Friday, November 19, 2010

Tester’s amendment for family-scale producers now part of Food Safety Bill

Thursday, November 18, 2010 

(U.S. SENATE) – U.S. Senator Jon Tester has reached an agreement with consumer groups and the bipartisan authors of the Senate’s Food Safety Bill to include his amendment to protect family-scale food producers from expensive federal paperwork and unnecessary new regulations.

“This important legislation is shaping up to be a much better bill with the inclusion of my amendment for family-scale producers, and it protects the jobs of family farmers and ranchers and processers,” Tester said today during a speech to the Senate.  “It really is time to get this bill passed and strengthen food safety for all Americans.”

Under Tester’s amendment, food producers who sell their goods directly to consumers and have less than $500,000 in annual sales would not be subject to the onerous new requirements designed for industrial-scale food producers.  Family-scale producers would, however, continue to be overseen by local and state food safety and health agencies.

Negotiators have agreed on the following minor revisions to include Tester’s amendment in the Food Safety Bill:

  • New language that gives U.S. Food and Drug Administration’s authority to withdraw an exemption from a farm or facility that has been associated with a food-borne illness outbreak.
  • The distance from a facility or farm that is eligible to be a local “qualified end-user” has been reduced from 400 miles to 275 miles, or within the same state.
Tester says his amendment is a major victory for family agriculture, safer food, and for the local food movement.

“We deal with consolidation in our energy sector, we deal with consolidation in our banking sector,” Tester said.  “We have consolidation in our food industry too. The fact is we need to not encourage that consolidation.  I think if we can get more locally grown food—if we can get producers to connect up the consumers eyeball to eyeball—that’s a positive thing.  And I don’t want to diminish their ability to do this.”

Although Tester is himself a family-scale grain farmer, Tester’s own farm does not qualify under the amendment because he does not sell grain directly to consumers.

The Senate is currently debating the Food Safety Bill.  A final vote on the bill, including Tester’s amendment, could happen as early as today.

  • Tester’s Food Safety Bill resource page is now available online at:
  • A summary of Tester’s revised amendment is online HERE
  • The latest version of Tester’s amendment is online HERE
  • A YouTube video of Tester’s Senate floor speech is online HERE

Why the Tester Amendment?
“[Family-scale producers] are small. There’s a pride of ownership there that is real.  They raise food; they don’t raise a commodity as happens when these operations get bigger and bigger. And there is a direct customer relationship with that customer or that farmer that means a lot.  And if a mistake is made, which rarely happens, it doesn’t impact hundreds of thousands of people.  We know exactly where the problem was.  And we know exactly how to fix it.” –Senator Jon Tester

Tuesday, November 16, 2010

Food and Ag Groups Rally Against Tester Amendment

As the Senate gears up to vote on a motion to limit debate and move the pending food safety bill forward on Wednesday, interest groups are kicking into high gear to lobby for and against key amendments.

Monday a group of 30 meat, pet food, and fresh produce industry groups sent a letter to the Health, Education, Labor, and Pensions Committee chairman and ranking members, Senators Tom Harkin (D-IA) and Michael Enzi (R-WY), respectively, urging key staff and lawmakers working on the bill to oppose a measure to exempt small farms and producers from the crux of the legislation.

"We believe an operation's size, the growing practices used, or its proximity to customers does not determine whether the food offered is safe," read the letter, which was signed by the American Meat Institute, the United Fresh Produce Association, and the United Egg Producers.

"What matters is that the operation implements prudent product safety practices, whether the product is purchased at a roadside stand, a farmers' market, or a large supermarket," continues the letter. "We support FDA food safety programs developed through a scientific, risk-based approach and that benefit public health."

As the food safety bill, which would increase the U.S. Food and Drug Administration's authority and mandate over the food supply, has languished, an amendment by Sen. Jon Tester (D-MT), now also backed by Sen. Kay Hagan (D-NC), has gained widespread support. The measure would ease the regulatory burden on small farmers and producers.

The National Sustainable Agriculture Coalition (NSAC) and several other sustainable ag groups have been issuing a last round of action alerts to rally support for the Tester amendment.

"The bill takes important steps to improve corporate food safety rules but it is not appropriate for small farms and processors that sell to restaurants, food coops, groceries, schools, wholesalers and at farm stands and farmers markets," said NSAC in its alert late last week.

NSAC asked its supporters to call Senators in support of the Tester provision to prevent "one-size-fits-all" regulations from being created.

Though the details are still being worked out, insiders expect the Tester amendment to garner enough support to be added to the bill. The FDA Food Safety Modernization Act, also known as S. 510, is also expected to pass, with bipartisan support, this week.


To read more on the debate over small farm and producer exemptions, see Debate Over Small Farm Exemptions Rolls On, October 26, 2010.

