The Village of Hartland, WI

 

The Village of Hartland , Wisconsin has invoked coordination with the Food and Drug Administration.  Hartland’s Trustees have insisted that the Food and Drug Administration coordinate with the Village as to regulations that seem to doom the e-liquid “vaping” industry that provides the most effective, safe means of attacking the smoking addiction that leads to 480,000 deaths a year.  Hartland’s Trustees have taken up the cause to try to save an industry vital to its economy and to the health of the people:  Johnson Creek Enterprises which produces the product that safely allows smokers to abandon life threatening cigarettes.  The FDA seems hell bent on destroying Johnson Creek as well as the entire industry through a set of regulations that create an impossible cost for industry survival.  Hartland’s Trustees have decided that they won’t let that happen without a fight.  And it’s a fight of the type encouraged by the President of the United States who happens to be the ultimate supervisor of the Food and Drug Administration.

When the Village invited Food and Drug to attend its hearing,  a spokeswoman for the agency left a voice message that the agency would send a letter addressing the Village Trustees’ “concerns”.   I seriously doubt that sending a letter is the level of coordination that is expected by President Trump. Since taking office he has repeatedly emphasized that control over many aspects of life must be returned to local government.

And the issue taken up by Hartland would seem to be the perfect type issue for local interest and involvement.  After all, smoking addiction strikes at the heart of public health that is a part of life subject to the police powers reserved to the states and local governments by the Tenth Amendment.

 

Since the Hartland, Wisconsin “coordination” the coordination process has been a topic of broad discussion.  Many call the Hartland approach “novel”, many call it “new”, some call it nonsensical to believe that a federal agency must coordinate with a small village.

But, if and when the Food and Drug Administration wants to know what we mean by “coordination”, our answer should be “why don’t you call the President and ask him?”  Because President Trump obviously knows the term.  He used it repeatedly in an Executive Order issued within the last two weeks.  In the Order directing that all designations under the Antiquities Act be reviewed he used the term four times in a two page order.  He ordered the Secretary of Interior to coordinate with local governments.

And, the order to coordinate is not new to this President.  John Fitzgerald Kennedy ordered all agencies to coordinate with local governments in a Presidential Memorandum on November 10, 1961.  He said he wanted “coordination of government activities outside of Washington significantly strengthened” in order to bring about a closer relationship with local governments on “economic problems, natural resources development, protection of equal rights and urban development efforts.”

Ronald Reagan ordered an Intergovernmental Review of Federal Programs in 1982, and directed all agencies to adopt “processes or refine processes for State and local elected officials to review and coordinate proposed Federal financial assistance and direct Federal development”.  He ordered the agencies to coordinate with local governments “as early in the program planning cycle as is reasonably feasible to explain specific plans and actions”, and to “make efforts” to reach consistency with local  plans and actions, and where that is legally impossible “explain the bases for …decision in a timely manner.”

Bill Clinton issued Executive Order 13132 in 1999  that contained the order to coordinate with local government.  Why?  Because, said the President

“The nature of our constitutional system encourages a healthy diversity in the public policies adopted by the people of the several states according to their own conditions, needs, and desires.  In the search for enlightened public policy, individual states and communities are free to experiment with a variety of approaches to public  issues.  One-size-fits-all approaches to public policy problems can inhibit the creation of effective solutions to those problems.”

He said further that “policies of the national government should recognize the responsibility of—and should encourage opportunities for—individuals, families, neighborhoods, local governments, and private associations to achieve their personal, social, and economic objectives through cooperative effort.”  To that end, he ordered all federal agencies to coordinate with local governments, and where national standards are being developed he ordered the agencies to “consult with appropriate state and local officials in developing those standards.”

And, President Obama ordered coordination by every agency with local governments in an executive order issued in June, 2011.

So, when an agency spokesperson says “we don’t know what coordination means” or when he or she asks local government “what do you mean by coordination”, perhaps the answer should be “why don’t you ask the President who supervises you what he meant when he ordered you to coordinate.”

Every one of the Presidential orders directed a process that was mandated by Congress to every federal agency by the National Environmental Policy Act in 1969.  That act orders every federal agency to enter into the coordination process regarding every “major federal action”, and issuance of regulations is considered a “major federal action”.  So, regardless of what subject is being regulated, when an agency begins to develop a regulation or set of regulations, coordination is necessary.

Some have said that the coordination process is only available for land issues.  But that simply is not so.  The National Environmental Policy Act (NEPA) makes it clear that it applies to  protect local governments and their citizens regarding all aspects of “man” and “his” environment, not just the natural resources of the environment.  Congress opens the act with a declaration of national policy “to encourage productive and enjoyable harmony between man and his environment” in order to “stimulate the health and welfare of man.”  In order to better provide for the public health, the Act created the Council on Environmental Quality which has defined the “human environment” as including all aspects of life: “ecological, aesthetic, historic, cultural, economic, social, [and] health”.

So, when Hartland invokes coordination regarding the “deeming regulations” which restrict an effective alternative to smoking that leads to death, it is invoking the process in precisely the situation anticipated by NEPA.  When invited to attend the Hartland hearing, Food and Drug said they were unable to make anyone available to come to the meeting but would send a letter addressing Hartland’s “concerns”.

We will see whether sending a letter is the degree of coordination expected by FDA’s President who as recently as last week said  he would continue the effort to return to the people the decisions important to their lives—taking them from the hands of Washington, DC “bureaucrats”.  If my experiences over the last twenty five years are any indication, sending a letter will not be the answer.  The state of Texas and the federal EPA thought writing a letter would suffice when four small towns with a population of around 6,000 invoked coordination over the first leg of the NAFTA Superhighway—but after 24 months of coordinated badgering by the towns, the Trans Texas Corridor was abandoned.

Maybe the Philistines should have sent a letter rather than Goliath?

 

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