tribution history of the food; (II) link
that history with the subsequent distribution of the food; (III) establish and
maintain a system for tracing the food
that is interoperable with the systems established and maintained by other such
persons; and (IV) use a unique identifier
for each facility owned or operated by
such person for such purpose, as specified under section 1011 and (ii) to the
extent practical, assess (I) the costs and
benefits associated with the adoption
and use of such technologies; (II) the
feasibility of such technologies for different sectors of the food industry; and
(III) whether such technologies are compatible with the requirements of this
subsection.” As a result, “the Secretary
shall issue regulations establishing a tracing system that enables the Secretary to
identify each person who grows, produces, manufactures, processes, packs,
transports, holds or sells such food in as
short a timeframe as practicable but no
longer than 2 business days…. The Secretary may include in the regulations establishing a tracing system (i) the
establishment and maintenance of lot
numbers; (ii) a standardized format for
pedigree information; and (iii) the use of
a common nomenclature for food.” This
bill also specifies that public meetings
and pilot projects should be conducted.
Of particular concern is the authority
of the HHS Secretary to perform studies
on and standardize formats for pedigree.
While the term pedigree is not defined
in the bill, the concept seems extremely
attractive: with a pedigree, you can see
the entire history and path of a product
at a glance. There is no need to do a laborious trace, since each handler of a
product adds their name to the list as the
product moves through the supply
chain. In an industry where the barriers
to entry are very low, resulting in numerous small operators (particularly in the
world of blenders, repackers and the
like), where price is a deciding factor in
purchasing decisions, where rework is a
fact of life and where substitutions are
not uncommon, accurately handling information to provide a pedigree seems
unlikely to be successful or economical
in the near term. Currently, S510 does
not explicitly require a full pedigree.
Forecasting the Future
No one knows what the final legislation on product tracing will look like. However,
there has been speculation that some key elements of the House bill might win out.
It appears likely that the Secretary of HHS would be required to conduct some pilots, and the only argument heard from industry on this aspect is that more pilots
should be conducted. It will be very difficult to capture the nuances and specific practices of each industry if only a few pilots are conducted. When IFT was contracted by
“The supply chain is only as
strong as its weakest link.”
the FDA to perform a mock traceback of the tomato supply chain, industry and trade
associations argued that the simplicity of the tomato supply chain was not representative of the complexity of other produce supply chains. If the diagrams that the FDA
shows illustrating the tomato supply chain are simple, I fear what complexity looks
like! A pilot study of a complex processed food will surely face some challenges—
primarily in the acquisition of so much data.
Industry, with support from trade associations, has begun making enhancements to
the way products are traced in anticipation of pending legislation, and in response to
the deficiencies illustrated by numerous outbreaks. Table 2 shows the vision for and
objective of product tracing in various sectors of the food industry, the way products
are currently identified and the way they might be identified moving forward. It appears that many industries are adopting the GS1 system of global standards. An
overview of the types of standards that GS1 supports (e.g., standards for expressing
data and transmitting data) can be found at www.gs1us.org for those in the U.S.
For tracebacks and trace-forwards to become more rapid, some parts of the food industry will need to change the way they record information, and in some cases, the
way they view product. IFT found that some firms assigned identifiers to pallets, or in
some cases even entire truckloads, making it very difficult to distinguish how the components of the pallet or truckload traveled through the supply chain. Additionally, the
“first in, first out” inventory rotation system, relied upon to a great extent by some
segments of the food industry, is wrought with exceptions, necessitating accurate
recordkeeping and not simply deduction of when a product was “likely” in inventory.
IFT recommended to the FDA that product be distinguished at the level of the lot
and be traced at the case level. Recognizing that the rate product moves throughout
the supply chain–particularly in and out of distribution centers and warehouses–is incredibly high, we hope that technological innovations will enable foods to be traced at
the case level in an economical and efficient way.
However, industry will not be alone in needing to make a change. While most recognize that providing records in an electronic format will increase the ability of regulatory agencies to analyze data orders of magnitude faster than today, IFT was surprised
to learn that during the course of our study, the FDA’s Center for Food Safety and
Applied Nutrition was resistant to collecting these types of records. It is discouraging
to hear FDA representatives complain about receiving information on paper, when
IFT also heard industry report that they hit the “print” button when federal or state
authorities asked for information, because hard copies were desired. Clearly, some segments of the food industry have information in an electronic format, and mechanisms
for industry to share and government to receive this information must be developed.
The FDA has taken positive steps with the Reportable Food Registry and PREDICT
tool for import screening, which are both electronic systems.