[PPT] - Modernization Act: What Exporters to the U.S. Need to Know Erik R. PowerPoint Presentation

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The Food Safety Modernization Act: What Exporters to the U.S. Need to Know

Erik R. Lieberman Prepared for AgroBalt 2014 April 4, 2014

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Food Marketing Institute

Trade association for the supermarket

industry

1,225 U.S. and international retail and

wholesale member companies operating more than 40,000 stores with annual sales

f more than $770 billion
Members range from largest international

chains to single-store operators

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Overview

The Food Safety Modernization Act (FSMA)

will have very large impacts on U.S. importers and exporters to the U.S.

Third-party food safety auditors will also face

major new changes if they “opt-in”

Very significant implications for the global

supply chain

Note that regulations reviewed are currently

proposals, they will be finalized next year and in 2016

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New Regulations Food Exporters to U.S Must Know

Foreign Supplier Verification Program (FSVP)
Accreditation of Third-Party Auditors
Preventive Controls for Food for Humans

(and Animals)

Produce Safety
Food Defense
Food Facility Reregistration
Sanitary Food Transportation Act (certain

exporters)

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Why Do Exporters Need to Know?

Because exporters will be required to

comply with many of these requirements starting in 2016 And

Because importers will be required to

verify that their foreign suppliers are complying starting in 2017

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FSVP Overview

FSMA (Sec. 301) requires all importers to

establish a FSVP program to verify that imported food is produced in compliance with:

– Preventive Controls Rules (for human and animal food)* – Produce Safety Rule*

AND

– Is not adulterated (Section 402 of Federal Food Drug and Cosmetic Act (FD&C Act)) – Is not misbranded with respect to allergen labeling requirements Section 403(w) of FD&C Act *or a standard that provides the same level of public health protection

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Who is an Importer?

Definition of importer in FSVP rule
The person in the U.S. who has purchased an article
f food that is being offered for import into the U.S:

– If the article of food has not been sold to a person in the U.S. at the time of U.S. entry, the importer is the person in the U.S. to whom the article of food has been consigned at the time of entry – If the article of food has not been sold or consigned to a person in the U.S. at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry – FDA definition not tied to U.S. Customs and Border Protection (CBP) definition of importer of record

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Food Import Requirements Before FSMA

Pre-FSMA, all U.S. standards apply to imported

food entering U.S., but no affirmative requirement to check production practices outside of U.S.

– All importing of food is considered to be introduction into U.S. interstate commerce – All applicable requirements of U.S. food law (FD&C Act) apply

Cannot be adulterated or misbranded
Prior notice
Food facilities must be registered

– Food importations by nonresident importers permitted

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New Requirements for Importers Created by FSMA

Affirmative obligation to verify that products

are being produced overseas in compliance with preventive controls, produce safety and U.S. law concerning adulteration and allergen labeling

Import certifications
Prior notice change

– Previous refusal of article by another nation

Prohibition on food imports by

nonresident importers/consignees

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FSVP Rule

Importers are required to:

– Review the compliance status of a food and the foreign supplier before importing – Conduct a hazard analysis for each food imported – Conduct foreign supplier verification and related activities including:

Maintaining a list of suppliers
Establishing written foreign supplier verification

procedures

Verifying that importer and customer of importer

adequately controls hazards within their control

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FSVP Rule (contd)

Importers are required to:

– Conduct foreign supplier verification and related activities including:

Verifying that foreign supplier adequately controls hazards

within their control through activities such as:

– Auditing – Lot-by-lot sampling and testing – Review of foreign supplier’s food safety records

– Reassess the effectiveness of their FSVP periodically – Use a DUNS number when filing entry with CBP – Maintain certain records – Violation of FSVP rule is punishable by criminal penalties – Compliance required as early as February 2017

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Accreditation of Third-Party Auditors Rule

FDA is required to set up a system for recognizing

accreditation bodies to accredit third-party auditors to conduct audits for purposes of verifying foreign supplier compliance with U.S. requirements, Voluntary Qualified Importer Program (VQIP) and import certifications

– VQIP is an expedited entry program for food – FDA can require high risk foods from regions/countries with food safety systems determined to be inadequate by FDA to be accompanied by a certificate for entry

Not a blanket regulation of all third-party auditors,
nly those that choose to opt-in

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From 78 Fed. Reg. 45783 (July 29, 2013)

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Third-Party Audit Rule

Facilities seeking to participate in VQIP and food

requiring a mandatory import certification must be audited by auditors accredited pursuant to the FDA program established by this regulation

Auditor(definition for certification body is same)

can be a foreign government, agency of a foreign government, foreign cooperative or any other eligible third-party

Audit must be conducted unannounced during 30-

day operating schedule provided by entity

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Third-Party Audit Rule (contd)

Two Categories of Audits

Consultative

– To determine compliance with FD&C Act and industry standards and practices – Used for internal purposes only – Cannot be used for determining eligibility for food or facility certification under FSMA or for onsite audit under FSVP

Regulatory

– To determine whether entity is in compliance with FD&C Act – Results used to determine eligibility for food or facility certification – May be used by importer in meeting onsite audit requirements for FSVP – Audit report must be submitted to FDA

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Third-Party Audit Rule (contd)

Auditor must immediately notify FDA when it

discovers any condition found during a regulatory

r consultative audit that could cause or contribute

to a serious risk to public health

FDA will withdraw accreditation from an auditor if

food or facility certified is linked to an outbreak of foodborne illness that has reasonable probability

f SAHCODHA

– Agency does have limited discretion in making such decisions

Program expected to be established by October

2016

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Preventive Controls for Human Food: Who is Covered?

