author: Mr. Justice Brennan Me. Justice Rehnquist,

text:
    SANDSTROM v. MONTANA
    No. 78-5384.
    Argued April 18, 1979 —
    Decided June 18, 1979

      BrenNAN, J., delivered the opinion for a unanimous Court. Rehn-qttist, J., filed a concurring opinion, in which Burger, C. J., joined, post, p. 527.

      Byron W. Boggs, by appointment of the Court, 439 U. S. 1126, argued the cause and filed a brief for petitioner.

      Michael T. Greely, Attorney General of Montana, argued the cause for respondent. With him on the brief were Mike McCarter and Denny Moreen, Assistant Attorneys General, and John Badonich.

   Mr. Justice Brennan

delivered the opinion of the Court.

The question presented is whether, in a case in which intent is an element of the crime charged; the jury instruction, “the law presumes that a person intends the ordinary consequences of his voluntary acts,” violates the Fourteenth Amendment’s requirement that the State prove every element of a criminal offense beyond a reasonable doubt.

I

On November 22, 1976, 18-year-old David Sandstrom confessed to the slaying of Annie Jessen. Based upon the confession and corroborating evidence, petitioner was charged on December 2 with “deliberate homicide,” Mont. Code Ann. § 45-5-102 (1978), in that he “purposely or knowingly caused the death of Annie Jessen.” App. 3. At trial, Sandstrom’s attorney informed the jury that, although his client admitted killing Jessen, he did not do so “purposely or knowingly,” and was therefore not guilty of “deliberate homicide” but of a lesser crime. Id., at 6-8. The basic support for this contention was the testimony of two court-appointed mental health experts, each of whom described for the jury petitioner’s mental state at the time of the incident. Sandstrom’s attorney argued that this testimony demonstrated that petitioner, due to a personality disorder aggravated by alcohol consumption, did not kill Annie Jessen “purposely or knowingly.”

The prosecution requested the trial judge to instruct the jury that “[t]he law presumes that a person intends the ordinary consequences of his voluntary acts.” Petitioner’s counsel objected, arguing that “the instruction has the effect of shifting the burden of proof on the issue of” purpose or knowledge to the defense, and that “that is impermissible under the Federal Constitution, due process of law.” Id., at 34. He offered to provide a number of federal decisions in support of the objection, including this Court’s holding in Mullaney v. Wilbur, 421 U. S. 684 (1975), but was told by the judge: “You can give those to the Supreme Court. The objection is overruled.” App. 34. The instruction was delivered, the jury found petitioner guilty of deliberate homicide, id., at 38, and petitioner was sentenced to 100 years in prison.

Sandstrom appealed to the Supreme Court of Montana, again contending that the instruction shifted to the defendant the burden of disproving an element of the crime charged, in violation of Mullaney v. Wilbur, supra, In re Winship, 397 U. S. 358 (1970), and Patterson v. New York, 432 U. S. 197 (1977). The Montana court conceded that these cases did prohibit shifting the burden of proof to the defendant by means of a presumption, but held that the cases “do not prohibit allocation of some burden of proof to a defendant under certain circumstances.” 176 Mont. 492, 497, 580 P. 2d 106, 109 (1978). Since in the court’s view, “[defendant's sole burden under instruction No. 5 was to produce some evidence that he did not intend the ordinary consequences of his voluntary acts, not to disprove that he acted ‘purposely’ or ‘knowingly,’ . . . the instruction does not violate due process standards as defined by the United States or Montana Constitution ...Ibid, (emphasis added).

Both federal and state courts have held, under a variety of rationales, that the giving of an instruction similar to that challenged here is fatal to the validity of a criminal conviction. We granted certiorari, 439 U. S. 1067 (1979), to decide the important question of the instruction’s constitutionality. We reverse.

II

The threshold inquiry in ascertaining the constitutional analysis applicable to this kind of jury instruction is to determine the nature of the presumption it describes. See Ulster County Court v. Allen, ante, at 157-163. That determination requires careful attention to the words actually spoken to the jury, see ante, at 157-159, n. 16, for whether a defendant has been accorded his constitutional rights depends upon the way in which a reasonable juror could have interpreted the instruction.

Respondent argues, first, that the instruction merely described a permissive inference — that is, it allowed but did not require the jury to draw conclusions about defendant’s intent from his actions — and that such inferences are constitutional. Brief for Respondent 3, 15. These arguments need not detain us long, for even respondent admits that “it’s possible” that the jury believed they were required to apply the presumption. Tr. of Oral Arg. 28. Sandstrom’s jurors were told that “[t]he law presumes that a person intends the ordinary consequences of his voluntary acts.” They were not told that they had a choice, or that they might infer that conclusion; they were told only that the law presumed it. It is clear that a reasonable juror could easily have viewed such an instruction as mandatory. See generally United States v. Wharton, 139 U. S. App. D. C. 293, 298, 433 F. 2d 451, 456 (1970); Green v. United States, 132 U. S. App. D. C. 98, 99, 405 F. 2d 1368, 1369 (1968). See also Montana Rule of Evidence 301 (a).

In the alternative, respondent urges that, even if viewed as a mandatory presumption rather than as a permissive inference, the presumption did not conclusively establish intent but rather could be rebutted. On this view, the instruction required the jury, if satisfied as to the facts which trigger the presumption, to find intent unless the defendant offered evidence to the contrary. Moreover, according to the State, all the defendant had to do to rebut the presumption was produce “some” contrary evidence; he did not have to “prove” that he lacked the required mental state. Thus, “[a]t most, it placed a burden of production on the petitioner,” but “did not shift to petitioner the burden of persuasion with respect to any element of the offense . . . .” Brief for Respondent 3 (emphasis added). Again, respondent contends that presumptions with this limited effect pass constitutional muster.

We need not review respondent’s constitutional argument on this point either, however, for we reject this characterization of the presumption as well. Respondent concedes there is a “risk” that the jury, once having found petitioner’s act voluntary, would interpret the instruction as automatically directing a finding of intent. Tr. of Oral Arg. 29. Moreover, the State also concedes that numerous courts “have differed as to the effect of the presumption when given as a jury instruction without further explanation as to its use by the jury,” and that some have found it to shift more than the burden of production, and even to have conclusive effect. Brief for Respondent 17. Nonetheless, the State contends that the only authoritative reading of the effect of the presumption resides in the Supreme Court of Montana. And the State argues that by holding that “[djefendant’s sole burden under instruction No. 5 was to produce some evidence that he did not intend the ordinary consequences of his voluntary acts, not to disprove that he acted ‘purposely’ or ‘knowingly,’ ” 176 Mont., at 497-498, 580 P. 2d, at 109 (emphasis added), the Montana Supreme Court decisively established that the presumption at most affected only the burden of going forward with evidence of intent — that is, the burden of production.

The Supreme Court of Montana is, of course, the final authority on the legal weight to be given a presumption under Montana law, but it is not the final authority on the interpretation which a jury could have given the instruction. If Montana intended its presumption to have only the effect described by its Supreme Court, then we are convinced that a reasonable juror could well have been misled by the instruction given, and could have believed that the presumption was not limited to requiring the defendant to satisfy only a burden of production. Petitioner’s jury was told that “[t]he law presumes that a person intends the ordinary consequences of his voluntary acts.” They were not told that the presumption could be rebutted, as the Montana Supreme Court held, by the defendant’s simple presentation of “some” evidence; nor even that it could be rebutted at all. Given the common definition of “presume” as “to suppose to be true without proof,” Webster’s New Collegiate Dictionary 911 (1974), and given the lack of qualifying instructions as to the legal effect of the presumption, we cannot discount the possibility that the jury may have interpreted the instruction in either of two more stringent ways.

First, a reasonable jury could well have interpreted the presumption as “conclusive,” that is, not technically as a presumption at all, but rather as an irrebuttable direction by the court to find intent once convinced of the facts triggering the presumption. Alternatively, the jury may have interpreted the instruction as a direction to find intent upon proof of the defendant’s voluntary actions (and their “ordinary” consequences), unless the defendant proved the contrary by some quantum of proof which may well have been considerably greater than “some” evidence — thus effectively shifting the burden of persuasion on the element of intent. Numerous federal and state courts have warned that instructions of the type given here can be interpreted in just these ways. See generally United States v. Wharton, 139 U. S. App. D. C. 293, 433 F. 2d 451 (1970); Berkovitz v. United States, 213 F. 2d 468 (CA5 1954); State v. Roberts, 88 Wash. 2d 337, 341-342, 562 P. 2d 1259, 1261-1262 (1977) (en banc); State v. War- button, 211 Kan. 506, 509, 506 P. 2d 1152, 1155 (1973); Hall v. State, 49 Ala. App. 381, 385, 272 So. 2d 590, 593 (Crim. App. 1973). See also United States v. Chiantese, 560 F. 2d 1244, 1255 (CA5 1977). And although the Montana Supreme Court held to the contrary in this case, Montana’s own Rules of Evidence expressly state that the presumption at issue here may be overcome only “by a preponderance of evidence contrary to the presumption.” Montana Rule of Evidence 301 (b)(2). Such a requirement shifts not only the burden of production, but also the ultimate burden of persuasion on the issue of intent.

We do not reject the possibility that some jurors may have interpreted the challenged instruction as permissive, or, if mandatory, as requiring only that the defendant come forward with “some” evidence in rebuttal. However, the fact that a reasonable juror could have given the presumption conclusive or persuasion-shifting effect means that we cannot discount the possibility that Sandstrom’s jurors actually did proceed upon one or the other of these latter interpretations. And that means that unless these kinds of presumptions are constitutional, the instruction cannot be adjudged valid. Ulster County Court v. Allen, ante, at 159-160, n. 17, and at 175-176 (Powell, J., dissenting); Bachellar v. Maryland, 397 U. S. 564, 570-571 (1970); Leary v. United States, 395 U. S. 6, 31-32 (1969); Carpenters v. United States, 330 U. S. 395, 408-409 (1947); Bollenbach v. United States, 326 U. S. 607, 611-614 (1946). It is the line of cases urged by petitioner, and exemplified by In re Winship, 397 U. S. 358 (1970), that provides the appropriate mode of constitutional analysis for these kinds of presumptions.

