Below are 3 examples to help you determine if your product is subject to the FDA Juice HACCP regulation (21 CFR 120). If you still have questions, then please reach out to the MDA Licensing Liaison to further assist you in this determination.
Example 1: Company A processes juice in a central kitchen and sells the juice to consumers from its own retail outlets. Is Company A's central kitchen considered a retail establishment? Are Company A's retail outlets considered retail establishments?
- Answer: Company A's central kitchen is not a retail establishment that is exempt from the regulation because it does not sell juice directly to consumers at that location. However, Company A's retail outlets are retail establishments under part 120, if they sell juice directly to consumers and do not sell juice to other business entities (i.e., retail outlets owned by another company).
Example 2: Company B processes juice in a central kitchen that sells juice directly to consumers from its central kitchen as well as supplying its retail outlets. Is the central kitchen a retail establishment? Are Company B's outlets retail establishments?
- Answer: Company B's central kitchen is a retail establishment under part 120, because it (1) sells juice directly to consumers and (2) does not sell juice to other business entities (i.e., it provides juice only to the retail establishments it owns). If the retail outlets owned by Company B sell juice directly to consumers, but not to other business entities, they are also retail establishments under part 120. FDA encourages central kitchens that are retail establishments under the rule to establish a HACCP system in the processing of juice.
Example 3: If Company C processes juice in a central kitchen that sells juice directly to consumers from its central kitchen and from its retail outlets, but also sells juice to other business entities, is the central kitchen a retail establishment?
- Answer: Even though Company C sells juice directly to consumers at its central kitchen, the central kitchen is not a retail establishment for purposes of part 120 because it sells juice to business entities that it does not own.
The Juice HACCP regulation applies to processors, repackers, or importers of juice sold at wholesale (sold or distributed to other business entities) including:
- 100% juice or juice concentrates (including persons using pasteurized or otherwise treated juice ingredients)
- Fruit or vegetable purees
- Non-Juice Beverage with a juice ingredient (e.g, lemonade using fresh squeezed lemon juice). NOTE: For beverages containing less than 100% juice, only the fresh juice ingredient is subject to HACCP principles
- Juice produced and sold within the same state as well as juice sold in interstate commerce
- Juice importers
The Juice HACCP regulation does NOT apply to:
- Juice produced at a retail establishment and sold exclusively and directly to consumers (e.g., stores, roadside stands, farmers markets, juice bars, etc.)
- Juice beverages (<100% juice) using only treated (i.e., pasteurized) juice ingredients which were produced under juice HACCP principles (e.g., juice beverage produced from a pasteurized concentrate or lemonade produced from pasteurized lemon juice)
- Fruit or vegetable by-products (e.g., citrus oil)
- Juice ingredient used in the production of a non-beverage food (e.g., fruit flavored candy)
- Beverages using whole fruits or vegetables without juice extraction (e.g., smoothies)
- Warehousing or storage of the juice only (without processing)
- Harvesting, picking, or transporting raw agricultural ingredients of juice products without otherwise engaging in processing
- Juice used solely as a starting material for a fermented alcoholic product (Ex. wine or hard cider) in which the juice becomes an alcoholic beverage and is no longer recognizable as juice at the time processing is complete
Juice is the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one of more fruits or vegetables, or any concentrates of such liquid or puree.
Juice concentrate means the aqueous liquid expressed or extracted from one or more fruits or vegetables and reduced in weight and volume through the removal of water from the juice.
- Processing - includes grinding, squeezing, extracting, expressing, pureeing or other actions to obtain the juice.
- Processor – means any person engaged in commercial, custom, or institutional processing of juice products, either domestic or foreign, including any person engaged in the processing of juice products that are intended for use in market or consumer tests.
- Retail Establishment – means an operation that provides juice directly to consumers and does not sell or distribute juice to other businesses. The term "provides" includes storing, preparing, packaging, serving, and selling juice.
Coconut is considered a fruit and any liquid extracted from coconut (i.e., water or milk from the meat) is considered a juice and is therefore subject to regulation.
- The regulation applies to any unfermented juice that is added to an alcoholic beverage (e.g., wine or cider) as an ingredient to adjust flavor or sweetness and retains and expresses its organoleptic (e.g., color, taste) and nutritional characteristics in the finished beverage (§120.1(a)). This would also apply to any non-alcoholic beverages (i.e., kombucha) for which the juice does not undergo full fermentation.
- The juice treatment (5-log pathogen reduction) must be applied directly to the juice, not to the fruit or vegetable (except for citrus juices).