Facilities that are currently required to

register with FDA as food facilities

Includes facilities that manufacture,

process, pack and hold food

Includes domestic and foreign facilities

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Preventive Controls for Human Food

Each owner, operator or agent in charge of

a facility is required to comply with the rule

The proposed requirements are similar to

HACCP systems

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Preventive Controls for Human Food (contd)

Each covered facility is required to prepare and

implement a written food safety plan which includes:

– A hazard analysis – Preventive controls – Monitoring – Corrective actions – Verification activities – Recordkeeping

Compliance required as early as August 2016
Violation of regulation is punishable by criminal

penalties

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Preventive Controls Rule for Animal Food

Proposed rule applies to the manufacturing,

processing, packing and holding of animal food

Establishes CGMPs for animal food for the

first time

Creates new preventive controls provisions

similar to those for human food

Violations are punishable by criminal

penalties

Compliance required as early as August

2016

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Produce Safety Rule

Establishes minimum standards for safe

growing, harvesting, packing and holding

f produce on farms
Applies to both domestic and imported

produce

Contains several exemptions

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Produce Safety Rule (contd)

Establishes food safety standards on:

– Worker training and health and hygiene – Agricultural water – Biological soil amendments – Domesticated and wild animals – Equipment, tools and buildings – Sprouts

Violations are punishable by criminal

penalties

Compliance required as early as December

2017

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Sanitary Food Transportation Act Rule

Only rail and motor vehicle carriers are regulated. Air and water

transportation is exempt

Foreign exporters are subject to regulation if they arrange for

transportation of an intact container onto a motor or rail vehicle

In-transit temperature monitoring is required for both TCS foods and

non-TCS foods(that are at risk of microbial spoilage if subject to temperature abuse)

Fully packaged shelf-stable foods are exempt
Raw agricultural commodities (RACs) are exempt when transported

by farms (whether or not they are shippers, carriers or receivers)

Rule applies to animal food and USDA-regulated meat, poultry and

egg products (in addition to FDA-regulated human food)

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Sanitary Food Transportation Act Rule (contd)

Verification of trailer pre-cooling is required
Carriers must provide in-transit temperature

data to receivers of product if the receiver requests it or evidence of a written agreement between the carrier and shipper that shipper is responsible for monitoring the temperature (if there is such an agreement)

Refrigerated/freezer compartments in trailers

must have thermometers, temperature- measuring devices or temperature-recording devices

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Sanitary Food Transportation Act Rule (contd)

Shippers must visually inspect trailers/vehicles for cleanliness

before loading unpackaged food items (a produce box with vents at the top is not considered packaged)

Shippers must specify to carriers in writing all necessary

sanitary requirements for vehicle and transportation equipment

Shippers and receivers must provide vehicle operators who

are expected to handle unpackaged food with hand washing facilities

Violations are punishable by criminal penalties
Food is becomes adulterated if transported in violation of rule
Compliance required as soon as March 2017

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Food Defense Rule

Applies to domestic and foreign facilities required to register under

section 415 of the Bioterrorism Act

Requires facilities to write and implement a food defense plan
Several exemptions—rule does not apply to holding of food (except

food in liquid storage tanks); certain small businesses are exempt; rule does not apply to animal food or activities of a facility subject to the Produce Safety Rule

Note that rule applies to certain facilities exempt from the Preventive

Controls Rule for human food, i.e. in compliance with seafood, juice, LACF rules, dietary supplement facilities)

Covers acts intended to cause massive public health harm,

including acts of terrorism

Does not include acts of sabotage by disgruntled employees
Violations are punishable by criminal penalties
Compliance required as soon as May 2017

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Required Food Defense Measures

Food defense plan must be written
Food defense plan must include:

– Written identification of actionable process steps – Written focused mitigation strategies – Written procedures for monitoring – Written corrective action procedures – Written verification procedures

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What Activities are Subject to Food Defense Rule?

Bulk liquid receiving and loading
Liquid storage and handling
Secondary ingredient handling
Mixing and similar activities
Or conduct your own vulnerability

assessment and go with that

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Food Facility Registration

All facilities that process, pack and hold food

for humans or animals intended for consumption in the U.S. (excluding meat and poultry facilities) must register with FDA

FSMA added a requirement that such

facilities reregister on every even-numbered year between Oct. 1 and Dec. 31

Violation is punishable by criminal penalties
Compliance required now

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