III

In Winship, this Court stated:

“Lest there remain any doubt about the constitutional stature of the reasonable-doubt standard, we explicitly hold that the Due Process Clause protects the accused against conviction except upon proof beyond a reasonable doubt of every fact necessary to constitute the crime with which he is charged.” Id., at 364 (emphasis added).

Accord, Patterson v. New York, 432 U. S., at 210. The petitioner here was charged with and convicted of deliberate homicide, committed purposely or knowingly, under Mont. Code Ann. § 45-5-102 (a) (1978). See App. 3, 42. It is clear that under Montana law, whether the crime was committed purposely or knowingly is a fact necessary to constitute the crime of deliberate homicide. Indeed, it was the lone element of the offense at issue in Sandstrom’s trial, as he confessed to causing the death of the victim, told the jury that knowledge and purpose were the only questions he was controverting, and introduced evidence solely on those points. App. 6-8. Moreover, it is conceded that proof of defendant’s “intent” would be sufficient to establish this element. Thus, the question before this Court is whether the challenged jury instruction had the effect of relieving the State of the burden of proof enunciated in Winship on the critical question of petitioner’s state of mind. We conclude that under either of the two possible interpretations of the instruction set out above, precisely that effect would result, and that the instruction therefore represents constitutional error.

We consider first the validity of a conclusive presumption. This Court has considered such a presumption on at least two prior occasions. In Morissette v. United States, 342 U. S. 246 (1952), the defendant was charged with willful and knowing theft of Government property. Although his attorney argued that for his client to be found guilty, “the taking must have been with felonious intent,” the trial judge ruled that “[t]hat is presumed by his own act.” Id., at 249. After first concluding that intent was in fact an element of the crime charged, and after declaring that “[w]here intent of the accused is an ingredient of 'the crime charged, its existence is ... a jury issue,” Morissette held:

“It follows that the■ trial court may not withdraw or prejudge the issue by instruction that the law raises a presumption of intent from an act. It often is tempting to cast in terms of a ‘presumption’ a conclusion which a court thinks probable from given facts. . . . [But] [w]e think presumptive intent has no place in this case. A conclusive presumption which testimony could not overthrow would effectively eliminate intent as an ingredient of the offense. A-presumption which would permit but not require the jury to assume intent from an isolated fact would prejudge a conclusion which the jury should reach of its own volition. A presumption which would permit the jury to make an assumption which all the evidence considered together does not logically establish would give to a proven fact an artificial and fictional effect. In either case, this presumption would conflict with the overriding presumption of innocence with which the law endows the accused and which extends to every element of the crime.” Id., at 274-275. (Emphasis added; footnote omitted.)

Just last Term, in United States v. United States Gypsum Co., 438 U. S. 422 (1978), we reaffirmed the holding of Moris-sette. In that case defendants, who were charged with criminal violations of the Sherman Act, challenged the following jury instruction:

“The law presumes that a person intends the necessary and natural consequences of his acts. Therefore, if the effect of the exchanges of pricing information was to raise, fix, maintain, and stabilize prices, then the parties to them are presumed, as a matter of law, to have intended that result.” 438 U. S., at 430.

After again determining that the offense included the element of intent, we held:

“[A] defendant’s state of mind or intent is an element of a criminal antitrust offense which . . . cannot be taken from the trier of fact through reliance on a legal presumption of wrongful intent from proof of an effect on prices. Cf. Morissette v. United States ....
“Although an effect on prices may well support an inference that the defendant had knowledge of the probability of such a consequence at the time he acted, the jury must remain free to consider additional evidence before accepting or rejecting the inference. . . . [ Ultimately the decision on the issue of intent must be left to the trier of fact alone. The instruction given invaded this fact-finding function.” Id., at 435, 446 (emphasis added).

See also Hickory v. United States, 160 U. S. 408, 422 (1896).

As in Morissette and United States Oypsum Co., a conclusive presumption in this case would “conflict with the overriding presumption of innocence with which the law endows the accused and which extends to every element of the crime,” and would “invade [the] factfinding function” which in a criminal case the law assigns solely to the jury. The instruction announced to David Sandstrom’s jury may well have had exactly these consequences. Upon finding proof of one element of the crime (causing death), and of facts insufficient to establish the second (the voluntariness and “ordinary consequences” of defendant’s action), Sandstrom’s jurors could reasonably have concluded that they were directed to find against defendant on the element of intent. The State was thus not forced to prove “beyond a reasonable doubt . . . every fact necessary to constitute the crime . . . charged,” 397 U. S., at 364, and defendant was deprived of his constitutional rights as explicated in Winship.

A presumption which, although not conclusive, had the effect of shifting the burden of persuasion to the defendant, would have suffered from similar infirmities. If Sandstrom’s jury interpreted the presumption in that manner, it could have concluded that upon proof by the State of the slaying, and of additional facts not themselves establishing the element of intent, the burden was shifted to the defendant to prove that he lacked the requisite mental state. Such a presumption was found constitutionally deficient in Mullaney v. Wilbur, 421 U. S. 684 (1975). In Mullaney, the charge was murder, which under Maine law required proof not only of intent but of malice. The trial court charged the jury that “ 'malice aforethought is an essential and indispensable element of the crime of murder.’ ” Id., at 686. However, it also instructed that if the prosecution established that the homicide was both intentional and unlawful, malice aforethought was to be implied unless the defendant proved by a fair preponderance of the evidence that he acted in the heat of passion on sudden provocation. Ibid. As we recounted just two Terms ago in Patterson v. New York, "[t]his Court . . . unanimously agreed with the Court of Appeals that Wilbur’s due process rights had been invaded by the presumption casting upon him the burden of proving by a preponderance of the evidence that he had acted in the heat of passion upon sudden provocation.” 432 U. S., at 214. And Patterson reaffirmed that "a State must prove every ingredient of an offense beyond a reasonable doubt, and . . . may not shift the burden of proof to the defendant” by means of such a presumption. Id., at 215.

Because David Sandstrom’s jury may have interpreted the judge’s instruction as constituting either a burden-shifting presumption like that in Mullaney, or a conclusive presumption like those in Morissette and United States Gypsum, Co., and because either interpretation would have deprived defendant of his right to the due process of law, we hold the instruction given in this case unconstitutional.

IV

Respondent has proposed two alternative rationales for affirming petitioner’s conviction, even if the presumption at issue in this case is unconstitutional. First, the State notes that the jury was instructed that deliberate homicide may be committed “purposely or knowingly.” App. 35 (emphasis added). Since the jury was also instructed that a person “intends” the ordinary consequences of his voluntary acts, but was not provided with a definition of “intends,” respondent argues that jurors could have interpreted the word as referring only to the defendant’s “purpose.” Thus, a jury which convicted Sandstrom solely for his “knowledge,” and which interpreted “intends” as relevant only to “purpose”, would not have needed to rely upon the tainted presumption at all.

We cannot accept respondent’s argument. As an initial matter, we are not at all certain that a jury would interpret the word “intends” as bearing solely upon purpose. As we said in United States v. United States Gypsum Co., 438 U. S., at 445, “[t]he element of intent in the criminal law has traditionally been viewed as a bifurcated concept embracing either the specific requirement of purpose or the more general one of knowledge or awareness.” See also W. LaFave & A. Scott, Criminal Law 196 (1972).

But, more significantly, even if a jury could have ignored the presumption and found defendant guilty because he acted knowingly, we cannot be certain that this is what they did do. As the jury’s verdict was a general one, App. 38, we have no way of knowing that Sandstrom was not convicted on the basis of the unconstitutional instruction. And “[i]t has long been settled that when a case is submitted to the jury on alternative theories the unconstitutionality of any of the theories requires that the conviction be set aside. See, e. g., Stromberg v. California, 283 U. S. 359 (1931).” Leary v. United States, 395 U. S., at 31-32. See Ulster County Court v. Allen, ante, at 159-160, n. 17, and at 175-176 (Powell, J., dissenting); Bachellar v. Maryland, 397 U. S., at 570-571; Carpenters v. United States, 330 U. S., at 408-409; Bollenbach v. United States, 326 U. S., at 611-614.

Respondent’s final argument is that even if the jury did rely upon the unconstitutional instruction, this constituted harmless error under Chapman v. California, 386 U. S. 18 (1967), because both defendant’s confession and the psychiatrist’s testimony demonstrated that Sandstrom possessed the requisite mental state. Brief for Respondent 4-13. In reply, it is said that petitioner confessed only to the slaying and not to his mental state, that the psychiatrist’s testimony amply supported his defense, Brief for Petitioner 15-16, and that in any event an unconstitutional jury instruction on an element of the crime can never constitute harmless error, see generally Carpenters v. United States, supra, at 408-409; Bollenbach v. United States, supra, at 614, 615. As none of these issues was considered by the Supreme Court of Montana, we decline to reach them as an initial matter here. See Moore v. Illinois, 434 U. S. 220, 232 (1977); Coleman v. Alabama, 399 U. S. 1, 11 (1970). The Montana court will, of course, be free to consider them on remand if it so desires. Ibid. Accordingly, the judgment of the Supreme Court of Montana is reversed, and the case is remanded for further proceedings not inconsistent with this opinion.

It is so ordered.

Me. Justice Rehnquist,

with whom The Chief Justice joins,

concurring.

