A Guide to Regulatory Terms

AECA: Arms Export Control Act

The basic U.S. law providing the authority and general rules for the conduct of foreign military sales and commercial sales of defense articles, defense services, and training. The AECA came into existence with the passage of the Foreign Military Sales Act (FMSA) of 1968

The Arms Export Control Act of 1976 (Title II of Pub.L. 94–329, 90 Stat. 729, enacted June 30, 1976, codified at 22 U.S.C. ch. 39) gives the President of the United States the authority to control the import and export of defense articles and defense services.  

The Act also places certain restrictions on American arms traders and manufacturers, prohibiting them from the sale of certain sensitive technologies to certain parties and requiring thorough documentation of such trades to trusted parties.

BIS: Bureau of Industry and Security

The Bureau of Industry and Security (BIS) is a licensing, regulatory, and enforcement agency that advances U.S. national security, foreign policy, and economic objectives by ensuring an effective export control and treaty compliance system and by promoting continued U.S. strategic technology leadership and a strong defense industrial base. The Bureau of Industry and Security (BIS) advances U.S. national security, foreign policy, and economic objectives by ensuring an effective export control and treaty compliance system, and by promoting continued U.S. leadership in strategic technologies. 

CBP: Customs and Border Protection

United States Customs and Border Protection (CBP) is the largest federal law enforcement agency of the United States Department of Homeland Security, and is the country’s primary border control organization. It is charged with regulating and facilitating international trade, collecting import duties, and enforcing U.S. regulations, including trade, customs, and immigration. CBP is one of the largest law enforcement agencies in the United States. 

3TG: Conflict Minerals  

Conflict resources are natural resources extracted in a conflict zone and sold to perpetuate the fighting. There is both statistical and anecdotal evidence that belligerent accessibility to precious commodities can prolong conflicts (a “resource curse”). The most prominent contemporary example has been the eastern provinces of the Democratic Republic of the Congo (DRC), where various armies, rebel groups, and outside actors have profited from mining while contributing to violence and exploitation during wars in the region.

The four most commonly mined conflict minerals (known as 3TGs, from their initials) are cassiterite (for tin), wolframite (for tungsten), coltan (for tantalum), and gold ore, which are extracted from the eastern Congo, and passed through a variety of intermediaries before being purchased. These minerals are essential in the manufacture of a variety of devices, including consumer electronics such as mobile phones, laptops, and MP3 players.

CCL: Commerce Control List

The Commerce Control List (CCL) is a list of items under the export control jurisdiction of the Bureau of Industry and Security, U.S. Department of Commerce. The CCL is a list of categories and product groups used to help you determine whether an export license is needed from the U.S. Department of Commerce for U.S. exports. These categories and product groups ultimately create an alphanumeric code (i.e. 4E001) known as an Export Control Classification Number (ECCN).

CFR: Code of Federal Regulations

The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations(sometimes called administrative law) published in the FederalRegister by the executive departments and agencies of the federal government of the United States. The CFR is divided into 50 titles that represent broad areas subject to federal regulation.

DDTC: Directorate of Defense Trade Controls

The Bureau of Political Military Affairs’ Directorate of Defense Trade Controls (DDTC) is the organization within the U.S. Department of State responsible for enforcing the International Traffic in Arms Regulations (ITAR). In accordance with 22. U.S.C. 2778-2780 of the Arms Export Control Act (AECA), DDTC is charged with controlling the export and temporary import of defense articles and defense services covered by the United States Munitions List (USML).

DDTC ensures that U.S. defense trade supports the national security and foreign policy interests of the United States, seeking to deny adversaries of the United States access to U.S. defense technology while ensuring interoperability among allies and coalition forces.

DFARs: Defense Federal Acquisition Regulations Supplement

A supplement to the FAR that provides DoD-specific acquisition regulations that DoD government acquisition officials – and those contractors doing business with DoD – must follow in the procurement process for goods and services.

DOC: Department of Commerce

The DOC focuses on promoting American businesses both in the United States and overseas.

