In 2013, the U.S. Food and Drug Administration ("FDA")
has proposed four major sets of regulations designed to implement
the
Food Safety Modernization
Act ("FSMA"). The first two, released in
January, focused on strengthening the regulations governing
manufacturing practices and establishing a new regime of
regulations covering farm operations. (Please
click here to view a summary of these
rules.)
Most recently, FDA released another two major proposed rules; these
rules concern imported foods and are intended to prevent food
safety problems before foods arrive on U.S. shores, rather
than relying on inspections at U.S. ports of entry as the primary
method to catch unsafe foods. The first proposed rule, regarding
Foreign Supplier Verification Programs
for Imports of Food for Humans and Animals
("FSVP"), will make food importers responsible for
overseeing their suppliers' compliance with food safety
regulations. The second, the proposed rule on
Accreditation of Third-Party
Audits/Certification Bodies to Conduct Food Safety Audits and to
Issue Certifications, will establish a program for
accreditation of independent auditors of foreign food producers.
(For the full text of FSMA and the two proposed rules, follow the
embedded hyperlinks above.)
On July 26, FDA published for comment two proposed regulations to
implement certain aspects of FSMA: the Foreign Supplier
Verification Program rule and the Accreditation of Third-Party
Auditors rule. The proposals each include a 120-day formal comment
period, closing November 26. FDA proposes the FSVP effective date
be 60 days after the date on which the final rule is published.
However, the Agency also proposes to provide additional time for
importers to come into compliance, generally setting a compliance
date of 18 months after the publication date of the final rule. In
many cases, the effective date for food importers will vary
depending on the effective dates for other recently proposed rules
regarding preventive controls, produce safety, and manufacturing
practices.
With respect to the Accreditation of Third-Party Auditors rule, FDA
did not specify timing to implementation of a final rule but stated
its intent to implement the program as soon as possible after
publication of the final rule and associated Model Accreditation
Standards.
Note that many more "FSMA" regulations are still in the
pipeline. Yet to come are regulations regarding pet food, the
sanitary transportation of food, intentional adulteration, and
record-keeping requirements for high-risk foods. Congress required
FDA to develop these rules, and FDA is under court pressure to
accelerate its timetable for issuing the rules.
The Proposed Foreign Supplier Verification Program
Rule
As reported in the proposed rule, about 15 percent of all food
consumed in the United States is imported, including approximately
50 percent of fresh fruit and 20 percent of fresh vegetables.
Historically, FDA has relied primarily on inspections and customs
controls at U.S. points of entry to stop unsafe foods from entering
the United States. When finalized, the FSVP rule will change the
food import paradigm from governmental attempts to catch a product
at the port to preventative efforts undertaken by industry to
ensure safety throughout the food supply chain.
The proposed rule, if issued in its current form, will require an
importer to develop, maintain, and follow an FSVP for each food
product it imports. An importer is the U.S. owner or
consignee of the food at the time of entry, or, if there is no U.S.
owner or consignee at the time of entry, the U.S. agent or
representative of the foreign owner or consignee. Each FSVP would
include several major requirements:
- Reviewing the compliance status of the food and the foreign supplier for compliance with FDA rules, before importing the food and periodically thereafter;
- Conducting a hazard analysis for each food to identify the hazards reasonably likely to occur and evaluate the hazard's severity should it occur;
- Conducting verification activities that provide adequate assurances that identified hazards are being controlled, which could include on-site auditing, sampling and testing, or other appropriate risk-based procedures, as well as general verification activities such as maintaining supplier lists and establishing adequate written procedures regarding verification activities;
- Taking appropriate corrective action if hazards are not being adequately controlled;
- Periodically reassessing the FSVP, at a minimum of every three years or sooner if the importer becomes aware of new information about potential hazards associated with the foods they import;
- Obtaining a Dun & Bradstreet Data Universal Numbering System ("DUNS") number for their company and ensuring that each food product offered for import in the U.S. has their name and DUNS number provided electronically at the time of filing for entry; and
- Keeping and maintaining certain records pertaining to compliance status reviews, hazard analysis, foreign supplier verification activities, investigations and corrective actions, and reassessments of their FSVPs.
The proposed rule imposes specific requirements and enumerates
options for implementation concerning each of these major
requirements. Currently, the verification activities requirement
leaves to importers' discretion whether to conduct their own
on-site audits or to rely on verification documentation from the
food supplier. Requiring on-site audits rather than including them
as an optional means of implementing an FSVP would significantly
increase compliance costs for importers. As written, FDA estimates
the new rules on imported food will cost $400 million to $500
million over a 10-year period. FDA's cost analysis assumes
these costs will be passed on to U.S. consumers, and the Agency is
requesting comment on the extent to which all of those costs will
be absorbed by U.S. consumers.
Modified provisions would apply to certain types of importers,
including importers of dietary supplements and dietary supplement
components who establish and verify compliance with certain
statutory specifications, very small food importers and importers
of food from very small foreign suppliers (entities with annual
food sales of no more than $500,000), and importers of food from
foreign suppliers in countries whose food safety system FDA has
officially recognized as comparable or determined to be equivalent
to that of the United States, subject to certain conditions.
In addition, the proposed rule exempts certain categories of
imported food from FSVP regulations. Those categories include
certain juice, fish, and fishery products; food for personal
consumption; alcoholic beverages; food that is transshipped,
meaning it is transferred between conveyances for reshipment; food
that is imported for re-export; and food for research or
evaluation.