The Fourteenth Amendment to the United States Constitution prohibits any State from depriving a person of liberty without due process of law, and in Mullaney v. Wilbur, 421 U. S. 684 (1975), this Court held that the Fourteenth Amendment’s guarantees prohibit a State from shifting to the defendant the burden of disproving an element of the crime charged. I am loath to see this Court go into the business of parsing jury instructions given by state trial courts, for as we have consistently recognized, “a single instruction to a jury may not be judged in artificial isolation, but must be viewed in the context of the overall charge.” Cupp v. Naughten, 414 U. S. 141, 146-147 (1973). And surely if this charge had, in the words of the Court, “merely described a permissive inference,” ante, at 514, it could not conceivably have run afoul of the constitutional decisions cited by the Court in its opinion. But a majority of my Brethren conclude that “it is clear that a reasonable juror could easily have viewed such an instruction as mandatory,” ante, at 515, and counsel for the State admitted in oral argument “that 'it’s possible’ that the jury believed they were required to apply the presumption.” Ante, at 514-515.

While I continue to have doubts as to whether this particular jury was so attentively attuned to the instructions of the trial court that it divined the difference recognized by lawyers between “infer” and “presume,” I defer to the judgment of the majority of the Court that this difference in meaning may have been critical in its effect on the jury. I therefore concur in the Court’s opinion and judgment.

       The statute provides:
      “45-5-101. Criminal homicide. (1) A person commits the offense of criminal homicide if he purposely, knowingly, or negligently causes the death of another human being.
      “(2) Criminal homicide is deliberate homicide, mitigated deliberate homicide, or negligent homicide.
      “45-5-102. Deliberate homicide. (1) Except as provided in 45-5-103 (1), criminal homicide constitutes deliberate homicide if:
      “(a) it is committed purposely or knowingly . . . .”

       Petitioner initially filed a notice of intent to rely on “mental disease or defect excluding criminal responsibility” as a defense. That defense required evidence that defendant was “unable either to appreciate the criminality of his conduct or to conform his conduct to the requirements of law.” Mont. Code Ann. §46-14-101 (1978). The defense was withdrawn at trial, with the petitioner contending that, although he was not “unable” to form the requisite intent, he did not have it at the time of the killing.

       See Chappell v. United States, 270 F. 2d 274 (CA9 1959); Bloch v. United States, 221 F. 2d 786 (CA9 1955); Berkovitz v. United States, 213 F. 2d 468 (CA5 1954); Wardlaw v. United States, 203 F. 2d 884 (CA5 1953); State v. Warbritton, 211 Kan. 506, 506 P. 2d 1152 (1973); Hall v. State, 49 Ala. App. 381, 385, 272 So. 2d 590, 593 (Crim. App. 1973). See also United States v. Wharton, 139 U. S. App. D. C. 293, 433 F. 2d 451 (1970). In addition, two United States Courts of Appeals have ordered their District Courts to delete the instruction in future cases. See United States v. Garrett, 574 F. 2d 778 (CA3 1978); United States v. Chiantese, 560 F. 2d 1244 (CA5 1977). The standard reference work for federal instructions, 1 E. Devitt & C. Blackmar, Federal Jury Practice and Instructions 405 (3d ed. 1977), describes the instruction as “clearly erroneous,” and as constituting “reversible error,” id., at 448.

       “Rule 301. (a) Presumption defined. A presumption is an assumption of fact that the law requires to be made from another fact or group of facts found or otherwise established in the action or proceeding.” (Emphasis added.)

       For purposes of argument, we accept respondent’s definition of the production burden when applied to a defendant in a criminal case. We note, however, that the burden is often described quite differently when it rests upon the prosecution. See United States v. Vuitch, 402 U. S. 62, 72 n. 7 (1971) (“evidence from which a jury could find a defendant guilty beyond a reasonable doubt”); C. McCormick, Evidence § 338, p. 790, and n. 33 (2d ed. 1972), p. 101, and n. 34.1 (Supp. 1978). We also note that the effect of a failure to meet the production burden is significantly different for the defendant and prosecution. When the prosecution fails to meet it, a directed verdict in favor of the defense results. Such a consequence is not possible upon a defendant’s failure, however, as verdicts may not be directed against defendants in criminal cases. United States v. Martin Linen Supply Co., 430 U. S. 564, 572-573 (1977); Carpenters v. United States, 330 U. S. 395, 408 (1947); Mims v. United States, 375 F. 2d 135, 148 (CA5 1967).

       Montana Code Ann. § 26-1-602 (1978) states:
      “ '[Disputable presumptions’ . . . may be controverted by other evidence. The following are of that kind:
      “3. that a person intends the ordinary consequence of his voluntary act.”
      Montana Rule of Evidence 301 provides:
      “(b)(2) All presumptions, other than conclusive presumptions, are disputable presumptions and may be controverted. A disputable presumption may be overcome by a preponderance of evidence contrary to the presumption. Unless the presumption is overcome, the trier of fact must find the assumed fact in accordance with the presumption.” (Emphasis added.)
      See also Monaghan v. Standard Motor Co., 96 Mont. 165, 173-174, 29 P. 2d 378, 379-380 (1934). At oral argument, the Attorney General of Montana agreed that “admittedly Montana law . . . states that a presumption requires a person to overcome that presumption by a preponderance of evidence.” Tr. of Oral Arg. 30.
      We do not, of course, cite this Rule of Evidence to dispute the Montana Supreme Court’s interpretation of its own law. It merely serves as evidence that a reasonable man — here, apparently, the drafter of Montana’s own Rules of Evidence — could interpret the presumption at issue in this case as shifting to the defendant the burden of proving his innocence by a preponderance of the evidence.

       The potential for these interpretations of the presumption was not removed by the other instructions given at the trial. It is true that the jury was instructed generally that the accused was presumed innocent until proved guilty, and that the State had the burden of proving beyond a reasonable doubt that the defendant caused the death of the deceased purposely or knowingly. App. 34-35; Brief for Respondent 21. But this is not rhetorically inconsistent with a conclusive or burden-shifting presumption. The jury could have interpreted the two sets of instructions as indicating that the presumption was a means by which proof beyond a reasonable doubt as to intent could be satisfied. For example, if the presumption were viewed as conclusive, the jury could have believed that, although intent must be proved beyond a reasonable doubt, proof of the voluntary slaying and its ordinary consequences constituted proof of intent beyond a reasonable doubt. Cf. Mullaney v. Wilbur, 421 U. S. 684, 703 n. 31 (1975) (“These procedural devices require (in the case of a presumption) ... the trier of fact to conclude that the prosecution has met its burden of proof with respect to the presumed . . . fact by having satisfactorily established other facts”).

       Given our ultimate result in this case, we do not need to consider what kind of constitutional analysis would be appropriate for other kinds of presumptions.

       Another line of our cases also deals with the validity of certain kinds of presumptions. See Ulster County Court v. Allen, ante, p. 140; Barnes v. United States, 412 U. S. 837 (1973); Turner v. United States, 396 U. S. 398 (1970); Leary v. United States, 395 U. S. 6 (1969); United States v. Romano, 382 U. S. 136 (1965); United States v. Gainey, 380 U. S. 63 (1965); Roviaro v. United States, 353 U. S. 53 (1957); Tot v. United States, 319 U. S. 463 (1943). These eases did not, however, involve presumptions of the conclusive or persuasion-shifting variety. See Ulster County Court v. Allen, ante, at 157, and n. 16; and at 169 (Powell, J., dissenting); Mullaney v. Wilbur, supra, at 703 n. 31; Leary v. United States, supra, at 35; Roviaro v. United States, supra, at 63; C. McCormick, Evidence 831 (2d ed. 1972).
      A line of even older cases urged upon us by respondent is equally inapplicable. In Agnew v. United States, 165 U. S. 36, 50 (1897), the trial court’s instruction expressly stated that the presumption was not conclusive, and this Court found that other problems with the instruction were cured by the charge considered as a whole. The other proffered eases simply involved general comments by the Court upon the validity of presuming intent from action. See Radio Officers v. NLRB, 347 U. S. 17, 45 (1954); Cramer v. United States, 325 U. S. 1, 31 (1945). See also Reynolds v. United States, 98 U. S. 145, 167 (1879) (religious objection to polygamy law not a defense).

       The statute is set out at n. 1, supra. In State v. McKenzie, 177 Mont. 280, 327-328, 581 P. 2d 1205, 1232 (1978), the Montana Supreme Court stated:
      “In Montana, a person commits the offense of deliberate homicide if he purposely or knowingly causes the death of another human being. Sections 94^5-102 (l)(a), 9A-5-101 (1), R. C. M. 1947. The statutorily defined dements of the offense, each of which the State must prove beyond a reasonable doubt, are therefore causing the death of another human being with the knowledge that you are causing or with the purpose to cause the death of that human being.” (Emphasis added.)
      Accord, State v. Collins, 178 Mont. 36, 45, 582 P. 2d 1179, 1184 (1978) (“committing the homicide 'purposely or knowingly’ is an element of deliberate homicide”).

       Respondent agrees that “intent” and “purpose” are roughly synonymous, see also Webster’s New Collegiate Dictionary 601 (1974), but contests the relevance of “intent” to “knowledge.” See Tr. of Oral Arg. 18; Brief for Respondent 8-9. This problem is discussed in Part IV, infra.

       The jurors were instructed:
      “INSTRUCTION NO. 7
      “ ‘Knowingly’ is defined as follows: A person acts knowingly with respect to conduct or to a circumstance described by a statute defining an offense when he is aware of his conduct or that the circumstance exists. A person acts knowingly with respect to the result of conduct described by a statute defining an offense when he is aware that it is highly probable that such result will be caused by his conduct. When knowledge of the existence of a particular fact is an element of an offense, such knowledge is established if a person is aware of a high probability of its existence. Equivalent terms such as ‘knowing’ or ‘with knowledge’ have the same meaning.
      “INSTRUCTION NO. 8
      “ ‘Purposely’ is defined as follows: A person acts purposely with respect to a result or to conduct described by a statute defining an offense if it is his conscious object to engage in that conduct or to cause that result.” App. 35-36.

