Food Safety Modernization Act

Proposed Rules

Tim Slawinski

Food and Dairy Division

Michigan Department of Agriculture and Rural Development

Agenda

• Overview of the Process

• Content of proposed rules

• Updates on feedback

• Potential Concerns

• To-Do List

February 2013

Food Safety Modernization Act (FSMA)

• Signed into Law January 4, 2011• Proposed rules published January 16, 2013

– Standards for Produce Safety– Preventive Controls for Human Food

• Animal feed rules yet to be released

• 120 day public comment period (ends 5/16/13)• FDA review of comments• Final rules published

February 2013

Compliance Dates

• Preventive Controls:– 1 Year – Large Businesses

>500 Employees

– 2 Years – Small Businesses <500 employees

– 3 Years – Very Small Businesses 3 options being considered

<$1M, <$500K, <250K

February 2013

Who’s in and Who’s out

• FDA Registration for Bioterrorism Act– Facilities Required to Register are in– 2 Levels of Exemptions:

• Not Required to Register– Full Exemption

• Required to Register, but Exemption in Rule– Partial Exemption

January 2013

Registration Required

• Firms that Manufacture, Process, Pack or Hold Human Food.– Confusion over who must register

• Farm Activity vs. Manufacturing• Mixed-Type Facilities (Farm and Manufacturing)

– Guidance documents now available

February 2013

Exempt from Registration

• Farms

• Restaurants

• Retail Food Establishments

• Non-Profit Food Facilities

• USDA Facilities

• Transport Vehicles

• Private Residence (Cottage Foods)January 2013

Partial Exemptions in the Rule

• Juice, Seafood & Low Acid Canned Food

• Certain types of storage facilities

• Alcoholic Beverages

• Dietary Supplements

• Low-Risk On-Farm Processing

• Very Small Businesses

• Tester AmendmentFebruary 2013

Modified Requirements• Qualified Facilities:

– Very Small Businesses– Tester Amendment

• <$500K annual sales and• 50% of sales local (in-state or within 275 mi.)

• Submit Documentation to confirm:– Firm meets “Qualified Facility” requirements– Compliance with State Law– Label Requirement

February 2013

Content of Preventive Controls

• Changes to 21 CFR 110 (CGMPs)– Applies to most partially exempt facilities

• Food Safety Plan Required– Similar to HACCP + Pre-req. programs

• Hazard analysis, preventive controls, monitoring, corrective action, verification, validation

February 2013

Warehouse

• Packaged Food:– CGMPs apply– Exempt from Food Safety Plan

• Modified Requirements for Refrigerated

• Raw Agricultural Commodities – Exempt from CGMPs– Exempt from Food Safety Plan

• Except for fruits and vegetables

February 2013

Warehouse

• RAC Fruits and Vegetables– Exempt from CGMPs– Food Safety Plan Applies

• Boxed Fruit in a CGMP Warehouse?– Is a Banana Box considered “Packaged”?

• WIP or Bulk Ingredient Storage?

January 2013

Mixed-Type Facilities

• On-Farm Manufacturing

• Both Rules Apply

• “Own RACs” vs. “Others RACs”

• Change to “RAC Exemption”– CGMPs apply to mixed-type facilities

February 2013

CGMP Changes

• Change from 110 to 117

• Editorial Changes

• Remove Recommendations– Some changed to requirements

• Add “Cross Contact”

• Change to “RAC Exemption”

February 2013

Cross Contact

• Wearing outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food-packaging materials, and to protect against the cross-contact of food

February 2013

Training

• Personnel responsible for identifying sanitation failures or food contamination– Education and/or experience requirement

• Food handlers and supervisors– “Appropriate” Training

February 2013

Food Safety Plan

• Hazard Analysis

• Preventive Controls– Hazards Reasonably Likely to Occur

• Monitoring

• Corrective Action

• Verification (includes Validation)

• Recall Plan

January 2013

Hazard Analysis

• Biological, Chemical, Physical Radiological

• Must include Environmental Pathogens in exposed RTE areas

• Identify Hazards Reasonably Likely to Occur (not just CCPs).

January 2013

Preventive Controls

• Hazard Reasonably Likely to Occur• Must Significantly Minimize or Prevent• Must Include “as appropriate”:

– Process controls– Food Allergen Controls– Sanitation Controls (Food Contact)– Recall Plan– Others

January 2013

Food Safety Plan Cont.

• Monitoring

• Corrective Action

• Verification– Validation required except for Allergen,

Sanitation and Recall Plan– Direct Observation Required– Reanalysis every 3 years

January 2013

Qualified Individual

• Trained in Risk-Based Preventive Controls • Prepare the food safety plan• Validate Preventive Controls• Review records effectiveness • Review corrective actions• Perform the reanalysis of the Food Safety

Plan

February 2013

Recall Plan

• Recall Plan Required– Notifications, Responsibilities,

Effectiveness, Disposition– Request for comment on Mock Recalls

• Traceability?– Mock Recall vs. Traceability Exercise

February 2013

Not “Required”

FDA has requested comment on:

•Product Testing

•Environmental Monitoring

•Supplier Verification

February 2013

• FDA Listening Session– April 24, 2013. – MDARD to host 1 of 5 in the nation.– Direct contact with FDA decision makers.– Limited on-site space available.– Webinar format for those off-site.

• Food Processors Working Group– April 10, 2013

February 2013

Industry Coordination

• Review the Proposed Rules

• Determine the impact

• Submit Comments to FDA by 5/16/13.

• Start preparing for change

February 2013

Value of Feedback

• Why submit comment to the FDA?– Help to shape the final rules– Guidance Documents

• Why inform MDARD?– Connected to other state agencies

February2013

Resources

• FDA FSMA Proposed Rules page– http://www.fda.gov/Food/FoodSafety/FSMA/ucm3

34120.htm?source=govdelivery

• Page Contents:– Fact Sheets on proposed rules– Full text of proposed rules– Links to submit comment to Federal

Register

February 2013

Questions? Byron Beerbower

MDARD

(517) 241-0934

beerbowerb@michigan.gov

Tim Slawinski

MDARD

(517) 335-3830

slawinskit@michigan.gov