Science and Law
4th March 2013

Science Monitoring to Ensure Compliance with the HazCom Standard

OSHA estimates that there are 945,000 different hazardous chemical products used in 7-million workplaces in the United States.  United States manufacturers or importers of hazardous chemicals are responsible for obtaining or developing a material safety data sheet (MSDS) and for proper labeling of each chemical or chemical mixture in the American workplace. 

Science Monitoring to Ensure Compliance with the HazCom Standard

OSHA estimates that there are 945,000 different hazardous chemical products used in 7-million workplaces in the United States.  United States manufacturers or importers of hazardous chemicals are responsible for obtaining or developing a material safety data sheet (MSDS) and for proper labeling of each chemical or chemical mixture in the American workplace.  This requirement resulted from the passage of OSHA’s Hazard Communication Standard (HCS or HazCom Standard) in 1983.

For the first time in many years, acceptable hazard communication in the United States has changed. OSHA’s recent modification to its longstanding Hazard Communication Standard will bring the US into conformance with the UN GHS. Changes in the HCS will force many workplaces to take a closer look at their hazard communication programs to ensure compliance with the new requirements. We will be doing a subsequent post on the new standard and implications for product manufacturers.

For the rest of this post, however, we focus on basic aspects of hazard communication that are influenced by monitoring the available science.

How is the HazCom Standard Relevant to Product Liability Conerns?

If an employee is harmed or alleges harm due to chemical exposure in the workplace, his sole remedy against his employer is typically worker’s compensation.  On the other hand, he can pursue a toxic tort lawsuit against the manufacturer or importer of the chemical.  The failure of a manufacturer or importer to properly communicate chemical hazards through appropriate labeling and an adequate MSDS is often the basis for these toxic tort cases. Since the advent of the hazard communication standard, failure to warn of hazards is a primary element in many legal actions.

What is the best way for a product manufacturer to ensure that he remains in compliance with the “HazCom Standard?”

We believe that there are three primary methods to best ensure compliance: (1) effective monitoring of the science related to the relevant products and exposures; (2) proper analysis of the science as it is identified; and (3) effective use of experts and consultants.

Monitoring the Science

As we have discussed in a previous post, monitoring the science is critical for product manufacturers. In order to stay in compliance with the HAZCOM standard it is critical to maintain keen awareness of what is being published in the scientific literature.  To do this properly, one must perform periodic and systematic searches on every chemical component associated with a chemical mixture, preferably as part of an overall science monitoring program.

Tools are now widely available to search the world’s most prominent biomedical literature with the most prominent resource being PubMed, an excellent resource to search the National Library of Medicine’s archives as well as up-to-date publications.  Through systematic and recurring searches of the scientific literature using these tools, it is possible to stay abreast of information relevant to potential safety concerns related to chemical components of a product.

While the literature indexed in any one scientific literature database is extensive, it is not exhaustive.  Some journals not indexed by PubMed may have data and information relevant to a safety assessment of individual chemical components of a product.  In order to maintain thorough awareness of all information potentially relevant to chemical components of a product, it may be necessary to utilize other proprietary services such as various offerings by Thomson Reuters and the American Chemical Society (e.g., STN Easy).

In addition to searching the published scientific literature, it is also important to be aware of presentations at scientific meetings and societies as well as information published in books, dissertations, and grant applications.  These sources can be searched using various internet databases.  Finally, industry trade organizations often publish important guidance related to chemical safety on their web sites. The overall science monitoring plan should be well documented and adhered to in a systematic and periodic fashion.  The program should include a written monitoring plan that documents the various resources that will be relied upon and how often they are monitored.  Following this plan will help to ensure that scientific information relevant to a safety assessment of your product is not overlooked and therefore that the HazCom standard is fully complied with.

Analysis and Interpretation of Relevant Scientific Findings

Scientific information outlined in the previous section pertaining to the safety of chemical components in a manufactured product (e.g., published literature, society presentations, books, dissertations, chemical research grants, and trade organization guidance) should be targeted, compiled and reviewed on a regular basis (e.g., monthly or quarterly).  Once this has been done, it is essential to make sure that the findings from the targeted studies are carefully analyzed and interpreted.

Importantly, just because the authors of a given study conclude there is a human health risk doesn’t mean that the study represents a need to change current HazCom communications.  Conversely, just because the authors of a study do not explicitly state a safety concern, doesn’t mean the absence of an event that may trigger the need to change current HazCom communications.  At the end of the day, it is the reliability of the study findings (as determined by the study design and data) and the relationship of the findings to the hazard of the chemical that defines whether a HazCom “triggering” event has been identified by the study.

