More Freedom Attack, Food Safety Act

On February 4, 2009 Representative Rosa DeLauro (D-CT) introduced the Food Safety Modernization Act of 2009 (HR 875), a bill that would establish the Food Safety Administration (FSA) within the Department of Health and Human Services (DHHS). HR 875 represents a tremendous expansion of federal power, particularly the power to regulate intrastate commerce. While the proposed legislation tries to address the many problems of the industrial food system, the impact on small farms if the bill becomes law would be substantial and not for the better. HR 875 is a major threat to sustainable farming and the local food movement. [Click here for the text: PDF or MS Word or HTML]

The bill would transfer the functions and resources of several divisions within the Food and Drug Administration (FDA), such as the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine into FSA. The National Marine Fisheries Service in the Department of Commerce would be transferred over to FSA as well. [Section 102(b)]

Under HR 875 the FSA, among other responsibilities, is charged to regulate food safety and labeling [Section 2(1)(A)] and to “lead an integrated, system-wide approach to food safety and to make more effective and efficient use of resources to prevent foodborne illness” [Section 2(1)(C)]. Other purposes of the Act are to modernize and strengthen federal food safety law and “to establish that food establishments have responsibility to ensure that all stages of production, processing, and distribution of their products or products under their control satisfy the requirements” of federal food safety law[Section 2(3),(4)]. Under the bill, farms are designated as ‘food production facilities’ [Section 3(14)]. Farms are also subject to all laws in the Act applying to food establishments except that they do not have to register with the FSA as most other food establishments are required to do [Section 3(13)(b)]. A “food establishment”, according to the bill, means “a slaughterhouse (except those regulated under the Federal Meat Inspection Act or the Poultry Products Inspection Act), factory, warehouse, or facility owned or operated by a person located in any State that processes food or a facility that holds, stores, or transports food or food ingredients” [Section 3(13)(A)].

HR 875 charges the administrator of FSA with developing a national food safety program to protect the public health [Section 201(a)(1)]. In carrying out the program, the administrator must “adopt and implement a national system for regular unannounced inspection of food establishments” [Section 201(c)(2)]. With respect to ‘food production facilities’ (farms), FSA is given the power by the bill to visit and inspect them to determine that they are operating in compliance with the food safety law [Section 206(a)(1)]–under HR 875 ‘food safety law’ refers to provisions of the Federal Food, Drug and Cosmetics Act, provisions of the Public Health Services Act, and the Food Safety Modernization Act of 2009 itself [Section 3(15)]. In addition, the agency would have the power to have access to and copy all records maintained by farms in order to be able to (1) determine whether the food is contaminated, adulterated or otherwise not in compliance with the food safety law or (2) track the food in commerce [Sections 206(b)]. Under Section 210 of the bill which is entitled “Traceback Requirements”, FSA is charged with establishing a national traceability system that requires farmers to keep records that enable FSA to track “the history, use, and location of an item of food” [Section 210(c)]. Farmers selling direct to consumers would have to make their customer list available to federal inspectors. The bill orders FSA to be consistent with existing statutes and regulations that “require recordkeeping or labeling for identifying the origin or history of food or food animals.” Interestingly, the National Animal Identification System (NAIS) is mentioned as some of the existing laws that the administrator should review even though there actually is no federal statute or regulation in place that mandates any part of NAIS [Section 210(d)(1)]. HR 875 cites NAIS as being authorized by the Animal Health Protection Act (AHPA) even though there is no mention of it anywhere in the AHPA [Section 210(d)(2)].

The food traceability records are not the only written documentation farmers are to supply FSA under the terms of the bill. HR 875 mandates that FSA issue regulations that “require each food production facility to have a written food safety plan that describes the likely hazards and preventive controls implemented to address those hazards” [Section 206(c)(2)]. If such a regulation does in fact call for a HACCP plan (Hazard Analysis Critical Control Point, ’Hass-sepp’), farmers will be required to do the following in developing a plan for their farming operation:

1. Conduct a hazard analysis (e.g., list the pathogens that could be present in the farming operation); 2. Determine the critical control points (e.g., identify points in the operation where pathogens would most likely be present or could be introduced); 3. Establish critical limits; 4. Establish monitoring procedures; 5. Establish corrective actions; 6. Establish verification procedures; and 7. Establish record-keeping and documentation procedures.

FSA’s rulemaking authority includes extensive power to regulate farming practices as well. HR 875 requires the agency to issue regulations that establish ”minimum standards related to fertilizer use, nutrients, hygiene, packaging, temperature controls, animal encroachment, and water” with respect to “growing, harvesting, sorting, and storage operations” [Section 206(c)(3)]; and, “with respect to animals raised for food”, the regulations are to establish “minimum standards related to the animal’s health, feed, and environment which bear on the safety of food for human consumption” [Section 206(c)(4)].

