which are most frequently identified by epidemiological
investigation as a cause of foodborne illness or injury:
- improper holding temperature;
- inadequate cooking;
- contaminated equipment
- unsafe source; and
- poor personal hygiene”
Food Code ‘interventions,’ although they add somewhat to the
above list, also overlap with risk factors. “Interventions are:
- management’s demonstration of knowledge;
- employee health controls;
- controlling hands as a vehicle of contamination;
- temperature parameters for controlling pathogens; and
- consumer advisory.”
So there exist two concepts that are not entirely in sync with one
another. Critical items are not risk factors or interventions per
se since their definition also includes food and environmental contamination.
You are correct in stating that there is nothing in Standard
1 which directly links to ‘critical items.’ One inference might
be drawn in the Compliance and Enforcement chapter of the Food
Code,
in section 8-405.11, which is a requirement for part C of Standard
1. That section requires correction at the time of the inspection
for critical violations of the Code. It might be argued that if you
change items from ‘fixed critical’ to ‘swing critical’ then
your regulation is no longer as stringent the Code since you would
no longer be required to obtain immediate corrective action all Food
Code critical items. It could be argued on the other side that this
is an implementation issue and not a regulatory foundation issue.
Section 8-405.11 is broader than the Standard 6 for Compliance and
Enforcement which requires immediate corrective action of out of
control risk factors and interventions.
The Clearinghouse Workgroup would hate to see you make changes
in your critical item designations until the Conference for Food
Protection
reaches agreement on the changes that are necessary in the Food
Code designations. There is wide disagreement on the critical items issue,
with opinion ranging from ‘make no changes’ to ‘eliminate
the concept entirely.’ The CFP Inspection Forms committee will
in 2004 again tackle the issue of critical items in an attempt to
reach consensus while incorporating either critical items or risk
factors into their model form. If CFP makes a recommendation accepted
by FDA, you could then accordingly make changes to your regulation
and maintain uniformity with the national model.
A more immediate solution to your dilemma would be to make minor
changes to your compliance and enforcement policy. To maintain your
high standards in this area, you could continue to require on-site
corrective action with documentation on the inspection form for all
critical item violations; this would maintain conformance with 8-405-11.
You could then impose the requirement for follow-up inspections only
for out of control risk factors and interventions that that contribute
to foodborne illness. You would still meet Standard 6 for Compliance
and Enforcement, provided the other criteria in that Standard are
met, and you would eliminate the unnecessary follow-up to violations
you feel do not warrant the resource expenditure.
Page Top
Standard #2
-
Number of Joint Training Inspections Required in Standard #2
The criteria in Standard #2 require 25 joint training inspections with a trainer who has
successfully completed all training elements required in the Standards.
Question/Problem
Can the requirement for 25 joint training inspections be waived
for candidates who have had a significant number of years of
experience in the field conducting field inspections? We believe
that Standard #2, as written, was intended to serve as a template
for new employees entering the food program. Many of our field
personnel have conducted hundreds of inspections independently.
We believe that joint field training inspections of these candidates
are an inefficient use of time. For experienced candidates, we
believe the joint training inspections can be waived and an assessment
of their inspection competency be made through the standardization
component. If candidates with experience do not successfully
complete their standardization, then a corrective action plan,
that may include joint field training exercise, could be developed
and implemented.
Clearinghouse Work Group Response
The language in Standard No. 2 regarding the 25 joint training inspections was
intended for new employees or employees new to the food safety program. In
order to accommodate an experienced food inspector, the supervisor can include
a simple statement or affidavit in the employee’s training file explaining
their background or experience that justifies a waiver of this requirement.
You are correct in stating that the standardization component is the test
for competency and should reveal any problem. However, as you suggested,
should an experienced inspector for whom a training waiver has been granted
fail the standardization component, a corrective action plan must be developed
and implemented.