       Indeed, with respondent’s interpretation of “intends” as going solely to “purpose,” it would be surprising if the jury considered “knowledge” before it considered “purpose.” With the assistance of the presumption, the latter would have been easier to find than the former, and there is no reason to believe the jury would have deliberately undertaken the more difficult task.


source: Caselaw Access Project

author: Me. Justice Makshall

license: Public Domain

text:
    UNITED GAS PIPE LINE CO. v. McCOMBS et al.
    No. 78-17.
    Argued February 22, 1979 —
    Decided June 18, 1979

      Marshall, J., delivered the opinion of the Court, in which all other Members joined, except Stewart, J., who took no part in the consideration or decision of the cases.

      Knox Bemis argued the cause for petitioner in No. 78-17. With him on the briefs were W. DeVier Pierson and James M.

      Costan. Richard A. Allen argued the cause for petitioner in No. 78-249. With him on the briefs were Solicitor General McCree, Deputy Solicitor General Barnett, and Howard E. Shapiro.

      Stanley L. Cunningham argued the cause for respondents in both cases. With him on the brief were Philip D. Hart and Terry R. Barrett.

      Together with No. 78-249, Federal Energy Regulatory Commission v. McCombs et al., also on certiorari to the same court.

        Frederick Moving filed a brief for the Associated Gas Distributors as amicus curiae urging reversal.

   Me. Justice Makshall

delivered the opinion of the Court.

Under § 7 (c) of the Natural Gas Act, producers who sell natural gas to pipelines for resale in interstate commerce must obtain a certificate of public convenience and necessity from the Federal Energy Regulatory Commission. Section 7 (b) of the Act obligates these producers to continue supplying gas in the interstate market until the Commission authorizes an “abandonment.” The principal issue presented by this case is whether a producer may, consistent with § 7 (b), ever terminate this service obligation without obtaining the agency’s express approval.

I

The natural gas involved in this case is produced from a 163-acre tract of land located in Karnes County, Tex., and known as the Butler B tract. In 1948, the owner of this land, B. C. Butler, Sr., executed an oil and gas lease with W. R. Quin as the lessee. Quin’s widow contracted in 1953 to sell petitioner United Gas Pipe Line Co. (United), for a 10-year period, all “merchantable natural gas . . . now or hereafter” produced from the Butler B tract. App. 7A. Because United was an interstate pipeline company, Ms. Quin applied to the Commission for a certificate of public convenience and necessity authorizing this sale. The certificate issued by the Commission contained neither a time limitation nor any designation of the depths from which the gas would be produced.

After United installed gathering facilities on the property and began receiving gas from a well 2,960 feet deep, the Butler B lease was assigned several times. H. A. Pagenkopf eventually obtained the leasehold, and in 1961, he agreed to extend the term of United’s gas purchase contract through February 7, 1981. Upon Pagenkopf’s application, the Commission issued a new certificate in 1963, authorizing continued service to United under the same terms as the earlier certificate. In March 1966, Pagenkopf assigned the Butler B. lease to a group headed by L. H. Haring, and shortly thereafter, the only successful well on the property stopped producing. Haring’s operator, Bay Rock Corp., notified United some months later that the existing wells were depleted and no other gas would be available at that time. United replied that it would remove its metering equipment for use elsewhere, but would reinstall the equipment “if, at some future date, you have further gas to deliver to us at the above delivery point, which will be subject to the terms of the above-captioned contract.” App. 8A-9A. Despite the Commission’s subsequent warning that § 7 (b) required the filing of an abandonment application if no further sales were contemplated, Haring never sought the Commission’s authorization for abandoning service to United.

During 1971 and 1972, Haring divided the Butler B leasehold horizontally and vertically, and he assigned to a group headed by respondent McCombs a working interest in the eastern 113 acres of the tract between the depths of 6,500 and 8,653 feet. A few months later, the group acquired a similar interest in the entire Butler B tract from depths of 8,700 to 9,700 feet. Drilling to these deeper horizons, the McCombs group discovered new gas reserves. In 1972, they contracted to sell this gas to respondent E. I. du Pont de Nemours & Co. for industrial uses in intrastate commerce. Upon learning of the renewed production, however, United asserted its rights under the 1953 contract, as extended in 1961, to purchase all gas produced from the property. When the McCombs group rejected this claim, United filed a complaint with the Commission.

The Commission upheld the Administrative Law Judge’s determination that the McCombs group could not sell the Butler B gas in intrastate commerce, at least through February 7, 1981. Opinion No. 740, App. to Pet. for Cert, in No. 78-17, pp. A-32 to A-33. In particular, the Commission found that the certificates issued to the group’s predecessors covered all gas produced from the property, including the reserves discovered in 1971 and 1972. Because these predecessors had commenced deliveries pursuant to the certificates, the Commission ruled that all reserves embraced by the certificates were “dedicated” to interstate commerce and could not be diverted from that market without obtaining the agency’s approval under § 7 (b). Noting that it had not authorized abandonment during the 5-year interruption in service, the Commission refused to grant its approval retroactively where, as here, the supply of natural gas was not in fact depleted. Accordingly, the Commission declared the sales in intrastate commerce violative of the Act, and ordered delivery to United of all gas derived from the Butler B leasehold.

A divided panel of the Court of Appeals for the Tenth Circuit set aside the Commission’s order. 570 F. 2d 1376 (1978). The court did not dispute the Commission’s determination that all gas underlying the Butler B tract had. been dedicated to interstate commerce. However, while acknowledging that § 7 (b) expressly requires Commission approval before a producer may withdraw dedicated natural gas from the interstate market, the majority held that “strict compliance” with this requirement was unnecessary here. 570 F. 2d, at 1381. In the court’s view, “there was no need for the formality of a Section 7 (b) hearing,” ibid., because

“the abandonment of the service in the instant case was accomplished, as a matter of law, when all of the parties recognized that the then known natural gas reserves were depleted in 1966 followed by failure to provide any service under the certificates for a period of five years during which time there was no evidence of other estimated gas reserves recoverable from the subject leaseholds.” Id., at 1382.

In sum, the Court of Appeals considered the facts so clear that the abandonment issue was no longer “within the expertise of the Commission.” Id., at 1381. The dissenting judge found this conclusion “directly contrary to the plain terms of § 7 (b),” which mandate approval by the Commission as the sole means of effectuating a valid abandonment. Id., at 1382.

We granted certiorari, 439 U. S. 892 (1978), and now reverse.

II

Congress could not have been more explicit in establishing Commission approval as a prerequisite for lawful abandonment of service within its jurisdiction. Section 7 (b) provides:

“No natural-gas company shall abandon all or any portion of its facilities subject to the jurisdiction of the Commission, or any service rendered by means of such facilities, without the permission and approval of the Commission first had and obtained, after due hearing, and a finding by the Commission that the available supply of natural gas is depleted to the extent that the continuance of service is unwarranted, or that the present or future public convenience or necessity permit such abandonment.” 52 Stat. 824, 15 U. S. C. § 717f (b).

Not only does the statute require companies to obtain the “approval of the Commission . . . after due hearing,” but it also prohibits abandonment absent specific findings by the Commission. The language of § 7 (b) simply does not admit of any exception to the statutory procedure.

This plain meaning has been acknowledged in several of our previous decisions. Emphasizing that the Natural Gas Act’s fundamental purpose was to assure the public a reliable supply of gas at reasonable prices, the Court noted in Atlantic Refining Co. v. Public Service Comm’n, 360 U. S. 378 (1959), that once gas has been dedicated to interstate commerce, “there can be no withdrawal of that supply from continued interstate movement without Commission approval.” Id., at 388, 389, 392 (emphasis added). The Court again addressed the necessity of obtaining the agency’s permission in Sunray Mid-Continent Oil Co. v. FPC, 364 U. S. 137 (1960). There, the Court upheld the Commission’s authority to insist upon issuing permanent certificates of convenience and necessity, reasoning that this power was essential to prevent companies from circumventing the regulatory scheme. For if producers could demand certificates of limited duration, and thereby escape federal regulation when the certificates expire, the abandonment procedures of § 7 (b) would be rendered meaningless. 364 U. S., at 142-144, 148. Of particular importance here, the Court specifically considered the impact that depletion of gas supplies would have on a company’s obligation to seek abandonment permission. Approving the Commission’s practice of issuing certificates that extend beyond the expected life of a given reserve, the Court stressed:

“[I]f the companies, failing to find new sources of gas supply, desired to abandon service because of a depletion of supply, they would have to make proof thereof before the Commission, under § 7 (b). The Commission thus, even though there may be physical problems beyond its control, [keeps] legal control over the continuation of service by the applicants.” Id., at 158 n. 25.

In short, Sunray makes clear that producers must secure Commission approval to abandon service even when there is little or no doubt that gas supplies are exhausted.

This Court expressed a similar understanding of the abandonment provision in United Gas Pipe Line Co. v. FPC, 385 U. S. 83 (1966), which upheld the Commission’s determination that a company had violated § 7 (b) of the Act by unilaterally abandoning jurisdictional facilities to avoid paying increased gas prices. In so holding, the Court reiterated that the “statutory necessity of prior Commission approval, with its underlying findings, cannot be escaped.” 385 U. S., at 89 (emphasis added). We reaffirmed this interpretation of § 7 (b) just last Term in California v. Southland Royalty Co., 436 U. S. 619 (1978). The lessees in Southland had dedicated to interstate commerce gas produced from a particular tract, but, when the lease expired, the lessors to whom the oil and gas rights had reverted arranged to sell the remaining gas in the intrastate market. This Court held that even expiration of the lease did not terminate the obligation to continue selling the gas in interstate commerce. To conclude otherwise, we reasoned, would enable private parties to circumvent the Commission’s authority over abandonments. And evasion of federal jurisdiction by this means could not be reconciled with the principle that “[o]nce the gas commenced to flow into interstate commerce from the facilities used by the lessees, § 7 (b) require[s] that the Commission’s permission be obtained prior to the discontinuance of 'any service rendered by means of such facilities.’ ” Id., at 527 (emphasis added).

Thus, we have consistently recognized that the Commission’s "legal control over the continuation of service,” Sunray, supra, at 158 n. 25, is a fundamental component of the regulatory scheme. To deprive the Commission of this authority, even in limited circumstances, would conflict with basic policies underlying the Act.

