Keep an eye on the Food Safety Modernization Act during the current lame-duck session of Congress. The Act significantly expands Food and Drug Administration powers originally granted under the Federal Food, Drug and Cosmetic Act of 1938 (Note 1). The Act substantially increases Federal bureaucracies, regulations and red tape for food producers. It passed the House in July 2009. The Senate version just passed a few days ago (Note 2).
The House and Senate must now reconcile and pass a single bill. There is little time left for the lame-duck Congress to do this. The incoming 2011 Congress will most likely slash the scope of the pending bill – if it considers the matter at all. This would be a good thing. But the question is what will the lame ducks do?
This is an important question. Ordinarily, the House and Senate versions of this bill would be easy to reconcile and pass. They are substantially the same and both passed by large majorities (Note 3). But there is one critical difference between the bills which must be preserved in the final version. The Senate will be key for reconciliation. The Senate will decide whether the bill passes or is defeated.
There are two reasons for this. First, the Democrat lame-duck majority in the Senate is narrower and more tentative than in the House. This is because many vulnerable Democrat senators are up for reelection in 2012 (Note 4). They can ill-afford to be caught on the wrong side of a legislative issue – especially something as innocently titled as the Food Safety Modernization Act.
This leads to the second and more important reason. The Food Safety Modernization Act would have died in the Senate without the so-called Testor Amendment passed on November 18 (Note 5). The amendment exempts small farms and small food businesses from the Act’s onerous food safety provisions. This is potentially a dangerous political issue for vulnerable incumbents, if the Act is passed without the amendment.
The final version of this bill must contain the Testor provisions; otherwise, it should be vigorously opposed. There are a few other considerations worth noting too.
1. Common criticisms of the proposed bill are false.
Any Google search will reveal countless posts raising unfounded alarms about the bill. The bill has its flaws, to be sure, but one of the most egregious claims is simply not true. This claim warns that your backyard vegetable garden will be regulated by the FDA. Grandma can no longer give you strawberries from her berry patch or bake you an apple pie with fruit from her backyard tree. Your neighbor can no longer give you tomatoes or green peppers from their vegetable garden. And you can forget about that “grow an extra row” program. No more home-grown food donated to charities and the needy. The new Food and Drug bill allegedly makes all these and similar activities illegal or subject to vast regulation and ponderous bureaucracies.
This is all nonsense. Both versions of the bill apply only to owners and operators of food facilities (Note 6). A food facility does not include your backyard vegetable garden or grandma’s apple tree.
2. Protection for small business is vital.
The biggest legitimate criticism of the bill, as already mentioned, is its severe impact on small farms and other small producers, distributors and retailers of foods. Alarmist criticisms about shutting-down farmer’s markets and roadside vegetable stands are accurate in this case. This problem was rectified in the Senate version of the bill.
3. Federal food embargo powers lack reasonableness tests or limits.
Both bills give vast, unchecked power to the Secretary of Health and Human Services to shut-down food production in any State or group of States. This is especially alarming in the Senate version of the bill [Section 207]. The Secretary’s current embargo authority requires “credible evidence or information” presenting “a threat of serious adverse health consequences.” These criteria are replaced with “good reason to believe” that food is “adulterated or misbranded.” In other words, the current standard is relaxed or dumbed-down.
4. There is little restriction on the FDA to devise rules and regulations.
This is a common problem with most congressional legislation. Congress delegates authority to the Executive Branch to devise and enforce new rules and regulations. The practicality, cost-effectiveness or efficacy of new rules and regulations is rarely a government concern (Note 7). One big issue here is that Congress is mandating that all food be traceable to its source. In many cases, this includes traceability of food to individual food handlers in processing plants or harvesters in the field (Note 8). On the face of it, this seems like a good idea; but it is also liable to be incredibly complicated and expensive.
