FDA Take Note: Approval of Ractopamine Use in Animal Ag *Is* a NEPA Issue

Court applies a legal doctrine of questionable relevance to dismiss NEPA challenge—for now.

Ractopamine hydrochloride.  Practically rolls off the tongue.  And although its use is banned in most countries—including Russia and China—it’s been approved for use here in the States since 1999.  Animal “finishing” operations feed it to pigs, cows and turkeys whose fat content and muscle growth is a major money issue.


Ractopamine molecule

Given the widespread knowledge of ractopamine’s health effects on humans (and animals), what did FDA do to investigate its being spread around the farm (as it’s excreted from the animals)?  Apparently, nothing.  That’s why the Center for Food Safety’s recent lawsuit against the Food and Drug Administration—and its tentative dismissal by the district court last week—is so interesting.

FDA and the drug company that markets ractopamine (which intervened in the lawsuit) argued that the suit should be dismissed because the plaintiffs hadn’t exhausted their “administrative remedies.”  The approvals in question were for drugs with ractopamine as the active ingredient from 2008-2014. The court agreed, but its dismissal was an odd way to handle the plaintiffs’ claims.

Square Peg, Round Hole: Administrative Exhaustion and Claims that NEPA was Ignored

Federal district courts are right to refuse jurisdiction in cases where the plaintiffs haven’t availed themselves of available administrative remedies.  See, e.g., McCarthy v. Madigan, 503 U.S. 140 (1992); McKart v. United States, 395 U.S. 185 (1969).  It makes sense: let the administrative process play all the way out before allowing the disaffected to rush into court and inveigle a judge to interrupt a work-in-progress.  McKart, 395 U.S. at 193.

But NEPA claims are atypical in this regard because they generally involve a plaintiff alleging that some agency decision was made without the requisite environmental analysis.  NEPA only ever applies to agencies’ decisions involving at least some discretion.  Many NEPA cases explain why this fact sets the NEPA claim askew of the exhaustion framework.

Rather than cite them all, let’s just review the statute providing the cause of action: the Administrative Procedure Act (APA).  Technically speaking the NEPA plaintiff alleging that an agency action is wrong on NEPA grounds must use the APA to claim that the subject action should be “h[e]ld unlawful and set aside . . . [because its] findings and conclusions [are] found to be . . . without observance of procedure required by law.”  5 U.S.C. § 706(2)(D).  The claim is that the action itself is tainted and void ab initio—not that, given more time or information, the agency would reconsider.

Indeed, the plaintiffs in this lawsuit couldn’t have availed themselves of FDA’s pre-decision administrative procedures at all. The court at least described why:

Due to statutory and regulatory requirements that applications to FDA for new drugs remain confidential . . . plaintiffs only became aware of the approvals, and FDA’s associated decision-making, when they were final and published in the Federal Register. Thus, plaintiffs were not able to participate in the administrative process prior to the FDA approvals at issue. Central to defendant-intervenor’s motion to dismiss, plaintiffs do not allege that they pursued any administrative remedies with the FDA relating to their NEPA grievances following the FDA approvals.

Center for Food Safety v. Hamburg (N.D.Cal. No. 4:14-cv-04932-YGR 2015) (Slip opinion at 4) (citations omitted).

Undeterred by this disability on plaintiffs’ part, the court focused on an FDA regulation ostensibly requiring anyone seeking to have an FDA action overturned in court to first “petition” FDA for what amounts to a rehearing.  Id. at 3-4 (citing 21 C.F.R. § 10.25(a), 10.45(b)).

Ractopamine: Coming to a Courtroom Near You

The initiating actions here were taken over seven years ago.  From the food and drug perspective, the fact that China—China—has since started requiring third party inspection of U.S. pork to verify it’s ractopamine free is cause enough for concern.  {See this report from Reuters.}

But from an administrative law perspective, the exhaustion ruling is what is so peculiar.  The district court put a lot of stock in a remark from the Supreme Court in Darby v. Cisneros, 509 U.S. 137 (1993), that plaintiffs ordinarily must exhaust all agency appeals required by statute or agency rule.  Id. at 147.  This might seem to protect FDA’s run-around.  But implied in Darby was the deference courts owe to administering agencies to define when their administrative process is final.  It’s deference that stems from Congress’s decision to delegate the underlying statute’s programs to that agency.  But that deference is hardly due where an agency has so clearly failed—as FDA did here—to integrate NEPA into its discretionary actions.  FDA doesn’t administer NEPA.  FDA is supposed to be constrained by NEPA.  And in this instance—as in so many others—FDA has shown itself ready to minimize NEPA into irrelevance.

FDA shouldn’t get to string the public out for as long as it would like.  Nothing in exhaustion doctrine says permit the agency to create a rabbit hole like this one.  If the agency actually meant to “reconsider” this action, this lawsuit filed over a year ago gave it plenty of opportunity to do that.  Lending credence to its regulation given how its pre-decision procedures were closed empowers FDA to take actions harmful to the environment ’til the cows come home (for “finishing”!) knowing no one will subject it to the scrutiny of a federal court for years to come.  Many courts have acted on that common sense in “exhaustion” claims for exactly this reason.  See, e.g., Jette v. Bergland, 579 F.2d 59, 63 (10th Cir. 1978) (“The bureau or agency does not discharge its duty [under NEPA § 102(2)(C)] by going through meaningless motions and never facing the question directly, nor does it aid the execution of the provision of this Act to raise technical questions concerning the exhaustion of department remedies.”).

When these lawsuits were filed, many noted that they raised troubling questions about how carefully FDA made the decision to allow this drug into the food supply and our wider environment given how many nations (about 160) had banned ractopamine for its well-known health risks.  Had FDA prepared an adequate NEPA document two, seven or sixteen years ago, maybe it would’ve reached the same conclusion.  To dismiss this suit and invite FDA to reconsider its old action yet again—without any guidance on what kind of NEPA analysis is appropriate—was a mistake. Plaintiffs, of course, can refile after their petition to the FDA is finished.  Let’s hope FDA sorts out its NEPA (and ractopamine) issues quickly.

Judge Rogers’s Order can be found here. fda order

{Image: Beef cows @ Durham Coop ©}

I teach environmental, natural resources, and administrative law at Penn State Law. Before teaching I was an enforcement lawyer at U.S. EPA. Along the way I've done work for environmental nonprofits and written a fair bit about NEPA.
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