Friday, June 19, 2009

HR 2749 - The Food Safety Enhancement Act of 2009

Sign the Oppose HR 2749 petition!

Update 6/18/09: On June 17, the Waxman amendment to HR 2749 was voted out of the House Commerce and Energy Committee and is headed to the House floor for consideration. It may be amended again before the House votes on HR 2749. See Talking Points for changes to the "Alarming Provisions".

On May 26, leading members of the House Energy and Commerce Committee released a discussion draft of the Food Safety Enhancement Act of 2009 (FSEA). Committee members supporting FSEA include Chair Henry Waxman (D-CA), Chair Emeritus John Dingell (D-MI), Frank Pallone (D-NJ, Chair of the Health Subcommittee), and Bart Stupak (D-MI, Chair of the Oversight and Investigation Subcommittee).

Even before the FSEA was formally introduced, the Health Subcommittee held a hearing on the discussion draft on June 3. (Six other food safety bills have been introduced, but none have gotten a hearing yet.) The discussion draft, with some changes, was introduced as HR 2749 on June 8 by Rep. Dingell. Rep. Pallone introduced an amendment “in the nature of a substitute to HR 2749″ on June 10. This version of HR 2749 has been voted out of the Health Subcommittee and is now headed to the full Energy and Commerce Committee for mark-up on June 17. The bill is on the fast track.

Passage of the FSEA into law would amend the Federal Food, Drug and Cosmetic Act (FFDCA). The bill proposes a substantial increase in power and resources for the Food and Drug Administration (FDA) and would significantly diminish existing judicial restraints on actions taken by the agency. Although the bill includes some provisions that could improve the mainstream food system, many of these are vaguely worded and do not clearly define the scope of the agency’s power, creating the potential for inappropriate application and enforcement. Small farms and local artisanal producers are part of the solution to the food safety problem in this country; the bill would impose on them a one-size-fits-all regulatory scheme and would disproportionately impact their operations for the worse. A detailed analysis of some of the key provisions is below [the citations are to the relevant section and page number of the June 10 version of the bill].

The Farm-to-Consumer Legal Defense Fund is opposed to HR 2749 because it would adversely impact small farms and food producers, without providing significant reforms in the industrial food system. HR 2749 does not address the underlying causes of food safety problems, including industrial agriculture practices and the consolidation of our food supply.

I. REGISTRATION REQUIREMENTS

Under current law, all “food facilities” are required to register with the Secretary of the Department of Health and Human Services (HHS) [21 USC § 350d]. The registration requirement is for one time only and no fee is charged. The FSEA would amend the current law to add significant requirements.

A. ANNUAL REGISTRATION FEE

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].

B. LIMITED EXCLUSION FROM REGISTRATION FOR FARMS

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:

“…a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves of, and cooling produce are considered part of harvesting. The term “farm” includes:

“(i) Facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership; and

“(ii) Facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.” [21 CFR § 1.227(3)] (emphasis added)

“Manufacturing/processing” is defined as “making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging.” [21 CFR § 1.227(6)] In other words, any farm that makes jam, cans vegetables, or packages cut fruit would not be considered a “farm” under the regulation unless the food is consumed only on the farm!

In a subsequent guidance document, FDA expanded the definition of “farm”: “The term ‘farm’ also includes facilities that manufacture/process, pack, or hold food, provided that all food used in those activities is grown, raised, or consumed on that farm or another farm under the same ownership.” (emphasis added). Under the guidance document, a “farm” can process food if the raw ingredients are grown or raised on that farm. In other words, a farmer could make lacto-fermented foods from his own produce; but a farmer who obtains produce from a neighbor to make such foods (unless consumed there) would no longer be considered a “farm” and would be subject to FDA registration.

Even under the guidance document, many small farms and artisanal producers could be required to register. FDA has not enforced this requirement strictly so far, but that is no guarantee about future actions by the agency. And if the agency were to revoke the guidance document and enforce the registration requirement in accordance with the definition of “farm” contained in the regulations, many farms would be required to register and, under the FSEA, pay an annual fee.

B. ELECTRONIC REGISTRATION

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].

