Logistics—bathrooms, beverages, snacks Agenda for the day Introductions

TIME TOPIC PRESENTER 1000-1030 am

Introductions, FSMA Ed, Nina, Betsy

1030-1200 pm

Wholesale Foods Jeff

1200-1230 pm

LUNCH, guests Provided on site

1230-100 pm

Outbreaks Dana

100-200 pm

Wholesale Foods Jeff

200-300 pm

Pools Erik

Ed Evanson, FCS Section supervisor, eevanson@mt.gov, 444-5309 Jeff Havens, Wholesale Foods, jhavens@mt.gov, 444-5302 Erik Leigh, Pools, eleigh@mt.gov, 444-5306 Nina Heinzinger, Training, nheinzinger@mt.gov, 444-0067 Betsy Miller, Dept. of Agriculture Food Safety Coordinator, bemiller@mt.gov, 444-0131 Dana Fejes, Communicable Disease Epidemiologist, dfejes@mt.gov, 444-3049 Other Staff:

Food Safety Modernization Act

Objectives Explain the purpose of FSMA Describe the rules and the affected entities Specify the different subparts of the regulations Identify the exemptions to certain regulations Discuss the effect on inspections

Explain the Produce Safety rule and its effects

Why is the law needed? Globalization

15 percent of U.S. food supply is now imported

Food processing more complex, greater quantity

More foods in marketplace

New hazards not previously seen

Shifting demographics

Growing population (about 30%) of individuals “at risk” for foodborne illness

Emphasis of the Updated Code 21 CFR Part 117*

Prevention

Inspections, Compliance, and Response

Import Safety

Enhanced Partnerships

*Applicable to firms that engage in interstate commerce, enforced by the FDA

The New Rules Human Foods Preventive Controls Animal Food Preventive Controls Produce Safety Foreign Supplier Verification Programs Third Party Certification—for foreign suppliers Sanitary Transportation Food Defense

Who is affected?

Wholesale Food Establishments Produce Growers (farms) Importers

Does not apply to:

Retail food operations

Must all food manufacturing plants follow all these rules?

Depends primarily on: Sales Number of employees

How are exemptions determined?

No—some are exempted from sections of the rules as qualified facilities

Very small business means, • Less than $1 million in sales and inventory (based on the previous 3

years) • Engaged in either or both interstate and intrastate commerce • Includes affiliates and subsidiaries Small business means, • a business (including any subsidiaries and affiliates) employing fewer

than 500 full-time equivalent employees with more than $1 million in sales

Definitions (21 CFR Part 117)

Definitions (21 CFR Part 117)

Qualified facility means: A very small business

OR: Limited annual monetary value of sales is defined as:

During the last 3 years, sales were less than $500,000;

AND Sales to "Qualified End Users" (in-state retailers, 275 miles or

less from the business) exceed sales to others

Modified Requirements for Qualified Facilities (Section 117.201)

Will submit FDA Form 3942a (by Dec., 2018)

Attests that it is a qualified facility Should maintain records from 2016 to support this

Exempt from subparts C and G (section 117.5)

part C=Hazard Analysis and Risk-Based Preventive Controls (Food Safety Plan)

part G=Supply Chain Program

A—General Provisions B—Current Good Manufacturing Practice C—Hazard Analysis and Risk-Based Preventive Controls D—Modified Requirements E—Withdrawal of a Qualified Facility Exemption F—Requirements Applying to Records That Must Be Established and Maintained G—Supply Chain Program

Subpart B—Good Manufacturing Practices (GMPs) All FDA registered facilities must comply with this subpart This is not a change Subpart C—Food Safety Plan (Preventive Controls) Firms that generate greater than $1 million per year outlines what must be included This is a change GMPs are currently under ARM 37.110.101(1)(8)/21 CFR 110 21 CFR 117 replaces 21 CFR 110; DPHHS plans to update ARM

Large businesses Small businesses NOT—very small businesses Must be prepared by a PCQI individual *PCQI= preventive controls qualified individual

• Very small businesses (less than $1 million)— maintain records that show that they are qualified facilities follow GMPs have until 2018 to document as qualified facility

• Small businesses (more than $1 million, less than 500 employees) have until Sept. 2017 to comply

• Large businesses (more than $1 million, more than 500 employees)

• Should be complying with FSMA (Sept. 2016)

No—FDA inspections will be updated Local inspections—follow the state rules, use the approved form

Flow Charts: http://sustainableagriculture.net/wp-content/uploads/2016/02/2016_2-FSMA-Final-Rule-Flowchart-V3.pdf FDA site on FSMA: https://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm Electronic CFR (code of Federal Regulations): https://www.ecfr.gov, go to Title 21, part 117

Betsy Miller, Dept. of Agriculture Food Safety Coordinator

The New Rules Human Foods Preventive Controls Animal Food Preventive Controls Produce Safety Foreign Supplier Verification Programs Third Party Certification—for foreign suppliers Sanitary Transportation Food Defense

Produce Rule What is it?

Establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables Focus on preventing microbial contamination (not chemical or physical)

Produce Rule What are the key requirements?

• Agricultural Water • Biological Soil Amendments • Animals • Worker Training and Health & Hygiene • Equipment, Tools, Buildings • Sprouts

Produce Rule Who is affected?

Not all farms must comply, some exemptions: • Annual produce sales <$25,000 • Produce destined for processing • Qualified Exempt- annual food sales

<$500,000 and majority are direct to consumer and sales are within Montana or 275 miles from farm

Produce Rule Will farms be inspected?

If a farm is covered, yes, there will be inspections • MT Dept. of Agriculture will most likely

do the inspections • Training will happen before regulation • Inspection details yet to be released by

FDA • Some of the largest farms inspected in

2018-2019

Produce Rule - FAQs My farm goes through a GAP audit, is that the same thing as FSMA?

No. Though similar, a Good Agricultural Practices (GAP) audit is not the same as the FSMA Produce Safety Rule. Passing an audit does not give you a pass from FSMA and vice versa. Buyers may still request GAP, even if your farm is exempt.

Produce Rule - FAQs Am I required to have a food safety plan for my farm?

No. The Produce Rule does not require a farm to have a food safety plan. However, it is suggested as a way to organize policies, procedures, and documentation

Produce Rule - FAQs What are the water testing requirements?

Covered farms will need to test agricultural water and create water quality profile. • Ground water: 4 initial samples over 1 year,

then once annually • Surface water: 20 initial samples over 2-4

years, then 5 times annually Only EPA method 1603 is accepted (membrane filtration)

Produce Rule - FAQs Where can I learn more?

Montana Dept. of Ag: www.foodsafety.mt.gov

FDA: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm

Produce Safety Alliance: https://producesafetyalliance.cornell.edu/

Produce Rule For additional questions or information:

Betsy Miller Produce Safety Coordinator MT Dept. of Agriculture 444-0131 bemiller@mt.gov