What’s true when it comes to chemical regulations in the U.S.

Given the details and complexities of chemical regulation, it is not surprising that there is some confusion over what it entails. It took me several classes and specific readings to nail down the details. The difficulties in accessing some of the information made me realize the importance of sharing it. I have tried to address the information I gathered through statements I have encountered. I have classified the statements as ‘true’, ‘half-true (/half-false)’ and ‘false’ and provided explanations.

Statement 1: There are 86,000 industrial chemicals currently present in the U.S.

Half-true.

In 2018, the EPA Toxic Substances Control Act (TSCA) inventory had listed about 86,000 chemicals but this had included all chemicals that have been in commerce since 1979. Many chemicals are no longer produced and, in 2019, the EPA updated the inventory for the first time in 40 years. We now know there are nearly 41,000 chemicals in commerce. But some of the chemicals that are no longer produced are still present in the environment. So we have somewhere between 41,000 and 86,000 chemicals in the U.S..

Statement 2: 99% of the industrial chemicals did not undergo safety testing prior to their release into the environment

Half-true.

It is true that only a very small percentage of chemicals underwent extensive safety testing prior to release (the number may be as low as 1%). But prior to 2016 (before the TSCA reform kicked in requiring EPA to make human and environmental safety findings for new chemicals), about 10 to 15% of chemicals submitted for review had some toxicity data associated with it. For the rest (~85 to 90% of chemicals), the EPA relied on predicative modeling data to assess chemical risks prior to allowing their release into the environment.

Statement 3: Chemicals released into the environment prior to the 2016 amendment of the TSCA will not be properly tested for safety

Half-true.

There were many chemicals released into the environment prior to 2016 and it is possible that we will never test all of them adequately for safety. However, the 2016 TSCA reform explicitly requires testing of pre-2016 chemicals. Chemicals which are believed to pose greater risks will be tested first and this process has already begun.

Statement 4: Current regulation does not account for chemical mixtures

Half-true.

The Food Quality Protection Act of 1996 requires that cumulative effects of all pesticides with similar modes of action be tested. It also states that all pesticides that can disrupt the endocrine system be tested along with all chemicals (including non-pesticides) that have the same property. TSCA requires that effects of chemical mixtures be studied and the Clean Air Act assesses cumulative carcinogenic effects of pollutants. However, cumulative effects of chemicals with different modes of action are often not studied.

Statement 5: EPA only relies on GLP studies to make regulatory decisions

False.

While initial registration of a chemical can be done by using only the manufacturer’s data (as the public does not have access to the chemical), pesticide re-registrations (done every 15 years) and chemical assessments after environmental release are done by looking at all available studies. However, the EPA does have a set of reasonable guidelines that need to be followed for them to consider open literature studies for regulatory purposes. These study guidelines also apply to chemical manufacturers.

Statement 6: GLP studies means good science

False.

GLP stands for good lab practices. What this means is that GLP labs are inspected by the EPA and GLP studies are more rigorous in following study guidelines, documenting results, calibrating instruments, etc. But if the study design is flawed/biased, the study results are meaningless.

Statement 7: Toxicity studies for a chemical are conducted in-house by the manufacturing company

Half-true.

Many manufacturing companies outsource their studies to EPA-approved contract labs that follow GLP. When these data are submitted to the EPA, it is reviewed by the agency (see next Statement) (P.S.: this process doesn’t guarantee the data generated is not fraudulent).

Statement 8: EPA blindly believes data provided by companies/contract labs

False.

The companies/contract labs provide EPA with the raw data and the summary document. EPA then has to redo the statistical analyses to verify conclusions and, if the data is being used quantitatively, the review should be carried out by two EPA scientists. There are also often multiple peer reviews within the EPA.

Statement 9: Data used for making regulatory decisions is not available to the public

Half-true.

The public has access to the summary document (that was verified by the EPA and was used for regulatory purposes) through the Freedom of Information Act. But they do not get access to the raw data, personal privacy data, or data containing trade secrets and other confidential business information. You can check out the other exemptions here.

