Regulatory updates on FSMA and combustible dust
Two topics of continuing importance to the oil processing industry in North America are the ongoing implementation process of the Food Safety Modernization Act (FSMA) regulations and the extremely slow-moving regulatory process concerning combustible dust. Both topics were covered in two presentations during the 120th Annual Summer Convention of the International Oil Mill Superintendents Association. The meeting was held June 20–24, 2014, at the Hilton Garden Inn Austin Downtown.
To say that Matt Frederking, vice president, Regulatory Affairs & Quality, Ralco (Marshall, Minnesota), is intimately acquainted with the nitty-gritty details of FSMA is an understatement.
Frederking began his presentation with an historical review of congressional work on food safety, which culminated in an Act that was signed into law on January 4, 2011. He noted that despite the numerous changes and implications for industry contained in the 89-page piece of legislation, many network and cable news channels reported on only one—that the Food and Drug Administration (FDA) could now conduct mandatory recalls.
“Our world has changed,” Frederking said, emphasizing that FSMA is not just about recalls and inspections. Rather, “it’s a call for a new, prevention-oriented food safety system that includes a broad prevention mandate, strong accountability for prevention, and a new system of import oversight.”
The major impacts of FSMA, according to Frederking, include:
- Increased facility registration requirements.
Under the 2002 Bioterrorism Act, registration was a one-time event. Under FSMA, facilities must renew and update registration every two years between October 1 and December 31 of even-numbered years, beginning in 2012. “Put it on your calendar to reregister in 2014, 2016, and so on,” advised Frederking.
- Mandated development and implementation of written food/feed safety plans as well as written food/feed defense plans (for high-risk products only).
Plans must include monitoring and verification, indicating controls are working, in addition to detailing corrective actions and recordkeeping. These records (production, maintenance, and the like) must be maintained for at least two years. Further, facilities will be required to reanalyze hazards and preventive controls, as well as their written food/feed safety plans, at least every three years (or sooner if significant changes in operations occur).
- Increased FDA access to existing records.
Section 101 authorizes FDA to access facility records if the agency believes there is “reasonable probability” that food, or similar foods, will cause serious adverse health consequences or death to humans or animals.
- Mandated development and implementation of foreign supplier verification program if a processor is importing food into the United States.
Records regarding imported foods must be maintained for at least two years.
- Payment of fees to FDA for reinspections, if a manufacturer is subject to mandatory recall, or utilizing FDA export certificates, or participating in the voluntary qualified import program.
Another impact will come via FDA’s partnerships with state regulatory agencies.
“We all need to be involved,” said Frederking. “The industry as a whole needs to be involved through the education and development process.” Once the final regulations are in place, he said, “You will see an inspector at least once every three or five years at a minimum. We all need to pay attention and understand the requirements of this law.”
Frederking also suggested that the processing industry could expect an increase in inspections by international regulatory entities. “Because we are demanding inspections elsewhere, other countries are going to inspect here. Be prepared.”
Combustible Dust Update
“There’s a lot going on [in regard to combustible dust],” noted Jess McCluer, director of safety and regulatory affairs for the National Grain and Feed Association (NGFA; Washington, DC).
According to McCluer, three entities are involved in the combustible dust rulemaking process in the United States: the Chemical Safety and Hazard Investigation Board (CSB), the Occupational Safety and Health Administration (OSHA), and the National Fire Protection Association (NFPA).
CSB, an independent federal agency that investigates industrial chemical accidents, studied combustible dust (CD) explosions from 2003–2006. Based on the study, the agency recommended in 2006 that OSHA:
- Develop—quickly—a CD regulation based on voluntary standards such as NFPA 654 – Standard for the Prevention of Fire and Dust Explosions from the Manufacturing, Processing, and Handling of Combustible Particulate Solids.
- Improve MSDS (Material Safety Data Sheets) requirements to better describe the explosive properties of dusts.
By 2008, the US House of Representatives approved a bill that required OSHA to develop a standard for CD—as CSB had recommended—within 90 days of enactment and a final standard within 18 months. In response, OSHA issued an Advance Notice of Proposed Rulemaking in October 2009. The agency originally had the CD standard “on a fast track to be done in two to three years from 2009,” said McCluer. However, OSHA in late 2011 changed the rule’s status from the pre-rule stage to a long-term action, and then added it back into the agency’s December 2012 regulatory agenda at the pre-rule stage. The latest indication of where the rulemaking process stands comes from The Wall Street Journal, which suggested in April 2014 that OSHA would promulgate a CD standard in “several years.”
“Conducting enforcement without a formal rule makes it difficult for industry to know what to do,” stressed McCluer. In lieu of a rule, OSHA is using the “general duty clause.” This is, at heart, an all-encompassing regulation that the agency uses “if there is a perceived violation that is not covered by any other regulation,” he said. OSHA then uses NFPA CD standards to justify citations. In addition, OSHA is using housekeeping requirements as an enforcement tool.
However, work done by the United Nations on its Globally Harmonized System of Classification and Labelling of Chemicals (GHS) to define CD adds to the uncertainty. GHS is an internationally agreed-upon system that serves as a “building block” for relevant EU and US standards.
Under a GHS Amendment to OSHA’s Hazard Communication Standard (HAZCOM; effective date: May 25, 2012), CD is classified as a “hazard, other than chemical” and is undefined beyond that. However, the new amendment may require manufacturers, distributors, and importers to generate new MSDS and labels—possibly for every ingredient. “The key questions are what is combustible dust and who is the manufacturer, distributor, or importer,” noted McCluer, adding that NFGA and several other trade associations have filed a legal petition for review challenging the HAZCOM CD requirements.
McCluer also gave an update on the status of NFPA 652, which is aimed at consolidating industry-specific standards into one all-encompassing CD standard. The final draft of NFPA 652 is almost complete, he said, and the final standard is scheduled to be issued in 2015.