Food Safety Modernization Act And Dietary Supplement ... Presentation 2015 EDIT… · Food Safety...

Food Safety Modernization Act And

Dietary Supplement Ingredients

Presented at

Nutrition Industry Association Fall Meeting

Presenter:

Joy Joseph

November 10, 2015

Marina del Rey Yacht Club

Los

Joy's Quality Management Systems

Introduction

´  In 2011 the president signed into law, the Food Safety Modernization Act (FSMA).

´ According to FDA’s records, high profile outbreaks of food borne illness over the last decade dictated the need for a food safety system that is preventive rather than reactive.


What Conditions Dictated the Need for FSMA?

´  Increases in food born illness.

´ Economic Adulteration

´ Lack of controls for both domestic and foreign supply.

´ Globalization

´ 15 percent of US food supply is imported.


FSMA-Food Safety Modernization Act

´  This legislature represents the most sweeping change in food safety in 75 years.

´  This new law is a paradigm shift that completely changes the playing field.

´  The outcome of FSMA is the publication of 7 proposed rules to ensure a safe food supply.


Proposed Rules

´ Proposed Rules

´ Standards for Growing, Harvesting, Packing and Holding Produce for Human Consumption

´ Current Good Manufacturing Practice and Hazard Analysis and Risks Based Preventive Controls for Human Food - Part 117


Proposed Rules

´ Current Good Manufacturing Practices and Hazard Analysis and Risk Based Preventive Controls for Food for Animals

´ Foreign Supplier Verification Programs (FSVP)

´ Certified Quality Auditors

´ Intentional Adulteration

´ Safe Transport

FSMA Proposed Rules

´ The Preventive control rule for Human Foods and the

´ Foreign Supplier Verification Program

´ will most likely affect food, dietary supplements, ingredient manufacturers, and will be the sources of the challenges presented today .


Final Rules

´  Two of these rules were finalized and were published in the Federal Register –September 17, 2015

´  Current Good Manufacturing Practice and Hazard Analysis and Risk Based Preventive Controls for Human Foods (FDA Briefing 9/10/15- DS are exempt ; Dietary Ingredients must comply with Part 117)

´  Current Good Manufacturing Practice and Hazard Analysis and Risk Based Preventive Controls for Animal Foods

´  Compliance Date-September 2016


Final Rules

´  Foreign Supplier Verification Program

´  Third Party Auditor Certification Program

´  Produce Rules

´  Finalized November 1,2015 . Expected any day noy for Federal Register Publication


FSMA - Food Safety

´ Food Safety

´ Food Quality

´ What is the Difference?

´ Who is Responsible?

´ What Changed?

´ What cGMPs are in Place?


Part 110-Current GMPs in Manufacturing , Packing, or Holding Human Food What was Missing

´  Part 110 is specific to conventional foods ´  Includes raw materials and ingredients as is defined in

section 201(f) of the act.

´  Contains non-binding guidance (denoted by "shall”) ´  Lacked controls necessary to ensure a safe supply. ´  Lacked specific language for testing and record

keeping.

´  Not specifically imposed upon foreign suppliers


21 CFR Part 111: DS cGMPs What was Missing

´ 111 specific to finished dietary Supplements

´ No defined rules for Ingredient suppliers.

´ Controls to ensure product quality

´ Dietary Supplement Manufacturers were responsible for raw material suppliers meeting specifications necessary to ensure product quality.


Definitions

´  Quality Control Operation

´  Reasonably foreseeable hazard

´  Significantly minimize

´  Validation

´  Verification

´  Small business

´  Safe moisture level


Dietary Supplement Manufacturers

What Are the Challenges? Are We Affected by these Rules?


FSMA Final Rule 21 CFR Part 117

Current Good Manufacturing Practice and Hazard Analysis and Risk Based Preventive Controls for Human Food


21 CFR Part 117

´ Current Good Manufacturing Practices and Hazard Analysis and Risk Based Preventive Controls for Human Food

´ Proposed Rule –FR Vol 78, NO 11 January 16, 2013

´ Supplemental Proposal- to September 15, 2014

´  Finalized- September 17, 2015


Part 117 - Preventive Controls Who is Covered

´ Facilities that manufacture, process, pack, or hold human food. ´ A. Ingredient manufacturers or holders

´ B. Dietary Supplement Manufacturers are exempt - Part 111


Quick Facts

´ This Rule is required by Food Safety Modernization Act (FSMA)

´ Focus – Preventing problems that may cause food born illness

´ This new rule will replace 21 CFR Part 110 (Food cGMPs)

´ Applies to Foreign and Domestic firms

´ It is supported by the Proposed Foreign Supplier Verification Program and a Proposed 3rd Party Certification Program for Foreign Firms

´ Phased in compliance dates Joy's Quality Management Systems

Definitions

´  Food - food as defined in section 201(f) of the Act and includes raw materials and ingredients