Requiring Commission approval, “after due hearing,” permits all interested parties to be heard and therefore facilitates full presentation of the facts necessary to determine whether § 7 (b)’s criteria have been met. Contrary to respondents’ assumption, see Brief for Respondents 20-21, the Commission does not automatically approve abandonments whenever production has ceased. Indeed, the agency recently refused to grant an application where the producer had not adequately tested for new gas reserves. Had the lessees in the instant case filed an application for abandonment between 1966 and 1971, United might well have demonstrated that exploration of the leasehold had been insufficient to justify finding “the available supply of natural gas . . . depleted to the extent that the continuance of service [was] unwarranted.” § 7 (b). And the Commission might have concluded that production from deeper reserves or other measures to restore service were feasible. Permitting natural gas companies to bypass abandonment proceedings simply .because known reserves appear depleted would obviously foreclose these factual inquiries. Consequently, the abandonment determination would rest, as a practical matter, in the producer’s control, a result clearly at odds with Congress’ purpose to regulate the supply and price of natural gas. See California v. Southland Royalty Co., supra, at 526-527, 529-530; Sunray Mid-Continent Oil Co. v. FPC, supra, at 142-147.

Moreover, the obligation to obtain Commission approval promotes certainty and reliability in the regulatory scheme. Knowledge that termination of service is lawful only if authorized by the Commission enables producers, prospective assignees, and other interested parties to determine with assurance whether a particular tract remains dedicated to interstate commerce. In contrast, the Court of Appeals’ test for de facto abandonment would invite speculation regarding the extent of the Commission’s jurisdiction. The confusion that would inevitably result from the lack of clear standards as to when producers must seek Commission approval fortifies our conclusion that Congress intended agency supervision of all abandonments.

Ill

Respondents maintain that even if producers must always obtain Commission approval for abandonment, the decision below should nevertheless be affirmed. In their view, the Court of Appeals actually concluded that the Commission had erred as a matter of law by refusing to authorize an abandonment retroactively. Assuming this was the true purport of the decision below, we believe the Court of Appeals lacked authority to set aside the Commission’s order on this ground.

Although respondents urged the agency to authorize an abandonment of service from Butler B, the Administrative Law Judge and the Commission rejected this suggestion in light of the clear evidence that the leasehold was still capable of production. Respondents, however, contend that because Haring acted in good faith in failing to seek agency approval, the Commission was obligated to treat their answer to United’s complaint as if it were an abandonment application filed in 1966. Thus, according to respondents, the Court of Appeals was entitled to conclude that the Commission should have ignored the evidence of subsequent production and authorized an abandonment based on the evidence available in 1966.

We need not determine whether § 7 (b) allows the Commission to approve an abandonment retroactively and disregard evidence of subsequent production. For the agency certainly did not abuse its discretion in declining to do so here. Authorizing abandonments retroactively would often deprive interested parties of the opportunity to be heard at a meaningful time and to present evidence on the likelihood of renewing gas production in the future. Thus, the Commission would be required to determine on a hypothetical set of facts what action it would have taken had an application been timely filed. Additionally, the jurisdictional status of all dedicated acreage would become uncertain, since the property would be subject to retroactive Commission pronouncements in the indefinite future. Frequent retroactive action would also undermine the statutory scheme by creating an incentive for producers to delay seeking agency approval in the hope that they could later establish good faith. Given this potential for disruption of § 7 (b)’s approval procedure, we believe it is within the Commission’s discretion to reject good faith alone as a sufficient justification for determining whether the evidence available in 1966 warranted granting an abandonment.

IY

Finally, respondents defend the judgment below on the ground that only the depleted shallow reserves underlying Butler B, as opposed to the newly discovered gas, were subject to the approval requirements of § 7 (b). In their view, the deliveries actually made in interstate commerce, rather than the certificates of public convenience and necessity, define the “service” that may not be abandoned without Commission approval. Although deliveries were once made from a reservoir approximately 2,900 feet deep, the “separate and distinct” gas from the deeper reservoirs was never delivered into interstate commerce. Thus, according to respondents, the current production is not subject to the requirements of § 7 (b), even though the certificates of public convenience and necessity cover all reservoirs located on Butler B.

Our prior decisions compel rejection of this narrow statutory interpretation. In California v. Southland Royalty Co., we expressly agreed with the Commission that the “initiation of interstate service pursuant to the certificate dedicated all fields subject to that certificate.” 436 U. S., at 525 (emphasis added). And as the Court emphasized in Sunray Mid-Continent Oil Co. v. FPC, “ 'once so dedicated there can be no withdrawal of that supply from continued interstate movement without Commission approval.’ ” 364 U. S., at 156, quoting Atlantic Refining Co. v. Public Service Comm’n, 360 U. S., at 389.

Applying these principles, the Commission determined that all reserves underlying Butler B were dedicated to interstate commerce pursuant to the certificates it had issued in 1954 and 1963, see supra, at 534, and n. 6, and therefore were subject to the requirements of § 7 (b). There being ample factual and legal justification for the Commission’s conclusions, see Sun Oil Co. v. FPC, 364 U. S. 170 (1960), we hold that § 7 (b) requires respondents to continue supplying in interstate commerce all gas produced from the leasehold until they properly obtain permission for abandonment.

• The judgment of the Court of Appeals is

Reversed.

Mr. Justice Stewart took no part in the consideration or decision of these cases.

       52 Stat. 825, as amended, 15 U. S. C. §717f (e). See Phillips Petroleum Co. v. Wisconsin, 347 U. S. 672 (1954). Pursuant to the Department of Energy Organization Act, 91 Stat. 565, the regulatory functions at issue here were transferred from the Federal Power Commission to the Federal Energy Regulatory Commission, effective October 1, 1977.

       Section 7 (b), 52 Stat. 824, 15 U. S. C. §717f (b), provides:
      “No natural-gas company shall abandon all or any portion of its facilities subject to the jurisdiction of the Commission, or any service rendered by means of such facilities, without the permission and approval of the Commission first had and obtained, after due hearing, and a finding by the Commission that the available supply of natural gas is depleted to the extent that the continuance of service is unwarranted, or that the present or future public convenience or necessity permit such abandonment.”

       Although Haring advised United that he would apply to the Commission for a successor producer certificate, no application was ever filed. App. to Pet. for Cert, in No. 78-17, pp. A-6 to A-7.

       The Secretary of tbe Commission wrote Bay Rock in January 1971 that it would be necessary to file an application for permission to abandon service and a notice of cancellation of rate schedule. Id., at A-100 to A-101. This letter also directed the lessee to submit either a copy of any agreement with United canceling the gas purchase contract or a statement from United “indicating its position with respect to the proposed abandonment.” Ibid. The Secretary had written a similar letter to Pagenkopf in August 1968, but he, too, failed to respond. Id., at A-97 to A-98.

       In addition to the Butler B interests, the McCombs group also owned an interest in an adjoining tract of land. In order to operate both tracts as a single entity, the group “unitized,” or combined, their interests in Butler B with those in the corresponding depths of the adjacent tract. As a result, a fraction of the production from each of four successful wells located on the total unitized acreage is attributable to the Butler B leasehold for purposes of the gas purchase contract and the Commission’s certificates. Id., at A-8 to A-10. See generally 6 H. Williams & C. Meyers, Oil & Gas Law 2-3 (1977 ed.).

       In determining the scope of Pagenkopf’s certificate, the Commission analyzed separately the depths covered and the duration of the obligation to sell gas in interstate commerce. The Commission based its conclusion that the certificates encompassed all reservoirs on the absence of any reference to particular depths in either the applications 'for certification, which incorporated the contract with United, or in the certificates issued Pagen-kopf and Ms. Quin. App. to Pet. for Cert, in No. 78-17, pp. A-29 to A-35. Referring to the same documents, the Commission interpreted Pagen-kopf’s certificate to encompass all gas produced from wells drilled before the contract’s expiration date, even if the gas is extracted after February 7, 1981. Ibid. However, the Commission refused to consider whether the certificate also covered gas produced from wells drilled after the contract’s expiration date. Id., at A-33, and n. 28; see Sun Oil Co. v. FPC, 364 U. S. 170 (1960). Since the parties have not challenged here these findings on duration, we express no view on the Commission’s ruling concerning production beyond 1981.

       The Commission did not address the validity of United’s gas purchase contract. McCombs has raised that issue in a separate suit, which is being held in abeyance pending completion of this litigation. McCombs v. United Gas Pipe Line Co., No. SA-73-CA-210 (WD Tex., filed Aug. 2, 1973).

       The Court of Appeals rendered this decision on rehearing after withdrawing an earlier opinion by a different panel. See 542 F. 2d 1144 (1976).

       Although Congress has recently revised the federal scheme for regulating natural gas, see the Natural Gas Policy Act of 1978, 92 Stat. 3351, that legislation does not affect the outcome of this case. With certain exceptions not relevant here, gas reserves dedicated to interstate commerce before November 8, 1978, remain subject to § 7 (b) of the Natural Gas Act. See §§ 2 (18), 104, 106 (a), and 601 (a) of the Natural Gas Policy Act, 92 Stat. 3354, 3362, 3365, 3409,15 U. S. C. §§ 3301 (18), 3314, 3316 (a), 3431 (a) (1976 ed., Supp. Ill); S. Conf. Rep. No. 95-1126, pp. 71-72, 82, 84-85, 123-124 (1978); H. R. Conf. Rep. No. 95-1752, pp. 71-72, 82, 84-85, 123-124 (1978).

       See Texaco, Inc., FERC Docket Nos. G-8820 et al, Order Granting Petition for Reconsideration and Modifying Prior Order (Nov. 1, 1977).

