Tag Archives: Food Safety

The Ohio Ag Law Blog–Ag Law Harvest

Written by Ellen Essman

Hemp, drones, meat labeling and more—there is so much going on in the world of ag law!  With so much happening, we thought we’d treat you to another round of the Harvest before the holidays.

Hemp for the holidays.  As 2020 and the first growing season approach, there has been a flurry of activity surrounding hemp.  States have been amending their rules and submitting them to the USDA for approval in anticipation of next year.  In addition, just last week USDA extended the deadline to comment on the interim final hemp rule from December 30, 2019 to January 29, 2020. If you would like to submit a comment, you can do so here. To get a refresher on the interim rule, see our blog post here.

In other hemp news, EPA announced approval of 10 pesticides for use on industrial hemp.  You can find the list here.  Additional pesticides may be added to the list in the future.

Congress considers a potential food safety fix.  It’s likely that over the last several years, you’ve heard about numerous recalls on leafy greens due to foodborne illnesses.  It has been hypothesized that some of these outbreaks could potentially be the result of produce farms using water located near CAFOs to irrigate their crops.  A bill entitled the “Expanded Food Safety Investigation Act of 2019” has been introduced to tackle this and other potential food safety problems.  If passed, the bill would give FDA the authority to conduct microbial sampling at CAFOs as part of a foodborne illness investigation.  The bill is currently being considered in the Senate Health, Education, Labor, and Pensions Committee.

Animal welfare bill becomes federal law.  In November, the President signed the “Preventing Animal Cruelty and Torture Act” (PACT), into law.  PACT makes it a federal offense to purposely crush, burn, drown, suffocate, impale, or otherwise subject non-human mammals, birds, reptiles, or amphibians to serious bodily injury.  PACT also outlaws creating and distributing video of such animal torture.  The law includes several exceptions, including during customary and normal veterinary, agricultural husbandry, and other animal management practices, as well as during slaughter, hunting, fishing, euthanasia, etc.

No meat labeling law in Arkansas? Last winter, Arkansas passed a law that made it illegal to “misbrand or misrepresent an agricultural product that is edible by humans.” Specifically, it made it illegal to represent a product as meat, beef, pork, etc. if the product is not derived from an animal.  Unsurprisingly, the law did not sit well with companies in the business of making and selling meat substitutes from plants and cells.  In July, The Tofurky Company sued the state in the U.S. District Court for the Eastern District of Arkansas, Central Division, claiming the labeling law violates the First and Fourteenth Amendments, as well as the dormant Commerce Clause. On December 11, the District Court enjoined, or stopped Arkansas from enforcing, the labeling law.  This means that the state will not be able to carry out the law while the District Court considers the constitutionality of the law.  We will be following the ultimate outcome of this lawsuit closely.

Ag wants to be part of the drone conversation. The Senate Committee on Commerce, Science, and Transportation is currently considering a bill called the “Drone Advisory Committee for the 21st Century Act.” If passed, the bill would ensure that the Federal Aviation Administration (FAA) includes representatives from agriculture, forestry, and rangeland, in addition to representatives from state, county, city, and Tribal governments on the Drone Advisory Committee (DAC).  Thus, such representatives would be part of the conversation when the DAC advises the FAA on drone policies.

Ag financing tools may get an upgrade. The “Modernizing Agriculture and Manufacturing Bonds Act,” or MAMBA (what a great name) was introduced very recently in the House Committee on Ways and Means.  Text of the bill is not yet available, but when it is, it should be located here. According to this fact sheet, the bill would make a number of changes to current law, including increasing “the limitation on small issue bond proceeds for first-time farmers” to $552,500, repealing “the separate dollar limitation on the use of bond proceeds for depreciable property” which would mean famers could use the full amount for equipment, breeding livestock, and other capital assets, and modifying the definition of “substantial farmland” to make it easier for beginning farmers to gain access to capital.

Shoring up national defense of agriculture and food is on the docket.  The Committee on Agriculture, Nutrition, and Forestry sent the National Bio and Agro-Defense Facility Act of 2019 (NBAF) to the floor of the Senate for consideration. Among other things, the bill would allow the USDA, through the National Bio and Agro-Defense Facility, to address threats from human pathogens, zoonotic disease agents, emerging foreign animal diseases, and animal transboundary diseases, and to develop countermeasures to such diseases.  Essentially, USDA and NBAF would see to national security in the arena of agriculture and food.

We hope you have a wonderful holiday season! We will be sure to continue the ag law updates in the next decade!

