![Page 1: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/1.jpg)
Logistics—bathrooms, beverages, snacks Agenda for the day Introductions
![Page 2: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/2.jpg)
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
![Page 3: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/3.jpg)
Ed Evanson, FCS Section supervisor, [email protected], 444-5309 Jeff Havens, Wholesale Foods, [email protected], 444-5302 Erik Leigh, Pools, [email protected], 444-5306 Nina Heinzinger, Training, [email protected], 444-0067 Betsy Miller, Dept. of Agriculture Food Safety Coordinator, [email protected], 444-0131 Dana Fejes, Communicable Disease Epidemiologist, [email protected], 444-3049 Other Staff:
![Page 4: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/4.jpg)
Food Safety Modernization Act
![Page 5: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/5.jpg)
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
![Page 6: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/6.jpg)
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
![Page 7: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/7.jpg)
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
![Page 8: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/8.jpg)
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
![Page 9: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/9.jpg)
Who is affected?
Wholesale Food Establishments Produce Growers (farms) Importers
Does not apply to:
Retail food operations
![Page 10: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/10.jpg)
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
![Page 11: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/11.jpg)
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)
![Page 12: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/12.jpg)
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
![Page 13: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/13.jpg)
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
![Page 14: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/14.jpg)
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
![Page 15: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/15.jpg)
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
![Page 16: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/16.jpg)
Large businesses Small businesses NOT—very small businesses Must be prepared by a PCQI individual *PCQI= preventive controls qualified individual
![Page 17: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/17.jpg)
• 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)
![Page 18: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/18.jpg)
No—FDA inspections will be updated Local inspections—follow the state rules, use the approved form
![Page 19: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/19.jpg)
![Page 20: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/20.jpg)
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
![Page 21: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/21.jpg)
Betsy Miller, Dept. of Agriculture Food Safety Coordinator
![Page 22: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/22.jpg)
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
![Page 23: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/23.jpg)
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)
![Page 24: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/24.jpg)
Produce Rule What are the key requirements?
• Agricultural Water • Biological Soil Amendments • Animals • Worker Training and Health & Hygiene • Equipment, Tools, Buildings • Sprouts
![Page 25: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/25.jpg)
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
![Page 26: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/26.jpg)
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
![Page 27: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/27.jpg)
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.
![Page 28: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/28.jpg)
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
![Page 29: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/29.jpg)
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)
![Page 30: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/30.jpg)
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/
![Page 31: Logistics—bathrooms, beverages, snacks Agenda for the day ...dphhs.mt.gov/Portals/85/publichealth/documents/FCS... · Explain the Produce Safety rule and its effects ; ... FSMA](https://reader036.vdocuments.site/reader036/viewer/2022070913/5fb4e415c36941536c5393c4/html5/thumbnails/31.jpg)
Produce Rule For additional questions or information:
Betsy Miller Produce Safety Coordinator MT Dept. of Agriculture 444-0131 [email protected]