All the requirements outlined above apply even if the farm is engaged in only intrastate commerce. Under the Federal Food, Drug and Cosmetics Act (FFDCA), FDA could only inspect farms that produce food for introduction into interstate commerce [21 USC 374]. Under HR 875, no nexus to interstate commerce is needed for a farm to be within FSA’s jurisdiction. The increased federal inspection power will have an impact particularly on those facilities slaughtering meat and poultry that are currently subject to minimal or no regulation by the United States Department of Agriculture (USDA).

HR 875 designates any facility slaughtering animals not subject to inspection under either the Federal Meat Inspection Act or the Poultry Products Inspection Act as a Category 1 food establishment [Section 3(5)–there are five categories of food establishments designated by the bill]. Such facilities are to be inspected on a daily basis and shall be subject to “antemortem, postmortem, and continuous inspection of each slaughter line during all operating hours” [Section 205(b)(1)]. Custom slaughterhouses and those farms processing poultry, officially and unofficially, under the federal exemption granted by Public Law 90-492 would now not be able to slaughter unless an FSA inspector is present. A common complaint among those using USDA-certified slaughterhouses is that there are not enough inspectors available to be present to oversee slaughtering in facilities under federal jurisdiction.

The federal government’s expanded power to regulate commerce under the bill would place the legality of the sale or other distribution of raw milk in intrastate commerce in jeopardy. FDA has long wanted a complete ban on the sale of raw milk. The agency’s mantra is that raw milk should not be consumed by anyone at any time for any reason. The agency does not consider this subject to be debatable and refuses to send representatives to any conference concerning the safety of raw milk when they know anyone with an opposing viewpoint will be present. At the 2005 National Conference on Interstate Milk Shipments (NCIMS), FDA supported a resolution calling for all States to prohibit the intrastate sale of raw milk. Under HR 875, FSA is given the statutory authority to unilaterally impose a ban.

Under HR 875, FSA has the power to adopt “preventative process controls to reduce adulteration of food” [Section 203]. Under Section 203, FSA is to issue regulations that “limit the presence and growth of contaminants in food prepared in a food establishment using the best reasonably available techniques and technologies” [Section 203(b)(1)(D)]. FDA has long made it clear that in its opinion the best available technology to limit contamination in milk is pasteurization.

In the event FSA does not issue a regulation establishing a ban, raw milk producers can expect regular, unannounced visits from inspectors. Under HR 875, farms processing raw milk are designated as Category 2 food establishments [Section 3(6)]. Category 2 food establishments are to be “randomly inspected at least weekly” [Section 205(b)(2)(B)]–those farms producing eggs not subject to the Federal Egg Products Inspection Act have also been designated Category 2 food establishments (at this time, many of these farms are subject to neither state nor federal regulation). The inspector paying a visit to the raw milk producer will have had training based on a curriculum developed by the Association of Food and Drug Officials (AFDO) [Section 305(b)]. AFDO’s position on raw milk is that all milk should be pasteurized.

FSA’s power to enforce the food safety law is considerable. The administrator can assess civil penalties of up to one million dollars for each violation [Section 405(a)(1)(A)]. Each day during which the violation continues is considered a separate offense [Section 405(a)(1)(B)]. The criminal sanctions are severe as well. If a violation with respect to an adulterated or misbranded food results in serious illness, the perpetrator can be imprisoned for up to five years [Section 401(b)(1)]; if the same results in death, the penalty can be up to ten years [Section 401(b)(2)]. In addition, the FSA has expanded authority to seize, detain and condemn food [Section 402(A)(1) & (C)(1)] . Under the FFDCA, FDA could only execute these powers pursuant to a court order [21 USC 334(a)].

There is every incentive for FSA to levy fines under the bill. HR 875 provides that fines collected by the agency shall be deposited in an account in the treasury [Section 405(e)(1)]. FSA “may use the funds in the account without further appropriation or fiscal year limitation . . . to carry out enforcement activities under the food safety law” [Section 405(e)(2)(A)]. The agency may also use the funds in the account “to provide assistance to States to inspect retail commercial food establishments or other food or firms under the jurisdiction of State food safety programs” [Section 405(e)(2)(B)]; this would give the States reason to support the bill despite the fact that it dilutes much of what is left of the their Tenth Amendment police power to regulate food.

A violation that could prove to be a substantial source of fines collected by the agency would be the manufacture, introduction, delivery for introduction, or receipt in interstate commerce of any food that is adulterated [Section 401(1)]. HR 875 has expanded the definition of “adulteration” in the FFDCA to include “bearing or containing a contaminant that causes illness or death among sensitive populations” [Section 3(3)(b)]. “Contaminant” is defined in the bill as “a bacterium, chemical, natural toxin or manufactured toxicant, virus, parasite, prion, physical hazard, or other human pathogen that when found on or in food can cause human illness, injury or death” [Section 3(10)]. What this means is that with this new definition of adulterated food, FSA will be lowering tolerance levels for contaminants that can be safely and lawfully present in food [Section 204(c)(1)(A)]. Many foods that would not be considered adulterated under current standards would be found to be adulterated under the definition contained in HR 875.