´  Cross Contact

´  Environmental Pathogen

´  Hazard

´  Mixed type facility

´  Monitor

´  Preventive controls

´  Qualified facility

´  Qualified individual


21 CFR Part 117

´  Subpart A - General Provisions

´  Subpart B - cGMPs- Revised Part 110, Food cGMPs

´  Subpart C - Hazard Analysis and Risk Based Preventive Controls

´  Subpart D - Modified Requirements

´  Subpart E - Withdrawal of an Exemption

´  Subpart F - Requirements Applying to Records that Must Be Established and Maintained

´  Subpart G- Supply Chain Program


Part 117: Subpart A

´ A food is adulterated if:

´  1. Unfit manufacturing conditions

´  2. Food has been manufactured, packed, prepared or held under unsanitary conditions

´  3. The owner, operator ,or agent in charge is required to comply. Non compliance is a prohibited act.


Part 117: Subpart B - GMPS

´ Personnel ´ Plants and Grounds

´ Sanitary operations

´ Sanitary Facilities

´ Equipment and Utensils

´ Processes and Controls

´ Warehousing and Distribution

´ Defect Action Levels


Part 117: Subpart C – Hazard Analysis and Risk Based Preventive Controls

´  A. Food Safety Plan

´ Written hazard analysis

´ Written preventive controls

´ Written procedures and frequency for monitoring

´ Written corrective action procedures

´ Written verification procedures/Validation

´  Supply Chain Program

´ Written recall plan and Associated Records

Prepared by a Qualified individual


What is a Hazard Analysis

´ Starts with a process flow chart

´ Analyze each step for introduction of hazards

´ Biological / Micro, Insects etc.

´ Chemical / Allergens, Radiological

´ Physical (wood, glass, rocks, plastic, etc.)


Part 117-Subpart D

´  This section having to do with Modified Requirements” is not addressed in this presentation


Part 117: Subpart F Records Requirements

´ Original records

´ Food Safety Plans - signed and dated

´ Retained – 2 years

´ Off site except for the FSP

´ May be stored offsite after 6 months

´ Must be made available or retrievable within 24 hours

´ Subject to public disclosure


Ingredient Manufacturers and Dietary Supplement Manufacturers

Are we affected by this rule?

Ingredient Manufacturers –YES

Dietary Supplement Manufacturers-NO


Part 117- Subpart G Supply Chain Program

´  The receiving facility must establish and implement a risk-based supply chain program for those raw materials and other ingredients for which the receiving facility has identified a hazard requiring a supply chain applied control.

´  A receiving facility that is an importer is in compliance with the foreign supplier verification program requirements and has documentation of verification activities providing evidence that hazards for raw materials and other ingredients have been minimized or prevented.


Subpart G- Supply chain Program

´  The Written Supply Chain Program must include:

´  Using approved suppliers

´  Determining appropriate supplier verification activities

´  Conducting supplier verification activities

´  Documenting supplier verification activities

´  Verifying a supply chain- applied control applied by an entity other than the receiving facility’s supplier with documentation


Supplier Verification Activities

´  Onsite audits

´  Sampling and Testing of raw materials and other ingredients

´  Review of Supplier food safety records

´  Other verification activities based upon supplier performance and any risk associated with the raw material or other ingredient.

´  Supplier performance and safety record will impact the type of verification activities required.


How Will FDA Implement Foreign Supplier Compliance

´ What happens if the foreign supplier is not compliant with “Preventive Controls for Human Foods”?

´ Did FSMA cover its bases?

´ Does US FDA have jurisdiction on foreign suppliers?


FSMA PROPOSED RULE

Foreign Supplier Verification Programs (FSVP) for IMPORTERS of FOOD for HUMANS and ANIMALS


FSMA Direction for FDA

´ FSMA directed FDA to increase inspection of foreign food facilities.

´ Congress provided FDA with authority to develop regulations that would facilitate inspection and require industry to share responsibility for food safety.


FSMA - Inspection, Compliance, and Response

Mandates Inspection frequency

More inspections

New Tools for FDA

Mandatory recall

Expanded Records Access

Expanded administrative detention

Suspension of registration

Enhanced product tracking and tracing


Foreign Supplier Verification Program

´ Proposed Good Manufacturing Practices and Hazard Analysis and Risk Based Preventive Controls for Human Food applies to foreign supply

´ Proposed Rule – FR Vol 78, No. 11 July 29, 2013

´ Comment Period Extended to November 26, 2013

´ Scheduled to become final November 2015


Proposed Rule – Foreign Supplier Verification Program

´ All importers must establish and follow an FSVP, unless exempted

´ An importer is: ´ The US owner or consignee

´ The US agent, or

´ The representative of the foreign owner or consignee


FSVP- Foreign Supplier Verification Programs

´ FSVP-Shifts the burden of ensuring safe food to importers

´ Importees must ensure that : ´ Suppliers uses procedures equivalent to

FDA preventive controls

´ Food is not adulterated or misbranded regarding allergen labeling


Foreign Supplier Verification Program (FSVP)

´ Importers will be required to conduct:

´ Hazard Analysis ´ Supplier verification ´ Complaint reviews, investigations and corrective

actions ´ Periodic reassessment of the FSVP

´  Importer identification at entry ´ Record Keeping


Importation of Dietary Supplements

´  Dietary Supplements subject to further processing are exempt from FSVP if Part 111 requirements are met.

