Letter to the Editor
We had an article entitled “The New GMP for Food Manufacturing”
published in the October/November issue of Food Safety Magazine. The article
was meant to be an overview of the use of a new process similar to HACCP
called HARPC and was written prior to the release of FDA’s final rule for
“Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based
Preventive Controls for Human Food.” It was based on the best information
we had at that time.
Jenny Scott, M.Sc., senior adviser, Office of Food Safety, FDA Center for
Food Safety and Nutrition, read the article and noted that some clarifications
would be useful to the readers based on the final rule, which was released after
our article was published, and on her extensive experience in developing and
interpreting the information. We thank Jenny for her clarifications (italics) and
therefore make note of the following items:
• The rules require that manufacturers have a program that would verify what their
suppliers were doing rather than the rules require a supplier approval and verification
program. We recommend that a supplier approval and verification program
would be valuable to a food manufacturer to ensure that ingredients and
packaging materials received meet their own food safety requirements.
• FDA does not approve or disapprove a food safety plan. They will have access to
plans and records as part of the inspection process. We recommend that a food
manufacturer develop its food safety plan with professionals trained in
and/or with experience in development of a plan, and work with FDA
and/or state regulatory agencies to ensure that the plan meets HARPC
requirements to identify hazards and establish preventive controls.
• The validation of each HARPC plan for each facility is to be done by a qualified
individual within 90 days, not before, the plan is implemented.
• HARPC is part of the total food safety plan, as a process, not to be confused with
being the food safety plan.
• Processing controls must be validated, not preventive controls.
• Radiological hazards are considered part of chemical hazards not as stand-alone
• HARPC includes the same hazard categories as HACCP, that is, biological,
chemical and physical, with the addition of the ones noted in the article.
• HARPC does not include intentional adulteration from acts of terrorism but does
include intentional adulteration from economically motivated adulteration.
• FDA requires that each facility reanalyze, not update, its HARPC plan every 3
years. We recommend, due to probable changes in ingredients,
products, processing technologies and facilities/equipment,
that food manufacturers should update their plan.
• Food facilities that are exempt from using HARPC are as
noted in the article but have areas that are best explained
by referring to the Current Good Manufacturing Practice,
Hazard Analysis and Risk-Based Controls for Human
Food 21 CFR Parts 1, 11, 16, 106, 110, et al. Section
117.5 that appeared in the Federal Register, Vol. 80,
No .180 on September 17, 2015. The fourth exemption
involves only low-acid canned food processors not
acidified canned food processors.
We trust that this information will help clarify
the identified interpretations of the rules and offers
best pratices to help manufacturers ensure food safety.
~Hal King, Ph.D., and Gary Ades, Ph.D.
CDC: Salmonella, E. coli
and Listeria Cause Almost
All Multistate Foodborne
A new Vital Signs report released
by the U.S. Centers for Disease Control
and Prevention (CDC) has revealed that
although multistate outbreaks constitute
more than 50 percent of
foodborne disease outbreaks,
they account for only 3 percent
of reported outbreaks in the U.S.
The report capitulates data
from CDC’s Foodborne Disease
Outbreak Surveillance System
between 2010 and 2014. CDC
scientists compared the number of
illnesses, hospitalizations and deaths
from outbreaks in two or more states
with those from outbreaks that occurred
in a single state. They found that the 120
multistate outbreaks during the 5-year
study were responsible for 11 percent of all
foodborne outbreak illnesses, 34 percent of
hospitalizations and 56 percent of deaths.
An average of 24 multistate outbreaks
occurred each year, involving 2 to 37 states.
Salmonella, Escherichia coli and Listeria
cause over 90 percent of all multistate
outbreaks—commonly found in beef,
chicken, fresh fruits and vegetables.
The report recommends that local, state
and national health agencies work closely
with the food industry to understand how
their foods are produced and distributed to
speed multistate outbreak investigations.
These investigations can reveal
fixable problems that
resulted in food becoming
lessons learned that
could help strengthen
The report also
highlights the need
for the food industry
to improve food safety
by following best
practices for growing,
processing and shipping