-
Recognized Credentials and Their Relationship to Standard 2 Curriculum
The criteria in Standard #2 require a candidate to satisfactorily complete training that
includes the following components:
- prevailing statutes, regulations, ordinances;
- public health principles;
- communication skills;
- microbiology;
- epidemiology; and
- HACCP
Question/Problem
Does a candidate, who has obtain certification as a Registered Environmental Health
Specialist, through a recognized national organization (such as NEHA) meet the intent of
this Standard?
Rationale: We believe that having a credential
as a Registered Environmental Health Specialist, does not, in and
of itself, meet the intent of the
Standard. We believe that the intent of the Standard is to
ensure that the candidate has specific training in each of the describe
disciplines. Credentials as a
Registered Environmental Health Specialist, though encouraged, may
not include curriculum specific to the disciplines described above.
Clearinghouse Work Group Response
The Work Group agrees that a credential cannot be taken
as prima fascia evidence that the training requirements are met. Specific
curriculum components must be examined in order to make determination
of whether the Standard has been met.
- Determining Training Component Equivalency
The criteria in Standard #2 require a candidate to satisfactorily complete training that
includes the following components:
- prevailing statutes, regulations, ordinances;
- public health principles;
- communication skills;
- microbiology;
- epidemiology; and
- HACCP
The Standards, however, does not specifically prescribe the amount of contact time a
candidate needs to fulfill the training requirements in any of the disciplines.
Question/Problem
Is
attending a one-hour presentation on food microbiology at a national
conference sufficient to meet this requirement? How is one
to equate the quality and length of training for equivalency? Besides
documentation in the form of certificates and documentation of
attendance, what criteria are to be used to demonstrate a candidate's
knowledge of the following
disciplines? Are there specific contact hours that need to
be associated with each of the disciplines?
Clearinghouse Work Group Response
The submitter is correct in that the Standard does not provide
specific guidance on the quality or length of class required
for equivalency. Originally a sample training plan (formerly
called the Level 1 Training Plan) was included as an attachment
to Appendix B that accompanies Standard No. 2., and the sample
plan was intended to serve as a general guide. However, it was
a very lengthy document that caused trouble when attempting to
download the appendix. A decision was made to post the sample
training plan on the Web as a separate document and refer readers
of Standard 2 to the appropriate site, still with the intention
that it be used as general guidance. The sample training plan
is now Appendix K and will be posted with the Standards in the
future.
In the sample training plan, the module for microbiology, for
example, recommends a half-day of on-site orientation to a laboratory
and eight contact hours of microbiology. The FDA filmed satellite
course on microbiology is offered as an alternative to a live course.
Currently, FDA basic food safety courses are being developed as
interactive web-based courses and will be available soon to jurisdictions
at no cost. The intention of providing only general guidance was
to give jurisdictions some flexibility in designing their training
programs and to allow training from a wide variety of sources.
It may well be that this is insufficient guidance.
Currently there are over 70 jurisdictions enrolled in self-assessment.
The FDA is planning to gather feedback from those jurisdictions.
This area of training is one area where information from the jurisdictions
about how they view an equivalency measure is needed. There are
many ways to go about measuring equivalency, but none of them are
simple. Establishing specific course objectives, contact hours,
or performance standards for the knowledge gained in order to measure
equivalency will be a large task. This may well be a task for stakeholder
group, another FDA work group or a CFP committee to tackle. The
Clearinghouse Work Group recommends another look at this issue
after the jurisdictions have reported back on their experiences.
-
Documents that Serve in Lieu of Training Certificates
I serve as the staff development and training officer for a large
county health district. I am responsible for keeping records of staff
attendance at training workshops and courses. Several of my staff
are having difficulty locating their
certificates related to their attendance at FDA State Training Branch
courses. Some
of these course were satellite broadcasts, other were classroom sessions.
As their training officer, I have kept an internal log of their attendance at
these and other courses.
Question/Problem
Since my position responsibilities include maintenance and verification of attendance at
training workshops and courses, can my Department records be used to verify staff’s
attendance at these training workshops and courses or must they be able to produce the
actual FDA certificate from the course?
