Washington Insider -- Thursday

By DTN's Washington Insider

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

EPA to Undertake PR Campaign with Farmers

Officials from the Environmental Protection Agency plan over the next several months to meet with farmers and agricultural interests about the agency's proposal to redefine the extent of the federal government's jurisdiction over the "waters of the United States." Federal law gives EPA and the Army Corps of Engineers jurisdiction over these bodies of water, so any change in the term's definition carries with it the ability for the government to have greater or lesser regulatory reach.

According to an EPA spokeswoman, agency officials, including Administrator Gina McCarthy, will try to clear up misunderstandings about the proposed rule and encourage the agriculture industry to submit formal comments on it. Nancy Stoner, the EPA's acting assistant administrator for water, previewed the agency's outreach efforts in a Monday blog post aimed at farmers. "'The rule keeps intact all Clean Water Act exemptions and exclusions for agriculture that farmers count on," Stoner wrote. "But it does more for farmers by actually expanding those exemptions."

In Missouri next week, McCarthy will visit a farm, meet with farmers, give a speech, meet with agricultural groups and give interviews to agricultural trade media. EPA will also announce more details of its outreach efforts next week. Farmers are perennially irritated with EPA and its regulations and many are distrustful of the latest proposal. McCarthy & Co. therefore have a major selling job ahead this summer.

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TTP Talks Resume Today; Japan, U.S. May Have Made Progress

The 12 Pacific Rim nations negotiating the Trans-Pacific Partnership (TPP) resume their talks today in Ottawa just days after remarks by Japan's chief negotiator, Hiroshi Oe, to reporters that the United States and Japan have made progress in their separate bilateral discussions on agricultural tariffs and trade.

Following meetings with acting Deputy US Trade Representative Wendy Cutler earlier this week, Oe told reporters that both sides still have differences and that "it would not be easy to solve those problems, and we did not agree on any issues or move closer" on different stances on beef and pork tariff rates.

Japan's portrayal of the outcome of the Oe-Cutler meetings is more optimistic that the substance of those meetings seems to warrant. Still, the accent is on the positive, so the door is not yet closed on the possibility of including Japan fully into the TTP discussions. Absent an agreement by Japan to lower its agricultural tariffs on a wide range of products, several TTP nations, and a number of U.S. agricultural groups, have called on U.S. negotiations to exclude Japan from the talks. The Ottawa TTP negotiations are scheduled to continue through the next 10 days.

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Washington Insider: Progress on Livestock Drug Use Cutbacks

One measure of how serious the Food and Drug Administration is taking its efforts to limit antibiotic use for livestock is its new public information and outreach effort. The agency has promised progress reports each six months, and now has released the first edition.

The current update begins by repeating what everyone knows, that "antibiotic resistance is a widely recognized concern." It notes that the rise of bacteria resistant to many, and in some cases, all standard treatments, means that scientists and medical professionals "are not alone in focusing on this problem." The agency also notes that the general public is increasingly aware of the ongoing research and how antibiotic resistance can affect their immediate communities.

The report then proceeds with some interesting results. It notes that in "December 2013, it "started the clock" on major changes regarding the use of antimicrobials in food producing animals," using a voluntary strategy of requesting the animal pharmaceutical industry to end its use of certain drugs used in feed in two ways: by removing from the labels approvals for "growth production/feed efficiency," and by requiring veterinary oversight and involvement in order to obtain these products when they are needed to assure animal health.

In this report, FDA focuses on changes made by drug companies to their products and labels and provides summaries of changes still in progress. It says that all 26 drug manufacturers affected by its Guidance have now agreed to phase out the use of medically important antimicrobials in food animals for food production purposes. And, it says the companies are cooperating by phasing in the oversight of a veterinarian for the remaining therapeutic uses.

The report also notes that while its guidance specified a three-year timeframe (until December 2016) for drug "sponsors" to complete the recommended changes to their antimicrobial products, "some" sponsors have already begun to implement them. The agency highlights published label changes that withdraw a production claim and changed products' marketing status from over-the-counter to available by prescription only. The rule changes are documented online and updated in real time when label changes are approved.

One additional drug label change currently is pending for one product, the report says — a change from over-the-counter marketing status to prescription status. Some 31 approvals for affected products have been withdrawn to date, and no drug approval withdrawals currently pending. After an approval is voluntarily withdrawn, those products no longer can be marketed or sold in the United States.

FDA says it will continue to work with the animal pharmaceutical industry, animal producers and the veterinary community to address antimicrobial resistance and preserve the effectiveness of antimicrobials of human health importance.

FDA is right, of course, about the intense concern among health professionals over the growth of antibiotic resistance by bacteria and about visibility of the very large amount of antibiotics used in livestock production. And, it apparently recognizes that its decision to use voluntary industry compliance with FDA guidance to both sharply limit the use of antibiotics to increase growth and keep important drugs available for therapeutic use is highly controversial, especially among advocate groups who would like to see large categories of drugs completely banned from use for livestock.

Still, FDA seems eager to point out that its voluntary program is being widely accepted by drug companies, although it provides little information about how much the program is actually reducing livestock drug use.

Bacterial drug resistance reduction programs are controversial within the livestock industry because many experts are convinced that most of the drug misuse that is promoting resistance is caused by physicians and hospitals, and that limiting livestock use will have little effect on that. And, they sometimes worry that reductions in livestock use will have little effect on overall bacterial drug resistance — and, that even broader drug regulation may be necessary in the future with still tighter rules on livestock use.

Thus, while FDA is able to report significant progress for its voluntary program, the issue may be far from over, Washington Insider believes.

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