Dow has a strong commitment to ensuring the safety and regulatory compliance of our products, and a vision of ending the use of animals in product safety research. That is why we are taking a leading role in the development of non-animal testing approaches that leverage the best science and technology for human and environmental safety assessments. These efforts are led by a team of dedicated scientists in our Predictive Toxicology group who have the goal of ensuring safety without animal testing by applying computational modelling, cell-based systems, or exposure- and risk-based evaluations. We have also established collaborations with customers, regulatory agencies and animal welfare organizations to help advance the application and acceptance of these approaches to minimize the need for animals in regulatory safety evaluations. All this is evidence of our commitment to the 3R’s — reducing, refining and replacing the use of animals in testing — while continuing to meet our commitment to product safety.
Until our vision is a reality, there will still be areas of health and safety assessment that cannot be addressed with non-animal approaches. Dow will continue to do what is required to maintain regulatory compliance and the safe handling and use of our products, which will include using animals in product safety testing when absolutely necessary.
The use of manufactured chemical products has generally increased over the years and in turn has contributed to our improved lifestyle, from new medicines to cleaner water, more energy-efficient cars, and affordable housing. While the number of children and adults suffering from asthma has increased, there is no scientific consensus that chemicals are among the major causes. According to the US Centers for Disease Control and Prevention (CDC), smoke from tobacco products, dust mites, outdoor pollution, cockroaches, pets, and mold are important triggers for asthma. Strenuous exercise, adverse weather, certain food or food additives and other stimuli also can trigger asthma.
There are a limited number of manufactured chemical products that can trigger and/or worsen asthma and/or respiratory allergy. The uses of such chemicals are regulated to limit the exposure, and exposures are well controlled at Dow. These substances are not usually associated with asthmatic reactions in the general public. Although a role for some types of chemical exposure cannot be ruled out, the direct contribution of chemicals is likely small compared with other lifestyle and environmental factors.
The knowledge that specific chemicals might bring about asthmatic conditions gives Dow cause for vigilance when it comes to product stewardship and the marketing of substances. In our role as a chemical manufacturer, we assess the hazards of our products. This is part of the overall evaluation using Dow's Product Safety Assessment process.
Chemicals Management Policy includes a broad array of voluntary and regulatory efforts regarding the safe and environmentally sound manufacture, distribution, handling and disposal of chemical products, intermediates and wastes. This encompasses testing products to assess hazards, evaluating potential exposures to products in intended applications to identify and manage risks, registering new products with proper authorities and notifying all interested parties of potential hazards and safe-handling procedures.
Dow supports a consistent, coordinated regulatory environment for products at global, national and regional levels to complement industry voluntary efforts and to ensure a level playing field. Where new or updated regulations are required, they should be based on established scientific principles that define safe conditions for use and impose requirements to assure that use is controlled within predefined safe conditions. Such a system must rely on risk assessment and risk management principles that are predictable, flexible and capable of responsibly addressing society's economic, environmental and safety requirements.
A more detailed description of Dow's Principles for Chemicals Management Systems is available here.
Dow’s internal guidelines and the policies of countries in which Dow does business govern the testing of new and existing industrial chemicals.
Dow conducts appropriate tests and modeling to determine the potential health and environmental effects of its products. The tests also help determine the specific levels of exposure that produce these effects, in particular the level at which no adverse effect is observed.
Dow utilizes a tiered testing approach to decide the appropriate studies to conduct. The procedure first applies existing scientific knowledge to determine the hazards of a product. Then it generates technical data about the health and environmental effects of the product in specific applications, and identifies what additional testing is warranted.
“New” chemicals are those that are not already identified by the government as in commerce as of a specified date. Some governments require a base set of test data to be generated on all new chemicals, while others first use computer models as surrogates for laboratory generated data and establish test priorities based on the results.
