Gillian Dagan, Ph.D.Cheif Scientific OfficerABC Research Laboratories

FSMA Overview

Came into effect January 4, 2011 New, comprehensive food oversight

system FSMA Covers:

Food for human consumption Pet Foods Does not cover dietary supplements, except for NDI draft guidance

FSMA Overview

Is anyone Exempt? For imports--NO

Tester Amendment: exemption for very small businesses or farms with sales less than $500,000 where the majority of food is distributed directly to consumers or restaurants and distribution is intrastate or within a 275 mile radius

Basis of Oversight

Risk-based approach to food safety Proactive through inspection and

certification Gives enforcement authority and

tools to prevent issues GOAL: not only enforcement of

food safety but also trade facilitation

Expectations

Foreign firms must register with FDA

Have a food safety planReanalysis required every 3 yearsMust include hazard analysis including

allergens, bioterrorismPreventative controls will include

environmental testing and finished product testing

Expectations

Product must be produced under the food safety plan, in compliance with regulations promulgated by the FDA, and cannot be adulterated or misbranded

Foreign firms will be held to the same standard as domestic firms

FSMA Timeline

Upon enactment: inspect records, collect fees, mandatory recall authority, ability to require import certificates, inspect foreign food facilities, identify smuggled food

July 2011: new requirements for registration, NDI, interim final rule on administrative detention of food, prior notice required for all imports

FSMA Timeline January 2012: draft standards for fresh

produce, guidelines for fresh produce, guidelines on intentional adulteration, high risk foods definition—still waiting

February 2012: interim final rule on records access and final regulation is imminent

July 2012: HA and risk-based controls, guidelines on intentional adulteration, VQIP, third-party accreditation process

FSMA Timeline

January 2013: program for accreditation of labs, traceability standard, FSVP, expand foreign government capacity, recognition of accreditation bodies, accreditation of third parties

User Fees

Reinspection of Imported Foods: recondition or relabel foods on detention, removal from DWPE, or destruction of condemned product

Reinspection of Food Facility: concerns implementation of needed corrective actions after first inspection of facility

Recalls: now FDA has power to initiate a recall

User Fees

In addition, foreign firms must register with FDA and have US agent that will receive the bill

FEES: $224/hr domestic, $325/hr international

Recall cost estimated at 50k per person, 250k per entity with 500k max plus FDA fees for time spent

Suspension of registration could be 1-6 months

Inspection of Food Facilities

FDA will ask for your safety plan Rules to this effect will be in 2012,

implementation in 2013 Need preventative controls, risk-

based, HACCP-like plan Issues will require a reinspection--

how fast will FDA be able to provide a "clean letter" for your buyers?

Mandatory Recall

Adulterated or misbranded food is grounds for a mandatory recall

Voluntary recalls are still allowed If mandated, FDA will initiate the

recall, publicize it, and bill you

Smuggled Food

Food brought into the US through fraudulent means or brought in with the intent to defraud or mislead

Criminal Investigation between FDA and Customs

Administrative Detention

Ability of FDA to administratively detain any food during an investigation/inspection if they suspect adulteration or misbranding

Prior regulations required credible evidence for harm

20 days + 10 days for seizure or injunction

Prior Notification

Requires importers to report all countries to which food has been denied entry

Submitted electronically through CBP and Prior Notification FDA System

Facility Registration

Under Bioterrorism Act facilities had to register bi-annually and denote a US agent

FDA can suspend registration and product will be stopped at the border

High Risk Foods/Firms

High Risk Foods/Firms

Inspected within first 5 years of FSMA and every 3 years thereafter

Importers will have to provide a certification from a verifiable entity like a third party lab

Based on food safety risk, country of origin, and testing of product

Science Based Risk Analysis

HACCP-like plan Environmental controls, sanitation,

how to recall, supplier certifications and verifications

What is the difference between this and HACCP?

Non-compliance is a criminal act!

Foreign Supplier Verification Program Provides assurances of compliance

with FSMA Required for imports except

products covered under low-acid canned food regulations and juice or seafood HACCP

Importers must maintain records for 2 years

Options for Penalties

Suspend Registration--"USA Rejected" label and you wait for reinspection

Seizures Injunctions Import Alerts Civil Penalties: $10,000-$100,000 Prosecution for Smuggled Food

VQIP

Voluntary Qualified Importer Program

Green Lane for Imports

Steps to Compliance

Determine what parts affect your products

Understand how to change behavior for compliance

Work with FDA and counsel to represent your interests to FDA

Questions?

Gillian DaganABC Research Laboratoriesgillian@abcr.com