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Policy and Regulation » North America

Title: Major Upcoming Developments in the USDA's Regulatory System on GMOs
Publication date: February 02, 2017
Posting date: February 02, 2017

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

 

Dear Friends and Colleagues

Major Upcoming Developments in the USDA's Regulatory System on GMOs

The US Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) is required to complete a study prior to drafting disclosure rules by July 2018, but the lack of funds has left the fate of the GMO disclosure law in limbo (Item 1). The law tasks the AMS to complete the rules by July 2018 and gives the agency broad authority to define the scope of the requirements while finalising three methods of disclosure.

The AMS is to create label language as well as a symbol that would indicate the presence of GM ingredients, and also outline how companies could comply with the law by adding an electronic label to food products, such as a Quick Response (QR) code that consumers can scan with a smartphone. But first the AMS must complete a study, which was mandated by lawmakers concerned about whether consumers had the tools to rely on electronic disclosures. The study is to assess the potential technological challenges that could impact whether consumers would use QR codes and other electronic methods to access information about GMOs in food products. If the study finds that there are significant technological challenges, the AMS may have to revise the use of electronic disclosure methods to remedy the concern.

It is surprising, therefore, that there are companies already set to use the QR code. The first GMO apples, engineered to resist browning when sliced, will arrive in select midwestern U.S. stores this February (Item 2). The fruit, produced by Okanagan Specialty Fruits and sold under the brand name Arctic Apples, will be packaged as "grab-and-go" slices. A customer will only know that the fruit is GM by scanning the packaging with a smartphone. The company says it is adhering to the new GMO food labeling act which allows businesses to use a QR code instead of clear wording that informs consumers if a product contains GMO ingredients.

Meanwhile, the USDA's Animal and Plant Health Inspection Service (APHIS) has recently published a proposal to overhaul its GMO regulations (Item 3). The revisions would be the first comprehensive revision of the agency's biotechnology regulations since they were established in 1987. The proposed revamp would fundamentally change how APHIS tackles which products to regulate, by creating a new trigger for regulation and by revising definitions to enable the agency to potentially address a broader array of biotechnology products, including those made with new gene silencing technologies.

Independent scientists have noted that while the proposed definition of genetic engineering would include gene-editing techniques, loopholes would still exempt simple gene-edited products. In addition, the proposed safety assessment (a weed risk analysis) still focuses on plant pest/noxious weed risk and is weaker than previous requirements. The proposed rule is available for public review and comments till May 19, 2017. 

 

With best wishes,

Third World Network
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Malaysia
Email: twn@twnetwork.org
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____________________________________________________________________________

Item 1

US GMO FOOD DISCLOSURE RULES REMAIN IN LIMBO

J R Pegg
Agrow

20 January 2017

https://www.agra-net.com/agra/agrow/markets-regulatory/north-america/us-gmo-food-disclosure-rules-remain-in-limbo--1.htm

USDA officials continue to struggle to find the money needed to jumpstart implementation of the national GMO (genetically modified organsim) disclosure law. The statute requires the USDA's Agricultural Marketing Service (AMS) to complete a study prior to drafting disclosure rules, but lack of funds has left the agency and the fate of the GMO disclosure law in limbo.

"In terms of the study, we are working to identify funding at this time," an AMS spokesperson has told Agrow. "So, no award has been made."

The continued delay adds to uncertainty about the future of the GMO disclosure law. It remains unclear if the statute has support from the Trump administration and even if the new White House is on board. The AMS faces an aggressive timeline for implementation. The law calls on the AMS to complete the rules by July 2018 and gives the agency broad authority to define the scope of the requirements while finalising three methods of disclosure.

The AMS would create label language as well as a symbol that would indicate the presence of GM ingredients and would also outline how companies could comply with the law by adding an electronic label to food products, such as a Quick Response (QR) code, that consumers can scan with a smartphone.

But first the AMS must complete the required study, which was mandated by lawmakers concerned about whether consumers had the tools to rely on electronic disclosures. The study is intended to assess the potential technological challenges that could impact whether consumers would use QR codes and other electronic disclosure methods to access information about GMOs in food products. If the study finds that there are significant technological challenges, the AMS may have to revise the use of electronic disclosure methods to remedy the concern.

The July deadline includes time for the public to comment on its findings. The AMS put out a request last October and called for interested parties to commit to submitting the study by May 30th.

Despite the lingering delays, the AMS "fully expects to meet all deadlines set forth in the law", the spokesperson said. The advanced notice of proposed rulemaking for the disclosure rules is "currently expected” to be published in early 2017, he added.
 


Item 2

GMO ARCTIC APPLES TO HIT SHELVES NEXT MONTH WITHOUT CLEAR LABELING

Lorraine Chow
EcoWatch

19 January 2017
http://www.ecowatch.com/gmo-arctic-apples-hit-shelves-2201013702.html

The first genetically modified (GMO) apples, which are engineered to resist browning when sliced, will arrive in select midwestern U.S. stores next month. The fruit, produced by Okanagan Specialty Fruits and sold under the brand name Arctic Apples, will be packaged as "grab-and-go" slices, according to Capital Press.

A customer will only know that the fruit is genetically modified by scanning the packaging with a smartphone. The company is adhering to the new GMO food labeling act which allows businesses to use a QR code instead of clear wording that informs consumers if a product contains GMO ingredients.

"We are selling it under the Arctic brand and we've had a lot of press and attention, so I assume most people will know what it is," Okanagan's founder and president Neal Carter told Capital Press.

The company's product can be identified with its logo of a snowflake inside an apple outline.

The apples first stirred up controversy in February 2015 when the U.S. Department of Agriculture (USDA) approved an aesthetically-improved genetically engineered food for the first time.

