By: Bruce Martin
Nutraceuticals, defined as “fortified foods or dietary supplements that provide health benefits in addition to basic nutritional value,” have gained a lot of popularity in the last couple of decades due to maturing populations and a rising awareness in preventative health measures. This definition includes not only special fortified foods, but also herbal products, dietary supplements, genetically modified foods and foods processed to include specific nutrients. According to a recently published report by Research and Markets, the global nutraceutical market is expected to grow from nearly $200 billion in 2016 to $285.0 billion by 2021. Likewise, from an M&A perspective, the Nutrition Capital Network (NCN) reported that the nutrition and health and wellness industry saw a 27% increase in M&A activity in 2017. This momentum is expected to increase as new applications continue to surface.
EH&S Considerations for Nutraceutical Manufacturing Facilities
In the USA, the Food and Drug Administration (FDA) regulates nutraceuticals under a different set of regulations when compared with those covering “conventional” foods and drug products. According to the Dietary Supplement Health and Education Act from 1994 (DSHEA), it is the manufacturer’s responsibility to ensure that a nutraceutical is safe before it is marketed. FDA is authorized to take action against any unsafe product after it reaches the market. Manufacturers have to make sure that the information on the product label is truthful and not misleading, but they are not obliged to register their products with the FDA nor get FDA approval before producing or selling nutraceuticals.
While the primary focus in this industry is compliance with product safety, product labeling and related concerns that are overseen by the FDA, the manufacturing activities associated with nutraceuticals have a number of environmental, health and safety (EH&S) requirements that must be considered.
Tank Management and Spill Prevention
Like the food and beverage industry, one key environmental program that may impact nutraceutical manufacturing sites is the oil pollution prevention program under the Clean Water Act (CWA). In general, any facility that has over 1,320 gallons of oil on site must develop and implement a Spill Prevention, Control and Countermeasure (SPCC) Plan. Nutraceutical manufacturing facilities, for example, have numerous gasoline and diesel fuel tanks on site to fuel trucks, heavy equipment, and emergency generators. One aspect of the SPCC Plan regulation requires inspection and testing of aboveground storage tanks in accordance with industry standards like the Steel Tank Institute or the American Petroleum Institute. Many facilities are not performing these required inspections or tests, and in fact,
are not even aware they are supposed to be testing their tanks. This creates a serious risk of a tank failure, which could lead to a spill or release that could have a costly impact on the environment.
Emergency Planning and Community Right-to-Know Act (EPCRA)
Because a number of materials and chemicals may be present onsite for fueling, water treatment, vessel clean outs, and by-product processing, the facility must also comply with the Emergency Planning and Community Right-to-Know Act (EPCRA), from both a chemical inventory perspective and for the Toxic Release Inventory (TRI), which quantifies releases to the environment.
Other EH&S Considerations
Facilities may be subject to storm water and wastewater regulations, and often face significant surcharges for high strength wastewaters to the sewer district. Moreover, with city water connections, a facility must install and test backflow prevention devices to ensure the municipal water supply does not get contaminated by the manufacturing operations. These facilities also generate hazardous waste on a regular basis that must be managed and properly recycled or disposed of.
Finally, employee health and safety (H&S) programs are an important consideration in a facility involved in manufacturing and handling nutraceuticals. Because a facility may handle a wide variety of ingredients in both liquid and powder form, well-established programs to manage worker respiratory protection and indoor air quality (IAQ) are critical. In addition, H&S concerns typical of other food and beverage related manufacturing operations are also commonly found in the nutraceutical manufacturing industry including hazard communication; process safety management for highly hazardous chemicals; electrical safety and lock-out, tag-out; and programs for powered industrial trucks.
Regardless of the type of manufacturing operation, it is critical to understand the range of potentially applicable regulatory programs and the risk associated with noncompliance. If you need assistance conducting your due diligence or performing environmental compliance, please contact Bruce Martin at Bruce.Martin@ehs-support.com.