AN OVERVIEW
Beverley Miller
Date: 25 October 2011
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The Food Safety Modernization Act, an
amendment of the Federal Food, Drug and
Cosmetic (FD&C) Act, was signed into law on
January 4, 2011 by President Obama.
The Act provides a legislative mandate to
require science-based preventive controls
across the food supply chain rather than a
reactive approach to food safety problems.
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Foodborne illness a big problem in the U.S.A.
Recent data from the Centers for Disease
Control & Prevention:
◦ About 48 million (1 in 6) Americans get sick;
128,000 are hospitalized and 3,000 die each year
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Foodborne diseases a largely preventable
public health burden
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1. Improving capacity to prevent food safety
problems;
2. Improving capacity to detect and respond
to food safety problems;
3. Improving the safety of imported food.
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Registration
◦ Biennial registration renewal as of October 1, 2012;
◦ Suspension of registration
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Hazard analysis and risk-based preventive
control
Authority to collect fees for re-inspection;
mandatory recalls; voluntary qualified
importer programme (VQIP);
Unique Identification Number for each
registered facility (study underway).
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Identification and inspection of facilities;
increased frequency of inspection. (In year 1at least 600 foreign facilities to be inspected)
Identification and inspection at ports of entry;
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Laboratory Accreditation for Analysis of
Foods; (Foreign labs which satisfy
accreditation standards shall be accredited);
Enhanced tracking/tracing of foods(starting
with pilot projects) & recordkeeping;
Foodborne illness surveillance system;
Mandatory recall authority.
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Section 202 of the Act, directs the FDA to:Establish a programme for the testing of foods
by accredited laboratories by January 2013;
Establish a publicly available registry of
accreditation bodies recognized by the Secretary
and of laboratories accredited by a recognized
accreditation body by January 2013;
Require that any changes that would affect the
recognition/accreditation be reported to the
Secretary.
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Foreign Supplier Verification Programme
(FSVP)
Voluntary Qualified Importer Programme
(VQIP)
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Monitoring records for shipments
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Lot-by-lot certification of compliance
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Annual on-site inspections
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Checking hazard analysis and risk-based
preventive control plan of foreign supplier
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Periodic testing and sampling shipments
Exemption : Seafood; Juice & LACF Facilities
(microb. hazards only) in compliance with
HACCP
Guidance /Regulations due January 2012
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Prior notice of imported food shipments
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Inspection of foreign food facilities
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Accreditation of third-party auditors (FDA can
accept 3rd party’s verification that facilities
comply with US requirements)
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Authority to require import certification for
high-risk foods;
FDA to establish Foreign Offices to provide
assistance on food safety measures.
Programme to begin no later than 18 months
after enactment of FSMA (by July 2012)
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1. Preventive Controls: FDA now has
legislative mandate to require comprehensive
prevention-based controls across the food
supply.
2.Inspection and Compliance: The legislation
recognizes the importance of inspection as a
means of holding industry accountable for its
responsibility to produce safe food. The law
specifies how often FDA should inspect food
producers
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Imported Food Safety: New tools to ensure
that imported foods meet US standards e.g.
importer verification of adequacy of
supplier’s preventive control; FDA’s ability to
accredit qualified third party auditors to
certify foreign facilities based on US food
safety standards.
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Response: FDA has mandatory recall authority
for all food products.
Enhanced Partnerships: The legislation
recognizes the importance of strengthening
existing collaboration among all food safety
agencies including foreign agencies.
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Biennial registration renewal: During period
Oct. 1 – Dec. 31 of even numbered year.
Suspension of registration by FDA: No
imports until informal hearing is held.
Re-inspection: No charge for initial
inspection. FY 2011, re-inspection costs
US$325.00/hour
Failure to comply with Recall orders: Fees to
be determined.
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Proposed inspections during FY 2012 (Oct.1,
2011-Sept. 30, 2011 will measure industry’s
compliance with current requirements NOT
future FSMA regulations.
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Role: To drive the process of ensuring
Jamaica’s preparedness to satisfy USFDA
requirements as elaborated in the Food safety
Modernization Act.
Membership: Multi-sector & multistakeholder based.
Operations/Meetings: Meets fortnightly
Responsibilities:
To provide guidance to Secretariat (established
at BSJ) in coordinating activities of regulatory
agencies and other stakeholders in preparing
for USFDA inspections
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To determine the extent of Jamaica’s
readiness to satisfy the requirements of the
USFDA FSMA.
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To identify needs of Jamaica’s regulatory
machinery in order to fulfill its role and
strengthen collaboration with US food safety
agencies;
To assist in the sourcing of funds to enable
both public and private sectors to upgrade to
the required level
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To keep stakeholders abreast of
developments under the FSMA.
To encourage, through the establishment of a
‘corporate’ mentoring programme, big
successful companies to mentor smaller
companies in need of development.
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Pre-assessment visits being conducted by
regulatory officials to determine the status of
each facility (Priority to FDA list).
List of Food Safety Consultants prepared and
available to stakeholders
Auditors have been identified and being
prepared to start conducting gap audits.
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BSJ collaborating with Department of
Chemistry (UWI) re the conduct of a Better
Process Control School (BPCS) scheduled for
January 9 -13, 2012.
FDA ‘s training of Processed food inspectors
in HACCP scheduled for January 30, 2012 and
joint inspections (FDA/BSJ) of Ackee firms to
start on January 31, 2012.
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Jamaica National Agency for Accreditation
(JANAAC) is currently accrediting a set of labs.
to collectively cover the range of tests by
January 2013.
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We all commit to the common goal of
ensuring Jamaica’s agri/agro-processed
exports into the USA by complying with the
requirements of the USFDA FSMA.
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The FDA website @ http://www.fda.gov.FSMA
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The FSM Secretariat at 619-1131
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BSJ Website @ www.bsj.org.jm