C. UNIQUE FACILITY IDENTIFIER

All food facilities required to register would also be required to have a “unique facility identifier” [section 101(b)(2)(G)–p. 6]. “The Secretary may, by guidance, specify the unique numerical identifier system to be used . . . .” [section 206, sec. 911 (c)–p. 101]

II. QUALITY CONTROL FOR REGISTRANTS

A. HAZARD ANALYSIS & PREVENTIVE CONTROLS

Under FSEA, the owner, operator or agent of a facility that must register must also undertake extensive paperwork requirements including the following:

1. Conduct a hazard analysis (or more than one if appropriate);

2. Identify, implement, and validate effective preventive controls;

3. Monitor preventive controls;

4. Institute corrective actions when monitoring shows that preventive controls have not been properly implemented or were ineffective;

5. Conduct verification activities;

6. Maintain records of monitoring, corrective action, and verification; and

7. 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.

B. FOOD SAFETY PLANS

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:

1. preventive controls being implemented;
2. procedure for monitoring preventive controls;
3. procedures for taking corrective action;
4. 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;
5. recordkeeping procedures;
6. procedures for the recall of articles of food, whether voluntarily or when required;
7. procedures for the trace back of articles of food, whether voluntarily or when required;
8. 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
9. 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.

C. RISK-BASED INSPECTIONS

Finally, 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.

The FSEA charges the Secretary with implementing an inspection schedule with the frequency of inspections dependent on the “risk presented by the facility”. Under the FSEA, “any facility that manufactures or processes raw products of animal origin” would be a high-risk facility and could be subject to inspections as frequently as every six months [section 105(a)–p. 36]. Refusing an inspection would constitute adulteration under the FSEA [section 207(a)–p. 101].

III. RECORDKEEPING AND TRACEABILITY REQUIREMENTS

Beyond registration, farms would not be exempt from several onerous requirements under the FSEA.

A. RECORDKEEPING

Under the FSEA, all food producers would have to make their records available to FDA inspectors. Under current law, FDA can examine the records of those in the food business (excluding farms and restaurants) 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” [21 USC 350c(a)]. Under the FSEA, all those in the food business, including farms, must turn over to FDA inspectors all records “bearing on whether the food is adulterated, misbranded or otherwise in violation of this Act . . .” [section 106(a)–p. 39]. This requirement “applies to all records relating to the production, manufacture, processing, packing, transporting, distribution, receipt, holding of [food]” that is maintained “in any format and at any location.” [section 106(a)–pp. 39-40]

In other words, 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].

B. TRACEABILITY

The FSEA charges the HHS Secretary with establishing a tracing system for food:

Such regulations shall require each person who produces, manufactures, processes, packs, transports, or holds such food–

* to maintain the full pedigree of the origin and previous distribution history of the food;
* to link that history with the subsequent distribution history of the food;
* to establish and maintain a system for tracing the food that is interoperable with the systems established and maintained by other such persons; and
* to use a unique identifier for each facility for such person for such purpose. [section 107(c)(2)(A)(i)–pp. 43-44]

The tracing system must enable the Secretary to “identify each person who grows, produces, manufactures, processes, packs, transports, holds, or sells such food in as short a timeframe as practicable but no longer than 2 business days.” In issuing related regulations, the Secretary may include:

“(A) the establishment and maintenance of lot numbers;

“(B) a standardized format for pedigree information; and

“(C) the use of a common nomenclature for food.” [section 107(c)(3)–p. 45]

“Pedigree” is not used in reference to food anywhere in the United States Code (USC) or the Code of Federal Regulations (CFR) nor is it referenced as such in any dictionary. FDA is being given power to invent a new meaning for this word. How far will the traceback extend to determine the full pedigree? Will it go back to the animal or harvested crop (or even seed) from which the food is produced? How will traceback be done on multi-ingredient foods? Will part of determining the full pedigree require tracing the inputs used in food? How large a database will be needed to store this information? What will the cost of it be? How many people will FDA have to hire in order to enforce traceability?

There is an exemption from the traceability requirements for direct-marketed food, “if such food is–

“(i) produced on a farm; and

“(ii) sold by the owner, operator, or agent in charge of such farm directly to a consumer or to a restaurant or grocery store.” [section 107(c)(4)(A)–p. 46].

For example, vegetables grown on a farm and sold at a farmers market would be exempt. But if that same farmer brought peaches from a neighbor’s farm to sell at the market, the peaches would not be exempt.

