It is the responsibility of all food safety professionals to assist their company in its compliance to food safety laws and regulations. If you can’t understand and navigate regulations or properly refer to them when you have a question, you may be one roadblock away from adding fundamental value to your company. In this article, we introduce you to the fundamentals of understanding and navigating food safety laws and regulations. Enjoy!
What are laws, or statutes?
Federal Law is created by Congress (only!) through a process in which a bill is voted upon. The Food Safety Modernization Act (FSMA) of 2011 is composed of many Statutes, written to “amend” (i.e. update) the Statutes of the Federal Food, Drug and Cosmetic Act (FD&C) of 1938. Statutes from Acts are “codified” (i.e. listed) into the United States Code (USC). The USC, organized into 54 titles, is where all of the “Laws of the Land” can be found. The FD&C Act is codified under the Title dedicated for food and drugs (Title 21 of the USC). To learn more about the USC, check out GPO’s landing page. Most food safety professionals do not read the “Statutory language” of the USC; instead, they read “Regulations”. More on that below.
What is “Statutory language”?
“Statutory language” is a term used when people speak about the specific wording of Statutes codified in the USC. Attorneys may challenge FDA’s interpretation of the Statutory language when FDA creates or enforces regulations.
What is “Statutory authority”?
When FDA writes that their authority comes from Congress, the term “Statutory Authority” is used, as FDA’s power is rooted in (and bound by) the Statutes legislated into Law by Congress that are codified in the USC.
Is the legality of FDA’s regulations ever challenged by questioning statutory authority?
When FDA creates regulations through the rulemaking process, there is a public comment period during which time stakeholders can contend that FDA is proposing regulations for which they do not have “Statutory authority”. In other words, “You can’t do that, FDA, because Congress never granted you the power to do so.” Attorneys (not food safety professionals) are trained to challenge FDA’s statutory authority. If you feel that FDA is abusing their power, then consult an attorney. To learn more about FDA’s statutory authority, check out this government webpage on legal authority.
How does FDA reference Statutes?
FDA often references Statutes by the section of the Act passed by Congress. FD&C 402 (“Adulterated”) is codified in Title 21, section 342, of the US Code (This is written: 21 USC 342). “Misbranded” is defined in the subsequent section, FD&C 403, is codified in the USC in section 343 (This is written: 21 USC 343). You will often see this cited as FD&C 403(w), which corresponds with subsection (w) of 21 USC 343, which addresses food misbranded due to undeclared allergens. For a cheat sheet of the FD&C sections and their corresponding sections in the USC, check out FDA’s webpage for FD&C Chapter IV.
How are Statutes referenced?
Food safety professionals will see Statutes of Acts (and their corresponding sections of the USC) referenced frequently in regulations. There are two that ought to be read immediately: FD&C 402 (or 21 USC 342), which is the definition of adulterated; and, FD&C 403(w) (or 21 USC 343(w)). These Statutes are often referenced by FDA in their justification of regulatory action, including recalls and issuing of warning letters. When food meets the definition of adulterated and/or misbranded, it is considered “violative”. If you are responsible for determining whether food is “in compliance”, you’ll want to know what it means to be violative.
How can I find statutes in the USC?
Searching for FD&C sections in the USC is cumbersome, as you’ll need to select multiple drop downs to find the section of choice, which does not include the FD&C section number (e.g. FD&C 402). Searching for the corresponding USC section number (21 USC 342) is simple. Just plug in the title and section numbers and hit “Search”.
FDA often cites sections of these Acts in regulations to emphasize the statutory authority behind them. It is rare for food safety professionals to ever read the Statutory language of these Acts. Familiarity with certain sections of these Acts, however, can be an indicator of a food safety professional’s level of maturity. For a cheat sheet of the FD&C sections and their corresponding sections in the USC, check out FDA’s webpage for FD&C Chapter IV.
What is the rulemaking process?
