On April 4, 2014, the Food and Drug Administration
("FDA") finalized an interim final rule and issued two
guidance documents outlining how the agency will implement its
expanded authority to access records under the Food Safety
Modernization Act ("FSMA"). Before FSMA, FDA's
records access authority was limited to records for food articles
that FDA reasonably believed to be adulterated and presented a
threat of serious adverse health consequences or death to humans or
animals.
Pursuant to FSMA, and the final rule, FDA may now access records for
food articles that the agency believes may be affected in a similar
manner to a suspect food, even if there is no evidence that the
specific food article is adulterated or presents a threat. The rule
finalizes without changes an interim final rule amending FDA regulations to
reflect FDA's enhanced authority to review records. It applies
to domestic and foreign entities that manufacture, process, pack,
transport, distribute, receive, hold, or import articles of food
for humans or animals. To help industry understand and comply with
the final rule, FDA also released two guidances, including a Small
Entity Compliance Guide.
FDA's expanded records access authority under FSMA is intended
to improve the agency's ability to respond to and contain
safety issues in the food supply by allowing FDA to access to food
records earlier than previously allowed. Instead of a
"reasonable belief" that a food is adulterated or
presents a threat of serious adverse health consequences, FDA now
needs only a "belief" that there is a "reasonable
probability" that exposure to a food will be harmful. This
allows FDA to inspect records if it reasonably believes a food is
likely to be affected in a similar manner as a suspect food. For
example, if FDA reasonably believes that an article of food was
processed under the same conditions as a food presenting a known
threat, FDA can inspect records related to the production of the
other food article, even though that food was not the subject of an
adverse event report or recall.
In addition to finalizing the rule, FDA issued two guidance
documents to help industry understand and comply with the
requirements of the final rule. One of the
guidances, FDA Records Access Authority Under Sections
414 and 704 of the Federal Food, Drug & Cosmetic Act
("General Guidance"), contains general
information and revises FDA's November 2005 guidance entitled
Guidance for Industry and FDA Staff: Guidance for records
access Authority Provided in Title III, Subtitle A, of the Public
Health Security and Bioterrorism Preparedness and Response Act of
2002; Final Guidance. FDA explains that the General
Guidance does not address or replace material contained in
FDA's staff manuals, the Regulatory Procedures Manual
("RPM"), or the Investigations Operations Manual
("IOM"), which focus on the operational and procedural
steps for FDA staff to follow for accessing records under the Food,
Drug, and Cosmetic Act ("FDCA").
The General Guidance clarifies that authority to access
records does not apply to farms, restaurants, recipes, or
financial, pricing, personnel, research or sales data. The
authority also does not apply to records for foods within
USDA's exclusive jurisdiction, such as meat, eggs, and poultry
products. Records access for commodity-specific regulations
were not amended by FSMA.
FDA does not elaborate much on what constitutes a "reasonable
belief" or "reasonable probability" of adverse
health consequences or death in the General Guidance.
Instead, the agency relies primarily on recent, highly publicized
food safety hazards as examples of the kinds of events that might
prompt it to request access to records. The General
Guidance also reassures industry that FDA will maintain the
confidentiality of the records it obtains. If a firm refuses to
permit access to records, penalties could include seizure of the
food, mandatory recall orders, administrative detention of the
food, and suspension of facility's registration for import,
export, or introducing the food into inter- or intrastate
commerce.
The other Guidance, What You Need to Know About Establishment and
Maintenance of Records; Small Entity Compliance Guide, is
targeted at small firms. The Small Entity Compliance Guide
offers a more streamlined format and provides additional details on
who is excluded from the requirements of the rule. For example, FDA
notes that several kinds of entities, such as fishing vessels not
engaged in processing and non-profit food establishments, are
excluded from the requirement to establish and maintain records,
but they are not excluded from the requirement to provide FDA
access to existing records.
Though the guidances do not offer much insight as to how, when, or
why FDA will exercise its enhanced records access authority, we can
expect that FDA will seek to use this authority during foodborne
illness outbreaks, particularly when investigating the source of
the contamination or when determining whether an entire supply
chain is affected.
Brigid DeCoursey, an associate in the Washington Office,
assisted in the preparation of this Alert.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.