FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

CLIFFORD W. COLWELL, JR.; JOHN 

BROFMAN; LYNN I. DEMARCO;

PROENGLISH, a nonprofit

organization; THE ASSOCIATION OF

AMERICAN PHYSICIANS & SURGEONS,

a nonprofit organization, No. 05-55450

Plaintiffs-Appellants, D.C. No.  v. CV-04-01748-BTM

DEPARTMENT OF HEALTH AND OPINION

HUMAN SERVICES; MICHAEL O.

LEAVITT Secretary of Dept. of

Health and Human Services, in his

official capacity,

Defendants-Appellees. 

Appeal from the United States District Court

for the Southern District of California

Barry T. Moskowitz, District Judge, Presiding

Argued and Submitted

February 13, 2007—Pasadena, California

Filed March 18, 2009

Before: Harry Pregerson, William A. Fletcher and

Marsha S. Berzon, Circuit Judges.

Opinion by Judge William A. Fletcher

3479
COUNSEL

Sharon Louise Browne, Pacific Legal Foundation, Sacramento, California, Arthur B. Mark, III, Trainor Fairbrook,

Sacramento, California, for the appellants. 

3482 COLWELL v. HHS
Tovah Calderon, Linda F. Thome, Asheesh Agarwal, US

Department of Justice, Civil Rights Division, Washington,

DC, Dennis John Dimsey, US Department of Justice, Civil

Division, Washington, DC, Thomas C. Stahl, Office of the US

Attorney, San Diego, California, for the appellees. 

OPINION

W. FLETCHER, Circuit Judge: 

Plaintiffs-Appellants bring a pre-enforcement challenge to

Policy Guidance issued by the Department of Health and

Human Services (“HHS”) in August 2003 (“2003 Policy

Guidance” or “Policy Guidance”). The stated purpose of the

Policy Guidance is to clarify the legal obligation of recipients

of federal funds to provide meaningful access for individuals

with limited English proficiency (“LEP”) to programs supported by those funds. The district court dismissed Plaintiffs’

suit under Federal Rule of Civil Procedure 12(b)(1), holding

under Article III that Plaintiffs lacked standing and that their

suit was unripe. We hold that Plaintiffs have standing and that

their suit is ripe under Article III, but that their suit should be

dismissed as unripe under the prudential criteria articulated in

Abbott Laboratories v. Gardner, 387 U.S. 136 (1967). We

therefore affirm the district court’s dismissal. 

I. Statutory and Regulatory Background

Section 601 of Title VI of the Civil Rights Act of 1964

mandates, “No person in the United States shall, on the

ground of race, color, or national origin, be excluded from

participation in, be denied the benefits of, or be subjected to

discrimination under any program or activity receiving Federal financial assistance.” 42 U.S.C. § 2000d. Section 602

requires that a federal agency providing financial assistance to

a federal program implement the statutory mandate “by issuCOLWELL v. HHS 3483
ing rules, regulations, or orders of general applicability which

shall be consistent with achievement of general objectives of

the statute authorizing the financial assistance in connection

with which the action is taken.” Id. § 2000d-1. 

There is an almost forty-year regulatory history leading up

to the 2003 Policy Guidance challenged in this case. The

Department of Health, Education, and Welfare (“HEW”) —

the predecessor to HHS and the Department of Education —

promulgated general implementing regulations almost immediately after the passage of Title VI. A 1964 regulation prohibits recipients of federal financial assistance from

“utiliz[ing] criteria or methods of administration which have

the effect of subjecting individuals to discrimination because

of their race, color, or national origin, or have the effect of

defeating or substantially impairing accomplishment of the

objectives of the program as respect individuals of a particular

race, color, or national origin.” 45 C.F.R. § 80.3(b)(2); see

Final Rule, 29 Fed. Reg. 16,298 (Dec. 4, 1964). 

Beginning in the late 1960s, HEW interpreted the prohibition against discrimination based on national origin as including discrimination against LEP individuals. In 1968, HEW

issued a guidance document providing that “(s)chool systems

are responsible for assuring that students of a particular race,

color, or national origin are not denied the opportunity to

obtain the education generally obtained by other students in

the system.” Notice, 33 Fed. Reg. 4955 (Mar. 23, 1968). In

1970, HEW made the guidance more specific, providing that

federally funded school districts were required “to rectify the

language deficiency in order to open the instruction to students who had ‘linguistic deficiencies.’ ” Notice, 35 Fed. Reg.

11,595 (July 18, 1970). Four years later, the Supreme Court

in Lau v. Nichols, 414 U.S. 563 (1974), agreed with HEW that

discrimination against LEP individuals was discrimination

based on national origin in violation of Title VI, holding that

the denial to LEP students of Chinese ancestry of a “meaning3484 COLWELL v. HHS
ful opportunity to participate in the educational program” of

the San Francisco public schools violated § 601. Id. at 567-68.

In 1976, after following the formal notice-and-comment

procedures of the Administrative Procedure Act (“APA”), 5

U.S.C. § 553, the Department of Justice (“DOJ”) promulgated

regulations governing “the respective obligations of federal

agencies [including HHS] regarding enforcement of Title VI.”

28 C.F.R. § 42.401. The DOJ regulations require that

[w]here a significant number or proportion of the

population eligible to be served or likely to be

directly affected by a federally assisted program

(e.g., affected by relocation) needs service or information in a language other than English in order

effectively to be informed of or to participate in the

program, the recipient shall take reasonable steps,

considering the scope of the program and the size

and concentration of such population, to provide

information in appropriate languages to such persons. This requirement applies with regard to written

material of the type which is ordinarily distributed to

the public. 

Id. § 42.405(d)(1). The DOJ regulations do not mention oral

translation. 

In 1980, HHS issued a Notice of Decision to Develop Regulations (“NDDR”) that stated that HHS was “considering

requiring certain classes of recipients to conduct selfevaluations of the extent to which their beneficiary population

is of limited English proficiency and the extent to which the

services provided are accessible to such persons,” as well as

“steps that recipients should be required to take to comply

with Title VI in this area,” including “the use of interpreters

and bilingual employees and the translation of forms and

informational materials.” Proposed Rules, 45 Fed. Reg.

