Frequently Asked Questions (FAQs)
Below are responses to some of the commonly received questions about the Food Safety Modernization Act and the Produce Safety Rule. If you have questions beyond the scope of this list, or would like further explanation, please contact Department of Agriculture Hawaii Produce Safety Program Principal Investigator, Dr. Leo Obaldo at Leonard.G.Obaldo@hawaii.gov or at (808) 832-0705.
– How do I know if the Produce Safety Rule applies to me?
– My farm is going to be fully covered, when do I need to comply?
– HELP! People are calling and emailing me saying they are from the FDA and are coming to inspect my farm! How do I know this is real?
– A third-party already does GAP audits on my farm, is that enough to comply?
– Am I required to have a food safety plan?
– I’ve heard that the water testing requirements are changing. What do I need to know?
– I am a hydroponic/aquaponic/aeroponic leafy green operations. How am I viewed?
– My farm just flooded. Can I still harvest the covered produce that was in that field?
– I’ve gotten sick due to a microorganism of public health concern (E. Coli, Listeria, Salmonella) from eating imported foods or covered produce or I have observed concerning or unsanitary conditions concerning covered produce. Who do I call?
– As someone who eats produce, how will this affect me?
How do I know if the Produce Safety Rule applies to me?
If you are a farm that grows, harvests, packs or holds produce* and makes on average more than $25,000/year in produce sales for 3 years, you may be covered by this rule.
Not covered farms include: (only one need apply)
– Making less than on average $25,000/year on produce sales for 3 years (microfarm)
– ALL covered produce is grown for personal or on farm consumption (no sales)
– ALL produce is rarely consumed raw**
Covered farms that have an exemption include (only one need apply):
– All covered produce receives commercial processing that adequately reduces pathogens (Commercial Processing Exempt)
– Making less than $500,000/year on food sales AND more than 50% of food (by value) sold to qualified end-users***. (Qualified Exempt)
If your farm does not apply to either category, you are covered under this rule.
As a reminder, even exempt farms still have some regulations they must follow.
*produce – means any fruit or vegetable (including mixes of intact fruits and vegetables) and includes mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts, and herbs. A fruit is the edible reproductive body of a seed plant or tree nut (such as apple, orange, and almond) such that fruit means the harvestable or harvested part of a plant developed from a flower. A vegetable is the edible part of an herbaceous plant (such as cabbage or potato) or fleshy fruiting body of a fungus (such as white button or shiitake) grown for an edible part such that vegetable means the harvestable or harvested part of any plant or fungus whose fruit, fleshy fruiting bodies, seeds, roots, tubers, bulbs, stems, leaves, or flower parts are used as food and includes mushrooms, sprouts, and herbs (such as basil or cilantro). Produce does not include food grains meaning the small, hard fruits or seeds of arable crops, or the crops bearing these fruits or seeds, that are primarily grown and processed for use as meal, flour, baked goods, cereals and oils rather than for direct consumption as small, hard fruits or seeds (including cereal grains, pseudo cereals, oilseeds and other plants used in the same fashion). Examples of food grains include barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds (e.g., cotton seed, flax seed, rapeseed, soybean, and sunflower seed).
**Rarely consumed raw – fruits and vegetables that are almost always cooked before being consumed. Produce on the following exhaustive list: Asparagus; beans, black; beans, great Northern; beans, kidney; beans, lima; beans, navy; beans, pinto; beets, garden (roots and tops); beets, sugar; cashews; cherries, sour; chickpeas; cocoa beans; coffee beans; collards; corn, sweet; cranberries; dates; dill (seeds and weed); eggplants; figs; ginger; hazelnuts; horseradish; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; squash, winter; sweet potatoes; and water chestnuts
***Qualified End-User – A qualified end-user means either the
1) person eating the food (via farmers market, on-farm store or similar establishment) or
2) a restaurant or
3) a retail food establishment (grocery store, convenience store or similar establishment) in the State of Hawaii.
Note: Selling to a broker (middleman) who sells the produce to a supermarket does not count as a qualified-end user.
My farm is going to be fully covered, when do I need to comply?
Compliance dates are staggered based on the average annual produce sales.
- Farms with more than $500,000 of average annual produce sales will be fully covered by the rule and will need to comply by Jan. 26, 2018.
- Farms with more than $250,000 but less than $500,000 of average annual produce sales will need to comply by Jan. 28, 2019.
- Farms with more than $25,000 but less than $250,000 of average annual produce sales will need to comply by Jan. 27, 2020.
An additional 2 years should be factored in for water testing requirements, unless you are a sprout grower.
HELP! People are calling and emailing me saying they are from the FDA and are coming to inspect my farm! How do I know this is real?
FDA is sending inspectors from the mainland to conduct inspections on all covered non-exempt farms to ensure compliance with the rule. HDOA does not currently have any regulatory powers and thus is only educational at this point in time. We hope to change that in the upcoming years to allow locals to inspect locals and be an in-state partner with farms to improve produce safety. We understand that most farmers are struggling in the current economic conditions and that many of you care about your customers and want to provide healthy, safe and fresh produce to feed local families. Thank you for working with us to decrease Hawaii’s dependency on mainland grown produce and increase our own food security here in the islands. In addition, emails from official FDA personnel will end with @fda.hhs.gov.
A third-party already does GAP audits on my farm, is that enough to comply?
Currently, a USDA GAP or Primuslabs audit is not sufficient to comply with the FSMA Produce Safety Rule. However, being GAP certified or having a farm food safety plan will make it easier for you to meet the requirements. Depending on the program you use, you may find that your audit requirements are higher than the FSMA Produce Safety Rule requirements. Contact the Hawaii Department of Agriculture if you have more questions. A USDA Voluntary Audit is NOT a substitute nor a replacement of an FDA or HDOA Mandatory Produce Safety Rule Inspection.