The rulemaking process is used by agencies to interpret and implement Statutes in the form of regulation. In short, the purpose of a “rule” is to modify, supplement or delete existing regulations, which are then codified in the Code of Federal Regulations (CFR). A rule consists of two fundamental components: (i) proposed regulation; and, (ii) a Preamble in which FDA explains how FDA intends to fulfill their congressional mandate through their proposed regulations. A comment period ordinarily precedes the publishing of a rule, during which time FDA seeks the input of industry stakeholders, among others. FDA addresses comments with concise answers in a Q&A format in the Preamble to each rule. Preambles frequently constitute >90% of published rules and contain rare insight into what can otherwise be regarded as vague regulations. For more information on rules and the rulemaking process, check out FDA’s landing page. Below is what the Preventive Controls for Human Food final rule looks like in the Federal Register online.
What is a regulation?
A regulation is often used by FDA to determine food to be compliant or violative. FDA publishes and maintains compliance policy guides (CPG) so that investigators take necessary regulatory action and exercise appropriate enforcement discretion when enforcing regulations. FDA defines regulations on their landing page: “Federal regulations are either required or authorized by statute. Some, such as FDA’s egg safety regulations, address a specific problem or known health hazard, while others, like citizen petition regulations, are administrative or procedural.”
What is the relationship between laws and regulations?
Below is a figure that generally illustrates the relationship between laws and regulations in the context of legislation, rulemaking and industry regulatory compliance.
What is the Code of Federal Regulations (CFR)?
CFR is described by the Government Publishing Office as being, “the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government.” To learn more, visit FDA’s landing page.
What is the eCFR?
“The online CFR is a joint project”, according to GPO, “authorized by the publisher, the National Archives and Records Administration's (NARA) Office of the Federal Register (OFR), and the Government Publishing Office (GPO) to provide the public with enhanced access to Government information.” To learn more, visit FDA’s landing page. Here is a link to title 21 of the e-CFR.
How is the CFR organized?
It is important to be familiar with subsection formatting for when it is necessary to understand or communicate where a regulation can be found in the CFR.
The CFR is organized in: Titles, which are made of: Chapters, Parts, Subparts, Sections and Subsections (21 CFR 117.130, which is Title 21, Part 117, section 117.130). The numbering convention for a subsection follows a convention difficult to follow (shown below):
Lower case letter, (a)
Lowercase roman numeral, (i)
Upper case letter, (A)
Italicized number, (1 )
Italicized lowercase roman numeral, (i)
Below is the longest subsection in the Preventive Controls for Human Food Regulations:
Below is the longest subsection in the Foreign Supplier Verification Program Regulations:
Complex subsections, like those shown above, are not shown in the CFR using indentations, which makes it difficult sometimes to see where these subsections begin and end. Fortunately, not all sections of the CFR are so complex. For example, the cGMP (21 CFR 117 Subpart B) rarely fragment further than the lowercase roman numerals (The two exceptions are 21 CFR 117.80(c)(9)(ii)(A) and (B)).
Why aren’t subparts included when referencing a section of the CFR?
Subparts just aren’t referenced when a section or subsection is referenced in this format. Subparts are often referenced rather as a convenient way for referring to a collection of sections. For example, Subpart L of 21 CFR 1 refers to the FSVP regulations (sections 1.500 - 1.514) and Subpart O of the same Part refers to the Sanitary Transportation of Human and Animal Food regulations (1.900 - 1.934). The regulations for Produce Safety (21 CFR 112), Intentional Adulteration (21 CFR 121) and Preventive Controls for Human Food (21 CFR 117) and Animal Food (21 CFR 507) are packaged in Parts, not subparts.
Why do people speak about compliance with rules rather than regulations?
Many people in the food industry speak (and write) about compliance with rules, rather than regulations. On its face, this is an error. When an FDA investigator is evaluating a facility’s regulatory compliance, applicable sections of the CFR (not sections of rules from which the regulation was proposed, created or amended) are used. However, it is commonly understood that the term “rule” and “regulation”, in some contexts, mean the same thing. Personally, I find the double use of the terms to create unnecessary confusion.
What is guidance?
A regulation requires compliance and is treated as a “must” or “shall”, while guidance encourages best practice and is expressed as a “should”. Guidance is produced after a rule is finalized to provide industry with additional clarity. Guidance may include (but is not limited to): summaries of regulation and enforcement discretion, examples of compliance, suggested templates, and Q&A. To read more about guidance, visit FDA’s landing page.
I hope you enjoyed this article. If you have any questions, please post!