there may be substantial changes to both rules before they’re
finalized by FDA some months from now, a quick read reveals that operations in compliance with the Harmonized
Standards will largely be in compliance with the requirements
of the Produce Safety proposed rule (the Produce Safety
proposed rule includes some numerical standards and testing
requirements for agricultural water and soil amendments that
the Harmonized Standards leave to individual operations to
establish). Meanwhile, FDA has asked for comments in the
Preventive Controls for Human Food rule whether handling
and processing operations, including those handling fresh
produce, should be required to have a Supplier Approval and
Verification program; if included in the final rule, this would
virtually mandate audits of fresh produce operations. Even if
the pending and finalized rules have requirements that exceed
the Harmonized Standards, the process for continuous improvement—that is, an annual review by the TWG—provides
ample time for adjustment of the Harmonized Standards before the rules are enforced by FDA.
Where We Go from Here
The Harmonized Standards have already found use beyond
audits. The On-Farm Food Safety (OFFS) project (http://
onfarmfoodsafety.org), created by FamilyFarmed.org with the
help of a USDA grant and a Technical Advisory Committee,
is a free, web-based program designed to help small operations
develop and implement on-farm food safety plans based on
user input. “The Harmonized Standards are the basis for our
On-Farm Food Safety online tool, which gives growers the
opportunity to create a customized food safety plan,” says Jim
Slama, president of FamilyFarmed.org. “It’s great to have one
standard that meets most of the relevant food safety auditors’
needs, and some growers using the tool have met the needs of
multiple buyers and certification needs. The tool has been a
great success. In the past year, there have been 12,033 unique
visitors to the OFFS website and nearly 300 food safety plans
have been completed or are near completion. As of December
2012, approximately 900 users have started a food safety plan
based on the Harmonized Standards.”
Experience has shown that more and more produce cus-
tomers are requiring audits of their suppliers, including small
and local suppliers, and that customers are realizing the costs
of redundant audits are adding to their own costs, regardless
of who pays for the actual audit. The broad acceptance of
the Harmonized Standards by major produce buyers seems
to show a road forward to meeting the industry’s objective of
reducing the audit burden without sacrificing safe produce
growing and handling practices. Even while some buyers have
restrictions on who can do the audits, having one checklist
for all audits has to reduce the audit burden of differing stan-
dards. Further, the expectation is that buyers, seeing the same
audit results from different audit organizations, will eventually
accept an operation’s existing audit results without requiring
another, thereby further reducing the audit burden. When
they see different audit results for the same operation, using
the same standards, from different audit organizations, questions will come back to where they rightfully belong—the audit
process—and the marketplace will begin to weed out the poor
performers.
However, we’re not there yet. Several suppliers have complained that the Harmonized Standards just added another audit to the list. Why? In some cases, the problem has been with
the customer, when the customer’s food safety department,
which decides which audits to accept, is disconnected from
the produce buyer, who has only a tick box of which audits
are acceptable. In other cases, the problem has been with the
supplier that is unwilling to ask, let alone challenge, whether
the customer would be willing to accept its existing audit using the Harmonized Standards. In both cases, suppliers are
encouraged to talk with their customers. If a supplier has a
customer unwilling to accept audits using the Harmonized
Standards, the supplier is encouraged to contact United Fresh
to assist in working with the customer. Wisely handled, a supplier already should be able to reduce the number of audits it
needs to endure to just a few, if not one.
In still other cases, the supplier is comfortable with its
existing audit company that doesn’t use the Harmonized
Standards, and all its customers already accept the single audit
it has. The objective of the Produce GAPs Harmonization Initiative has always been to reduce the audit burden, not add to
it, and these were not the types of operations that the Harmonized Standards were developed to help. If all of a supplier’s
customers have been satisfied with a single audit performed to
a different standard, then we see no advantage to the operation’s changing the audit it uses. But this is not the norm. As
operations grow and diversify their customer base, experience
has demonstrated that customers’ audit requirements will be
different. For them, the Harmonized Standards offer a
solution. n
For more information about the Produce GAPs Harmonization
Initiative and the Harmonized Standards, please visit
www.unitedfresh.org/gap_harmonization or contact Dr. David
Gombas, coordinator for the initiative, at dgombas@unitedfresh.org.
David E. Gombas, Ph.D., is senior vice president, food safety and
technology, at the United Fresh Produce Association. He provides
food safety, microbiology, regulatory and public policy assistance
for the fresh and fresh-cut produce industry. He has numerous
publications on food safety and is co-editor, writer or technical
reviewer for seven commodity-specific food safety guidelines.
David is currently coordinator of the Produce GAPs Harmonization Initiative and the
U.S. National Technical Working Group for GlobalG.A.P., and serves on the National
Advisory Committee on Microbiological Criteria for Foods (NACMCF). David received
his B.Sc. degree in food science from Rutgers University, his M.Sc. degree from the
Massachusetts Institute of Technology and his Ph.D. in food microbiology from the
University of Massachusetts. He has held food safety and microbiology positions
with the National Food Processors Association, Campbell Soup Company, Kraft
Foods and the National Center for Food Safety and Technology.