bake - June 2013 - 16

legislation

Preventive Controls
The Food and Drug Administration (FDA) has released for

from require-

public comment its proposed rule on preventive controls

ments or

for human food that focuses on preventing problems that

modify require-

can cause foodborne illness. The comment period has been

ments for certain

extended to Sept. 16.

low-risk activities. Second, they are

The proposed rule, which is required by the FDA Food Safety

ﬂexible, in that ﬁrms

Modernization Act (FSMA), would apply to many domestic and

could develop preven-

foreign ﬁrms that manufacture, process, pack or hold human

tive controls that ﬁt their

food. These ﬁrms would be required to have written plans that

products and operations, as

identify hazards, specify the steps that will be put in place to

long as they are adequate to

minimize or prevent those hazards, identify monitoring proce-

signiﬁcantly minimize or prevent

dures and record monitoring results and specify what actions

all food safety hazards that are

will be taken to correct problems that arise.

reasonably likely to occur. 

Under the proposed rule, the ﬁrst compliance date would be

The proposed hazard analysis and risk-based preven-

one year after the ﬁnal rule is published in the Federal Register.

tive control requirements are similar to Hazard Analysis and

Recognizing that smaller businesses may need more time to

Critical Control Points (HACCP) systems, which were pioneered

comply with the requirements, FDA is proposing to allow two

by the food industry and are required by FDA for juice and

years for small businesses and three years for very small busi-

seafood. Operators of a facility would be required to under-

nesses to comply

stand the hazards that are reasonably likely to occur in their
operation and to put in place preventive controls to minimize

High-proﬁle outbreaks of foodborne illness over the last

or prevent the hazards. Although this proposed rule aligns well

decade and data showing that such illnesses strike one in six

with HACCP, it differs in part in that preventive controls may be

Americans each year have caused a widespread recognition

required at points other than at critical control points and crit-

that the US needs a modern food safety system that prevents

ical limits would not be required for all preventive controls.

food safety problems in the ﬁrst place. The FSMA, signed into
law on January 4, 2011, embraces preventing food safety prob-

Each covered facility would be required to prepare and imple-

lems as the foundation of a modern food safety system and

ment a written food safety plan, which would include hazard

recognizes the need for a global approach to food safety.

analysis, preventive controls, monitoring procedures, corrective actions, veriﬁcation and recordkeeping. Facilities would

The proposed rule on preventive controls for human food would

be required to keep a written food safety plan, including the

apply to facilities that manufacture, process, pack or hold it. In

hazard analysis. 

general, with some exceptions, the new preventive control provisions would apply to facilities that are required to register with

A qualiﬁed individual would be required to prepare the food

FDA under FDA’s current food facility registration regulations.

safety plan, develop the hazard analysis, validate the preventive
controls, review records and conduct a re-analysis of the food

Under the proposal, each owner, operator or agent in charge

safety plan (or oversee these activities). To be qualiﬁed, an

of a facility, with certain exceptions, would be required to

individual would be required to successfully complete training

comply with the hazard analysis and risk-based preventive

in accordance with a standardized curriculum or be otherwise

controls. The preventive controls are science- and risk-based,

qualiﬁed through job experience to develop and apply a food

in that the rule would require controls only where necessary to

safety system. 

prevent hazards to public health and exempt certain facilities

JOHN U N R EIN

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