       Respondents contend that the Commission recently approved a retroactive § 7 (b) abandonment in Arkansas Louisiana Gas Co., FPC Docket No. CP76-329 (Mar. 8, 1977). In that case, a certificated pipeline had agreed to sell excess gas, but its supply became depleted in 1971. Although the pipeline did not seek abandonment permission until 1977, the Commission approved the abandonment because the supply of excess gas was still depleted and there was no likelihood of obtaining additional gas. The agency's decision therefore had no retroactive impact.

       Relying on four lower court decisions that did not involve § 7 (b), respondents argue that the Commission was required to approve abandonment retroactively here. None of these cases, however, supports respondents’ contention that the Commission abused its discretion in this suit. In Ellwood City v. FERC, 583 F. 2d 642 (CA3 1978), cert. denied, 440 U. S. 946 (1979), and Niagara Mohawk Power Cory. v. FPC, 126 U. S. App. D. C. 376, 379 F. 2d 153 (1967), the Courts of Appeals found no abuse of discretion in the Commission’s decision to give retroactive effect to certain rate schedules and licensing orders. Accordingly, neither decision addresses whether the Commission was required to exercise its discretion in this manner. Moreover, retrospective action was taken in Niagara Mohawk to prevent the utility from benefiting by its failure to comply with the law, a consideration that militates against granting retroactive approval in the instant action.

        Plaquemines Oil & Gas Co. v. FPC, 146 U. S. App. D. C. 287, 450 F. 2d 1334 (1971), merely held that once the Commission chooses “to regard as being done that which should have been done,” id., at 290, 450 F. 2d, at 1337, it must apply this principle consistently within the same case. Finally, Highland Resources, Inc. v. FPC, 537 F. 2d 1336 (CA5 1976), involved a producer that, relying on a published order of the Commission, failed to submit certain rate applications. After the agency changed its filing requirements, the producer promptly tendered the appropriate papers. The Commission nevertheless refused to give the application retroactive effect. The Court of Appeals set aside this aspect of the Commission’s order, holding that a producer should not be penalized for its reliance on the agency’s own pronouncements. There was no such reliance, however, in the present litigation. See n. 4, supra.

       Since the Commission and lower federal courts have held that § 7 (b) prohibits abandonment of service without agency approval even where the producer has not obtained a certificate, see, e. g., Cumberland Natural Gas Co., 34 F. P. C. 132 (1965); Mesa Petroleum Co. v. FPC, 441 F. 2d 182 (CA5 1971), respondents contend that §7 (b)’s reference to “service rendered” can never be measured by the certificate of public convenience and necessity. See n. 2, supra. Respondents, however, misperceive the basis for these decisions. Because a company may not circumvent the regulatory scheme by failing to comply' with the certification requirement, the Commission must, in such cases, rely on sources other than a certificate to ascertain the scope of a dedication in interstate commerce. These cases obviously do not preclude the agency from referring to certificates when they exist.

       The agency’s decisions have reflected a similar understanding of §7 (b). For example, in Cumberland Natural Gas Co., supra, where the producer had not yet obtained a certificate of convenience and necessity, the Commission held that “dedication of reserves for sale in interstate commerce occur [red] at least as soon as deliveries commenc[ed]” from any part of the 9,000-acre leasehold contractually committed to an interstate pipeline. 34 F. P. C., at 136. Accordingly, the agency required that all gas subsequently produced from the entire dedicated leasehold, even if discovered after the dedication, be sold in interstate commerce until the Commission approved an abandonment. Id., at 136-137. See also Pioneer Gathering System, Inc., 23 F. P. C. 260, 263 (1960); Murphy Oil Corp. v. FERC, 589 F. 2d 944 (CA8 1978); Mitchell Energy Corp. v. FPC, 533 F. 2d 258 (CA5 1976).


author: Mr. Justice Marshall

text:
    UNITED STATES et al. v. RUTHERFORD et al.
    No. 78-605.
    Argued April 25, 1979 —
    Decided June 18, 1979

      Marshall, J., delivered the opinion for a unanimous Court.

      Solicitor General McCree argued the cause far the United States et al. With him on the briefs were Assistant Attorney General Shenefield, Deputy Solicitor General Barnett, Elinor Hadley Stillman, Barry Grossman, and Richard M. Cooper.

      Kenneth Ray Coe argued the cause for respondents. With him on the brief were Kirkpatrick W. Dilling and Dennis M. Gronek.

      Briefs of amici curiae urging reversal were filed by Francis X. Bellotti, Attorney General, and Jonathan Brant, Assistant Attorney General, for the Commonwealth of Massachusetts et al.; and by Grace Powers Manaco for the American Cancer Society, Inc.
      Briefs of amici curiae urging affirmance were filed by David H. GiU II for the Committee for Freedom of Choice in Cancer Therapy; by Stephen Tornay for the McNaughton Foundation of California; by Kirkpatrick W. Dilling and Dennis M. Gronek for the National Health Federation; and by Daniel H. Smith for the Northwest Academy of Preventive Medicine.
      Briefs of amici curiae were filed by George Deukmejian, Attorney General, Robert Philibosian, Chief Assistant Attorney General, Daniel J. Kremer, Assistant Attorney General, and Earley D. Mayfield and Robert M. Foster, Deputy Attorneys General, for the State of California; by Dennis 8. Avery for the American Academy of Medical Preventics; by David Laufer for the Cancer Control Society; and by David S. King for the Save the United States Movement, Improving Public Health and Physical Fitness of the United States Citizens.

   Mr. Justice Marshall

delivered the opinion of the Court.

The question presented in this case is whether the Federal Food, Drug, and Cosmetic Act precludes terminally ill cancer patients from obtaining Laetrile, a drug not recognized as “safe and effective” within the meaning of §201 (p) (1) of the Act, 52 Stat. 1041, as amended, 21 U. S. C. § 321 (p) (1).

I

Section 505 of the Federal Food, Drug, and Cosmetic Act, 52 Stat. 1052, as amended, 21 U. S. C. § 355, prohibits interstate distribution of any “new drug” unless the Secretary of Health, Education, and Welfare approves an application supported by substantial evidence of the drug’s safety and effectiveness. As defined in § 201 (p) (1) of the Act, 21 TJ. S. C. § 321 (p) (1), the term “new drug” includes

“[a]ny drug . . . not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling . . .

Exemptions from premarketing approval procedures are available for drugs intended solely for investigative use and drugs qualifying under either of the Act’s two grandfather provisions.

In 1975, terminally ill cancer patients and their spouses brought this action to enjoin the Government from interfering with the interstate shipment and sale of Laetrile, a drug not approved for distribution under the Act. Finding that Laetrile, in proper dosages, was nontoxic and effective, the District Court ordered the Government to permit limited purchases of the drug by one of the named plaintiffs. 399 F. Supp. 1208, 1215 (WD Okla. 1975). On appeal by the Government, the Court of Appeals for the Tenth Circuit did not disturb the injunction. However, it instructed the District Court to remand the case to the Food and Drug Administration for determination whether Laetrile was a “new drug” under §201 (p) (1), and, if so, whether it was exempt from premarketing approval under either of the Act’s grandfather clauses. 542 F. 2d 1137 (1976).

After completion of administrative hearings, the Commissioner issued his opinion on July 29, 1977. 42 Fed. Reg. 39768 (1977). He determined first that no uniform definition of Laetrile exists; rather, the term has been used generically for chemical compounds similar to, or consisting at least in part of, amygdalin, a glucoside present in the kernels or seeds of most fruits. Id., at 39770-39772. The Commissioner further found that Laetrile in its various forms constituted a “new drug” as defined in § 201 (p)(l) of the Act because it was not generally recognized among experts as safe and effective for its prescribed use. See 42 Fed. Reg. 39775-39787 (1977). In so ruling, the Commissioner applied the statutory criteria delineated in Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U. S. 609, 629-630 (1973), and concluded that there were no adequate well-controlled scientific studies of Laetrile’s safety or effectiveness. 42 Fed. Reg. 39775-39787 (1977).

Having determined that Laetrile was a new drug, the Commissioner proceeded to consider whether it was exempt from premarketing approval under the 1938 or 1962 grandfather provisions. On the facts presented, the Commissioner found that Laetrile qualified under neither clause. See id., at 39787-39795. First, there was no showing that the drug currently known as Laetrile was identical in composition or labeling to any drug distributed before 1938. See 21 U. S. C. § 321 (p) (1); n. 3, supra. Nor could the Commissioner conclude from the evidence submitted that, as of October 9, 1962, Laetrile in its present chemical composition was commercially used or sold in the United States, was generally recognized by experts as safe, and was labeled for the same recommended uses as the currently marketed drug. See § 107 (c)(4), 76 Stat. 789; n. 3, supra.

On review of the Commissioner’s decision, the District Court sustained his determination that Laetrile, because not generally regarded as safe or effective, constituted a new drug under §201(p)(l). 438 F. Supp. 1287, 1293-1294 (WD Okla. 1977). The court also approved the Commissioner’s denial of an exemption under the 1938 grandfather clause. However, concluding that the record did not support the Commissioner’s findings as to the 1962 grandfather provision, the District Court ruled that Laetrile was entitled to an exemption from premarketing approval requirements. Id., at 1294-1298. Alternatively, the court held that, by denying cancer patients the right to use a nontoxic substance in connection with their personal health, the Commissioner had infringed constitutionally protected privacy interests. Id., at 1298-1300.

The Court of Appeals addressed neither the statutory nor the constitutional rulings of the District Court. Rather, the Tenth Circuit held that “the 'safety’ and ‘effectiveness’ terms used in the statute have no reasonable application to terminally ill cancer patients.” 582 F. 2d 1234, 1236 (1978). Since those patients, by definition, would “die of cancer regardless of what may be done,” the court concluded that there were no realistic standards against which to measure the safety and effectiveness of a drug for that class of individuals. Id., at 1237. The Court of Appeals therefore approved the District Court’s injunction permitting use of Laetrile by cancer patients certified as terminally ill. However, presumably because the Commissioner had found some evidence that Laetrile was toxic when orally administered, see 42 Fed. Reg. 39786-39787 (1977), the Court of Appeals limited relief to intravenous injections for patients under a doctor’s supervision. 582 F. 2d, at 1237. In addition, the court directed the FDA to promulgate regulations “as if” the drug had been found “ ‘safe’ and ‘effective’ ” for terminally ill cancer patients. Ibid.