82,972, 82,972-73 (Dec. 17, 1980). The purpose of the NDDR

COLWELL v. HHS 3485
was to solicit public comments before the issuance of a Notice

of Proposed Rulemaking (“NPRM”). Id. An NPRM, however,

was never issued, and the proposed regulations were never

promulgated. 

In 1998, the Office for Civil Rights (“OCR”) of HHS

issued an internal guidance memorandum “intended to insure

consistent application of Title VI standards in assessing the

compliance of HHS recipients with respect to the provision of

health and social services to LEP persons.” OCR LEP Guidance Memorandum (Jan. 29, 1998), http://www.hhs.gov/

ocr/lepfinal.htm. The guidance memorandum sets out multiple

“factors for OCR staff to consider in determining whether

federally-assigned providers of medical care or social services

are taking steps to overcome language barriers to health care

and social services encountered by LEP persons.” Id. The factors to be considered included “[the provider’s] size, the size

of the LEP population it serves, the setting in which interpreter services are needed, the availability of staff members

and/or volunteers to provide interpreter services during the

hours of operation, and the proficiency of available staff

members or volunteers available to provide the needed services.” Id. at 8.7 

In 2000, President Clinton issued an Executive Order “to

improve access to federally conducted and federally assisted

programs and activities for persons who, as a result of

national origin, are limited in their English proficiency

(‘LEP’).” Exec. Order No. 13,166, 65 Fed. Reg. 50,121 (Aug.

11, 2000). The Order provided:

[E]ach Federal agency shall examine the services it

provides and develop and implement a system by

which LEP persons can meaningfully access those

services consistent with, and without unduly burdening, the fundamental mission of the agency. Each

Federal agency shall also work to ensure that recipients of Federal financial assistance . . . provide

3486 COLWELL v. HHS
meaningful access to their LEP applicants and beneficiaries. 

Id. The Order incorporated by reference a contemporaneously

issued DOJ Policy Guidance addressed to “Executive Agency

Civil Rights Officers.” See Enforcement of Title VI of the

Civil Rights Act of 1964—National Origin Discrimination

Against Persons With Limited English Proficiency; Policy

Guidance, 65 Fed. Reg. 50,123 (Aug. 16, 2000). 

The DOJ Policy Guidance begins, “This policy guidance

does not create new obligations but, rather, clarifies existing

Title VI responsibilities.” Id. at 50,123. It then provides that

[r]ecipients who fail to provide services to LEP

applicants and beneficiaries in their federally

assisted programs and activities may be discriminating on the basis of national origin in violation of

Title VI and its implementing regulations. Title VI

and its regulations require recipients to take reasonable steps to ensure “meaningful” access to the information and services they provide. What constitutes

reasonable steps to ensure meaningful access will be

contingent on a number of factors. Among the factors to be considered are the number or proportion of

LEP persons in the eligible service population, the

frequency with which LEP individuals come in contact with the program, the importance of the service

provided by the program, and the resources available

to the recipient. 

Id. at 50,124. 

In compliance with the Executive Order, HHS issued its

own Policy Guidance in 2000. See Policy Guidance on the

Prohibition Against National Origin Discrimination As It

Affects Persons With Limited English Proficiency, 65 Fed.

Reg. 52,762 (Aug. 30, 2000). The 2000 Policy Guidance was

COLWELL v. HHS 3487
republished for public comment a year and a half later, resulting in a 2002 version of the Policy Guidance. Policy Guidance on the Prohibition Against National Origin

Discrimination As It Affects Persons With Limited English

Proficiency, 67 Fed. Reg. 4968 (Feb. 1, 2002). The 2002 Policy Guidance was again republished and reopened for public

comment. After receipt of almost 200 comments, and an

extensive question and answer session, the HHS revised and

republished it as a “Policy Guidance Document” in 2003.

Notice, Guidance to Federal Financial Assistance Recipients

Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons, 68

Fed. Reg. 47,311, 47,312 (Aug. 8, 2003). 

The stated purpose of the 2003 Policy Guidance “is to

assist recipients in fulfilling their responsibilities to provide

meaningful access to LEP persons under existing law” and to

“clarif[y] existing legal requirements for LEP persons by providing a description of the factors recipients should consider

in fulfilling their responsibilities to LEP persons.” Id. at

47,313. Like the documents that preceded it, the 2003 Policy

Guidance provides a several-factor test that recipients of HHS

financial assistance can use to determine the nature and extent

of their obligation under Title VI to provide LEP individuals

with meaningful access to HHS funded programs and activities. The factors described in the 2003 Policy Guidance are:

(1) the number or proportion of LEP persons eligible to be

served or likely to be encountered by the program, activity, or

service provided by the recipient; (2) the frequency with

which LEP individuals come into contact with the recipient’s

program, activity, or service; (3) the nature and importance of

the recipient’s program, activity, or service; and (4) the

resources available to the recipient and costs. See Policy

Guidance, 68 Fed. Reg. at 47,322. 

The non-discrimination requirements of Title VI may be

enforced either through termination of federal financial assistance or “by any other means authorized by law.” 42 U.S.C.

3488 COLWELL v. HHS
§ 2000d-1. The first enforcement step is normally an investigation by HHS, often instigated by private complainants. If

the investigation shows that a recipient of HHS funds is not

in compliance with Title VI, HHS must attempt to bring the

recipient into compliance by informal or voluntary means. Id.

§ 2000d-1; 45 C.F.R. §§ 80.7(d)(1), 80.8(d). The 2003 Policy

Guidance provides that if an investigation results in “a finding

of noncompliance, HHS must inform the recipient of the noncompliance through a Letter of Findings that sets out the areas

of noncompliance and the steps that must be taken to correct

the noncompliance.” Policy Guidance, 68 Fed. Reg. at 47,321.

