gmo labeling part 2• unknowing sale of product containing gmo ingredients • alcoholic beverages...

www.khlaw.com

Washington, D.C. ● Brussels ● San Francisco ● Shanghai ● Paris

GMO Labeling Part 2:The Current and Future Status of GMO Labeling

August 12, 2015

Evangelia C. PelonisCounsel

Keller and Heckman LLP1001 G Street NW

Suite 500 WestWashington, DC 20001

+1 [email protected]

mailto:[email protected]

│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 201522

Update on case challenging the VT GMlabeling law

Possible use of USDA Process Verifiedseal

House passes the Safe and AccurateFood Labeling Act

White House Announces UpdatedCoordinated Framework

GMO Labeling


FDA does not currently mandate labelingof food that contain GMO ingredientsunder 21 U.S.C. 321(n)

Reason:

• GMO ingredients pose no safety risks tohuman beings; and

• Food derived from GMO ingredients does notdiffer in any meaningful way from other food

GMO Labeling-Federal


FDA published draft guidance regardingvoluntary GM labeling in 2001

FDA concerned with “GMO Free”/”Non-GMO” claims because of potential abilityto mislead consumers

See FDA Guidance for Industry: “Voluntary Labeling Indicating Whether FoodsHave or Have Not Been Developed Using Bioengineering; Draft Guidance”(released January 2001), available athttp://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/labelingnutrition/ucm059098.htm

GMO Labeling-Federal

http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/labelingnutrition/ucm059098.htm

http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/labelingnutrition/ucm059098.htm


3 states passed GM labeling laws in 2013-2014

• Vermont

• Connecticut

• Maine

Oregon and Colorado considered GM ballotinitiatives on November 4, 2014 – Failed

Vermont’s law effective July 1, 2016

GMO Labeling-State Laws


Mandate only applies to the followingproducts sold at RETAIL:• Processed Food: choice of “partially produced

with genetic engineering,” “may be produced withgenetic engineering” or “produced with geneticengineering”

• Raw Agricultural Commodities (RAC):“produced with genetic engineering”

‒ must appear on packaging or shelf if RAC not separatelypackaged

• NOTE: If product subject to GMO labelingmandate, then manufacturer cannot also label oradvertise product as “natural”

GM Labeling under the VT Law


Labeling does not have to include:

• The identity of the GMO ingredient

• The placement of the term “geneticallyengineered” immediately preceding thecommon name or descriptor of theproduct (e.g. “GE syrup”)

GM Labeling under the VT Law


Exemptions from Labeling Requirements• Animals fed GMO food

• Unknowing sale of product containing GMO ingredients

• Alcoholic beverages

• Food containing less than 0.9% by weight GMOingredients

• 3rd Party Certification that food is GMO free

• Food produced using enzymes or processing aidsderived from GMO material

• Medical food

• Food intended for immediate human consumption andfood served in restaurants

VT: Exemptions


Vermont’s Attorney General has formallyadopted regulations to implement themandatory labeling requirement

• specify the scope of the labeling requirement

• provide details regarding requirements forclaim wording, prominence, and placement

Consumer Protection Rule 121http://www.ago.vermont.gov/assets/files/PressReleases/Consumer/Final%20Rule%20CP%20121.pdf

VT: Regulations

http://www.ago.vermont.gov/assets/files/PressReleases/Consumer/Final Rule CP 121.pdf




June 2014: Legal challenge of VT GM lawby GMA and other trade associations

• Trade Associations: challenged the law primarily onFirst Amendment, Commerce Clause, and preemptiongrounds

– Unconstitutional because violation of compelled commercialspeech rights under the First Amendment--state must showthey have a "substantial interest" to compel commercialspeech

– The plaintiffs also sought a preliminary injunction in the caseto prevent implementation until the lawsuit is resolved

VT Legal Challenge


• Vermont: Law not unconstitutional and notpreempted

– it only requires disclosure of fact

– manufacturer can add information to provide context toconsumer

VT Legal Challenge (continued)


On April 27, 2015, Judge Christina Reiss, Chief Judge ofthe U.S. District Court for the District of Vermont, allowedVermont’s law to stand

• denied the plaintiffs’ motion for a preliminaryinjunction (no irreparable harm)

• dismissed specific counts related to the CommerceClause (except for Internet)

• dismissed preemption-based challenges

The court did find that plaintiffs are likely to prevail ontheir claim that the law’s ban on the use of “natural”claims for foods containing or possibly containing GMingredients is unconstitutional

VT Law Survives First Challenge


In the context of the First Amendment challenge, theJudge Reiss said that Vermont’s labeling requirementdoes not warrant “strict scrutiny” and that “reasonablescrutiny” would be sufficient

In denying the plaintiffs’ motion for a preliminaryinjunction, the court did not appear to be persuaded thatplaintiffs would suffer “irreparable harm” pendingresolution by trial; instead, the judge concluded thatplaintiffs had identified only “the ‘possibility’ of harm”

Although several aspects of the plaintiffs’ challenge havesurvived the State’s Motion to Dismiss and proceed to atrial on the merits, future of plaintiff’s case is unclear

