And another piece of legislation involving, surprise surprise, Waxman. Read the full text of H.R. 2749: Food Safety Enhancement Act of 2009.

The Farm-to-Consumer Legal Defense Fund has an extensive discussion here.

Here’s some highlights:

1. The FSEA would require facilities to register annually [section 101(b)(1)–p. 3], rather than a one-time registration. Registrants would also be required to pay an annual fee of $500, to be adjusted for inflation [section 101, Part6, sec 743(b)(1)(A)–p. 10].

2. The term “facility” does not include “farms” for purposes of registration in either the current law or under the bill [21 USC § 350d(b)(1)]. But what exactly is a “farm”? The FDA’s current regulations take a very narrow view of what qualifies as a farm.

3. The FSEA would also mandate that registrations be submitted in electronic format only [section 101(b)(1)(C)–p. 4]. Amish and Mennonite food producers having to register would thus be faced with a choice of violating either their religious faith or the law, while other food producers could face added expense and problems if they do not have the necessary technology. Failure to properly register would constitute misbranding and would be a violation of the law [section 101a–p. 3].

4. Under FSEA, the owner, operator or agent of a facility that must register must also undertake extensive paperwork requirements including the following: Conduct a hazard analysis (or more than one if appropriate); Identify, implement, and validate effective preventive controls; Monitor preventive controls; Institute corrective actions when monitoring shows that preventive controls have not been properly implemented or were ineffective; Conduct verification activities; Maintain records of monitoring, corrective action, and verification; and Reanalyze for hazards. [section 102(b), sec 418A(a)–p. 18] Failure to comply with any of these requirements would constitute adulteration under section 102(a) [p. 17]. These requirements apply even if a facility engages solely in intrastate commerce, such as a local baker selling at a farmers market.

5. Before a facility can ship any food in interstate commerce, a written food safety plan must be developed and implemented. The plan must include the hazard analysis and any reanalysis as well as a description of each of the following elements: preventive controls being implemented; procedure for monitoring preventive controls; procedures for taking corrective action; verification activities for the preventive controls, including validation, review of monitoring and corrective action records, and procedures for determining whether the preventive controls are effectively preventing, eliminating, or reducing to an acceptable level the occurrence of identified hazards or conditions; recordkeeping procedures; procedures for the recall of articles of food, whether voluntarily or when required; procedures for the trace back of articles of food, whether voluntarily or when required; procedures to ensure a safe and secure supply chain for the ingredients or components used in making the food manufactured, processed, packed, transported or held by such facility; and procedures to implement the science-based performance standards issued. [section 102, sec 418A (a)(2)–pp. 24-26] The requirements for the hazard analysis, preventive controls and the food safety plan will strain the time and resources of small producers, putting many of them out of business. As a result, consumers will lose local food sources and be forced to obtain more of the foods from the industrial system–the system responsible for the food safety problems in the first place.

6. On recordkeeping, FDA would now be empowered to go on a ‘fishing expedition’ and search records without any evidence whatsoever that there has been a violation. Even farmers selling direct to consumers would have to provide the federal government with records on where they buy supplies, how they raise their crops, and a list of customers. Refusing a records inspection would constitute adulteration [section 207(a)–p. 102].

7. All registered facilities will be subject to federal inspection even if they engage only in intrastate commerce. In contrast, under current law, inspection can be made only of a “factory, warehouse or establishment” of a firm engaged in interstate commerce [21 USC 374(a)(1)] Note that the massive recalls during the last several years have all involved facilities that shipped interstate.

8. On “growing standards,” the FDA is directed that any issued regulation “may include standards addressing manure use, water quality, employee hygiene, sanitation and animal control, and temperature controls, as the Secretary determines to be reasonably necessary.” [section 104(b), sec 419A(b)(3)–p. 32]

9. Like raw milk? Too bad: Aside from produce, the Secretary is charged with issuing “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” [section 103(b), sec 419–pp. 29-30]. Food that “has been manufactured, processed, packed, transported, or held under conditions that do not meet [these] standards” is considered as adulterated under the FSEA. FDA would have the power to make pasteurization of raw milk a performance standard.

10. The FSEA would give FDA considerable enforcement powers. Under current law, FDA can administratively detain food if there is “credible evidence or information indicating that such article [of food] presents a threat of serious adverse health consequences or death to human or animals” [21 USC 334(h)(1)(A)]. The FSEA would lower the standard for detention, permitting the government to detain food simply if there is “reason to believe that the article [of food] is adulterated, misbranded or otherwise in violation of this act” [section 132(a)–p. 82]. In other words, the agency could detain food based on a suspicion of a paperwork error.

11. The FSEA creates severe criminal and civil penalties. Under current law, anyone committing a violation of the FFDCA can be imprisoned for up to three years if the violation was committed “with the intent to defraud or mislead” [21USC 333(a)(2)]. Under the FSEA, anyone who “knowingly violates” certain prohibitions contained in the FFDCA, such as the prohibition against introducing adulterated or misbranded food into interstate commerce [21 USC 331(a)], can be imprisoned for up to ten years [section 134(a)(3)–p. 85]. Note that such actions as failing to register a facility or not conducting a hazard analysis constitutes “misbranding”. So, an Amish farmer who knowingly refuses to register his facility, or a local baker who knowingly failed to fill out the extensive required paperwork, could be thrown in jail.

The Legal Fund ends with this conclusion:

The FSEA gives the Food and Drug Administration tremendous power while making the agency less accountable for its actions. It fails to describe how the resources it provides are to be allocated. The industrial food system and food imports are badly in need of effective regulation, but the bill does nothing to prevent FDA from concentrating a disproportionate amount of its resources on local food producers.
The stated purpose of the FSEA is to “improve the safety of food in the global market.” It was disclosed at the June 3rd hearing that, out of the 378,000 food facilities that have registered with FDA, 220,000 of them are foreign facilities that export to the United States. Rep. Dingell commented that the percentage of our food coming from out of the country will increase in the future. This creates massive food insecurity in our country, yet the bill continues to push the federal government’s policy of food interdependence.

While information FDA obtains may be exempt from disclosure under the Freedom of Information Act [5 USC 52(a)], it may still be provided “to any foreign government agency; or any international organization established by law, treaty or other governmental action and having responsibility–to facilitate global or regional of harmonization of standards and requirements in an area of responsibility of the Food and Drug Administration; or to promote and coordinate public health efforts . . .” [section 112(b)(4)–p. 71].

Food security is achieved by becoming as self-sufficient as possible in food production. Lessening the regulatory burden on small farms and local artisanal producers will improve both food security and food safety. If the FSEA is implemented, many small producers will not have the economies of scale to be able to comply with its onerous requirements.

The Food Safety Enhancement Act needs to be defeated. Any food safety bill should target industrial food processors and imports while leaving the local food system alone. Readers need to contact their Representatives to urge them to oppose the bill. To contact legislators by zip code, use the finder tool at www.Congress.org or call the Capitol Switchboard at 202-224-3121.

Will the power grab never end?