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,
                   v.                           D.C. No.
                                             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
3482                 COLWELL v. HHS




                       COUNSEL

Sharon Louise Browne, Pacific Legal Foundation, Sacra-
mento, California, Arthur B. Mark, III, Trainor Fairbrook,
Sacramento, California, for the appellants.
                        COLWELL v. HHS                        3483
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 sup-
ported 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, 

(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 Fed-
eral 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 issu-
3484                   COLWELL v. HHS
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.” 

   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 imme-
diately after the passage of Title VI. A 1964 regulation pro-
hibits 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 prohibi-
tion against discrimination based on national origin as includ-
ing 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 stu-
dents who had ‘linguistic deficiencies.’ ” Notice, 35 Fed. Reg.
11,595 (July 18, 1970). Four years later, the Supreme Court
in Lau v. Nichols, 

(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 “meaning-
                       COLWELL v. HHS                         3485
ful opportunity to participate in the educational program” of
the San Francisco public schools violated § 601. 

  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 infor-
    mation 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 per-
    sons. This requirement applies with regard to written
    material of the type which is ordinarily distributed to
    the public.

The DOJ regulations do not mention oral
translation.

   In 1980, HHS issued a Notice of Decision to Develop Reg-
ulations (“NDDR”) that stated that HHS was “considering
requiring certain classes of recipients to conduct self-
evaluations 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
3486                   COLWELL v. HHS
was to solicit public comments before the issuance of a Notice
of Proposed Rulemaking (“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 Guid-
ance 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.” 

tors to be considered included “[the provider’s] size, the size
of the LEP population it serves, the setting in which inter-
preter 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 ser-
vices.” 

   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 burden-
    ing, the fundamental mission of the agency. Each
    Federal agency shall also work to ensure that recipi-
    ents of Federal financial assistance . . . provide
                       COLWELL v. HHS                        3487
    meaningful access to their LEP applicants and bene-
    ficiaries.

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.” 

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 discriminat-
    ing on the basis of national origin in violation of
    Title VI and its implementing regulations. Title VI
    and its regulations require recipients to take reason-
    able steps to ensure “meaningful” access to the infor-
    mation and services they provide. What constitutes
    reasonable steps to ensure meaningful access will be
    contingent on a number of factors. Among the fac-
    tors to be considered are the number or proportion of
    LEP persons in the eligible service population, the
    frequency with which LEP individuals come in con-
    tact with the program, the importance of the service
    provided by the program, and the resources available
    to the recipient.

  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
3488                    COLWELL v. HHS
republished for public comment a year and a half later, result-
ing in a 2002 version of the Policy Guidance. Policy Guid-
ance on the Prohibition Against National Origin
Discrimination As It Affects Persons With Limited English
Proficiency, 67 Fed. Reg. 4968 (Feb. 1, 2002). The 2002 Pol-
icy 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 Dis-
crimination 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 pro-
viding a description of the factors recipients should consider
in fulfilling their responsibilities to LEP persons.” 

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 activi-
ties. 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 assis-
tance or “by any other means authorized by law.” 42 U.S.C.
                       COLWELL v. HHS                         3489
§ 2000d-1. The first enforcement step is normally an investi-
gation 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. 

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 non-
compliance 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 jurisdic-
    tion over the program involved, a full written report
    of the circumstances and the grounds for such action.

see also 42 U.S.C. § 2000d-1. Recipients of
HHS funds are entitled to judicial review of a funding termi-
nation decision. 

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
3490                    COLWELL v. HHS
HHS Recipient.” Plaintiffs have submitted the voluntary com-
pliance agreements to which Defendants refer and have sub-
mitted no evidence that any proceeding extended beyond the
voluntary compliance stage. None of the voluntary compli-
ance 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 Califor-
nia, 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 com-
                       COLWELL v. HHS                     3491
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 Medi-
cine 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 transla-
tor 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 ill-
ness is not serious.” He alleges that under the Policy Guid-
ance 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 daugh-
ter 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
3492                    COLWELL v. HHS
language — English — in American political and governmen-
tal 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 ProEn-
glish 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 disrup-
tion of their professional life, economic costs, possible harm
to their professional reputation, and distraction from their pro-
fessional 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 pre-
serving freedom in the practice of ethical medicine and
opposes government interference in the one-on-one patient-
physician relationship.” AAPS alleges that many of its mem-
bers 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 likeli-
hood of civil rights complaints.” AAPS alleges that the Policy
Guidance “requires physicians to be responsible for the com-
petency 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.”
                          COLWELL v. HHS                      3493
   The district court dismissed Plaintiffs’ complaint for lack of
subject matter jurisdiction under Federal Rule of Civil Proce-
dure 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, 

, 380 (9th Cir. 2002)
(quoting Williamson v. Gen. Dynamics Corp., 

,
1149 (9th Cir. 2000)). At the pleading stage, “general allega-
tions embrace the specific facts that are necessary to support
the claim.” Lujan v. Defenders of Wildlife, 

, 561
(1992) (internal citation omitted). The burden of establishing
ripeness and standing rests on the party asserting the claim.
Renne v. Geary, 

, 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 neces-
sary to satisfy its burden of establishing that the court, in fact,
possesses subject matter jurisdiction.” St. Clair v. City of
Chico, 

, 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.,

, 820 (9th Cir. 2002). We also review de novo
a district court’s dismissal for lack of ripeness. See Manufac-
tured Home Cmtys. Inc. v. City of San Jose, 

,
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
3494                    COLWELL v. HHS
case or controversy requirement of Article III for both stand-
ing 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,” 

:

    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 ‘hypotheti-
    cal,’ ” . . . . Second, there must be a causal connec-
    tion 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.”

