At the end of last year, the FDA released the third major final rule under the Food Safety Modernization Act (FSMA): the Produce Safety Rule.
This rule governs how farmers raise and harvest fruits, vegetables, nuts, mushrooms and sprouts. It covers an incredibly wide range of issues, including building and equipment standards, employee training, water quality and testing, wildlife contact, grazing and working animals, and more. While the rule does not include any fees, the FDA estimates that it could cost twenty-five thousand dollars annually for a small to mid-size farm to comply—a crippling sum for many farmers.
So the first and most important question is: does this rule apply to you? The rule applies to businesses that grow, harvest, pack or hold produce. If your only products are meat or value-added, then the rule doesn’t apply to you.
For produce farmers, the rule contains three blanket exemptions:
1. Produce grown for personal consumption;
2. Farms that sell less than twenty-five thousand dollars of produce annually (adjusted for inflation);
3. Farms that only raise produce that FDA determined is “rarely consumed raw.”
For the last exemption, FDA has created an exhaustive list: asparagus; black beans, great northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplant; figs; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts. Some of the items on this list are puzzling, but the issue isn’t whether or not you agree that these foods are rarely consumed raw; under the regulation, if you grow only these crops, you are exempt.
If you grow, harvest, pack, or hold produce, and do not fit into one of those three exemptions, then you are subject to at least some portion of the Produce Safety Rule.
Produce that is going to be processed with a kill step (such as in canning) is subject to the record keeping and some other portions of the rule, but not subject to the more costly requirements on how it is grown and harvested.
The largest exemption comes from the Tester-Hagan provision, which WAPF and other organizations fought to include when Congress passed FSMA. Farmers who sell less than five hundred thousand dollars worth annually of all food (adjusted for inflation) and who sell more than half directly to “qualified end users” are exempt from most of the requirements. “Qualified end users” include both individual consumers wherever they are located and restaurants or retailers that are either within the same state or the same Indian reservation as the farm or within two hundred seventy-five miles of the farm. The retailers and restaurants must in turn sell directly to the consumer, so that the farmer is not more than one step removed from the final consumer for the majority of the farm’s sales.
Farmers who are exempt under the Tester-Hagan provision must:
1. Keep records to prove that they qualify and
2. Label their food or have a sign at the point of sale with the name and full physical address of the farm.
If the farm is connected to a foodborne illness outbreak, or the FDA determines that there are conditions at the farm that threaten human health, the agency can revoke the exemption on a case-by-case basis.
If not exempted, produce farmers will have between two and four years to come into compliance with the substantive provisions of the regulations, depending on their size. There remains significant ambiguity about how many of the provisions apply to real-world situations, and the FDA has stated that it plans to issue guidance documents.
This article does not constitute legal advice. Please consult an attorney if you have questions about the regulations that apply to your farm.
RAW CHEESE UPDATE
Last year, FDA added a new dimension to its attacks on raw cheese by calling for comments on the topic of “potential intervention measures to reduce the risk of foodborne illness” from raw milk cheeses. The underlying premise was that more regulations are needed—despite statistics showing that aged raw milk cheeses are the source of remarkably few illnesses. WAPF responded with in-depth comments on the current safety measures that are already in place and the science supporting the safety of aged raw cheeses. WAPF’s comments to FDA are available at westonaprice.org/press/raw-milk-cheese-as-safe-as-pasteurized/.
While FDA has made no public announcements since the comment period closed, the American Cheese Society (ACS) recently announced that it met with the FDA in mid-February to discuss the issue of raw cheese regulation. Seven cheesemakers, ranging in size from a producer who makes twenty pounds of cheese per week to producers who make more than twenty thousand pounds of cheese per week, spoke with FDA personnel about their operations. ACS has not released the text of their testimony.
ACS has stated that the next step is to “gather industry stakeholders, scientists, technical experts, and FDA regulators to discuss the effectiveness of current regulations, and to determine what preventive controls, based on scientific data and FSMA compliance requirements, truly make sense for the cheesemaking community.” ACS has a somewhat worrisome history of highlighting its close relationship with FDA while not standing up for producers under attack by FDA, so it bears close watching as to who is included in these meetings.
In 2006, there were six artisan cheesemakers in the U.S. while today there are over two thousand, many of whom produces raw cheese.
GMO LABELING FIGHT HEATS UP
Last summer, the U.S. House of Representatives passed a bill, nicknamed the Deny Americans the Right to Know (DARK) Act, that would overturn all state laws on the labeling of GMOs and permanently enshrine the failed federal policy of “voluntary” labeling.
Although the grassroots opposition successfully stalled the bill for several months, the DARK Act is now rearing its ugly head in the U.S. Senate. On March 1, Senator Pat Roberts (R-KS) pushed the Senate version, S.2169, through the Senate Agriculture Committee by a vote of fourteen to six. Three Democrats—Senators Joe Donnelly (IN), Heidi Heitkamp (ND) and Amy Klobuchar (MN)—joined all the committee Republicans in advancing Roberts’ legislation.
In response, Senators Jeff Merkley (D-OR), Patrick Leahy (D-VT), Jon Tester (D-MT), and Bernie Sanders (I-VT), have filed a competing bill which would also pre-empt state laws—but by establishing a mandatory federal labeling requirement. Under Merkley’s bill, food companies would either have to include the words “genetically engineered” next to each GMO ingredient or in a notation at the bottom of the ingredient list, or use a symbol that would be established by the FDA (such as a “T” for transgenic in a triangle, as Brazil does). The last option is obviously the least useful and poses concern for those who have been fighting for transparency in our food system. Even so, the Merkley bill would at least provide for mandatory, on-package labels, which is more than we have now and far more than the DARK Act would provide.
It’s likely that the DARK Act cannot pass as it is currently written. However, there’s talk of a compromise that would involve QR codes—the small boxes on packages that can be scanned by a smartphone, which then takes you to the website where you can hunt for product information. Such codes are not an appropriate substitute for on-package labeling, and the only reason to use them is to hide information from consumers. More discussion on the problems with QR codes is in the Winter 2015 issue of Wise Traditions. Several legislators who have stated that they oppose the DARK Act have indicated that they would vote for this sort of a hollow compromise, raising concerns that it may have enough votes to pass.
We know that the biotech industry and big food companies desperately want a federal bill to pass before July 1, when the Vermont law for mandatory GMO labels would go into effect. Please watch for action alerts and take the time to call your members of Congress! Americans have the right to know—just as the citizens of over sixty other countries already do—whether there are GMOs in their food.