215 F.3d 45 (D.C. 2000)
Barrick Goldstrike Mines Inc., Appellantv.Carol M. Browner, et al.,Appellees
No. 99-5298
United States Court of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued May 8, 2000Decided June 16, 2000

Appeal from the United States District Court for the District of Columbia(99cv00958)
Richard E. Schwartz argued the cause for appellant. With  him on the briefs was Thomas C. Means.
Todd S. Kim, Attorney, U.S. Department of Justice, argued  the cause for the federal appellees.  With him on the brief  were Lois J. Schiffer, Assistant Attorney General, Mary F.  Edgar and Andrew C. Mergen, Attorneys.
Before:  Edwards, Chief Judge;  Randolph and Garland,  Circuit Judges.
Opinion for the Court filed by Circuit Judge Randolph.
Randolph, Circuit Judge:


1
This is an appeal from the  judgment of the district court dismissing the complaint of  Barrick Goldstrike Mines Inc.  The case arises under   313  of the Emergency Planning and Community Right-to-Know  Act ("EPCRA"), 42 U.S.C.   11023.  EPCRA requires certain types of facilities that "manufactured," "processed" or  "otherwise used" listed "toxic chemicals" in amounts exceeding specified thresholds to report "releases" of these chemicals by July 1 of each year to the Environmental Protection  Agency.  Id.   11023(b)(1).  EPA uses the information to  administer a "toxic release inventory" program pursuant to  EPCRA.  The program makes the toxic release information  public. Although the toxic release inventory program originally applied only to manufacturing facilities, EPA extended it  by regulation to several other industry groups, including  metal mining.  See 62 Fed. Reg. 23,834 (1997).  Barrick  mines gold and other precious metals in Nevada.  The company alleges that in applying the program to mining, EPA in  fact revised the program;  that its revisions were substantive; that they were not made through rulemaking, as they should  have been;  and that the revisions were made instead through  statements in "rulemaking preambles" and in detailed directives issued in the form of "guidance" and a letter.  Brief  of Appellant Barrick at 4.  On EPA's motion the district  court dismissed the complaint for lack of jurisdiction and  because it was not ripe.  The court issued no written opinion.


2
EPCRA contains no judicial review provision.  Barrick  therefore invoked the district court's general federal question  jurisdiction (28 U.S.C.   1331) and sought, pursuant to the  Administrative Procedure Act (5 U.S.C.   701-706, and 28  U.S.C.   2201), a declaratory judgment that the three EPA  actions were contrary to law.  As to jurisdiction, the question  is whether Barrick has challenged "final agency action" within the meaning of the APA, see 5 U.S.C.   704.  As to  ripeness, we must determine whether Barrick, like the drug manufacturers in Abbott Laboratories v. Gardner, 387 U.S.  136 (1967), but unlike the cosmetics companies in Toilet  Goods Ass'n v. Gardner, 387 U.S.158, 164 (1967), must change  its conduct or risk costly sanctions, and whether the issues  presented in Barrick's complaint are suitable for review at  this time.  See Clean Air Implementation Project v. EPA,  150 F.3d 1200, 1204-05 (D.C. Cir. 1998).


3
1. Barrick claimed that for certain mining operations,  including its own, EPA had revised the so-called de minimis  exception set forth in 40 C.F.R.   372.38(a) without conducting a rulemaking.  Barrick moves waste rock.  The rock  contains trace concentrations of listed substances--toxic  chemicals--including copper, nickel, silver and other metal bearing minerals.  Under EPA's de minimis regulation, if a  toxic chemical in a mixture amounts to less than 1% (or in the  case of a carcinogen, less than 0.1%) the substance is not  counted as having been released and does not count toward  the manufacturing, processing or "otherwise used" threshold. Id.  In EPA's "Metal Mining Facilities" guidance, posted on  EPA's website in January 1999,1 the agency stated that the  chemicals in waste rock are not eligible for this de minimis  exception because waste rock is not "manufactured, processed  or otherwise used."  Office of Pollution Prevention and Toxics, EPA, EPCRA Section 313 Industry Guidance:  Metal  Mining Facilities 3-28 (Jan. 1999) [hereafter "1999 Guidance"].