Clearinghouse Work Group Response
Department records can be used to verify training attendance under certain
circumstances. While certificates issued by course sponsors are the ideal proof of
attendance, other official documentation can serve as satisfactory verification of
attendance. The key to a document's acceptability is that someone with
responsibility keeps the records according to an established protocol. Someone such
as yourself who is the training officer or a supervisor who has first-hand knowledge of
the employees' attendance at the sessions can serve as the recordkeeper. By
established protocol, we mean logs/records that are completed based on on-site sign-in
sheets, have information validated from a certificate at the time of issuance, or other
accurate verification of actual attendance. The National Environmental Health
Association is keeping automated attendance records for their courses; and in the future,
FDA will offer an individual transcript of courses taken through ORA U. These kinds
of official automated records kept by course sponsors are acceptable also. Keep in
mind when establishing a records system that a Standards Auditor must be able to verify
that the various elements of Standard 2 have been accomplished for each applicable
employee and within timeframes for new or reassigned employees. Now
that documentation of training efforts is so important to regulators,
it is more important than
ever for employees to retain course certificates as their personal
proof of attendance should questions arise, and they should be encouraged
to do so regardless of other
available records systems.
The Clearinghouse Work Group will ask the CFP Accreditation Committee to look at the
issue of logs/training records and take under consideration the amount of information to
be kept, what information elements must be kept, and for how long.
- Who Must Meet Standard 2
In our department, some of the Environmental Health Specialists have been assigned to
the plan review program. Their responsibilities include review of plans for both new
construction and remodeling of existing facilities. In the course of their duties
they conduct plumbing inspections, rough-in equipment inspections, pre-opening inspections
and other construction related verifications. Their responsibilities do NOT include
operational inspections to assess a facilities adherence to Food Code critical limits
pertaining to food storage, preparation and processes.
Question/Problem
Are the Environmental Health Specialists (EHS) assigned specifically to the plan review
program required to meet the standardization criteria in Standard #2?
Clearinghouse Work Group Response
The Work Group gives a cautious, qualified "no" when answering whether EHS
personnel assigned to plan review only are required to meet the standardization criteria
in Standard 2. If a person's duties are strictly limited to construction inspections
only, then standardization is not wholly job-related and is not required. In this
situation, these positions have a similar relationship to the program as do administrators
and other support personnel and take on a function similar to that of a building
inspector. There is some concern expressed, though, that without
the on-going (maintenance) responsibilities in operations required
by the standardization procedures
that these inspectors may lose familiarity with developing trends
in food operations and, therefore, lose effectiveness in design and
equipment evaluation critical to new and
remodeled construction.
If the plan review personnel in question conduct inspections of operating facilities
even on a limited basis, as back up to other field personnel, in crisis situations, for
compliance or other reasons, or if they rotate assignments with inspectional personnel,
then they must meet the standardization criteria in Standard 2.
- Code Criteria for Standardization
Question/Problem
The Standards do not allow flexibility for standardizations to be
conducted to a jurisdiction’s own food code when the standardizer
and the candidate are from the same jurisdiction.
Recommendation: Recommend that the Clearinghouse provide the option for
standardization to a jurisdictions own food code, provided that the jurisdiction’s
food code meets the criteria in Standard #1 - Regulatory Foundation
Clearinghouse Workgroup Response
This question points out a possible misunderstanding of this portion
of Standard 2. It is the intention of Standard 2 that standardization
exercises within a jurisdiction can be based, generally, upon
the jurisdiction’s
own regulation or ordinance, with some cautions and explanations
provided in the following paragraphs.
FDA’s standardization of jurisdiction officials
is and will continue to be based upon the FDA Food Code since
it represents
the national technical and scientific criteria for food safety
in the food service and retail food setting and promotes uniformity
across the nation. The FDA standardization process, along with
the Food Code as a model, furthers the goal of national uniformity.