Sunday, November 7, 2010

Biotechnology in fruit and vegetables: a lot of research, few approvals

(GMO Compass 23 October 2010) A multitude of plants bearing fruit and vegetables is the subject of research world-wide. Many plants developed in this manner with new traits have been tested successfully in greenhouses and in field trials. However, few endeavours currently are made towards the commercial use of such types of fruit and vegetables, as indicated by a study published in the current issue of the professional journal Nature Biotechnology.
To date, the commercial use of plants with new, biotechnologically-conferred traits has been restricted world-wide to soybeans, maize, rapeseed, cotton and, for the past four years, sugar beets.
For other cultivated plants – yielding fruit, vegetables, nuts and flowers – genetically modified (GM) varieties have not yet reached the market. Exceptions are the virus-resistant papayas that have been farmed on Hawaii for years and which in the meanwhile occupy 90 per cent of local fields and the GM squash (similar to zucchini) grown regionally in the USA, as well as GM carnations.
Fruits, vegetables and other ‘specialties’ are all of great significance in agriculture. However, new varieties with traits achieved through biotechnological processes have played no role to date. The reasons for this have been investigated in a study by Jamie Miller and Kent Bradford, two scientists at the University of California (Davis, USA). To do so, they assessed publications in scientific magazines and field trials with GM plants in 24 countries during a time period of almost six years (January 2003 to October 2008).
World-wide, 313 publications were registered on research projects with fruit, vegetables and other plant types. According to Miller and Bradford, a majority of cases indicated that the particular approach to the transfer of a new trait functioned in principle. In addition to the USA, the list compiled by the scientists cites publications from research groups from Europe, India, Japan, China, Brazil, South Korea, Israel, Tunisia and many other countries. During the time period under scrutiny, more than 800 field trials with such plants were conducted in the USA alone.
According to the study, "biotechnological plant research" addressed 77 ‘specialty types’ and transferred 206 various individual traits. The majority of these were farm-related traits (known as ‘input traits’), such as resistance to diseases or to pests but also such as an enhanced tolerance of drought, salt or heat stress. Increasingly, research projects aim towards modified product characteristics (‘output traits’) of nutrient composition or of enrichment with compounds beneficial to health.
However, this multifaceted and ‘successful’ research does not lead to commercial applications. According to Miller and Bradford, the ‘bottleneck’ is formed by the approval procedures to which all GM plants are subject world-wide and that have become more elaborate and demanding in the past years. Approvals for GM fruits and vegetables – such as tomatoes – mostly lie more than ten years in the past and new applications have not been submitted.
From the point of view of companies, new GM varieties of fruit and vegetables hardly are financially attractive. In addition to the costs associated with research, GM plants – in contrast to new breeds produced through other methods – are subject to costs incurred by the approval procedure. Miller and Bradford indicate a cost of as much as 15 million dollars for each new GM plant (event). A further consideration is that the market for such plant varieties as a rule is significantly smaller than is the case for field produce such as maize or soy.
A secondary risk for companies is consumer acceptance of food from GM plants. Such acceptance is difficult to anticipate and the rejection of such food is very pronounced in some regions. Collectively, reliable experience hardly exists with regard to consumer reaction towards GM varieties of fruit and vegetables.
In the opinion of both Californian scientists, the market introduction of such varieties will remain financially risky as long as their possible advantages are not more highly considered during approval.

Monday, November 1, 2010

U.S. Says Genes Should Not Be Eligible for Patents

New York Times, October 29, 2010

Reversing a longstanding policy, the federal government said on Friday that human and other genes should not be eligible for patents because they are part of nature. The new position could have a huge impact on medicine and on the biotechnology industry.

The new position was declared in a friend-of-the-court brief filed by the Department of Justice late Friday in a case involving two human genes linked to breast and ovarian cancer.

"We acknowledge that this conclusion is contrary to the longstanding practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA," the brief said.

It is not clear if the position in the legal brief, which appears to have been the result of discussions among various government agencies, will be put into effect by the Patent Office.

If it were, it is likely to draw protests from some biotechnology companies that say such patents are vital to the development of diagnostic tests, drugs and the emerging field of personalized medicine, in which drugs are tailored for individual patients based on their genes.

"It's major when the United States, in a filing, reverses decades of policies on an issue that everyone has been focused on for so long," said Edward Reines, a patent attorney who represents biotechnology companies.

The issue of gene patents has long been a controversial and emotional one. Opponents say that genes are products of nature, not inventions, and should be the common heritage of mankind. They say that locking up basic genetic information in patents actually impedes medical progress. Proponents say genes isolated from the body are chemicals that are different from those found in the body and therefore are eligible for patents.

The Patent and Trademark Office has sided with the proponents and has issued thousands of patents on genes of various organisms, including on an estimated 20 percent of human genes.

But in its brief, the government said it now believed that the mere isolation of a gene, without further alteration or manipulation, does not change its nature.

"The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is 'isolated' from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth,” the brief said.

However, the government suggested such a change would have limited impact on the biotechnology industry because man-made manipulations of DNA, like methods to create genetically modified crops or gene therapies, could still be patented. Dr. James P. Evans, a professor of genetics and medicine at the University of North Carolina, who headed a government advisory task force on gene patents, called the government’s brief “a bit of a landmark, kind of a line in the sand.”

He said that although gene patents had been issued for decades, the patentability of genes had never been examined in court.

That changed when the American Civil Liberties Union and the Public Patent Foundation organized various individuals, medical researchers and societies to file a lawsuit challenging patents held by Myriad Genetics and the University of Utah Research Foundation. The patents cover two genes, BRCA1 and BRCA2, and the over $3,000 analysis Myriad performs on the genes to see if women carry mutations that predispose them to breast and ovarian cancers.

In a surprise ruling in March, Judge Robert W. Sweet of the United States District Court in Manhattan ruled the patents invalid. He said that genes were important for the information they convey, and in that sense, an isolated gene was not really different from a gene in the body. The government said that that ruling prompted it to re-evaluate its policy.

Myriad and the University of Utah have appealed.

Saying that the questions in the case were "of great importance to the national economy, to medical science and to the public health," the Justice Department filed an amicus brief that sided with neither party. While the government took the plaintiffs' side on the issue of isolated DNA, it sided with Myriad on patentability of manipulated DNA.

Myriad and the plaintiffs did not comment on the government's brief by deadline for this article.

Mr. Reines, the attorney, who is with the firm of Weil Gotshal & Manges and is not involved in the main part of the Myriad case, said he thought the Patent Office opposed the new position but was overruled by other agencies. A hint is that no lawyer from the Patent Office was listed on the brief.