“Existing” chemicals are those that have been identified by governments as already in use in commerce as of a specified date. Additional testing of existing chemicals may be required if a chemical presents an unreasonable risk of injury or when substantial quantities are produced with the potential for extensive human or environmental exposure.
Chemicals are among the most thoroughly evaluated and regulated materials in commerce. Chemicals are developed, manufactured, distributed and used under a strict and comprehensive set of government rules. Dow takes very seriously its responsibility to protect people and the environment throughout the life cycle of our products, from manufacturing to disposal/recycle. Commitment to this responsibility is evident in our 2015 Sustainability Goals.
That commitment includes conducting research, modeling and laboratory studies to fulfill both product stewardship responsibilities (as outlined in the industry principles of Responsible Care®) as well as voluntary goals and objectives that enhance product safety. The research, modeling and testing conducted by our scientists provides the necessary information for risk assessments to ensure that our chemical products can be used safely. This information is obtained in a manner that complies with international and local regulatory requirements further establishing the reliability and credibility of industry science.
In recent years some have questioned the reliability and credibility of public health and environmental research conducted and/or funded by the chemical industry in general and Dow, specifically. Such opinions, however, fail to recognize that studies conducted and funded by Dow have long been and continue to be recognized as valid and credible by government agencies, non-governmental organizations (NGOs), and the scientific community at-large. This view was endorsed by a NGO cross-sector panel in the Keystone Center, Research Integrity Roundtable report “Improving the Use of Science in Regulatory Decision-Making: Dealing with Conflict of Interest and Bias in Scientific Advisory Panels, and Improving Systematic Scientific Reviews.”1
Studies conducted and funded by Dow are necessary and valuable contributions to the understanding of potential public health and environmental effects related to the manufacture and use of its products. Several procedures have been established that authorize independent review of scientific studies, in order to assure that the quality and credibility of studies conducted or funded by Dow meet the highest scientific standards. The practices and procedures by which policymakers and the public can be assured that studies performed by or funded by Dow meet scientific high standards include:
- All studies required by governments are conducted in accordance with Good Laboratory Practice (GLP) regulations which require full availability of the recorded, quality-assured data files2 and which allow for unannounced audits by government authorities, such as the FDA or EPA. Dow also follows GLP requirements voluntarily for many other studies that it conducts.
- An internal Quality Assurance Group reports independently of day to day laboratory management and audits all studies conducted to ensure compliance with GLP regulations. Employees also undergo training to understand the requirements of GLP regulations.
- Studies are conducted according to internationally agreed upon protocols and test guidelines.
- Scientists are encouraged to submit their results in the peer-reviewed scientific literature and to present them in scientific forums.
- All research involving human subjects is reviewed and conducted to comply with generally accepted ethical standards and requirements. This includes the Common Rule, the Nuremberg Code, the Declaration of Helsinki, and any other applicable local government requirements and guidelines which are at least equivalent to those provided by the Common Rule.
- All animal studies are conducted in full compliance with state and federal animal welfare regulations. In addition, Dow is accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International, an achievement recognized as the highest attainable by the animal care profession.
- Studies that demonstrate adverse effects are made publicly available in a timely manner to comply with the U.S. laws of TSCA 8e and FIFRA 6a2 or similar equivalent regulations in other countries.
Dow firmly supports and has full confidence in these processes. Research studies that adhere to GLPs deserve the very highest degree of confidence regarding (1) the specific and detailed experimental protocol design, (2) the measurements taken, and (3) the accuracy of the reported results because all of these elements must meet GLP quality control and quality assurance requirements. Moreover, studies based on regulatory requirements use standardized methods that have been scientifically validated and approved by regulatory bodies.
Finally, GLP studies facilitate transparency and the ability of others to reproduce the test results. Dow recognizes that not only GLP studies are relevant for establishing safety of its products, but on occasion, non-GLP studies such as academic research published in the peer reviewed literature or unpublished reports are relevant. In such cases, Dow affirms the conclusion espoused in the Keystone Center, Research Integrity Roundtable Report that non-GLP studies should meet transparent criteria for relevance and credibility consistent in order to be included in any safety assessment1.