If a recipient’s compliance cannot be achieved voluntarily,

HHS is authorized to discontinue federal financial assistance,

45 C.F.R. § 80.8(a), but no such discontinuance can take

effect until 

(1) the responsible Department official has advised

the applicant or recipient of his failure to comply and

has determined that compliance cannot be secured

by voluntary means, (2) there has been an express

finding on the record, after opportunity for hearing,

of a failure by the applicant or recipient to comply

with a requirement imposed by or pursuant to this

part, (3) the expiration of 30 days after the Secretary

has filed with the committee of the House and the

committee of the Senate having legislative jurisdiction over the program involved, a full written report

of the circumstances and the grounds for such action.

Id. § 80.8(c); see also 42 U.S.C. § 2000d-1. Recipients of

HHS funds are entitled to judicial review of a funding termination decision. Id. § 2000d-2; 45 C.F.R. § 80.11. 

HHS spends less than $500,000 annually on enforcement of

LEP-related compliance with Title VI. At oral argument

before the district court Defendants advised that “HHS has

never moved beyond the voluntary compliance stage with any

COLWELL v. HHS 3489
HHS Recipient.” Plaintiffs have submitted the voluntary compliance agreements to which Defendants refer and have submitted no evidence that any proceeding extended beyond the

voluntary compliance stage. None of the voluntary compliance agreements submitted involve any of the plaintiffs before

this Court. So far as the record shows, no recipient has ever

had its HHS federal funding terminated for violating Title

VI’s prohibition against national origin discrimination in its

treatment of LEP individuals. 

II. Procedural Background

Plaintiffs-Appellants Clifford W. Colwell, Jr., M.D., John

Brofman, M.D., and Lynn I. DeMarco, M.D. (collectively

“Physician Plaintiffs”) and two nonprofit organizations,

ProEnglish and the Association of American Physicians and

Surgeons (collectively “Organizational Plaintiffs”), filed a

complaint in federal district court against Defendants HHS

and the Secretary of HHS seeking declaratory and injunctive

relief against the 2003 Policy Guidance. Plaintiffs allege that

“Defendants are threatening to enforce and are enforcing this

Policy Guidance that orders medical service providers and

others to provide free translation services to limited English

proficient (LEP) persons, ensures the competency of the

translation, and exposes these providers to liability under both

federal law and malpractice claims.” 

Plaintiff Colwell is licensed to practice medicine in California, with a specialty in orthopedics. He has recently retired

from a position as head of the Division of Orthopedic Surgery

at the Scripps Clinic. Dr. Colwell alleges that the 2003 Policy

Guidance “interferes with his one-on-one physician patient

relationship by eliminating his professional judgment on how

best to communicate with his patients,” “compels him to

speak in a specific manner not of his choosing,” and “forces

him to translate his own English words into an language other

than English at his own cost.” Dr. Colwell alleges that com3490 COLWELL v. HHS
plying with the “translation requirement is extremely onerous

and the cost will be prohibitive.” 

Plaintiff Brofman practices pulmonary medicine, inpatient

and outpatient and consultative and primary care in Illinois.

Dr. Brofman alleges that the Policy Guidance “has a direct

financial impact on his practice.” He alleges that before the

issuance of the 2003 Policy Guidance he determined at the

initial appointment of an LEP patient whether a translator was

necessary. If he determined that a translator was necessary, he

encouraged the patient to bring a translator to subsequent

appointments. Dr. Brofman alleges that if the 2003 Policy

Guidance requires that he pay a translator for an LEP patient,

the cost will be “at least $75 an hour.” He alleges that this

additional cost “may force [him] to reduce his access to LEP

patients.” 

Plaintiff DeMarco is a partially retired Professor of Medicine at Truman Memorial Hospital in Missouri. He alleges

that prior to the issuance of the 2003 Policy Guidance he used

his professional judgment to decide “whether an interpreter or

translator was required when treating LEP patients.” He

alleges that “[n]ow he must provide an interpreter and translator even when he does not believe it is necessary or face the

threat of being reported to the HHS Office of Civil Rights.”

Dr. DeMarco alleges that he believes “it would be appropriate

to use a family member for translation when treating an LEP

patient if the family member is fluent in English and the illness is not serious.” He alleges that under the Policy Guidance he “may not request that the LEP patient use a family

member[.]” Dr. DeMarco provides the following example: “In

June 2003, I saw a Hispanic patient with a ten-year old daughter who was fluent in English and could have easily translated

what her mother was saying to me. However, because of the

HHS Policy Guidance I was not able to use her.” 

Plaintiff ProEnglish is a nonprofit advocacy organization

“dedicated to the preservation and promotion of a common

COLWELL v. HHS 3491
language — English — in American political and governmental life.” ProEnglish alleges that some of its members are

medical doctors who are subject to the 2003 Policy Guidance.

Plaintiff Colwell alleges that he is a member of ProEnglish.

ProEnglish alleges that the Policy Guidance “undermines or

nullifies the English language goals and programs that ProEnglish has conducted in recent years, is currently conducting,

and expects to undertake in the future.” ProEnglish alleges

that the “adoption and enforcement” of the Policy Guidance

will make its “activities far more difficult, if not impossible,

to attain.” ProEnglish asserts that some of its members “fear

that they will now be the target of complaints filed with the

HHS Office of Civil Rights” and that its members “will face,

at a minimum, emotional strain, inconvenience, and disruption of their professional life, economic costs, possible harm

to their professional reputation, and distraction from their professional duties.” ProEnglish also alleges that its members’

speech is being “unconstitutionally chilled.” 

