June 4, 2015
TO: JPA Members
FROM: Patricia Faison
JPA Regulatory Update
(1) FDA Publishes Draft Guidance on Voluntary Qualified Importer Program
(2) Organic Industry Proposed Check-Off Program
(3) EPA Issues Proposed Rule Establishing 2016 Renewable Fuel Standards
FDA Publishes Draft Guidance on Voluntary Qualified Importer Program
On June 4, 2015, JPA members were notified that the Food and Drug Administration (FDA) had announced publication of the "Draft Guidance for Industry: FDA's Voluntary Qualified Importer Program," a voluntary, fee-based program for the expedited review and importation of foods into the U.S., which can be accessed here. The FDA recently issued the Federal Register notice (80 FR 32136; June 5, 2015), available here, with additional details regarding the proposed requirements.
Of particular note, the FDA estimates at this time, a flat fee of $16,400 will be paid by all VQIP participants. The Agency is requesting comments on whether and how this fee might be a burden on small businesses. The FDA notes that after considering all comments, the Agency will publish a notice in the Federal Register advising of the actual fee for participating importers. The Agency also estimates that up to 200 qualified importers will be accepted in the first year of the program - 2018. The FDA also estimates that it will take 80 hours for the importer to compile the necessary information and complete the VQIP application. Further, the Agency estimates an additonal 20 hours will be required each year to renew the application.
As noted earlier, comments must be submitted to the FDA on the draft guidance by August 19, 2015. Comments related to the proposed collection of information referenced in the Federal Register notice must be submitted by August 4, 2015. If you believe JPA should submit comments to the FDA regarding the draft guidance, please provide your input to me by the close of business on July 3, 2015.
Organic Industry Proposed Check-Off Program
On May 13, 2015, JPA staff notified members that the Organic Trade Association (OTA) announced a petition had been submitted to the United States Department of Agriculture (USDA) to implement a research and promotion check-off program for the organic industry. It was noted that the organic check-off program (known as GRO Organic (Generic Research and Promotion Order for Organic)) could raise more than $30 million for the organic industry with the program designed to address the industry's most pressing needs.
The USDA recently issued a notice, available here, announcing the Agency will accept alternative proposals or partial proposals on an organic industry promotion, research and information order until July 20, 2015. The Agency had earlier established June 19 as the deadling but due to requests from organic stakeholders for additional time, the deadline has been extended 30 days.
JPA will continue to monitor and provide updates, as information becomes available.
EPA Issues Proposed Rule Establishing 2014, 2015 and 2016 Renewable Fuel Standards
Updates regarding the Renewable Fuel Standard (RFS) have been previously shared with members. The RFS requires transportation fuel to contain a minimum volume of fuel made from renewable materials (e.g., corn-based ethanol) and establishes minimum requirements for production of renewable fuels each year. There is concern that the significant amount of corn diverted by the RFS to fuel production increases the cost of corn for food and animal feed. Earlier this year, JPA members were notified that three bills had been introduced in Congress to repeal the RFS and eliminate the volume of fuel made from renewable materials like corn-based ethanol.
Today, the Environmental Protection Agency (EPA) issued a proposed rule in the Federal Register (80 FR 33100; June 10, 2015), available here, to establish annual percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuels that apply to all motor vehicle gasoline and diesel produced or imported in 2014, 2015 and 2016. The EPA has published a Fact Sheet, available here, summarizing the proposed requirements. The EPA is proposing renewable fuel volumes below those established by Congress but the volumes would be increased above historical levels in the U.S.
- In part, the EPA is proposing toIncrease the cellulosic biofuel standard from 33 million ethanol-equivalent gallons in 2014 to 106 million ethanol-equivalent gallons for 2015 and 2016 million ethanol-equivalent gallons in 2016.
- Increase the required volume of biomass-based diesel from 1.63 billion gallons in 2014 to 1.7, 1.8 and 1.9 billion gallons for the years 2015, 2016 and 2017, respectively.
- For 2015 and 2016, increase the volume of advance biofuel from 2.68 billion gallons in 2014 to 2.9 billion gallons in 2015 and 3.4 billion gallons in 2016.
- For 2015 and 2016, increase the volume of total renewable fuel from 15.93 billion gallons in 2014 to 16.3 billion gallons in 2015 and 17.4 billion gallons in 2016.
The EPA is accepting comments on the proposed volume requirements by July 27, 2015. The Agency intends to take final action on the proposal by November 30, 2015.
Please do not hesitate to contact me with questions or comments.
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