United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued April 1, 2022 Decided May 10, 2022
No. 21-5282
CSL PLASMA INC., ET AL.,
APPELLANTS
v.
U.S. CUSTOMS AND BORDER PROTECTION AND
CHRIS MAGNUS, COMMISSIONER, U.S. CUSTOMS AND BORDER
PROTECTION,
APPELLEES
Appeal from the United States District Court
for the District of Columbia
(No. 1:21-cv-02360)
Baruch Weiss argued the cause for appellants. With him
on the briefs were R. Stanton Jones, Stephen K. Wirth, and John
Swanson.
Lewis S. Yelin, Attorney, U.S. Department of Justice,
argued the cause for appellees. With him on the brief were
Brian M. Boynton, Principal Deputy Assistant Attorney
General, and H. Thomas Byron III, Attorney.
Before: ROGERS and RAO, Circuit Judges, and GINSBURG,
Senior Circuit Judge.
2
Opinion for the Court filed by Circuit Judge RAO.
RAO, Circuit Judge: In June 2021, U.S. Customs and
Border Protection (“CBP”) announced that aliens seeking to
sell blood plasma could no longer enter the United States using
“B‑1” business visitor visas. Before this policy went into
effect, a significant amount of the plasma used for medical
treatments and research in this country came from Mexican
nationals selling their plasma on the U.S. side of the southern
border. CSL Plasma Inc., as well as other companies (“plasma
companies”), had invested substantial resources to develop
plasma collection facilities near the border to take advantage
of this market.
The plasma companies sued, alleging that CBP’s policy
runs afoul of the Administrative Procedure Act (“APA”) and
unlawfully cuts off a major source of plasma that they use to
manufacture therapies to treat a range of diseases. The district
court concluded the plasma companies were not within the
“zone of interests” of the B-1 business visitor classification set
out in the Immigration and Nationality Act (“INA”) and sua
sponte dismissed the suit for lack of subject matter jurisdiction.
We reverse. Whether the plasma companies are within the
statutory zone of interests is a merits issue, not a jurisdictional
one. See Lexmark Int’l, Inc. v. Static Control Components, Inc.,
572 U.S. 118, 128 n.4 (2014). Moreover, the plasma
companies’ claims easily fit within the zone of interests of the
B‑1 classification, and therefore they have a cause of action
under the APA.
I.
CSL Plasma and the other plaintiffs “collect[] human
blood plasma from individual donors for use in the
development and manufacturing” of medical therapies.
3
According to their complaint,1 the plasma companies have long
depended on donations by “many thousands” of paid Mexican
donors, who contribute a substantial portion of the plasma
collected by the companies and whose donations make up
some five to ten percent of all plasma collected nationwide.
Until June of last year, Mexican donors would enter the United
States and sell plasma at dozens of border area facilities in
exchange for roughly $50 per donation. They typically entered
the country using “border crossing cards,” a combined B‑1/B-2
(business and pleasure) visa that permits an alien to enter the
United States for multiple limited stays.2 See 22 C.F.R.
§ 41.32; 8 C.F.R. § 212.1(c)(1)(i).
For decades, CBP and its predecessor agencies allowed
Mexicans with border crossing cards to enter the United States
to sell plasma. Even at the peak of the COVID-19 pandemic,
when B‑1 visa holders were generally prohibited from entering
the United States, the Department of Homeland Security
“designated plasma donors as ‘essential’ and plasma collection
a ‘critical infrastructure industry.’” That changed in June 2021,
when CBP instructed its border agents not to allow aliens to
enter with B‑1 visas if they were planning to sell plasma.3 To
1
The district court dismissed the case on zone of interests grounds,
which, as explained below, go to whether plaintiffs had a cause of
action. We assume the truth of a complaint’s well-pled factual
allegations when we review dismissals for failure to state a claim.
See Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009).
2
The term “B‑1” comes from the regulations describing categories
of nonimmigrants by reference to the relevant INA provisions. See
22 C.F.R. § 41.12 (citing Immigration and Nationality Act, Pub. L.
No. 82-414, § 101(a)(15)(B), 66 Stat. 163, 167 (1952) (codified at 8
U.S.C. § 1101(a)(15)(B))).
