FSMA gives FDA broad new powers, including the authority
to mandate that companies recall products as well as the ability to review internal records at farms and food production
plants. For the first time, food processing companies would
be required to design and document an exhaustive program
of sanitary measures varying from pest control to what factory
workers are allowed to wear while on duty.
This proposed rule applies to facilities that manufacture,
process, pack or hold human food, which means this generally applies to facilities that are required to register with FDA
under Section 415 of the FD&C. The proposed rule exempts
certain facilities, but the rule explicitly states that FDA may
withdraw certain exemptions if it determines it is necessary
to protect the public health. This revocation provision will
“FSMA gives FDA broad new powers, including the authority to
mandate that companies recall products as well as the ability to review
internal records at farms and food production plants.”
The Preventive Controls proposed rule will implement Section 103 of FSMA, which requires food facilities to evaluate
potential food safety hazards, identify and implement preventive controls, verify that the controls are adequate to control
the hazards identified, take corrective action when needed
and maintain a written food safety plan. The requirements
outlined are similar to the Hazard Analysis and Critical Control Points (HACCP) systems currently in place for juice and
seafood, in which facility operators are required to understand
the hazards that are reasonably likely to occur and to establish
controls to minimize and prevent the hazards.
allow FDA to reassess its enforcement parameters. Facilities
such as warehouses that only store packaged foods and that
are not exposed to the environment would not be subject to
the proposed rule, nor would other activities that are already
governed by established HACCP regulations, such as those
involving seafood, low-acid canned foods and juice. Dietary
supplements would also be exempt, as they must comply with
the current Good Manufacturing Practices for supplements.
Furthermore, each covered facility would be required to
prepare and implement a written food safety plan by a quali-
fied individual (someone who successfully completes training
75 x 4.625
875 x 4. 75
1/4 x 4.875
( Carpe Diem )
FreeStyle Automated Sample Clean-up system for
SPE, GPC, Immunoaffinity Columns, Concentration, &
Fractionation. Use it now for food, feed, environmental,
& yes… fish sample clean-up too.
www.pickeringlabs.com
FreeStyle
125x 4.875
PickeringLabs_FoodSafetyMagazine_3.378X4.875.indd 1
5/12/13 11: 21 PM