- Juice subject to the juice HACCP regulation is NOT allowed to be sold without a 5-log pathogen reduction.
- Juice sold at retail (therefore exempt from the juice HACCP regulation) is allowed to be sold without a 5-log reduction but MUST be properly labeled with a statement conspicuously posted on the principal display panel and must read:
-
WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems.
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If a firm sells or distributes any amount of juice to other businesses, the Retail Food Establishment exemption no longer applies, and they would be considered a juice processor subject to Juice HACCP. All their juice products must be produced accordingly under Juice HACCP principles. This includes processing the juice to produce a minimum 5-log reduction in the pertinent microorganism.
Below are 3 examples to help you determine if your product is subject to the FDA Juice HACCP regulation (21 CFR 120). If you still have questions, then please reach out to the MDA Licensing Liaison to further assist you in this determination.
Example 1: Company A processes juice in a central kitchen and sells the juice to consumers from its own retail outlets. Is Company A's central kitchen considered a retail establishment? Are Company A's retail outlets considered retail establishments?
- Answer: Company A's central kitchen is not a retail establishment that is exempt from the regulation because it does not sell juice directly to consumers at that location. However, Company A's retail outlets are retail establishments under part 120, if they sell juice directly to consumers and do not sell juice to other business entities (i.e., retail outlets owned by another company).
Example 2: Company B processes juice in a central kitchen that sells juice directly to consumers from its central kitchen as well as supplying its retail outlets. Is the central kitchen a retail establishment? Are Company B's outlets retail establishments?
- Answer: Company B's central kitchen is a retail establishment under part 120, because it (1) sells juice directly to consumers and (2) does not sell juice to other business entities (i.e., it provides juice only to the retail establishments it owns). If the retail outlets owned by Company B sell juice directly to consumers, but not to other business entities, they are also retail establishments under part 120. FDA encourages central kitchens that are retail establishments under the rule to establish a HACCP system in the processing of juice.
Example 3: If Company C processes juice in a central kitchen that sells juice directly to consumers from its central kitchen and from its retail outlets, but also sells juice to other business entities, is the central kitchen a retail establishment?
- Answer: Even though Company C sells juice directly to consumers at its central kitchen, the central kitchen is not a retail establishment for purposes of part 120 because it sells juice to business entities that it does not own.
No, to be considered an organization a for-profit business must be incorporated (LCC, S-corp, C-corp, or Benefit corporation).
No, to be considered an organization a for-profit business must be incorporated (LCC, S-corp, C-corp, or Benefit corporation).
‘Hay ground’ would likely meet the definition of continuous living cover (since this is most often a perennial crop such as alfalfa, clover, and/or grass hay). However, establishing hayland by itself is not grant eligible; an applicant would need to demonstrate activities that “develop enterprises, supply chains, and markets for continuous living cover”, which is part of the grant criteria.
‘Hay ground’ would likely meet the definition of continuous living cover (since this is most often a perennial crop such as alfalfa, clover, and/or grass hay). However, establishing hayland by itself is not grant eligible; an applicant would need to demonstrate activities that “develop enterprises, supply chains, and markets for continuous living cover”, which is part of the grant criteria.
While this is a competitive grant process, there is not a minimum acreage requirement. The application focuses on the impact the grant will have on your business and how funds will accelerate growth in sales or market and or supply chain outlets for CLC agricultural products. We encourage all that are interested to apply.
While this is a competitive grant process, there is not a minimum acreage requirement. The application focuses on the impact the grant will have on your business and how funds will accelerate growth in sales or market and or supply chain outlets for CLC agricultural products. We encourage all that are interested to apply.
No, to be considered an organization a for-profit business must be incorporated (LCC, S-corp, C-corp, or Benefit corporation).
‘Hay ground’ would likely meet the definition of continuous living cover (since this is most often a perennial crop such as alfalfa, clover, and/or grass hay). However, establishing hayland by itself is not grant eligible; an applicant would need to demonstrate activities that “develop enterprises, supply chains, and markets for continuous living cover”, which is part of the grant criteria.
While this is a competitive grant process, there is not a minimum acreage requirement. The application focuses on the impact the grant will have on your business and how funds will accelerate growth in sales or market and or supply chain outlets for CLC agricultural products. We encourage all that are interested to apply.
Yes, staff time can be included but the funded position must meet the purposes and priority of the grant.