DOD: Department of Defense

The United States Department of Defense is an executive branch department of the federal government charged with coordinating and supervising all agencies and functions of the government directly related to national security and the United States Armed Forces. Under the direction of the President, the Secretary of Defense exercises authority, direction, and control over the Department of Defense.

DPL: Denied Persons List

The Bureau of Industry and Security within the Department of Commerce maintains alist of “Denied Persons,” made up of foreign governments, corporations, groups, and individuals that have beendeniedexport privileges. U.S.persons are generally prohibited from dealing withDenied Personsunder the terms of specific denial orders.

EAR: Export Administration Regulations

Export Administration Regulations (EAR) are a set of rules and regulations as well as legal protocols related to United States export control law. EAR is largely a legal document that defines the type of products and data that can be lawfully exported. Its aim is to ensure national security by incorporating commercial and research aims.

ECCN: Export Control Classification Number

An Export Control Classification Number (ECCN) is an alpha-numeric, five-character classification number used to identify items for United States export control purposes.

ICE: Immigration and Customs Enforcement

The U.S. Immigration and Customs Enforcement (ICE) is a federal law enforcement agency under the U.S. Department of Homeland Security, principally responsible for immigration enforcement, with additional responsibilities in countering transnational crime.
ICE’s mission is executed through the enforcement of more than 400 federal statutes and focuses on immigration enforcement, preventing terrorism and combating the illegal movement of people and goods.

Incoterms: International Commercial Terms

The Incoterms or International Commercial Terms are a series of pre-defined commercial terms published by the International Chamber of Commerce (ICC) relating to international commercial law. They are widely used in international commercial transactions or procurement processes and their use is encouraged by trade councils, courts and international lawyers. A series of three-letter trade terms related to common contractual sales practices, the Incoterms rules are intended primarily to clearly communicate the tasks, costs, and risks associated with the global or international transportation and delivery of goods. Incoterms inform sales contracts defining respective obligations, costs, and risks involved in the delivery of goods from the seller to the buyer, but they do not themselves conclude a contract, determine the price payable, currency or credit terms, govern contract law or define where title to goods transfers.

The Incoterms rules are accepted by governments, legal authorities, and practitioners worldwide for the interpretation of most commonly used terms in international trade. They are intended to reduce or remove altogether uncertainties arising from the differing interpretations of the rules in different countries. As such they are regularly incorporated into sales contracts worldwide.

IEEPA: International Emergency Economic Powers Act

The International Emergency Economic Powers Act (IEEPA), Title II of Pub.L. 95–223, 91 Stat. 1626, enacted October 28, 1977, is a United States federal law authorizing the president to regulate international commerce after declaring a national emergency in response to any unusual and extraordinary threat to the United States which has its source in whole or substantial part outside the United States.

ITAR: International Traffic in Arms Regulations

ITAR is part of a web of laws and regulations prohibiting U.S. individuals and companies from engaging in business with prohibited/sanctioned countries and persons for various economic, financial, anti-terrorism and human rights issues.

The laws and regulations are designed to protect U.S. national security, so the most sensitive information and technology don’t get into the wrong hands.

Physical enforcement of the ITAR; and all import and export laws of the United States is performed by Homeland Security Investigations Special Agents (formerly U.S. Customs) under Immigration and Customs Enforcement, an agency of the Department of Homeland Security.

The ITAR implements the AECA (Arms Export Control Act) and is managed by the Directorate of Defense Trade Control (DDTC) under the Department of State. The ITAR covers all military articles, services and technologies.

The ITAR is vague and open to interpretation. That is not by mistake but by design to allow the government the most flexibility and control over the military articles and services and, again, to protect the U.S. from national security and anti-terrorism acts. ITAR covers:

  • Companies that deal directly in defense articles and services;
  • Manufacturers who produce defense articles and services (even if they never export their articles or services);
  • Brokers and agents who connect buyers and sellers;
  • Collaborators with non-U.S. persons and companies including universities or groups studying USML-controlled articles, technology and services; and
  • Anyone dealing with all other goods, services and technologies that exceed the Commerce control under the EAR or that have a specific military application.

