FSMA: What Indiana Fruit and Vegetable Growers Need to

know

Manpreet Singh, PhD. Department of Food Science

What is New?

•  The FDA-FSMA is the biggest reform of our food safety laws in more than 70 years

•  Signed into law on January 4, 2011

•  Improve capacity to PREVENT food safety problems

Why do we need changes?

•  Burden of Foodborne illness (CDC, 2012) – 1 in 6 Americans get sick each year (~ 48

million) – 128,000 are hospitalized – 3,000 die

•  Paradigm shift in our foods –  Imported foods (Globalization) – More foods in the marketplace – New hazards in foods?

What is the focus?

•  Create a system that addresses the whole spectrum of food safety issues and roles of involved personnel

•  Accountability - responsibility for prevention •  Applies the prevention principle to imported

foods •  Encourage partnerships between other

government agencies: federal, state, local; industry and consumers

Five Proposed Rules Establish

Food Safety Framework

•  Produce Safety Standards - Published Jan. 2013

•  Preventive Controls for Human Food - Published Jan. 2013

•  Foreign Supplier Verification Program

•  Preventive Controls for Animal Food

•  Accredited Third Party Certification

Source: Slide from FDA presentation

Key Aspects of Proposals

•  Confirm industry’s primary role on food safety

•  Risk-based and flexible

•  Address small business issues

•  Extensive government, stakeholder Input

The Four Main Themes

Prevention

Inspections, Compliance, and Response

Import Safety

Enhanced Partnerships

Source: FDA presentation on FSMA update

Prevention – General Approach

•  Identify the hazards •  Understand the cause of the hazards •  Implement preventive controls •  Monitor effectiveness •  Review and adjust

Sec.  103.  Hazard  analysis  and  risk-­‐based  preven8ve  controls  

Compliance with preventions standards

•  Process controls •  Food allergen controls •  Sanitation controls •  Recall plan •  In addition, seeking comment on supplier

approval and verification program

Inspection, Compliance and Response

•  Mandated inspection frequency – Risk based

•  New tools for FDA – Mandatory recall – Expanded records access – Suspension of registration – Enhance product tracing – 3rd party testing

Import Safety

•  Importers responsible for ensuring their foreign suppliers have adequate preventive controls

•  Third party inspections to certify that foreign facilities meet US requirements

•  There will be a voluntary qualified importer program – expedited review

•  Can deny entry if FDA access for inspection is denied

Enhanced Partnerships

•  Rely on inspections from other agencies •  State/local/federal capacity building •  Improve foodborne illness surveillance •  National agriculture and defense strategy •  Consortium of laboratory networks •  Streamlined recall information

PROPOSED PRODUCE SAFETY RULE

What does the proposed produce safety rule establish?

•  Science-based minimum standards for the safe

growing, harvesting, packing, and holding of produce on farms

•  Proposes new standards in the following areas: – Worker Training and Health and Hygiene – Agricultural Water – Biological Soil Amendments of Animal Origin – Domesticated and Wild Animals – Equipment, Tools, and Buildings – Sprouts

•  Fact sheet on produce safety rule: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm

Health and Hygiene

•  The proposed rule would require that farm personnel use hygienic practices, including hand washing and maintaining adequate personal cleanliness

Agricultural Water

•  Potential carrier of microorganisms of public health concern

•  The proposed rule would require all agricultural water be safe and of adequate sanitary quality

•  Require that, at the beginning of the growing season, the agricultural water be inspected to identify microbial hazards

Soil Amendments

•  Biological soil amendments of animal origin may contain pathogens of public health concern, hence: the rule proposes three types of measures to reduce the risk: – Types of treatment, – Methods of application, and – Time intervals between the application of a

biological soil amendment of animal original and crop harvest

Domesticated and Wild Animals

•  The rule proposes certain requirements, such as adequate waiting period between grazing of domesticated animals and harvesting produce from that growing area

•  Farms would be required to monitor for significant wild animal intrusion

Equipment, tools, and buildings

•  The proposed rule also would set standards for certain equipment and tools, buildings, and sanitation used for produce operations on farms

Who Would be Covered?

•  Farms that grow, harvest, pack or hold most produce in raw or natural state (raw agricultural commodities)

•  Farms and “farm” portions of mixed-type facilities

•  Domestic and imported produce

•  Farms with annual sales > $25,000 per year

•  Limitations on coverage are proposed

Limitations on Coverage

•  Produce for personal or on-farm consumption

•  Produce not a Raw Agricultural Commodity

•  Certain produce rarely consumed raw (e.g. Potatoes)

•  Produce that will receive commercial processing

•  Farms with sales of $25,000 or less per year (<1% of all

produce commerce)

•  Qualified exemption and modified requirements (3-year

average)

Recordkeeping Required But Not Burdensome

•  The proposed rule would require certain records, to document that standards are being met –  Example: agricultural water testing results

•  Records already kept for other purposes need NOT be duplicated

Compliance Dates Staggered

•  Effective Date: 60 days after final rule is published •  Not covered: Farms with sales ≤$25,000/year

Compliance Dates

•  Very small farms -  Average annual value of food sold >$25,000 and ≤

$250,000 -  Four years after the effective date to comply -  For some water requirements, six years

Compliance Dates

•  Small farms -  Average annual value of food sold > $250,000 and ≤

$500,000 - Would have three years after the effective date to

comply - Would have five years for some water requirements

•  Other covered farms - Other covered businesses would have to comply two

years after the effective date - Would have four years for some water requirements

Provisions of the Proposed FSMA Rules Affecting Farmers

“significant changes will be needed in key provisions of the two proposed rules affecting small and large farmers. These provisions include water quality standards and testing, standards for using raw manure and compost, certain provisions affecting mixed-use facilities, and procedures for withdrawing the qualified exemption for certain farms” …… FDA, 2013

Resources

•  FDA presentations on FSMA rules •  FDA core presentation on FSMA •  FDA presentation of prevention controls •  www.fda.gov/fsma •  Updates on FSMA by FDA

Thank you