It is certainly the intention of the Standards that jurisdictions
adopt the Food Code as faithfully as possible. The Food Code continues
to be a primary means of promoting regulations based on science,
providing the same level of protection to consumers across the
country, and providing a level playing field for the industry.
The specific goal of Standard 2, however, is to ensure
that personnel are trained and prepared to competently conduct
inspections within their jurisdiction. This is further demonstrated by the curriculum
component number 1 of Standard 2 that includes “prevailing statutes, regulations, ordinances; . . .,” meaning those
prevailing in the jurisdiction. Standard 2 further states that
a jurisdiction’s field standardization must be similar to
the FDA Procedures for Standardization and Certification of
Retail Food Inspection/Training Officer. This means that it must include
eight joint standardization inspections, be conducted by a “training
standard,” determine the inspector’s ability to apply
the knowledge and skills obtained from the training curriculum,
and address the five performance areas. The five performance areas
to be addressed are spelled out in the Standard as follows:
- Conducting risk-based inspections,
- Recognizing good retail practice
requirements,
- Applying HACCP principles to the inspection process,
- Demonstrating
knowledge and use of essential inspection equipment, and
- Communicating in an effective manner.
The five performance areas target the behavioral elements
of an inspection. The behavioral elements of an inspection being
defined
as the manner, approach and focus of an inspection which targets
efforts to the most important public health risk factors and communicates
vital information about the inspection to management in a way that
it can be received, understood and acted upon. The goal of standardization
is to assess not only technical knowledge but also an inspector’s
ability to applying his or her technical knowledge in a way that
targets time and resources spent in a facility to most benefit
the regulatory agency and the consuming public. A customized standardization
procedure must still meet the standardization goals.
It should be noted that it is possible and highly beneficial
to use the FDA Food Code, standardization forms and procedures
even
when a jurisdiction has adopted modifications to the Food Code.
Usually regulation’s differences can be noted and discussed
during the exercises, and thereby enhance the knowledge and understanding
of the candidate. For example, it is valuable for a candidate to
assess the foods offered for sale in a facility and to make a determination
of whether or not the facility would be required under the FDA Food
Code to post a ‘Consumer Advisory’ whether or
not the jurisdiction has adopted that requirement. The value derived
is an increased awareness of the foods that may pose a particular
risk to some individuals. Additionally, use of the FDA standardization
form ensures a broad knowledge of the regulations that might not
be tested using a condensed inspection form format.
One further advantage exists in using the “FDA Procedures
for Standardization and Certification of Retail Food Inspection/Training
Officers” and its accompanying forms verbatim. The scoring
and assessment tools presented in the ‘Procedures’ can
be used without modification. The scoring and assessment tools
are specifically tied to the standardization inspection form and
other assessment forms that are a part of the procedures. Jurisdictions
that change the limits of the standardization form to fit a local
regulation are cautioned that a redesign of the scoring assessment
of the candidate’s performance on the field inspections and
other exercises is also necessary, and this sometimes proves to
be a very difficult task.
-
Number of Joint Inspections for Field Training
Question/Problem
Twenty-five joint inspections for field training of new or newly
assigned inspectors is too many. It needs to be reevaluated and justified.
Recommendation: We recommend to the CFP the revaluation and justification
of the number of joint inspections for field training. We recommend
a significant reduction of the number of joint inspections for
field training (currently 25) to something like 10, and they should
cover a variety of risk levels.
Clearinghouse Workgroup Response
Standard 2 requires that field personnel perform a number of separate
training activities and pass a performance measure to assure
initial and continued competency in the performance of food safety inspections.
