[MPWG] Proposed rule available for public inspection: FDA public comment period (9/29/2014-12/15/2014) on rules to implement the Food Safety Modernization Act (FSMA)

[De Angelis, Patricia]

On September 29, 2014, the U.S. Food and Drug Administration will open a
75-day comment period to accept public comments on revisions to proposed
rules on produce safety that are designed to implement the Food Safety
Modernization Act (FSMA).  The proposed revisions are intended to be "more
flexible and less burdensome in key areas," and are already available for
public inspection with this link from the FDA website (1) (Click the
"Federal Register Notice" link below):

Proposed Rule Supplement


   - Federal Register Notice
      <https://www.federalregister.gov/articles/2014/09/29/2014-22447/standards-for-the-growing-harvesting-packing-and-holding-of-produce-for-human-consumption>
      - Questions & Answers
      <http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247559.htm#produce>
      - Print-Friendly Fact Sheet (PDF: 1.9MB)
      <http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM412921.pdf>


FSMA was signed into law by President Obama in January 2011 to enable the
FDA to prevent safety problems in the U.S. food supply "rather than
primarily reacting to problems after they occur." (2)   It's being called
"the most sweeping reform of our food safety laws in more than 70 years."
(3) In 2013, the FDA proposed regulations to implement FSMA, called
the Standards
for the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption.

Amid outbreaks of listeria, *E. coli*, salmonella and other food-borne
illnesses, food safety advocacy groups have been pressuring the FDA to
complete these regulations. (4) At the same time, the botanicals industry,
extension specialists , and small farmers/growers have been weighing in on
aspects of the regulations that will impact them. (5)

The new regulations will impact medicinal plant products that are intended
for human consumption because they fall mainly into the category of
"dietary supplements" in the United States, which are regulated by the Food
and Drug Administration as "foods." (6)

The FDA's proposed revisions seek to make the FSMA regulations more
flexible, practical and targeted. (7) The FDA must complete these
regulations by August 30, 2015 and publish the final regulations by October
31, 2015. (8)

You can view all 943 of the comments that were posted in the 2013 comment
period by going to the Federal Register website (9) and clicking on "View
all documents and comments in this Docket":
http://www.regulations.gov/#!docketDetail;D=FDA-2011-N-0921

Comments on the proposed revisions to the proposed regulations to implement
FSMA will be accepted electronically and in writing between September 29,
2014 and December 15, 2014. (10)

More information on FSMA and botanicals:
(1) FSMA Proposed Rule for Produce Safety (includes fact sheet and summary
of revisions)
http://www.fda.gov/Food/guidanceRegulation/FSMA/ucm334114.htm

(2) Background on the FDA Food Safety Modernization Act (FSMA)
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm239907.htm

(3) FDA Food Safety Modernization Act (FSMA)
http://www.fda.gov/Food/GuidanceRegulation/FSMA/

(4) Obama Administration Sued for Delay of FSMA
http://www.foodsafetynews.com/2012/08/obama-administration-sued-for-delay-on-fsma-implementation/#.VCLKM_ldUaY

(5) FSMA's Role in Supplement Regulation
http://www.naturalproductsinsider.com/articles/2014/05/fsma-s-role-in-supplement-regulation.aspx

(6) Using Dietary Supplements Wisely (with more information on how they are
regulated)
http://nccam.nih.gov/health/supplements/wiseuse.htm

(7) Constituent update: FDA Seeks to Make FSMA Proposals More Flexible,
Targeted
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm415132.htm

(8) FDA agrees to new deadlines on FSMA final rules
http://www.foodnavigator-usa.com/Regulation/FDA-agrees-to-new-deadlines-on-FSMA-final-rules

(9) regulations.gov
http://www.regulations.gov/#!docketDetail;D=FDA-2011-N-0921

(10) DHS-FDA Proposed Rule on Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption
https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-22447.pdf

Patricia S. De Angelis, Ph.D.
Botanist/US Fish & Wildlife Service
Chair/Medicinal Plant Working Group
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