FA-RM: June 2009

Q1: Does FDA have jurisdiction over INTRAstate commerce?

A1: As a federal agency, the FDA has jurisdiction over INTERstate commerce. For example, the prohibited acts regarding adulteration and misbranding in the current Federal Food, Drug and Cosmetic Act (FFDCA) all refer to INTERstate commerce. However, the existing law states that "in any action to enforce the requirements of [FFDCA] . . . the connection with INTERstate commerce required for jurisdiction in such action shall be presumed to exist." [1a] Combined with court decisions addressing the connection between INTRAstate and INTERstate commerce, it is unclear what kind of showing defendants would have to make to rebut the presumption and avoid federal regulation. The agency's regulatory power is limited to commerce, however, so non-commercial activities (such as growing your own vegetables for personal consumption) are not regulated.

Under current law, a business qualifying as a "food facility" must register with FDA, even if that business only engages in INTRAstate commerce. [1b] In addition, the agency can inspect the records of a business that engages solely in INTRAstate commerce if there is a "reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals." [1c]

[1a] 21 USC 379(a)
[1b] 21 USC 350(d)
[1c] 21 USC 350(c)

Q2: Would HR 2749 expand the FDA's regulation of INTRAstate commerce?

A2: Yes. Under HR 2749, FDA's regulatory control over INTRAstate commerce would grow considerably. The bill would allow for inspections of firms whose business is strictly within a State. [2a] It would impose, among other requirements, a mandate for all firms in the food business to comply with national performance standards for various foods set by the Department of Health and Human Services (HHS). [2b] It would also require most firms in the food business to establish a traceback system for their products, even if those products never cross State lines. [2c]

[2a] Section 105(a)-pp. 42-43
[2b] Section 103(b)-pp. 36-37
[2c] Section 107(c)-p. 54

Q3: I have a garden and sell produce at a road-side stand on my property. Would HR 2749 apply to me?

A3: Yes, you would now have to follow federally-established standards for growing produce. [3a] Produce not grown as required by these standards would be considered as adulterated under the Federal Food, Drug and Cosmetic Act (FFDCA). [3b] Further, you would be required to make your business records available to FDA inspectors. [3c] The inspectors would have the power to show up unannounced without a warrant to search your records without any evidence whatsoever that you have committed a violation of the law. If you refuse to let the inspector see your records, you would be guilty of adulteration under FFDCA. [3d]

[3a] Section 104(b)-pp. 38-41
[3b] Section 104(a)-p. 38
[3c] Section 106(a)-p. 48
[3d] Section 207(a)-pp. 119-120

Q4: I sell produce from my garden at a local farmers market, under HR 2749 would I have to register as a "food facility" with FDA?

A4: Farms are exempt from the registration requirement under current law. [4a] HR 2749 would not eliminate this exemption. "Farm" is narrowly defined under current regulations [4b]; so, it is possible that many farms that have not registered in the past, could be required to do so if FDA has more resources at its disposal to enforce registration.

For example, a farm that sells vegetables straight from the garden (i.e., no processing) would not be a "food facility". If FDA strictly interprets the definition of "farm", a farm that sells canned vegetables at the market would be a "food facility" because canning is considered "processing" under the law. [4c] Under federal regulation, a farm that processes food would not be considered a "farm" for purposes of the registration requirement unless ALL of the processed food is consumed ON the farm. [4d]

Under HR 2749, those who sell vegetables from the garden at farmers markets would be required to follow federal standards for growing produce [4e]; and their business records would be subject to random warrantless searches by FDA inspectors even if the agency has no evidence of any violation of the law. [4f-see Q3/A3 above]

[4a] 21 USC 350d
[4b] 21 CFR 1.227(3)
[4c] 21 CFR 1.227(6)
[4d] 21 CFR 1.227(3)
[4e] Section 104(b)-pp. 38-41
[4f] Section 106(a)-p. 48

Q5: I own a bakery and sell my goods at a local farmers market, how would HR 2749 apply to me?

A5: HR 2749 would apply to you in the following ways:
1 - Your bakery would qualify as a "food facility" and you would need to register with FDA each year [5a] and pay an annual fee ($500 in 2010 [5b], and increasing in future years as indexed for inflation [5c]).
2 - You would have to register in electronic format. [5d]
3 - You would be required to have a unique facility identifier number. [5e]
4 - You would be required to conduct an analysis identifying potential hazards at your food facility; and you must implement controls to prevent those hazards from occurring as well as a plan for what to do in the event that any do occur. [5f]
5 - If your products cross state lines, you must develop a FOOD SAFETY PLAN. [5g-also see Q6/A6 below]
6 - You would also be required to establish and maintain a system for tracing the food you produce. It is uncertain at this point what this traceability system will require, but the requirements are likely to be extensive.
[5h]

[5a] Section 101(b)-p. 6 [4b] Section 101(b)-p. 13
[5c] Section 101(c)-p. 14
[5d] Section 101(b)-p. 7
[5e] Section 206(a)-p. 118
[5f] Section 102(a)-p. 21
[5g] Section 102, sec 418A(a)-p. 28
[5h] Section 107(c)-p. 54-58

Q6: What will a FOOD SAFETY PLAN involve?

