The FDA is at it again! Attempting to legislate rules and laws beyond their jurisdiction, but this time they are after the food on your table! The Food Safety Modernization Act (FSMA act) is a direct attack upon the farm to table continuum.  I published a comment against this in attempt to show how the very base idea is completely unnecessary. Get involved by commenting on Federal Registry issues at


November 21, 2013
Public Comments Processing Attn: FDA-2011-N-0921-0199
Division of Dockets Management (HFA-305), Food and Drug Administration (FDA),
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852
Re- Comment on proposed listing of Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption Docket No. FDA-2011-N-0921-0199
To Whom It May Concern,
We appreciate the opportunity to submit comments and information concerning the proposed rules to
set  forth  procedures,  processes,  and  practices  that  minimize  the  risk  of  serious  adverse  health
consequences or death, including those reasonably necessary to prevent the introduction of known or
reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances
that the produce is not adulterated on account of such hazards  as published in the Federal Register /
Vol. 78, No. 11/ Wednesday, January 16, 2013.


  1. The  proposed  rules  are  presuppositional  in  thought  and  contradictory  in  practice  as  the following quotes are from the proposed ruling itself:

(a) “SUMMARY: To minimize the risk of serious adverse health consequences or death
from consumption of contaminated produce, the Food and Drug Administration (FDA)
is  proposing  to  establish  science-based minimum  standards  for  the  safe  growing,
harvesting, packing, and holding of produce, meaning fruits and vegetables grown for
human consumption.” 1

(b) “As described in the Preliminary Regulatory Impact Analysis (PRIA), making a precise
estimate of the rule’s likely effectiveness is extremely difficult, because FDA has only
limited data that would establish a clear baseline estimate of how contamination occurs
and the likely impact of the proposed provisions on that baseline, with respect to
causing human illness.” 2

(c) “Contamination  of  produce  can  occur on-farm  during  growing (either in an open
environment  or  in  a  fully  or  partially  enclosed  building),  harvesting,  packing,or
holding; or elsewhere along the farm to table continuum.”3

The preceding quotes illustrate that there is a presupposed thought that the rules will establish a
beneficial baseline of data that will show the sources of contamination for the foods and allow
safer foods. Yet all the while these regulations will clearly impact business productivity by
applying regulations that will definitively cost the producer and effect the free market.  The
burden of these procedures and policies will effect the farm to table continuum as it is now
known with no control group to return to if the regulations or policies fail to increase the safety
of the food. These proposed rules need to be removed due to the science-based procedure as
stated in the summary has not been employed prior to the determination of the sources of
contamination. The proposed action is a double blind protocol experiment in that both parties
the  consumer  nor  the  FDA  will  directly  know  the  outcome  of  the  experiment  until  the
regulations  are  in  place.  This  shows  that  a  predetermined  decision  was  made  to  instill
regulations without sound science based evidence for the prevention of contamination in the
farm to table continuum.

The proposed action should be withdrawn since:
• It fails to address the purpose and need of the ruling.
• There is insufficient data to properly estimate the cost of imposing the regulations.
• The sources of contamination have not been identified prior to the implementation of the
• The lack of data indicates that a procedural method needs to be established on a smaller scale to
established a science based protocol that can be implemented once the sources of contamination
has been identified.
• Utilizing the limited data that was provided by the FDA in making this ruling, the potential for a
person  to  die  from  contaminated  produce  in  the  United  States  was  approximately  one  in
34,597,951. 45
• There are current sufficient guides and regulations in place specifically, the Guide to Minimize
Microbial  Food  Safety  Hazards  for  Fresh  Fruits  and  Vegetables  (U.S.  FDA,  1998)
recommended  good agricultural (GAPs) and manufacturing practices (GMPs) for  growers,
packers, and shippers to address common risk factors in their operations, thereby minimizing
food safety hazards potentially associated with fresh produce. The second document , the Guide
to Minimize Microbial Food Safety Hazards of Fresh cut Fruits and Vegetables (U.S. FDA,
2006) was intended to be used in conjunction with the GAPs/GMPs Guide and the FDA Food
Code(U.S. FDA, 2005)6
• Per Centers for Disease Control (CDC) instances of confirmed bacterial infections has greatly
decreased since 1996-1998 to 2010 7

If the Food and Drug Administration wish to continue with the existing proposal or any further
procedure,  process,  or  practice  then  the  sources  of  contamination  must  be  identified  .  Once  the
contaminates are identified they must be applied to a model of policies that would prevent the future
contamination of produce. Then a full precise economic impact study for the proposed action must be
completed and the massive negative economic effects considered prior to drafting the final action.
James McMillan

1Federal Register / Vol. 78, No. 11/ Jan.16, 2013, page 3504, FDA-2011-N-0921-0199, Summary
2Federal Register / Vol. 78, No. 11/ Jan.16, 2013, page 3506, FDA-2011-N-0921-0199, Summary
3Federal Register / Vol. 78, No. 11/ Jan.16, 2013, page 3507, FDA-2011-N-0921-0199, Summary
6   page 4
7   figure 1 and 2

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4 Comments on this article. Feel free to join this conversation.

  1. Melissa W. November 25, 2013 at 1:18 pm - Reply

    Extremely well-written and concise!

    • Clinton November 26, 2013 at 10:42 am - Reply

      Thanks again Melissa for letting me know about this. I attended a seminar to help create a substantive comment. I pray that this will be looked upon and used to see how the base reasoning is not warranted. The data that they provided shows that 8 people died in 10 years from contaminated produce. If this ruling would pass I can guarantee that more than eight people will die from the lack of proper nutrition due to creating more food desserts in the urban areas.

  2. Anne November 25, 2013 at 10:06 pm - Reply

    This is very well written and logically presented. Good job Clinton!

    • Clinton November 26, 2013 at 10:49 am - Reply

      Thanks Anne! I looked on the other comments that were submitted and there is a lot of comments from concerned farmers and consumers. The problem is that the majority do not realize is that opinion really doesn’t matter in this process. Without actual data or procedural failure the comment goes to a pile that really doesn’t get looked at again. However with data or substantive information that can be verified and brought up in a court of law then then those go into another pile to be considered or reviewed to see if the Department will get in trouble when appealed by enacting the rule with the information already revealed.

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