OEE: Office of Export Enforcement

The Office of Export Enforcement (OEE) is a part of the United States Department of Commerce, Bureau of Industry and Security. BIS is the principal agency involved in the development, implementation, and enforcement of export controls for commercial technologies and for many military technologies as a result of the President’s Export Control Reform Initiative…. OEE is singularly focused on export enforcement and work closely with intelligence analysts and licensing officers within a single bureau of the government to enforce export control laws and regulations. 

OFAC: Office of Foreign Assets Control

The Office of Foreign Assets Control (OFAC) is a financial intelligence and enforcement agency of the U.S. Treasury Department. It administers and enforces economic and trade sanctions in support of U.S. national security and foreign policy objectives. Under Presidential national emergency powers, OFAC carries out its activities against foreign states as well as a variety of other organizations and individuals, like terrorist groups, deemed to be a threat to U.S. national security.

RoHS: Restrictions of Hazardous Substances

  • RoHS stands for Restriction of Hazardous Substances and impacts the entire electronics industry and many electrical products as well. The original RoHS, also known as Directive 2002/95/EC, originated in the European Union in 2002 and restricts the use of six hazardous materials found in electrical and electronic products. All applicable products in the EU market since July 1, 2006 must pass RoHS compliance.
  • Directive 2011/65/EU was published in 2011 by the EU, which is known as RoHS-Recast or RoHS 2. RoHS 2 includes a CE-marking directive, with RoHS compliance now being required for CE marking of products. RoHS 2 also added Categories 8 and 9, and has additional compliance recordkeeping requirements.
  • Directive 2015/863 is known as RoHS 3. RoHS 3 adds four additional restricted substances (phthalates) to the list of six. RoHS 3 Deadline is 22 July 2019

The definition and aim of the RoHS directive is quite simple. The RoHS directive aims to restrict certain dangerous substances commonly used in electronic and electronic equipment.

EU RoHS specifies maximum levels for the following 10 restricted substances. The first six applied to the original RoHS while the last four were added under RoHS 3, which takes effect July 22, 2019.

  • Cadmium (Cd): < 100 ppm
  • Lead (Pb): < 1000 ppm
  • Mercury (Hg): < 1000 ppm
  • Hexavalent Chromium: (Cr VI) < 1000 ppm
  • Polybrominated Biphenyls (PBB): < 1000 ppm
  • Polybrominated Diphenyl Ethers (PBDE): < 1000 ppm
  • Bis(2-Ethylhexyl) phthalate (DEHP): < 1000 ppm
  • Benzyl butyl phthalate (BBP): < 1000 ppm
  • Dibutyl phthalate (DBP): < 1000 ppm
  • Diisobutyl phthalate (DIBP): < 1000 ppm

Related to RoHS is WEEE, which stands for Waste from Electrical and Electronic Equipment. WEEE Directive 2002/96/EC mandates the treatment, recovery and recycling of electric and electronic equipment (90% ends up in landfills). All applicable products in the EU market must pass WEEE compliance and carry the “Wheelie Bin” sticker.

REACh: Registration, Evaluation, Authorization and of Chemicals

REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. Its 849 pages took seven years to pass, and it has been described as the most complex legislation in the Union’s history and the most important in 20 years. It is the strictest law to date regulating chemical substances and will affect industries throughout the world. REACH entered into force on 1 June 2007, with a phased implementation over the next decade. The regulation also established the European Chemicals Agency, which manages the technical, scientific and administrative aspects of REACH.

SVHC: Substances of Very High Concern

REACH also addresses the continued use of chemical substances of very high concern (SVHC) because of their potential negative impacts on human health or the environment. From 1 June 2011, the European Chemicals Agency must be notified of the presence of SVHCs in articles if the total quantity used is more than one ton per year and the SVHC is present at more than 0.1% of the mass of the object.

USML: United States Munitions List

The United States Munitions List is a list of articles, services, and related technology designated as defense and space-related by the United States federal government. This designation is pursuant to sections 38 and 47(7) of the Arms Export Control Act (22 U.S.C. 2778 and 2794(7)). These articles fall under the export and temporary import jurisdiction of the Department of State.

