PUBLISHED

UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

No. 15-2562

SEASIDE FARM, INC.,

Plaintiff - Appellant,

v.

UNITED STATES OF AMERICA,

Defendant - Appellee.

Appeal from the United States District Court for the District of 

South Carolina, at Beaufort. C. Weston Houck, Senior District 

Judge. (9:11-cv-01199-CWH)

Argued: October 26, 2016 Decided: December 2, 2016

Before WILKINSON, NIEMEYER, and SHEDD, Circuit Judges.

Affirmed by published opinion. Judge Wilkinson wrote the 

opinion, in which Judge Niemeyer and Judge Shedd joined.

ARGUED: Daniel A. Speights, SPEIGHTS & RUNYAN, Hampton, South 

Carolina, for Appellant. Michael Shih, UNITED STATES DEPARTMENT 

OF JUSTICE, Washington, D.C., for Appellee. ON BRIEF: A. G. 

Solomons, III, SPEIGHTS & RUNYAN, Hampton, South Carolina, for 

Appellant. William B. Schultz, General Counsel, Daretia M. 

Hawkins, Senior Attorney, UNITED STATES DEPARTMENT OF HEALTH AND 

HUMAN SERVICES, Washington, D.C.; Elizabeth H. Dickinson, Chief 

Counsel, Michael Shane, Associate Chief Counsel for Enforcement, 

UNITED STATES FOOD AND DRUG ADMINISTRATION, Washington, D.C.; 

Benjamin C. Mizer, Principal Deputy Assistant Attorney General, 

Mark B. Stern, UNITED STATES DEPARTMENT OF JUSTICE, Washington, 
2

D.C.; William N. Nettles, United States Attorney, Barbara 

Bowens, Assistant United States Attorney, OFFICE OF THE UNITED 

STATES ATTORNEY, Columbia, South Carolina, for Appellee.
3

WILKINSON, Circuit Judge:

This case involves a Federal Tort Claims Act (“FTCA”), 

28 U.S.C. §§ 1346(b), 2671-2680, suit by a tomato farmer against 

the United States. Seaside Farm, Inc., alleges that the Food and 

Drug Administration negligently issued a contamination warning 

in response to an outbreak of Salmonella Saintpaul that devalued 

Seaside’s crop by $15,036,293.95. The district court held that 

FDA was exercising a discretionary function in connection with 

the contamination warning and dismissed the case under 28 U.S.C. 

§ 2680(a). That ruling was essential to protect FDA’s vital role 

in safeguarding the public food supply, and we affirm the 

judgment.

I.

Salmonella Saintpaul is a rare strain of bacteria that 

causes moderate-to-severe illness in humans. Symptoms include 

fever, diarrhea, nausea, and abdominal pain. Salmonella can also 

enter the bloodstream and cause more serious health 

complications, including death. FDA consequently considers 

salmonella a “serious health concern.” 74 Fed. Reg. 33,030, 

33,031 (July 9, 2009).

A.

On May 22, 2008, the New Mexico Department of Health 

notified the Centers for Disease Control and Prevention that a 

number of local residents had been infected with Salmonella 
4

Saintpaul. Similar reports soon arrived at CDC from Texas. After 

interviewing patients, CDC discovered a “strong statistical 

association” between the infections and eating raw tomatoes. 

J.A. 713. This observation was supported by a “historical

association” between salmonella and tomatoes generally. 

J.A. 432. CDC subsequently notified FDA that tomatoes were the 

“leading hypothosis” for the source of the outbreak. J.A. 660.

By June 1, 2008, CDC was investigating 87 incidents of 

Salmonella Saintpaul across nine states. J.A. 147. FDA, 

including its various component parts such as the Center for 

Food Safety and Applied Nutrition, decided to issue an initial 

contamination warning to consumers in New Mexico and Texas. The 

contamination warning informed consumers that the outbreak was 

likely associated with tomatoes, but acknowledged that the exact 

type and the origin of the contaminated tomatoes was unknown. 