We granted certiorari, 439 U. S. 1127 (1979), and now reverse.

II

The Federal Food, Drug, and Cosmetic Act makes no special provision for drugs used to treat terminally ill patients. By its terms, § 505 of the Act requires premarketing approval for “any new drug” unless it is intended solely for investigative use or is exempt under one of the Act’s grandfather provisions. See nn. 2, 3, supra. And § 201 (p)(l) defines “new drug” to encompass “[a]ny drug .. . not generally recognized ... as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.” See supra, at 546-547.

When construing a statute so explicit in scope, a court must act within certain well-defined constraints. If a legislative purpose is expressed in “plain and unambiguous language, . . . the . . . duty of the courts is to give it effect according to its terms.” United States v. Lexington Mill & Elevator Co., 232 U. S. 399, 409 (1914). See Andrus v. Sierra Club, ante, p. 347. Exceptions to clearly delineated statutes will be implied only where essential to prevent “absurd results” or consequences obviously at variance with the policy of the enactment as a whole. Helvering v. Hammell, 311 U. S. 504, 510-511 (1941). See TVA v. Hill, 437 U. S. 153, 187-188 (1978); United States v. Key, 397 U. S. 322, 324-325 (1970); United States v. American Trucking Assns., 310 U. S. 534, 543-544 (1940). In the instant case, we are persuaded by the legislative history and consistent administrative interpretation of the Act that no implicit exemption for drugs used by the terminally ill is necessary to attain congressional objectives or to avert an unreasonable reading of the terms “safe” and “effective” in § 201 (P)(l).

A

Nothing in the history of the 1938 Food, Drug, and Cosmetic Act, which first established procedures for review of drug safety, or of the 1962 Amendments, which added the current safety and effectiveness standards in §201 (p)(l), suggests that Congress intended protection only for persons suffering from curable diseases. To the contrary, in deliberations preceding the 1938 Act, Congress expressed concern that individuals with fatal illnesses, such as cancer, should be shielded from fraudulent cures. See, e. g., 79 Cong. Rec. 5023 (1935) (remarks of Sen. Copeland, sponsor of the Act); 83 Cong. Rec. 7786-7787, 7789 (1938) (remarks of Reps. Phillips and Lea). Similarly, proponents of the 1962 Amendments to the Act, including Senator Kefauver, one of the bill’s sponsors, indicated an understanding that experimental drugs used to treat cancer “in its last stages” were within the ambit of the statute. See, e. g., 108 Cong. Rec. 17399 (1962) (remarks of Sen. Kefauver); id., at 17401 (comments of Sen. Eastland). That same understanding is reflected in the Committee Reports on the 1962 Amendments. Both Reports note with approval the FDA’s policy of considering effectiveness when passing on the safety of drugs prescribed for “life-threatening disease.”

In implementing the statutory scheme, the FDA has never made exception for drugs used by the terminally ill. As this Court has often recognized, the construction of a statute by those charged with its administration is entitled to substantial deference. Board of Governors of FRS v. First Lincoln- wood Corp., 439 U. S. 234, 248 (1978); Bayside Enterprises, Inc. v. NLRB, 429 U. S. 298, 304 (1977); Udall v. Tallman, 380 U. S. 1, 16 (1965). Such deference is particularly appropriate where, as here, an agency’s interpretation involves issues of considerable public controversy, and Congress has not acted to correct any misperception of its statutory objectives. See Red Lion Broadcasting Co. v. FCC, 395 U. S. 367, 381 (1969); Zemel v. Rusk, 381 U. S. 1, 11-12 (1965). Unless and until Congress does so, we are reluctant to disturb a longstanding administrative policy that comports with the plain language, history, and prophylactic purpose of the Act.

B

In the Court of Appeals’ view, an implied exemption from the Act was justified because the safety and effectiveness standards set forth in § 201 (p) (1) could have “no reasonable application” to terminally ill patients. 582 F. 2d, at 1236. We disagree. Under our constitutional framework, federal courts do not sit as councils of revision, empowered to rewrite legislation in accord with their own conceptions of prudent public policy. See Anderson v. Wilson, 289 U. S. 20, 27 (1933). Only when a literal construction of a statute yields results so manifestly unreasonable that they could not fairly be attributed to congressional design will an exception to statutory language be judicially implied. See TVA v. Hill, 437 U. S., at 187-188. Here, however, we have no license to depart from the plain language of the Act, for Congress could reasonably have intended to shield terminal patients from ineffectual or unsafe drugs.

A drug is effective within the meaning of §201 (p) (1) if there is general recognition among experts, founded on substantial evidence, that the drug in fact produces the results claimed for it under prescribed conditions. See Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U. S., at 629-634; n. 7, supra. Contrary to the Court of Appeals’ apparent assumption, see 582 F. 2d, at 1236, effectiveness does not necessarily denote capacity to cure. In the treatment of any illness, terminal or otherwise, a drug is effective if it fulfills, by objective indices, its sponsor’s claims of prolonged life, improved physical condition, or reduced pain. See 42 Fed. Reg. 39776-39786 (1977).

So too, the concept of safety under §201(p)(l) is not without meaning for terminal patients. New if any drugs are completely safe in the sense that they may be taken by all persons in all circumstances without risk. Thus, the Commissioner generally considers a drug safe when the expected therapeutic gain justifies the risk entailed by its use. For the terminally ill, as for anyone else, a drug is unsafe if its potential for inflicting death or physical injury is not offset by the possibility of therapeutic benefit. Indeed, the Court of Appeals implicitly acknowledged that safety considerations have relevance for terminal cancer patients by restricting authorized use of Laetrile to intravenous injections for persons under a doctor’s supervision. See 582 F. 2d, at 1237; supra, at 551.

Moreover, there is a special sense in which the relationship between drug effectiveness and safety has meaning in the context of incurable illnesses. An otherwise harmless drug can be dangerous to any patient if it does not produce its purported therapeutic effect. See 107 Cong. Rec. 5640 (1961) (comments of Sen. Kefauver). But if an individual suffering from a potentially fatal disease rejects conventional therapy in favor of a drug with no demonstrable curative properties, the consequences can be irreversible. For this reason, even before the 1962 Amendments incorporated an efficacy standard into new drug application procedures, the FDA considered effectiveness when reviewing the safety of drugs used to treat terminal illness. See nn. 8, 9, supra. The FDA’s practice also reflects the recognition, amply supported by expert medical testimony in this case, that with diseases such as cancer it is often impossible to identify a patient as terminally ill except in retrospect. Cancers vary considerably in behavior and in responsiveness to different forms of therapy. See 42 Fed. Reg. 39777 (1977). Even critically ill individuals may have unexpected remissions and may respond to conventional treatment. Id., at 39777, 39805. Thus, as the Commissioner concluded, to exempt from the Act drugs with no proved effectiveness in the treatment of cancer “would lead to needless deaths and suffering among ... patients characterized as ‘terminal’ who could actually be helped by legitimate therapy.” Id., at 39805.

It bears emphasis that although the Court of Appeals’ ruling was limited to Laetrile, its reasoning cannot be so readily confined. To accept the proposition that the safety and efficacy standards of the Act have no relevance for terminal patients is to deny the Commissioner’s authority over all drugs, however toxic or ineffectual, for such individuals. If history is any guide, this new market would not be long overlooked. Since the turn of the century, resourceful entrepreneurs have advertised a wide variety of purportedly simple and painless cures for cancer, including liniments of turpentine, mustard, oil, eggs, and ammonia; peat moss; arrangements of colored floodlamps; pastes made from glycerin and limburger cheese; mineral tablets; and “Fountain of Youth” mixtures of spices, oil, and suet. In citing these examples, we do not, of course, intend to deprecate the sincerity of Laetrile’s current proponents, or to imply any opinion on whether that drug may ultimately prove safe and effective for cancer treatment. But this historical experience does suggest why Congress could reasonably have determined to protect the terminally ill, no less than other patients, from the vast range of self-styled panaceas that inventive minds can devise.

We note finally that construing § 201 (p) (1) to encompass treatments for terminal diseases does not foreclose all resort to experimental cancer drugs by patients for whom conventional therapy is unavailing. Section 505 (i) of the Act, 21 U. S. C. § 355 (i), exempts from premarketing approval drugs intended solely for investigative use if they satisfy certain preclinical testing and other criteria. An application for clinical testing of Laetrile by the National Cancer Institute is now pending before the Commissioner. Brief for United States 35 n. 23. That the Act makes explicit provision for carefully regulated use of certain drugs not yet demonstrated safe and effective reinforces our conclusion that no exception for terminal patients may be judicially implied. Whether, as a policy matter, an exemption should be created is a question for legislative judgment, not judicial inference.

The judgment of the Court of Appeals is reversed, and the ease is remanded for further proceedings consistent with this opinion.

So ordered.

       Section 505, as set forth in 21 U. S. C. §355, provides in part:
      “(a) ... No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) of this section is effective with respect to such drug.
      “(b) . . . Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a) of this section. Such person shall submit to the Secretary as a part of the application (1) full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use ....
      “(d) ... If the Secretary finds . . . that (1) the investigations . . . required to be submitted to the Secretary ... do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions; ... (4) ... he has insufficient information to determine whether such drug is safe for use under such conditions; or (5) . . . there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; or (6) based on a fair evaluation of all material facts, such labeling is false or misleading in any particular; he shall issue an order refusing to approve the application. ... As used in this subsection . . . , the term 'substantial evidence’ means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.
      “(i) . . . The Secretary shall promulgate regulations for exempting from the operation of the foregoing subsections of this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs. . . .”
      The Secretary has delegated his approval authority to the Commissioner of the Food and Drug Administration. See 21 CFR §5.1 (a)(1) (1978).