Plaintiff Association of American Physicians and Surgeons

(“AAPS”) is a national nonprofit organization of “medical

doctors with over 5,000 members” that is “dedicated to preserving freedom in the practice of ethical medicine and

opposes government interference in the one-on-one patientphysician relationship.” AAPS alleges that many of its members are medical professionals subject to the 2003 Policy

Guidance. Plaintiffs Colwell and DeMarco allege that they are

members of AAPS. AAPS alleges that the Policy Guidance

“forces physicians to make significant financial outlays for

expanded translation and interpreter services or face the likelihood of civil rights complaints.” AAPS alleges that the Policy

Guidance “requires physicians to be responsible for the competency of the medical translation and interpreter service they

provide,” thus exposing “physicians to increased risk from

medical errors and omissions which will escalate insurance

costs.” As a result, according to AAPS, its members “may be

forced to limit their exposure by not accepting LEP patients.”

3492 COLWELL v. HHS
The district court dismissed Plaintiffs’ complaint for lack of

subject matter jurisdiction under Federal Rule of Civil Procedure 12(b)(1). It held under Article III that Plaintiffs lacked

standing and their suit was unripe. Plaintiffs timely appealed.

III. Standard of Review

“A complaint should not be dismissed unless it appears

beyond doubt that the plaintiff can prove no set of facts in

support of the claim that would entitle it to relief.” Daniel v.

County of Santa Barbara, 288 F.3d 375, 380 (9th Cir. 2002)

(quoting Williamson v. Gen. Dynamics Corp., 208 F.3d 1144,

1149 (9th Cir. 2000)). At the pleading stage, “general allegations embrace the specific facts that are necessary to support

the claim.” Lujan v. Defenders of Wildlife, 504 U.S. 555, 561

(1992) (internal citation omitted). The burden of establishing

ripeness and standing rests on the party asserting the claim.

Renne v. Geary, 501 U.S. 312, 316 (1991). In support of a

motion to dismiss under Rule 12(b)(1), the moving party may

submit “affidavits or any other evidence properly before the

court . . . . It then becomes necessary for the party opposing

the motion to present affidavits or any other evidence necessary to satisfy its burden of establishing that the court, in fact,

possesses subject matter jurisdiction.” St. Clair v. City of

Chico, 880 F.2d 199, 201 (9th Cir. 1989) (citations omitted).

We review de novo a district court’s dismissal for lack of

standing, construing all material allegations in favor of the

plaintiff. Schmier v. U.S. Court of Appeals for the Ninth Cir.,

279 F.3d 817, 820 (9th Cir. 2002). We also review de novo

a district court’s dismissal for lack of ripeness. See Manufactured Home Cmtys. Inc. v. City of San Jose, 420 F.3d 1022,

1025 (9th Cir. 2005). 

IV. Discussion

Plaintiffs’ suit challenges only the 2003 Policy Guidance.

For the reasons that follow, we hold that their suit satisfies the

COLWELL v. HHS 3493
case or controversy requirement of Article III for both standing and ripeness. However, we hold that it does not satisfy the

criteria for prudential ripeness. 

A. Case or Controversy Requirement of Article III

[1] Article III federal courts are limited to deciding “cases”

and “controversies.” U.S. Const. art. III, § 2. Two components

of the Article III case or controversy requirement are standing

and ripeness. 

1. Article III Standing

[2] The “irreducible constitutional minimum” of Article III

standing has three “elements,” Lujan, 504 U.S. at 560:

First, the plaintiff must have suffered an “injury in

fact” — an invasion of a legally protected interest

which is (a) concrete and particularized, . . . and (b)

“actual or imminent, not ‘conjectural’ or ‘hypothetical,’ ” . . . . Second, there must be a causal connection between the injury and conduct complained of

— the injury has to be “fairly . . . trace[able] to the

challenged action of the defendant, and not . . . th[e]

result [of] the independent action of some third party

not before the court.” . . . Third, it must be “likely,”

as opposed to merely “speculative,” that the injury

will be “redressed by a favorable decision.” 

Id. at 560-61 (alterations in original). 

[3] Reading the complaint generously, as we must under

Federal Rule of Civil Procedure 8(a), the Physician Plaintiffs

have satisfied all three elements. First, they have alleged that

they have suffered, or will suffer, “injury in fact” as a result

of Defendants’ issuance of the Policy Guidance. Plaintiff Colwell alleges that the Policy Guidance interferes with his relationship with his patients and with the exercise of his

3494 COLWELL v. HHS
“professional judgment,” and that it forces him to hire translators that he would not otherwise hire “at his own cost.” Plaintiff Brofman alleges that the Policy Guidance has a direct

adverse impact on his practice, and that if he needs an interpreter for an LEP patient the cost will be at least $75 per hour.

Plaintiff DeMarco alleges that the Policy Guidance has

already obliged him to discontinue his prior practice of using

family members to translate for his patients, and will oblige

him to do so in the future. 

[4] Second, the Physician Plaintiffs have alleged a causal

connection between the actions of the Defendants and their

injury. Defendants are responsible for the issuance of the Policy Guidance that has allegedly caused injury to Plaintiffs.

Their actions are not the result of the “independent action of

some third party not before the court.” Lujan, 504 U.S. at

560-61.

[5] Third, the Physician Plaintiffs have alleged that their

injury will be “redressed by a favorable decision.” Id. at 561.

If the Policy Guidance is withdrawn, the injury of which the

Plaintiffs complain will be redressed. 

There are three related but distinct Article III standing

requirements for associations. “An association has standing to

bring suit on behalf of its members when [1] its members

would otherwise have standing to sue in their own right, [2]

the interests at stake are germane to the organization’s purpose, and [3] neither the claim nor the relief requested

requires the participation of individual members in the lawsuit.” Friends of the Earth, Inc. v. Laidlaw Envtl. Servs.

(TOC), Inc., 528 U.S. 167, 181 (2000) (bracketed numbers

added) (citing Hunt v. Wash. State Apple Adver. Comm’n, 432

U.S. 333, 343 (1977)). 

[6] The Organizational Plaintiffs have adequately alleged

compliance with the three requirements for associational

standing. First, Plaintiff Colwell alleges that he is a member

COLWELL v. HHS 3495
of Plaintiff ProEnglish, and Plaintiffs Colwell and DeMarco

allege that they are members of Plaintiff AAPS. As we have

just discussed, Plaintiffs Colwell and DeMarco have standing

in their own right. 

