Milling & Baking News - December 10, 2013 - 18

Washington 

Bakers urge F.D.A. to keep food
safety G.M.P. regulations simple
WASHINGTON - While generally
supportive of a risk-based approach
taken by the Food and Drug Administration in connection with a set of
regulations proposed in connection
with the Food Safety Modernization
Act, the American Bakers Association
urged the agency to keep its guidance
"as simple as possible."
The comments by Lee Sanders, senior vice-president of government
relations and public affairs for the
A.B.A., were submitted Nov. 15 in
response to a request for comments
in connection with a rulemaking
proposal by the F.D.A. published in
the Jan. 16 Federal Register. "Current
Good Manufacturing Practice and
Hazard Analysis and Risk-Based Preventive Controls for Human Food"
was proposed by the F.D.A. as an update of its existing good manufacturing practice regulations.
In addition to asking the F.D.A.
to "keep it simple," Ms. Sanders in a
20-page letter reviewed a number of
aspects of the regulations, endorsing
some and offering guidance about others. Simplicity will allow companies to
design programs suited for particular
facilities and product lines, she said.
"A.B.A. applauds the risk-based
approach that F.D.A. has taken in
proposing to implement section 418
and the agency's recognition that
a 'one-size-fits-all' approach is not
appropriate with respect to hazard
analysis and preventive controls,"
she said. "We urge F.D.A. to retain
that flexibility in the final rule and
to consider the recommendations for
clarification presented in our comments above. We ask F.D.A. to keep
any guidance as simple as possible to
allow for flexible design of programs
that are optimal for a specific manufacturing facility and line of product
being produced. Finally, once a final
rule is published, A.B.A. urges F.D.A.
to ensure that its inspectors are appropriately trained not only on the
requirements of that rule, but also on
the fact that the rule allows facilities
the flexibility to determine the best
approach through which they may
satisfy the regulatory requirements."
In its January proposal, the F.D.A.
said the new rule would add preventive controls provisions required
in the Food Safety Modernization
Act requiring that covered facilities
maintain a food safety plan, perform
18 / December 10, 2013 Milling & Baking News

hazard analysis and institute preventive controls "for the mitigation of
those hazards." The F.D.A. said facilities also would need to monitor
controls, verify their effectiveness,
apply corrective actions when needed and maintain documentation of
these actions. Additionally, the F.D.A.
described the new rule as an update

the exemption, the storage facilities
would be required to conduct other
activities for "packaged food that
requires time/temperature control
to significantly minimize or prevent
the growth of, or toxin production by,
microorganisms of public health significance."
Product testing should not be required: The F.D.A. proposal does not
require testing of finished product,
and the A.B.A. agrees, Ms. Sanders
said. She noted finished product is

'We ask F.D.A. to keep any guidance as
simple as possible to allow for flexible design
of programs that are optimal for a specific
manufacturing facility and line of product
being produced.'
- Lee Sanders, American Bakers Association

of its G.M.P. regulations, last revised
more than 25 years ago.
More specifically, the rule would
establish requirements for:
A written food safety plan;
Hazard analysis;
Preventive controls for hazards
that are reasonably likely to occur;
Monitoring;
Corrective actions;
Verification; and
Associated records.
"The application of the preventive
controls would be required only in
cases where facilities determine that
hazards are reasonably likely to occur," the F.D.A. said.
Supporting a flexible, risk-based
approach: Ms. Sanders expressed
A.B.A. appreciation for the recognition in the rule of "the importance
and health benefits of a risk-based
approach to public safety, in which
industry and agency resources are
targeted toward known or reasonably foreseeable risks." More specifically, she noted the proposal requires
preventive controls only for "hazards
reasonably likely to occur." She said
that language here and later in the
rules is not intended to be speculative but is based on history and experience that reveals a genuine food
safety risk.
Exemption for packaged foods
storage facilities: An issue that long
has been a concern of the A.B.A. and
other packaged foods companies (a
citizen's petition on the issue was
submitted by industry groups), Ms.
Sanders said the baking industry
strongly supports an exemption. With

"likely of limited or no value because
a facility cannot test each and every
food product to guarantee safety."
She continued, "Testing only demonstrates that the sample taken was
pathogen free; it cannot verify that
the entire lot is pathogen free."
Monitoring of customer complaints should not be required: Ms.
Sanders said each verification activity specified in F.S.M.A. has a "sound
scientific basis" aimed at enhancing food safety. Reviewing customer
complaints has no such basis, she
said. "The overwhelming majority of
these inquiries involve issues that are
wholly unrelated to food safety such
as questions about pricing, availability, promotions and packaging (e.g.,
difficulty opening the product),"
she said. Ms. Sanders said bakers
rarely first identify food safety issues
through customer complaints.
Opposing requirements to validate
allergen controls: While declaring that
the A.B.A. and its members are committed to reducing the possibility of
allergen cross-contact in baking facilities and the appearance of undeclared
allergens in baked foods, Ms. Sanders
said monitoring that labels are correct
rather than validation is the appropriate approach for this issue.
Issues related to records and information: Noting there is no evidence
of shortcomings in the recordkeeping
of food facilities, Ms. Sanders said,
"A.B.A. agrees that it is important
for records to be reliable and secure,
and A.B.A. supports an approach to
encourage electronic recordkeeping,
the application of Part 11 appears
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Milling & Baking News - December 10, 2013

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