Indep. Turtle Farmers Of La. Inc v. U.S.A

703 F.Supp.2d 604

INDEPENDENT TURTLE FARMERS OF LOUISIANA, INC.v.UNITED STATES of America, et al.

Civil Action No. 1:07-cv-00856.

United States District Court,

W.D. Louisiana,

Alexandria Division.

March 30, 2010.

COPYRIGHT MATERIAL OMITTED

Randall A. Smith, J. Geoffrey Ormsby, L. Tiffany Hawkins Davis, Smith Fawer New Orleans, LA, for Independent Turtle Farmers of Louisiana, Inc.

Andrew E. Clark, U.S. Dept. of Justice, Washington, DC, Donald W. Washington, Jones Walker et al., Lafayette, LA, John A. Broadwell, U.S. Attorneys Office, Shreveport, LA, for United States of America, et al.

RULING

DEE D. DRELL, District Judge.

Presently before the Court are four motions, two filed by the Plaintiff, and two filed by the Defendants. For the reasons below, the Court's disposition as to each of these motions will be as follows:

(1) the Plaintiff's Motion to Supplement the Administrative Record (Doc. 45) will be GRANTED IN PART AND DENIED IN PART;

(2) the Defendants' Motion to Supplement the Administrative Record (Doc. 46) will be GRANTED;

(3) the Plaintiff's Motion for Summary Judgment (Doc. 58) will be GRANTED IN PART AND DENIED IN PART; and

(4) the Defendants' Motion for Summary Judgment (Doc. 60) will be GRANTED IN PART AND DENIED IN PART.

Disposition will follow by a separate judgment.

I. Background

This case is, in essence, a dispute over the validity of a thirty-five-year-old ban on the sale of baby turtles. Upon closer examination, this lawsuit brings the Court to an intersection between ongoing developments in the legal, scientific, and regulatory fields, each of which is an ever-changing area. The Plaintiff, Independent Turtle Farmers of Louisiana, Inc. (“ITFL”), is an association of commercial turtle farmers seeking to lift or amend the ban. Named as defendants in the case are the United States of America, the United States Department of Health and Human Services (“DHHS”), and the United States Food and Drug Administration (“FDA”).

In 1975, the FDA enacted a ban on the sale of viable turtle eggs and live turtles with a carapace (shell) of less than four inches in length (“Turtle Ban”). 21 C.F.R. § 1240.62 (Appendix A to this ruling). The text of the FDA regulation at issue states that, “[e]xcept as otherwise provided in this section, viable turtle eggs and live turtles with a carapace length of less than 4 inches shall not be sold, held for sale, or offered for any other type of commercial or public distribution.” Id. § 1240.62(b). The four limited exceptions referenced in the Turtle ban include sales “for bona fide scientific, educational, or exhibitional purposes, other than use as pets,” non-commercial sales, export-only sales, or sales of marine turtles excluded from the definition of “turtles.” See id. § 1240.62(e). Finally, the regulation provides that the Commissioner

either on his own initiative or on behalf of any interested person who has submitted a petition, may publish a proposal to amend this regulation. Any such petition shall include an adequate factual basis to support the petition, and will be published for comment if it contains reasonable grounds for the proposed regulation.

Id. § 1240.62(e). The Turtle Ban remains the only federally-enacted ban on the sale of any pet.

The Turtle Ban was enacted primarily to curb the spread of salmonellosis, a condition associated with exposure to bacteria called Salmonella. In the preamble to the regulation, the FDA stated that “[c]hildren are particularly susceptible to salmonellosis, tend to have more severe cases than adults, and are subject to infection transmitted when playing with pet turtles.” 40 Fed.Reg. at 22543 (May 23, 1975).¹ Furthermore, the FDA relied upon studies which indicated that as much as fourteen percent of salmonellosis cases in the United States (or 280,000 of approximately 2,000,000 cases annually) were “turtle-related.” See id. As a result, the FDA concluded that “a total ban with the exceptions provided by § 1240.62(d) is the only effective method at the present time [in 1975] that will eliminate the possibility of human illness due to contaminated turtles.” Id. (emphasis added). It is arguable that the Turtle Ban accomplished at least its immediate goal. One 1980 study cited by the Defendants indicated that the FDA ban on interstate shipment of pet turtles, combined with state certification laws, had significantly reduced turtle-related salmonellosis cases in the United States. (Doc. 60-5, Exh. B).²

In the intervening decades since the enactment of the Turtle Ban, scientific advances and societal changes have obviously taken place. For instance, as the ITFL points out, liquid antibacterial hand soap has become a common item. More relevantly, however, researchers have undertaken various scientific efforts to reduce the incidence of Salmonella in baby turtles. The ITFL cites studies conducted by university professors, and submitted to the FDA, demonstrating that certain treatment methodologies can reduce or eliminate Salmonella from the eggs and hatchlings of red-eared slider (“RES”) turtles. ³ Nonetheless, the FDA maintains that the Turtle Ban has sharply reduced reducing turtle-related salmonellosis cases. According to the FDA, further research is needed to show that turtles can be produced free of Salmonella, without resistance to treatments, and without a risk of future Salmonella re-colonization.

