Farm Produce Safety Initiative
The Indiana State Department of Health (ISDH) Food Protection Program has a produce safety team available with a variety of resources to assist with managing food safety risks and to help produce growers comply with new federal regulations regarding the growing, harvesting, packing and transportation of fresh produce. The Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption rule was enacted in November of 2015 as part of the Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA). The rule establishes science-based minimum standards regarding the safe production and handling of produce on the farm, focusing on preventative measures to minimize contamination that could cause illness or death. Not all farms are subject to the rule. See the Produce Safety Rule Coverage and Exemptions flow chart to determine if your farm is exempt.
Produce Safety Rule Key Requirements shows an overview of the requirements of the Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption.
Questions can be directed to email@example.com or to the Farm Food Safety Consultant in your area.
Senate Enrolled Act 331 Information and Registration for Growers
Indiana Senate Enrolled Act (SEA) 331 was signed into law on March 15, 2018, with an effective date of July 1, 2018. This law allows ISDH to enter or inspect, at reasonable times, any produce farm that grows, harvests, packs, or holds covered produce as defined by 21 CFR 112 (FSMA Produce Safety Rule) that is intended for human consumption and is subject to 21 CFR 112.
Under SEA 331, produce farms must comply with the requirements in 21 CFR 112. If a produce farm has a qualified exemption under 21 CFR 112, the farm is only required to comply with the specific requirements outlined in 21 CFR 112. ISDH staff will begin on-farm inspections during the 2019 growing season for farms with more than 500,000 dollars in annual sales.
Produce farms that are covered under the FSMA Produce Safety Rule are required to register with the Indiana State Department of Health and send the it to the address at the top of the form.
Registration Application for Produce Farms
Produce Safety Rule Compliance Date Chart
Produce Safety Rule Compliance Dates
Agricultural Water (Subpart E)
Large farm (>$500K)
Small Farm ($250K - $500K)
Very Small Farm (>$25K - 250K)
Schedule an On-Farm Readiness Review Today
ISDH will partner with produce safety subject matter experts from Purdue University Extension and individuals from Indiana State Department of Agriculture to review your farm. This review will allow you to walk through your operation, step-by-step, and see what you are doing right, what you need to improve, and problem-solve with trained professionals about how to inexpensively change, if necessary, to meet the new food safety requirements. This is a confidential service, so what happens on the farm stays on the farm. Best of all, there is no cost to growers. To schedule your free review, please email ProduceSafety@isdh.in.gov
EDUCATE BEFORE AND WHILE WE REGULATE
Produce Safety Inspection starts July 2019
Under Indiana Senate Enrolled Act (SEA) 331, the Indiana State Department of Health will begin produce safety inspections in July 2019. This new produce inspection program is focused on promoting food safety and preventing foodborne illness linked to fresh generally eaten raw produce. Farms or operations that have sales over $500,000 are the focus of the 2019 inspection. During inspection, farms will be evaluated based on the Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) 21 CFR 112 Produce Safety Rule.
The “What to expect during an inspection” handout shows an overview of the inspection and contact information of the Food Safety Farm Consultant.
Growers who would like additional consultant prior to the inspection, we encourage you to schedule an On Farm Readiness Review during which staff from ISDH, Indiana State Department of Agriculture, and Purdue University Extension perform a 2- to 3- hour walking through of the operation and provide constructive feedback related to rule compliance. To schedule an OFRR, please email firstname.lastname@example.org.
Resources and Educational Information
Dropped Produce - English
Dropped Produce - Spanish
Safe Produce Indiana is a joint program of the Indiana State Department of Agriculture and Purdue University offering training on Good Agricultural Practices (GAPs), Sprout Safety Alliance Training, information and support regarding scientifically supportive farm safety practices, and more.
Indiana State Department of Agriculture (ISDA) is a partner of the Safe Produce and Produce Safety initiative and serves as the advocacy arm for farm operations.
Produce Safety Alliance Farm Resources on the Produce Safety Rule
Sprout Safety Alliance Resources on regulations for sprout growers
Frequently Asked Questions (FAQ)
The following frequently asked questions are intended to help growers and stakeholders better understand the U.S. Food Safety Modernization Act (FSMA), Produce Safety Rule (PSR) and Indiana’s approach to supporting safe produce.
Should you have additional questions, please feel free to call Vivien McCurdy at 317-233-3220.
Q. Who should register a produce farm with the State of Indiana?
A. Farms covered under the FSMA Produce Safety Rule shall register their farm. Anyone selling wholesale produce intended for raw consumption should register their farm with the Indiana State Department of Health.
Q. Why does ISDH ask produce farms to register?
A. ISDH asks produce farms to register because produce safety is important to your business and community, and enables more efficient communication. Benefits to registration include:
- Your ability to demonstrate to buyers that you are an “approved source” for food establishments.
- Receipt of timely information on produce safety regulations and services available to support growers and distributors.
- Public health professionals can alert farms of recalls, potential hazards, and ways to minimize risk to the farm and consumer.
- Access to Food Safety Farm Consultants who are available to growers and distributors to provide readiness assessments for compliance with the Food Safety Modernization Act, Produce Safety Rule.