[7] Second, the interests at stake in this suit are “germane”

to the purposes of the two associations. Plaintiff ProEnglish

alleges that it is “dedicated to the preservation and promotion

of a common language — English,” and that the Policy Guidance will interfere with the achievement of its goals. Plaintiff

AAPS alleges that it is “dedicated to preserving freedom in

the practice of ethical medicine,” and that the Policy Guidance will interfere with the “one-on-one patient-physician

relationship.” 

[8] Third, although members of the Organizational Plaintiffs are individual plaintiffs in the suit before us, the claim

and relief sought in this suit does not require their presence.

Stated another way, the claims and relief sought in this suit

could be pursued even if the Organizational Plaintiffs were

the only plaintiffs. 

2. Article III Ripeness

[9] Standing and ripeness under Article III are closely

related. For a suit to be ripe within the meaning of Article III,

it must present “ ‘concrete legal issues, presented in actual

cases, not abstractions.’ ” United Pub. Workers v. Mitchell,

330 U.S. 75, 89 (1947) (quoting Elec. Bond & Share Co. v.

Sec. & Exch. Comm’n, 303 U.S. 419, 443 (1938)). But

whereas “standing is primarily concerned with who is a

proper party to litigate a particular matter, ripeness addressees

when that litigation may occur.” Lee v. Oregon, 107 F.3d

1382, 1387 (9th Cir. 1997); see also Sacks v. Office of Foreign Assets Control, 466 F.3d 764, 773 (9th Cir. 2006)

(“ ‘[T]he constitutional component of the ripeness inquiry . . .

, in many cases, . . . coincides squarely with standing’s injury

in fact prong.’ ”) (internal citation omitted); Thomas v.

3496 COLWELL v. HHS
Anchorage Equal Rights Comm’n, 220 F.3d 1134, 1138 (9th

Cir. 2000) (“The constitutional component of the ripeness

inquiry is often treated under the rubric of standing and, in

many cases, ripeness coincides squarely with standing’s

injury in fact prong.”). As is apparent from our description

above, Plaintiffs’ stake in the legal issues is concrete rather

than abstract. Mitchell, 330 U.S. at 89. Even in its present

form, Plaintiffs’ suit is a concrete challenge to the 2003 Policy Guidance. Therefore, we hold that the ripeness requirement of Article III is satisfied. 

However, that does not end the ripeness inquiry, for ripeness doctrine reflects both constitutional and prudential considerations. “The ripeness doctrine is ‘drawn both from

Article III limitations on judicial power and from prudential

reasons for refusing to exercise jurisdiction.’ ” Nat’l Park

Hospitality Ass’n v. Dep’t of Interior, 538 U.S. 803, 808

(2003). The next part of the inquiry, to which we now turn,

is whether Plaintiffs’ suit satisfies the prudential criteria for

ripeness articulated in Abbott Laboratories v. Gardner. 

B. Prudential Ripeness

Plaintiffs allege three claims. First, they claim that the 2003

Policy Guidance should not have been issued without following the notice-and-comment procedure required by the APA,

5 U.S.C. § 553. Second, they claim that the prohibition in

Title VI against discrimination based on national origin does

not include a prohibition against discrimination based on limited English proficiency, and that the 2003 Policy Guidance

therefore exceeds the authority delegated to the Secretary of

HHS by Title VI. Third, they claim that the Policy Guidance

infringes on their First Amendment rights. 

As will appear, whether we should reach Plaintiffs’ second

and third claims depends on whether we can decide their first

claim. For the reasons that follow, we hold, under the criteria

for prudential ripeness, that Plaintiffs’ first claim is not ripe.

COLWELL v. HHS 3497
Because it is not ripe, we do not reach their second and third

claims. We therefore affirm the district court’s dismissal of

Plaintiffs’ suit. 

[10] The question of prudential ripeness “is best seen in a

twofold aspect, requiring us to evaluate both the fitness of the

issues for judicial decision and the hardship to the parties of

withholding court consideration.” Abbott Labs., 387 U.S. at

149; see also Nat’l Park Hospitality Ass’n, 538 U.S. at 808.

“[A] regulation is not ordinarily considered the type of agency

action ‘ripe’ for judicial review under the APA until the scope

of the controversy has been reduced to more manageable proportions, and its factual components fleshed out, by some

concrete action applying the regulation to the claimant’s situation in a fashion that harms or threatens to harm him.” Lujan,

497 U.S. at 891. 

1. Fitness of the Issue for Judicial Decision

[11] Plaintiffs’ first claim turns on whether the 2003 Policy

Guidance is a substantive rule or a general statement of policy. Under the APA, a federal administrative agency is

required to follow prescribed notice-and-comment procedures

before promulgating substantive rules. See 5 U.S.C. § 553.

However, notice-and-comment is not required prior to issuance of “interpretive rules, general statements of policy, or

rules of agency organization, procedure or practice.” Id.

§ 553(b)(A). Plaintiffs contend that the 2003 Policy Guidance

is a substantive rule. Defendants contend that it is a “general

statement of policy” and thus not subject to the notice-andcomment requirement. Defendants do not contend that the

Guidance Policy is an “interpretive rule.” 

In Mada-Luna v. Fitzpatrick, 813 F.2d 1006 (9th Cir.

1987), we distinguished a substantive rule from a general

statement of policy:

The critical factor to determine whether a directive

announcing a new policy constitutes a rule or a gen3498 COLWELL v. HHS
eral statement of policy is “the extent to which the

challenged [directive] leaves the agency, or its

implementing official free to exercise discretion to

follow, or not to follow, the [announced] policy in an

individual case . . . . 

To the extent that the directive merely provides

guidance to agency officials in exercising their discretionary power while preserving their flexibility

and their opportunity to make “individualized determination[s],” it constitutes a general statement of

policy . . . . In contrast, to the extent that the directive “narrowly limits administrative discretion” or

establishes a “binding norm” that “so fills out the

statutory scheme that upon application one need only

determine whether a given case is within the rule’s

criterion,” it effectively replaces agency discretion

with a new “binding rule of substantial law.” 

