Controlled chemicals and ITAR compliance

The United States Department of State created the International Traffic in Arms Regulations (ITAR) compliance to regulate the movement of articles of defense, including controlled chemicals.1  

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ITAR works in conjunction with Commerce Control Lists (CCL) to enforce international regulations relating to chemical control in the US, particularly those materials that could be utilized in the production of chemical weapons or explosives "dual use chemicals".

Maintaining ITAR compliance necessitates innovative solutions to detect these chemicals and provide the best available data for informed decision-making at the crossroads of scientific research, commerce, and law.

This article will highlight the significance of ITAR compliance and its impact on various stakeholders in the supply chain. Additionally, the article will delve into the difficulties faced in ensuring ITAR compliance and showcase the advantages of Scitegrity's Controlled Substances Squared solution as a solution for ITAR compliance.

CCL and ITAR compliance in the supply chain

ITAR compliance places restrictions on the handling and utilization of military-related chemicals, agents, precursors, explosives, and energetic materials, which are often used in the laboratory and industrial settings.2

This regulation affects the supply chain of controlled chemicals in industries, academic institutions, and life science companies. Moreover, ITAR compliance may necessitate the declaration of specific details on chemical shipments.2

Failure to comply with ITAR regulations could result in hazardous research conditions, slowed work procedures, and penalties under civil or criminal law. Hence, it is imperative to ensure ITAR compliance when working with chemicals that are likely covered under ITAR or CCL.

Challenges to ensuring CCL and ITAR compliance

Ensuring chemical compliance is a complicated and intricate process. The initial step towards compliance, which is identifying regulated chemicals, is often the most difficult. Two common methods for identifying a chemical are by name and structure.

Relying solely on name searching can lead to compliance problems as there can be multiple names for the same chemical, and legislation often regulates not only named chemicals but also the broader controlled chemical space.

This can encompass the salts and esters of the named substance and more comprehensive definitions, such as chemical family controls and generic statements.

As a result, it is crucial to consider these definitions as well, which can only be achieved by evaluating the chemical's structure against regulations. Ensuring compliance with CCL and ITAR regulations subsequently requires a proactive approach.3

Additionally, regulations and the substances that are controlled vary greatly between countries. These factors highlight the need for a compliance solution that is trustworthy, all-encompassing, and user-friendly.

CCL and ITAR compliance solutions with Scitegrity Limited

The Controlled Substance Squared platform offered by Scitegrity provides an innovative solution to meet the requirements of various chemical regulations, including ITAR, CCL, Controlled Drugs, and the Chemical Weapons Convention.

The technology encodes controlled chemicals and chemical space, allowing rapid screening against controlled substance lists and legislation worldwide with the simple entry of a chemical name or structure.4

Controlled Substance Squared, which is updated weekly, can perform a quick screening of large collections of chemicals against controlled substance lists and regulations, such as ITAR compliance lists and CCL, reducing the complexity of chemical identification.4

This is especially useful in addressing compliance challenges for chemicals that are subject to different regulations worldwide, including national legislation and regional and international agreements.

At Scitegrity, leading scientific and data-driven experts work to develop comprehensive and user-friendly solutions for ITAR compliance and chemical regulation. The products and services offered by Scitegrity enhance the controlled chemical compliance and identification process in various workflows.

References and Further Reading

  1. Article - DDTC Public Portal. (2016). State.gov. https://www.pmddtc.state.gov/ddtc_public?id=ddtc_kb_article_page&sys_id=24d528fddbfc930044f9ff621f961987
  2. Export Controlled Items | Research and Innovation. (2022). Uoregon.edu. https://research.uoregon.edu/manage/export-controls/export-controlled-items
  3. Controlled and Regulated Chemicals: Ensuring Compliance in Research and Manufacturing. Scitegrity Chemicals Compliance White Paper, Scitegrity (2022). Scitegrity.com https://blog.scitegrity.com/resources/controlled-substance-squared-white-paper
  4. Regulated Chemicals | Controlled Substance Lists | Scitegrity. (2022). Scitegrity.com. https://www.scitegrity.com/controlled-substances

About Scitegrity

Want to know if your chemical is controlled, regulated, has the potential for abuse or just need a tariff code?

Our regulatory and chemistry experts encode chemical regulations from around the world allowing you to simply answer these questions and more by drawing or looking up a chemical structure.

We make regulatory compliance a simple, robust, background process. Join with 5 of the worlds top 10 pharma, chemical suppliers, regulators, CROs, forensics labs and more who trust and rely on our solutions.

Scitegrity was founded in 2011 by ex-Pfizer, GSK and Roche chemists and data scientists with the goal of making compliance to chemical regulations are far more robust, accurate and automatic.

By automatically checking all the chemicals an organisation has at the structure level, it allows enterprise wide automatic compliance checks against hundreds of regulations globally, even for novel and proprietary chemical collection running into millions of chemicals.

Last updated: Mar 10, 2023 at 5:15 AM

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