3
The parties dispute the nature of CBP’s decision. The plasma
companies allege that CBP announced a substantive change in policy
4
justify this plasma policy, as we will call it, CBP explained in
a memorandum that “selling plasma constitutes labor for hire
in violation of B‑1 nonimmigrant status, as both the labor (the
taking of the plasma) and accrual of profits would occur in the
U.S., with no principal place of business in the foreign
country.” CBP said paid plasma donors were not proper B‑1
visitors because that category excludes anyone coming to
engage in “labor” within the meaning of the INA’s B-1
classification.4
After learning of CBP’s plasma policy and failing to
secure a political solution, the plasma companies filed suit and
sought a preliminary injunction ordering CBP not to implement
the policy and to allow plasma donors to enter with B‑1 visas.
The plasma companies maintained that selling plasma is a
legitimate B‑1 business visitor activity and that they have
relied on CBP’s prior longstanding practice of allowing B‑1
visa holders to enter the United States to sell plasma. The
companies alleged multiple violations of the APA, claiming
CBP had adopted an erroneous interpretation of the INA’s B‑1
business classification; changed its longstanding policy in an
through a press release, while CBP maintains that it clarified its
established interpretation of the B‑1 business visitor definition in an
internal guidance document. We need not resolve this dispute for the
purpose of this appeal, as it does not bear on the zone of interests
analysis.
4
The INA’s B‑1 business visitor classification extends to
an alien (other than one coming for the purpose of
… performing skilled or unskilled labor …) having
a residence in a foreign country which he has no
intention of abandoning and who is visiting the
United States temporarily for business.
8 U.S.C. § 1101(a)(15)(B).
5
arbitrary and capricious way by failing to consider the plasma
companies’ reliance interests and the policy’s public health
effects; and implemented the policy change through an
unofficial memorandum even though it was a legislative rule
that required notice and comment.
After the parties briefed the preliminary injunction
motion, the district court sua sponte dismissed the complaint
“for lack of standing.” CSL Plasma Inc. v. U.S. Customs &
Border Prot., 2021 WL 5869149, at *1 (D.D.C. Dec. 3, 2021).
The court explained that the APA’s “zone of interests”
requirement was a matter of prudential standing and
jurisdictional. Id. at *3. The plasma companies’ interests were
not within the zone of interests protected by the B‑1
classification because the “B‑1/B-2 program … has always
been intended to limit the influx of foreign workers to protect
American labor.” Id. at *4 (cleaned up). Thus, only “workers
affected by foreign labor,” not businesses, could be proper
plaintiffs to challenge the government’s interpretation of the
B‑1 classification. Id. The plasma companies’ interests were
merely “coincidental” to the purpose of the statute and
therefore outside the statutory zone of interests. Id. at *5. The
district court dismissed the entire complaint for lack of subject
matter jurisdiction, and it denied the motion for a preliminary
injunction as moot. Id. at *6. The plasma companies appealed.
II.
The district court erred in considering the zone of interests
test a question of subject matter jurisdiction.
For the plasma companies to sue under the APA, they must
have been “adversely affected or aggrieved by agency action
within the meaning of a relevant statute.” 5 U.S.C. § 702. To
determine whether a plaintiff has a cause of action we consider
whether a plaintiff’s claims fall within the relevant statute’s
6
“zone of interests” by “using traditional tools of statutory
interpretation.” Lexmark, 572 U.S. at 127. The Supreme Court
has made clear that the zone of interests test is a merits issue
because it addresses whether the plaintiff “has a cause of action
under the statute.” Id. at 128. That inquiry “does not implicate
subject-matter jurisdiction.” Id. at 128 n.4 (cleaned up); see
also Bell v. Hood, 327 U.S. 678, 682 (1946) (failure to plead a
cause of action is not a jurisdictional defect). Our cases have
repeatedly recognized the non-jurisdictional nature of the zone
of interests test since Lexmark was decided in 2014. See, e.g.,
Crossroads Grassroots Pol’y Strategies v. FEC, 788 F.3d 312,
319 (D.C. Cir. 2015) (explaining the zone of interests test is
neither a component of “prudential standing” nor a
jurisdictional question); Am. Inst. of Certified Pub. Accts. v.