VSD: Voluntary Self Disclosure

A Voluntary Self Disclosure, otherwise known as a VSD, in the context of Federal Regulations, is a disclosure of information to the appropriate government agency that relates to potential violations of the regulations when the regulations and law carry civil or criminal liabilities for said violations.

AIAG: Automotive Industry Action Group                                  

The Automotive Industry Action Group (AIAG) is a not-for profit association founded in 1982 and based in Southfield, Michigan. It was originally created to develop recommendations and a framework for the improvement of quality in the North American automotive industry. The association’s areas of interest have expanded to include product quality standards, bar code and RFID standards, materials management, EDI, returnable containers and packaging systems, and regulatory and customs issues. 

APQP: Advanced product quality planning

Advanced product quality planning (APQP) is a framework of procedures and techniques used to develop products in industry, particularly in the automotive industry. It is similar to the concept of Design for Six Sigma (DFSS).

According to the Automotive Industry Action Group (AIAG), the purpose of APQP is “to produce a product quality plan which will support development of a product or service that will satisfy the customer.” It is the process employed by General Motors, Ford, Chrysler and their suppliers for their product development systems.

IMDS:  International Material Data System

The International Material Data System (IMDS) is a global data repository that contains information on materials used by the automotive industry. Several leading auto manufacturers use the IMDS to maintain data for various reporting requirements.

In the IMDS, all materials present in finished automobile manufacturing are collected, maintained, analyzed and archived. IMDS facilitates meeting the obligations placed on automobile manufacturers, and thus on their suppliers, by national and international standards, laws and regulations.

MSA: Measurement System analysis

A measurement systems analysis (MSA) is a thorough assessment of a measurement process, and typically includes a specially designed experiment that seeks to identify the components of variation in that measurement process.

  1. Measurement System Analysis:
    1. Accuracy – The difference between the average of observed values and the standard
    1. Repeatability – Variation in measurement when a person measures the same unit repeatedly with the same measuring gage (or tool)
    1. Reproducibility – Variation in measurement when two or more persons measure the same unit using the same measuring gage (or tool)
    1. Stability – Variation in measurement when the same person measures the same unit using the same measuring gage (or tool) over an extended period of time.
    1. Linearity – The consistency of the measurement across the entire range of the measuring gage.

PPAP: Production Part Approval Process

The PPAP process is designed to demonstrate that a supplier has developed their design and production process to meet the client’s requirements, minimizing the risk of failure by effective use of APQP. Requests for part approval must therefore be supported in official PPAP format and with documented results when needed.

The purpose of any Production Part Approval Process (PPAP) is to:

  1. Ensure that a supplier can meet the manufacturability and quality requirements of the parts supplied to the customer.
  2. Provide evidence that the customer engineering design record and specification requirements are clearly understood and fulfilled by the supplier.
  3. Demonstrate that the established manufacturing process has the potential to produce the part that consistently meets all requirements during the actual production run at the quoted production rate of the manufacturing process.

PFMEA: Process Failure Mode and Effect Analysis

PFMEA is a methodical approach used for identifying risks on process changes. The Process FMEA initially identifies process functions, failure modes their effects on the process. If there are design inputs, or special characteristics, the effect on end user is also included.

10 Steps to Conduct a PFMEA

  1. Review the process
    1. Use a process flow chart to identify each process component
  2. Brainstorm potential Failure Modes
    1. Review Existing Documentation and data for clues
  3. List potential effects of a failure
    1. There may be more than one for each failure
  4. Assign Severity rankings
    1. Severity rankings are based on the severity of the consequences of failure
  5. Assign Occurrence rankings
    1. Occurrence rankings are based on how frequently the cause of the failure is likely to occur
  6. Assign Detection ranking
    1. Based on the chances the failure will be detected prior to the customer finding it.
  7. Calculate the RPN
    1. (Risk Priority Number= Severity X Occurrence X Detection)
  8. Develop the action plan
    1. Define who will do what by when
  9. Take Action
    1. Implement the improvements identified by your PFMEA team
  10. Calculate resulting RPN
    1. Re-evaluate each of the potential failures once improvements have been made and determine the impact of the improvements.

