Washington Insider- Tuesday

Major Overhaul of Biotech Regulations

Here's a quick monitor of Washington farm and trade policy issues from DTN's well-placed observer.

Congress Returns to Full Agenda of Spending Bills

Following their Independence Day recess, Congressional appropriations committees today resume work on the fiscal 2016 spending bills despite an increasingly bleak outlook for any of the measures to be enacted before the start of the government's new fiscal year on Oct. 1.

Congress is scheduled to be in session for the remainder of July, after which it will adjourn for the entire month of August and first week of September. As a result, the prospects for moving many of the spending measure to the House and Senate floors is fading amid political battles and the growing reluctance of Republican leaders to commit valuable floor time to problematic bills.

Appropriators in both chambers appear resigned to waiting until next fall at the earliest for any resolution of the budget debate that clouds the outlook for their bills. Observers say lawmakers probably will move as many of the bills as possible while waiting for talks between the White House and congressional leaders that could provide more relief from budget sequestration. It is almost taken for granted that Congress either will need to resort to a continuing resolution to keep the government running after Sept. 30 or shut down the "non-essential" parts of government beginning Oct. 1. Running a distant third in the betting is that Congress will approve all 12 FY16 spending bills by the theoretical end-of-the-fiscal-year deadline.

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Rewriting Clean Water Regulation Would Cost $5 Million, CBO Estimates

The Congressional Budget Office estimates that the cost to the Environmental Protection Agency and U.S. Army Corps of Engineers to rewrite a controversial Clean Water Act regulation would be $5 million between 2016 and 2020. Of that amount, $4 million would be required to conduct extensive outreach, address public comments and prepare a report to Congress as required under the Federal Water Quality Protection Act. Another $1 million would be needed to conduct the field work and data analysis necessary to develop new rules for issuing permits under the alternative regulatory regime outlined in legislation working its way through Congress.

A Senate bill would direct the Obama administration to rewrite a regulation clarifying the scope of the Clean Water Act. The proposal, which has been approved by the Senate Environment and Public Works Committee, would require the agencies to complete a new clean water rule no later than Dec. 31, 2016, that would only include streams with enough flow to transport pollutants at levels that would impair traditional navigable waters.

Members of Congress who support the requirement to redraft the clean water rule may disagree with CBO's estimate, but it is unlikely that they will blink at a price tag of that averages $1 million a year over five years in a federal budget of $3.8 trillion.

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Washington Insider: Major Overhaul of Biotech Regulations

Last week, the White House announced a major overhaul of regulations covering genetically modified crops. It said that the effort is "in response to significant advances in biotechnology that have made much of the current regulatory framework obsolete."

The July 2 White House memo went to the Food and Drug Administration, the Environmental Protection Agency and USDA. The recipients were ordered to review and update the Coordinated Framework for the Regulation of Biotechnology and to take a year to do the necessary work. The memo noted that "Advances in science and technology … have dramatically altered the biotechnology landscape, and can enable the development of products that were not previously possible, thus requiring a further update of the [framework] to facilitate the appropriate federal oversight."

The administration notes that it will set up a working group comprising representatives from each of the three agencies to both undertake the framework update and develop a long-term strategy for ensuring that the federal government is able to assess and manage the risks of biotech products.

In addition, the White House also is calling on the agencies to commission external reviews of the potential risks of biotech products by outside experts.

The "coordinated framework" was first issued by the White House in 1986 and spelled out formally which agencies had responsibility for regulating different aspects of biotech crops and other products.

At that time, most biotech crops were developed by splicing genetic material from one plant into another to implant a beneficial trait. Now the process is much more sophisticated to the point that new "gene editing" technologies have emerged that allow scientists to quickly, cheaply and accurately make small changes to a precise parts of a plant's genome. Crops created this way occupy a gray area now in which it is unclear which federal agency, if any, should be responsible for ensuring safety.

The current effort will be only the second time the framework has been overhauled since the 1986 launch — not surprising since the processes used and the determinations assigned have been almost endlessly controversial. Much of the biotech industry has hopes that the application of more precise, smaller genetic changes will reduce the temptation to regard them as Frankensteinian in nature — and that may be true in some cases, observers suggest.

Still, broad consumer suspicions regarding biotech techniques are deep seated now, and extend to mistrust of both the scientists who undertake the studies and the evaluations themselves. Thus, while the science has advanced and controls of biotech processes are far more precise — and, potential results seem likely to include far more consumer benefits.

The bitter debates may well change with a new framework but they are unlikely to diminish in intensity or importance and should be watched carefully by producers as they proceed, Washington Insider believes.


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(GH/CZ)