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April 15, 2005

In this Issue


House Members Drop RFS Bill; House Committees Close to Finishing Energy Package, While Senate Still Working



BSE UPDATE:


National Drought Preparedness Act Introduced in Senate


Senate Panel Approves Johnson to Head EPA


Senate Committee Adopts Ag HOS Rules, Does Not Make Permanent


Bankruptcy Reform on Way to Bush


CAFTA Passage Unsure Over Sugar


EU to Restrict U.S. Corn Gluten Imports Over Syngenta Mishap


Court Surprises FDA by Ephedra Ruling


Hatch, Durbin Re-Start Supplement Legislation Talks


Kennedy Offers Obesity Bill


New Bills

 

House Members Drop RFS Bill; House Committees Close to Finishing Energy Package, While Senate Still Working

A group of 22 bipartisan members of the House this week introduced legislation to set a national renewable fuels standard (RFS) of 4 billion gallons by 2006 and 8 billion gallons by 2012, more than doubling current renewable fuels production.

The legislation is a companion piece to a bill introduced last month by Sens. Richard Lugar (R-IN) and Tom Harkin (D-IA). Eligible biofuels under the terms of both bills are ethanol, biodiesel and cellulosic biomass fuels.

The RFS bill is expected to be included in the omnibus energy package both sides of Capitol Hill hope to enact this year, and will likely be the vehicle for any changes, extensions or modifications of some limited provisions passed in the last session.

In the House, floor debate is scheduled on its bill next week. The House Ways & Means Committee this week finished work on energy tax provisions, without reference to last year’s ethanol and biodiesel tax incentives, while the House Energy & Commerce Committee completed its work on the overall energy framework favored by the House. The House Resources Committee has also finished its work on the bill.

The Senate Energy & Natural Resources Committee continues to work on its version of energy legislation, albeit at a slower pace than in the House. Senate leaders have said their bill will be ready for the floor within a couple of months, setting up conference committee action late this summer or early fall.

While the House bill contains a controversial provision from last session’s energy wrangle protecting the manufacturers of the gasoline additive MTBE from liability, Senate sources indicate their bill will not, leaving the matter for conference. At the same time, the House bill contains a Resources Committee provision to allow drilling in the coast plain of the Arctic National Wildlife Refuge (ANWR), language that’s died in the Senate more than once.

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BSE UPDATE

USDA Blows Off Allegations of U.S. BSE Coverup

Allegations by a former USDA veterinarian that the department covered up possible cases of BSE in the U.S. due to sloppy testing were dismissed out of hand by department officials this week, saying USDA is not going to go back and review any animal testing.

Veterinarian Dr. Lester Friedlander, a former USDA inspector who was fired by the department in 1995 (and who has a pending lawsuit against USDA), made the allegations in a series of speeches across Canada this week, including an appearance before the agriculture committee of Canada’s Parliament.

Friedlander alleges brain samples from suspect animals were sent to private labs which confirmed BSE, but USDA ran its own tests and announced the results were negative. He said other USDA inspectors had told him of the incidents, but they would not go public because they feared losing their jobs and federal pensions. “I don’t know if that’s true. That’s just what they told me,” United Press International (UPI) quoted him in an April 14 report.

USDA denied the allegations throughout the week. In an April 14 meeting with reporters, Secretary of Agriculture Mike Johanns said, “…the gentleman that is making these allegations is really doing so with no proof whatsoever…He gets a lot of attention because he makes baseless claims…there just isn’t any accuracy in what he’s saying.”

Johanns said the department is dedicated to being as transparent about the testing process as possible, even risking public criticism for putting out too much information.

Friedlander was widely quoted saying he’d take a lie detector test to help confirm his testimony. However, Friedlander said later his statement about a lie detector test was misquoted. He told UPI when he made that statement he was referring to a 1991 incident in which he alleges a department official told him that he ever found a case of BSE to not say anything.