´  Importers whose customers are compliant with CFR Part 111 for hazard analysis, supplier verification need only to provide written assurance of compliance

´  Finished Dietary Supplements are subject to FSVP

´ Hazard Analysis

´ Conduct Supplier Verification

Joy's Quality Manage ment Systems

FSMA - Proposed Rule for Accreditation of Third Party Auditors

To further support the FSMA and to ensure adequate compliance to the Food Safety Preventive Controls requirements:

´ FSMA mandated that FDA establish a program for the Accreditation of Third – Party Auditors for foreign food facilities


Proposed Rule - Accreditation of Third / Party Auditors

´  Good Manufacturing Practices and Hazard Analysis and Risk Based Preventive Controls for Human Food requires inspection and certification of foreign supply

´  Proposed Rule –FR Vol 78, NO 11 July 26, 2013

´  Comment Period Extended to November26, 2013

´  Scheduled to become final November, 2015


Accreditation of Third party Auditors

´  FDA would recognize accreditation bodies based upon competency and impartiality.

´ Accreditation bodies would certify qualified third party auditors.

´  Third Party auditors would audit and issue certifications for foreign facilities and foods.

´  Foreign facilities may choose third party auditors.


Accreditation of Third Party Auditors

´  Third party certifications would be used by FDA to admit certain imported foods into the US where a safety risk has been posed Or

´  If an importer eligible to participate in the Voluntary Qualified Importer Program

´ Otherwise neither Third–Party nor FSVPs would require the use of accredited auditors


FDA Oversight

´ FDA will monitor performance of auditors

´ FDA will receive reports of every regulatory audit

´ FDA will have access to records of consultative audits

´ FDA must have immediate notification of serious risk to public health.


Intentional Adulteration

´ Applies to Domestic and Foreign Firms

´ To protect food from intentional adulteration when the intent is to cause large scale public harm.



Vulnerable Food systems identified as:

´ Bulk Liquid Receiving and Loading

´ Liquid Storage and Handling

´ Secondary Ingredient handling

´ Mixing and similar activities



FOOD DEFENSE PLAN

´ Actionable process steps

´ Focused mitigation strategies

´ Monitoring

´ Corrective action

´ Verification

´ Training

´ Record keeping Joy's Quality Management Systems

How Are We Challenged

´ Should Dietary Supplement Manufacturers and Distributors have a plan of action for product safety?

´ What will be the responsibility with regard to suppliers both domestic and foreign?

´ What requirements apply to the receiving facility?



´ Will dietary supplements be adulterated if their supplier failed to comply with “Preventive Controls (117)”

´ How will dietary supplement manufacturers know if their suppliers are compliant?

´  Have your responsibilities increased or decreased?



´ Supply Chain Control ? ´ What kind of verification agreements

need to be in place with brokers or other supply chain members to ensure compliance?

´ What is the relationship between Subpart G-Supply Chain and FSVP.

´  Will DS manufacturers need to hire third party auditors to ensure compliance?


Why are we looking at New and Proposed Rules

Dietary Supplement cGMPs were finalized in June 2007. Are we compliant?

FDA says “Our Industry Is Not Fully Compliant”

This is 2015 FSMA Proposed Rules are scheduled to be finalized in 2015-2016 How many years do we need to comply? Do we need a head start?


How To Prepare!

´ Learn the proposed rules ´ Know the source of materials domestic and

foreign ´ Know who the manufacturer is ´ Know whether or not your suppliers are

compliant ´ Begin testing products for Identity, Purity

and Contaminants ´ Know what your challenges may be!


What Dietary Supplement Manufacturers MUST NOT DO

´ Buy from suppliers who have not been verified compliant to the new rules.

´  Ignore that chemicals or other non food approved additives may have been added to products.

´  Buy from suppliers who deny FDA or Certified auditors entry for inspections.

´  Use materials that have been adulterated economically, intentionally, or unintentionally due to lack of knowledge.


Approved and Preferred Suppliers!

´ Get ready!

´ Be prepared!

´ Don’t wait for the notice that your product has been detained at the border!


QUESTIONS ?

Joy A .Joseph

Joy’s Quality Management Systems

Contact: [email protected]


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