Statement 10: EPA decisions, especially controversial ones, are not reviewed by outside experts

False.

EPA decisions, especially the controversial ones, are reviewed by independent expert panels. Scientific Advisory Panels (SAP), the Scientific Review Board (SRB), Scientific Advisory Committee on Chemicals (SACC), and National Academy of Sciences (NAS)’s National Research Council panels are the major panels that have reviewed different EPA decisions. These review meetings are open to public and the meeting documents are published online. However, the EPA does not have to follow their advice.

Statement 11: The public doesn’t have any say in EPA’s regulatory processes

False.

Laws like FIFRA, FFDCA, and TSCA require EPA to engage the public at specific times during the registration process. For example, the EPA must engage the public when it receives an application for a new chemical registration or use, when it is setting or altering tolerances (maximum allowable residue levels), when it is cancelling a product, etc. Typically, more engagement is sought when the chemical or product is unfamiliar/complex but opportunities for public to participate exist for even routine assessments. Also, the EPA has to respond to public comments and make the comments and responses public. I encourage you to check this webpage to understand more about public participation and how you can get involved.

Statement 12: Organic agriculture doesn’t use pesticides

False.

Organic agriculture uses pesticides but lesser pesticides are used than in conventional agriculture. Most of the pesticides are naturally occurring substances but some synthetic pesticides are also allowed (P.S.: the toxicity of a pesticide is not predicted by its origin).

Statement 13: Organic pesticides are not properly regulated/tested for safety

False.

Organic pesticides are also regulated by the EPA and they require a safety finding just like conventional pesticides. The USDA determines what pesticides can be used in organic farming.

Statement 14: Formulated pesticide products and inert ingredients are not tested by the EPA

Half-true.

While active ingredients are always tested for safety, formulated pesticide products are tested in only some scenarios. For example, field testing for pesticide volatility, dissipation, and ground water monitoring are done with formulated products. Field testing for pesticide effects on mammalian, avian, aquatic, pollinator, and plant species are also done with formulated products. However, lab toxicity studies that assess human health effects are done on active ingredients. And as it is not possible to test all formulated products (there can be many formulated products for an active ingredient), only the commonly used ones or the ones which pose the greatest risk are often tested. The inert ingredients (formulated product minus active ingredient) are tested under TSCA though the EPA pesticide office has performed screening-level assessments on them.

Statement 15: If a chemical has been properly tested for safety, it must be safe.

False.

The absoluteness of the statement indicates that science is perfect and has all the answers. The truth is far from it. There are almost always uncertainties and unknowns in decision-making. Regulators try to deal with it by using uncertainty factors, but this doesn’t guarantee safety because there is extrapolation of results from one effect to another and from animals to humans. Also, not all health effects and possible combinations of effects are (or can be) studied. Risk assessment involves a lot of assumptions and determinations and results can vary depending on who is carrying out the assessment. Regulation is based on probabilities of harm as there is nothing like ‘zero risk’. For example, for cancer, the acceptable lifetime risk to the general population is between 1 in a million to 1 in 10,000. Thus, if a chemical has a 1 in a 10 million chance of causing cancer, it is considered ‘safe’.

Statement 16: Cosmetics are not regulated prior to release

Half-true.

The finished cosmetic product is not tested for safety prior to release. The FDA has the authority to regulate the finished cosmetic product only after it has been released. But the FDA can regulate cosmetics as a drug if it claims to “cure, mitigate, treat, or prevent diseases” or if it is “intended to affect the structure or any function of the body”. Also, if the individual chemicals used in the finished cosmetics are TSCA chemicals, then the EPA regulates them under TSCA (see Statements 2 and 3).

Statement 17: Food additives are regulated prior to release

Half-true.

Food additives have ‘softer’ regulations compared to pesticides, industrial chemicals, and drugs. While additives have to undergo safety testing, the FDA has to make a safety finding within 75 days. If the agency doesn’t adhere to the timeline, the additive can enter the market without a safety analyses. Also GRAS (generally recognized as safe) ingredients do not need to undergo safety testing.

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