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Japan Won’t Commit to Date on Lifting U.S. Beef Ban; Johanns Concerned About Possible Sanctions

The Japanese government remains silent on when U.S.-Japan beef trade may resume according to a report sent by the Japanese government to the U.S. Trade Representative (USTR) this week in response to USTR’s call for resumption of trade at the earliest possible date. The Japanese said “this is not a trade issue, but a food safety issue,” and stressed the need to protect human health and confidence in the food supply as it continued its internal review and regulatory process.

However, threats by members of Congress to slap trade sanctions on Japan if beef trade doesn’t resume soon have Secretary of Agriculture Mike Johanns concerned, according to reports. He asked that congressional leaders reconsider any attempt to sanction Japan over beef sales.

“The problem is for every action there is a counter-action and that just gets you in a situation where you can be facing some very difficult consequences on both sides,” he said. “Why should we even go there?”

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National Drought Preparedness Act Introduced in Senate

Sens. Tim Johnson (D-SD) and Pete Domenici (R-NM) introduced this week legislation to create a national drought policy to provide assistance to state and local governments to formulate drought preparedness plans and help deliver drought assistance to affected farmers and ranchers. A bipartisan group of midwestern and mountain state senators joined them.

Johnson, whose state is experiencing its fifth consecutive year of drought, said it was time for the federal government to take the same approach to drought preparedness as it does to other disasters, including floods, hurricanes and tornadoes.

The bill would create a national drought policy, moving away from ad hoc emergency assistance programs; enhance delivery of federal drought assistance where USDA and Federal Emergency Management Agency (FEMA) will work through a USDA council on relief to “bring all drought programs to the table”; assistance to state and local governments to create drought preparedness plans, and facilitate the development of national forecasting and monitoring network to improve the reporting of drought conditions and forecasting of future droughts.

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Senate Panel Approves Johnson to Head EPA

The Senate Environment & Public Works Committee this week voted 17-1 to approve Stephen Johnson to be the next administrator of EPA, but only after Johnson nixed a controversial EPA program that prompted two Senators to threaten to place a hold on his nomination.

Johnson, currently EPA acting administrator and the first career federal scientist nominated to head the agency, was lambasted during his confirmation hearing by Sen. Barbara Boxer (D-CA) over an EPA cosponsored study with the chemical industry in which low-income families would have been compensated to allow the agency to research pesticide effects on infant children. Johnson killed the program following his hearing.

Boxer said she continues to have concerns about EPA programs that are more “about politics than science,” but voted for Johnson’s nomination. Sen. Tom Carper (D-DE) voted against the nomination, saying he had not received requested information from Johnson on how EPA antipollution proposals differ from White House priorities.

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Senate Committee Adopts Ag HOS Rules, Does Not Make Permanent

While agriculture interests were pleased that the Senate Committee on Commerce, Science & Transportation approved this week safety provision of the highway reauthorization package defining agricultural commodities and farm supplies under the agricultural hours of service (HOS) exemption, they were disappointed the committee did not make the provision permanent or protect it from secretarial discretion to roll back or remove the exemption. The House-passed highway bill contains a provision making the ag HOS exemption permanent, setting up a Senate floor fight and/or a conference committee confrontation on the issue.

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Bankruptcy Reform on Way to Bush

With House passage this week of a Senate bill that supporters and critics agree is the most sweeping federal bankruptcy reform package in 25 years, the way is clear for a presidential signature. However, the reform, while hailed by agriculture and financial services industries, was not without controversy.

One major controversy surrounds the process by which the House effectively voted on a Senate bill while disallowing any floor amendments. Senate Majority Leader Bill Frist (R-TN) said it was similar to the process followed with the recent tort reform measure enacted earlier this year. No conference committee was required because the Senate approved the legislation first and the House approved the Senate version without amendments.

The bill requires bankruptcy filers who have the means to enter into court-ordered repayment plans under Chapter 13 of the bankruptcy code rather than escaping all debt when they file under Chapter 7. At the same time, the bill aims to reduce “abusive and frivolous” filings. Opponents said the bill is a congressional gift to credit card companies and banks, saying it will hurt consumers with a legitimate need for bankruptcy debt protection.

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CAFTA Passage Unsure Over Sugar

Congressional approval of the Central American – Dominican Republic - Free Trade Agreement (CAFTA) remains in doubt over continuing and vigorous opposition by the sugar industry - with some GOP but solid Democratic support in both chambers - over claims substantial sugar exports by CAFTA nations will hurt domestic producers.