Q. Is there a fee for registering a farm with the Indiana State Department of Health?
A. Indiana currently does not charge a fee to register
Q. How do produce farms register with the state?
A. Registration is easy and free. To access the Registration Form for Produce Farms visit: http://www.in.gov/isdh/25773.htm
Q. How often do I need to register?
A. With the passage of the Food Safety Modernization Act, Produce Safety Rule, covered farms and all farms selling wholesale, are asked to re-register using the updated form. Annual registration is not required. Re-registration is requested when changes occur as a result of federal or state requirements or when changes to ownership, character of business, or location of business take place.
Food Safety Modernization Act (FSMA)
Q. What is the Food Safety Modernization Act (FSMA)?
A. To improve food safety, the U.S. Food and Drug Administration’s Food Safety Modernization Act (FSMA) was signed into law in 2011.There are four pillars and seven rules of FSMA. Pillars include preventive controls, inspections and compliance, imported food safety, and response. The seven rules of FSMA are:
- Accredited Third-Party Certification Rule
- Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Rule
- Mitigation Strategies to Protect Food Against Intentional Adulteration Rule
- Preventive Controls for Animal Food Rule
- Preventive Controls for Human Food Rule
- Sanitary Transportation of Human and Animal Food Rule
- Standards for Produce Safety Rule
Produce Safety Rule
Q. What is the Produce Safety Rule?
A. Under the U.S. Food and Drug Administration’s Food Safety Modernization Act, the Produce Safety Rule establishes for the first time, scientifically defensible minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption.
Q. Is there guidance for Small Businesses under the Produce Safety Rule?
A. Yes. The U.S. Food & Drug Administration recently released guidance to assist small businesses with the Produce Safety Rule mandated by the Food Safety Modernization Act (FSMA). View or download the Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation - Small Entity Compliance Guide.
Q. What is “Rarely Consumed Raw” Produce”?
A. Produce that typically requires cooking, a kill-step, which helps to reduce microbial risk. The FDA has published an excellent fact sheet detailing rarely consumed raw produce. https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM576496.pdf
Q. What produce is covered by the Produce Safety Rule?
A. Fruits: Apples, apricots, apriums, Asian pears, avocados, babacos, bananas, blackberries, blueberries, boysenberries, cantaloupes, carambolas, chayote fruit, cherries (sweet), citrus (such as clementine, grapefruit, lemons, limes, mandarin, oranges, tangerines, tangors, and uniq fruit), currants, genip, gooseberries, grapes, guavas, honeydew, huckleberries, kiwifruit, kumquats, lychees, mangos, other melons (such as Canary, Crenshaw and Persian), mulberries, nectarines, papayas, passion fruit, peaches, pears, pineapples, plantains, plums, plumcots, quince, raspberries, strawberries, sweetsop, tomatoes, watermelons, and mixes of intact fruits (such as fruit baskets).
Fungus: Mushrooms (farmed not wild).
Herbs: Burdock, herbs (such as basil, chives, cilantro, oregano, and Parsley), and turmeric.
Nuts: Almonds, brazil nuts, chestnuts, macadamia nuts, pine nuts, and walnuts.
Vegetables: Artichokes-globe-type, Belgian endive, broad beans, broccoli, Brussels sprouts, cabbages, Chinese cabbages (Bok Choy, mustard, and Napa), carrots, cauliflower, celeriac, celery, chicory (roots and tops), cowpea beans, cress-garden, cucumbers, curly endive, dandelion leaves, fennel-Florence, garlic, green beans, Jerusalem artichokes, kale, kohlrabi, leek, lettuce, mustard greens, onions, parsnips, peas, peas-pigeon, peppers (such as bell and hot), radishes, rhubarb, rutabagas, scallions, shallots, snow peas, soursop, spinach, sprouts (such as alfalfa and mung bean), summer squash (such as patty pan, yellow and zucchini), Swiss chard, taro, turnips (roots and tops), watercress, yams; and mixes of intact vegetables.
Is Your Farm Covered by the Produce Safety Rule?
Q. How do I know if I am covered by the Produce Safety Rule?
A. To help determine if you are covered by the Produce Safety Rule, see FDA’s Produce Rule Coverage and Exemptions fact sheet.
Q. If a farm is exempt from the Food Safety Modernization Act, Produce Safety Rule, is registration still required?
A. If produce is grown, harvested, packed, held, or distributed wholesale (i.e., an operation that processes, manufactures or packages food for resale) then registration is encouraged, but not required.
Q. What types of consultation is available from ISDH to farmers?
A. ISDH is committed to supporting the farming community. Food Safety Farm Consultants provide resources to farmers on ways to reduce microbial risk on the farm, in the packaging and holding facility, and in transit. Preparing farmers for full implementation of the Produce Safety Rule is a primary objective. Consultants work with farmers to help better understand the requirements of the rule and educate owners and their farm teams on readiness. Their services are at no cost to farmers and range from brief telephone discussions to mock audits, and on-site farm consultations. Email ProduceSafety@isdh.IN.gov.
Q. What is an On-Farm Readiness Review?
A. This review will allow you to walk through your operation, step-by-step. ISDH staff along with subject matter experts from Purdue University Extension and the Indiana State Department of Agriculture will provide feedback and suggestions for improvement based on the regulations lined out in the Produce Safety Rule 21 CFR Part 112. This is a confidential service, so what happens on the farm stays on the farm. Best of all, there is no cost to growers.
*Funding for this statement, publication, press release, etc. was made possible, in part, by the Food and Drug Administration through grant PAR-16-137. The views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.*