Dow is strongly committed to the safe manufacture, use, and disposal of its products. Our scientists have expert knowledge of the chemicals we manufacture, especially as this relates to the development and interpretation of the science needed to comply with the laws and regulations of the chemical industry on a global basis. As members of professional associations, our scientists adhere to both personal and professional commitments to act in accordance with codes of ethics of their professions3. Finally, research should be judged on the basis of scientific merit, without regard for funding source or where the studies are conducted (e.g. academia, government, or industry)4.
1 Keystone Center, Research Integrity Roundtable. (2012). Improving the Use of Science in Regulatory Decision making: Dealing with Conflict of Interest and Bias in Scientific Advisory Panels, and Improving Systematic Scientific Reviews. Read more.
2 Furthermore, of the various types of data and information employed in risk assessment, GLP derived data will most readily meet the requirements of the Information Quality Act (USEPA 260/R-02-008. Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency, October, 2002). Read more.
3 Read more at Toxicology.org.
4 Conolly, R.B., Beck, B.D., and Goodman, J.I. (1999). Stimulating research to improve the scientific basis of risk assessment. Toxicological Sciences, 49, 1-4.
One of the basic tenets of toxicology is “the dose makes the poison.” That is, as a dose increases, whether it is a prescription drug or an industrial chemical, the likelihood of a toxic response increases as well.
Recently, some scientists have challenged this well-established tenet with a new hypothesis, that low doses of chemicals — below those that have previously shown no hazardous effect — are actually causing previously unrecognized toxicity. They are arguing that there is a low-dose effect of chemical exposure and that standard toxicological testing has missed these hazards.
This claim is unsubstantiated. Guideline-approved toxicological studies required by regulatory agencies cover the range of adverse effects and are notable for their extensive assessment of pathology, clinical chemistry observations, and other measures of adverse effects, in general. It is rare that adverse effects escape the attention of the regulatory agencies. Our growing sophistication in understanding how chemicals cause biological effects allows us to identify those substances that are most critical for further testing or regulatory action. In contrast, the low dose claims are still controversial, have not held up to scrutiny, and are generally discounted by regulatory scientists and agencies. The experimental results claimed to support the low dose claims have not been replicated in studies conducted according to thoroughly tested, robust guideline studies approved for regulatory purpose. Thus, the low-dose hypothesis remains just that — a hypothesis that should be subjected to the scrutiny of scientific peers.
One alternative hypothesis is that low doses of chemicals can actually have a beneficial effect. This hypothesis, called “hormesis,” suggests that a substance that is harmful at high exposure levels can be beneficial at low levels, generally producing reversible adaptation that is discontinued once the environmental exposure ceases, e.g. liver metabolic enzymes that are induced when one eat a charcoal-grilled steak. Although there is some limited evidence to support the hypothesis of hormesis, this concept remains as controversial as the low-dose theories of toxicity.
rts that sub-therapeutic dosages of a drug, far below the usual therapeutic dose prescribed by mainstream physicians, can cure various disorders. Homeopathy has been disproven and is not viewed as a responsible approach to the pharmaceutical management of disease.
Dow believes that the weight of evidence supports the idea that low exposures to chemical substances present in the environment do not pose a significant risk of adverse effect. These environmental exposures are typically hundreds, if not hundreds or thousands to a million times less than the safe exposure level that pose no health risk to begin with. We remain open to scientific advances that will help better inform the regulatory process so that human populations can be adequately protected, while taking advantage of the benefits that modern chemistry can provide.
Information about exposure to our products comes from our experience with our own employees in our manufacturing facilities or in our customer facilities. Dow has had considerable experience conducting industrial hygiene surveys during the manufacture and use of our products. We also learn from the experience of government agencies and professional societies, as well as the experiences of other companies.