In New York State raw milk producers have been fined for food adulteration when milk samples tested positive for pathogens even though, in most cases if not all, there was no record of anyone becoming sick from the suspect milk. If the bill is passed into law, this experience will be repeated on a national basis.

Those selling strictly in intrastate commerce can still be potentially liable for food adulteration charges or for any other prohibited act in HR 875 relating to interstate commerce. The bill provides that “in any action to enforce the requirements of the food safety law, the connection with interstate commerce required for jurisdiction shall be presumed to exist” [Section 406]. In other words, the farmer will have the burden of proof in establishing that no sales were made in interstate commerce. What type of evidence would the farmer have to provide to show that none of the product sold ever crossed state lines? There are a number of prohibited acts contained in the bill that do not require the farmer to be doing business in interstate commerce for a violation to occur (e.g., refusing to allow inspection, refusing access to inspect or copy a record, failing to maintain a required record, etc.–[Section 401(4)-(6)]).

Passage of HR 875 into law will result in a much greater degree of federal control of food production and food regulation in the individual States as well as on a national level. The Feds would control to a much greater degree the inputs farmers can use [Section 206(c)(3) & (4)] as well as the products farmers can produce (raw milk). Unannounced federal inspections of small farms will be the order of the day, reducing the level of protection provided by the Fourth Amendment. There will be little left of the States’ police power to regulate food. HR 875 calls for the “integration of the inspection and compliance programs in food processing establishments” of the FSA, state and local agencies [Section 207(e)(3)(E)]. The federal government will be dictating the standards used in these programs to the States.

The burdensome requirements the bill imposes on small farms and the intrusive federal control it creates over small farm operations threaten the future viability of sustainable agriculture and the local food movement. HR 875 has been assigned to both the House Committee on Energy and Commerce and the House Committee on Agriculture. It needs to be stopped. Anyone who values freedom of food choice and the rights and independence of small farmers should contact their elected representatives and the members of the two committees to ask that they oppose HR 875. Updates on the status of this bill will be provided on this site.

If things don’t change it will be:

2010-50%-80% of small farms forced to sell to large corporations.

2012-90-95% of small farms wiped out

We have a very reasonable price in mind for our farms and would entertain any offer. Problem is, no-one is buying. The Mormon church was for a while but they shut down all their operations in our county and are leasing their farms.

There were 2 corporate farming concerns in our county a few years ago, the farms that they bought have lain fallow since they left because even though they are offering them at a very cheap price they ruined them by growing vegetable crops without rotating with grain crops.

The one corporate farming concern that moved in last year isn’t buying land, they are just leasing.

Heres the first line from the "purpose" section of the legislation.

(1) the safety of the food supply of the United States is vital to the public health, to public confidence in the food supply, and to the success of the food sector of the Nation’s economy;

We already have plenty of laws on the books regulating the cleanliness of factories, the criminalization of poisons/toxins in foods, etc. Maybe the gov't should try to do a better job of enforcing the laws already on the books before they make more.

FDR did something like this in ‘35 or so.

'Twas FDR's cowed Supreme Court, actually. In one of the first big cases to spring up after his "pack the courts" threat, the Supremes showed that they were now his little Chia pets. (They had shown some spine in a few decisions just before his threat.)

The court case was Wickhard v Filburn. It was a lovely way for FDR to announce the death of the Tenth Amendment without having to go to the press about it. Grr.

particularly the power to regulate intrastate commerce

Sorry, but that was declared a non-issue back in the 30's. According to the Supreme Court, the government can look at the aggregated effects of any intrastate production (like growing wheat for your own faarm's consumption), and note that it has interstate implications... and thus, the Feds can regulate it. Nice, isn't it?

Now, the silly little fact that ANYTHING, seen in the national aggregate, has interstate implications, should not trouble anyome. That "interstate commerce" clause is now just as powerful as the "general welfare" clause (which, by the way, had nothing to do with transfer payments to poor folk, when written)... and that Tenth Amendment might as well be written in invisible ink.

Thank you for contacting me about H.R. 875, the Food Safety Modernization Act of 2009. I appreciate hearing from you and I welcome the opportunity to respond.

It is my view that American consumers should be able to make informed decisions about the food they eat or provide for their families. As such, I support reasonable measures that will ensure consumer access to information, as well as a regulatory framework that adequately protects consumers. I also share you concern that the Food and Drug Administration (FDA) requires a major overhaul to modernize outdated and ineffective food inspection procedures. The particular bill you mentioned, H.R. 875, has been referred to the House Committee on Agriculture and the Committee on Energy and Commerce, a committee on which I am fortunate to serve. I will be sure to keep your views in mind should the Committee or the full House of Representatives have an opportunity to consider this or other relevant legislation in the future.

Again, I appreciate hearing from you. Please do not hesitate to contact me about other issues of concern to you in the future.

Sincerely,

John Sarbanes

Member of Congress

The reply. Since when is common sense and “reasonable” the key words on infringing upon ever piece of the Constitution.

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