Even after the long fight over the passage of the Food Safety Modernization Act (FSMA), the reality is that much of the work is just now beginning. The real-world impact of the FSMA will depend in large part on how the agency implements it through the rulemaking process and how much funding Congress allocates.
The appropriations process began in earnest in late May, when the House Agricultural Appropriations Subcommittee released the initial draft of the appropriations bill for Fiscal Year (FY) 2012 agriculture, rural development, the Food and Drug Administration, and related agencies. The FDA’s total budget is a staggering 3.65 billion dollars, yet even that is 560 million dollars less than what the agency had requested. The bill includes anticipated revenues from user fees under the FSMA, specifically twelve million dollars from recall fees, fourteen million dollars from food reinspection fees, and thirty-six million dollars for voluntary qualified importer program fees. WAPF has opposed the imposition of user fees because they are effectively a “food tax” and because they could disproportionately impact small- and medium-scale producers. Fortunately, the amount allocated for user fees on domestic producers is relatively small, although we will closely monitor the situation as the appropriations bill moves through the process.
Ultimately, the real issue is how FDA will use its funds, whether appropriated by Congress or from user fees. While the Tester-Hagan amendment protects direct-marketing, smallscale producers from having to develop HACCP plans, they remain subject to inspection as they were even before the FSMA passed. In addition, medium-scale producers and those who do not direct-market most of their products are subject to the full scope of the bill. Both types of producers could therefore be impacted by the proposed user fees and by how FDA chooses to prioritize its inspection and enforcement actions. Thus, the FDA’s budget, and how it uses it, is a significant issue for our farmers and producers.
The other prong of FSMA implementation is the rulemaking process. In early May, FDA issued the first new rules under the Food Safety Modernization Act (FSMA), meeting the first deadlines imposed by the Act. Both of these rules were issued as “interim final rules,” which means they will go into effect even before the public comment period closes. This method was specifically directed in the FSMA.
The first rule addresses prior notice of food shipments imported from other countries. Under current law, anyone who is importing food that is subject to FDA’s jurisdiction (that is, anything except meat, poultry or egg products) must submit prior notification to the FDA. (See 21 C.F.R. § 1.278-1.279.) The FSMA added the new requirement that such notice include “any country to which the article has been refused entry.” (FSMA Sec. 304.) The FDA’s new rule amends the regulations accordingly.
The second rule addresses the standard for FDA to administratively detain food. Administrative detention is a limited enforcement power — the agency can detain an article of food for no more than thirty days. (See 21 C.F.R. § 1.379.) The purpose of the detention is to keep the food out of commerce while the FDA institutes a seizure or injunction action.
The FSMA lowered the standard necessary for FDA to administratively detain food, from “credible evidence” that the food “presents a threat of serious adverse health consequences of death” to “reason to believe” that the food is “adulterated or misbranded.” The FDA’s recent interim rule incorporates the new, lower standard.
We strongly disagree with the lowering of the standard. The practical impact of the change, however, is unclear. In the preamble to the new rule, FDA notes that, while it was given authority to administratively detain food in 2002, it has never used that authority, but instead has relied on the other enforcement tools in its arsenal. (76 Fed. Reg. 25538, 25540.) But the agency also noted that, with the lower standard, it is “more likely to use administrative detention” when the food “may cause temporary or medically reversible adverse health consequences.” (76 Fed. Reg. 25540.) So the FDA may begin using administrative detention, but the majority of its actions are still likely to be through other methods: immediate seizure, recalls, or by referral to State authorities (which is frequently how it attacks raw milk and raw milk cheese producers).
These first two rules involved no exercise of discretion by the agency —they tracked the FSMA language entirely. The real issues will arise when FDA proposes rules to implement the HACCP and produce safety standard provisions of FMSA. FDA has begun the process of developing these rules, holding several public meetings and inviting informal comments. WAPF is staying involved to protect the interests of our farmers and food producers, and recently submitted initial comments to the FDA (see below). Once the FDA publishes proposed rules, we will need all of our members to be involved in submitting public comments, so stay tuned for action alerts later this year.
Comments Submitted to FDA
To the U.S. Food and Drug Administration:
The Weston A. Price Foundation and the Farm and Ranch Freedom Alliance jointly submit these comments on the Preventative Controls for Facilities under the FDA Food Safety Modernization Act (FSMA).
The Weston A. Price Foundation (WAPF) is a nonprofit organization with members in every state and internationally. WAPF was founded in 1999 to disseminate the research of Dr. Weston Price, whose studies of isolated nonindustrialized peoples established the parameters of human health and determined the optimum characteristics of human diets. WAPF is dedicated to restoring nutrient-dense foods to the human diet through education, research and activism.
The Farm and Ranch Freedom Alliance (FARFA) is a non-profit organization headquartered in Texas with members in 45 states. FARFA advocates for farmers, ranchers, and homesteaders through public education and lobbying to assure their independence in the production and marketing of their food, and to prevent the imposition of unnecessary regulatory burdens that are not in the public interest. FARFA also advocates for consumers’ access to information and resources to obtain healthy foods of their choice.
I. Definition of on-farm processing activities
The initial issue that must be addressed is what constitutes “processing” such that a farm is considered a “facility.” Activities such as placing berries in containers, mixing different greens to create a salad mix, pouring honey into jars, and placing herbs or pre-weighed produce into bags are not considered by most people to be processing. But under the current guidance documents, although the language is unclear, farms that do these normal chores may become facilities. This is not an appropriate way to regulate farms.