Id. at 1013-14 (emphasis in original); see also Municipality of

Anchorage v. United States, 980 F.2d 1320, 1324-25 (9th Cir.

1992). 

The D.C. Circuit distinguishes a substantive rule from a

general statement of policy in much the same way. In

McLouth Steel Products Corp. v. Thomas, 838 F.2d 1317

(D.C. Cir. 1988), that court wrote:

A policy statement is one that first, does not have “a

present-day binding effect,” that is, it does not “impose any rights and obligations,” and second, “genuinely leaves the agency and its decision-makers free

to exercise discretion.” . . . The question for purposes of § 533 is whether a statement is a rule of

present binding effect; the answer depends on

whether the statement constrains the agency’s discretion. 

COLWELL v. HHS 3499
Id. at 1320; see also Cement Kiln Recycling Coal. v. Envtl.

Prot. Agency, 493 F.3d 207, 226-27 (D.C. Cir. 2007) (applying the distinction articulated in McLouth Steel to the analogous issue under the Resource Conservation and Recovery

Act). 

The 2003 Policy Guidance purports to be a general statement of policy not subject to the APA’s notice-and-comment

requirement. On its first page, it provides, “It has been determined that this revised HHS LEP Guidance does not constitute a regulation subject to the rulemaking requirements of the

Administrative Procedure Act, 5 U.S.C. § 553.” Policy Guidance, 68 Fed. Reg. at 47,311. However, we need not accept

an agency’s characterization “at face value.” Hemp Indus.

Ass’n v. Drug Enforcement Admin., 333 F.3d 1082, 1087 (9th

Cir. 2003). 

[12] Plaintiffs contend that the Policy Guidance imposes

obligations on them and limits the discretion of HHS to such

a degree that it constitutes a binding norm of substantive law.

If Plaintiffs are correct, notice and comment were required

under § 553. Defendants, on the other hand, contend that the

Policy Guidance is mere guidance to HHS in the exercise of

its discretion and has no binding effect. If Defendants are correct, notice and comment were not required. Neither position

is entirely borne out by the text of the 2003 Policy Guidance.

As we read the Policy Guidance, it is ambiguous. 

Much of the Policy Guidance is written in non-mandatory

terms. It begins by stating that “failure of a recipient of Federal financial assistance from HHS to take reasonable steps to

provide LEP persons with meaningful opportunity to participate in HHS-funded programs may constitute a violation of

Title VI and HHS’s implementing regulations.” Guidance, 68

Fed. Reg. at 47,313 (emphasis added). It then states that the

“purpose of this policy guidance is to assist recipients in fulfilling their responsibilities to provide meaningful access to

LEP persons under existing law” and that the “policy guid3500 COLWELL v. HHS
ance clarifies existing legal requirements for LEP persons by

providing a description of the factors recipients should consider in fulfilling their responsibilities to LEP persons.” Id.

(emphasis added). A footnote immediately thereafter adds the

following: 

The policy guidance is not a regulation but rather a

guide. Title VI and its implementing regulations

require that recipients take reasonable steps to ensure

meaningful access by LEP persons. This guidance

provides an analytical framework that recipients

may use to determine how best to comply with statutory and regulatory obligations to provide meaningful access to the benefits, services, information, and

other important portions of their programs and activities for individuals who are limited English proficient. 

Id. at 47,313 n.2 (emphasis added). 

[13] The Policy Guidance is riddled with words and

phrases that, if read alone, would indicate that the guidance is

not mandatory and that it imposes no new obligations —

“suggest,” “should,” “encouraged,” “may be helpful,” and

“clarifies.” See, e.g., id. at 47,314 (“As indicated above, the

intent of this guidance is to suggest a balance that ensures

meaningful access by LEP persons to critical services while

not imposing undue burdens on small business, small local

government, or small nonprofits.”) (emphasis added); id.

(“The correct mix should be based on what is both necessary

and reasonable in light of the four-factor analysis.”) (emphasis added); id. at 47,315 (“Recipients have substantial flexibility in determining the appropriate mix.”); id. (“[T]he use of

certified interpreters is strongly encouraged.”) (emphasis

added); id. at 47,720 (“For the recipient who decides to

develop a written implementation plan, the following five

steps may be helpful in designing such a plan; they are typically part of effective implementation plans.”) (emphasis

COLWELL v. HHS 3501
added); id. at 47,322 (in the Q & A section noting that the

guidance document “[c]larifies that failure to take one or

more of these steps does not necessarily mean noncompliance

with Title VI”) (emphasis added). 

[14] On the other hand, the Policy Guidance contains a

great deal of language suggesting that its directions are mandatory. For example, in the Appendix to the Policy Guidance,

a Question and Answer provide: “Q. Does the guidance

impose new requirements on recipients? A. No . . . . This

guidance synthesizes the legal requirements that [the Office

of Civil Rights of HHS] has been enforcing for over three decades.” Id. at 47,322 (emphasis added). Earlier in the Policy

Guidance, immediately after the notation that recipients

“should” consider the four factors, the Policy Guidance states

that the four factors “are the same criteria HHS will use in

evaluating whether recipients are in compliance with Title VI

and the Title VI regulations.” Id. at 47,313 (emphasis added).

The Policy Guidance also states that “a recipient may not

require an LEP person to use a family member or friend as an

interpreter.” Id. at 47,317 (emphasis added); see id. at 47,323.

It goes on to note that “quality and accuracy of [language]

services is critical to avoid serious consequences to the LEP

person and to the recipient.” Id. at 47,316. 

Other provisions in the Policy Guidance also suggest that

they are mandatory. See id. at 47,314 (the guidance document

notes that “[w]hile designed to be a flexible and factdependant standard, the starting point is an individualized

assessment that balances” the factors contained in the fourfactor balancing test) (emphasis added); id. at 47,315

(“[Q]uality and accuracy of language services is nonetheless

part of the appropriate mix of LEP services required.”)