An
academic training curriculum, the twenty-five joint training
inspections and the twenty-five independent inspections are intended to
ensure adequate
preparation for field standardization and ultimately for the
performance of their duties as food inspectors. These are each designed
as separate
activities. While the submitter of the problem feels that twenty-five
joint inspections are too many, other managers and trainers feel
that the number may be too few. While more would be better, twenty-five
was
chosen because it represents an amount of work that can be performed
in a reasonable time period for most jurisdictions, probably two weeks
or
less. The joint inspections are intended to be practical field
training that gives the new employee an opportunity to ask questions and
the supervisor/trainer
an opportunity to train, observe, and assess future training
needs of the employee. Twenty-five inspections do not appear to be an unreasonable
training module. In addition, twenty-five joint inspections represent
an amount of one-on-one training during which a reasonably intelligent
person can assimilate the details of the duties being required
of them
and to encounter a wide variety of situations that exist in the
work environment. The twenty-five independent inspections performed before
standardization
then allows for a sufficient amount of individual work for the
employee to gain confidence and to identify questions or issues that will
inevitably
arise once they are conducting inspections on their own. Also,
note that the training is not required to be done by an ‘FDA standardized
officer.’ The Standard says that the joint inspections must be done
with a trainer who has successfully completed the training elements
of the Standard. This can be a supervisor or other designated individual.
The Clearinghouse believes that the training element for new
or newly
assigned employees should remain as currently state
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Number of Inspections in the Standardization Exercise
Question/Problem
The number of inspections for field standardization is too many
due to limited standardized staff resources and travel considerations.
Recommendation: We recommend to the CFP the reduction of inspections
for field standardization, e.g. six.
Clearinghouse Workgroup Response
The number of inspections required for standardization is an issue
that has been discussed and agonized over by many people. Remember
that the standardization process is a performance measure. It
differs considerably from joint training inspections in that
the candidate is not allowed to receive technical information
regarding observations from the ‘standard’ during
a standardization inspection. The fact that the candidate and
the ‘standard’ must have comparable results within
a percentage range makes this a testing process. The fewer the
number of inspections, the more difficult it will become for
the candidate to perform satisfactorily during the standardization
and the more critical individual inspections and individual technical
items become. Fewer inspections in the process will raise the
performance bar. Standardization must represent a reasonably
challenging measure, but it must not be so stringent a measure
that a competent individual cannot succeed. The Clearinghouse
Workgroup believes that eight (8) should remain the minimum number
of Standardization inspections.
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Training Plan in Appendix K
Question/Problem
There is confusion as to whether Appendix K is for guidance only
or if it will be used to evaluate a jurisdiction for compliance with the
Standard. The training modules in “K” are too narrow and need
to be expanded.
Recommendation: We recommend that the Clearinghouse clarify whether
Appendix K is for guidance only or if it is to be used as an evaluation
tool for compliance. We recommend additional related courses to “K” be
added, such as: interpersonal skills; pesticides/toxicology; equipment
and mechanics; foreign languages; cultural diversity; personal
safety; H20/ww systems; information technology.
Clearinghouse Response
Standard 2 is clear in stating that Appendix K is provided as an
example. It is not intended for use as an evaluation measure,
but is provided as an illustration of a good, comprehensive program.
Appendix K was developed jointly by the program managers for
the states of the FDA Southwest Region and has been used by many
of those states for training staff for a number of years.
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Criteria for the Education/Training Requirements
Question/Problem
The Education and Training Requirement in Standard #2 provides
no details or guidance as to content. We need more guidance for designing
our curriculum, and information about how to measure course equivalency.
Recommendation: We recommend to the Clearinghouse the clarification
of the Continued Education and Training requirement so it relates
to curriculum requirements. Suggested wording to add to the first
paragraph of Element #4 at the end of the 2nd sentence: “…following
activities that relate to the components of curriculum in Element
#1”.
Clearinghouse Response
It is true that the Standard does not provide any details about
the content for each of the curriculum elements. Currently, jurisdictions
have maximum flexibility in designing or assembling training
in each of the six elements to meet the intent of that portion
of the Standard. Those of you who have been in the food safety
profession for a number of years may remember the origins of
the Managers Certification program. Manager Certification started
out in the early 1980’s with a specific course outline
and a specific number of classroom hours that had to be devoted
to each topic. Then the issue of who would qualify the individual
training courses as meeting the requirements arose. Then the
issue of whether or not the same knowledge could be conveyed
in a shorter amount of time surfaced. The good concept that started
out in the early 1980’s fairly simply was finally resolved
to everyone’s satisfaction at the 2002 Conference for Food
Protection with passage of the issue approving of the certifying
process for training providers.