By June 6, 2008, reports of Salmonella Saintpaul had risen 

to 145 incidents and 23 hospitalizations across sixteen states. 

J.A. 149. CDC notified FDA that the outbreak threatened the 

entire country. 

On June 7, 2008, FDA issued an updated contamination

warning titled, “FDA Warns Consumers Nationwide Not to Eat 

Certain Types of Raw Red Tomatoes.” J.A. 149. The contamination

warning explained the nature of Salmonella Saintpaul and 

specified certain types of tomato as the likely vehicles for the 
5

bacteria. It also provided a list of countries and seven states, 

including South Carolina, whose tomatoes remained unassociated 

with the outbreak. The media, however, reported the 

contamination warning without mentioning that some tomatoes were 

not implicated. FDA officials also stressed the magnitude and 

national scope of the outbreak but likewise failed to mention 

any “safe” tomatoes.

Over the next month, CDC accumulated enough data to trace 

Salmonella Saintpaul to jalapeño and serrano peppers imported 

from Mexico. FDA withdrew the contamination warning as a result 

and announced that fresh tomatoes were no longer associated with 

the outbreak. At that point in time, Salmonella Saintpaul was 

linked to 1,220 infections across forty-two states and the 

District of Columbia. J.A. 150.

B.

Seaside harvested a crop of tomatoes in South Carolina 

while the Salmonella Saintpaul contamination warning was in 

effect. On May 18, 2011, Seaside brought suit against the United 

States under the FTCA alleging that FDA negligently issued the 

contamination warning and impaired the value of Seaside’s crop 

by $15,036,293.95. The government claimed that the suit was 

barred by the FTCA provision protecting the government’s 

exercise of discretionary functions, see 28 U.S.C. § 2680(a), 

and moved to dismiss the case. The district court denied the 
6

motion as premature and ordered limited jurisdictional 

discovery, giving Seaside the opportunity to establish some 

nondiscretionary duty that FDA may have breached.

A three-year discovery fight ensued. The parties frequently 

disagreed over the scope of authorized inquiry, although the 

government ultimately produced over 12,000 pages of unredacted 

FDA guidance manuals, internal deliberations, daily situation 

reports, and confidential emails relevant to the Salmonella 

Saintpaul outbreak. Seaside also had the opportunity to take 

multiple depositions of CDC or FDA employees. Finally, the 

government provided an additional 13,000 pages of discovery 

material that was generated in a related case.

On December 15, 2015, the district court dismissed the case 

for lack of subject matter jurisdiction. The district court 

reasoned that FDA had broad discretion to warn the public about 

a contaminated food supply, and that Seaside failed to allege 

any statute, regulation, or policy that required FDA to proceed 

in a particular manner. The district court also acknowledged 

that contamination warnings implicate competing policy 

considerations of protecting the public from serious health 

risks and minimizing any adverse economic impact on associated 

industries. Seaside appeals. 
7

II.

The FTCA provides a limited waiver of sovereign immunity 

for civil actions against the United States. 28 U.S.C. 

§§ 1346(b)(1), 2674. This waiver extends to certain claims 

resulting from “the negligent or wrongful act or omission of any 

employee of the Government while acting within the scope of his 

office or employment.” Id. § 1346(b)(1). The discretionary 

function exception, however, preserves sovereign immunity and 

insulates the government from liability for “the exercise or 

performance [of] a discretionary function or duty on the part of 

a federal agency or an employee of the Government, whether or 

not the discretion involved be abused.” Id. § 2680(a). FTCA 

plaintiffs have the burden of showing that the discretionary 

function exception does not foreclose their claim. Welch v. 

United States, 409 F.3d 646, 651 (4th Cir. 2005); Williams v. 

United States, 50 F.3d 299, 304 (4th Cir. 1995). 

