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 FDA’s Proposed Food Safety Rule

FSMA Farmer Comment Template and Guidelines

By Dave Colson (August 9, 2013)

In January 2013, the Food and Drug Administration released its proposed rules for implementing the Food Safety Modernization Act (FSMA) passed by Congress in 2011. A year in the writing, these proposed rules would have a broad-reaching effect on farmers marketing fruits and vegetables in their raw state. While food contamination can come from a variety of sources, including biological, physical and chemical, the FDA chose to write rules only to control possible contamination from biological sources alone. Potential routes of foodborne illness covered under the rule include agricultural water sources, biological soil amendments of animal origin, worker health and hygiene, equipment, tools and buildings and domestic and wild animals. FDA is seeking comments on the proposed rules until November 22, 2013.

The National Sustainable Agriculture Coalition (NSAC), of which MOFGA is a member, has engaged in the FSMA process with four guiding principles in mind:

Everyone has a role in ensuring a safe food supply.

Regulators should focus on the highest risk.

Regulations should be science-based when possible.

One size does not fit all: Regulations must be scale-appropriate to be effective; a one-size-fits-all approach will put small farms and processors out of business and undermine other public health goals, such as increased production, availability and access to healthy foods.

The FDA has held meetings around the country, called “listening sessions,” during which farmers and others may ask questions or comment on the proposed rules. On August 19 from 9:30 a.m. until 12:30 p.m., FDA representatives will be at the Augusta Armory to hold a listening session, the only one scheduled in Maine and one of only three in New England. Comments should be submitted to FDA, but this session will be an opportunity to directly communicate with FDA on the rules.

Here are a few areas in the proposed rules on which MOFGA encourages farmers and consumers to comment:

Exemptions. Called Qualified Exemptions, these would include farms with less than $500,000 in sales who sell more than half of the monetary value of their products directly to consumers or restaurant and retail establishments. Among the questions are these: What type of records do you need to keep in order to qualify for the exemption? What food products are included in the metric? And if an exemption is lost, what is the process for getting it back?

Records. Farms will have to prove they qualify for the exemption by providing sales records and possibly other types of information. Potential costs to farms with sales in the $25,000 to $500,000 range have been estimated at $4,700 to $30,500 annually.

What foods? The FDA proposes including all food produced by a farm, which means that a dairy farm with milk sales in the $500,000 range that sells some produce at a roadside stand would be fully responsible for all of FDA’s Food Safety Rules.

How to get an Exemption back. FDA allows for a process in which any inspector can remove an Exemption based on the “material conditions” on a farm. FDA needs to make clear what conditions would be considered improvement areas and what would rise to a loss of an Exemption, how the affected farm and its produce would be handled, and how the operation would get the Exemption back.

Facilities. Farms designated as “Farm Mixed-Type Facilities” would have to register. These are farms in which products from multiple operations are collected (such as multi-farm CSA or food hubs), or minimal processing such as cutting or chopping is done, or other value-added processes, such as making jams and jellies, are performed.

Health and Hygiene. Requirements under this section are basic food safety standards but would require some additional steps.

Assign personnel to ensure compliance

Establish and keep records of employee training

Establish and keep records of training for visitors

Make available for employees and visitors toilet and hand washing facilities

Take measures to prevent contamination of produce and food contact surfaces

Agricultural Water. The Act calls for maintenance of all agricultural water sources that are used for irrigation or
washing (such as wells, ponds, streams) by regularly inspecting each source and keeping the source free of debris, trash, domesticated animals and other possible sources of contamination. Farmers must immediately discontinue use of a source of agricultural water and/or its distribution system and not use the water source and/or its distribution system when they have reason to believe that the agricultural water is not safe and of adequate sanitary quality for its intended use.

Testing. Any non-surface agricultural water (wells) must be tested at the beginning of each growing season and every three months thereafter during the growing season. Surface water such as ponds, rivers or streams must be tested every seven days.

Limits for generic E. coli are provided in the rule.

Manure, or “Biological Soil Amendments of Animal Origin.” The rule states, “You must handle, convey and store any biological soil amendment of animal origin in a manner and location such that it does not become a potential source of contamination to produce, food-contact surfaces, water sources, and water distribution systems.” It goes on to require:

Composting that maintains aerobic conditions at a minimum of 131°F (55 °C) for 15 days, with a minimum of five turnings, and is followed by adequate curing.