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How not to let food safety liability risk ruin your appetite

Food is likely on the minds of many people as we head into the holiday season.  Being an agricultural attorney, it’s hard to think about food without also worrying about food product liability.  Whether growing turkey or romaine lettuce, producing food for human consumption is a risk-laden endeavor that can lead to legal liability for a farmer.  That’s why knowing and following Good Agricultural Practices (GAPs) is imperative for farmers who raise produce, eggs, meats, and other foods for direct human consumption.  Employing those production practices is critical to producing a safe food product.   But what if a food isn’t safe and causes illness or death?

No one wants to believe their food product would harm someone or that their customers would sue them for such harm.  But it’s a reality that food producers must face.  I’ve recently had the pleasure of working with farmers in OSU’s Urban Master Farmers Program and OEFFA’s Begin Farming Program who are taking these risks to heart and learning not only about GAPs, but also about tools that address food product liability risk.  Teaching these producers has reminded me of how important it is to remind all producers about these tools.  So here’s a rundown on four important food product liability tools:

  1. Management practices.  In addition to using production practices such as GAPs, a producer’s management practices can also manage food liability risk.  Thorough employee training, for instance, ensures that everyone is following GAPs and other risk management procedures.  Documentation of production procedures can be useful evidence when determining liability for a food product.  Keeping records of such documentation along with other records such as sales and training records can help inform what caused the incident and whether it can be traced to a producer’s product.  Regulatory compliance, such as following Ohio’s Uniform Food Safety Code, might also be necessary, depending upon the food product.  Each of these management practices feed into a solid risk management plan.  This requires a producer to engage in continuing education.
  2. Insurance.  An insurance policy can be an excellent way to manage food safety liability risk.  But to obtain adequate insurance coverage, a producer should review all food products and food sales activities with an insurance professional.  A farm’s standard liability policy might offer adequate coverage for the foods and food sales activities.  Alternatively, a producer may need to add an endorsement or “rider” or obtain a separate commercial food product liability policy.  The goal is to ensure coverage for medical and related costs if someone contracts a food borne illness from a particular food product sold in a particular way.  It’s also important to revisit the insurance coverage when taking on a new activity or creating a new food product.  Doing so will ensure maximum protection and reduce the possibility that an incident is not covered.
  3. Recall insurance and planning.  A producer who sells a sizeable quantity of food products through a number of sources or a food broker may need to consider recall insurance.  This type of policy will kick in when a food product must be recalled because it has been identified as a food safety risk.  It can help cover the costs of notifying the public about the product and removing the product from stores, institutions and consumers.  Likewise, having a detailed recall plan can minimize such costs by ensuring that the recall process is responsive, efficient and effective.
  4. Business entity formation.  “Do I need an LLC?” is a common question we receive, and the answer is usually “it depends.”  Organizing as a Limited Liability Company (LLC) or Corporation won’t prevent a producer’s liability, but it can limit the liability to the assets of the business.  An LLC, for example, contains a producer’s business assets and separates them from the producer’s personal assets, such as a home.  If there is a legal liability incident, the LLC assets would be subject to that liability.  It would be difficult for someone to get beyond the LLC and into the producer’s personal assets.  The LLC doesn’t relieve the producer from liability, but it can safeguard those personal assets.

Talking about legal liability has a way of ruining one’s appetite, but hopefully that won’t stop food producers from thinking seriously about food product liability risk.  The good news is that like most liability exposure areas, tools can help minimize liability risks for our food producers.  Using those tools might just help settle our worries about food product liability.

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Changes proposed for the Ohio Uniform Food Safety Code

Written by Ellen Essman, Senior Research Fellow 

Throughout the month of November, the Ohio Department of Health (ODH) announced proposed amendments to rules, as well as the rescission and replacement of one rule, in the Ohio Administrative Code (OAC) Chapter 3717-1, the Ohio Uniform Food Safety Code.  The changes are being recommended due to the required five year review of rules by ODH, as well as to “update the rules to be consistent to the current version of the Food and Drug Administration’s (FDA) Model Food Code,” which is required under Ohio law.