While mixing and packaging can be steps in processing, they should not be classified in that manner when they occur on a farm and utilize only produce grown on that farm. These actions should only be classified as processing when they occur in a different location and/or when they involve produce from multiple farms.
II. Retail food establishments
The next step is to clearly set out which entities that conduct processing or manufacturing are retail food establishments and therefore not required to register as facilities or comply with the new HARPC requirements. As set out in section 102(c) of the FSMA, the agency shall amend the existing definition of retail food establishment to clarify that entities selling directly to customers at locations such as farmers markets and through CSAs qualify as retail food establishments.
The FSMA authorizes FDA to also recognize other “direct sales platforms.” See FSMA section 102(c)(1)(C). We encourage the agency to include buyers’ clubs and online ordering systems in this definition.
III. Qualified facilities
The FSMA recognized that small facilities selling directly to consumers or local businesses should be left to the primary jurisdiction of state and local authorities.
For farms that have a small processing operation, the determination of whether they qualify for the “qualified facility” provision should be based on the gross sales of the facility, not the farm portion. This is consistent with the statutory language, which provides that the gross sales test is based on the “average annual monetary value of the food manufactured, processed, packed, or held at such facility.” See FSMA section 103(l)(1)(C)(ii)(I).
The required documentation under section 103(l)(2)(B) should be kept to a minimum, consistent with the statute’s intention of not imposing unnecessary burdens on these food producers. For example, documentation that a facility’s gross sales meet the statutory test should be allowed through copies of tax returns and/or sales receipts.
The clear intention of the FSMA is that FDA should defer to the state and local authorities in the regulation of qualified entities. It would not be appropriate for FDA to adopt regulations that place it in the role of evaluating the scope, appropriateness, or enforcement of state and local laws. Therefore, all FDA should require is for an entity to submit basic documents from state or local authorities showing that it is in compliance with applicable state, local, or county food safety laws. See FSMA section 103(l)(2)(B)(i)(II) . Copies of even one state or local license, permit, or registration should be sufficient.
IV. Exemption for “Very Small Businesses ”
Section 103(l)(5) of the FSMA directs FDA to conduct a study to analyze the food processing sector, including the risks associated with different types of operations and the scale and duration of activities. The results of that study will impact the definition of “very small business.”
Pending the results of that study, we initially propose that FDA define “very small businesses” as food producers with fewer than 20 employees. The Small Business Administration classifies food manufacturing businesses as “small business” if they have fewer than 500-1,000 employees (depending on the precise type of food manufacturing). See http://www.sba.gov/sites/default/files/Size_Standards_Table.pdfsba.gov/sites/default/files/Size_Standards_Table.pdf, Subsector 311. SBA has referred to businesses in general that have fewer than 20 employees as “very small.” See http://www.sba.gov/advocacy/7495.
V. Determination of “low risk”
The level of risk associated with a type of food is not always consistent. Foods prepared on a small-scale using certain processes may be low risk, while the same food prepared on a large-scale using other processes may be high risk. For example, spinach grown on a sustainable, small-scale farm, harvested by hand by trained workers, and sold locally without commingling with other farms’ products, has not been associated with any significant outbreaks. Yet the same food – spinach – becomes a high risk food when it is grown on a large scale, harvested by machine, and commingled in a centralized processing plant.
In assessing risk under the FSMA, the agency should consider scale, the level of automation, and commingling, in addition to other factors.
The FSMA mandates that FDA not “require a facility to hire a consultant or other third party to identify, implement, certify, or audit preventative controls.” FSMA section 103(n)(3)(D). The FDA should respect the intent of this provision and develop regulations that do not require outside consultants either explicitly or in practical terms because of their complexity.
All fees imposed under the FSMA, including re-inspection fees, should be on a sliding scale based on the size of the facility.
FDA’s regulations should recognize and respect traditional food preparation techniques for cheeses, fermented foods, oil extraction, broth, and cultured dairy products. Traditional techniques provide numerous benefits, particularly nutritional. The term “science-based” should not be treated as a synonym for “industrial technology.” Regulations should be based on fact, not fear or assumptions that high-tech methods are superior.
The FSMA establishes a clear structure that recognizes the fact that not all food processing should be regulated by the FDA in the same manner. Specifically:
• Farms are not facilities;
• Food processors or manufacturers who sell more than half their products directly to individual consumers are also not facilities, but are retail food establishments and exempt from both registration and HARPC;
• Food processors or manufacturers who sell less than half their products directly to individual consumers, but who sell more than half directly to some combination of individual consumers and local retailers or restaurants are “qualified facilities” if they gross under half a million dollars, and are therefore exempt for HARPC;
• “Very small” businesses are exempt from HARPC regardless to whom they sell.
In developing regulations and guidance documents, FDA should respect the underlying intention of the structure created by FSMA. On-farm activities, direct sales, and small businesses are different from the long, complex, large-scale supply and processing chains that characterize the majority of the food supply. FDA should carefully consider the budget constraints that must be imposed due to the federal deficit and focus its regulatory and enforcement activities on the highest risk activities by large facilities, which impact the largest number of people.
The Weston A. Price Foundation and Food and Ranch Freedom Alliance
This article appeared in Wise Traditions in Food, Farming and the Healing Arts, the quarterly journal of the Weston A. Price Foundation, Summer 2011.