In order to prevent apples from browning, the company "silenced" an enzyme called polyphenol oxidase (PPO) that drives oxidation in apples. The benefit of these apples, as the company said, is that it cuts down food waste—about 40 percent of apples are currently wasted, with much of that waste from superficial bruising and browning.

Like the industry norm, Arctic Apples do not fully oxidize for three weeks after being cut into but without the flavor-altering, chemical additives used by the traditional sliced apple business.

The cost savings "can be huge," Carter told NPR. "Right now, to make fresh-cut apple slices and put them in the bag, 35 or 40 percent of the cost is the antioxident treatment. So you could make a fresh-cut apple slice 30 percent cheaper."

Okanagan touts that its Arctic Goldens, the variety that will hit shelves next month, "offer the same nutritional value as the conventional Golden Delicious apple you know and love, but do so even better, especially as ready to eat, preservative free slices!"

The company will also be selling GMO Granny Smith and Fuji in the future after gaining USDA approval. The USDA deregulated the GMO Fuji apple in September despite receiving more than 620 comments from individuals and consumer groups who were opposed to the variety, GMO food in general, as well as concerns over a lack of clear GMO labeling.

"It's not only an unnecessary product, but the risks have not been fully examined," said Wenonah Hauter, executive director of Food & Water Watch.

Hauter added that there could be unintentional consequences of the fruit.

"Regulators have glossed over the possible unintentional effects of this technology, including the potential economic impacts on farmers, the potential of contamination for non-GMO and organic apple crops and the potential impact of the non-browning gene silencing, which could also weaken plant defenses and plant health," she said.

Carter told Capital Press that Midwestern retailers were chosen for the first sales this winter because they seemed like a good fit demographically.

When the publication asked if Midwest consumers may be more accepting of GMO apples compared to the East or West coasts, Carter said consumer research did not indicate that and that it was not a consideration.

"We don't want to skew our test marketing results by choosing stores that may be more friendly to genetic engineering," he said.

Five hundred, 40-pound boxes of Arctic Goldens will be sold at 10 unnamed stores in the Midwest in February and March. Okanagan is aiming to produce more than 6,000 more boxes of the fruit for the region after the fall 2017 crop.


Item 3

USDA PUBLISHES PLAN TO OVERHAUL GMO RULES

J R Pegg
Agrow

20 January 2017

https://www.agra-net.com/agra/agrow/markets-regulatory/north-america/usda-publishes-plan-to-overhaul-gmo-rules--1.htm

The USDA's Animal and Plant Health Inspection Service (APHIS) has published a proposal to overhaul its genetically modified organism regulations, calling for sweeping changes to reflect the changing landscape of biotechnology.

The revisions would be the first comprehensive revision of the agency's biotechnology regulations since they were established in 1987. The proposed revamp would fundamentally change how the APHIS tackles which products to regulate by creating a new trigger for regulation and by revising definitions to enable the agency to potentially address a broader array of biotechnology products, including those made with new gene silencing technologies.

The plan would also implement the agency's authority to regulate GM plants that may pose noxious weed risks. The APHIS was given this oversight in 2000 but has yet to incorporate it into its biotechnology regulations.

"The proposed rule is based on the best available science, will better enable APHIS to focus its resources on regulating genetically engineered organisms that may pose plant pest or noxious weed risks, and will enhance regulatory flexibilities that stimulate innovation and competitiveness," the agency states.

The regulations in question govern the introduction, importation, interstate movement and field testing of GM plants and organisms. Currently, the APHIS considers all new GMOs as "regulated" until it assesses if the product falls under its authority and determines if it poses a plant pest or noxious weed risk. The APHIS explains the existing approach as "regulate first and analyse later", being focused on the process of modification, rather than the product.

The proposal would effectively flip that approach, shifting to a framework that first assesses new GMOs to determine if they pose plant pest or noxious weed risks before regulating. Products that meet the criteria for regulation and are not exempted would undergo a regulatory review, including a plant pest and/or noxious weed risk analysis process. If any risk was confirmed, the APHIS would then impose regulatory controls.

The agency is also proposing to no longer strictly regulate on the basis of whether or not a GMO was created using genetic material from a plant pest. "Our experience has shown that the use of genetic material from plant pests has not resulted in the creation of plant pest risks in recipient organisms," the APHIS explains. "We would only regulate if the GE organism itself posed a plant pest or noxious weed risk."

The rule is "likely to result in a broader range of GM organisms being required to come in for review, but fewer would be subject to regulatory controls by APHIS over movement via permitting".

The push by the APHIS at the close of the Obama administration suggests that agency officials remain keen to finally change the much-criticised GMO regulations, but it is unclear whether the incoming Trump administration will support the effort.

A past rulemaking, launched in 2008, stalled and was abandoned in 2015. The new proposal comes amid increased concern from environmentalists and the Government Accountability Office about the inability of the APHIS to regulate GM crops and plants made with new gene editing tools.

Last year, the agency confirmed that it lacked the authority to regulate a non-browning mushroom and a pink flesh pineapple that were made with CRISPR-Cas9 gene editing technology.

Food advocacy and environmentalists have long pressed the APHIS to tighten its regulations, arguing that the existing rules rely too much on industry data and fail to adequately assess the safety of GM crops for human and animal consumption.

Biotechnology companies and researchers, however, see the existing rules as cumbersome and say that they discourage innovation into new GM products.

The agency's proposal has already drawn sceptism from grower groups and the American Farm Bureau Federation, which questioned the need for a major overhaul of the GMO regulatory regime. Critics have voiced concern that the proposal could needlessly expand the APHIS' authority and disrupt trade with foreign markets.

The APHIS will take comments on the proposal until May 19th and intends to have public meetings to discuss its plan during the comment period.


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