Baking&Snack - March 2013 - 111

Q&A: FOOD SAFETY
Richard Stier

Although the Food Safety Modernization Act (FSMA) was passed
more than two years ago, more questions than answers still exist
about how the law will affect bakeries and snack manufacturers.
To clarify the many convoluted issues surrounding this law,
Baking & Snack Editor Dan Malovany interviewed Richard Stier,
an expert on food safety and contributing editor to the magazine.
Mr. Stier is a consulting food scientist with international experience in food safety including Hazard Analysis and Critical Control
Point (HACCP) programs, food plant sanitation, quality systems,

process optimization, good manufacturing practice (GMP) compliance and food microbiology.
The biggest issue with FSMA is that FDA has only now started
issuing regulations to enforce the act. On Jan. 4, the agency announced two proposed rules, the first requiring food manufacturers to develop a written plan to prevent their foods from causing
foodborne illness and the second covering farms.
In this exclusive report, Mr. Stier talks about the myriad pocketbook concerns that may arise as the government issues regulations.

FSMA’s Potential
Pocketbook Issues

Here’s what the law may cost you and how it will change your operations in the long run.
Dan Malovany: What’s the biggest
lesson learned from the past year
in food safety as it relates to bakeries and snack food operations?

Richard Stier: The biggest lesson is the
importance of vendor quality, which incidentally is one of the elements in FSMA.
The problems caused by the now defunct
Peanut Corp. of America in 2009 seemed
small compared with the number of recalls that resulted from mangoes, onions
and especially the nuts and nut products distributed by Sunland, Inc., in New
Mexico. In 2012, the Food and Drug
Administration responded to an outbreak
of salmonella linked to salted peanut butter
product. To date, Sunland issued recalls
on approximately 300 products, which
resulted in excess of 100 companies having
to make recalls of their own because they
had either distributed Sunland products or used its ingredients without
further processing.
Surprisingly, the list of companies affected by the Sunland recall includes large processors that should know better. Sunland’s
problems were underscored by a thirdparty audit, which highlighted various issues. And to top it off, FDA in November
used its new authority under FSMA to sus-

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pend Sunland’s facility registration, thus effectively halting the company’s operations.
So, the message is this: Take a step
back, and take a long look at your vendor
quality program. Are you relying solely
on certificates of analysis? A third-party
audit? Or are your requirements more
stringent? Small companies may have to
take an even longer look because they
often do not have the money, personnel and
expertise to develop, implement and maintain a comprehensive and effective vendor
quality program.

What can bakers expect from
FSMA regulations in 2013?
When we saw drafts of regulations early
this year, people must remember that they
are only drafts. There will be a comment
period, probably 60 to 90 days. Among the
first responses to the draft regulation could
well be requests to expand the comment
period by one to two months. So, even
with the draft regulations issued early this
year, the comment period may last for five
or six months. The agency will then need
to evaluate all the comments and prepare
the final regulation. Realistically, the industry will probably not see the final regulations until 2014.

Some experts speculate that FDA may
also issue guidance documents to the industry. There are pros and cons to this
tactic. In FDA-speak, guidance documents
are not really guidance at all. Instead, they
seem to have the force of law. For example,
FDA investigators expect processors to
follow the guidance — or clearly do something as effective as what is described in
the document.

Since FSMA became law, what issues have surfaced that will need
to be addressed?
Perhaps the biggest is the processors’ rights
under current and upcoming regulations.
In working with the industry, I have heard
several reports of FDA investigators informing companies that they would be allowed to take photographs in–plant under
FSMA provisions. This is not the case now,
nor is there such a provision in the act.
Bakers and snack food producers must
have a documented policy to deal with
regulatory inspections. This policy should
include how to work with investigators,
what records the agency can access, a camera policy and rules regarding collection
of samples. In addition, the camera policy
should be posted in the main lobby.

March 2013 / Baking & Snack / 111

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Baking&Snack - March 2013

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