IV. GROWING STANDARDS

The FSEA will also directly impact produce farmers by authorizing FDA to tell them how they can grow their crops. The bill would require the HHS Secretary to establish by regulation “science-based standards for the safe growing, harvesting, packing, sorting, transporting, and holding of raw agricultural commodities that–(1) are from a plant or a fungus; and (2) for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death to human or animals.” [section 104(b), sec 419A(a)–p. 31]

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]

In issuing the regulation, the Secretary “shall take into consideration, consistent with ensuring enforceable public health protection, the impact on small-scale and diversified farms, and on wildlife habitat, conservation practices, watershed-protection efforts, and organic production methods” [section 104(b), sec 419A(b)(7)–pp. 32-33]

Based on the FDA’s track record with “good agricultural practices”, the agency is unlikely to adequately address the differences between industrial operations and sustainable farms. The danger is that FDA will adopt regulations that treat small farms growing a diversity of crops organically (whether certified or not) the same as a facility growing thousands of acres of a single crop conventionally. The regulations could be expensive and burdensome, or simply not feasible, for small farms. Any produce that does not meet the established safety standards would be considered adulterated under the FSEA [section 104(a)–p. 30].

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 and irradiation of meat performance standards.

V. ENFORCEMENT POWERS

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.

A. RECALL POWER

The FSEA would not only expand the ability of FDA to detain food but would also significantly increase the agency’s recall powers. The agency already has the power to request a voluntary recall [21 CFR 7.45(a)], administratively detain food [21 USC 334(h)(1)(A)], or file for a court order to seize food [21 USC 334(a)(1)] or prohibit the food from being distributed[21 USC 332(a)].

Under the FSEA, the powers of the HHS Secretary would be expanded.

The HHS Secretary may request a voluntary recall if there is “reason to believe [the food] is adulterated, misbranded or otherwise in violation of [the FFDCA]” [section 111(b), sec 420(b)–p. 61].

Under the FSEA, the Secretary also would have the power to order the distribution of food to cease if there is “reason to believe that the use or consumption of, or exposure to, an article of food may cause adverse health consequences to humans or animals . . . ” [section 111(b), sec 420(c)–p. 62].

The firm affected would have 24 hours to appeal the order and request an informal hearing [section 111(b), sec 420(d)–pp. 62-63]; after providing an opportunity for a hearing, the Secretary could either vacate the order or amend the order to require a recall of the food [section 111(b), sec 420(e)–p. 63].

If there is a reasonable belief that a food subject to an order to cease distribution “presents a threat of serious adverse health consequences to humans or animals”, the Secretary may issue an emergency recall order without having to conduct a hearing beforehand [section 111(b), sec 420(f)–pp. 64-65].

Although consumer groups have urged that FDA be granted mandatory recall authority, the “reasonable belief” standard provides too much latitude to the agency and is open to abuse, particularly absent prior judicial review.

B. POWER TO QUARANTINE

Finally, the bill would give FDA the power to order a quarantine of a geographic location. The FSEA provides:

“If the Secretary determines that there is credible evidence or information that an article of food presents a threat of serious adverse health consequences or death to humans or animals, the Secretary may quarantine any geographic area within the United States where the Secretary reasonably believes such food is located or from which such food originated. The authority to quarantine includes prohibiting or restricting the movement of food or of any vehicle being used or that has been used to transport or hold such food within the geographic area” [section 133(b)(1)–pp. 83-84].

In other words, the agency can halt the movement of all food in a geographic area. Farmers markets and local food sources could be shut down, even if they are not the source of the dangerous contamination. The agency could take this drastic action without any court order. The only requirements are that the HHS Secretary “notify an appropriate official of the State affected” and issue a public announcement [section 133(b)(2)–p. 84].

C. CRIMINAL & CIVIL PENALTIES

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 bill also provides fines of up to $100,000 for each violation for individuals; and a corporation or other entity can be fined up to $500,000 for each violation. Each day during which a violation continues shall be considered a separate offense [section 135a–pp. 85-86]. These fines can be imposed for any prohibited act, which would include violations of the growing standards or paperwork requirements. In contrast, under current law, civil fines are half as high and only levied if someone has introduced or delivered for introduction into interstate commerce adulterated food. [21 USC 333(f)(2)(A)]

While higher penalties may be necessary to deter industrial food companies from repeated dangerous violations, the agency has a track record of pursuing small farmers and producers; these penalties could be imposed to ruin people for actions that pose no threat to human health.

VI. 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.

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