In: Economics
The Food Safety Modernization Act is the largest reform to food safety laws in over 70
years. The Act shifts focus from responding to contamination to preventing it. Some argue that "the
produce industry is experiencing overwhelming regulations". What are some arguments that could convince people about this statement ?
The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. The law also gives FDA important new tools to hold imported foods to the same standards as domestic foods and directs FDA to build an integrated national food safety system in partnership with state and local authorities.
Building a new food safety system based on prevention will take
time, and FDA is creating a process for getting this work done.
Congress has established specific implementation dates in the
legislation. Some authorities will go into effect quickly, such as
FDA’s new authority to order companies to recall food, and others
require FDA to prepare and issue regulations and guidance
documents. The funding the Agency gets each year, which affects
staffing and vital operations, will also affect how quickly FDA can
put this legislation into effect. FDA is committed to implementing
the requirements through an open process with opportunity for input
from all stakeholders.
The following are among FDA’s key new authorities and mandates. Specific implementation dates specified in the law are noted in parentheses
Prevention
For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply. This mandate includes:
Mandatory preventive controls for food facilities: Food
facilities are required to implement a written preventive controls
plan. This involves: (1) evaluating the hazards that could affect
food safety, (2) specifying what preventive steps, or controls,
will be put in place to significantly minimize or prevent the
hazards, (3) specifying how the facility will monitor these
controls to ensure they are working, (4) maintaining routine
records of the monitoring, and (5) specifying what actions the
facility will take to correct problems that arise. (Final rule due
18 months following enactment)
Mandatory produce safety standards: FDA must establish
science-based, minimum standards for the safe production and
harvesting of fruits and vegetables. Those standards must consider
naturally occurring hazards, as well as those that may be
introduced either unintentionally or intentionally, and must
address soil amendments (materials added to the soil such as
compost), hygiene, packaging, temperature controls, animals in the
growing area and water. (Final regulation due about 2 years
following enactment)
Authority to prevent intentional contamination:FDA must issue
regulations to protect against the intentional adulteration of
food, including the establishment of science-based mitigation
strategies to prepare and protect the food supply chain at specific
vulnerable points. (Final rule due 18 months following
enactment)
Inspection and Compliance
The FSMA recognizes that preventive control standards improve food safety only to the extent that producers and processors comply with them. Therefore, it will be necessary for FDA to provide oversight, ensure compliance with requirements and respond effectively when problems emerge. FSMA provides FDA with important new tools for inspection and compliance, including:
Mandated inspection frequency: The FSMA establishes a mandated
inspection frequency, based on risk, for food facilities and
requires the frequency of inspection to increase immediately. All
high-risk domestic facilities must be inspected within five years
of enactment and no less than every three years thereafter. Within
one year of enactment, the law directs FDA to inspect at least 600
foreign facilities and double those inspections every year for the
next five years.
Records access: FDA will have access to records, including industry
food safety plans and the records firms will be required to keep
documenting implementation of their plans.
Testing by accredited laboratories: The FSMA requires certain food
testing to be carried out by accredited laboratories and directs
FDA to establish a program for laboratory accreditation to ensure
that U.S. food testing laboratories meet high- quality
standards.
Response
The FSMA recognizes that FDA must have the tools to respond effectively when problems emerge despite preventive controls. New authorities include:
Mandatory recall: The FSMA provides FDA with authority to issue
a mandatory recall when a company fails to voluntarily recall
unsafe food after being asked to by FDA.
Expanded administrative detention: The FSMA provides FDA with a
more flexible standard for administratively detaining products that
are potentially in violation of the law (administrative detention
is the procedure FDA uses to keep suspect food from being
moved).
Suspension of registration: FDA can suspend registration of a
facility if it determines that the food poses a reasonable
probability of serious adverse health consequences or death. A
facility that is under suspension is prohibited from distributing
food. (Effective 6 months after enactment)
Enhanced product tracing abilities: FDA is directed to establish a
system that will enhance its ability to track and trace both
domestic and imported foods. In addition, FDA is directed to
establish pilot projects to explore and evaluate methods to rapidly
and effectively identify recipients of food to prevent or control a
foodborne illness outbreak. (Implementation of pilots due 9 months
after enactment)
Additional Recordkeeping for High Risk Foods: FDA is directed to
issue proposed rulemaking to establish recordkeeping requirements
for facilities that manufacture, process, pack, or hold foods that
the Secretary designates as high-risk foods. (Implementation due 2
years after enactment).
Imports
The FSMA gives FDA unprecedented authority to better ensure that imported products meet U.S. standards and are safe for U.S. consumers. New authorities include:
Importer accountability: For the first time, importers have an
explicit responsibility to verify that their foreign suppliers have
adequate preventive controls in place to ensure that the food they
produce is safe. (Final regulation and guidance due 1 year
following enactment)
Third Party Certification: The FSMA establishes a program through
which qualified third parties can certify that foreign food
facilities comply with U.S. food safety standards. This
certification may be used to facilitate the entry of imports.
(Establishment of a system for FDA to recognize accreditation
bodies is due 2 years after enactment)
Certification for high risk foods: FDA has the authority to require
that high-risk imported foods be accompanied by a credible third
party certification or other assurance of compliance as a condition
of entry into the U.S.
Voluntary qualified importer program: FDA must establish a
voluntary program for importers that provides for expedited review
and entry of foods from participating importers. Eligibility is
limited to, among other things, importers offering food from
certified facilities. (Implementation due 18 months after
enactment)
Authority to deny entry: FDA can refuse entry into the U.S. of food
from a foreign facility if FDA is denied access by the facility or
the country in which the facility is located.
Enhanced Partnerships
The FSMA builds a formal system of collaboration with other government agencies, both domestic and foreign. In doing so, the statute explicitly recognizes that all food safety agencies need to work together in an integrated way to achieve our public health goals. The following are examples of enhanced collaboration:
State and local capacity building: FDA must develop and
implement strategies to leverage and enhance the food safety and
defense capacities of State and local agencies. The FSMA provides
FDA with a new multi-year grant mechanism to facilitate investment
in State capacity to more efficiently achieve national food safety
goals.
Foreign capacity building: The law directs FDA to develop a
comprehensive plan to expand the capacity of foreign governments
and their industries. One component of the plan is to address
training of foreign governments and food producers on U.S. food
safety requirements.
Reliance on inspections by other agencies: FDA is explicitly
authorized to rely on inspections of other Federal, State and local
agencies to meet its increased inspection mandate for domestic
facilities. The FSMA also allows FDA to enter into interagency
agreements to leverage resources with respect to the inspection of
seafood facilities, both domestic and foreign, as well as seafood
imports.
Additional partnerships are required to develop and implement a
national agriculture and food defense strategy, to establish an
integrated consortium of laboratory networks, and to improve
foodborne illness surveillance.