VT Law Survives First Challenge


Plaintiff/trade associations appealed theApril decision to the U.S. Court of Appealsfor the Second Circuit based on FirstAmendment grounds

Goal: get 2nd Circuit to agree to“intermediate scrutiny” (Central Hudson)

• Position that “reasonable scrutiny”inappropriate because although label is factualit is misleading

VT Law: Appeal to Second Circuit


Industry continues to hope that the judiciarycould stay (whether temporarily orpermanently) the implementation of theVermont law, which currently is set to takeeffect on July 1, 2016

VT Law: Appeal to Second Circuit


On May 1, 2015, USDA Secretary TomVilsack wrote a letter explaining thatAgricultural Marketing Service (AMS) hadfor the first time reviewed non-GMOproducts to use the "USDA ProcessVerified" Seal

"USDA Process Verified" Seal


Letter to Agency employees but picked upby the AP

The seal is for use on agricultural products

Here, the seal was permitted on soy andcorn products produced by SunOpta



USDA AMS certifies that the company's internalstandard has been met based on auditing theirdocumented quality management system

This is not a new government standard thatdefines non-GMO

Letter says that other companies are pursuingthe use of the seal on non-GMO agriculturalproducts

Success and use of program unclear



Safe and Accurate Food Labeling Act of2015 (H.R. 1599)• March 25, 2015: Reps. Mike Pompeo (R-Kan.) and G. Butterfield

re-introduced the bill

• June 10, 2015: Pompeo and Butterfield circulated a reviseddiscussion draft

• June 18, 2015: the House Subcommittee on Health held ameeting to discuss the role biotechnology plays on the nation’sfarms, food supply, and economy

– Industry and legal experts explained impact of state GM labeling requirementson interstate commerce and consumers

• July 23, 2015: the House passed the Act in a 275-150 vote

• Opposition call the bill the DARK (Deny Americans the Right toKnow) Act

Federal GMO Bills


As passed, the bill would:

1) require the submission of a premarket biotechnologynotification to FDA for any new GM organism intended to beused in food applications (akin to FDA’s current voluntaryconsultation process);

2) permit FDA to require “GM labeling” only where there is a“material difference” between the GM food and itsconventional counterpart (in terms of functional, nutritional,compositional, allergenic, or other properties), and wherethe “disclosure of such material difference is necessary toprotect public health and safety or to prevent the label orlabeling of the food so produced from being false ormisleading in any particular”;

Safe and Accurate Food Labeling Act


3) require USDA to maintain and publish an Internetregistry of all GM crops permitted for use in foodapplications;

4) establish a certification program administered by USDA topermit voluntary “non-GM” claims on food labels (akin tothe current USDA organic labeling regime);

5) require FDA to promulgate regulations defining the term“natural” for use on food labels; and

6) preempt state and local restrictions on GM crops and GMfoods and any labeling requirements related to “GM”claims or “natural” claims



As part of the vote, the House considered andrejected four amendments that would have:• prohibited the use of the term “natural” on foods containing GM

components (Rosa DeLauro, D-Connecticut);

• struck and replaced the entire bill with only the section creating avoluntary “non-GM” claim program administered by USDA(Chellie Pingree, D-Maine);

• required any U.S. company that labels foods as containing GMcomponents for foreign markets to label its products in the sameway for the domestic market (Peter DeFazio, D-Oregon); and

• preserved tribal sovereignty to restrict the cultivation of GMcrops on tribal lands (Jared Huffman, D-California).



Since 1992, the U.S. government has regulatedGMOs under a regulatory framework called the“Coordinated Framework for the Regulation ofBiotechnology” (Coordinated Framework), whichexplains the different roles played by the threemajor agencies:



1. FDA regulates GMOs under the Federal Food, Drug, andCosmetic Act, and ensures the safety and proper labeling ofGMO-derived foods and feed

2. EPA regulates plant-incorporated protectants — a type ofpesticide that is bioengineered into crops — under the FederalInsecticide, Fungicide, and Rodenticide Act (FIFRA), and setstolerance limits or exemptions from tolerance for pesticideresidues on or in food and animal feed; EPA also regulatescertain biological control organisms under the Toxic ControlSubstances Act (TSCA)

3. USDA’s Animal and Plant Health Inspection Service (APHIS)regulates GMOs under the Plant Pest Act; APHIS reviews GMcrops to determine whether they meet the definition of a “plantpest” and may pose risks to domestic agriculture



White House announced that FDA, EPA andUSDA will update the Coordinated Frameworkto reflect advances in science and technologysince 1992

Memo sent to heads of agencies says existingGMO regulatory framework has created“unnecessary costs and burdens associatedwith uncertainty about agency jurisdiction, lackof predictability of timeframes for review, andother processes. . .”

Agencies to update and modernize their rules


www.khlaw.com

Washington, D.C. ● Brussels ● San Francisco ● Shanghai ● Paris

Thank You!

Evangelia C. Pelonis+1 202.434.4106

[email protected]

Please check out our new daily blog:www.dailyintakeblog.com

mailto:[email protected]

http://www.dailyintakeblog.com/

gmo labeling part 2• unknowing sale of product containing gmo ingredients • alcoholic beverages...

Documents