November 1 2013
The kinds of new product labels that
can be used without first submitting them to
USDA's Food Safety and Inspection Service for
review will increase, thanks to a final rule
published online this morning (http://1.usa.gov/HjgCxx)
and set to publish next week in the
Labels with negative or special
claims, like "gluten-free," will still have to
be submitted, but other claims for which a
regulation has been established, like "low fat,"
can be generically approved under the new
system, which will take effect 60 days after
publication of the final rule.
The rule has been a long time coming.
The proposal was published in December 2011 and
received nearly 50 comments (see FCN
March 9, 2012, Page 15), many of them in favor
of the changes because it will streamline the
approval process and leave FSIS' labeling
department staff of 18 technical and
administrative specialists free to examine only
those labels with special claims, says Rachel
Edelstein, assistant administrator in the
agency's Office of Policy and Program
The labeling office, led by Rosalyn
Murphy-Jenkins, director of the labeling and
program delivery staff, has been working on
guidance, published along with the final rule
to help the food industry determine when labels
must be submitted and when a generic approval is
The final rule was sent to the White
House Office of Management and Budget in July
(see FCN July 12, 2013, Page 3), and
was released back to USDA for publication on
Edelstein explains that the rule
wasn't immediately published because the
agency wanted to discuss it with other
agencies within USDA and make sure all offices
were prepared and aware of the change. Then the
two-week government shutdown further delayed the
The final rule is not greatly changed
from the proposed version, she confirms.
"We analyzed all the comments, and
this document responds to all the comments,"
Edelstein says. "It makes a few clarifying
changes, but largely it's consistent with the
Companies that want to submit a label
that can be generically approved can still do
so, but those labels won't be prioritized for
expedited review, she adds. The benefit of the
expanded criteria for labels that can be
generically approved is that companies won't
have to wait for the green-light from FSIS to
begin using it.
Expanding the situations in which a
label can be generically approved should reduce
the number of submissions landing in the
labeling staff's inbox, Edelstein explains. "It
will allow the labeling staff to focus on the
really complicated labels, the labels with
special claims, or [ones] that may have some
public health implications."
Murphy-Jenkins and her staff have
been working on guidance that will be published
with the rule, in addition to updating existing
guidance on the kinds of labels that do not need
to be reviewed before use.
There will be a list of labels that
can be generically approved, in addition to
claims that must be submitted, Murphy-Jenkins
says. "It's a list that will be updated
periodically. Companies are coming out with new
types of statements on labels all the time."
should help alleviate concerns
While the industry has been waiting
anxiously for the publication of the final rule,
Murphy-Jenkins admits there's been some
uncertainty over whether FSIS inspectors
conducting label examinations will accept labels
that have been generically approved.
In most scenarios, this is likely to
come down to "distinguishing between what is a
special statement or claim and what is not," but
the final rule helps draw a bright line on this
topic, she says.
There will be a 60-day implementation
period that should help the labeling staff
continue working to clear out the backlog of
labels that resulted from the government
shutdown. Some of the labels submitted during
that time could be generically approved under
the current regulations, Murphy-Jenkins
"Expanding the reg gives us an
opportunity, and gives the industry the
opportunity, to be more familiar with the
regulations," she says. "Hopefully our guidance
will help clarify some of that... and give us a
little more consistency in focusing on special
claims and statements that are not defined.
Nutrition regulations, for example, are very,
very prescriptive. People who take the time to
sit down and read the regulations should be
ready to apply."
Expanding the generic approval
system, combined with the Label Submission and
Approval System (LSAS), should help streamline
operations at FSIS' labeling department, which
envisions an eventual transition to a completely
electronic operation, Murphy-Jenkins adds (see
FCN April 26, 2013, Page 17). LSAS,
which was introduced in May 2012, will be
updated in light of the final rule. Until then,
users can still access its generic labeling
advisor to determine what can be generically
approved under the existing regulation, she
In addition to the guidance that will
be published with the final rule, FSIS' labeling
staff will be offering webinars to further
explain the new generic approval system,
Look for reaction to this rule in
next week's Food Chemical News Week in
Review and online at
FoodChemicalNews.com. -- A.
with permission from Food Chemical News.
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