Dow seeks information about the use and potential misuse of our products through dialogue with our customers, distributors, and other downstream users of our products. Commensurate with product risk, Dow seeks to gather information about the use of its products. For products with higher hazard, we inquire about the end use, handling, storage, transport and disposal of substances to ensure that our customer is aware of the potential hazards and has appropriate risk management measures in place. Dow’s ongoing dialogue with downstream partners is an essential element to the continuous improvement of our product stewardship practices.
Dow educates and trains employees, based on their job function, on the proper handling, recycling, use and disposal of products and known product uses. We have a system that encourages employees, such as our sales force and technical service personnel, to feed back information on new uses, identified misuses or adverse effects for use in our product risk characterizations.
It is rare that Dow would undertake human testing. Human subjects research can, however, help to inform an understanding of the possible interactions that chemicals can have with humans. Human studies can be more representative and useful than animal tests in determining health outcomes, establishing no observed effect levels, and studying mechanisms of toxicity. However, human subjects research is accomplished only under strict protocols, after other testing methods have been utilized.
Human studies generally fall into two categories: (1) human clinical studies, in which volunteers are deliberately exposed to substances, and (2) field epidemiological or exposure studies, in which data are collected about populations measured under natural exposure conditions.
Ethical standards have been established by the US government and several international bodies to protect the participants in human subjects research and to convey that information to prospective test subjects prior to obtaining their consent. The Dow Human Studies Review Board (HSRB) is registered with the Office of Human Research Protections (OHRP) within the US Department of Health and Human Services (HHS).
Dow supports the American Chemistry Council’s “Policy on Human Subjects Research” which states: “All research involving human subjects will be conducted in accordance with either the Common Rule, the Declaration of Helsinki, or the Guideline for Good Clinical Practice, depending on the entity or entities to which the research results may be submitted and other relevant factors.”
Humans have been exposed to the effects of combinations of chemicals (so-called ‘mixtures’) from foods, beverages and air. These complex mixtures of naturally occurring chemicals and low levels of industrial chemicals are readily managed, eliminated, or utilized by the complex biology systems that have evolved ever since our existence. In fact, life is not possible without exposure and utilization of complex mixtures of chemicals provided in the diet. Nevertheless, concerns about the safety of mixtures continued to be raised and Dow’s expertise positions us to respond to these concerns with the best scientific practices and information.
Existing research indicates that mixtures of chemicals are unlikely to cause adverse effects when all of the individual chemicals are at safe levels. In general, environmental exposures to industrial and agricultural chemicals exist at concentrations too low to cause adverse health effects (generally in the parts per trillion to parts per billion range). Dow therefore considers that a single chemical risk assessment approach – as required by existing regulatory schemes - is in most cases sufficiently protective of human health and the environment. This is in part addressed by the large safety factors (or uncertainty factors) that are used to further reduce the safe exposures determined in toxicological studies. However, in situations where screening assessments identify exceptions to this general rule, Dow supports, and has pioneered the use of cumulative risk assessments to further evaluate the safety of the combination of chemicals.
Dow has been a leader is providing scientific approaches, such as the Maximum Cumulative Ratio (MCR) screening tool, to examine the potential risks of mixtures. Dow is also leading efforts to assess new toxicological and risk assessment tools, known as high throughput toxicity testing and exposure assessments, to pave the way to risk assessment in the 21st century. Based on research conducted to date, it appears that the toxicity of many mixtures encountered by individuals in the real world is usually driven by one or just a few chemicals within the mixture.
In summary, Dow considers that combined effects are unlikely when all of the chemicals of the mixture are at safe levels, which is often the case in real-world mixtures. Consequently Dow believes, as a general rule, a single chemical and source by source risk assessment approach to be an effective means for identifying the drivers of risk of a mixture. Dow also believes that existing regulations – such as EU REACH or global Plant Protection Regulations, which utilize large safety factors to keep exposure low - are sufficiently protective of human health and the environment.
