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You Are Here Sunflower Magazine > Sunflower & the Produce Rule


Sunflower Magazine

Sunflower & the Produce Rule
November 2013

There has been a lot of confusion recently about whether the Food and Drug Administration (FDA) will regulate sunflower seed in its Produce Rule under the Food Safety and Modernization Act (FSMA). FDA is accepting comments on the Proposed Rule until November 15. The National Sunflower Association (NSA) is submitting comments on the Rule and encourages industry and sunflower producers to do so as well.

Congress enacted the FSMA in response to growing public concern about food-borne illnesses — particularly salmonella and E. coli — transmitted by contaminated fruits, vegetables, and meat. The goal of the Act is to move toward a food safety system that is more focused on preventing food-borne illness than just detecting it.

The focus of the Produce Rule, one of five included in the legislation, is on foods consumed in raw form by humans. It sets thresholds for determining which raw commodities consumed by humans should be regulated. Produce consumed in raw form by more than 0.1% of the U.S. population, and on more than 0.1% of “eating occasions,” would be subject to the Rule.

The Rule uses data from the National Health and Nutrition Examination Survey (NHANES) to determine which produce crops — almost all of which are fruits and vegetables — exceed these thresholds. NHANES is a program of studies performed by the Center for Disease Control and Prevention to assess health and nutritional status based on in-depth surveys questioning people about what they have recently eaten.

The Rule specifically exempts food grains and oilseeds, including barley, corn, sorghum, wheat, soybeans, cottonseed and “other plants used in the same fashion.” While sunflower seed is not listed, there is no question that it should be exempt: 86% of the annual sunflower crop is produced for oil. Of the % of the crop produced for nonoil use (confectionery seed), 13.9% are roasted, heat-treated, or exported. That leaves only 0.1% of annual sunflower production that is consumed raw by humans, either in-shell or in kernel form.

It is virtually impossible to evaluate whether such a miniscule part of the sunflower crop meets the 0.1% population and “eating occasion” thresholds established under the Produce Rule. In fact, sunflower seeds are so rarely consumed raw that they are not listed by NHANES as a food queried to or responded with by those surveyed.

The question is whether human consumption of one-tenth of one percent of sunflower production warrants subjecting the entire crop to the same sanitary production, harvesting and processing standards as fruits and vegetables, which are widely consumed in raw form. If FDA were to make such a decision, farmers would respond by simply not growing the crop. Even the European Union does not impose such exacting requirements under its highly regulated agricultural system.

This clearly was not the intent of Congress in enacting the FSMA. The NSA is working in Washington, D.C., to convince FDA to exempt all sunflower seed from the Produce Rule. While we are confident that the facts warrant an exemption for sunflower seed, it should not be assumed this will happen on its own. To that end, the NSA is submitting detailed comments to FDA outlining why the exemption is justified. And we ask all sunflower growers and companies in our industry to submit comments to FDA before the November 15 deadline. We also ask that you send copies of your comments to — and then contact members of — your congressional delegation to urge them to meet with FDA officials and raise their concern with the Rule during the next month.

The economic viability of our industry is at risk. There are many things going on in Washington that none of us can control or influence. But application of the FSMA Produce Rule to sunflower is not one of them. You can make a significant difference.

The address at FDA for comments and contact details for Members of Congress from sunflower states are provided below.





Div. of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, RM 1061

Rockville, MD 20852

Re: Docket No. FDA-2011-N-0921; Regulatory Information

Number RIN 0910-AG35; 21 CFR parts 1, 16, 106, et al - Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (‘the “Proposed Rule” or “Proposal”).

www.regulations.gov



Senator Heidi Heitkamp (ND)

502 Hart Senate Office Building

Washington, DC 20510

(202) 224-2043

Heidi Heitkamp's email



Senator John Hoeven (ND)

338 Russell Senate Office Building

Washington, DC 20510

(202) 224-2551

John Hoeven’s email

Congressman Kevin Cramer (ND)

1032 Longworth House Office Building

Washington, DC 20515

(202) 225-2611

Kevin Cramer's Email



Senator Al Franken (MN)

309 Hart Senate Office Building

Washington, DC 20510

(202) 224-5641

Al Franken's email



Senator Amy Klobuchar (MN)

302 Hart Senate Office Building

Washington, DC 20510

(202) 224-3244

Amy Klobuchar's email



Congressman Collin Peterson (MN-7)

2109 Rayburn House Office Building

Washington, DC 20515

(202) 225-2165

Collin Peterson's email



Senator Tim Johnson (SD)

136 Hart Senate Office Building

Washington, DC 20510

(202) 224-5842

Tim Johnson's email



Senator John Thune (SD)

511 Dirksen Senate Office Building

Washington, DC 20510

(202) 224-2321

John Thune's email



Congresswoman Kristi Noem (SD)

1323 Longworth House Office Building

Washington, DC 20515

(202) 225-2801

Kristi Noem's email



Senator Deb Fischer (NE)

383 Russell Senate Office Building

Washington, DC 20510

(202) 224-6551

Deb Fischer's email



Senator Mike Johanns (NE)

404 Russell Senate Office Building

Washington, DC 20510

(202) 224-4224

Mike Johann's email



Congressman Adrian Smith (NE)

2241 Rayburn House Office Building

Washington, DC 20515

(202) 225-6435

Adrian Smith's email



Senator Jerry Moran (KS)

361A Russell Senate Office Building

Washington, DC 20510

(202) 224-6521

Jerry Moran's email



Senator Pat Roberts (KS)

109 Hart Senate Office Building

Washington, DC 20510

(202) 224-4774

Pat Roberts' email



Congressman Tim Huelskamp (KS-1)

129 Cannon House Office Building

Washington, DC 20515

(202) 225-2715

Tim Huelskamp's email



Senator Michael F. Bennet (CO)

458 Russell Senate Office Building

Washington, DC 20510

(202) 224-5852

Michael F. Bennet's email



Senator Mark Udall (CO)

730 Hart Senate Office Building

Washington, DC 20510

(202) 224-5941

Mark Udall's email



Congressman Cory Gardner (CO-4)

213 Cannon House Office Building

Washington, DC 20515

(202) 225-4676

Cory Gardner's email



Senator John Cornyn (TX)

517 Hart Senate Office Building

Washington, DC 20510

(202) 224-2934

John Cornyn's email



Senator Ted Cruz (TX)

185 Dirksen Senate Office Building

Washington, DC 20510

(202) 224-5922

Ted Cruz's email



Congressman Mac Thornberry (TX-13)

2329 Rayburn House Office Building

Washington, D.C. 20515

(202) 225-3706

Mac Thornberry's email



Congressman Mike Conaway (TX-11)

2430 Rayburn House Office Building

Washington, DC 20515

(202) 225-3605

Mike Conaway's email



Congressman Randy Neugebauer (TX-19)

1424 Longworth House Office Building

Washington, DC 20515

(202) 225-4005

Randy Neugebauer's email



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