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Alright, I was going to argue each point, but here's a real summary. It's a little left leaning and obviously the FDA regulations will clear up some problems. This analysis is based on the discussion draft and subsequent news articles. Some footnotes were lost in the copy paste, feel free to inquire about details. Discussion draft available at: http://energycommerce.house.gov/index.php?option=com_content&view=article&id=1640:energy-and-commerce-subcommittee-hearing-on-food-safety-enhancement-act-of-2009&catid=132:subcommittee-on-health&Itemid=72The Food Safety Enhancement Act of 2009 (“FSEA”) contains amendments to the Federal Food, Drug, and Cosmetic Act (“FDCA”). I. Registration Requirements The FDCA requires that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered with the FDA Secretary. 21 USC 350d(a). This does not apply to facilities already regulated by the USDA under the Federal Meat Protection Act, Poultry Products Inspection Act, or Eggs Product Inspection Act. This exemption includes both the processing plants and the farms providing the livestock. The proposed definition of a facility in the FSEA is unchanged from the FDCA. The term `facility' includes any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food. Such term does not include farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels … 21 USC 350d(b). A restaurant is a facility that prepares and sells food directly to consumers for immediate consumption, but does not include facilities that provide food to interstate conveyances. 21 CFR § 1.227(10). The provided examples of facilities that provide food in interstate conveyances are commercial aircraft and central kitchens that do not prepare and serve food directly to consumers. FDA Guidance, pg 6. The regulations state the term restaurant includes food stands. 21 CFR § 1.227(10). The guidance characterizes roadside stands as retail food establishments, so long as selling food directly to consumers is their primary function. FDA Guidance, pg 6. A retail food establishment may manufacture and process food that is directly sold to a consumer. Additionally, the term facility does not include the private residence of an individual, even if food is manufactured/processed, packed, or held there. 21 CFR § 1.227(2), FDA Guidance, pg 6. A private residence “must meet customary expectations for a private home and does not otherwise include commercial facilities in which a person also happens to reside.” It does, however, include the parcel of real property. This means that if the processing takes place in the residence or in a detached building that would be considered part of the residence, no registration is required. However, if there is a processing facility located at the residence, it would be required to register. For further guidance, see the FDA’s online Q & A which provides examples of fine line distinctions for when registration is and is not required: http://www.foodsafety.gov/~dms/ffregui4.html. The term holding means storage of food in a facility, such as a warehouse, cold storage, silo, grain elevator, or liquid storage tanks. 21 CFR § 1.227(6). A farm is “a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both.” 21 CFR § 1.227(3). Harvesting is further defined to include some on-farm food preparation; specifically, washing, trimming of outer leaves, and cooling produce. A farm would also include a facility that packs or holds food if all food is grown or raised on that farm or consumed on that farm or another farm under the same ownership; or manufactures/processes food, if all of the food used in such activities is consumed on that farm or another farm under the same ownership. 21 CFR § 1.227(3). A farm is exempt from registering only if all of its activities are included in the exemptions. “In order to make the determination, the FDA will consider whether the activity that would require registration is merely incidental to the activities of an exempt facility.” 68 Fed. Reg. 22, 5381 (Feb. 3, 2003). For example, if a facility meets the farm definition, it is also allowed to apply pesticides to pre-harvested crops, wash crops in chlorinated water, place stickers on fruit, and place a raw agricultural commodity directly into consumer-ready packages. However, a farm that grows fruit and also processes the fruit into juice or jam is a mixed-type facility and registration is required. Therefore, the problem is that a mixed-type farm facility may still be very small. Appendix 1 provides additional information on the USDA’s much more detailed classification of farms. The FSEA does not change the types of facilities required to register, but it does add some requirements that may be burdensome for small facilities. In the FSEA, each facility is required to submit registration annually in electronic format. HR 759, pg 4. This may pose a problem for small farms where high-speed internet service is not widely available. In Virginia, only 57% of farms have internet access; and of those, 65% are using dial-up connections. Additionally, Amish and Mennonite food producers may find this requirement clashes with their religious beliefs. Another barrier for small facilities is the annual registration fee. The annual fee for each facility is $1,000 (in 2010 and adjusted for inflation going forward), regardless of the size of the facility or its risk category. HR 759, pg 10. This fee structure would be better if it resembled the fees for reinspection and food recalls. Under that system, the facilities using the FDA’s services pay the fees in a manner proportional to that use. See HR 759, pg 44-45. II. Hazard Analysis and Performance Standards On their face, the hazard analysis, hazard monitoring, and the implementation of a food safety plan do not pose a significant hurdle for small facilities. However, the amendment goes on to say that: “The Secretary of Health and Human Services <…> shall issue guidance or promulgate regulations to establish science-based standards for conducting .” HR 759, pg 25. The extent of the science-based standards is not provided, but there are two provisions that suggest the regulations may be onerous. First, the Secretary is directed to consider the impact on small businesses; and second, the Secretary is to define the terms “small business” and “very small business.” HR 759, pg 26-27. Classification as a small business or a very small business is not an exemption from the regulations, but merely delays their application by 6 months for small businesses and 18 months for very small businesses. HR 759, pg 27.