       The requirements for investigative use are set forth in § 505 (i) of the Act, 21 U. S. C. § 355 (i). See n. 1, supra.

       In the Federal Food, Drug, and Cosmetic Act of 1938, 52 Stat. 1041, Congress exempted from the definition of “new drug” any drug that was subject to the Pure Food and Drug Act of 1906, ch. 3915, 34 Stat. 768, if its labeling retained the same representations concerning conditions of use made prior to 1938. This exemption is currently contained in § 201 (p) (1) of the Act, as codified in 21 U. S. C. §321 (p) (1). The Drag Amendments of 1962 added a second grandfather clause, which provides:
      “In the case of any drug which, on the day immediately preceding the enactment date [October 10, 1962], (A) was commercially used or sold in the United States, (B) was not a new drug as defined by section 201 (p) of the basic Act as then in force, and (C) was not covered by an effective [new drug] application under section 505 of that Act, the amendments to section 201 (p) made by this Act shall not apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to such drug on that day.” § 107 (c)(4), 76 Stat. 789.

         The suit was originally instituted by a cancer patient, Juanita Stowe, and her husband, Jimmie Stowe. After Ms. Stowe’s death, two other patients, Glen L. Rutherford and Phyllis S. Schneider, and Ms. Schneider’s husband, filed an amended complaint on behalf of a class composed of all cancer patients and spouses responsible for the costs of treatment. By order entered April 8, 1977, the District Court certified a class consisting of terminally ill cancer patients. 429 F. Supp. 506 (WD Okla.). The Government did not seek review of that order.

       The District Court subsequently entered similar orders for other individuals who submitted affidavits averring their membership in the certified class of terminally EL cancer patients. See App. 1-6.

       The Commissioner initiated proceedings with an announcement in the Federal Register seeking public comment. 42 Fed. Reg. 10066-10069 (1977). Notice was also afforded to certain known proponents of Laetrile. See id., at 39785-39786.

       The Act does not define what constitutes general recognition of a drug’s safety and effectiveness under §201 (p)(l). However, based on the structure and purpose of the statutory scheme, this Court in Wein-berger v. Hynson, Westcott & Dunning, Inc., 412 U. S., at 629-634, interpreted § 201 (p) (1) to require an “expert consensus” on safety and effectiveness founded upon “substantial evidence” as defined in § 505 (d) of the Act, 21 TJ. S. C. § 355 (d). See n. 1, supra.

       Under the 1938 Act, a “new drag” was one not generally recognized by qualified experts as safe for its recommended use. §201 (p) (1), 52 Stat. 1041. The Drug Amendments of 1962, Pub. L. 87-781, 76 Stat. 789, redefined the term to include drugs not generally recognized as effective or safe for their intended use. §201 (p) (1), 21 U. S. C. §321 (p)(l). See swpra, at 546-547, 551. In addition, the Amendments provided that no new drug application may be approved absent substantial evidence that the drug is effective as well as safe under prescribed conditions. § 505 (d), 21 U. S. C. § 355 (d). See n. 1, supra.

       The Senate Report states:
      “The Food and Drug Administration now requires, in determining whether a 'new drug’ is safe, a showing as to the drug’s effectiveness where the drug is offered for use in the treatment of a life-threatening disease, or where it appears that the ‘new drug’ will occasionally produce serious toxic or even lethal effects so that only its usefulness would justify the risks involved in its use. In such cases, the determination of safety is, in the light of the purposes of the new drug provisions, considered by the Food and Drug Administration to be inseparable from consideration of the drug’s effectiveness. The provisions of the bill are in no way intended to affect any existing authority of the Department of Health, Education, and Welfare to consider and evaluate the effectiveness of a new drug in the context of passing upon its safety.” S. Rep. No. 1744, 87th Cong., 2d Sess., pt. 1, p. 15 (1962).
      See also H. R. Rep. No. 2464, 87th Cong., 2d Sess., 3 (1962).
      The FDA’s practice was further amplified by HEW Secretary Ribicoff in testimony on the bill that ultimately became the 1962 Amendments:
      “If the drug is offered for treatment of progressive or life-threatening diseases, such as' cancer, ... we now consider its effectiveness. In such cases the determination of safety is, in the light of the purpose of the new drug provisions, inseparable from consideration of the drug’s effectiveness.” Hearings on S. 1552 before the Subcommittee on Antitrust and Monopoly of the Senate Committee on the Judiciary, 87th Cong., 1st Sess., 2588 (1961).

       To be sure, it may not always be realistic to infer approval of a judicial or administrative interpretation from congressional silence alone. See, e. g., Helvering v. Hallock, 309 U. S. 106, 119-121 (1940); Toucey v. New York Life Ins. Co., 314 U. S. 118, 140-141 (1941). But once an agency’s statutory construction has been “fully brought to the attention of the public and the Congress,” and the latter has not sought to alter that interpretation although it has amended the statute in other respects, then presumably the legislative intent has been correctly discerned. Apex Hosiery Co. v. Leader, 310 U. S. 469, 487-489 (1940). See United States v. Bergh, 352 U. S. 40, 46-47 (1956). See, e. g., Pub. L. 94-295, 90 Stat. 575; Pub. L. 94-278, 90 Stat. 411; and Pub. L. 91-513, 84 Stat. 1281 (amending § 201 of the Act, 21 U. S. C. § 321).
      The issue presented in this case plainly has not escaped public or legislative notice. Whether Laetrile should be freely accessible to cancer patients has been a frequent subject of political debate. Seventeen States have legalized the prescription and use of Laetrile for cancer treatment within their borders, and similar statutes have been defeated in 14 other States. See CCH F. D. Cosm. L. Rep. ¶ 42,292 (1978); Comment, Laetrile: Statutory and Constitutional Limitations on the Regulation of Ineffective Drugs, 127 U. Pa. L. Rev. 233, 234 n. 8 (1978). That Congress is aware of the FDA’s policy concerning Laetrile is evident from Senate Subcommittee hearings on the Commissioner’s 1977 ruling. See Hearing before the Subcommittee on Health and Scientific Research of the Senate Committee on Human Resources, 95th Cong., 1st Sess. (1977).

       See L. Goodman & A. Gilman, The Pharmacological Basis of Therapeutics 325-339 (5th ed. 1975).

       See statement of Dr. Theodore Klumpp, Chief, Drug Division, FDA, June 23, 1941, CCH F. D. Cosm. L. Rep. ¶ 71,053.59 (1977); n. 13, infra.

       See, e. g., 42 Fed. Reg. 39768, 39787 (1977) (statement of Dr. Carl Leventhal, Deputy Director of - the Bureau of Drugs, FDA, and Assistant Professor of Neurology and Pathology at Georgetown University) (“The safety of a drug for human use depends, in large measure, on the therapeutic effectiveness of the particular drug. ... In the case of cancer, treatment with an ineffective drug will . . . inexorably lead to the patient’s death”); ibid, (statement of Dr. George J. Hill II, Chairman of the Department of Surgery at Marshall University School of Medicine, W. Ya.) (Ineffectual treatment can lead to delay in accepted modes of therapy and needless deaths; thus, “[i]n the absence of scientific evidence of effectiveness, no drug intended for use in treating cancer can be regarded as safe”).

       See, e. g., id., at 39805 (statement of Dr. Peter Wiemik, Chief of the Clinical Oncology Branch of the National Cancer Institute’s Baltimore Research Center) (“[N]o one can prospectively define the term ‘terminal’ with any accuracy. A patient can be said to be terminal only after he dies. Many patients who are critically ill respond to modem day management of cancer”); ibid, (statement of Dr. Joseph Ross, Professor of Medicine, University of California School of Medicine at Los Angeles) (“[T]he distinction of ‘terminal’ patients from ‘non-terminal’ patients may not be reliably determined and an assumption that Laetrile may be given to [‘terminal’] patients with impunity may deprive such patients of therapeutic measures which could help them”).

       The Commissioner noted that these unexpected behavior patterns may account for anecdotal claims of Laetrile’s effectiveness. Users of Laetrile who experience spontaneous remissions or delayed responses to conventional therapy after its abandonment may ascribe their improvement to Laetrile without any objective basis for that attribution. See, e. g., id., at 39777 (statement of Dr. Daniel S. Martin, researcher in cancer immunology and chemotherapy); id., at 39800 (statement of Dr. Emil J. Frereich, Chief of the Division of Oncology at University of Texas Medical School at Houston); ibid, (statement of Dr. Melvin Krant, Director of Cancer Project at the University of Massachusetts Medical Center). Particularíy since accepted cancer treatments such as chemotherapy and radiation often have painful side effects, the Commissioner concluded that patients who subjectively perceive improvement after substituting Laetrile for these modes of therapy may erroneously believe that their condition has been arrested or ameliorated. See id., at 39777, 39799-39800.

       CCH Fed. F. D. Cosm. L. Admin, Reps., 1907-1949, p. 745 (1951); id., at 1408; id., at 1170-1171, 1298-1299; id., at 224; FDA Ann. Reps., 1950-1974, pp. 309, 464; id., at 45; id., at 412.

       See n. 1, supra. At present, some 300 experimental drugs are available to critically ill cancer patients at authorized institutions. See Brief for United States 34 n. 23; National Cancer Institute, Extramural Clinical Trial Programs of the Division of Cancer Treatment, General Overview and Scope of Contract-Supported Activities (1979). During 1977, over 90,000 cancer patients participated in investigative programs under the auspices of the National Cancer Institute or the Veterans’ Administration. Brief for United States 35 n. 23.

       Respondents urge that we consider the District Court’s rulings on the constitutional and grandfather clause questions as alternative bases for sustaining the judgment below. However, since the Court of Appeals addressed neither issue, we remand the case for further consideration of respondents’ claims. See Vermont Yankee Nuclear Power Corp. v. National Resources Defense Council, Inc., 435 U. S. 519, 549 (1978); Arlington Heights v. Metropolitan Housing Dev. Corp., 429 U. S. 252, 271 (1977).