The discretionary function exception represents “the 

boundary between Congress’ willingness to impose tort liability 

upon the United States and its desire to protect certain 

governmental activities from exposure to suit by private 

individuals.” United States v. S.A. Empresa de Viacao Aerea Rio 

Grandense (Varig Airlines), 467 U.S. 797, 808 (1984). It was 

meant to “protect the government from liability that would 

seriously handicap efficient government operations.” Id. at 814 
8

(quoting United States v. Muniz, 374 U.S. 150, 163 (1963)). 

Congress also wanted to “prevent judicial ‘second-guessing’ of 

legislative and administrative decisions grounded in social, 

economic, and political policy through the medium of an action 

in tort.” Id. Consequently, federal courts lack jurisdiction 

over claims falling within the discretionary function exception. 

Holbrook v. United States, 673 F.3d 341, 345 (4th Cir. 2012); 

Williams, 50 F.3d at 304-05.

III.

Seaside contends the district court improperly concluded 

that the discretionary function exception barred its claim. 

Seaside also argues that it did not receive adequate discovery 

before the case was dismissed, and faults the district court for 

improperly limiting the scope of inquiry to jurisdictional 

issues. We shall discuss each contention in turn.

A.

Government conduct is protected by the discretionary 

function exception if it “involves an element of judgment or 

choice,” and implicates “considerations of public policy.” 

Berkovitz v. United States, 486 U.S. 531, 536-37 (1988); see 

United States v. Gaubert, 499 U.S. 315, 322-25 (1991); Varig 

Airlines, 467 U.S. at 813-14; Dalehite v. United States, 346 

U.S. 15, 32-36 (1953). We begin by asking whether any “federal 

statute, regulation, or policy specifically prescribes a course 
9

of action.” Berkovitz, 486 U.S. at 536. If not, we consider 

generally “the nature of the actions taken and . . . whether 

they are susceptible to policy analysis.” Gaubert, 499 U.S. at 

325. The relevant inquiry is whether the decision “in an 

objective, or general sense, . . . is one which we would expect 

inherently to be grounded in considerations of policy.” Baum v. 

United States, 986 F.2d 716, 721 (4th Cir. 1993). We do not 

examine, therefore, “whether policy considerations were actually

contemplated in making [the] decision.” Smith v. Washington 

Metro. Area Transit Authority, 290 F.3d 201, 208 (4th Cir. 2002) 

(emphasis in original). In fact, if a statute or regulation 

permits discretion, “it must be presumed that [decisions] are 

grounded in policy when exercising that discretion.” Holbrook, 

673 F.3d at 345 (quoting Gaubert, 499 U.S. at 324).

The Federal Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. 

§ 301 et seq., provides that FDA may “cause to be disseminated 

information regarding food . . . in situations involving, in the 

opinion of the [Commissioner], imminent danger to health or 

gross deception of the consumer.” Id. § 375(b) (emphasis added).

A notice in the Federal Register emphasizes that “FDA's implicit 

or explicit authority to disseminate information under [21 

U.S.C. § 375(b)] is not accompanied by any procedural 

requirements.” 50 Fed. Reg. 43,060, 43,063 (Oct 23, 1985). The 

FDCA plainly delegates broad discretion, and we presume FDA is 
10

firmly grounded in considerations of public policy when acting 

pursuant to that discretion.

Seaside argues in response that various FDA guidance 

manuals eliminate this discretion and prescribe some mandatory 

course of action. Seaside points to provisions that establish 

standard operating procedures, contamination warning protocols, 

“essential steps,” and major considerations for emergency 

response activities.

It would be the rare guidance manual that did not contain 

some arguably mandatory language. It is our duty, however, to 

construe the nature of the statutory and regulatory regime as a 

whole. Indeed, “[t]he price of circulating internal guidance 

should not be an exponential increase in exposure to a tort 

suit.” Holbrook, 673 F.3d at 347. It is questionable, moreover, 

whether something as informal as a guidance manual can overcome 

a statutory consignment of agency discretion. But even if we 

were to so assume, it would not aid appellant’s case. For after 

reviewing the FDA guidance manuals, we still find the agency 

possesses significant discretion. 