There is no small business distinction or farm exemption for the science-based performance standards that apply to food or food classes. HR 759, pg 28. Rather, the Secretary must establish science-based regulations “for the safe growing, harvesting, packing, sorting, transporting, and holding of raw agricultural commodities that (1) are from a plant or a fungus; and (2) for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death to humans or animals.” HR 759, pg 29. The regulations can address hazard prevention; all aspects of farming from growing to transit or storage; manure, water quality, and sanitation; or anything else determined necessary. HR 759, pg 29. This is a very broad rulemaking authority which could greatly increase costs for small farms and may restrict farming on small plots and/or eliminate organic farming methods.
The FDA is currently developing new industry guidance for leafy greens, melons, and tomatoes. The Food Safety Working Group says that the FDA will be accepting public comments over the next two years, after which, the FDA is to work to require adoption of the recommended approaches through regulation. To accomplish this, the Secretary need only determine that the industry guidance would minimize the risk of serious adverse health consequences. If so, the guidance could become a mandatory standard. Notice, there is no requirement that the Secretary find the standards are necessary, only that they would minimize risk. HR 759, pg 29.
The FDA has published a voluntary guide that has been in use since October 1998: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables. This guide’s first footnote states:
This document has been prepared as guidance by the Food and Drug Administration (FDA) and the USDA. This guidance represents the current thinking of FDA and USDA on a number of microbial food safety hazards and on good agricultural and management practices common to the growing, packing, and transport of most fresh fruits and vegetables. It does not create or confer any rights for or on any person and does not operate to bind FDA or USDA or the public. The agencies encourage growers, packers, and shippers to use the general recommendations in this guidance to tailor food safety practices appropriate to their particular operations. An alternative approach may be used if such approach would effectively serve to reduce microbial hazards that could result in foodborne illness and if such approach satisfies applicable statutes and regulations.
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm064574.htm
Unfortunately, there is no such provision provided for in the FSEA that allows an organic grower to tailor food safety to their particular operation. And, should the Secretary adopt this guidance, it would become mandatory. Additionally, the FDA already has 20 food compliance programs published on its website, any or all of which could become mandatory to anyone who grows food, makes cheese, produces milk, etc.
Also of concern is California’s Leafy Greens Marketing Agreement (“LGMA”). The LGMA builds on the recommendations in the FDA’s Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, but it only pertains to fresh and fresh-cut lettuce and leafy greens. LGMA, pg 9. It requires a farmer to have a detailed food safety assessment by trained food safety personnel if an animal of significant risk (i.e. deer, pig, cattle, goats, and sheep) intrudes on the growing area. LGMA, pg 47. If fecal matter is found, the produce must be destroyed. Additionally, it requires that the grow area be 400ft away from composting operations and manure, 30ft from grazing land, and 30ft from leach fields. LGMA, pg 49. It even requires that the harvester have empty pockets and hair restraints. LGMA metrics, pg 6. This guidance could be adopted by the Secretary and forced upon growers nationwide.
