Whether Official Opinions of the General Counsel for the Department of Health, Education, and Welfare Construing HEW Regulations Have Binding Effect in a Prosecution for Violation of Those Regulations

D ecem ber 14, 1977

77-70 MEMORANDUM OPINION FOR THE
GENERAL COUNSEL OF THE DEPARTMENT
OF HEALTH, EDUCATION, AND WELFARE

Effect of Agency Interpretation of Regulations—
Confidentiality of Alcohol and Drug Abuse Patient
Records

Your letter states that your Office has provided the Civil Service
Commission with authoritative advice on the applicability and effect of
certain provisions o f your Departm ent’s regulations, 42 CFR §2.1, et
seq., governing the confidentiality of alcohol and drug abuse patient
records. In addition, you point out that the statutes authorizing these
regulations provide that any disclosure o f records in violation of the
regulations is subject to a criminal penalty. See 21 U.S.C. § 1175(0; 42
U.S.C. § 4582(b).1 The question posed is w hether your official opinions
construing the regulations “ have any binding precedential effect” in a
prosecution for violation of the regulations.
There are actually two issues: (1) w hether your official interpretation
can make conduct a violation of the regulations that would not other­
wise be so, and (2) whether your official interpretation that conduct
does not violate the regulations would serve as a defense to an other­
wise valid prosecution.
W ith respect to the first issue, the basic law is to be found in M.
Kraus and Brothers v. United States, 327 U.S. 614, 621-22 (1946). Brief­
ly, that case holds that where a criminal penalty is provided for violat­
ing a regulation, the regulation is to be construed strictly in the same
manner as a criminal statute. While publicly made administrative inter­
pretations may aid a court in construing a regulation, it cannot fill gaps

1 W e concur that the statutes provide criminal and not civil penalties. The use o f the
term “fine” rather than “penalty” in the body o f the statute indicates that Congress
intended a criminal sanction. See 18 U.S.C. § 1. This is confirmed by the strong emphasis
that the legislative history of 21 U.S.C. § 1175(f) places on maintaining the confidentiality
o f patient records. See H.R. Rep. 92-920, 92d Cong., 2d Sess., at 33. See, generally,
Kennedy v. Mendoza Martinez, 372 U.S. 144 (1963); Helvering v. Mitchell, 303 U.S. 391,
399-406(1938).

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in the regulation or make vague language certain. The text o f the
regulation controls. The principle laid down in Kraus has never been
questioned or modified by the Supreme Court. We agree that your
administrative interpretation that certain conduct is prohibited by the
regulation would not bind a court in a prosecution unless the interpreta­
tion were duly promulgated as part of the regulation.
With respect to the second issue, the Supreme Court has held that
good faith reliance upon an authorized official construction of a crim i­
nal statute is a valid defense to a prosecution for violating it. United
States v. Pennsylvania Chemical Co., 411 U.S. 655, 674 (1973); United
States v. Laub, 385 U.S. 475, 487 (1967); Cox v. Louisiana, 379 U.S. 559,
571 (1965); Raley v. Ohio, 360 U.S. 423, 437-38 (1959). As expressed in
United States v. Laub, supra, 385 U.S., at 488, the principle is that:
Ordinarily, citizens may not be punished for actions undertaken in
good faith reliance upon authoritative assurances that punishment
will not attach.
The defense is akin to entrapment and is based on consideratons of due
process. Cox v. Louisiana, supra; Raley v. Ohio, supra, 360 U.S., at 438.
The question whether a particular statement is an “authoritative
assurance” may be one of fact. However, the Court has ruled that
interpretative regulations published by the Agency primarily responsi­
ble for enforcement are such assurances. United States v. Pennsylvania
Chemical Co., 411 U.S., at 673-75. Moreover, in United States v. Laub
(at 485-486), the Court held that the Government was bound by a
construction expressed by the responsible enforcement Agency in press
releases, congressional testimony, and other official albeit informal
public statements.
On the basis of these cases, we believe that a treatment program
official who released patient records in good faith reliance upon one of
your interpretations could not be successfully prosecuted. To that
extent, they would have a binding effect upon the Government.
Because your official constructions of the regulations may have an
exculpatory effect, we believe that it would be desirable to coordinate
the issuance of these constructions with the Narcotics and Dangerous
Drugs Section of the Criminal Division, which supervises prosecutions
in this area. In addition, such coordination would provide authoritative
guidance to United States Attorneys with respect to the effect of the
regulations on the conduct of drug cases. While the Office of Legal
Counsel does not have any responsibility for criminal law enforcement,
we would be happy to arrange for a meeting between your office and
the Narcotics and Dangerous Drugs Section to discuss an arrangement
suitable to both divisions.

M a ry C. L a w to n
Deputy Assistant Attorney General
Office o f Legal Counsel
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