The rates of some neurobehavioral diseases in children and adults do appear to be increasing, while others have stayed the same or are decreasing. Scientists urge caution in interpreting any disease trends. Before concluding that such trends reflect an actual change in the burden of disease, scientists must evaluate how changes in diagnostic methods, disease classification, or reporting practices might have caused artificial changes in disease rates over time.
Further investigation is especially important for diseases such as autism, which has no known causes. Dow supports efforts to strengthen and standardize health and environmental data collection efforts internationally so that disease trends can be analyzed and used for further investigation. However, we believe it is premature to link diseases such as autism and ADHD to chemicals without further rigorous scientific investigation. In our role as a chemical manufacturer, we assess the hazards of our products. This is part of the overall evaluation using Dow's Product Safety Assessment process.
Certain substances are classified as Persistent Organic Pollutants (POPs) or as Persistent, Bioaccumulative and Toxic (PBT) under the United Nations Stockholm Convention on Persistent Organic Pollutants. Because the use of these substances has generated a range of public health and environmental concerns, the Convention has led to strict measures to eliminate or reduce emissions of these substances to the environment.
Dow supports the objectives of the Convention, which aims to protect human health and the environment from POPs. Dow further believes in the importance of including the proper and transparent implementation of a listing process that is based on sound science, including a weighted evaluation of all relevant scientific evidence. A process that considers both the benefits and the societal impact of such an action is imperative.
In order to help address these concerns, and as part of our commitment to ensuring product safety, Dow conducts tests and modeling to detemine the potential health and environmental effects of our products. Consistent with latest methods used nationally, regionally, and internationally, Dow uses a weight-of-evidence approach for the evaluation of POPs and PBT characteristics of substances. We continue to collaborate with governments and scientists around the world on research to refine and improve upon these approaches so that substances are appropriately characterized and any risks posed by POPs or PBT substances can be managed accordingly.
We are committed to promoting a risk-based approach to manage the risks associated with POPs and PBTs throughout the product life cycle. We work hard to ensure our products are manufactured, stored, transported, used, disposed and recycled in a manner that shows the highest regard for human health, safety and environmental stewardship, and is in full compliance with all applicable laws and regulations.
Dow supports taking precautionary action to protect human health and the environment.
Dow supports a precautionary approach as set out in Principle 15 of the Rio Declaration on Environment and Development: “In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.”
The Rio Declaration was amended at the Johannesburg summit to include health impacts, in addition to environmental impacts.
Dow believes that measures should be risk-based and cost-effective. Additionally, the selected chemicals management measure should be:
- Proportional to the objective being pursued
- The least burdensome option that provides adequate protection from the risk
A risk characterization consists of conducting a qualitative or quantitative assessment of the probability that a given chemical will produce an adverse effect at a given dose or exposure level. Conversely, an assessment could determine levels of exposure at which a chemical would not be expected to present a risk.
Companies and governments use the information learned from chemical testing and exposure assessments to make determinations about how to properly manage the risks posed by chemicals in their various uses.
Some examples include:
Occupational Exposure Limits
Companies, independent professional associations and governments establish occupational exposure limits to assist in the management of chemical exposures in the workplace. (Chemical users are advised to consult the Safety Data Sheet for information specific to the chemicals in their workplaces.)
- The US Occupational Safety and Health Administration (OSHA) sets and enforces Permissible Exposure Limits (PEL). The MAK Commission sets occupational exposure limits in Germany, and other countries have similar occupational safety authorities who establish and enforce occupational exposure limits.
- The American Conference of Governmental Industrial Hygienists (ACGIH) sets Threshold Limit Values (TLV) which represent the concentration to which almost all workers can be exposed daily for a working lifetime without adverse effects.
- Dow sets Industrial Hygiene Guidelines (IHG) for the purpose of identifying suggested workplace exposure guidance.