This is another typical example of congressional largesse. It is another feels-good idea that is more or less a waste of taxpayer money. The Senate version of the bill [Section 305(a)] requires the Department of Health and Human Services to develop improved food safety standards and methods for developing nations. The Secretary is further directed to provide training and other resources in this regard. This is a misuse of scarce resources, however benevolent the motivation. It is particularly so in these difficult economic times. This mandate spends money we simply don’t have. Congress just doesn’t get the message about lower spending.
6. Alarms regarding the Codex Alimentarius are unfounded (Note 9).
The World Trade Organization, of which the United States is a founding member, adopted the Codex in 1995 as a means for settling international trade disputes involving food. The purpose of the Codex is not to infringe national sovereignty but, rather, to prevent nations from erecting protectionist trade barriers by imposing unreasonable safety standards on food imports. The reverse is also true. A country who fails to substantially comply with Codex food safety standards is liable for damages suffered by importers.
Anyone who bothers to research this issue would discover that the United States has been the principal beneficiary of this arrangement. In the fifteen years since the WTO was established, twenty Codex Alimentarius trade disputes have been brought before the WTO. Of these, the United States initiated eleven complaints against other countries and only two complaints have been lodged against the US (Note 10).
One last point needs to be made and this is a big one. The factors which gave rise to the Food Safety Modernization Act were a rash of highly pub-licized incidents of food contamination over the past few years. In most every case, the FDA failed to identify or correct serious food safety problems during recent facility inspections (Note 11). In other words, these problems were caused by government’s failure to competently do its job.
To address this deficiency, our already-ineffective government assigns more power and responsibility to itself. It issues more elaborate and compre-hensive regulations. Root causes are not addressed. Consequently, there is little reason to believe that the Food Safety Modernization Act will materially improve safety of the nation’s food supply.
1 The original Act was passed in 1938 (21 USC 301) after a legally produced health elixir killed 107 people. The product, called Elixir Sulfanilamide, contained poisonous ethylene glycol and caused a national outcry. [FDA Consumer Magazine, “Sulfanilamide Disaster,” by Carole Ballantine, June 1981.] The new Act replaced the outdated Food and Drug Act of 1906 (34 USC 768) and designated the Food & Drug Administration as its principal authority. The FDA was authorized to devise and enforce food and drug safety standards and inspect factories. The Act was expanded in 1962 in response to the grim thalidomide tragedy in Europe. The law was modified to require drug makers to prove the safety and effectiveness of their products. [Time, “Medicine: The Thalidomide Disaster,” August 1962.] The last significant change to the Act occurred in 1976 after Senate testimony revealed that faulty medical devices were responsible for several thousand injuries and deaths in the United States. The new law applied safety and effectiveness standards to medical devices. [FDA, Supra, “Medical Device and Radiological Health Regulations Come of Age,” Carol Rados, January 2006. [http://www.fda.gov/RegulatoryInformation/Legislation/default.htm.] All of these Acts are, of course, unconstitutional because regulating food and drug safety is not an enumerated power under Article 1, Section 8 of the Constitution or the 9th Amendment. However, these vast powers have been rationalized by judicial activism under the Commerce Clause and the General Welfare Clause. In “Twelve Constitutional Amendments to Save America, Part 1” posted on this website, the pervasive problem of judicial activism is corrected with new constitutional Amendments 28-31. The constitutionality of the original 1938 Act was never seriously challenged until 1952 (US v. Cardiff, 344 US 174), when the Supreme Court ruled that FDA factory safety inspection provisions were too vague to be criminally prosecuted. The original 1906 Act was constitutionally upheld in 1914 by an 8-1 decision (US v. Antikamnia Chemical Co., 231 US 654), which is why the 1938 Act was not comprehensively challenged.
2 The bill began in the House as HR 2749, The Food Safety Enhancement Act of 2009. It was introduced in June 2009 by its sponsor Representative John Dingell (D-MI). The House bill passed in July 2009. In March 2010 the Senate version was introduced by its sponsor Senator Dick Durbin (D-IL). The bill passed the Senate on November 30, 2010. A complete copy of the bill, known in the Senate as S.510, can be obtained at http://www.govtrack.us/congress/billtext.xpd?bill=s111-510. HR2749 can be obtained at http://www.govtrack.us/congress/bill.xpd?bill=h111-2749.