IRS, 804 F.3d 1193, 1199 (D.C. Cir. 2015) (same).
The district court’s legal error resulted in a procedurally
improper dismissal. A court may dismiss a case at any time for
lack of subject matter jurisdiction. The zone of interests
inquiry, however, is not jurisdictional, and therefore it could
not be the basis for a sua sponte dismissal absent extraordinary
circumstances. Cf. Am. Inst. of Certified Pub. Accts., 804 F.3d
at 1199 (explaining that the zone of interests test must be
treated procedurally like any other “non-jurisdictional issue”);
see also Baker v. Dir., U.S. Parole Comm’n, 916 F.2d 725,
726–27 (D.C. Cir. 1990) (per curiam) (explaining the narrow
circumstances in which a non-jurisdictional sua sponte
dismissal without notice is appropriate). The government did
not file a motion to dismiss, and so the district court could not
dismiss on zone of interests grounds without finding the
required extraordinary circumstances. Therefore, the district
court erred in dismissing for lack of subject matter jurisdiction.
7
III.
The substantive question of whether the plasma companies
fall within the B‑1 classification’s zone of interests is a purely
legal question squarely before this court.5 We thus address the
zone of interests question and hold that the plasma companies
are within the statute’s zone of interests and therefore they have
a cause of action to challenge the plasma policy. Cf. Mendoza
v. Perez, 754 F.3d 1002, 1020 (D.C. Cir. 2014) (reaching a
merits issue despite erroneous jurisdictional holding below
because the issue was “purely legal” and “fully briefed” by
both sides).
A.
To determine whether the plasma companies have a cause
of action, we consider whether their alleged injuries are
“arguably within the zone of interests to be protected or
regulated by the statute.” Match-E-Be-Nash-She-Wish Band of
Pottawatomi Indians v. Patchak, 567 U.S. 209, 224 (2012)
(cleaned up). The zone of interests test does not require that the
statute directly regulate the plaintiff, nor does it require specific
congressional intent to benefit the plaintiff. See Amgen Inc. v.
Smith, 357 F.3d 103, 108 (D.C. Cir. 2004). Instead “the salient
consideration … is whether the challenger’s interests are such
that they in practice can be expected to police the interests that
the statute protects.” Id. at 109 (cleaned up). Under this
“lenient” test, “the benefit of any doubt goes to the plaintiff,”
5
The government recognizes that the district court erred in treating
the zone of interests test as jurisdictional but argues that we should
nonetheless affirm the district court’s dismissal under Rule 12(b)(6)
for failure to state a claim because the plasma companies fall outside
the B‑1 classification’s zone of interests. The plasma companies
similarly address the merits of this issue, arguing that their interests
are “incontrovertibl[y]” protected by the B‑1 classification.
8
and “the test forecloses suit only when a plaintiff’s interests are
so marginally related to or inconsistent with the purposes
implicit in the statute that it cannot reasonably be assumed that
Congress authorized that plaintiff to sue.” Lexmark, 572 U.S.
at 130 (cleaned up). When a claim arises under the APA, the
zone of interests test requires considering the “substantive
provisions” of the underlying statute, the “alleged violations of
which serve as the gravamen of the complaint.” Bennett v.
Spear, 520 U.S. 154, 175 (1997).
The gravamen of the plasma companies’ complaint is that
CBP adopted an overly restrictive interpretation of the B-1
statutory classification in its plasma policy. The question we
must answer is whether the plasma companies’ injuries are
within the zone of interests of the INA’s B-1 business visitor
classification. The INA creates a category of “nonimmigrant”
temporary visitor that includes
an alien (other than one coming for the purpose
of … performing skilled or unskilled labor …)
having a residence in a foreign country which
he has no intention of abandoning and who is
visiting the United States temporarily for
business.