Acceptable Daily Intake
The Acceptable Daily Intake (ADI) is a numerical estimate of a daily oral exposure to the human population, including sensitive subpopulations such as children, that is not likely to cause harmful effects during a lifetime. ADIs are generally used for health effects that are thought to have a threshold or low dose limit for producing effects. (Also called reference dose, or RfD). An ADI is derived from a No Observed Adverse Effect Level (NOAEL) or the Lowest Observed Adverse Effect Level (LOAEL) by applying safety or uncertainty factors, and is usually expressed in milligrams per kilogram per day. ADIs are not normally used for chemicals if the endpoint of concern is the potential to cause cancer. Similar values are set and used by environment, health and safety authorities throughout the world.
- The US Environmental Protection Agency (EPA) calculates RfDs for chemical substances which form the basis for their regulatory limits, for example, for pesticide residues on food crops. These RfDs are also presented to state regulatory authorities for the purposes of establishing legal environmental exposure limits.
- The US Food and Drug Administration (FDA) uses ADIs to determine safe levels of chemical substances that may be directly or indirectly added to foods.
- For substances thought to pose a risk of cancer, a different risk assessment procedure is frequently employed. Under some theories of cancer causation, substances thought to cause cancer are presumed to have no safe level of exposure. Some government agencies use mathematical computer models — linear non-threshold models — rather than NOAELs and safety factors to describe the dose-response relationship for animal carcinogens.
One example of a state government agency’s application of risk values for carcinogens is California’s Proposition 65, The Safe Drinking Water and Toxics Enforcement Act of 1986, which was enacted as a ballot initiative in November 1986. Proposition 65 was intended by its authors to inform California citizens about exposures to chemicals known to cause cancer, birth defects or other reproductive harm through risk assessment and product warnings. California’s Office of Environmental Health Hazard Assessment uses risk assessment methods to calculate lifetime No Significant Risk Levels (NSRL) for substances determined to be “known to the State of California to cause cancer.” Products that might expose a user to a level greater than this NSRL must be assessed for adequate warnings.
Dow supports the accumulation of information to support risk-based decision making to protect the health and safety of all populations, including children (and others considered to be more sensitive sub-populations).
Current risk assessment practice incorporates precautionary (or safety) factors to accommodate scientific uncertainties. Typically, a 10-fold safety factor is applied to accommodate the uncertainty of extrapolating findings from studies conducted in laboratory animals to humans. An additional 10-fold safety factor may then be applied to allow for variability or unique sensitivities among humans.
Scientists have examined the question of unique or greater vulnerability of children and have concluded that, while there are some examples of chemicals and exposure scenarios where children are more vulnerable, there are many more examples where they are not. Their conclusion is that because we cannot automatically conclude that children are more vulnerable to the effects of chemicals, decisions to impose additional safety factors, beyond the two ten-fold safety factors discussed above, should be made on a case-by-case basis, taking into account the inherent hazards of the chemical, exposure scenarios and the weight of the scientific evidence.
Dow supports efforts to strengthen and standardize health and environmental data collection efforts internationally so that children's disease trend data can be analyzed and used for further scientific investigation. We support continued research into the causes of childhood morbidity and mortality using rigorous scientific methods, such as those outlined in the US National Children's Study. We caution against drawing “cause and effect” conclusions from studies that are intended to merely link health and environmental databases. Dow also supports mode-of-action and mechanistic research that will allow us to identify specific circumstances where childhood exposures represent a unique risk that must be managed through exposure mitigation and/or regulatory action.
Product Safety Pages
- Animals in Research
- Chemical Exposure and Asthma
- Chemical Managements
- Chemical Testing
- Credibility of Industry Science
- Dose Response Assessment
- Human Testing
- Neurobehavioral Effects
- POPs and PBTs
- Precautionary Principle
- Risk Values
- Occupational Exposure Limits
- Acceptable Daily Intake
- Sensitive Populations