The FDA Emergency Response Plan, for example, begins with a 

qualification that “the nature and severity of an 

emergency . . . will determine . . . the specific actions . . . 

for each emergency.” J.A. 923. It continues to explain that “the 

exact activities performed . . . will vary by the type and 
11

severity of the emergency,” J.A. 925, and that any given plan 

may “require[] significant adjustments during an incident,” 

J.A. 926 (emphasis added). There is even an express disclaimer: 

“[T]hese identified steps do not comprise the entire scope of 

the FDA emergency response. Emergencies are unpredictable and 

dynamic; therefore, the Agency’s strategy, while containing core 

activities, must be unique to each situation.”1 J.A. 925-26. 

Remaining provisions then speak in broad terms of what FDA “may” 

or “should” do, subject to the overarching nature of the 

emergency. See Fortney v. United States, 714 F.Supp. 207, 208 

(W.D.Va. 1989) (holding that “should” is indicative of 

discretion), aff’d, 912 F.2d 722 (4th Cir. 1990). The FDA 

Emergency Response Plan thus envisions a fluid combination of 

variable responses and “real-time determination of the necessary 

course of action.” J.A. 926. 

The policy considerations inherent in a contamination 

warning are also evident. The FDCA expressly directs FDA to 

 1 The core activities that comprise the FDA Emergency 

Response Plan, such as “Performing Initial and On-Going 

Planning,” are all described at a high level of generality. 

J.A. 926. But a general directive that does not “specifically 

prescribe[] a course of action” likewise does not operate to 

restrict the exercise of agency discretion. Berkovitz, 486 U.S. 

at 536. Furthermore, “[t]he existence of some mandatory language 

does not eliminate discretion when the broader goals sought to 

be achieved necessarily involve an element of discretion.” 

Holbrook, 673 F.3d at 348 (quoting Miller v. United States, 163 

F.3d 591, 595 (9th Cir. 1998)).
12

“protect the public health by ensuring that foods are safe, 

wholesome, [and] sanitary.” 21 U.S.C. § 393(b)(2)(A); see

Gaubert, 499 U.S. at 324 (“It will most often be true that the 

general aims and policies of the controlling statute will be 

evident from its text.”). As the district court rightly noted, 

decisions regarding contamination warnings are “grounded in the 

policy of protecting the public from a health risk, and reducing 

adverse economic impact.” J.A. 1077. Discretion is necessary to 

evaluate available information, assess the sufficiency and 

reliability of evidence, resolve conflicting data, determine the 

overall nature of a health threat, and ultimately settle on a 

course of action. Both the timing and content of a contamination 

warning reflect this analysis. See Fisher Bros. Sales, Inc. v. 

United States, 46 F.3d 279 (3d Cir. 1995) (en banc). Acting too 

soon or waiting too late each entail profound potential 

consequences.

Seaside insists that there remains a genuine dispute as to 

whether the government ultimately executed its decision in a 

reasonable manner. Seaside complains that the contamination 

warning was overly broad, based on insufficient evidence, and 

wholly inadequate to notify consumers that South Carolina 

tomatoes remained safe for consumption. Seaside then emphasizes 

that no tomato in the United States ever tested positive for 

Salmonella Saintpaul, and that FDA actually neglected to test 
13

sample tomatoes before issuing the contamination warning. 

Finally, Seaside asserts that, despite considerable evidence 

linking the outbreak to Mexico when the contamination warning 

was issued, FDA omitted that information without a defensible 

justification. Seaside suggests this decision was made for 

impermissible “political” reasons beyond the scope of FDA’s 

discretion. Reply Br. of Appellant at 20.

