IBIE, special edition & show preview -- 2013 - (Page 56)
CRITICAL ISSUE: FSMA
Preventive -a-glance
controls at
The Current Good Manufacturing Practice
and Hazard Analysis and Risk-Based
Preventive Controls for Human Food
proposal issued by the Food and Drug
Administration focuses on six preventive
controls every food and beverage manufacturer must consider when conducting a food
safety analysis. The controls include:
Hazard analysis: Identifies and
evaluates known or reasonably foreseeable hazards for each type of food
manufactured, processed, packed or
held at a facility.
Preventive controls: Requires
controls to be identified and implemented to provide assurances that hazards
that are reasonably likely to occur will be
significantly minimized or prevented.
Monitoring: Provides assurances that
preventive controls are consistently performed and records are kept to document monitoring.
Corrective actions: Requires plant
management to establish and enact
written corrective action procedures
in the event that preventive controls
fail and an unanticipated problem
occurs. Plant management would be required
to correct problems, minimize the likelihood of
reoccurrence, evaluate the food for safety and
prevent affected food from entering commerce,
when necessary.
Verification: Ensures preventive controls are consistently implemented and
are effective.
Recordkeeping: Requires plant manReco
agement to keep a written food safety
em
plan, including the hazard analysis.
Managers also would be required to
keep records of preventive controls,
monitoring, corrective actions and
verification.
56 / SPECIAL EDITION /
IBIE 2013
posed Current Good Manufacturing
Practice (cGMP) regulations, Douglas Marshall, PhD, chief scientific officer, microbiology, Eurofins
Microbiology Laboratories, Ft.
Collins, CO, pointed out a significant change. “Be aware of the difference in FDA language,” he said.
“Many ‘should’ verbs in the cGMPs
have become ‘shall’ verbs.” Should,
he noted, conveys “may,” while shall
implies “must.”
What’s coming
Significantly, the proposed regulations will not apply to ambient-temperature food warehouses, although
it covers refrigerated and freezer
facilities. The American Bakers
Association and the Snack Food
Association (SFA) joined with other
food industry groups to lobby for
this exemption.
As for regulations not yet released
that carry out other sections of
FSMA, Dr. Marshall urged companies to read carefully the appendices
to regulations already proposed. It’s
here, he noted, that FDA indicates
where it may take FSMA regulations
in the future, especially concerning
microbiological matters.
For example, food industry managers are well aware of current rules
concerning sanitation of food-con-
tact surfaces, but new regulations
may address non-contact surfaces
such as walls, ceilings and exterior
surfaces of equipment, according
to Dr. Marshall. “It looks like the
regulations will go for ‘required’ —
not just ‘recommended’ — language
for non-contact surfaces,” he said
to attendees at this year’s technical
conference of the Biscuit & Cracker
Manufacturers’ Association. “FDA is
seeking comments on this.”
How to pay for FSMA is also
up in the air, according to Martin
Hahn, partner, Hogan Lovells
US LLP, Washington, and general counsel to SFA, speaking at
SNAXPO 2013. The budget submitted by the Obama administration includes user fees for initial
inspections and registrations.
“Remember, FDA already has the
ability to charge fees for violations
and re-inspections,” Mr. Hahn
said. In the past, the food industry has been able to ward these off
through its lobbying efforts.
Another interesting aspect to
the law is that the written records,
which must be supplied to FDA
under FSMA, will be subject to
the Freedom of Information Act,
although with company names redacted, Mr. Hahn said.
FBN
— with Laurie Gorton
Court orders FDA to step up its efforts
Delays in writing rules to carry out the Food Safety Modernization
Act (FSMA) landed the Food and Drug Administration (FDA)
in court. On June 21, US District Judge Phyllis Hamilton of the
Northern District of California ordered the agency to release all proposed FSMA regulations by Nov. 30, 2013, with comments to close
no later than March 31, 2014. Final regulations must be published
in the Federal Register by June 30, 2015.
Congress wrote a July 2012 deadline into the law to compel
FDA to complete rulemaking promptly. That date came and went
without results. In August 2012, the Center for Food Safety (CFS), a
Washington, DC-based advocacy group, sued FDA over that failure.
New federal regulations are routinely reviewed by the Office
of Management and Budget. CFS asked that step be omitted for
FSMA rules, but the court disagreed. It also declined to require the
quarterly progress reports CFS asked FDA to supply.
Table of Contents for the Digital Edition of IBIE, special edition & show preview -- 2013
IBIE, special edition & show preview -- 2013
Table of Contents
IBIE Perspective - Amid challenges, opportunities persist
State of the Industry - Dizzying changes among baking’s leaders
A changing of the guard
Making Baking History - Progress on Parade
Capital Spending Survey - Making the safe bet
Survey reaches wide sample
IBIE Tech - Going Mobile
ABA Perspectives - Big changes since IBIE 2010
ABA: On the Front Lines
Keep on track with FTRAC
Let's Keep on Truckin'
An Ounce of Prevention
BEMA Initiatives - Collaborative Solutions
Critical Issue: FSMA - Predict & Prevent
Court orders FDA to step up its efforts
Food Safety: ANSI/ASB/Z50.2
Equipment Advances - Clean and Simple
Formulating R&D - Brave New World
Intel about ingredient trends
Critical Issue: Commodity Prices - Long and Winding Road
Ingredients: Creating Simple Labels - Simple Options
Critical Issue: Sodium Reduction - How Low Can You Go?
Ingredients: Ancient Grains - What's Old is New Again
New Product Trends: Baked Foods - Change Afoot
New Product Trends: Snacks - Reinventing Snack Time
Special Section: Bake
The Next Cupcake?
Ingredient Transparency
Food trucks on the move
New Tech Tools
IBIE 2013: A World of Possibilities
Ready to Launch
Pizza Popularity
Revel in Vegas
2013 Exhibitor List
Ad Index
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