Senate Food Safety Bill 11-24-09.pdf

SENATE FOOD SAFETY BILL SENT TO FLOOR
By Connie Kirby and Calli Daly
The Congressional debate regarding what steps are necessary to keep our food supply safe
continues.
On November 18 th, the U.S. Senate Health, Education, Labor and Pensions Committee
(HELP) passed the Food Safety Modernization Act of 2009, S. 510. The U.S. House of
Representatives passed a comparable bill, H.R. 2749, on July 30, 2009.
With the commitment of Chairman Tom Harkin (D-IA) to continue to address several
contentious issues before the bill is considered by the full senate, several amendments were
offered and withdrawn by members of the committee. One of these amendments was sponsored
by Senator Jeff Merkley (D-OR) and addressed country of origin labeling (COOL) for processed
foods.
In short, S. 510 will impact many of the day-to-day operations of processors by increasing
FDA authority and efforts related to prevention, detection and mitigation, and import
verification. NW delegation members Senators Patty Murray (D-WA) and Jeff Merkley both
serve on the committee and support this bill. S. 510 has bi-partisan support and most of its
provisions are supported by the food processing industry. The industry wants to work with the
Chairman to improve the language related to traceability, finished product testing and fees.
At press time, the bill had not yet been scheduled for debate by the full Senate. A summary of
key provisions and amendments directly affecting NWFPA members follows (see callout). While
final legislation will be a result of a conference, processors should expect some form of these
provisions to take effect anywhere from 1 ½ to 3 years from the date of enactment.

Provisions of S. 510 Affecting NW Food Processors
Title I Prevention
Sec. 101 Inspection of Records allows the FDA access to and copies of all records relating to the manufacture,
processing, packing, distribution, receipt, holding, or importation of a product that FDA reasonably believes are
needed to assist the FDA in determining whether there is a reasonable probability that the use of or exposure to the
food will cause serious adverse health consequences or death to humans or animals.
Sec. 102 Registration provides for biennial registration renewal and suspension of registration preventing import or
sale of food; hearing on suspension and corrective action plan.
Sec.103 HACCP requires a registered facility to develop a written HACCP plan with documentation of hazard analysis
of naturally occurring and accidental and intentional contaminants, preventative controls, performance monitoring,
corrective actions, and verification; make available to FDA and revised when significant changes are made to the
process or every 3 years; general standards due from FDA in 18 months.
Sec.104 Performance standards Requires that, every 2 years, FDA will issue guidance documents, action levels or
regulations pertaining to the most significant food contaminants of products or product classes known at the time.
Sec.106 Food defense requires guidance documents after 1 year that include a model assessment and examples of
mitigation strategies; regulations after 2 years that protect against intentional adulteration of short shelf‐life, bulk
foods with a high risk of intentional contamination.
Sec.107 Fees allows for fees for reinspection‐related costs, failure to comply with a recall order, or participation in a
voluntary qualified importer program.
Sec.111 Sanitary transport of food requires the FDA to promulgate regulations requiring shippers, carriers by motor
vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary
transportation practices.
Title II Detect and Respond
Sec. 201 Targeting inspection resources requires FDA to target inspection resources based on risk profile of the food,
a facilities compliance history, the rigor of the facility’s HACCP plan, and any other appropriate criteria.
Sec. 205 Trace back pilot project requires FDA to conduct a pilot project on a recently recalled product type to
develop methods that are applicable to small business and that use technologies that enhance trace back and
forward.
Sec.207 Mandatory recall authority provides FDA with mandatory recall authority; requires establishment of an
internet search engine of recalls in effect.
Sec. 208 Administrative detention expands administrative detention authority for FDA to include adulterated or
misbranded food and lowers the bar of evidence to take action.
Title III Imported Food
Sec. 310 Foreign supplier verification program requires importers to perform verification activities than ensure that
the food is in compliance with FDA regulations according to a FDA guidance plan.
Sec. 302 Voluntary qualified importer program provides for expedited importation of foreign products that comply
with a voluntary review program.
Sec. 303 Import certification grants FDA authority to require certification for high risk foods seeking importation into
the US.
Sec. 308 Accreditation of third party auditors provides for accredited third party consultative and regulatory audits of
foreign facilities for purposes of certification or eligibility for the voluntary qualified importer program.
Title IV Miscellaneous provisions
Sec. 401 Funding provides for statutory funding and field staffing increases through 2014.
Sec. 402 Whistleblower protection provides whistleblower protection to an employee who reports, has or is about to
testify about, or refuses to participate in an activity they reasonably believe to be a violation of the FFDCA.
Amendments passed
Fish guidance requires FDA to update the HACCP Guidance document for fish and fish products.
Small producers of ag commodities requires consultation and outreach, including small businesses and entities that
sell directly to consumers and farmer representatives.
Amendments offered and withdrawn
Trace back of processed foods requires establishment of standards for a tracing system in processed foods.
Salmon COOL expands COOL to canned salmon.
Restitution for erroneous recalls provides restitution to address damages from erroneous recalls.
Protection of proprietary records provides for protection of facility records, trade secrets, and proprietary
information.
Duplicative oversight by USDA and FDA addresses issues for facilities raised because of duplicative regulatory
jurisdiction.
COOL for processed foods requires the FDA to promulgate labeling rules for processed food to identify the country in
which the final processing occurred and that such labeling does not identify the country of origin of the ingredients.