Unfortunately, Seaside misunderstands the nature of the 

discretionary function inquiry. The decision to issue a 

contamination warning, especially in the middle of an escalating 

salmonella outbreak, clearly implicates the policy 

considerations which FDA was established to weigh. The FDCA even 

contemplates considerations regarding our commercial 

relationship with foreign countries. See 21 U.S.C. § 393(b)(3). 

Seaside fails to identify any mandatory requirements governing 

FDA’s decision, including any directive to test sample tomatoes 

before issuing the contamination warning. Not only is the FDA 

Emergency Response Plan phrased in permissive terms, but it 

envisions “[i]nvestigative, laboratory, and technical/scientific 

staff” pursuing multiple avenues of obtaining information. 

J.A. 929. These would encompass, inter alia, such things as 

gathering field reports from state agencies, healthcare 

providers, and affected patients, to employing FDA’s bank of 

pre-existing scientific knowledge about the association between 
14

certain foods and food-borne illnesses. Whether the agency 

pursued its investigation, interpreted relevant evidence, or 

balanced policy considerations in what Seaside believes to be an 

optimal manner does not affect the discretionary function 

analysis. Seaside essentially invites us to engage in the very 

judicial second guessing that the discretionary function 

exception forbids. 

We therefore conclude that the decision to issue a 

contamination warning “involves an element of judgment or 

choice,” that implicates “considerations of public policy.” 

Berkovitz, 486 U.S. at 536-37. The government rightly observes 

that contamination warnings -– in both timing and content -- are 

a prototypical discretionary function.2

B.

Seaside next contends it was not allowed sufficient 

discovery. District courts exercise broad discretion over 

discovery issues. Carefirst of Md., Inc. v. Carefirst Pregnancy 

Ctrs., Inc., 334 F.3d 390, 402-03 (4th Cir. 2003). A party is 

not entitled to discovery that would be futile or otherwise 

inadequate to establish a sufficient basis for jurisdiction. See

Rich v. United States, 811 F.3d 140, 146 (4th Cir. 2015).

 2 In view of our ruling on the discretionary function 

exception, we have no need to address the government’s 

contention that the contract rights exception to the FTCA 

likewise forecloses Seaside’s claim. See 28 U.S.C. § 2680(h).
15

The district court was correct to recognize that the 

discretionary function exception is a jurisdictional threshold 

that must be considered before moving to the merits of an FTCA 

claim. Williams, 50 F.3d at 308; Smith, 290 F.3d at 211. The 

district court was thus well within its discretion to limit 

discovery to this dispositive issue. Rich, 811 F.3d at 146.

Indeed, unlike in Rich, policy would be inevitably implicated in 

the issuance of the contamination warning and in drafting its 

contents. See id. at 147. Other circuits considering the 

discretionary function exception agree –– if they even allow 

discovery at all. See, e.g., Gonzalez v. United States, 814 F.3d 

1022, 1031-32 (9th Cir. 2016) (refusing discovery because 

available agency guidelines established discretion); Baer v. 

United States, 722 F.3d 168, 176-77 (3d Cir. 2013) (refusing 

discovery because available agency guidelines did not foreclose 

discretion); Davila v. United States, 713 F.3d 248, 263-64 (5th 

Cir. 2013) (refusing discovery because the plaintiff failed to 

allege any “well-pleaded facts or evidence to refute the 

government's assertion . . . that no [nondiscretionary] policy 

exists”); Ignatiev v. United States, 238 F.3d 464, 467 (D.C. 