This drive for sterile produce has led some large California producers to develop “super metrics” with much larger buffer zones. The buffers are completely stripped of vegetation, exasperating environmental problems and doing little to reduce the risk of contamination (if not actually increasing the risk).
III. Inspections and Recordkeeping
All registered facilities must be inspected on a risk-based schedule. HR 759, pg 32-34. There are three categories of facilities and higher risk facilities are subject to more frequent inspections. However, higher risk facilities are not subject to a higher registration fee.
A category 1 food facility is a high-risk facility that manufactures or processes food, including any facility that manufactures or processes raw products of animal origin. Inspections must occur every 6 to 18 months. A category 2 facility is a low-risk facility that manufactures or processes food or a facility that packs or labels food. Inspections must occur every 18 months to 3 years. A category 3 food facility is a facility that holds food. Inspections must occur every 3 to 4 years. HR 759, pg 33-34. The definitions of high-risk and low-risk facilities are not provided. The distinctions provided by the categories alone do not account for the size of a facility or the amount or type of processing. However, the Secretary may inspect a facility more frequently, if appropriate, based on the type of food, compliance history, and other factors. HR 759, pg 34-35.
The records inspection requirement is overbroad. It requires “each person” (no mention of a facility) who “produces, manufactures, processes, packs, transports, distributes, receives, or holds an article of food in the United States” to provide records on request “relating to the production, manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of such article maintained by or behalf of such person in any format and at any location.” HR 759, pg 36-37.
The Secretary is directed to promulgate regulations for recordkeeping that could require recordkeeping for up to three years by persons (not facilities) who produce, manufacture, process, pack, transport, distribute, receive, or hold food. HR 759, pg 37-38. The Secretary is to consider the size of the business, but may require that records are maintained in a standardized electronic format. HR 759, pg 38.
Farms, which are exempt from the registration requirements and mandatory inspections, may be inspected under the FDA’s general authority. The FSEA amends 21 USC 374 (Factory inspection) to include farms, removing an explicit exemption. HR 759, pg 38. The FDA would have authority to inspect any farm producing food for interstate commerce (a very low standard). These amendments reiterate that farms are required to produce records for inspectors. 21 USC 374(a).
IV. Food Tracing, Reportable Food Registry, and Assessment
The amendments add a new food tracing system that will require each person (not facility) who produces, manufactures, processes, packs, transports, or holds food “to maintain a full pedigree” of the origin, previous distribution history, and subsequent distribution history of the food. HR 759, pg 42. Food is exempt if it is produced on a farm and sold directly to a consumer or restaurant. HR 759, pg 43. Note this exemption is for food, not for farms. This means that if there is food stored on the farm that is not for direct sale to a consumer or restaurant, the traceability requirements would apply.
The reportable food registry requires that registered food facilities report food when there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals. 21 USC 350f(a). The amendments would also require farms engaged in interstate commerce (see footnote 11 above), restaurants, and retail food establishments to participate in this program. HR 759, pg 63.
Subtitle B of the FSEA directs the Secretary to assess the frequency and sources of human illness associated with the consumption of food. HR 759, pg 73-74. The results of the assessment may rank food categories based on their hazard to human health, and may address: (1) the safety of commercial harvesting and process as compared with recreational or subsistence purposes; (2) the safety of food products that are domestically harvested and processed as compared with those from outside the U.S.; and (3) contamination from handling prior to and after sale of food. HR 759, pg 75. The assessment will not distinguish between large and small for-profit farms and it will not distinguish between local or long-distance food as long as it is domestic.
V. Quarantine Authority and Miscellaneous
If the Secretary determines that an article of food presents a threat to humans or animals, the Secretary may quarantine any geographic area in the U.S. where it is reasonably believed the food is located or originated. HR 759, pg 80. This is a broad grant of authority that gives the Secretary unbounded power to quarantine an area of any geographic size for any amount of time. If an industrial farm produced tainted tomatoes, the Secretary could quarantine and have authority over an area that includes other farms, restaurants, retail food establishments, food transportation, and even home gardens.