LCCMR funding supports this grant opportunity, so all expenses must follow the LCCMR guidelines and be approved by their staff. The guidance they have provided (below) includes salaried staff and payment for professional/technical services. Please review the Guidance on Allowable Expenses for the full details. The excerpt below was taken from this document.
Eligible Expenses (excerpt)
"Eligible expenses are those expenses solely incurred through project activities that are directly related to and necessary for producing the project outcomes described in the proposal. All proposed expenses must be specified in the proposal submitted. Please note that for non-state entities all funds are awarded on a reimbursement basis, unless otherwise authorized, and all eligible expenses will need to be documented. Eligible expenses may include:
a. Eligible expenditures incurred only after the effective date as approved by LCCMR.
b. Wages and expenses of salaried Recipient employees if specified, documented, and approved. For State Agencies: use of unclassified staff only OR request approval for the use of classified staff accompanied by an explanation of how the agency will backfill that part of the classified staff salary proposed to be paid for with these funds. This is subject to specific discussion and approval by LCCMR.
c. Fringe benefit expenses, such as FICA/Medicare, retirement, and health insurance of Recipient's employees, if specified.
d. Professional and technical services specified in the approved Work Plan that are rendered by individuals or organizations not a part of the Recipient;"
Yes, the LCCMR funding guidelines for royalties, copyrights, patents, and sale of products and assets are defined in MN Statute 116P.10 and they apply to our grant program. The MDA looked into it but were not able to pursue any changes to our statutory language this legislative session.
The review committee will be using the Project Evaluation Profile in the RFP to score each application. Awards will be made based on the scoring criteria. Projects will not be limited by crop. (The Project Evaluation Profile can be found on page 11 of the RFP.)
Yes, your organization can submit two applications for review but however we will limit funding to only one grant per organization. As stated on page 6 of the RFP: “Projects must be conducted by an organization in Minnesota and limited to one (1) grant per organization.”
If all expenses outlined in your proposal will incur after the contract has been signed by all parties, then you can answer “no”. The question is referring to only those expenses you are requesting to fund with the grant.
Grant funds are dispersed on a reimbursement basis. All grantee requests for reimbursement must correspond to the approved grant budget. To receive grant payments, grantees must provide proof that grant project work has been done by submitting details of each purchase on receipts or invoices, and proof that the vendors have been paid. Biannual progress reports are required to be submitted during the duration of the project. Grant payments shall not be made on grants with past due progress reports unless the MDA has given the grantee a written extension. (page 8-9 of RFP)
The goal of the grant is to develop enterprises, supply chains, and markets for continuous living cover crops and cropping systems in the early stage of commercial development. Some of this development will take time. Please focus your outcomes on the work included for this grant period, but you may include the outcomes and impacts that this project will have on the future.
Proposals will be scored using the Project Evaluation Profile listed on page 11 of the RFP. There is not a criteria for the length of time a farmer has been working with a crop, evaluations will be made using the criteria described in the RFP.
No, there are not parameters on the number of acres you can plant in any crop.
Grant funds are dispersed on a reimbursement basis. All grantee requests for reimbursement must correspond to the approved grant budget. To receive grant payments, grantees must provide proof that grant project work has been done by submitting details of each purchase on receipts or invoices, and proof that the vendors have been paid. Biannual progress reports are required to be submitted during the duration of the project. Grant payments shall not be made on grants with past due progress reports unless the MDA has given the grantee a written extension. (page 8-9 of RFP)
Yes, funds can be used to purchase crop seeds and stock. LCCMR funding supports this grant opportunity, so all expenses must follow the LCCMR guidelines and be approved by their staff. Please review the Guidance on Allowable Expenses for the full details. Additional information on royalties, copyrights, patents, and sale of products and assets are defined in MN Statute 116P.10
Yes, funds can be used to purchase equipment. LCCMR funding supports this grant opportunity, so all expenses must follow the LCCMR guidelines and be approved by their staff. Please review the Guidance on Allowable Expenses for the full details. Additional information on royalties, copyrights, patents, and sale of products and assets are defined in MN Statute 116P.10
No, proposals will be scored using the Project Evaluation Profile listed on page 11 of the RFP. There is not a requirement to be certified organic or to be in a Farm Service Agency program.
All expenses incurred for which the grantee will seek reimbursement, must be documented and record retained. Record keeping is most important during the time period of the grant (May 2023- May 2025). Follow-up surveys may be done to help us determine the long-term impacts of the grant. The MDA may request follow-up information from grantees beyond the term of the grant agreement.
No, water testing is not required as part of this grant.