(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 Col-
well alleges that the Policy Guidance interferes with his rela-
tionship with his patients and with the exercise of his
                        COLWELL v. HHS                      3495
“professional judgment,” and that it forces him to hire transla-
tors that he would not otherwise hire “at his own cost.” Plain-
tiff Brofman alleges that the Policy Guidance has a direct
adverse impact on his practice, and that if he needs an inter-
preter 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 Pol-
icy 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.” 

-61.

   [5] Third, the Physician Plaintiffs have alleged that their
injury will be “redressed by a favorable decision.” 

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 pur-
pose, and [3] neither the claim nor the relief requested
requires the participation of individual members in the law-
suit.” Friends of the Earth, Inc. v. Laidlaw Envtl. Servs.
(TOC), Inc., 

, 181 (2000) (bracketed numbers
added) (citing Hunt v. Wash. State Apple Adver. Comm’n, 

, 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
3496                    COLWELL v. HHS
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 Guid-
ance 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 Guid-
ance will interfere with the “one-on-one patient-physician
relationship.”

   [8] Third, although members of the Organizational Plain-
tiffs 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,

, 89 (1947) (quoting Elec. Bond & Share Co. v.
Sec. & Exch. Comm’n, 

, 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, 

, 1387 (9th Cir. 1997); see also Sacks v. Office of For-
eign Assets Control, 

, 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.
                        COLWELL v. HHS                       3497
Anchorage Equal Rights Comm’n, 

, 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. 

. Even in its present
form, Plaintiffs’ suit is a concrete challenge to the 2003 Pol-
icy Guidance. Therefore, we hold that the ripeness require-
ment of Article III is satisfied.

   However, that does not end the ripeness inquiry, for ripe-
ness doctrine reflects both constitutional and prudential con-
siderations. “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, 

, 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 follow-
ing 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 lim-
ited 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.
3498                   COLWELL v. HHS
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 

; see also Nat’l Park Hospitality 

.
“[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 pro-
portions, and its factual components fleshed out, by some
concrete action applying the regulation to the claimant’s situa-
tion in a fashion that harms or threatens to harm him.” 

.

        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 pol-
icy. 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 issu-
ance of “interpretive rules, general statements of policy, or
rules of agency organization, procedure or practice.” 

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-and-
comment requirement. Defendants do not contend that the
Guidance Policy is an “interpretive rule.”

   In Mada-Luna v. Fitzpatrick, 

(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 gen-
                       COLWELL v. HHS                           3499
    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 dis-
    cretionary power while preserving their flexibility
    and their opportunity to make “individualized deter-
    mination[s],” it constitutes a general statement of
    policy . . . . In contrast, to the extent that the direc-
    tive “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.”

(emphasis in original); see also Municipality of
Anchorage v. United States, 

, 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, 

(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 “im-
    pose any rights and obligations,” and second, “genu-
    inely leaves the agency and its decision-makers free
    to exercise discretion.” . . . The question for pur-
    poses of § 533 is whether a statement is a rule of
    present binding effect; the answer depends on
    whether the statement constrains the agency’s discre-
    tion.
3500                   COLWELL v. HHS

see also Cement Kiln Recycling Coal. v. Envtl.
Prot. Agency, 

, 226-27 (D.C. Cir. 2007) (apply-
ing the distinction articulated in McLouth Steel to the analo-
gous issue under the Resource Conservation and Recovery
Act).

   The 2003 Policy Guidance purports to be a general state-
ment of policy not subject to the APA’s notice-and-comment
requirement. On its first page, it provides, “It has been deter-
mined that this revised HHS LEP Guidance does not consti-
tute a regulation subject to the rulemaking requirements of the
Administrative Procedure Act, 5 U.S.C. § 553.” Policy Guid-
ance, 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., 

, 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 cor-
rect, 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 Fed-
eral financial assistance from HHS to take reasonable steps to
provide LEP persons with meaningful opportunity to partici-
pate 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 ful-
filling their responsibilities to provide meaningful access to
LEP persons under existing law” and that the “policy guid-
                        COLWELL v. HHS                        3501
ance clarifies existing legal requirements for LEP persons by
providing a description of the factors recipients should con-
sider in fulfilling their responsibilities to LEP persons.” 