While most of the amendments to the rules are grammatical, or have to do with formatting or updating language, small, substantive changes are made in several rules.  For instance, the proposed changes in OAC 3717-1-01 would change several definitions to be “consistent with FDA’s Model Food Code.”  It would further “correct the definition of general use pesticide and restricted use pesticide to be consistent with the Ohio Department of Agriculture’s law,” among other changes.  Proposed changes to OAC 3717-1-02.3 to make it mandatory for all food employees to cover or “restrain” their hair in some way.  The changes recommended for 3717-1-03.2 would add requirements for the storage of utensils being used during cooking, prohibit the use of latex gloves in food service operations and retail food establishments, and add “nail brushes” to the list of control measures used by “food employees contacting ready-to-eat food with bare hands.”  Changes proposed for OAC 3717-1-03.4 would add new requirements for the contents of a HACCP plan.  Suggested modifications to 3727-1-08.2 would make it mandatory for the “[c]ustom processing of game animals, migratory waterfowl or game birds in a food service operation or retail food establishment…[to] be done only at the end of the work shift or day to prevent any cross contamination of product for sale or service.”

Finally, ODH proposes that 3717-1-20, which concerns existing facilities and equipment in a food service operation or food service operation, be rescinded and replaced.  Although this seems like a major change, there are no real substantive changes between the current rule and the proposed replacement; ODH is simply suggesting a considerable reorganization of the rule’s wording and formatting. The entire rules package is available here.

A hearing on the changes will be held on Thursday, December 20, 2018 at 11:00 a.m. at ODH.  The address is: 35 East Chestnut Street Columbus, Ohio 43215.  The hearing will take place in ODH Basement Training Room A.  Those who may be affected by the rules are invited to attend and participate. Any written comments must be submitted by 5:00 p.m. on December 18, 2018 to ODHrules@odh.ohio.gov.  More information about the hearing, as well as a brief description of the changes being made to each rule, can be found in this document.

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Produce Growers: Still Time to Comment on Federal Produce Safety Standards

Catharine Daniels, Attorney, OSU Extension Agricultural & Resource Law Program

As the temperatures start to climb, many producers are gearing up for planting season. If you are a farmer who grows, harvests, packs, or holds fruits and vegetables intended for human consumption, you should be aware of the proposed produce safety standards that were released by FDA on January 16, 2013, as part of the Food Safety Modernization Act. The proposed rule could impact your business later this year. The comment period has been extended: originally all comments were due by May 16, 2013, but now with the extension, you have until September 16, 2013 to submit comments. So if you have not had a chance to review and comment on the proposed rule, there is still time.

What does the proposed produce safety rule do? The focus of the proposed rule is foodborne illness prevention. The goal is to now focus on preventing a foodborne illness outbreak rather than reacting to one. Foodborne illness outbreaks are a major concern and produce is often associated with such outbreaks. As a producer, you are responsible for ensuring your product is safe. If you fail to do so, you could face liability.

The proposed rule establishes “science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms.” To address foodborne illness prevention, the proposed rule identifies seven routes of microbial contamination where prevention is key and sets standards for each:

  • Agricultural Water – The rule proposes requiring all agricultural water to be safe and of adequate sanitary quality for its intended use and to be inspected at the beginning of the growing season to identify conditions that are reasonably likely to introduce pathogens. An alternative to the water requirements may be permitted if the alternative is scientifically established to provide the same amount of protection as the proposed requirement.
  • Biological Soil Amendments of Animal Origin – Types of treatment, methods of application, and time intervals between the application of a biological soil amendment of animal origin and crop harvest are three proposed measures to reduce risk. An alternative to these requirements is also permitted as long as the alternative is scientifically established to provide the same amount of protection as the proposed requirement.
  • Health and Hygiene – The rule proposes farm personnel be required to use hygienic practices, including hand washing and maintaining adequate personal cleanliness.
  • Domesticated and Wild Animals – For domesticated animals, the rule proposes waiting an adequate period between grazing of the animals and harvesting produce from that growing area. If working animals are being used where produce has been planted, the rule requires farms to take measures to prevent pathogens from being introduced onto the produce. For wild animals, the rule requires farms to monitor for significant wild animal intrusion immediately before harvest and as needed during the growing season.
  • Equipment, Tools, and Buildings – Some of the key requirements proposed for equipment and tools includes: using equipment and tools that are of adequate design, construction, and workmanship, inspecting, maintaining, and cleaning all food-contact surfaces of equipment and tools, and storing and maintaining equipment and tools to prevent contamination. Some of the key requirements proposed for buildings includes: requiring buildings to be a suitable size, construction, and design to facilitate maintenance and sanitary operations, buildings must provide sufficient space for placement of equipment and storage of materials, and requiring the plumbing system be properly designed, installed, and maintained.
  • Sprouts – Requirements include: treating seeds before sprouting, testing spent sprout irrigation water for pathogens, and monitoring the growing environment for Listeria species or Listeria monocytogenes.
  • Training – Training would be required for farm personnel would handle produce or food-contact surfaces, and for supervisors.