Also, during the 2002 CFP, five issues were submitted that involved
the training and certification of health officials. The issues
were combined, approved as amended, assigned to a committee for
assessment and for review of Standard 2, and charged to return
with recommendations to the 2004 Conference. It is not possible
to know what the committee will recommend regarding the training
and certification of health officials. At this time, the Clearinghouse
Workgroup believes that the best course of action is to wait for
the recommendations of the committee and actions of the CFP.
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Standard #3
- Change the Term HACCP in Standard 3.
Question/Problem
The term “HACCP” doesn’t convey the clear intent of identifying
and controlling risk.
Recommendation: Recommend to the Clearinghouse that Standard #3 wording
be revised to eliminate acronyms by replacing HACCP with “Risk Control” in
the Standard 3 title.
Clearinghouse Workgroup Response
The language in the title of this Standard uses the term “HACCP Principles,” which
was intended to distinguish the concept from a pure HACCP process.
The intent of the Standard is for the inspection program to focus on the control
of
risk factors, which in most instances coincides with hazards or hazard
control points under the HACCP concept. Further, the inspection program is
intended
to support or enhance an establishment’s own management systems or
encourage the development of one if it is lacking entirely. Industry
management systems are, for the most part, based on HACCP principles.
The term HACCP
is generally recognized and understood by industry and by food safety
officials. The Clearinghouse Workgroup does not support changing the
title as recommended.
- Risk-Base Inspection Form
Question/Problem
Most jurisdictions don’t utilize a risk-based inspection form. We recommend
to FDA that the CFP Model Inspection Form replace the present inspection
report form in Annex 7 of the Food Code. This will encourage use of the new
form.
Clearinghouse Workgroup Response
The CFP Model Inspection Form has not completed the approval process
as yet. Jurisdictions are currently being asked to pilot the form to identify
any improvements that are needed or to identify any flaws that need to
be corrected. When that process is completed and the CFP votes its final
approval, the FDA will consider endorsing the form and placing it in Annex
7 of the Food Code as a model.
- Guidance for Short- and Long-term Compliance Policy
Question/Problem
There is a lack of guidance in the area of policy development concerning
short- and long-term compliance issues.
Recommendation: We recommend to FDA that it provide representative examples
of acceptable policies addressing the following: on-site corrective actions;
long-term risk factor control; follow-up activities.
Clearinghouse Working Group Response
This issue will be referred to the FDA for consideration. While most
jurisdictions want the flexibility to develop their own policies given
that compliance and enforcement procedures are controlled in different
legal documents among jurisdictions, there is no reason why good examples
cannot be provided. Many jurisdictions will be approaching the conclusion
of the self-assessments in March of 2003. The Clearinghouse Workgroup will
recommend to FDA that it provide examples on their internet website of
good compliance policies as they become available.
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Better Guidance for Establishment Risk Categories
Question/Problem:
There is a lack of clear criteria in defining risk categories. This
results in the loss of uniformity and consistency. FDA should provide more
definitive guidance and criteria for determining risk categories/classification.
Clearinghouse Workgroup Response
There is guidance for determining risk categories provided in Annex
4 of the Food Code. The Clearinghouse Workgroup agrees, however, that
better guidance is needed. In addition, this may be another area where
the jurisdictions, themselves, may be able to provide good examples for
others to use. In any regard, this is an area where consensus opinion
of the jurisdictions would be very helpful. The Clearinghouse recommends
referring this issue to the CFP Program Standards Committee for deliberation.