3 Even in the Senate, where bills usually pass along narrow partisan lines, the bill passed 73-25.
4 See “Tea Party 2012 Election Strategies: Part 2 – Los Vulnerables,” posted on this website.
5 Republicans submitted four amendments and Democrats submitted fourteen amendments. [SA 4691-4694, 4696-4702, 4708-4710, 4713-4716 at http://www.govtrack.us/congress/bill.xpd?bill=s111-510&tab=amendments.] The full text of the Testor Amendment can be obtained at http://tester.senate.gov/Legislation/upload/tester_amendment_agreement_summary.pdf. It is incorporated in S510, primarily under Section 103.
6 HR2749 Section 101 and S510 Section 102.
7 The proposed 36th Amendment eliminates this problem. See “Twelve Constitutional Amendments to Save America, Part 3 – Fiscal Responsibility” posted on this website.
8 HR2749 Section 107 and S510 Section 204.
9 The Codex Alimentarius [literally ‘food code’] Commission was created in 1963 by the United Nations Food and Agriculture Organisation and the World Health Organisation. The Commission was established to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme. The main purposes of this Programme are protecting health of the consumers and ensuring fair trade practices in the food trade, and promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations. These standards are codified as Sanitary and Phytosanitary Standards (SPS). SPS was adopted by the WTO in 1995 when the WTO first came into existence. Details are available from WTO and WHO websites. The Codex sovereignty issue allegedly comes into play in the Senate version of the bill [Section 305(c)(5)]. However, this provision merely directs the Secretary of HHS to make “recommendations on whether and how to harmonize requirements under the Codex Alimentarius.” It specifies no other action.
10 WTO disputes initiated by the United States under the Codex are WT/DS- 03, 41, 05, 021, 26, 76, 203, 245, with cases listed in the order they were settled. Cases brought against the US are WT/DS- 100, 144. Two large pending cases involve the US and Europe. Europe currently bans hormone-enhanced beef imports from the US, as well as genetically modified grains, on grounds that they are unhealthy. The US disputes these claims.
11 Such as the E.coli bacterial contamination of spinach; the E.coli contamination of meat from Nebraska Beef; tainted hamburgers served to California school children, which resulted in the recall of one million pounds of ground beef produced by Valley Beef; poisonous dog food imported from China; tainted food snacks of Veggy Booty; and most recently, in July 2010, another E.coli contamination involving Fresh Express lettuce; and in August 2010, the nationwide recall of millions of salmonella-contaminated eggs. In most every case, FDA inspection and enforcement deficiencies failed to identify or correct these
food safety problems. New York Times, “Food Problems Elude Private Inspectors,” by Michael Moss and Andrew Martin, March 5, 2009. MSNBC.com, “Lettuce Recalled for Possible E.coli,” July 15, 2010. Consumer Reports, “One Million Pounds of Ground Beef Recalled Due to E.coli,” August 9, 2010 and Ibid., “Bad Eggs: Ten Ways to Cut Your Salmonella Risk,” September 1, 2010. There was also the highly celebrated 2008 incident involving tainted Mexican food sold by retailers and served by restaurants. The FDA wrongly fingered the tomato and cilantro producers for contamination. These industries suffered millions in losses and recall costs. The true culprit turned out to be jalapeño peppers. Chicago Tribune, “FDA: Salmonella Found in Jalapeño,” by Stephen Hedges, July 22, 2008. Consumer Affairs, “Jalapeños from Mexico Recalled: Peppers Linked to Salmonella Outbreak; Tomatoes Cleared,” Mark Huffman, July 22, 2008. MedicineNet.com, “Texas Firm Recalls 1.7 Million Pounds of Beef and Chicken Products,” by Bill Hendrick and Louise Change, M.D., December 16, 2010 at http://www.medicinenet.com/script/main/art.asp?articlekey=114317.