2014-09-27

Revised Rules for the Food Safety Modernization Act #FDA #organic #healthcare #petition

9.26: co.pol/healthcare/fda/
Revised Rules for the Food Safety Modernization Act:
petition to FDA:
I read with interest that your agency has released
several revised rules pertaining to the
2011 Food Safety Modernization Act (FSMA).
I was pleased to see that the FDA listened to stakeholders.
Your revisions are heading in the right direction,
but unfortunately they don't go nearly far enough.

Your agency initially said farmers had to wait nine months
to harvest whenever they apply biological soil enhancements
(e.g., manure, agricultural tea, and yard refuse
rather than synthetic chemicals).
This runs contrary to organic regulations,
and puts many organic fields out of production
for an entire growing season.
While it's good that the FDA has decided to
defer its decision on an appropriate interval
between manure application and harvest, pending further study,
it is still of concern that small and organic farmers
do not know what the final outcome will be
or how long they will have to wait to hear.
I'm also concerned about your statement that you will
work with the USDA to encourage growers to
use compost instead of raw manure.
"Encouragement" can quickly turn to "pressure."
Organic farmers should have the freedom to follow organic guidelines,
which include raw manure.

The FDA's water quality standards mandated that farmers test
and chemically treat their irrigation water on a weekly basis.
If the water exceeds the FDA's standards for generic E. coli,
farmers would either have to cease to use it or chemically treat it.
In the revised rule, the FDA is now providing more options for
water sources that don't immediately meet quality standards.
These restrictions, however, still make it complicated and expensive
for small or family farmers to comply,
and even with them
some farmers will have to chemically treat their water,
which again runs afoul of standard organic farming practices.

Under FSMA, your agency placed spent grain
under the same regulations as pet food.
Under the revised rule, food manufacturers like brewers or bakers
will not be subject to additional controls under the animal feed rule
except for upholding current Good Manufacturing Practices
to prevent physical or chemical contamination.
However, it is apparent that cGMPs like these
are already being followed,
since there hasn't been a single reported case
of an animal or human being harmed by spent grain.

The original rule provided that small farmers
have only sixty days to come into compliance,
whereas regular facilities have anywhere from one to six years.
In the revised rule, the FDA has agreed to provide
greater specificity on the conditions that could
result in a revoked exemption.
Farmers would have an extended compliance period
-- 120 days instead of sixty -- so while it's a little better,
it's still a far cry from the one-to-six year compliance period
that large agricultural facilities enjoy!

You've made a good start. But please listen very carefully
to the farmers who will be dealing with your rules,
and don't make them break the guidelines set forth by
the National Organic Program
in order to comply with the FDA's new and unnecessary regulations.