remain vigilant in recognizing and addressing current and reasonably foreseeable
hazards in their food and facilities.
TK: First of all, FDA had to provide clear differentiation between certain on-farm
procedures (e.g., crating, boxing, washing, and sorting) and food processing activities. Without clear differentiation, many farms would be required to register with
FDA as food processors and, therefore, comply with PCHF. Standards for produce
safety would apply to all foreign and domestic farming operations that intend to sell
produce into U.S. markets.
on white papers and via task forces that
will guide industry on the validation of
new technologies. However, in many
cases, FDA has to learn as it moves to
higher levels of enforcement.
FSM: Are there any differences in rules/
approaches between goods: fresh produce
from the field versus prepacked products
from the manufacturer?
DA: No fundamental differences: They
are all risk based and prevention
JR: Surely. To some extent, farmers have
been let off the hook. The problem is,
the farm is the furthest upstream supply
spot and the beginning of most evil.
Ramming preventive controls downstream shows the inability of FDA to
understand what needs to be done to
prevent problems. Once the trash is
dumped in the stream, it is impossible
to clean out or control.
WC: FDA’s recognition of the need for
different approaches based on product
type and production conditions is reflected in several of the FSMA regulations. Operations that produce whole,
intact raw agricultural commodities
have a different set of considerations
than processed, prepackaged products;
hence, each is addressed in a different
rule, while meeting the same food safety
objective of minimizing reasonably foreseeable hazards.
Producers of prepackaged produce
must adhere to the Preventive Controls
for Human Food (PCHF) regulation,
whose controls are more appropriately
focused on control of the manufacturing environment and handling practices.
AS: There are no differences in the basic
principles. Produce Safety ( 21 C.F.R.
112), however, is heavily focused only
on biological hazards, whereas PCHF
( 21 C.F.R. 117) focuses on biological,
chemical (including radiological), and
physical hazards. As trainers, we teach
these regulations as they are written but
also alert those in the food industry to
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