For untreated manure applied in a manner that does not contact produce during application, the minimum application interval (manure waiting period) is 9 months. (This is a much longer time than the Organic Standards period of 90/120 days)

Standards for Working Animals and Grazing. If you allow animals to graze or use them as working animals in fields where produce is grown, and there is a reasonable probability that grazing or working animals will contaminate produce, farmers must take the following measures: an adequate waiting period between grazing and harvesting for produce in any growing area that was grazed to ensure the safety of the harvested crop; and if working animals are used in a growing area where a crop has been planted, measures to prevent the introduction of known hazards onto produce.

Wild Animal Intrusion. If under the circumstances there is a reasonable probability that animal intrusion will contaminate produce, farmers must monitor those areas that are used for a produce activity for evidence of animal intrusion. If animal intrusion, as made evident by observation of significant quantities of animals, animal excreta or crop destruction via grazing, occurs, growers must evaluate whether the produce can be harvested.

Growing Harvesting, Packing, Holding Produce

If you grow, harvest, pack or hold excluded produce (i.e.: produce not usually consumed raw) and conduct such activities on produce covered by the rules, and the excluded produce is not grown, harvested, packed or held in accordance with this part, you must take measures during harvest activities to keep covered produce separate from excluded produce; and adequately clean and sanitize, any food-contact surfaces that contact excluded produce before using such food-contact surfaces on covered produce.

You must use food-packing material that is adequate for its intended use. If you reuse food-packing material, you must take steps to ensure that food-contact surfaces are clean, such as by cleaning and sanitizing food-packing containers or using a clean liner.

Equipment, Tools, Buildings and Sanitation

Equipment and tools are those that are intended to contact produce and those instruments or controls used to measure, regulate or record conditions to control or prevent the growth of undesirable microorganisms or other contamination. Examples include knives, implements, mechanical harvesters, waxing machinery, cooling equipment (including hydro-coolers), grading belts, sizing equipment, palletizing equipment and equipment used to store or convey harvested covered produce (such as containers, bins, food-packing material, dump tanks, flumes and vehicles or other equipment used for transport that are intended to have contact with produce).

Buildings. Any fully- or partially-enclosed building used for covered activities, including minimal structures that have a roof but do not have any walls; and storage sheds, buildings, or other structures used to store food-contact surfaces (such as harvest containers and food-packing materials) must be maintained to protect covered produce from being contaminated with known or reasonably foreseeable hazards and to prevent the equipment and tools from attracting and harboring pests.

Records. Records include: the name and location of the farm; actual values and observations obtained during monitoring; an adequate description (such as the commodity name, or the specific variety or brand name of a commodity, and, when available, any lot number or other identifier) of covered produce applicable to the record; the location of a growing area (for example, a specific field) or other area (for example, a specific packing shed) applicable to the record; and the date and time of the activity documented. Additionally, these records must be created at the time an activity is performed or observed; be accurate, legible, and indelible; and be dated, and signed or initialed by the person who performed the activity documented.

Talking points

The main point here is that there is a difference between direct market, short supply chains and complex, long supply chains. The scale and risk involved in a farming operation must be taken into account in the rulemaking process. When vegetable products are delivered to the end user and consumed in a short timeframe, the time needed to support the growth of pathogens is negligible. The exemptions for gross sales income attempted to address this. MOFGA supports including either sales exemptions or a supply chain risk assessment analysis in the rules.

The rules need to conform to other programs, such as the National Organic Program. Compost handling should be similar to NOP guidelines, and the manure waiting period should be the 90/120-day period growers use now.

Irrigation water needs to be linked to the relative risk associated with the source. Maine’s water resources rate quite highly in quality, according to the Maine DEP listings. The regulations should take this into consideration, as well as the practical aspect of cost and how often a water test can reasonably be done by farmers.

For more information and to submit comments to FDA on the Food Safety Modernization Act see:

National Sustainable Agriculture Coalition

New England Farmers Union

FDA Food Safety Modernization Act

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