Sen. Mike Crapo (R-ID) said the sugar industry “made a compelling case” during a recent hearing in the Senate Finance Committee. Crapo said current law allows most CAFTA nations duty-free access for their ag exports to the U.S., but the U.S. does not enjoy the same access to CAFTA markets. CAFTA, he said, gains access for U.S. commodities at the cost of sugar. Idaho is a large sugar beet-producing state.

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EU to Restrict U.S. Corn Gluten Imports Over Syngenta Mishap

To prevent unapproved genetically modified corn seed or its products from finding their way to Europe, the European Union (EU) this week said it is drafting tougher new restrictions on corn gluten imports from the U.S. The action comes in the wake of Swiss-based Syngenta reporting several weeks ago that an unapproved version of its genetically modified corn seed was mistakenly sold over a three-year period.

The import restriction could be in place as early as next week, EU sources said. U.S. exporters will have to provide proof from an internationally accredited laboratory that their exports to the EU do not include any of the unapproved corn strain, under the EU draft plan. A spokesman said most of the 25 EU member nations supported the action.

Syngenta, in publicly supporting the EU action, said it is developing a test to detect the corn seed and that it should be available in time to meet the EU testing requirements.

EU authorities say they are concentrating on corn gluten feed because they have confirmed the presence of the unapproved Syngenta seed strain in that product. Authorities are also testing corn oil and corn flour imported from the U.S. Some of the corn grown from the unapproved seed is thought to have been sold in Europe, Canada and Japan.

The European Food Safety Authority said this week the presence of the unapproved corn in food products was unlikely to pose any threat to health or the environment. Last week, the EU said it would leave the ongoing investigation into the Syngenta situation to the U.S. Syngenta has agreed to pay a $375,000 fine levied by the U.S. government.

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Court Surprises FDA by Ephedra Ruling

On April 13, the U.S. District Court for the District of Utah Central Division ruled against FDA and for the plaintiffs, Neutraceutical Corporation and Solaray, Inc., in a case concerning FDA’s action to ban dietary supplements containing ephedra. In February 2004, FDA issued a regulation calling such supplements adulterated, and declaring them to pose an “unreasonable risk of illness or injury.” The agency was sued by the supplement manufacturers, which asked the court to rule FDA’s action violated provisions of the Dietary Supplement Health & Education Act (DSHEA) and to order FDA to re-issue its regulation to specify supplements containing 10 mg or fewer of ephedra per daily dose are not adulterated and may be sold legally.

The court agreed with the plaintiffs, making the following points. DSHEA expressly provides that dietary supplements be regulated as foods. Among other things, this means they do not need to demonstrate benefits or to provide data comparing benefits and risks, as is required for drugs and medical devices. In its determination ephedra-containing supplements pose an “unreasonable risk,” the court stated, FDA cross-referenced medical device provisions of the law, as well as provisions of the Toxic Substances Control Act, which say that a product not able to demonstrate benefit, in the face of even a small risk, poses an “unreasonable” risk. However, the court said, the medical device provisions are not applicable to dietary supplements and FDA cannot require of supplement manufacturers that they do risk-benefit analyses.

Further, the court said, DSHEA specifically places on FDA the burden to demonstrate a supplement is not safe before the agency can take action to remove it from the market. This determination must be made on a specific dose-related basis, according to DSHEA. Therefore, FDA must prove that each dose of the ingredient is unsafe before it takes action against a given dosage in a product. In FDA’s analysis of the risks of ephedra products, it referenced a study of the risk of “a chronic ephedrine dose of 1.5 mg every four hours,” which FDA used as indication of the risk of this low dose (9 mg per day) of ephedra. The court said this evidence was not appropriate, because the comparison was with an injected, not an oral product, and the risk attendant to the oral product was determined by a mathematical extrapolation, not by a “preponderance of evidence.”

The court ordered FDA to re-issue its regulation in accord with the ruling, i.e., to allow legal marketing of products with 10-mg per day or lower doses of ephedrine alkaloids, and not to take any enforcement action against such products.

