Friday, December 3, 2010

Food Safety Enhancement or Government Overreach?-Updated

In August of 2009, the House of Representative passed a bill known as the Food Safety Enhancement Act of 2009 (HR 2749) in order to essentially amend the Federal Food, Drug, and Cosmetic Act , which was passed in 1938 to first give authority to the Food and Drug Administration to oversee the food, drug, and cosmetic safety. This bill has since been amended on several occasions.

The House bill passed last year gives further regulatory power to the FDA and the Secretary of Health and Human Services with regards to food processing and food transport safety. It requires greater accountability and tracking by food manufacturers (with the exception of those under the regulation of the Department of Agriculture). It also requires further foodborne pathogen surveillance by the Center for Disease Control and Surveillance. It also increases fees and penalties to entities in violation of regulations.

The Senate version of the bill (S 510) is currently being discussed in the Senate during the current lame duck session and was introduced by Illinois Senator, Dick Durbin. The Senate bill introduces other components which include bringing the Department of Defense and the Department of Homeland Security in the mix and will incur a cost of $3.4 billion to taxpayers between 2010 and 2015.

Here is a brief overview:

The amendments accompanying this bill are intended to protect small farms. One component of one amendment, the Manager's Amendment, states the following:
(d) SMALL ENTITY COMPLIANCE POLICY GUIDE.- Not later than 180 days after the issuance of the regulations promulgated under subsection (m) of section 418 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)), the Secretary shall issue a small entity compliance policy guide setting forth in plain language the requirements of such section 418 and this section to assist small entities in complying with the hazard analysis and other activities required under such section 418 and this Section.

However, the language of the amendments leave the FDA and other government agencies room to define what small entities are or what "hazard analysis" entails. Additionally, another component regulates people who may be engaged in farming or gardening and may distribute their produce:
(2) USE OF OR EXPOSURE TO FOODS OF CONCERN.-If the Secretary believes that there is a reasonable probability that the use of or exposure to an article of food, and any article of a food, that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article can be acted upon by the FDA.

Obviously, no one would knowingly share vegetables or food that may be contaminated. However, would such a bill component make individuals liable if something they brought to a church potluck made people sick or if vegetables they sold at the farmer's market contained salmonella? Should such nebulous regulatory power be extended to the FDA and other government departments and agencies?

As with any bill, its necessity must be viewed in the light of the Constitution. As the Senate discusses this bill during the week of Thanksgiving, we must consider the potential that the Department of Homeland Security and regulators at the FDA, who are unelected and thus unaccountable to the American people, may have the power to regulate the cranberry sauce and turkey at your dinner table? Do agencies and departments under the executive branch have the Constitutional authority to regulate and legislate?


On Tuesday, November 30th, S510 was passed by the Senate by a 73-25 margin with both of Illinois' Senators voting yes. However, due to the fact that part of this Senate bill outlines collection of revenue, it will likely be blocked by the House, as it is unconstitutional:

Section 107 of the bill includes a set of fees that are classified as revenue raisers, which are technically taxes under the Constitution. According to a House GOP leadership aide, that section has ruffled the feathers of Ways and Means Committee Democrats, who are expected to use the blue slip process to block completion of the bill.

Article 1 Section 7 states, " All Bills for raising Revenue shall originate in the House of Representatives; but the Senate may propose or concur with Amendments as on other Bills."

The bill can be re-written from scratch when the new session convenes in January, or it can be re- addressed by the Senate after the House passes a new bill. However, it would need unanimous approval to limit debate and pass the bill before the end of the year.

Crossposted here.

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