Page Top
Standard #4
- Citing Code Provisions during Inspections
Standard #4 requires an on-going quality assurance program that
evaluates inspection uniformity to ensure inspection quality, inspection
frequency and uniformity among the
regulatory staff. The assessment protocol defines 10 areas for evaluating each
candidate. Area #4 requires the assessment of the candidate
to ensure that the proper local code provisions for the CDC-identified
risk factors and Food Code
interventions are cited.
Question/Problem
Is the expectation of this component of the QA evaluation that the candidates cite the
specific Section number for each of the violations recorded on the inspection report?
Rationale: While we recognize the importance of understanding the
regulatory foundation for all violations cited during inspections, the citing of specific
section numbers for each violation recorded on the inspection form seems unduly
arduous. The FDA, in its own Food Code standardization process does not require this
level of documentation. Instead a reference sheet is used
that associates a section number with the specific out-of-compliance
observation.
To further complicate this assessment, many jurisdictions have
condensed the FDA Food Code Standardization form into fewer items
under each of the risk factor. The 5 page
FDA Standardization form, while a good data collection tool, is not considered a good
communication tool for prioritizing critical areas with the target audience – retail
food protection managers/operators. State and local jurisdictions are exploring
methods to condense the form and still maintain a meaningful assessment of risk factors as
identified in FDA’s Baseline. This often leads to consolidating
items to shorten the inspection form.
Consolidating items under broad risk categories present the challenge
of assessing which provision of the Food Code the candidate actually
cited when noting the
violation. The FDA Standardization form can be used to illustrate this point.
In FDA’s reference sheet for citing specific sections of the
Food Code, six (6) separate sections of the Food Code are listed
under:
Food from Approved Source
- All food from regulated food processing plants/no home prepared or canned
foods.
- 3-201.11 - Compliance with food law
- 3-201.12 - Food in a hermetically sealed container
- 3-201.13 - Fluid milk and milk products
- 3-202.13 - Shell eggs
- 3-202.14 - Eggs and milk products, pasteurized
- 5-101.13 - Bottled drinking water
The candidate is only required to make a determination of whether “A” above
is “IN”, “OUT”, Not Observed (“NO”), or Not Applicable
(“NA”). The candidate is not required to assess
which one of the Sections applies unless specifically asked to
do so by the Standard.
FDA has recognized the difficulty with citing specific code provisions
within its own standardization procedure. We believe that the assessment of this component should
be the jurisdiction’s development of a reference sheet much as FDA uses for citing
specific sections of the Code. Assessing a specific candidates'
abilities to cite the appropriate section of their Code as it pertains
to observed violation should be a
component of the 2 field inspections conducted by the candidate
and the programs QA officer.
Clearinghouse Work Group Response
The submitter raises several issues that need clarification.
Standard No. 4 does not dictate a particular form to be
used in routine inspections. Certain provisions of Standard No. 3 and Standard No. 6 require that
the risk-control factors and risk interventions be identified as "in, out, not
applicable, or not observed." Those provisions aside, there are no prohibitions
against combining items on a routine inspection form. When several provisions of the
local code are combined under one item, it is a very good idea that a reference sheet be
made available to inspectors; otherwise, uniformity of marking becomes very difficult to
achieve. The reference sheet should clearly list the provisions
that have been combined under each item heading or number.
Standard No. 4 is made up of two parts. The first requirement is for an on-going
quality assurance program that assures quality inspections in the ten identified aspects
and describes the actions that will be implemented when deficiencies in any of the ten are
identified. The second requirement describes the measurement that will be used to
determine whether the quality assurance program in place is successful. The
Standard does not dictate the specifics of the quality assurance
program itself.
One of the quality aspects of Standard No. 4 is that each
inspector be able to cite the proper local code provisions for
the CDC-identified
risk factors and Food Code
interventions, but accuracy in citing all local code provisions
is not required.
