The Impact of the Food Safety Modernization Act on Small Food - - PowerPoint PPT Presentation

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The Impact of the Food Safety Modernization Act on Small Food Businesses in South Carolina

Roland McReynolds, Esq. CFSA Executive Director

CFSA is a farmer-driven, membership-based non-profit that supports farming that is good for consumers, good for our farmers and farmworkers, and good for the land.

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• Heavily engaged in FSMA legislative process
• Active in developing comments on FSMA

proposed rules on behalf of sustainable ag

• Provide food safety training tailored to

diversified and organic farms

• GAP training videos for diversified farms on

YouTube

CFSA’s Food Safety Work

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• Became law in Jan. 2011
• Draft regulations issued by FDA in Jan. 2013; certain

portions of drafts revised and re-issued Sept. 2014

• Final regulations to be issued Aug. 2015
• Requires food processing/manufacturing facilities to

adopt HACCP-like systems, known as HARPC (Hazard Analysis and Risk-Based Preventive Controls)

About the Food Safety Modernization Act

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Processing/manufacturing defined as “making food from one

• r more ingredients, or synthesizing, preparing, treating,

modifying or manipulating food, including food crops or

• ingredients. Examples of manufacturing/processing activities

are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging.” 21 CFR 1.227(b)(6)

What is a Food Processing/Manufacturing Facility?

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• Cheese makers
• Grain mills
• Most produce distributors
• Wholesale bakeries
• Coffee roasters
• Candy manufacturers
• Soft-drink makers
• Jam and jelly makers
• Producers of pickles and fermented foods
• BBQ and other sauces

Examples of Covered Facilities

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• Facilities that make the majority of their sales direct to consumers, including

restaurants, grocery stores, retail bakeries.

• Non-profit food establishments
• Private homes
• Fishing vessels
• Farms, unless then conduct certain processing activities
• Establishments already subject to Seafood HACCP, juice HACCP, and FDA’s

regulations for Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers

• Alcoholic beverage manufacturers
• Meat processing facilities regulated by USDA or SC Meat & Poultry Inspection

Division

• Establishments that solely hold packaged food that is not exposed to the

environment

• Establishments that only store raw agricultural commodities other than fruits and

vegetables

Entities that Are NOT Covered

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• HARPC must include
• written food safety plan
• hazard analysis
• food safety plan monitoring
• corrective actions
• validation of plan
• periodic reanalysis and revision of plan
• documentation

HARPC Requirement

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• Compliance officer: Facilities must have an individual,

trained to standards set by FDA, to oversee all aspects of the HARPC program

• Supplier Verification: Facilities required to ensure that

their suppliers are in compliance with FDA rules

• Environmental and Product Testing: Facilities are

required to include testing in their validation program

HARPC Requirement

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• In 2013 FDA estimated the annual cost of compliance with the

HARPC requirement at $13,000/year

• 73% of the aggregate costs would fall on businesses with

20 or fewer employees

• In 2014, FDA added estimates for the cost of:
• Supplier Verification: $3,350/year for businesses

w/fewer than 20 employees

• Environmental Testing: $2,891/year for businesses

w/fewer than 20 employees

• Product Testing: $12,000/year for businesses w/fewer

than 20 employees

The Cost of HARPC

www.carolinafarmstewards.org “[FDA] concludes that the proposed rule will have a significant economic impact on a substantial number of small entities… The regulatory costs of this proposed rule may discourage at least some new small businesses from entering the industry.” Very small businesses would face $31,000 in HARPC costs annually

The Cost of HARPC

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• Large businesses (>500 employees) will have 1 year to

come into compliance

• Small businesses (<500 employees) will have 2 years
• Very Small businesses (<$1 million in annual sales of

human food; $2 million for animal food facilities) can qualify for protection from HARPC requirements if state law allows for alternative oversight

Compliance Timelines

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• FDA proposing HARPC as amendment to

existing Current Good Manufacturing Practices (CGMP) regulations

• SC adopts CGMPs by reference, and so will

automatically impose HARPC on all food facilities, including qualified Very Small business, unless the legislature takes action to establish a ‘safe harbor’

SC Set to Adopt FDA’s Requirements in Full

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Very small business can be exempted from HARPC requirement if it can provide: “[D]ocumentation (which may include licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight), as specified by the Secretary, that the facility is in compliance with State, local, county, or other applicable … food safety law”

Tester-Hagan Amendment

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S.284 would allow SC to continue to regulate safety practices at qualified Very Small food processing facilities, without imposing the additional $31,000 in annual costs that the HARPC requirement will otherwise create for those Very Small businesses

Taking Advantage of Tester-Hagan Amendment

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Questions?

Roland McReynolds, Esq. Executive Director roland@carolinafarmstewards.org 919.542.2402