Information relevant to the HazCom standard can be found in the text of the article or in figures, tables, charts, or other types of graphical representations.  The key to assessing whether there is information in the study relevant to changes in your hazard communication program lies in the details of the interpretation of the study, including the study design and other important factors.

The design of the study is critical to whether or not it should be interpreted as identifying a hazard with respect to a product or exposure.  For example, uncorroborated case reports and in vitro studies such as Ames tests are not definitive findings of human health hazard (nevertheless, these studies must go into an overall consideration of hazard as set forth by Appendix B #2 in the Standard).  Cross sectional study designs (e.g., a study set in a single manufacturing plant that uses historical controls) are more reliable than case reports, but even this study design is generally not reliable evidence for a causal relationship between a chemical constituent and an adverse health outcome.  Even more controlled, observational study designs – such as case control or retrospective cohort studies – can be poorly designed (i.e., subject to confounding or bias) and therefore not indicative of a reliable causal association between a chemical exposure and a safety concern.

In addition to study design, there are a number of other factors that are important to assess before making a determination that a safety endpoint is a reliable source of concern.  The following specific factors should be carefully evaluated.

  • Statistical Significance:  Appendix B (#4) of the HazCom standard explicitly states that a finding must be statistically significant in order for it to trigger any actions consistent with HazCom.  Thus, if epidemiological data is provided, the 95% confidence interval should not overlap 1.0.  If some sort of objective metric is shown to be different in exposed vs. control populations (e.g., indicators of neurotoxic damage; lymphocyte proliferation assays; increased rate of allergic reactions; etc.), there should be an appropriate statistical test demonstrating that the finding is statistically elevated or depressed.  In the absence of a statistically significant finding, no reliable conclusion can be drawn regarding a HazCom warning or change to the MSDS.
  • Exposure Parameters:  Just because a statistically significant change has been identified in an individual study, it does not mean that the finding is a relevant scientific finding. The exposure must be taken into account.  A proper exposure assessment must take into account route of exposure (were the subjects exposed to the chemical on the skin, orally, intra-nasally, or via inhalation?); the exposure level (how much of the chemical were the subjects exposed to?); and exposure extent and duration (how long and for what durations were the subjects exposed to the chemical?).  The bottom line is that a detailed evaluation of the exposure parameters must be made before determining that a study is (or is not) relevant to changes in hazard communications under the HazCom standard.
  • Dose Response:  In order to reliably assess the characteristics of a chemical hazard, it is important to have some knowledge regarding how different doses affect the subjects.  Thus, do higher levels of exposure cause more health hazard (a positive dose response relationship) or is the health hazard demonstrated similarly with different doses after some threshold level of exposure is achieved?  Without any knowledge of the dose response relationship, it is difficult to make a definitive assessment regarding whether the chemical poses true adverse human health consequences.
  • Extrapolation from animal to human data:  If the data evaluated are related to animal exposures, then some basis for an extrapolation to human health must be provided in order for there to be a reasonable basis upon which to consider the study relevant to the HazCom standard.  Many times, because of differences in enzymatic pathways or other species differences, data from animal studies are not generalizable to human health.

Effective use of Experts and Consultants

As can be seen from the previous section, the analysis and interpretation of scientific data are complex and nuanced.  Therefore, it is necessary to have the information reviewed and assessed to provide a reliable interpretation of the study, to determine the implications of the findings, whether they are relevant to a change in hazard communications, and whether there is any need for follow up.  In order for this to be done most effectively, the data must be carefully assessed by scientists who are also knowledgeable about the specific nature of the factors assessed as well as litigation risks and data interpretation.

In general, it is less important to have specific subject matter experts and more important to have professionals who understand the regulatory landscape as well as the exposure characteristics and the toxicokinetics of chemical exposures.  Good examples of effective consultants include occupational physicians, certified industrial hygienists, and occupational toxicologists.  These types of professionals understand the nuance of different types of occupational study data as well as the complexities of analyzing human health data for regulatory compliance, including the HazCom standard.

Once your expert has had a chance to carefully review the scientific data relevant to an assessment of chemical hazards, he or she must provide written documentation of his or her conclusions.  You may wish to have initial discussions about the implications of a given study verbally so that you can understand your experts’ viewpoint and his or her conclusions about the implications of the findings.  Once you have a clear understanding, it is important to have your expert memorialize his or her conclusions in a written document for the product’s file.  This document should demonstrate an adherence to a systematic methodology outlined in the written science monitoring plan in the evaluation of the chemical or product.  This will help to provide a basis for the scientifically defensible evaluation by the expert and will also help to demonstrate that your company is providing responsible product stewardship.

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