The Proposed Third-Party Accreditation Rule
The proposed rule on Accreditation of Third-Party Auditors will
establish a program for approving third-party auditors, or
certification bodies, to conduct food safety audits and issue
certifications of foreign facilities and the foods they produce.
Importers are generally not required to obtain certifications.
However, FDA may use accredited auditor certifications in deciding
whether to admit certain imported foods the Agency determines pose
a food safety risk or whether to permit an importer to participate
in pilot programs aimed as expediting product entry.
The proposed rule includes eligibility requirements for
accreditation bodies and third-party auditors. Both must meet
standards for legal authority, competency and capacity,
independence, quality assurance, and records procedures. FDA would
monitor the accreditation bodies and third-party auditors and could
revoke recognition or accreditation for good cause.
Under the proposed rule, an accreditation body, which may be a
foreign body or agency or a private third party, is required
to:
- Assess third-party auditors for accreditation;
- Monitor performance of the third-party auditors it accredits and notify FDA of changes in, or denials of, accreditation;
- Assess and correct any problems in its own performance;
- Submit reports and other notifications to FDA;
- Protect against conflicts of interest; and
- Maintain and provide FDA with access to records.
An accredited third-party auditor, which may include a foreign
government, foreign cooperative, or other third party, would audit
and issue certifications for foreign facilities and goods, and is
required to:
- Ensure audit agents are competent and objective;
- Conduct rigorous audits;
- Submit reports of regulatory audits to FDA;
- Notify FDA upon finding any condition posing a serious risk to the public health;
- Assess and correct any problems in performance;
- Protect against conflicts of interest; and
- Maintain and provide FDA with access to records.
FDA intends to issue draft model accreditation standards
describing the qualifications a certification body must have in
order to qualify for accreditation. The draft model accreditation
will be subject to public review and comment prior to finalization.
As described in the proposed rule, once an accreditation body
provides sufficient documentation demonstrating eligibility
warranting recognition and receiving such recognition based on the
prescribed standards, it may begin conducting accreditation
activities under the program and will not be subject to a waiting
period.
FDA intends to use certifications issued by accredited third-party
auditors to provide food importers with a system upon which they
may rely to meet supplier verification requirements under the
FSVP.
FDA Perspectives on the Two New Rules
The proposed regulations are related to the preventive controls
programs for food manufacturers and processors contained in
FDA's recently proposed Current Good Manufacturing Practice
rule. FDA views the proposed regulations as a flexible, risk-based
approach to foreign supplier verification, focusing on foreseeable
food safety risks identified through a hazard assessment process,
rather than all risks covered by the adulteration provisions of the
Food, Drug, and Cosmetic Act. FDA believes its approach is
sufficiently general and flexible to apply to a variety of
circumstances, without being unduly burdensome or restrictive of
the imported food trade. However, the Agency acknowledges that the
costs associated with compliance are considerable and will be at
least $400 million to $500 million over a 10-year period. Combined
with the third-party accreditation framework, which will create a
system of comprehensive oversight to help FDA make admissibility
decisions regarding imported foods posing safety risks, the
proposed rules provide the government with new tools for holding
importers accountable for verifying that the food they import is
safe and for doing so in a manner that is transparent to FDA.
Industry and Consumer Impact
FDA believes consumers would benefit from required on-site audits
to ensure food suppliers are meeting safety standards, and consumer
advocacy groups will undoubtedly push for them to be mandatory
under the new rules. Large importers may already have systems in
place mirroring the proposed requirements as part of efforts to
protect their brands and food safety image. Some importers who have
previously implemented robust quality systems may believe that it
is unfair for other companies to avoid such costs, especially when
a foodborne illness outbreak could dramatically reduce sales in an
entire product category.
Importers and suppliers of foreign foods will be affected by the
costs of implementing programs to comply with the new rules, and
they may also reconsider what records they generate in the first
instance in the face of record-keeping requirements. FDA recognizes
that food entities and suppliers may have concerns about their
trade secrets and confidential or sensitive information becoming
public in light of the proposed record requirements, and it
encourages industry stakeholders to raise such concerns over
records access during the notice and comment period.
Industry stakeholders have also informed FDA of concerns regarding
access to sufficient numbers of qualified third-party auditors and
certification bodies under current conditions. FDA is encouraging
public comment and submission of data concerning the availability
of these entities to participate in the program or their ability to
scale up their current capabilities, the effect the program may
have on foreign and domestic food firms' ability to provide
certifications to their customers, whether foreign and domestic
firms will be affected to the same degree, and whether capacity
issues may be more prevalent in certain areas of the world or with
respect to certain types of food firms or products.
Opportunities to Shape the Final Version of the
Rules
To learn more of the views of the public, industry, and other
stakeholders, FDA has been holding a series of public meetings. In
addition, FDA is accepting (and is required to review) written
comments.
Businesses potentially affected by the proposed rules should
consult an attorney to determine the extent of the new obligations
and should begin to determine the costs imposed by the rules'
requirements. The public comment period is open until November 26,
and interested parties and those likely to be affected by the
proposed rules should voice their concerns now. As written here,
care should be taken to ensure that the comments are as effective
as possible. Even small changes to the proposed rules as written
could result in major savings, or costs, to industry
stakeholders.
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.