**DEPARTMENT OF HEALTH AND HUMAN SERVICES**

**Food and Drug Administration**

**\[Docket No. 2004N-0230\]**

**21 CFR Part 110**

**Food; Current Good Manufacturing Practice Regulations; Public
Meetings**

Comments from the Association of Food and Drug Officials

The Association of Food and Drug Officials (referred to henceforth as
\"AFDO\") is pleased to provide the following comments to the U.S. Food
and Drug Administration regarding 21 CFR Part 110 -- \"Current Good
Manufacturing Practice in Manufacturing, Packing or Holding Human Food.

AFDO is the preeminent organization in the U.S. of federal, state and
local regulatory officials, having promoted science-based food safety
through the development of model laws and regulations and providing
uniform training over its 108 year history. AFDO is well recognized for
having advocated an integrated food safety system for the U.S. to
eliminate duplication and gaps in our current system of regulating
foods. It is from this perspective that AFDO is providing comments
relative to the proposal to modernize what we believe are critical
regulations.

Many states have adopted 21 CFR Part 110 in whole or in part and it is
generally recognized that this regulation serves as a foundation to
others which have been promulgated at the state level. Regulations
specific to smoked fish, custom slaughterhouses, acidified foods, food
salvage dealers and other food establishment types are built from the
regulatory standards provided in 21 CFR Part 110. For this reason, AFDO
believes these regulations must be comprehensive, science based and have
a clear food safety focus. Not only do these regulations serve as a
foundation for other state regulations, but they also provide a
prerequisite foundation for mandated HACCP systems. AFDO has always
believed that HACCP is systematic and the concepts of HACCP should be
employed universally to all food industry sectors. Good Manufacturing
Practices, as a recognized prerequisite to HACCP should be universally
applied as well.

Undoubtedly, uniformity among all regulatory agencies is so very
important to FDA, the States, industry and consumers. As states conduct
more than 80 percent of all inspections of food processors and
distributors and approximately 8,000 contract inspections for FDA, AFDO
believes FDA must seek \"buy in\" from the states on what proposed new
changes or philosophy the new GMP\'s may have.

While AFDO strongly believes there is reason to update these important
regulations, we also recognize the value and flexibility that results
from the broad fashion in which the regulations are written and can be
interpreted. From a regulatory perspective, this is a true strength of
the regulation.

Because of this, there is an excellent regulatory history at the state
level associated with the application of this regulation. This is
particularly true with Section 110.80; \"Processes and Controls.\" This
Section has allowed states to require food plants to take all reasonable
precautions to assure manufacturing practices do not contribute to
contamination. Absent such reasonable precautions, enforcement actions
are taken until compliance is fully accomplished. Additionally, Section
110.80(b)(2) which requires manufacturing, packaging and storage to be
conducted under controlled conditions allows state programs to take
appropriate intervention steps when it is believed the health of
consumers may be impacted. Examples of this are as follows:

1.  New York prohibited the processing of uneviscerated fish following
    several botulism outbreaks which occurred there.

2.  A number of states were able to require the refrigeration of shell
    eggs following large numbers of Salmonella outbreaks associated with
    this product.

3.  Many states can require HACCP concepts within the structure of a
    scheduled process for food processing plants where HACCP plan
    requirements are not mandated.

Food safety is always evolving as a result of emerging pathogens and new
control technologies. Additionally, many new issues and concerns such as
food allergens remind us how critically important sanitation, labeling,
and proper manufacturing practices in food plants are. We believe that
21 CFR Part 110 must also evolve and updating this regulation is
appropriate, in our view. We offer the following recommendations:

1.  As 21CFR Part 110 is a regulation and not a guideline, we believe
    any requirements within this document must be mandated in the
    context of "shall" and not "should". This, in our opinion, would
    have a much greater impact on strengthening the regulation and
    creating uniformity between state and federal regulatory agencies.

2.  As the GMP\'s serve as a prerequisite foundation for HACCP systems,
    and it is well recognized that HACCP cannot work effectively without
    food manufacturing firms adhering to them. AFDO would like to see
    the GMPs evolve from a quality control system to more of a required
    strategy of food safety intervention. Much of what we find weak in
    21 CFR Part 110 is its focus, in certain areas, on quality issues
    rather than food safety issues.

3.  Definitions for "Batter", "Blanching" and "Quality Control
    Operation" are examples of this and these definitions seem out of
    place. Definitions for "Ready To Eat Foods", "HACCP Plan,"
    \"Allergens\" and \"Sanitation Standard Operating Procedure\" (SSOP)
    would seem more food safety focused and appropriate for including in
    the regulation. We also believe definitions within this document
    should be uniform with other federal food safety regulations.

4.  Food plants that manufacture or handle high-risk foods should be
    required to meet a higher standard. For plants whose products are
    identified as high-risk for Listeria monocytogenes, AFDO believes
    that a formalized action plan to effectively control or minimize the
    potential for this pathogen contaminating finished product should be
    developed and implemented by them. AFDO has just recently endorsed a
    plan developed by the Smoked Seafood Working Group of the National
    Fisheries Institute and National Food Processing Association which
    we included in our \"Cured, Salted, and Smoked Fish GMP\" guideline
    document.

5.  FDA should require food safety competency and food safety training
    for select personnel in food plants, particularly where high-risk
    foods are handled or where food plants are unable to gain
    compliance.

6.  AFDO supports lowering cold holding temperatures for potentially
    hazardous foods to 41 F to be consistent with the FDA Food Code and
    State requirements.

7.  The regulations must remain flexible enough to allow new
    technologies for combating food safety concerns to be introduced.

AFDO recognizes that the regulatory community will be changed
fundamentally by revising these regulations. Because much of what we do
in our food protection strategies is guided by law which stems from
21CFR Part 110, we view FDA's efforts here as very critical. We are
thankful for the opportunity to comment.