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 statu-
    tory and regulatory obligations to provide meaning-
    ful access to the benefits, services, information, and
    other important portions of their programs and activ-
    ities for individuals who are limited English profi-
    cient.

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., 

(“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); 

mix should be based on what is both necessary
and reasonable in light of the four-factor analysis.”) (empha-
sis added); 

(“Recipients have substantial flexibil-
ity in determining the appropriate mix.”); 

of
certified interpreters is strongly encouraged.”) (emphasis
added); 

(“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 typi-
cally part of effective implementation plans.”) (emphasis
3502                    COLWELL v. HHS
added); 

(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 man-
datory. 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 dec-
ades.” 

(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.” 

(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.” 

(emphasis added); see 

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.” 

   Other provisions in the Policy Guidance also suggest that
they are mandatory. See 

(the guidance document
notes that “[w]hile designed to be a flexible and fact-
dependant standard, the starting point is an individualized
assessment that balances” the factors contained in the four-
factor balancing test) (emphasis added); 

(“[Q]uality and accuracy of language services is nonetheless
part of the appropriate mix of LEP services required.”)
(emphasis added); 

(“[T]he extent of the recipi-
ent’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 four-
factor analysis.”) (emphasis added); 

(in the Q &
                        COLWELL v. HHS                      3503
A section noting that “OCR will determine compliance on a
case by case basis, in light of” the four-factor balancing test)
(emphasis added); 

-23 (“Some large documents
may contain no vital information, and others will contain vital
information that will have to be translated. Again, the obliga-
tion to translate will depend on application of the four fac-
tors.”) (emphasis added).

   Finally, Plaintiffs point out that the Policy Guidance con-
tains a safe harbor provision. 

The Policy Guid-
ance 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 docu-
ments,” 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.” 

Because one can ensure that one is in com-
pliance by using the safe harbor, the existence of the safe har-
bor implies there are obligations for which compliance is
mandatory. See Gen. Elec. Co. v. Envtl. Prot. Agency, 

, 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 fol-
low.

  In Toilet Goods Association, Inc. v. Gardner, 

(1967), the Court applied the two-part prudential ripeness test
3504                   COLWELL v. HHS
it had articulated the same day in Abbott Laboratories. Plain-
tiff in Toilet Goods Association was an association of cosmet-
ics manufacturers and distributers that brought a pre-
enforcement 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 promul-
gation 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 regu-
    lation is justified thus depends not only, as petition-
    ers 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 reg-
    ulation. . . . This will depend not merely on an
    inquiry into statutory purpose, but concurrently on
    an understanding of what types of enforcement prob-
    lems are encountered by the FDA, the need for vari-
    ous sorts of supervision in order to effectuate the
    goals of the Act, and the safeguards devised to pro-
    tect 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
                       COLWELL v. HHS                      3505
    in the framework of the generalized challenge made
    here.

The Court’s analysis in Toilet Goods Associa-
tion 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 

.
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 lan-
guage in the MOA. See, e.g., Municipality of 

(“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., 

our attention to
the following excerpt from the MOA: ‘This MOA . . . is writ-
ten 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:
3506                    COLWELL v. HHS
    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 adop-
    tion. 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.

   [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 enforce-
ment proceeding against one of them — we will be in a better
position to determine whether the 2003 Policy Guidance func-
tions 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

.

       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, 

, 706 (9th Cir. 2004).
“The rule in Abbott Laboratories has been carefully circum-
scribed to regulations that pose an immediate dilemma.”
                       COLWELL v. HHS                      3507
Ass’n of Am. Med. Colls. v. United States, 

, 783
(9th Cir. 2000). Plaintiffs must show that postponing review
imposes a hardship on them “that is immediate, direct, and
significant.” Municipality of 

.

   [17] Plaintiffs contend that if they cannot pursue a pre-
enforcement challenge to the 2003 Policy Guidance they will
be exposed to liability under both federal law and state mal-
practice law. However, Plaintiffs acknowledge that HHS “has
not threatened any direct action against” them. Nor do Plain-
tiffs 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 ter-
mination 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 com-
pliance, 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 pro-
ceedings against Plaintiffs based on the 2003 Policy Guid-
ance, 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, 

, 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 peti-
tioners will be afforded no additional opportunity to make the
arguments to the agency that they now present in this peti-
tion.”).

   [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 finan-
cial sanction other than termination of federal funding. See 45
C.F.R. § 80.8; Gebser v. Lago Vista Ind. Sch. Dist., 

, 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
3508                    COLWELL v. HHS
contemplate a condition ordering payment of monetary dam-
ages”). 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 discrim-
ination under Title VI. See Alexander v. Sandoval, 

, 285 (2001); see also Barnes v. Gorman, 

(2000) (no punitive damages under Title VI). Plaintiffs’ sug-
gestion 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. “Sim-
ply stated, plaintiffs have failed to demonstrate any hardship
that outweighs our and the agencies’ interest in delaying
review.” Municipality of 

.

   [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, Plain-
tiffs’ 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
                        COLWELL v. HHS                      3509
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 pro-
ceed 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.