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Hatch, Durbin Re-Start Supplement Legislation Talks

Following a District Court decision that FDA must re-visit its ephedra “ban,” (see related article), Sens. Orrin Hatch (R-UT) and Dick Durbin (D-IL) are reportedly discussing trying to move forward with legislation they had worked on last year with Sen. Tom Harkin (D-IA) to require adverse event reporting to FDA by dietary supplement manufacturers. The legislation, deriving last year from agreement among the three Senators to work together on such a bill, ran out of steam at the end of the 108th Congress. Hatch reportedly was approached subsequently by one or more Utah supplement manufacturers, expressing concern about specific provisions of the then-draft bill and about general concerns related to mandatory adverse event reporting. This contrasted with strong support for such legislation, at least in concept, by other supplement groups, including the Council for Responsible Nutrition and the American Herbal Products Association.

Among the stronger opponents of the legislation being considered last year was Neutraceutical Corporation, one of the plaintiffs in the ephedra lawsuit. Opponents of the adverse event reporting legislation have expressed concern about whether and to what extent such a reporting system would provide fodder for frivolous lawsuits.

It is not clear if, when, or what precise legislation might be introduced in the Senate, but reportedly Durbin is particularly anxious to move forward.


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Kennedy Offers Obesity Bill

This week Sen. Edward Kennedy (D-MA) introduced the “Prevention of Childhood Obesity Act.” This legislation would appoint a federal commission on food policies to promote good nutrition, establish guidelines for food and physical activity advertisements, and provide grants to states to implement anti-obesity plans, including curricula and training for educators for obesity prevention activities in school and after-school programs.

In his floor statement Kennedy said, “Childhood obesity is the obvious result of too much food and too little exercise…Children are exposed to 40,000 food advertisements a year -- one food commercial every minute -- urging them to eat candy, snacks, and fast food. Vending machines are now in 43 percent of elementary schools and 97 percent of high schools, offering young students easy access to soft drinks and snacks that can double their risk of obesity...”

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New Bills

A number of new bills have been introduced. Click here to send a request for a copy of the text or more information about the bill.

S.767
Sen. Christopher “Kit” Bond (R-MO) introduced a bill to establish a Division of Food and Agricultural Science within the National Science Foundation.

S.799
Sen. Edward Kennedy (D-MA) offered the “Prevention of Childhood Obesity Act” to provide for the coordination of federal policies and activities to prevent obesity in childhood, to provide for state childhood obesity prevention and control, and to establish grant programs to prevent childhood obesity within homes, schools, and communities.

S.802
A bill offered by Sen. Pete Domenici (R-NM) would establish a National Drought Council within the Department of Agriculture.

H.R.1545
Rep. Chris Cannon (R-UT) proposed legislation to amend the IRS code to treat expenses for certain meal replacement and dietary supplement products that qualify for FDA-approved health claims as expenses for medical care.

H.R.1563
Rep. Gil Gutknecht (R-MN) introduced a bill to establish a Division of Food and Agricultural Science within the National Science Foundation.

H.R.1620
A bill offered by Rep. Brad Sherman (D-CA) would establish the Commission on Freedom of Information Act Processing Delays.

H.R.1626
Rep. David Wu (D-OR) introduced a bill which would authorize the Secretary of Health and Human Services to negotiate prices for prescription drugs on behalf of Medicare beneficiaries and for the reimportation of prescription drugs.

H.R.1650
A bill offered by Rep. Nancy Johnson (R-CT) would allow tax credits to holders of stem cell research bonds.

H.R.1655
Rep. Michael Michaud (R-ME) introduced a bill to establish an America Rx program to establish fairer pricing for prescription drugs for individuals without access to prescription drugs at discounted prices.

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Inside Track is produced as a service to clients of Policy Directions, Inc., a Washington, DC-based government relations/strategic government communications firm founded in 1995, specializing in customized advocacy on health care; food; biomedical research; biotechnology, human drug, and medical device regulation; federal nutrition policy and programs; and environmental policies and programs. For more information about PDI, please e-mail info@poldir.com.

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