Donna Clements

Donna Clements

Donna Clements

Produce Safety Alliance, Cornell University | "FSMA Produce Safety Rule and how it may affect the composting industry"

Moreno Valley, CA |

Donna Clements has served as the Produce Safety Alliance (PSA) Southwest Regional Extension Associate since 2015. Based in Riverside, California, Donna’s role with PSA is to offer training courses on the FSMA Produce Safety Rule, provide technical assistance to growers and produce safety educators, and develop educational food safety resources. Before joining PSA she worked at the University of Maryland as a produce safety trainer. Donna’s involvement in the fresh produce industry began while working on her family’s fruit and vegetable farm. She received both her Bachelor of Science and Master of Science degrees in Plant Science from the University of Maryland.

Session Code: C2

Session Name: Food Safety

Session Time: Tues, January 26, Round 2, 4:00-5:00 PM EST

Session Description: Understand how the Produce Safety Rule (PSR) of the Food Safety Modernization Act may affect you:
– learn current FDA risk assessment and associated research efforts
– learn benefits and challenges of using compost and identify science-based management strategies to minimize food safety risks

Presentation Title: FSMA Produce Safety Rule and how it may affect the composting industry

Presentation Description: The Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR) is intended to reduce the number of foodborne illness outbreaks associated with fruits and vegetables. This regulation includes provisions specific to the production, handling, storage, and application of certain agricultural inputs such as biological soil amendments of animal origin (BSAAO), including compost (treated BSAAO) and manure (untreated BSAAO). These provisions are designed to reduce the potential for BSAAO to contaminate fresh produce. Although FDA does not have jurisdiction over companies that manufacture treated BSAAO, these suppliers should familiarize themselves with the relevant PSR requirements that directly affect their clients (e.g. necessary documentation that produce growers will need upon inspection).

The PSR establishes two categories of BSAAO, treated and untreated, and an additional two categories within the treated BSAAO (i.e. two levels of treatments with associated microbiological criterion to which each treatment process is designed to achieve). These categories are used to establish provisions associated with practices and documentation. Understanding treatment status (i.e. treated or untreated) and treatment level (i.e. 21 CFR §§112.54(a) or (b)) is critical to meeting the safe handling, storage and application provisions in the PSR while still reaping the benefits of soil health. In addition to reducing human pathogens, phytopathogens, insect larvae, and weed seeds, the composting process has the additional benefit of stabilizing nutrients to minimize leaching and runoff potential. Two thermophilic compost treatment processes are codified in the PSR as scientifically validated to meet human pathogen reduction criterion: windrow and aerated static pile composting. Growers using BSAAO that have been treated with alternative methods may need to provide science and documentation validating that these amendments have been properly treated to meet one of the two associated BSAAO treatment levels. In addition to PSR requirements for treatment and application, growers using treated BSAAO (e.g. compost) may be required to keep documentation that the amendment was properly handled, conveyed and stored.

This session will highlight PSR standards in Subpart F, the current FDA risk assessment associated with BSAAO, and associated research efforts. Time will be spent discussing how commonly-used BSAAO (e.g. agricultural tea, vermicompost, pelletized poultry litter) are categorized under the PSR, and how these requirements may affect the compost industry. This session will outline the benefits and challenges of using treated BSAAOs, and identify science-based management strategies to minimize food safety risks associated with the treatment, storage, and handling of BSAAO, especially in light of existing National Organic Program, third-party Good Agricultural Practices recommendations and commodity-specific marketing agreements.


Donna Clements, Produce Safety Alliance
Topic: Intersection of FSMA PSR with other industry standards, and resources for the compost industry

David T. Ingram, United States Food and Drug Administration
Topic: FSMA PSR requirements – Subpart F (BSAAO) and how the compost industry can support growers

Billy Mitchell, Local Food Safety Collaborative
Topic: Paperwork necessary for the where, what, and how you source BSAAO