WASHINGTON, Dec. 19, 2013 – FDA today said it is planning major
changes to its proposed produce and preventative-control food safety rules and
will seek additional public comment once they are completed.
The regulations are part of an overhaul mandated by the 2011
Food Safety Modernization Act (FSMA).
Provisions that will be altered include those dealing with
water quality standards and testing, raw manure and compost, mixed-use
facilities and exemptions for certain farms, the agency said.
The FDA said it expects the proposed changes to be finalized
by early summer.
“We have heard the concern that these provisions, as
proposed, would not fully achieve our goal of implementing the law in a way
that improves public health protections while minimizing undue burden on farmers
and other food producers,” Michael Taylor, the FDA’s deputy commissioner for
foods and veterinary medicine, said in a statement.
A number of farming and agriculture groups had complained
the original proposed rules, first released in January 2013, were too
burdensome and inflexible, particularly for small farmers.
For example, many said a provision requiring all
agricultural water to meet EPA’s recreational water quality standards would
require overly rigorous rounds of expensive and regular testing. Producers also
complained they had little control over the sources of their water and so could
not be held responsible for deficiencies in quality.
The United Fresh
Produce Association, in particular, singled out the proposed produce safety
rule’s definition of “mixed-type facilities,” which it argued were “not based
on risk nor an understanding of actual operations in the produce industry.”
“[A] one-size-fits-all approach that lumps produce packing
sheds, warehouses and coolers together with food processing plants does not
increase public health and is likely counterproductive,” the association wrote
in its comments.
Agriculture industry stakeholders indicated they were generally
pleased with today’s announcement, particularly FDA’s decision to allow another
round of public comment before the final rules are due in June 2015.
“We think this is great news,” said Ray Gilmer, vice
president of issues management and communications at United Fresh.
“Because this is such a complex regulatory structure, trying
to regulate a very broad diverse produce industry with so many types of farms
and operations, it is the wisest course to release a second round” of proposed
rules, he said, adding that his association was looking forward to working with
FDA on changes.
In September, the National State Departments of Agriculture
(NASDA) released its own policy statement
in support of a second draft of proposed rules.
But National
Sustainable Agriculture Coalition (NSAC) Policy Director Ferd Hoefner said changes
offered in today’s announcement might not be enough for many producers.
Hoefner said he would also like to see adjustments to
exemptions for direct marketing operations, more coordination with state agriculture
departments, and new economic cost-benefit and environment analyses, among
other changes.
“Farmers need to know that food safety rules are not going
to put them out of business,” he said in a statement.
According to the Centers for
Disease Control and Prevention, about 48 million Americans are sickened
each year by foodborne diseases, 128,000 are hospitalized, and 3,000 die.
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