food, rather than relying on food producers to do so voluntarily. Furthermore, H.R.
2749 mandates that firms pay for the FDA’s costs associated with recalls.
Mandatory recall authority will shift some control from companies to the FDA
and could affect a company’s ability to contain a recall. Companies with food safety
weaknesses could be significantly affected by FDA intervention.
produce must be accompanied by coun-try-of-origin labeling.
Inspections and Registration of Facilities
H.R. 2749 will bring about changes in the registration of food facilities, requiring
companies to register annually beginning in 2010, at a fee of $500 per facility. Products from non-registered facilities would be considered misbranded, and their sale prohibited. Registered food facilities will be inspected by the FDA and will be required to
comply with mandated documentation requirements and give the FDA greater access
to their records. Refusing, impeding or delaying inspections would be prohibited.
The FDA’s authority to establish record-retention requirements presents a new challenge, as it could significantly affect
companies that currently lack the infrastructure to capture and report relevant
Opportunity for Reassessment
Food safety is, of course, critically important to businesses throughout the
supply chain—from farmers and food
producers to distributors and retailers. A
company faced with a significant food
safety problem could face potential remediation costs in the tens, or even hun-
“…rising consumer awareness—
and wariness—places the onus on
businesses to adopt appropriate food
safety standards and let the public know
Required Food Safety Plans
H.R. 2749 also will require mandatory
Hazard Analysis and Critical Control
Points (HACCP) plans. In addition, food
facilities serving U.S. customers must implement comprehensive food safety and food defense plans. The FDA will be able to
set safety standards that ensure the safe production and harvesting of fruits and vegetables, with compliance a requirement for food producers and distributors.
Many companies conduct some sort of analysis and have a control program in
place, but this bill requires a risk-based analysis and scientific validation of the system
of preventive controls. Companies must manage these new requirements and integrate
required control activities into existing food safety programs.
about their efforts.”
Improved Tracking and Traceability
H.R. 2749 will allow the FDA to issue regulations that require food producers,
manufacturers, processors, transporters or handlers to maintain the origin and distribution history of food products. It will also provide for a reinspection fee for facilities
that commit violations that require additional inspections by the FDA. Technology
will be essential in determining the origin, movement and reporting of food in the
supply chain. Furthermore, this legislation will mandate the recall and notification—to
both the FDA and consumers—of adulterated or misbranded articles of food.
In addition to fees, companies could face other financial impacts due to the need
to maintain distribution histories and collect data related to the origin and movement
of products. The FDA will have the ability to determine which technologies and
methodologies may be used. Therefore, companies with programs already in place
might need to implement new systems and processes, if the FDA does not approve
their existing technologies and methodologies.
Imports Required to Meet Domestic Standards
This bill will hold importers to the same safety standards as domestic food produc-
ers (existing law and the changes noted above), while implementing an importer regis-
tration fee program. Among the H.R. 2749 requirements: All processed food labels
must indicate the country where the final processing occurred, food manufacturers
must disclose the country of origin for all source ingredients on their Web sites and
dreds, of millions of dollars and
significant damage to its reputation and