Dec. 16, 2013—The first major reform of
food safety laws in seven decades, the Food Safety Modernization Act, was
enacted in January 2011 with the intent of making food safer and reducing
foodborne illness. However, the Food and
Drug Administration’s plans to put FSMA rules in place are too broad to do the
job well, according to farmers.
Among Farm Bureau’s top concerns with
the proposed regulations is FDA’s apparent unwillingness to focus on commodities
that are associated with foodborne illness.
“We urge FDA to reconsider standards
that take into account the relative risks and comparative benefits associated
with individual commodities. FDA should initially propose regulations for only
those commodities with a history of microbial contamination,” Farm Bureau wrote
in lengthy comments recently submitted to the FDA.
Only once those regulations are
successfully put in place and enforced, should FDA even consider expanding
regulations to cover other commodities.
“We know that there have been problems
with E. coli in leafy greens or with salmonella in tomatoes, for example, and
the industry has voluntarily taken the initiative to curb some of those
problems,” said Kelli Ludlum, American Farm Bureau Federation food safety
specialist. “That’s where it really
makes sense for FDA to focus their efforts.
Unfortunately, they’ve chosen to go significantly broader than that and
regulate a whole scope of commodities that have never had foodborne illnesses,
and, because of the way they’re grown and consumed, are very unlikely to have
Including low- and no-contamination risk
commodities is a waste of both growers’ and the governments’ time and money.
“Instead of shrinking the size of the
haystack in which they’re looking for that public health threat needle, by
choosing to regulate all produce, they’re only making that haystack bigger,
which neither farmers nor government inspectors and regulators have the
resources for,” Ludlum said.
Firm in its opposition to regulating all
produce, Farm Bureau said that if FDA retains lists of “covered” and “exempt”
produce, “the factors and/or standards that cause a specific commodity to be
listed must be clearly explained and justified by science-based risk status.”
In addition, FDA must establish a
process for regular review of the lists and clarify whether and how a commodity
can move from one list to another.
Also in the comments, Farm Bureau raised
red flags about other aspects of FSMA, including a regulatory process that
could prevent a scientifically sound and effective set of rules.
While appreciative of FDA’s approval of
Farm Bureau’s comment extension request, the organization said it still has
concerns about the regulatory process.
Specifically, because considerable changes to the draft rules are
expected to be made as a result of public comments, Farm Bureau believes a
second draft of the proposed rule should be put out for public comment.
“Given the complexity of the proposed rules,
the current process of responding to comments on this draft rule with a final
rule as a next step does not allow FDA to craft a sound and operable food
safety framework. An interim step, such
as a second draft rule or interim final rule, is needed to work through the
regulatory process with adequate stakeholder input. ”
Congressional lawmakers are also calling for another round of comments. In a recent letter to FDA Commissioner
Margaret Hamburg, 75 Democratic and Republican members of Congress called for a
second draft of regulations for public comment before issuing final Food Safety
Modernization rules. The 30 senators and 45 House members said they were
concerned about the impact of proposed rules on farmers and businesses that an
additional comment period could help alleviate.
“Despite your agency’s efforts to engage with stakeholders during the
rulemaking process, we remain concerned about the ambiguity surrounding many
aspects of these proposed rules,” the letter said.
Additionally, because many of the FSMA
rules overlap, farmers and others who will be affected by them should have the
opportunity to evaluate them as a complete package, Farm Bureau noted in its
“We encourage FDA to
release a second draft of the combined produce safety, preventive controls for
human food and animal feed, foreign supplier verification program and
third-party audit certification rules to allow for sufficient review as to how
all the rules are intended to work together,” Farm Bureau wrote.