Cir. 2001) (remanding for limited jurisdictional discovery); In 

re Orthopedic Bone Screw Prod. Liability Litig., 264 F.3d 344, 

365 (3d Cir. 2001), as amended (Oct. 10, 2001) (upholding 

limited jurisdictional discovery).
16

In any event, Seaside had three years of discovery. The 

government produced over 25,000 pages of material relevant to 

FDA practices and the Salmonella Saintpaul outbreak. Seaside 

also had the opportunity to take multiple depositions of CDC or 

FDA employees. This was more than adequate to determine whether 

FDA had some nondiscretionary duty or otherwise exercised 

discretion that was not susceptible to policy analysis. While 

Seaside expresses frustration at its inability to obtain 

additional information relevant to whether the contamination 

warning was justified, that issue is separate and distinct from 

the question of jurisdiction and the discretionary function 

exception. 

Relying on Kerns v. United States, 585 F.3d 187 (4th Cir. 

2009), Seaside insists that the facts necessary to determine 

jurisdiction are “inextricably intertwined” with the merits of 

the case and thus additional discovery was still necessary. See

id. at 195. We disagree. Kerns, in fact, acknowledged that the 

discretionary function exception is a threshold issue that can 

be “wholly unrelated to the basis for liability under the FTCA.” 

Id. at 196. So it is here. Whether FDA was negligent is an 

entirely different question from whether FDA was given the 

discretion to draft and issue a contamination warning, and 

whether exercising that discretion implicates policy 

considerations. While we do not suggest the agency’s attempt to 
17

warn the public of a major unfolding health crisis represented 

an abuse of the discretion entrusted to it, the discretionary

function exception applies “whether or not the discretion 

involved be abused.” 28 U.S.C. § 2680(a); see Gaubert, 499 U.S. 

at 322-25; Holbrook, 673 F.3d at 349-50.

The value of any kind of immunity, applied here as a 

jurisdictional bar, declines as litigation proceeds. See

Mitchell v. Forsyth, 472 U.S. 511, 525-27 (1985) (explaining 

that qualified immunity in 42 U.S.C. § 1983 litigation “is in 

part an entitlement not to be forced to litigate the 

consequences of official conduct” and “even such pretrial 

matters as discovery are to be avoided if possible, as 

‘[i]nquiries of this kind can be peculiarly disruptive of 

effective government’” (quoting Harlow v. Fitzgerald, 457 U.S. 

800, 817 (1982)). Exposing FDA to extensive rounds of discovery 

on the merits would undermine the discretionary function 

exception and introduce the very litigation pressures Congress 

clearly meant to avoid. See Wu Tien Li-Shou v. United States, 

777 F.3d 175, 186 (4th Cir. 2015); Holbrook, 673 F.3d at 349-50; 

cf. Harlow, 457 U.S. at 818 (“Until this threshold [42 U.S.C. 

§ 1983] immunity question is resolved, discovery should not be 

allowed.”). The district court was thus well within its 

discretion to order discovery in the manner that it did.
18

IV.

We refuse to place FDA between a rock and a hard place. On 

the one hand, if FDA issued a contamination warning that was 

even arguably overbroad, premature, or of anything less than 

perfect accuracy, injured companies would plague the agency with 

lawsuits. On the other hand, delay in issuing a contamination 

warning would lead to massive tort liability with respect to 

consumers who suffer serious or even fatal consequences that a 

timely warning might have averted. All this would loom if 

contamination warnings were not protected by the discretionary 

function exception.

Every public health emergency is different. There is no 

boilerplate warning that can account for the unknown variables 

of a pathogenic outbreak. There is little room for leisured 

hindsight when the decision is one that must be made under the 

pressure of events and, in many cases, on the basis of imperfect 

information. After three years of discovery, Seaside failed to 

identify any mandatory duty that FDA may have breached, or any 

discretionary decision that was not firmly rooted in the very

policy considerations that FDA was intended to exercise. While 

we acknowledge and regret any financial loss Seaside may have

incurred as a result of the Salmonella Saintpaul contamination

warning, allowing Seaside’s claim to proceed would allow the law 
19

of tort to distort one of the most critical of governmental 

functions, that of safeguarding the public health and welfare.

The judgment is accordingly affirmed.

AFFIRMED