Finally, the FSEA adds subsection (z) to the misbranding section, which states a food is misbranded if it was manufactured, processed, packed, or held in a facility that is not duly registered under section 415. HR 759, pg 3. Because farms are exempt from the registration requirements of § 415, food from farms may be “misbranded.” Similarly, exempt farms are not required to meet the requirements of §§ 418 and 419, so farm food may be “adulterated.” HR 759, pg 17, 27.
VI. Concessions Made Since the Release of the Discussion Draft
Due to pressure from industry and attempts to appease certain lawmakers, the FDA reduced its annual registration fee from $1,000 to $500 for each facility. While the reduction in fees is good for small facilities, it was clearly done with larger interests in mind. The FDA also agreed to an annual cap, ensuring that no single firm will pay more than $175,000.
The annual cap is problematic because small single-facility operations will shoulder the expense of large multi-facility firms after they reach the cap. To illustrate the benefit of this annual cap on large firms, consider the USDA’s ERS discussion of farm concentration:
Concentration of production refers to the relative size of an industry's largest firms. In farm structure discussions, concentration has become a larger issue than the declining number of farms. The census of agriculture provides a measure of concentration, the percent of farms (starting with the largest and working down) needed to produce a certain level of output. For example, in 1997 the largest 2 percent of farms accounted for 50 percent of gross farm sales. In contrast, one needed to count down to the largest 8 percent of farms to get to 50 percent of sales in 1969.
http://www.ers.usda.gov/Briefing/FarmStructure/glossary.htm
Another example is the wet corn milling industry. Three firms have more than 80% of the market share for corn sweetener. After the cap is reached, all expenses for inspections and registration will be carried by small facilities, which likely make less profit per facility.
It is also reported that civil penalties will be smaller than those proposed in the discussion draft. Naturally, more compromises are in the works as the bill continues to move forward.
VII. The Effect of the FSEA on Value-Added Farm Products
As small farms find it harder to compete with industrial food producers, it is becoming a financial necessity to provide value-added farm products. Adding value to farm foods can include cleaning, cooling, cooking, combining, churning, culturing, grinding, extracting, drying, handcrafting, packaging, and distributing. However, processing food products also exposes a farm to additional regulations. Currently, if the food will be involved in interstate commerce, the FDCA regulations will apply. However, with the addition of the amendments in the FSEA, many regulations will apply to food that stays in state and additional fees and restrictions will be imposed (as discussed above).
As noted above, the FSEA amendments do not change which facilities are required to register. However, the registration fee, mandatory inspections of each facility, hazard analyses, and food safety plans are new requirements which would apply to small facilities.
Additionally, even exempt food processors (private residences, restaurants, and retail food establishments) would be subject to the records inspection requirements, quarantine authority, and food tracing. Food is exempt from food tracing if is produced on a farm and sold directly to a consumer or restaurant. HR 759, pg 43. This does not include processing of food (unless it is the minimal processing discussed above, which does not destroy the farm exemption). If a farm were to process food (e.g.: make jelly out of fruit), it would lose its exemption and registration would be required. If the jelly were made in a private residence (exempt) and sold at a food stand (exempt retail food establishment), it may be exempt depending on the final rules clarifying when a farm sells food directly to a consumer or restaurant. At least one organic association thinks an exemption for all farm-based producers will appear in the floor amendments.
VIII. Conclusion
The FSEA may be a decent attempt at bolstering industrial food safety. However, as it is currently written, it provides overbroad authority to the FDA for rulemaking, inspections, and access to recordkeeping; the impact on small facilities is rarely considered; and it fails to take into account the decreased risk of contamination when food is grown on small farms or with organic methods and travels only short distances. The definition for farms is a recurring problem throughout the FDCA and the FSEA. A potential solution would be to provide a separate definition for small family farms (as the USDA does) and to include the safety benefits (or lack thereof) of food from small farms and local foods in the assessment.
The FSEA does place additional restraints on small facilities and farms. However, the problems were created when the FDA imposed the initial registration requirements in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Small farms selling food and value-added foods for local consumption from the farm, at roadside stands, and/or at farmers’ markets, are not activities that should be subject to federal regulation under the guise of bioterrorism or food safety. The FDCA and its amendments should make that distinction clear.
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