(emphasis added); id. at 47,319 (“[T]he extent of the recipient’s obligation to provide written translations of documents

should be determined by the recipient on a case-by-case basis,

looking at the totality of the circumstances in light of the fourfactor analysis.”) (emphasis added); id. at 47,322 (in the Q &

3502 COLWELL v. HHS
A section noting that “OCR will determine compliance on a

case by case basis, in light of” the four-factor balancing test)

(emphasis added); id. at 47,322-23 (“Some large documents

may contain no vital information, and others will contain vital

information that will have to be translated. Again, the obligation to translate will depend on application of the four factors.”) (emphasis added). 

Finally, Plaintiffs point out that the Policy Guidance contains a safe harbor provision. Id. at 47,319. The Policy Guidance notes that a “ ‘safe harbor’ means that if a recipient

provides written translations under these circumstances, such

action will be considered strong evidence of compliance with

the recipient’s obligations.” It goes on to state that the “safe

harbor provisions apply to the translation of written documents,” and that the safe harbor provisions therefore “do not

affect the requirement to provide oral interpreters where an

application of the four factor test leads to the determination

that oral language services are needed and are reasonable.” Id.

(emphasis added). Because one can ensure that one is in compliance by using the safe harbor, the existence of the safe harbor implies there are obligations for which compliance is

mandatory. See Gen. Elec. Co. v. Envtl. Prot. Agency, 290

F.3d 377, 384 (D.C. Cir. 2002). That argument, however, is

not applicable in this case because any requirement of written

translation is mandated not by the 2003 Policy Guidance, but

rather by the 1976 DOJ regulation promulgated after notice

and comment. See 28 C.F.R. § 42.405(d)(1). Plaintiffs do not

challenge that regulation in this suit. As for oral translations,

as to which the Policy Guidance arguably provides new

requirements, the safe harbor provision, by its own terms,

does not apply. Guidance, 68 Fed. Reg. at 47,319. Thus, the

presence of the safe harbor provision does not imply that the

Policy Guidance provides binding norms that HHS must follow. 

In Toilet Goods Association, Inc. v. Gardner, 387 U.S. 158

(1967), the Court applied the two-part prudential ripeness test

COLWELL v. HHS 3503
it had articulated the same day in Abbott Laboratories. Plaintiff in Toilet Goods Association was an association of cosmetics manufacturers and distributers that brought a preenforcement challenge to regulations promulgated under the

Federal Food, Drug, and Cosmetic Act. Plaintiff in Toilet

Goods Association alleged that the regulations exceeded the

authority granted under the Act. The Court held that promulgation of the regulations was final agency action within the

meaning of the APA and that plaintiff’s suit was a case or

controversy under Article III. But the Court nonetheless held

the suit unripe as a prudential matter. The regulations allowed

inspection of manufacturing premises but were unclear in

important respects. 

The Court wrote:

At this juncture we have no idea whether or when

such an inspection will be ordered and what reasons

the Commissioner will give to justify his order. The

statutory authority asserted for the regulation is the

power to promulgate regulations ‘for the efficient

enforcement’ of the Act, § 701(a). Whether the regulation is justified thus depends not only, as petitioners appear to suggest, on whether Congress refused

to include a specific section of the Act authorizing

such inspections, although this factor is to be sure a

highly relevant one, but also on whether the statutory

scheme as a whole justified promulgation of the regulation. . . . This will depend not merely on an

inquiry into statutory purpose, but concurrently on

an understanding of what types of enforcement problems are encountered by the FDA, the need for various sorts of supervision in order to effectuate the

goals of the Act, and the safeguards devised to protect legitimate trade secrets . . . . We believe that

judicial appraisal of these factors is likely to stand on

a much surer footing in the context of a specific

application of this regulation than could be the case

3504 COLWELL v. HHS
in the framework of the generalized challenge made

here. 

Id. at 163-64. The Court’s analysis in Toilet Goods Association strongly suggests that we should hold Plaintiffs’ suit

unripe because of the ambiguity in the Policy Guidance, and

because of the likelihood that this ambiguity will be reduced

or resolved based on the enforcement activities HHS may

undertake in the future. 

A case from our own circuit suggests even more strongly

that we should hold Plaintiffs’ suit unripe. In Municipality of

Anchorage, the question was precisely the same as in our

case, and the facts were remarkably similar. 980 F.2d at 1320.

Plaintiffs contended that a Memorandum of Agreement

(“MOA”) between the Environmental Protection Agency and

the Army Corps of Engineers was a substantive rule subject

to the APA’s notice and comment requirement. See 5 U.S.C.

§ 553. Defendants, on the other hand, contended that the

MOA was a general policy statement not subject to the

requirement. Plaintiffs pointed to seemingly mandatory language in the MOA. See, e.g., Municipality of Anchorage, 980

F.2d at 1324 (“Plaintiffs point to language in the MOA stating

that it ‘must be adhered to’ and that it ‘will [be] use[d] . . .

when making . . . determination[s] of compliance with the

Guidelines . . . .’ ”) (emphasis and alterations in original).

Defendants pointed to language in the MOA suggesting that

the document contained no more than discretionary policy

guidance. See, e.g., id. (“[Defendants] direct our attention to

the following excerpt from the MOA: ‘This MOA . . . is written to provide guidance for agency field personnel . . . . The

MOA does not change the substantive requirements of the

Guidelines. It is intended to provide guidance regarding the

exercise of discretion under the Guidelines.’ ”) (emphasis in

original). 

We held the suit unripe under the prudential ripeness

criteria of Abbott Laboratories. We wrote: 

COLWELL v. HHS 3505
Examining the language of the MOA, it is not at all

clear that the EPA and the Corps intend to be bound

by the document. On the other hand, one cannot state

without reservation that the agencies do not intend to

be bound. The MOA seems to send mixed messages

as to the binding intent of the agencies in its adoption. In a situation such as this, we are convinced

that the better course is to withhold court review

. . . . Thus, we conclude that only agency action

under the MOA “can make the issue determinable

and thus fit for review.” . . . It is clear to this court

that the judicial process will clearly gain by waiting

for a concrete application of the MOA. 