Because of these concerns, the Turtle Ban has remained in effect for almost thirty-five years. Nearly four years ago, the ITFL decided to challenge the Turtle Ban. Pursuant to 21 C.F.R. § 1240.62, the ITFL presented a petition dated April 10, 2006 to the FDA, along with a lengthy volume of attachments, seeking to lift or amend the Turtle Ban. Included were two affidavits, one from the Louisiana Commissioner of Agriculture and Forestry, and the other from Mark Mitchell (“Dr. Mitchell”), a veterinarian and professor at Louisiana State University. Both affidavits concluded that the sale of baby turtles as pets posed no greater risk of causing salmonellosis than the sale of other pets. (Doc. 58-3, Exh. 11). In a separate letter submitted to the FDA, Dr. Mitchell also maintained that research conducted on the use of non-antibiotic compounds to control the incidence of Salmonella contamination in RES turtles concluded that “ Salmonella was significantly reduced or eliminated in water, eggs or hatchlings.” (Doc. 58-4, Exh. 12). Finally, Dr. Mitchell opined that the Turtle Ban is patently unfair because the FDA guidelines covering the “poultry, beef, swine, vegetables, and fruit” industries are less stringent, because Salmonella “cannot be completely controlled” in those products. (Doc. 58-4, Exh. 12).

In a letter dated May 31, 2006, the FDA denied the ITFL's petition to lift the Turtle Ban. Specifically, the FDA concluded that the ITFL's “submission ... does not demonstrate that Salmonella-free turtles can be consistently produced and that, if Salmonella-free turtles are produced, they will not be recontaminated with Salmonella sp. after shipment.” (Doc. 58-4, Exh. 18). The FDA distinguished between the pet turtle industry and the food industry by noting that the “at-risk population” protected by the Turtle Ban consists of small children.

Following the FDA's decision, the ITFL filed this lawsuit on May 18, 2007, seeking a judgment from the Court: (1) declaring that the Turtle Ban exceeds the FDA's statutory authority; (2) declaring that continued enforcement of the Turtle Ban is arbitrary and capricious under the Administrative Procedure Act, 5 U.S.C. § 706(3)(a), (c); (3) declaring that the ITFL's Fifth Amendment rights have been violated; (4) enjoining enforcement of the Turtle Ban; (5) awarding the ITFL costs and fees; and (6) awarding the ITFL any other relief to which it may be entitled. (Doc. 1). Subsequently, the ITFL filed a Motion for Discovery and Extra-Record Supplementation (Doc. 10), which was granted on March 27, 2008 (Doc. 24). Two motions to compel filed by the ITFL (Docs. 28, 38) were also granted by the magistrate judge (Docs. 35, 43).

On April 1, 2009, the parties each filed a motion to supplement the administrative record (Docs. 45, 46), which, according to both parties, lacked at least some documents that should have properly been included in the record when it was filed. Other documents remain in dispute, and will be discussed and delineated below. Shortly after these motions were filed, the parties submitted competing motions for summary judgment (Docs. 58, 60). These four motions remain pending. After a careful review of the record, the parties' filings, and the law applicable to the various facets of this case, the Court is now prepared to rule.

II. Law and AnalysisA. Judicial Review

A threshold question before us is whether this case may properly be reviewed at this point, given its procedural posture and its history before the administrative agency. Under the APA, “[a] person suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action within the meaning of a relevant statute, is entitled to judicial review thereof.” 5 U.S.C. § 702. The statute provides the following guidelines to determine whether agency action is reviewable:

Agency action made reviewable by statute and final agency action for which there is no other adequate remedy in a court are subject to judicial review. A preliminary, procedural, or intermediate agency action or ruling not directly reviewable is subject to review on the review of the final agency action. Except as otherwise expressly required by statute, agency action otherwise final is final for the purposes of this section whether or not there has been presented or determined an application for a declaratory order, for any form of reconsideration, or, unless the agency otherwise requires by rule and provides that the action meanwhile is inoperative, for an appeal to superior agency authority.

Id. § 704. Accordingly, “[t]he APA permits ‘non-statutory’...