I. Diacetyl – Recent Developments
Last April, the Department of Labor announced a national emphasis program to focus on the health hazards of microwave popcorn butter flavorings containing diacetyl. This program directed OSHA to conduct inspections at facilities where workers may be at the greatest risk of exposure. The program also had certain elements aimed at educating stakeholders about the hazards posed by butter flavorings containing diacetyl as well as other flavoring chemicals. The initiative requires inspections of all workplaces where butter-flavored microwave popcorn is being manufactured, which OSHA plans to complete by the end of this year. It instructs manufacturers on methods for controlling hazards associated with exposure at inspected work sites. It also provides educational material to plant operators about mandatory compliance with protective measures already required by law as well as providing outreach and information to both employers and employees.

Subsequent to this announcement, legislation was introduced in the House of Representatives under H.R. 2693, which would direct OSHA to issue a standard regulating worker exposure to diacetyl. One of the principal sponsors of this bill, Congresswoman Rosa DeLauro of Connecticut, chairwoman of the House Appropriations Subcommittee on Agriculture, Rural Development and the FDA and related agencies, issued a press release in May calling on FDA to re-examine the designation of GRAS for diacetyl. The letter noted in the spring of this year the Centers for Disease Control, in its morbidity and mortality weekly report, called for healthcare providers to report additional suspected cases of respiratory disease in workers exposed to flavoring chemicals, including but not limited to diacetyl. HR 2693 has subsequently been adopted by the U.S. Senate, despite opposition from the administration and many Republican Congressmen. The legislation calls upon the Secretary of Labor, no later than 90 days after the bill becomes law, to adopt an interim final standard regulating worker exposure to diacetyl. The interim final standard would apply to all locations in the flavor manufacturing industry that manufacture, use, handle or process diacetyl; hence all microwave popcorn production and packaging establishments that use diacetyl-containing flavors in the manufacture of microwave popcorn. The legislation also goes on to state the interim final standard would have to provide no less protection to employees than the recommendations contained in the NIOSH alert entitled “Preventing Lung Disease in Workers Who Use or Make Flavorings” (NIOSH Publication 2004-110) and include the following:
 

• Requirements for engineering, work practice control and respiratory protection to minimize exposure to diacetyl;
• Requirements for a written exposure control plan that indicates specific measures the employer will take to minimize employee exposure and to determine the effectiveness of those control measures on a bi-annual basis;
• Requirements for airborne exposure assessments to determine levels of exposure and assure adequacy of controls;
• Requirements for medical surveillance for workers and referrals for prompt medical evaluation;
• Requirements for protective equipment and clothing for workers exposed to diacetyl; and
• Requirements to provide written safety and health information and training to employees, including hazard communication information, labeling and training.

In a statement issued Sept. 24, OSHA announced it would undertake a rule-making under its legislation concerning diacetyl exposure in the workplace. At the same time, it also issued a bulletin providing information on health effects for workers exposed to butter flavorings in microwave popcorn processing plants, information on exposure controls that may be used to reduce exposure to butter flavorings and information on applicable OSHA standards. Furthermore, OSHA also issued a hazard communication guidance document to alert employers, workers, manufacturers and importers about new information related to health hazards associated with diacetyl and food flavorings which contain it. It also provided additional guidance on how to develop material safety data sheets and hazard warning labels to be in compliance with OSHA’s hazard communication standard.

OSHA is also in the process of conducting an outreach by holding meetings for the various stakeholders as part of its continuation of the information collected efforts.

While the scientific community is still evaluating the exact causation trigger linking these chemical ingredients to the impact on workers’ lungs, companies still need to address and, to the extent reasonably practicable, minimize the amount of risk workers may be exposed to in the workplace. There are a series of general recommendations which NIOSH has made available to the public. Those recommendations are as follows:

1. Substitution. NIOSH defines this as substituting a less-hazardous material in order to reduce a potential workplace hazard. However, substitution does not always represent a feasible approach in flavor manufacturing or could result actually in the substitution of the more-hazardous material. Accordingly, this requires careful evaluation by a flavor manufacturer before electing to pursue this route.

2. Engineering Controls. Engineering controls are considered one of the primary means to minimize workplace exposure to potentially hazardous flavorings. This includes the use of a closed production system, improvements to ventilation, isolating areas where flavoring ingredients are openly handled, personal ventilation and respiratory equipment and temperature controls.

3. Administrative Controls. These come down to the basics at any workplace. It extends beyond just making sure material safety data sheets are easily available to employees. It includes enforcing safe work practices to limit the release of chemicals and dust into the workplace, maintaining appropriate seals on containers with unused or residual amounts of the flavorings or ingredients, good housekeeping practices, establishing and following all standard protocols for cleaning the workplace, mixing tanks and other containers and restricting access to areas where flavorings are openly handled so only workers wearing the appropriate level of personal protective equipment are entering or working in these areas.

4. Employee and Worker Education. Maintaining employee awareness of hazardous exposures in the production process is a vital element of any health and safety program. Workers need to be informed and updated about materials that may contain flavoring agents and any potential hazards. Employees need to be given general information and specific hazard warnings for workplace postings, proper container labeling, access to and availability of material safety data sheets and updated training. It is incumbent upon employers to make sure this information is updated regularly and access to it is made, and in fact, encouraged. Workers need to be trained about the various means available in the workplace to eliminate or limit exposure, not only to themselves but to their follow workers.

5. Personal Protective Equipment. The use of proper respiratory protection as well as skin and eye protection, is an essential part of workplace safety. It is important for companies to enforce the use of chemical-resistant gloves and proper-fitting eyewear and respiratory gear for workers with potential exposure in the workplace. Specific guidelines need to be established and enforced about when to use such equipment for each job, based upon the knowledge of the tasks that need to be performed, the substances that are being used and a full assessment of the potential exposures. OSHA provides detailed requirements for respiratory protection standards under existing Federal regulations. OSHA regulations require companies provide personal protective equipment whenever necessary to address hazards which are “capable of causing injury or impairment” to any body function; this includes whether the exposure is by absorption, inhalation or by physical contact. Respirators selected for use should be certified by NIOSH in accordance with federal regulations. Respiratory equipment should be serviced on a regular basis and employees fully trained in the proper use of this equipment.

One of the more difficult issues employers have to wrestle with is the monitoring of worker health. This always raises a concern as to potential liability exposure for a company that does this type of monitoring. The NIOSH recommendations call for testing on an annual basis, though on an even more frequent basis if abnormalities are detected. However, before any company engages in such practice, it should carefully evaluate not only what type of monitoring program will be instituted but how it will be maintained, as well as an evaluation of potential availability of coverage under health plans for routine physicals and other types of medical monitoring. This is separate and apart from any type of exposure monitoring done through regular air sampling. As for workplace air monitoring, it’s important any company brought in is fully familiar with OSHA and NIOSH standards, is certified in air sampling and is in a position to assess and recommend any type of additional engineering or other appropriate control measures to improve workplace safety.
Should a facility find employees are experiencing symptoms of respiratory illness such as prolonged or work-related difficultly in breathing, shortness of breath on exertion, pursuant coughing, wheezing or chest tightness or who are demonstrating symptoms consistent with skin rashes, nasal irritation or irritated eyes, these are all clear signals that there is a need for immediate response on the part of the facility operator.

Patrick J. McNamara, Esq. has served since 1994 as General Counsel to NAFFS. Copies of the various reports and documents referenced in his speech can be obtained from NAFFS or directly from him; please contact him at pmcnamara@njlegalink.com or call his office at (201)896-4100. The complete version of Mr. McNamara’s presentation is available at www.naffs.org.