Id. at 1325. 

[15] We therefore conclude in the case before us that the

issue is not now fit for decision. If and when the parties are

able to provide examples of the manner in which the HHS has

used the Policy Guidance — as, for example, in an enforcement proceeding against one of them — we will be in a better

position to determine whether the 2003 Policy Guidance functions as a substantive rule or as a general statement of policy.

If and when the case is presented to us in that posture, we will

be able “to stand on a much surer footing.” Toilet Goods

Ass’n, 387 U.S. at 164. 

2. Hardship to the Parties of Withholding Court

Consideration

[16] Plaintiffs contend that they will suffer hardship if we

do not decide their suit in its current posture. Hardship in this

context “does not mean just anything that makes life harder;

it means hardship of a legal kind, or something that imposes

a significant practical harm upon the plaintiff.” Natural Res.

Def. Council v. Abraham, 388 F.3d 701, 706 (9th Cir. 2004).

“The rule in Abbott Laboratories has been carefully circumscribed to regulations that pose an immediate dilemma.”

3506 COLWELL v. HHS
Ass’n of Am. Med. Colls. v. United States, 217 F.3d 770, 783

(9th Cir. 2000). Plaintiffs must show that postponing review

imposes a hardship on them “that is immediate, direct, and

significant.” Municipality of Anchorage, 980 F.2d at 1326. 

[17] Plaintiffs contend that if they cannot pursue a preenforcement challenge to the 2003 Policy Guidance they will

be exposed to liability under both federal law and state malpractice law. However, Plaintiffs acknowledge that HHS “has

not threatened any direct action against” them. Nor do Plaintiffs allege that HHS has requested that they comply with the

Policy Guidance. Moreover, under Title VI’s regulatory

framework, Plaintiffs are several steps removed from any termination of their federal funding. See 45 C.F.R. §§ 80.7(d)(1),

80.8(d). Before Plaintiffs’ Title VI funding can be terminated

there must be an effort to achieve informal or voluntary compliance, an administrative hearing, and notice to congressional

committees. Judicial review is available in an Article III court

of any funding termination. If HHS initiates compliance proceedings against Plaintiffs based on the 2003 Policy Guidance, Plaintiffs will have an opportunity to challenge the

Policy Guidance on the same legal bases on which it relies in

the suit now before us. Cf. Croplife Am. v. Envtl. Prot.

Agency, 329 F.3d 876, 882 (D.C. Cir. 2003) (“In this case, by

contrast, EPA has enacted a firm rule with legal consequences

that are binding on both petitioners and the agency, and petitioners will be afforded no additional opportunity to make the

arguments to the agency that they now present in this petition.”). 

[18] Finally, there is no indication that Plaintiffs may be

subject to any fines by HHS or to financial liability to private

parties. The regulations do not contemplate any kind of financial sanction other than termination of federal funding. See 45

C.F.R. § 80.8; Gebser v. Lago Vista Ind. Sch. Dist., 524 U.S.

274, 288-89 (1998) (describing administrative enforcement

provisions of Title IX, which are nearly identical to those of

Title VI, and stating that “the regulations do not appear to

COLWELL v. HHS 3507
contemplate a condition ordering payment of monetary damages”). Plaintiffs are not potentially liable to their LEP

patients under Title VI, for the Supreme Court has held that

there is no private right of action for disparate impact discrimination under Title VI. See Alexander v. Sandoval, 532 U.S.

275, 285 (2001); see also Barnes v. Gorman, 536 U.S. 181

(2000) (no punitive damages under Title VI). Plaintiffs’ suggestion that they could be subjected to malpractice liability,

is entirely speculative and would depend on state law that

they have neither presented nor explained in this suit. 

[19] We agree with Plaintiffs that they may be affected by

the 2003 Policy Guidance, for they have alleged that they are

spending money on language assistance and have altered their

conduct as a result of the 2003 Policy Guidance. However,

this hardship is insufficient to overcome the uncertainty of the

legal issue presented in the case in its current posture. “Simply stated, plaintiffs have failed to demonstrate any hardship

that outweighs our and the agencies’ interest in delaying

review.” Municipality of Anchorage, 980 F.2d at 1326.

[20] Since Plaintiffs’ first claim is not ripe, we think it

inadvisable to proceed to their second and third claims. The

questions presented in those claims are potentially difficult,

and we do not wish to decide them unnecessarily or on an

undeveloped record. If and when Plaintiffs’ first claim

becomes ripe, a court will be able to decide whether the 2003

Policy Guidance is invalid because it was not issued after

notice and comment. If the Policy Guidance is invalid, Plaintiffs’ second and third claims will become moot. Further,

many of the considerations that counsel against deciding the

first claim at this juncture under the prudential ripeness

criteria apply as well to the second and third claims. Most

prominently, if we were to decide Plaintiffs’ second and third

claims now, we would do so without knowing the manner in

which HHS will apply the 2003 Policy Guidance. The manner

of enforcement might make an important difference to the

merits of Plaintiffs’ second claim, and would certainly make

3508 COLWELL v. HHS
such a difference to the merits of their third claim. Also, and

critically, the hardship considerations we have just surveyed

apply equally to the second and third claims, so there is no

imperative to proceed now. We therefore apply the prudential

ripeness doctrine to the case as a whole and decline to proceed on the current record. 

Conclusion

We hold under Article III that Plaintiffs have standing to

bring their pre-enforcement challenge to the 2003 Policy

Guidance, and that their suit is ripe. However, we hold under

the criteria for prudential ripeness articulated by the Supreme

Court in Abbott Laboratories, that Plaintiffs’ first claim is not

ripe. Because Plaintiffs’ first claim is not ripe, we do not

reach their second and third claims. We affirm the judgment

of the district court dismissing the suit. 

AFFIRMED. 

COLWELL v. HHS 3509