Am I required to have a food safety plan?
No, you are not required to have an on-farm food safety plan under the FSMA Produce Safety Rule. However, having a plan is an excellent way to organize and manage your safety policies and procedures. Additionally, if you are exempt from the rule, have a food safety plan to show your buyers can demonstrate your commitment to safe produce. Multiple online resources exist to help you create a plan. Find templates and guides by visiting Cornell University’s Produce Safety Alliance or University of Hawaii’s College of Tropical Agriculture and Human Resources.
I’ve heard that the water testing requirements are changing. What do I need to know?
The FDA is exploring ways to simplify the microbial quality and testing requirements for Production (Growing) water. Until further guidance is released, it is recommended that covered farms use the testing standards currently listed in the Produce Safety Rule. For Production/Growing Water, that means testing standard results of less than the geometric mean value of 126 CFU of generic E.coli AND statistical threshold value of less than 410 CFU of generic E.coli. The Post Harvest Water Rules (Harvesting, Packing and Holding activities) are already in effect and will be enforced. For example, there should be NO detectable E. coli in harvesting, packing or holding water.
I am a hydroponic/aquaponic/aeroponic leafy green operations. How am I viewed?
You are viewed as a regular dirt farmer and regulated as such, with special care given to the subpart E (Water) rules due to the amount of water in your operation that may contact the harvestable portion of your crop.
In terms of microgreens vs sprouts:
Historically, the primary criterion we have used to distinguish between the two product categories has been the growth stage of the leaves. Sprouts are usually harvested when the cotyledons (or seed leaves) are still un- or under-developed and true leaves have not begun to emerge. In contrast, microgreens reach a later stage of growth, typically associated with the emergence of “true” leaves. Microgreens are also typically grown in soil or substrate and harvested above the soil or substrate line. Because microgreens are not sprouts, they are not subject to the requirements in subpart M sprouts. However, microgreens are considered covered produce for the purposes of the Produce Safety Rule and, unless exempt or excluded the provisions in subpart A, microgreens and microgreen farms are subject to all other subparts of the Produce Safety Rule (Industry guidance for compliance with and recommendations for implementation of the standards for the growing, harvesting, packing and holding of produce for human consumption).
My Farm just flooded. Can I still harvest the covered produce that was in that field?
Unfortunately, the likely answer is not for human food. Flood water (the flowing or overflowing of a field with water outside a grower’s control) that has touched the harvestable portion of a covered crop or has likely touched the harvestable portion runs a high risk of being contaminated with microorganisms of public health concern or other chemical concerns and thus should not be harvested as the produce is considered adulterated unless testing can show otherwise. This affects most plants that grow directly on or close to the soil, including lettuce, carrots and onions. Orchards of apples and oranges may still be harvestable, but this depends on the severity of the flood and is evaluated on a case by case basis. Contaminated crops must be tested for mold, bacteria, chemicals and heavy metals before being considered for animal food. Pooled water (excess rain water that resulted directly from rain and did not flow from outside of a farmer’s control) should be evaluated but does generally not contaminate the produce. After a flood (unintentional application of flood water and contents of flood water), Organic Certification does not need to undergo the 3 year soil remediation before first certified organic harvest unless prohibited substances are showed to be retained and remaining in the soil and can be found on final marketable produce. Questions for organic certification should be directed to your local USDA contact. Here are some resources that may guide you.
For the General Public:
I’ve gotten sick due to a microorganism of public health concern (E. Coli, Listeria, Salmonella) from eating imported foods or covered produce or I have observed concerning or unsanitary conditions concerning covered produce. Who do I call?
While the Hawaii Produce Safety Program can publish informational communications and other material explaining concerns of public interest (as they relate to produce safety) on our website, the Program is not the defining authority nor does it have any state or federal empowerment to do inspections or enforcement of any kind in any capacity and thus cannot respond to any covered produce related illness outbreaks with any meaningful action. The Program may learn about various outbreaks through our associated state partners at the Hawaii Department of Health, Hawaii Department of Agriculture, and our federal counterparts at the FDA and CDC, and look to them for guidance and information.
Here is a potentially helpful directory:
FDA Consumer Complaint Hawaii Resident Post Officer (808-522-8011 X1104)
– Sick from imported or foreign food or want to report a farm produce safety concern.
Hawaii Department of Health Disease Outbreak Control Division (808-586-4586)
– To report a food related illness
Hawaii Department of Health Food and Drug Branch (808-586-5947)
– Sick from or questions concerning a recall, packaged food/drink, cosmetics, drugs, medical devices, or related consumer products.
Food Safety Branch (808-586-8000)
– To make a food related complaint about an restaurant/establishment
Hawaii Department of Agriculture Pesticides Branch (808-973-9402)
– Questions concerning pesticide usage.
Hawaii Poison Center (1-800-222-1222)
– Sick from pesticides
Hawaii Department of Agriculture Commodities Branch (808-832-0700)
– Agricultural theft and dealer licensing, seafood inspection, fresh fruit and vegetable inspection, feed inspection, seed inspection, cacao/chocolate inspection, coffee certification, Food safety certification via USDA/Primuslabs audits, egg grading
As someone who eats produce, how will this affect me?
As a consumer, you should still take measures to reduce microbial contamination on fruits and vegetables at home. Steps include:
- Wash your hands, utensils and surfaces with soap and water before preparing fresh produce.
- Wash fruits and vegetables with clean water before eating or cutting.
- Avoid cross-contaminating produce with raw meat, poultry or seafood products.
- Refrigerate perishable fruits and veggies at 40 degrees or below.
- Do not leave cooked produce out of refrigeration for more than two hours.