8 U.S.C. § 1101(a)(15)(B). To ascertain the interests this
classification protects, “we must consider [its] context and
purpose” within the INA’s larger scheme. Indian River Cnty.
v. U.S. Dep’t of Transp., 945 F.3d 515, 530 (D.C. Cir. 2019)
(cleaned up).
The B‑1 provision creates a classification of nonimmigrant
temporary visitors who may enter the United States in order to
transact business. This business visitor classification imposes
a lower barrier to enter the country than other nonimmigrant
classifications, particularly the temporary worker
9
classifications.6 With narrow exceptions, any alien coming to
the United States to perform labor is presumptively
inadmissible and must secure an affirmative determination
from the Department of Labor that there are no Americans
available to perform the same work. 8 U.S.C. § 1182(a)(5)(A).
B‑1 business visitors face no comparable burden. By
regulation, an alien who meets the definition of a B‑1
“nonimmigrant” presumptively can enter the country and, if he
is a Mexican seeking to enter only the border area, can do so
using a border crossing card. See 22 C.F.R. § 41.121
(“Nonimmigrant visa refusals must be based on legal
grounds.”); id. § 41.32 (describing eligibility for border
crossing cards).
In its plasma policy memorandum, CBP maintains that
donors from Mexico who are “selling plasma” are engaged in
“labor for hire” and therefore cannot use a B‑1 nonimmigrant
visa to enter the United States for that purpose. Because the
plasma companies rely on Mexican plasma donors who enter
this country using B‑1 visas, the companies maintain that their
interests are such that “in practice [they] can be expected to
6
For example, the total number of H-visa temporary workers is
capped, unlike the number of B‑1 business visitors. See 8 U.S.C.
§ 1184(g)(1)(B). In addition, temporary non-agricultural laborers
can enter only “if unemployed persons capable of performing [their]
service or labor cannot be found in this country.” Id.
§ 1101(a)(15)(H)(ii)(b). This requires employer certification of the
need for the workers. Id. § 1184(c)(1); see also id. § 1182(a)(5)(A)
(prohibiting aliens from entering to perform labor unless the
Department of Labor determines that they will not compete with
American labor). As the plasma companies stated in their complaint,
such certification would not be possible for plasma donors, whom
the companies do not treat as employees.
10
police the interests that the statute protects.” Amgen, 357 F.3d
at 109 (cleaned up). We agree.
The B‑1 business visitor classification is designed to
protect at least two classes of interests: American workers
facing competition from immigrant labor and American
businesses benefitting from transactions with B‑1 business
visitors. American workers are protected because the
classification specifically excludes aliens coming “for the
purpose of … performing skilled or unskilled labor.” 8 U.S.C.
§ 1101(a)(15)(B). The advantages of the B‑1 business visitor
classification are denied to aliens coming for employment in
competition with American workers. This court has held that
labor unions, for instance, can sue to enjoin expansive readings
of the B‑1 classification to protect the interests of domestic
workers. See Int’l Union of Bricklayers & Allied Craftsmen v.
Meese, 761 F.2d 798, 804–05 (D.C. Cir. 1985). An overly
expansive reading of the B‑1 classification would allow an end
run around the requirements for a work visa, and thus workers
and their unions can fall within the statutory zone of interests.
The B‑1 classification also affirmatively promotes
American business interests. Congress provided a path for
aliens to enter the United States for temporary business
purposes, presumably because those visits would benefit the
people and companies that do business with them. An
excessively strict interpretation of the B‑1 classification could
therefore undermine the congressional policy of permitting
temporary border crossings to facilitate business transactions.
