FSMA
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3717-1-20, which concerns existing facilities and equipment in a food service operation or food service operation, be rescinded and replaced.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.
Written by: Evin Bachelor, Law Fellow, and Ellen Essman, Sr. Research Associate
We’re back from the American Agricultural Law Association’s 2018 symposium, which was held in Portland, Oregon this year. We had the chance to hear from lawyers and experts from across the nation on various legal issues facing agriculture. Stay tuned to the Ag Law Blog for an update on what we learned at the symposium, but first, here’s the latest in agricultural law news:
Vote to designate watersheds in distress tabled by Ohio Soil and Water Conservation Commission. As recently reported in the Ag Law Blog, the Ohio Soil and Water Conservation Commission held a meeting this week to discuss whether to designate certain sub-watersheds in the Western Lake Erie Basin as “in distress.” Such designation would trigger additional management and reporting requirements on farmers in affected watersheds. The Commission voted 4-3 to table the discussion and wait for the Joint Committee on Agency Rule Review (JCARR) to examine the Ohio Department of Agriculture’s proposed rule changes next month. This week’s vote maintains the status quo without extending the “in distress” designation to other watersheds.
FDA releases two FSMA draft guidance documents. The Food and Drug Administration recently released draft guidance documents explaining how to follow rules under the Food Safety Modernization Act (FSMA). One document, titled “Guide to Minimize Food Safety Hazards of Fresh-cut Produce,” provides guidance on how to follow the Preventive Controls Rule under FSMA. “Fresh-cut produce,” is defined as “any fresh fruit or vegetable or combination thereof that has been physically altered from its whole state after being harvested from the field without additional processing.” The guidance would affect manufacturers, processors, packers, and holders of fresh-cut produce. The document covers current good manufacturing practices, as well as “new requirements for hazard analysis and risk-based preventive controls.” The draft guidance document, in addition to information on how to submit a comment on the guidance, is available here.
The second draft guidance document is titled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry.” This document provides guidance on how to follow FSMA’s Produce Safety Rule. The guidance would affect produce farms. The guidance covers personnel qualifications and training, health and hygiene practices, biological soil amendments, contamination from domesticated and wild animals, suggestions for practices during the growing, harvesting, packing, and holding of produce, sanitation of equipment, recordkeeping on produce farms, and other topics. According to a press release about the two guidance documents, FDA will be holding a series of four public meetings at various places around the U.S. to discuss the second draft guidance document with those affected. FDA will be announcing the details about the meetings in the Federal Register soon.
It is important to remember that these are draft guidance documents. Furthermore, guidance documents are just that—guidance. In other words, the documents are there as suggestions on how to follow rules, and “do not establish legally enforceable responsibilities.”
EPA renews dicamba registration for cotton and soybeans, and updates labels. On October 31, 2018, the United States Environmental Protection Agency (EPA) shared its decision on changes to applying dicamba, the much discussed herbicide. EPA renewed the herbicide’s registration until December 20, 2020 for application to growing (what EPA terms “over-the-top”) dicamba-resistant cotton and soybean plants.
Below is EPA’s list of label alterations to dicamba products for the 2019-2020 growing season:
- Two-year registration (until December 20, 2020)
- Only certified applicators may apply dicamba over the top (those working under the supervision of a certified applicator may no longer make applications)
- Prohibit over-the-top application of dicamba on soybeans 45 days after planting and cotton 60 days after planting
- For cotton, limit the number of over-the-top applications from 4 to 2 (soybeans remain at 2 OTT applications)
- Applications will be allowed only from 1 hour after sunrise to 2 hours before sunset
- In counties where endangered species may exist, the downwind buffer will remain at 110 feet and there will be a new 57-foot buffer around the other sides of the field (the 110-foot downwind buffer applies to all applications, not just in counties where endangered species may exist)
- Clarify training period for 2019 and beyond, ensuring consistency across all three products (Xtendimax with Vapor Grip Technology, Engenia Herbicide, DuPont FeXapan Herbicide)
- Enhanced tank clean out instructions for the entire system
- Enhanced label to improve applicator awareness on the impact of low pH’s on the potential volatility of dicamba
- Label clean up and consistency to improve compliance and enforceability
EPA’s press release is available here. More information on dicamba registration for resistant cotton and soybeans is available here.
Judge reduces jury verdict against Bayer’s Monsanto. As we predicted in a previous edition of The Harvest, Bayer’s Monsanto quickly challenged a quarter billion dollar verdict granted by a San Francisco jury to a plaintiff who alleged that Monsanto’s Roundup weed killer caused his cancer. Monsanto asked the judge to reconsider the jury’s verdict, and on Monday, October 22nd, the judge reduced the punitive damages portion of the jury verdict from $250 million to $39.25 million. The judge accepted the jury’s finding that Monsanto acted with malice, but said that the evidence did not justify a quarter billion dollar award. The judge did uphold the $39.25 million compensatory damages verdict. In total, the plaintiff would receive a $78.5 million award. Just this week, the plaintiff accepted the reduction in the award, saying that he will not ask the judge to reconsider the decision on damages. However, the litigation seems likely to continue, so stay tuned to the Ag Law Blog for more updates about the glyphosate and Roundup lawsuits.
Blockchain: the future of information sharing? We keep hearing about Blockchain technology, but what is it? Blockchain is a digital system that allows users to securely transfer information and money without an intermediary to facilitate the transfer. The transfers are recorded and timestamped, and the information contained in the “blocks” cannot be modified without the agreement of a majority of network users. The system is decentralized in nature, meaning that the information is not stored in one location but is rather is stored on servers across the globe. This makes the system more secure and less prone to modification because no single user can control the blockchain. Its early uses were for digital cryptocurrencies like Bitcoin, but its uses have expanded into information. The system has a potential in almost every sector of the economy, agriculture included. For example, Walmart announced plans to utilize blockchain to quickly track products like produce all the way from the ground to the consumer. By tracking information on foods like produce, companies like Walmart hope to be able to quickly determine sources of contamination in its food supply. This would not only be a way to save lives, but to also not have to waste produce that was not contaminated. For more information on Blockchain, here is a webinar from the National Agricultural Law Center that goes more in depth on what blockchain is, how it works, and how it can be utilized to help agriculture.
Tags: ag law harvest, watersheds in distress, FSMA, dicamba, Monsanto, Blockchain
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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:
- Food sales average less than $500,000 per year during the last 3 years.
- 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.
