Implications of FSMA Rules on the Food Packaging Industry · 2017-10-12 · Foreign Supplier...

1EAGLE Certification Group includes EAGLE Registrations Inc. and EAGLE Food Registrations Inc.

Implications of FSMA Rules on the Food Packaging Industry

Anne CooperFood Technical Manager

EAGLE Certification Group

2EAGLE Certification Group includes EAGLE Registrations Inc. and EAGLE Food Registrations Inc. 2

What is FSMA?

Does it affect the packaging industry?

When do I need to comply?

What will I have to do?

What new obligations may I have in event of a recall?

Presentation Objectives


What is the Food Safety Modernization Act? The FDA Food Safety Modernization Act (FSMA), the most sweeping reform

of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

There are 7 FSMA Food Rules (laws).

What is FSMA?


1. Preventive Controls for Human Food

2. Preventive Controls for Animal Feed

3. Produce Safety

4. Foreign Supplier Verification

5. Protection of Food from Intentional Adulteration

6. Sanitary Transportation of Human & Animal Food

7. Accreditation of Third Party Certification Bodies

7 FSMA Pillars (Rules)


How does FSMA affect the Packaging Industry?


Regulatory Definitions Tied to Packaging


FSMA and Packaging

Section 201(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(f)): The term "food" means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.

Definitions of “Food”


FSMA and Packaging

Section 201(s) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 321(s)): The term "food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food…”



FSMA and Packaging

Section 415 of the Bioterrorism Act (21 CFR 1.227(b)(4)), on Registration of Food Facilities: Food has the meaning given in Section 201(f) of the [Federal Food, Drug, and Cosmetic Act] (21 U.S.C. 321(f)), (i) Except for purposes of this subpart, it does not include: (A)Food contact substances as defined in section 409(h)(6) of the act (21 U.S.C. 348(h)(6)), or (B) Pesticides as defined in 7 U.S.C. 136(u).



FSMA and Packaging

Section 409(h)(6) of the Federal Food, Drug, and Cosmetic Act (U.S.C. 348(h)(6)): In this section, the term ‘‘food contact substance (FCS) ’’ means any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.”



Sanitary Transportation - Final Rule Excludes Food Contact Substances In April 2016, FDA published its Final Rule on Sanitary Transportation of

Human and Animal Food and explicitly exempted food contact substances from the scope due to the low risk of microbial contamination

Sanitary Transportation


Foreign Supplier Verification Programs – Final Rule includes food contact substances, but FDA may exclude most from requirements in implementing guidance to industry. In August 2016, FDA published its Final Rule on The Food and Drug

Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules, extending the compliance deadline for importers of food contact substances until May 28, 2019 in order to consider how the rule should apply to them.

Currently, FSVP only covers importers/foreign suppliers of substances being directly added to food.

The Food Packaging Coalition has provided FDA draft language for guidance that would exclude all but imported finished food contact articles subject to specific alerts or hazards.

Foreign Supplier Verification Programs


Notify FDA of recall – Section 206

Administrative Detention – Section 207

Records Access – FSMA §101 – amends FFDCA §414

FSMA Compliance

What will I have to do if I make FCS?


In the event of a recall of packaging… Recall Authority – FSMA §206 – amends FFDCA §423 Standard: reasonable probability of serious adverse health

consequences or death. Grants FDA “class 1” mandatory recall authority if company

fails to conduct voluntary recall. FDA may impose fees for failure to comply. Civil penalties up to $50K for individual and $250K for any other entity that

violates recall. Companies must pay costs associated with recall. Highly unlikely to be applied to food contact material suppliers.

Recalls


Administrative Detention – FSMA Section 207 Final rule effective February 5, 2013

• Standard: reason to believe food is adulterated or misbranded .

• Highly unlikely for food contact material suppliers

FSMA


Records Access -FSMA §101 - amends FFDCA §414

Standard: reasonable probability of serious adverse health consequences or death

Broadens FDA’s authority to access records of products related to the affected food (e.g., food contact materials) if the Secretary reasonably believes they are likely to be affected in a similar manner

No specific record-keeping requirements for food contact materials suppliers, but any records kept must be produced within 24 hours of an official request from FDA

Records


It Depends!!

Look for FSVP rule Guidance Document, being developed…

Packaging Deadline extended to MAY 2019

FSMA Compliance Date

When will I have to comply?


Packaging Manufacturing is Indirectly Involved

If a customer who is under FSMA determines there is a risk with your packaging items, then you will be required to control the risk they identified - CFR 117.405(c)• Their verification may include auditing of your facility• Audit is required if the hazard is SAHCOD (Serious Adverse

Health Consequence or Death) General requirements for Supply Chain

• Found in CFR 117.410

FSMA


Regulatory compliance does not always require explicit governmental approval, but packaging must ALWAYS be safe for the intended use.

Core Principle : Packaging must not yield any constituents to the food that would be harmful to public health or that would cause undesirable changes in taste or odor.

Global GMPs

Food Contact Compliance Globally


FDA websitewww.fda.gov/Food/IngredientsPackagingLabeling

Kyra Douglas, Sr. Dir. of Global Regulatory AffairsPlastics Industry Association [email protected]

Food Packaging Coalition http://www.plasticsindustry.org

FSMA Resources

Resources

http://www.fda.gov/Food/IngredientsPackagingLabeling

mailto:[email protected]

http://www.plasticsindustry.org/


Founded in 1994 and headquartered in Dayton, OH Accredited Certification Body for many ISO standards, food and packaging In 2018, will grow to hold more than 2,500 active certificates Serve 15 countries and utilize over 100 competent auditors Actively involved in the following industry associations:

• FSSC Board of Stakeholders• Global Food Safety Initiative (GFSI) Auditor Competence Technical Working Group & Accreditation Task Force

• Safe Quality Food Institute (SQFI) Ethical Sourcing Committee & Storage and Distribution Code Technical

Advisory Committee

Who We Are

22EAGLE Certification Group includes EAGLE Registrations Inc. and EAGLE Food Registrations Inc.

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Implications of FSMA Rules on the Food Packaging Industry · 2017-10-12 · Foreign Supplier...

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