Transcript Slide 1

FSMA’s Potential Impact
on Food Exports from
Sri Lanka
By Jeffrey Read, MSFS
Center for Food Safety and Applied Nutrition
Agenda
• Food Safety Modernization Act (FSMA) Background;
• Overview of FSMA mandates for imported food;
• Rule Making Process;
• Preventive Framework;
• Proposed Rules on Preventive Controls & Foreign Supplier Verification;
• Supplemental Rules – Open for Comments Until December 15, 2014;
and
• Questions and Answers
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Food Safety Modernization Act
• Signed into law by President Obama on January 4, 2011.
• Focuses on preventing food safety problems rather vs. reacting to them.
• Provides FDA new enforcement authorities 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.
• Gives new tools to hold imported foods to the same standards as
domestic foods
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Why is the law needed?
Foodborne illness is a significant burden
– About 48 million (1 in 6 Americans) get sick each year
– 128,000 are hospitalized
– 3,000 die
Food supply more high-tech and complex
– 15 percent of U.S. food supply is imported
– More foods in the marketplace
– New hazards in foods not previously seen
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Main Themes of the Legislation
Click to add text
Prevention
Inspections,
Compliance,
and Response
Enhanced
Partnerships
Import Safety
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Import Safety Mandates
• Sec. 301. Foreign supplier verification program
Based on comments received, rule has been re-opened for
comments on specific portions of the rule.
• Sec. 302. Voluntary qualified importer program
No rule has been proposed at this time.
• Sec. 303. Certification for high-risk food imports
Comment period for rule closed in May 2014, FDA is reviewing the
comments.
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Import Safety Mandates
• Sec. 304. Prior notice of imported food shipment
Final rule published May 2011
• Sec. 305. Capacity building
International Food Safety Capacity-Building Plan
• Sec. 306. Inspection of foreign food facilities
Ongoing
• Sec. 201. Targeting of inspection resources
Ongoing
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Import Safety Mandates
• Sec. 307. Accreditation of third-party auditors
Rule proposed FDA considering comments.
• Sec. 308. Foreign Offices of the Food and Drug
Administration.
• Sec. 309. Smuggled Food
See FDA Strategy
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The Rulemaking Process
Step 1: FDA Proposes a Rule and Requests Comments
Comment on rules at http://www.regulations.gov.
Step 2: FDA Considers Your Comments and Issues a Final Rule
This final rule is also published in the FR and FDA’s official docket on
http://www.regulations.gov.
Step 3: Companies Comply with the Rule Based on the “Effective Date”
Additional Tools: FDA Issues Guidance Documents to Assist Industry
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Rules Implement Preventive
Framework
Safety standards established by FDA
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Standards for produce safety
Preventive controls for human food
Preventive controls for animal food
Sanitary Transportation of Human and Animal Food
Focused Mitigation Strategies to Protect Food Against Intentional
Adulteration
Industry must verify standards are met
– Foreign supplier verification program
– Accreditation of third-party auditors
Additional rules and guidance coming
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Proposed Rule
Preventive Controls for Human Food
Supplement now open for comments.
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Preventive Controls for Human
Food
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Prevent problems that can cause foodborne illness
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Domestic and foreign firms that manufacture, process, pack or hold human food. The
rule describes some exempt facilities.
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Written food safety plans that:
a) identify hazards;
b) specify the steps (preventative controls) that will be put in place to minimize or
prevent those hazards;
c) identify monitoring procedures;
d) record monitoring results; and
e) specify what actions will be taken to correct problems that arise.
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Facilities would also need to comply with the updated Good Manufacturing
Practices
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Proposed Supplemental Rule
Based on FDA’s outreach efforts and public comments, the FDA is
proposing revisions to its proposed rule on preventive controls for
human food that are more flexible and less burdensome in key areas.
You can submit comments until December 15, 2014 :
http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0920-1553
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Preventive Controls for Human
Food
Summary of Key Revisions
1. Farms that pack or hold food from other farms are not subject to the
preventive controls rule
2. Definition of a very small business proposed at less than $1 million in
sales
3. Withdrawal of qualified exemptions process further clarified
4. Product testing, environmental monitoring, supplier controls proposed
5. Economically motivated adulteration language proposed
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Proposed Rule
Foreign Supplier Verification Programs (FSVPs)
Supplement now open for comments.
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Foreign Supplier Verification Programs
(FSVPs)
• Importers would be required to develop, maintain, and follow an FSVP
for each food imported, unless an exemption applies.
• The requirements vary based on:
– Type of food product
– Category of importer, such as very small
– Nature of the hazard identified in the food
– Who is to control the hazard
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FSVP Requirements
In general, importers would need to conduct the following activities as part
of their FSVPs:
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Hazard analysis
Supplier verification activities
Corrective actions (if necessary)
Periodic reassessment of the FSVP
Importer identification at entry
Recordkeeping
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Proposed Supplemental Rule
Based on FDA outreach efforts and public comments, the FDA is
proposing revisions to its proposed rule on foreign supplier verification
programs intended to provide more flexibility in determining
appropriate verification measures based on food and supplier risks.
You can submit comments until December 15, 2014 :
http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0143-0247
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FSVP Supplement
Summary of Key Revisions
1.
Hazard analysis
2. Supplier verification
3. Consistency with other proposed FSMA rules
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For More Information
Web site: http://www.fda.gov/fsma
• Sign-up for FSMA E-mail updates.
• Send questions to [email protected]
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Thank You! - Questions?
Please Contact FDA/OIP’s
Asia-Pacific Office
at [email protected]