FDA Responds to Concerns of Hazard Analysis,
Preventive Controls for Human Food Proposed Ruling
The Food and Drug Administration (“FDA”) Food Safety Modernization Act (“FSMA”) was signed into law on January 4, 2011. With this sweeping legislation, Congress ought to improve FDA’s ability to prevent, detect, and respond to food safety problems and foodborne illness outbreaks. As part of its implementation of FSMA, on January
16, 2013, FDA issued a proposed rule entitled Current Good Manufacturing Practice and
Hazard Analysis and Risk-Based Preventive Controls for Human Food. This proposed
rule would, among other things: (1) modernize the current good manufacturing practice
(“cGMP”) requirements for human food; and ( 2) require registered food facilities to establish and implement hazard analysis and risk-based preventive controls for human food.
The comment period for the proposed rule closed in late 2013.
FDA received numerous public comments expressing concern with certain key definitions that would
directly impact the coverage and scope of the proposed rule, and on issues related to supplier
verification, product testing, and environmental monitoring. On September 29, 2014, FDA issued a
supplemental proposed rule on preventive controls for human food in an effort to address some of
these concerns, and to make the original proposal more flexible, practical, and targeted. Some of
the more notable modifications are discussed below.
Exemptions to the cGMP and Hazard Analysis and Preventive Controls Requirements
The original and supplemental proposed rules contain several key exemptions to the cGMP and
hazard analysis and preven-
tive controls requirements.
For example, the rules
would expressly exempt:
(1) facilities engaged solely
in the “storage of raw agri-
cultural commodities (other
than fruits and vegetables)
intended for further distri-
bution or processing” from
the hazard analysis and
preventive controls require-
ments; and ( 2) “the holding
or transportation” of raw agricultural commodities from the cGMP requirements. Facilities that are
“solely engaged in the storage of packaged food that is not exposed to the environment” would be
subject to less onerous, modified hazard analysis and preventive controls requirements rather than
the full requirements. Establishments that qualify as “farms” would be exempt from both the cGMP
and hazard analysis and preventive controls requirements because they are not required to register
with FDA as food facilities. In the case of both holding/storage facilities and farms, the definitions of
“packing” and “holding” are essential to determining whether a facility falls within the exemptions.
Numerous comments raised concerns that activities normally conducted at farms and
establishments such as warehouses or grain elevators, to safely store food or prepare it
for distribution, may fall outside the definitions of “holding” or “packing.” These activities
include breaking down pallets, affixing labels, assembling sales kits, fumigating product,
or cleaning product by sifting, sieving, or screening it. In response, FDA proposed to
revise the definitions of “holding” and “packing” to include certain incidental activities.
Specifically, “holding” was amended to include “activities performed incidental to storage
of a food (e.g., activities performed for the safe or effective storage of that food and
activities performed as a practical necessity for the distribution of that food (such as
blending of the same raw agricultural commodity and breaking down pallets)).” Similarly,
“packing” was revised to include “activities performed incidental to packing a food (e.g.,
activities performed for the safe or effective packing of that food (such as sorting, culling, and grading)).” The definition of “farm” was also expanded to include farms that
pack and hold raw agricultural commodities grown on another farm not under the same
ownership. These revised definitions would permit holding/storage facilities and farms to
engage in a more expansive list of activities without losing their exemptions.
Defining Hazards to Anticipate
Commenters suggested that using the HACCP term, “hazard reasonably likely to occur,” to
define those events that a facility should anticipate, may erroneously suggest that all necessary
preventive controls must be established at critical control points. To avoid any confusion, FDA
proposed a new term: “significant hazard.” This new term is intended to clarify that controls should
be based on both probability and severity of the hazard, and that manufacturers subject to the rule
would have flexibility to determine where to implement controls.
New Product Testing, Environmental Monitoring, and Supplier Verification Requirements
In its original proposed rule, FDA did not propose specific provisions for product testing, environmental monitoring, and supplier verification, but instead requested comments on the appropriateness of
establishing such requirements. The supplemental proposed rule includes new provisions governing
all three areas that are intended to be flexible and risk-based.
Specifically, in order to verify the implementation and effectiveness of preventive controls, registered
food facilities would be required to, as appropriate to the facility, food, and the nature of the preventive control: (1) conduct product testing for a pathogen, appropriate indicator organism, or other
hazard; and ( 2) in circumstances where contamination of a ready-to-eat-food with an environmental
pathogen is a significant hazard, conduct environmental monitoring for a pathogen or appropriate
indicator organism by collecting and testing environmental samples. Registered facilities would also
be required to have written procedures for such testing, corrective action procedures to address any
identified issues, and maintain any associated records.
The supplemental proposed rule also includes detailed supplier control provisions. As a threshold
matter, supplier controls would be necessary when a receiving facility identifies a significant hazard
related to raw materials or ingredients, and that hazard is controlled by the supplier or another
upstream provider. The requirements of a supplier program would be two-fold. A receiving facility
would need to: (1) verify that materials are indeed coming from an approved supplier; and ( 2) verify
that the supplier is in fact controlling hazards as required.
The supplemental proposed rule would generally permit the receiving facility to determine
an appropriate supplier verification activity (i.e., onsite auditing, sampling and testing, review
of supplier food safety records, or some other risk-based verification activity) based on the
facility’s evaluation of the food and supplier risks (such as the nature of the raw material
and the supplier’s compliance and performance history). Annual on-site auditing would
only be required when there is a reason to believe that a hazard will cause serious adverse
health consequences or death to humans or animals, the hazard is controlled by the supplier, and the receiving facility did not establish that some other supplier verification activity
and/or less frequent auditing would adequately address the risks. The proposed provisions
related to supplier programs generally align with FDA’s proposed foreign supplier verification
The comment period on the supplemental proposed rule on preventive controls for human food
closed on December 15, 2014. Under a court order, FDA is expected to issue the final rule by
August 30, 2015. The proposed deadline for compliance with the final rule is one year from publication for most businesses, but two years for “small businesses,” and three years for “very small businesses.” Food facilities should begin evaluating their existing cGMP and preventive controls systems
in light of the proposal, and start to develop procedures and infrastructure to support compliance.