SPC: Statistical Process Control

Statistical process control (SPC) is a method of quality control which employs statistical methods to monitor and control a process. This helps to ensure that the process operates efficiently, producing more specification-conforming products with less waste (rework or scrap). SPC can be applied to any process where the “conforming product” (product meeting specifications) output can be measured. Key tools used in SPC include run charts, control charts, a focus on continuous improvement, and the design of experiments. An example of a process where SPC is applied is manufacturing lines.

(SPC) Statistical Process Control is the use of statistical techniques such as control charts to analyze a process or its output so as to take appropriate actions to achieve and maintain a state of statistical control and to improve the process capability.

There are two phases in statistical process control studies.

  1. The first is identifying and eliminating the special causes of variation in the process. The objective is to stabilize the process. A stable, predictable process is said to be in statistical control.
  2. The second phase is concerned with predicting future measurements thus verifying ongoing process stability. During this phase, data analysis and reaction to special causes is done in real time. Once stable, the process can be analyzed to determine if it is capable of producing what the customer desires.

A demonstration of solid statistical process control techniques proves an individual’s ability to monitor and improve manufacturing processes.

INCOTERMS: International Commerce Terms

Incoterms is more of an abbreviation that stands for International Commercial Terms.

Anyone who has indulged in international trade will admit that this is a very vital term. It represents a useful way of communication. Therefore, it helps to reduce any confusion that may arise between the sellers and buyers

CTPAT: Customs-Trade Partnership Against Terrorism

The Customs-Trade Partnership Against Terrorism (C-TPAT) is a voluntary supply-chain security program led by U.S. Customs and Border Protection (CBP) focused on improving the security of private companies’ supply chains with respect to terrorism. The program was launched in November 2001 with seven initial participants, all large U.S. companies. As of December 1, 2014, the program had 10,854 members. The 4,315 importers in the program account for approximately 54% of the value of all merchandise imported into the U.S.

SCIP: Substances of Concern In articles as such or in complex objects (Products)

SCIP is the database for information on Substances of Concern In articles as such or in complex objects (Products) established under the Waste Framework Directive (WFD).

Companies supplying articles containing substances of very high concern (SVHCs) on the Candidate List in a concentration above 0.1% weight by weight (w/w) on the EU market have to submit information on these articles to ECHA, as from 5 January 2021. The SCIP database ensures that the information on articles containing Candidate List substances is available throughout the whole lifecycle of products and materials, including at the waste stage. The information in the database is then made available to waste operators and consumers.

WFD: Waste Framework directive

Understanding WFD

The Waste Framework Directive sets out measures addressing the adverse impacts of the generation and management of waste on the environment and human health, and for improving efficient use of resources which are crucial for the transition to a circular economy.

As part of the implementation of the EU’s action plan for the circular economy adopted in 2015, the revised Waste Framework Directive entered into force in July 2018. It gave ECHA the task to develop a database with information on articles containing substances of very high concern (SVHCs) on the Candidate List. New substances are regularly added to the Candidate List under REACH.

Companies that produce, import or supply articles containing Candidate List substances must submit information on these articles placed on EU market to the SCIP database, as from 5 January 2021. These articles can be produced in the EU or imported from non-EU countries.

The information in the database may help waste operators in sorting and recycling articles that contain Candidate List substances, and support consumers in making informed choices and considering how to best use and dispose of such articles. Overall, the database should contribute to the progressive substitution of SVHCs in articles and to the development of safer alternatives.

The SCIP database has three main objectives:

  1. Decrease the generation of waste containing hazardous substances by supporting the substitution of substances of concern in articles placed on the EU market.
  2. Make information available to further improve waste treatment operations.
  3. Allow authorities to monitor the use of substances of concern in articles and initiate appropriate actions over the whole lifecycle of articles, including at their waste stage.

The SCIP database complements the existing communication and notification obligations for Candidate List substances in articles under REACH.