Safety Benchmarks
Our work
Safety benchmarks are an essential part of assessing the risk chemicals pose to human health. At bibra, we specialise in identifying and deriving these benchmarks. They represent the estimated maximum exposure, generally qualified by route (through skin contact, inhalation, or ingestion), that will pose no significant threat. Our approach involves extensively analysing evidence from occupational and epidemiological studies and laboratory animal assays. When available, we also incorporate data on the chemical’s absorption, distribution, metabolism, and excretion (ADME). By combining these data sources, bibra ensures accurate and scientifically robust safety benchmarks that meet our clients’ needs.
Existing Safety Benchmarks
Expert Groups both independent and industry-led, will often establish these safe limits as part of their reviews of chemical substances. They use various terminologies like Acceptable Daily Intake (ADI), Reference Dose (RfD), and Maximum Residue Limit (MRL) and more surprisingly, different quantitative views on how to account for uncertainty. Where a benchmark is set by the authoritative body in a particular industry sector, this becomes an important influence on a bibra risk assessment for clients in that same business area. With bibra's expertise, companies can confidently align their products and practices with the highest safety standards.
Bibra’s Role in Identifying Safety Benchmarks
Our in-house database, TRACE, is ideal for the speedy identification of existing safety benchmarks, and provides a reliable and efficient method of data searching and retrieval. Our scientists have extensive experience of assessing and recording safety benchmarks from a range of sources, comparing the values, and discussing the approach taken in their derivation. This is particularly beneficial to our clients when existing benchmarks from Expert Groups need further clarification or supplementation.
Deriving a new Safety Benchmark
There may be instances where no appropriate Expert Group assessments can be identified, or existing benchmarks don't fit specific scenarios. In such cases, bibra steps in to derive and develop safety benchmarks tailored to the client’s needs. This process will usually involve identifying a critical data point from a laboratory animal experiment, and adjusting to account for the likely differences in how humans and other species (usually a rodent) respond to chemicals in general or (much more rarely) to that specific test chemical. This adjustment is made in line with sector-specific guidance to ensure the most accurate and applicable benchmark for our clients.
Bibra’s Expertise Across Industries
Our team has an unrivalled level of expertise in deriving safety benchmarks in chemical risk assessments. Our work spans various sectors – from pharmaceuticals to consumer goods. We are particularly skilled in addressing complex challenges in industries like medical devices, chemicals (particularly toxicity issues generated by REACH), electronic cigarettes, food additives and materials in contact with food.
Our comprehensive approach ensures that businesses across these sectors meet safety standards and regulatory requirements effectively. For more information on how bibra can help you with safety benchmarks, contact us today.
Some of our case studies in this area
NAMs for NGRAs
Blog articles
Traditionally, toxicological risk assessment has involved identifying a point of departure (PoD) such as a NOAEL or LOAEL in a study of small creatures, adjusting it to be relevant to humans (to derive, for example, a TI or DNEL), and then calculating the margin of safety to a measured or estimated external exposure. As part of this process, toxicologists have to account for the uncertainties that arise in moving from the species, route and duration of the laboratory animal study to the real human world.
FDA memoranda: genotoxicity and carcinogenicity assessments of ENDS
Blog articles
As discussed in a previous blog post, the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has issued several “scientific policy memoranda” that provide some great insights into the Agency’s evaluation process. In June 2024, the FDA made two new memos available that relate to the genotoxicity and carcinogenicity assessment of chemical constituents of Electronic Nicotine Delivery Systems (ENDS).
FDA memoranda: shedding light on health risk assessment of ENDS in PMTA submissions
Blog articles
In 2016, the United States (US) Food and Drug Administration (FDA) ruled that Electronic Nicotine Delivery Systems (ENDS) were to be regulated just like more traditional tobacco products, meaning that ENDS (e-cigarettes and e-liquids) are subject to premarket review requirements, despite containing no tobacco. ENDS manufacturers must therefore submit a Premarket Tobacco Product Application (PMTA) to the FDA Center for Tobacco Products (CTP) in order to have any chance of legally marketing their products in the US.