Here, the plasma companies easily clear the low hurdle of
pleading injuries within the zone of interests protected by the
B‑1 classification. The plasma companies depend heavily on
B‑1 visitors in the border region. They have invested hundreds
of millions of dollars to construct and staff dozens of facilities
11
geared toward collecting plasma from Mexican donors. The
plasma companies made these investments in reliance on the
large number of Mexicans who cross the border to sell plasma:
they allege Mexican B‑1 visitors “comprise the majority of
donors at most of the border centers” and that the domestic
population of the border areas could not support the substantial
plasma collection activities of these facilities. By denying
plasma donors the benefit of the B‑1 classification, CBP’s
policy directly harms the companies’ businesses by depriving
them of plasma they need to manufacture and develop their
therapeutic products. Therefore, the companies may sue to
vindicate the interests protected by the INA’s B-1
classification.
In reaching this conclusion, we note the fact-specific
nature of the zone of interests test. That these plasma
companies have a cause of action should not be read as
providing either a floor or a ceiling for the type of business that
is within the B‑1 classification’s zone of interests. Some
businesses may have interests so “marginally related to” the
statute’s protected interests that it would be “unreasonable” to
find that they have a cause of action. Clarke v. Secs. Indus.
Ass’n, 479 U.S. 388, 399 (1987). On the other hand, a business
with less at stake than the very substantial investments of the
plasma companies may still meet the “lenient” standard of
being within the statutory zone of interest. Lexmark, 572 U.S.
at 130.
The companies bringing this suit established dozens of
plasma collection facilities specifically relying on B‑1 visitors
for donations. CBP’s policy barred these visitors from entering
to sell plasma on a B‑1 visa. The district court erred in holding
that the companies were not proper plaintiffs to challenge the
policy.
12
B.
The government’s arguments to the contrary do not place
the plasma companies outside the zone of interests of the B‑1
classification. The government maintains that plasma donation
is not B‑1 “business” because it is “purely domestic” and lacks
“a connection to international trade or commerce.” Therefore,
the companies have no cause of action. We reject the
government’s unduly restrictive application of the zone of
interests test and its narrow interpretation of the B‑1
classification.
First, a party need not show it will prevail on the merits of
its case to show its claim falls within the statute’s zone of
interests. See Nat’l Coal Ass’n v. Hodel, 825 F.2d 523, 527
(D.C. Cir. 1987) (per curiam) (plaintiffs “obviously need not
prevail on all issues of statutory interpretation” to pass the zone
of interests test). On the government’s view, the plasma
companies are not even in the class of plaintiffs able to
challenge CBP’s plasma policy unless they are correct that the
transactions at issue are “business” within the meaning of the
statute. This approach collapses the zone of interests question
of whether the companies can sue into the ultimate merits
question of whether the companies can win. As explained
above, the plasma companies rely on Mexican donors, who
enter the United States using their B‑1 visas. CBP’s plasma
policy narrowly interprets the B‑1 classification and prohibits
using a B‑1 visa to enter the United States for the purpose of
selling plasma. Whether or not the plasma companies
ultimately prevail on the merits, their allegations are sufficient
to establish that they are “reasonable candidates” to challenge
CBP’s plasma policy. Clarke, 479 U.S. at 403.
Second, the government’s zone of interests argument is
without merit on its own terms. The government claims that an
13
activity is “business” within the meaning of the B‑1
classification only if it has a “connection” to international
commerce or is a “necessary incident” to international trade.
Because the donors do not engage in the plasma business in
Mexico, and the donation and compensation take place in the
United States, the government claims the donors are not
engaged in international business or commerce. According to
the government, all B‑1 “business” must be part of an
international commercial operation.
The government’s limitation of the B‑1 classification is
found in neither the text of the statute nor longstanding judicial
and agency interpretations. There is no international nexus
requirement in the B‑1 classification. The statutory definition
simply includes aliens “visiting the United States temporarily
for business” and specifically excludes aliens “coming for the
purpose of study or of performing skilled or unskilled labor or
as a representative of foreign press, radio, film, or other foreign
information media coming to engage in such vocation.” 8
U.S.C. § 1101(a)(15)(B). These are the only statutory carve
outs from the general “business” category, and nowhere does
the B‑1 classification use the term “international” or otherwise
suggest that the “business” must be of a particular type.
