the Fall 2014
SAFETY continued on page 5
In This Issue:
Page 5 …….............. NWA Moves to New Location
Page 22 …........................ Food Safety in the News
Page 30 …........................... Ready to Take Charge?
Food Safety Laws
Obstructed by User Fees
Reps. Sam Farr (CA) and Rosa DeLauro (CT) have requested the Food and Drug Administration to stop
asking Congress for user fees to implement the Food
Safety Modernization Act.
The lawmakers, in a letter sent to Secretary Sylvia
Mathews Burwell of the Department of Health and Human Services, asked the FDA to discontinue the request
for user fees when it presents the FDA’s fiscal year 2016
budget request to Congress because the proposed fees
hide the true cost of implementation. Congress rejected
the last five requests to implement the food safety law
through user fees and will likely do so again, according
to the letter.
“No bill to authorize such fees has been introduced and
even if enabling legislation is introduced this year, it is
highly unlikely that any new law will be enacted in time
to fund these vital FSMA implementation steps,” the
lawmakers wrote in the letter.
Farr and DeLauro said that Congress has provided some
of the funding necessary for FSMA, but “much more
funding will be required to make the larger, up-front investments necessary to ensure the public health benefits
the law promises.” The lawmakers asked the FDA to
request enough funds from Congress to support implementation of the food safety law.
FDA must have resources to retrain the existing inspection workforce, hire new staff and contract with state
inspectors, Farr and DeLauro said in the letter. The FDA
must provide training and technical assistance to help
growers and processors to meet the law’s new requirements. Other investments must be made in a new risk-based oversight system, the letter said.
FDA says that it needs $400 million for FSMA, and the
user fees suggested would not even come close to that
funding need. Congressional funding of FDA sufficient
to enable FDA to implement what Congress has told
them to do is needed to do their job, as instructed by
FSMA (and Congress).
Food-Safety
Inspections to
Change in
Post-FSMA
The Food & Drug Administration is retooling inspectors to be specialized in food and teaching them to
assess a company’s food-safety culture for the first
time when deciding whether to return for another
inspection. That is the primary message that Mike
Taylor, the FDA ‘s food-safety chief, said at the
United Fresh Produce Association’s Washington
Conference in September.
The attendees had hoped that Mr. Taylor would detail
the new provisions of the produce safety proposal,
but he arrived to the meeting empty-handed as the
White House has yet to complete the final review.
The Office of Budget & Management (OMB) has
the new proposals, and no one knows when they will
release them.
Taylor did lay out the “sea change” its field force is
undergoing to prepare for the new food-safety law.
Bringing companies into compliance will be the new
benchmark of FDA’s field force - - not collecting evidence for enforcement actions, Taylor pledged. The
FDA is shifting away from general inspectors who
are trained to check drug, food and medical device
firms for a more ‘specialized’ food inspector who can
call technical experts at FDA for advice during business assessments.
A company’s food-safety culture will influence how
often inspectors will check on a firm, whether it’s
the food-safety commitment of the top leaders at a
company or the effort a facility takes in developing
the right plans, he said. “This focuses us on those
few that don’t have a food safety culture and need
our attention to get compliant,” he said.
While the new versions of the produce safety and
preventive controls (proposed) rules are not out yet,
Taylor said the industry should expect to see greater
flexibility in the water quality and testing provisions
and a different direction on the raw manure-compost
section. “You will see important new ideas in there,”
he said.
After Taylor’s comments, two busloads of attendees
traveled to the FDA’s College Park, Maryland office
to discuss a wide range of issues with regulators in
charge of drafting the FSMA rules and overseeing
various sampling programs.
One FDA official told the group to expect new supplier verification and product testing requirements in
the supplemental FSMA rules. Also mentioned was
to ‘expect a fix to the problem of neighboring farms
being designated facilities if they pack other farms’
produce.’ “This is an area we considered when developing the supplemental,” said Samir Assar, FDA’s
produce safety staff director.
Based on extensive outreach and public comment, the
U.S. Food and Drug Administration proposed revisions to four rules designed to help prevent food-borne
illness. When finalized, the proposed rules will implement portions of the FDA Food Safety Modernization
Act (FSMA), which aims to strengthen food safety by
shifting the focus to prevention rather than responding
to problems after the fact.
Since FSMA was signed into law in January 2011, the
FDA has proposed seven rules to implement FSMA.
The four updated proposed rules include: produce-safety; preventive controls for human food; preventive controls for animal food; and the foreign supplier
verification program.
“Ensuring a safe and high-quality food supply is one of
the FDA’s highest priorities, and we have worked very
hard to gather and respond to comments from farmers
and other stakeholders regarding the major proposed
FSMA regulations,” said FDA Commissioner Margaret
A. Hamburg, M.D. “The FDA believes these updated
proposed rules will lead to a modern, science-based
food safety system that will better protect American
consumers from potentially hazardous food. We look
forward to public comment on these proposals.”
The FDA is making changes to key provisions of the
four proposed rules based on feedback received from
the public during meetings and thousands of comments
submitted to the agency on the proposed rules.
“Based on valuable input from farmers, consumers, the
food-industry and academic experts, the FDA is proposing to update these four proposed rules to ensure a more
flexible and targeted means to ensure food safety,” said
Michael R. Taylor, the FDA’s deputy commissioner for
foods and veterinary medicine.
In response to public comments, the FDA is proposing to revise the water quality testing provisions in the
proposed produce safety rule to account for natural
variations in water sources and to adjust its approach to
manure and compost used in crop production pending
further research on this issue.
FDA Releases
Updated
Proposals to Improve
Food Safety