This is a reasonable requirement in that the legal process used for enforcement in the
majority of jurisdictions requires that a firm accused of a violation of a regulation or
code must be charged against a particular provision of that regulation or code. It
is reasonable to expect that an inspector with the responsibility and authority to charge
a violation should know, or be able to identify, the specific charge that they are
making. For example, when an inspector cites a firm for serving home-canned foods,
he/she should know that the proper citation is the one related specifically to
"hermetically sealed containers.” Standard No. 4
requires that you address and assure in some fashion that your inspectors
are able to do this, but does not dictate
your process.
The process for measuring the success of your quality
assurance program is the procedure described in Appendix D. This procedure involves two on-site inspections
during every self-assessment period (three years). A file
review of the three most recent inspection reports of the same
establishments must accompany the field exercise in
order to be able to judge the quality aspects:
- Repeat violations;
- Follow up on compliance and enforcement;
- Discussion and documentation of long-term corrective options; and
- Assignment of the firm to the proper priority category and inspection frequency.
Notice that the file review does not specifically target
aspect 4. - Citing of proper local code provisions. Determinations
of whether the inspector is able to cite proper local code provisions
are to be addressed during the one-on-one, on-site
inspections.
There is just a final caution that it may not be wise
to rely on the measurement/testing process of Standard No. 4
as your sole
check for quality. While
it is practical and acceptable to combine this QA check as a part of the standardization
process, they are intended to serve separate purposes. When FDA personnel
standardize state and local officials, the submitter is correct in stating that citing the
specific provision is not required. That is because most jurisdictions that have
adopted the Code use a different paragraph numbering system that is compatible with their
own regulations or laws. However, in the FDA internal personnel standardization
process, individual Code section and paragraph citing is required. It
is recommended that during your internal standardization process
you include a verification of the
knowledge of specific local code provisions.
- Completion of Assessment Protocols
Much of the criteria contained in Standard 4 are predicated on an inspection program
containing risked based approaches outlined in earlier Standards - in particular Standard
#3. Our initial review of Standard #4 indicates that many of the 10 items contained
as part of the Quality Assurance Program have not as yet been integrated into our retail
food program. Some of these items include:
- Document compliance status of risk factor/interventions;
- Obtains & documents on-site corrective action for risk factors appropriate to the
violation;
- Documents offered options for long-term control of risk factors; and
- Verifies that the establishment is in the proper risk category.
Since our retail food program is lacking some key components, the assessment protocol
outlined in Standard #4 can not be completed as designed. Assessing staff’s
consistency in these areas through joint on-site inspections and corresponding file
reviews seems premature until all the components are in place.
Question/Problem
Our internal self-assessment process has revealed significant gaps in our quality
assurance program. Several components contained in Standard #4’s criteria must
be developed and integrated into our program before a meaningful field and file review can
be performed against all the 10 components outlined in the Quality Assurance Program.
For this initial self-assessment, is it sufficient to note the gaps within our current
quality assurance program as rationale for why we do not meet Standard #4 or must we also
complete a field and file review for each of our staff? If we are to continue on
with a field and file review, against what criteria do we assess compliance with the Q.A.
components we already have in place?
Clearinghouse Working Group Response
If a cursory look at a Standard compared to your program is sufficient to reveal
gaps that prevent you from meeting the Standard and provides a rational
for your conclusion, then it
is not necessary for you to proceed further. No one wants you to spend time that is
not productive. You only need go as far as necessary to identify
the gaps you would need to fill then establish a plan for ultimately
meeting the Standard.
- Spreadsheet with Embedded Formulas
Question/Problem
No current uniform software exists to document achievement of Standard
#4. We recommend that FDA develop software for use with Standard
4 needed for consistency, convenience, and uniformity.
Clearinghouse Workgroup Response
The Clearinghouse group’s understanding of this request is
for a spreadsheet with mathematical formulas embedded in the columns
and/or rows to calculate compliance according to the completed
tables and charts provided in the Appendices to Standard 4. We
believe that there may be jurisdictions that have developed such
spreadsheets and are willing to share those tools with others.
The Workgroup will recommend that FDA seek such a tool from participating
jurisdictions.
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