Judicial decisions reinforce the plain meaning of the
statute and include no international nexus requirement. The
distinction between business and labor—as opposed to
between international and domestic business—runs back to
1929 at least. When interpreting a similar classification in a
predecessor statute, the Supreme Court addressed whether two
Canadians who crossed “from Canada to the United States
daily to labor for hire” were “‘visiting the United States …
temporarily for business.’” Karnuth v. United States ex rel.
Albro, 279 U.S. 231, 233, 235 (1929) (quoting Immigration
Act of 1924, Pub. L. No. 68-139, § 3, 43 Stat. 153, 154). The
14
Canadians claimed they were just business visitors, but the
Court held that “it cannot be supposed that Congress intended,
by admitting aliens temporarily for business, to permit their
coming to labor for hire in competition with American
workmen.” Id. at 244. Instead, “business” “must be limited in
application to intercourse of a commercial character.” Id. The
touchstone for “business” was simply the “commercial
character” of the activity and included no international nexus.
The distinction between local and international activity
emerged in cases that defined the “labor” exception to
“business” visits. These decisions addressed the practical
reality that if business visitors could not engage in literally any
work or “labor” while in the United States, the “business”
classification would be an empty set. See Garavito v. INS, 901
F.2d 173, 175 (1st Cir. 1990) (noting that at least some work
activities must be permissible under a B‑1 visa in order to
conduct “business”). The Third Circuit, for example, has
explained that the Executive reasonably distinguishes between
“local employment” that is outside the B‑1 classification and
“activities that are a necessary incident to international trade or
commerce” and therefore permissible “business.” Mwongera
v. INS, 187 F.3d 323, 329 (3d Cir. 1999) (cleaned up).
The cases from the Board of Immigration Appeals
(“BIA”) cited by the government also rely on an international
connection to distinguish business activity from “labor” within
the meaning of the INA. See, e.g., Matter of Camilleri, 17 I. &
N. Dec. 441, 444 (BIA 1980) (a truck driver crossing from
Canada to the United States to deliver commodities was a
business visitor); Mwongera, 187 F.3d at 329 (upholding the
BIA’s determination that “extending a retail sales business that
was incorporated in the United States” was “labor” and not
proper B‑1 “business”). The cases are concerned with the
meaning of “labor” and, contrary to the government’s
15
assertions, do not impose an international nexus requirement
on what constitutes “business.”
Department of State regulations have codified these
principles: the fundamental distinction is between business and
labor, and the international nexus matters only for
understanding the B‑1 restriction on “labor.” Under the
principal regulation, “business … refers to conventions,
conferences, consultations and other legitimate activities of a
commercial or professional nature. It does not include local
employment or labor for hire.” 22 C.F.R. § 41.31(b)(1). The
“local” designation applies only to “employment or labor for
hire.” The term “international” appears nowhere in the
regulatory definition of “business,” and the examples of
“business” include activities that could easily involve only
domestic commerce, such as business conventions or
conferences. None of the examples requires or even implies an
international nexus. In defending its plasma policy, the
government cannot graft an international nexus requirement
onto the statutory term “business.”
The plasma companies are within the statutory zone of
interests because they have asserted an injury that bears a
“plausible relationship to the policies” underlying the B‑1
classification. Clarke, 479 U.S. at 403.7
7
Although this decision on the zone of interests necessarily
implicates the merits and although both parties ask us to resolve the
underlying merits, we decline to reach issues not decided by the
district court. See Capitol Servs. Mgmt., Inc. v. Vesta Corp., 933 F.3d
784, 789 (D.C. Cir. 2019) (“[W]e are a court of review, not of first
view.”) (cleaned up).
16
***
The zone of interests test is a lenient one, not to be
conflated with either the court’s subject matter jurisdiction or
the underlying merits of the case. The B‑1 classification
protects the interests of American businesses such as the
plasma companies, so they have a cause of action under the
APA to challenge CBP’s plasma policy. We therefore reverse
the judgment of the district court and remand the case for
further proceedings consistent with this opinion.
So ordered.