Who is exempt from the proposed rule? The standards and requirements of the proposed rule will apply to farms that grow, harvest, pack, or hold fruits and vegetables intended for human consumption in its raw or natural state. The rule however, does exempt certain farms. Total exemptions include:

  • Produce that is rarely consumed raw, such as potatoes.
  • Produce that is destined for further processing, such as green beans destined for a canning operation.
  • Produce intended for personal or on-farm consumption.
  • Farms that sell $25,000 or less of food per year.

A farm could also be partially exempt from the rule if the farm meets two requirements:

  1. Food sales average less than $500,000 per year during the last 3 years.
  2. Sales to qualified end-users exceed sales to others during the same period.

For purposes of the second requirement, a qualified end-user is a consumer, restaurant, or retail food establishment. The consumer may be located anywhere, but the restaurant or retail food establishment must be located in the same state as the farm or not more than 275 miles away from the farm.

If your farm does qualify for a partial exemption, then you must comply with certain labeling requirements. If a label is already required on the produce, then the name and business address of the farm where the produce was grown must be included on that label. If a label is not already required, then the name and business address must be displayed at the point of purchase.

Could I lose my exemption status? Yes. FDA may withdraw an exemption if:

  • There is an investigation of a foodborne illness outbreak directly linked to your farm, or
  • FDA determines it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with your farm.

How soon do I have to start complying with the rule? After the final rule is published, it will become effective within 60 days. Farms would have between two and four years to comply with the rule depending on the value of food their operation sells during the previous three-year period:

  • Businesses selling less than $250,000 per year would have 4 years after the effective date to comply and 6 years to comply with some of the water requirements
  • Businesses selling between $250,000 and $500,000 per year would have 3 years after the effective date to comply and 5 years for some of the water requirements
  • Businesses selling more than $500,00 per year would have 2 years after the effective date to comply and 4 years to comply with some of the water requirements.

The proposed rule is currently open for comments. Comments must be submitted by September 16, 2013 to be considered. For more information on the proposed rule and to submit a comment, visit: http://www.fda.gov/Food/FoodSafety/FSMA/ucm334114.htm.

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Taking on Food Safety: Ohio’s New Produce Marketing Agreement

Fruit and Vegetable Producers Should Consider New Voluntary Approach to Food Safety Certification

Fruit and vegetable producers of all sizes now have the option of participating in a voluntary food safety certification program in Ohio.   The Ohio Produce Marketing Agreement (OPMA) offers producers food safety standards and an opportunity to attain food safety certification through third party inspections.   Born from growing concerns about fruit and vegetable contamination outbreaks, the OPMA takes an aggressive yet voluntary approach to addressing food safety risk. 

The OPMA is the first “agricultural marketing agreement” developed under a new law in Ohio.   The agricultural marketing agreement law allows agricultural commodities to create voluntary marketing programs to expand or improve the market for their commodity.   Marketing programs may promote the sale and use of products, develop new uses and markets for products; improve methods of distributing products to consumers or standardize the quality of products for specific uses.  To create a voluntary marketing program, the commodity group must obtain the approval of both the Ohio Department of Agriculture and producers within the commodity group.  A summary of the agricultural marketing agreement law is available here.    

The voluntary advisory board that governs OPMA is preparing the program for final approval, which should occur within the next few months.  Producers may begin participating in the program now, however.

OPMA offers producers three levels or “tiers” of food safety certification based on types and scale of produce sales.  All tiers require membership in OPMA, annual training and demonstration of the core food safety standards via an inspection.  The core standards address  water quality, inputs and composting, traceback and good handling practices.   A farm that completes the certification process may market itself as an OPMA certified farm and use the OPMA logo for marketing purposes.   

While OPMA will certainly provide marketing advantages, fruit and vegetable producers should consider the  program’s legal benefits.  Adopting the recommended research-based food safety standards, participating in regular training and passing an OPMA inspection will reduce the risk of a food safety incident and resulting liability.  Given recent outbreaks resulting in sickness and deaths from produce consumption, food safety is a serious issue for produce farmers.  OPMA certification gives producers an opportunity to minimize exposure to food safety liability.

Another benefit for producers is the voluntary, self-regulating nature of the program.  High participation in OPMA indicates commodity willingness to address food safety practices and ensure safe food products.  A sound voluntary program with high participation rates may negate the need for regulatory action or meet requirements of the still-evolving federal Food Safety Modernization Act.   

For more information the Ohio Produce Marketing Agreement, visit www.opma.us.

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