with an HACCP course certificate. HACCP plans are not required by U.S. law, but
FSMA food safety plans are. There needs to be harmonization in the implementation of these requirements.
Those who are importing food and food materials are generally aware that there
are FSVP requirements. Since FSVP training is not required by FSMA, food processors do not seem interested in taking the FSVP course. This might change when
auditors and inspectors look for FSVP compliance.
TK: To my knowledge, FDA offers a comprehensive and evolving training strategy
through public and private alliances. Exporting companies can find the specific pro-
grams that meet their needs; the training
opportunities are very broad and easy to
find. The Institute of Food Technologists
offers a number of resources and updated
courses for FSMA training.
Food companies are sending personnel
from a variety of areas such as transportation, trade, and the executive suite to
FSM: Exceptions to the FSMA rules are helpful to small businesses, but are we sending
the right message about food safety?
DA: Absolutely not. This decision was political and not based on public health.
JR: No. Food safety is a universal issue regardless of company size. While the lobbyists may have won this one in 2011, the concept of small-business exclusion is
inconsistent at best.
DB: I would agree that we might be sending the wrong message given the growth of
small “boutique” processors, such as organic, raw milk, etc., given their risk potential.
WC: While I believe regulations should be somewhat flexible to allow an operation to determine the most appropriate methods to meet regulatory requirements
and produce safe food, I think this flexibility should not just be a factor of size but
rather the diversity of practices and conditions that exist in the industry.
Food safety hazards can occur in any-size operation, and all consumers should be
afforded safe food. On the basis of risk, small-scale and local operations should employ the same practices and types of controls as larger players to ensure a safe supply
chain. Though there may be differences and some constraints for smaller players to
navigate, the same care should be taken to protect public health and their brand.
Further, FDA provides tools to support smaller operations’ food safety management systems through development of guidance documents and other resources.
AS: Many small food businesses feel targeted by FSMA. They feel that it is their size
that will drive them out of the marketplace. They seek exemptions as a legal way not
to spend their already limited funds to meet FSMA requirements, at least for a certain time period. As trainers, we emphasize that although there are exemptions, having a food safety plan is good business and will be received favorably by consumers.
TK: According to FSMA, covered facilities have a number of years to comply with
the regulations, based upon business size. The regulations also establish compliance
dates for the CGMP requirements a year prior to the deadline for implementing the
the role of private certification schemes
and third-party audits for supporting
FSMA compliance were discussed. The
2017 public hearing differed in tone
than previously expressed at public
meetings, with the agency communi-
cating greater interest in working with
GFSI and private third-party schemes.
FDA also has been in dialogue with
GFSI to determine whether audits and
certain schemes can serve as an appropriate verification activity under FSVP
for produce. As such, the agency is
working to understand auditor competency requirements and oversight of the
program for alignment with FSMA. Additionally, FDA is gathering information
through a pilot program with third-party
auditors under the FSMA Accredited
Third-Party Certification Program.
On the matter of whether there is
sufficient training for exporters, there
has been a proliferation of consultants and technical trainers, as well as
programs offered through universities
and trade associations. Though readily
available in a variety of platforms and
formats, many are not sufficient, as I
observe many individuals attempting
to deliver these services without being a
PCQI themselves and lacking the education, and/or practical experience to truly
connect the concepts for participants in
a meaningful way.
AS: In the region I serve, GFSI requirements currently accept only HACCP
plans from audited establishments.
Food industry personnel who received
training on PCHF and are developing
or have developed their FSMA food
safety plans are now asking to attend
in-classroom HACCP courses so that
they may also demonstrate compliance
“FDA’s recognition of the need for different
approaches based on product type and
production conditions is reflected in several
of the FSMA regulations.”
–Willette M. Crawford, Ph.D., M.P.H.