A6: Your FOOD SAFETY PLAN would have to include a hazard analysis that identifies potential hazards in your operation. The plan must also include descriptions of a variety of procedures you follow to prevent hazards from occurring and corrective actions to take if any does occur. In addition, you would need to describe your procedures for recordkeeping, conducting recalls, and traceback. Further, the plan must include how you ensure a "safe and secure food supply chain" for the items and ingredients you use as well as how you implement any science-based performance standards required by FDA. [6a]

[6a] Section 102, sec 418A(b)-pp. 29-30

Q7: I have read a summary of HR 2749 and am alarmed by the provision giving the Department of Health and Human Services (HHS) the power to quarantine any geographic area within the country. How broad is this power?

A7: Under HR 2749, the HHS Secretary would have the power to prohibit ALL MOVEMENT of ALL FOOD within a geographic area. No court order is needed to exercise this power. The Secretary only has to notify the appropriate official of the State(s) affected and issue a public announcement. [7a]

[7a] Section 133(b)-pp. 98-99

Q8: I am a raw milk consumer. Is it true that under HR 2749 would give FDA the power to institute a complete ban on the sale of raw milk?

A8: Yes, HR 2749 requires the HHS Secretary to issue "science-based performance standards . . . applicable to foods or food classes." The Secretary is to "identify the most significant foodborne contaminants and the most significant resulting hazards . . . and to minimize to an acceptable level, prevent or eliminate the occurrence of such hazards." [8a] FDA would have the power to make pasteurization of all raw milk a performance standard. Based on both its public statements and its record of taking enforcement actions against farmers, FDA is vehemently opposed to the consumption of raw milk and would like to ban its distribution.

Even if FDA does not issue a performance standard requiring pasteurization, the likelihood is that if HR 2749 passes into law, the agency will be increasing its enforcement actions against raw milk producers whose products cross state lines. FDA has indicated that raw milk is a priority item with the agency; with the passage of HR 2749, it would have much greater resources to go after raw milk than it did before. FDA could take enforcement action directly or through state agencies funded by FDA.

The way to stop this threat is to support HR 778, a bill that would, in effect, end the ban on raw milk for human consumption in interstate commerce. [8b] If you have not already done so, contact your Representative and Senators asking them to co-sponsor and/or vote for HR 778. You may send a message to them through the petition service by clicking on "Support HR 778 Now" at www.farmtoconsumer.org/petitions_new.htm

[8a] Section 103(b)-p. 37
[8b] 21 CFR 1240.61

Q9: I purchase products from an Amish producer who has said he would not register his facility because the electronic filing requirement violates his religious beliefs. What are the criminal and civil penalties he could be facing if he is charged with violating the law?

A9: Under HR 2749, failing to register a food facility would constitute "misbranding." [9a] If any of the "misbranded" products are introduced or "delivered for introduction into interstate commerce", the producer could be sentenced to up to ten years and be assessed criminal fines. [9b] Under HR 2749, anyone knowingly violating certain prohibitions contained in the FFDCA such as the prohibition against introducing adulterated or misbranded food in interstate commerce, could face these penalties.

In addition, the Amish producer could be facing substantial civil penalties. Under HR 2749, any individual who knowingly violates a provision of section 331 of FFDCA (prohibited acts) relating to food, can be fined up to $100,000; a corporation can be fined up to $7.5 million. [9c]

[9a] Section 101(a)-p. 6
[9b] Section 134-p. 100
[9c] Section 135(a)-p. 101

Q10: I'm a farmer who sells products direct to consumers. I want to protect the privacy of those who purchase from me and do not want to turn over to FDA any customer information I have in my records. What are the potential penalties if I refuse?

A10: Under HR 2749, FDA would have access to all records relating to the food producer's distribution of products. Failing to provide records to FDA would constitute adulteration. [10a] The criminal penalty for refusing access to records would be up to ten years imprisonment. [10b] The civil fines could be up to $100,000 for an individual and $7.5 million for a corporation. [10c]

[10a] Section 207(a)-pp. 119-120
[10b] Section 134-p. 100
[10c] Section 135(a)-p. 101

More HR 2749 information is posted through links at