4
Counsel for EPA admitted at oral argument that EPA's  position on the application of the de minimis exception to  waste rock is final.  If Barrick does not conform to EPA's  view in fulfilling its reporting obligation it will be subject to  an enforcement action and fines.  Even without counsel's  concession, the finality of EPA's position is clear enough. That the issuance of a guideline or guidance may constitute  final agency action has been settled in this circuit for many  years.  See, e.g., Better Gov't Ass'n v. Department of State,  780 F.2d 86, 92-96 (D.C. Cir. 1986);  Ciba-Geigy Corp. v.  EPA, 801 F.2d 430, 435 & n.7, 436 (D.C. Cir. 1986).  In Better  Government we rejected the proposition that if an agency  labels its action an "informal" guideline it may thereby escape  judicial review under the APA.  780 F.2d at 93.  In CibaGeigy we held that a letter from an agency official stating the  agency's position and threatening enforcement action unless  the company complied constituted final agency action.  801  F.2d at 436-39, 438 n.9.  In Appalachian Power Co. v. EPA,  208 F.3d 1015, 1020-23 (D.C. Cir. 2000), we held again that a  guidance document reflecting a settled agency position and  having legal consequences for those subject to regulation may  constitute "final agency action" for the purpose of judicial  review.  For finality to be found in these cases two conditions  had to be satisfied:  "First, the action must mark the 'consummation' of the agency's decision making process, Chicago &  Southern Airlines, Inc. v. Waterman S.S. Corp., 333 U.S. 103,  113 (1948)--it must not be of a merely tentative or interlocutory nature.  And second, the action must be one by which  'rights or obligations have been determined,' or from which  'legal consequences will flow,' Port of Boston Marine Terminal Assn. v. Rederiaktiebolaget Transatlantic, 400 U.S. 62, 71  (1970)."  Bennett v. Spear, 520 U.S. 154, 177-78 (1997).  Here  there is no doubt that EPA will refuse to apply the de  minimis exception to Barrick's waste rock and that its refusal to do so has legal consequences--namely, that Barrick is  bound to keep track of its movement of waste rock and report  the movements as releases of toxic substances.2


5
As against this EPA contended at oral argument that the  1999 Guidance changed nothing;  that EPA had already taken  the position Barrick complains about in the preamble to the rule subjecting the mining industry to the toxic reporting  program;  and that Barrick should have aimed its complaint  at the preamble, but had not done so. There are three reasons  for rejecting this line of reasoning.3  First, EPA never made  the argument in its brief in this court.  See, e.g., Carducci v.  Regan, 714 F.2d 171, 177 (D.C. Cir. 1983).  It did not even  cite the page or pages in the preamble that supposedly  support its position.  Second, Barrick did indeed challenge  EPA positions expressed in the preambles (Complaint p 25;Brief at 4) and did so in a timely fashion because no statute of  limitations applied.  Third, we have recognized that final  agency action may result "from a series of agency pronouncements rather than a single edict."  Ciba-Geigy, 801 F.2d at  435 n.7.  Hence, a preamble plus a guidance plus an enforcement letter from EPA could crystallize an agency position  into final agency action within APA   704's meaning.  Fairly  read, this is what Barrick's complaint alleges.4


6
We also agree with Barrick that this aspect of its case is  ripe for judicial review.  The questions presented are purely  legal.5  Nothing we can imagine happening would bring the  issues into greater focus or assist in determining them. And  there is certainly the prospect of hardship to Barrick.  Its  only alternative to obtaining judicial review now is to violate  EPA's directives, refuse to report releases involving waste  rock, and then defend an enforcement proceeding on the  grounds it raises here.  In that respect the case is indistinguishable from Ciba-Geigy Corp. v. EPA, 801 F.2d at 438-39,  in which we held an analogous claim ripe for judicial review.


7
2. Barrick's second claim deals with whether it is "manufacturing" a "toxic chemical" when, in the course of extracting  gold from ore, trace amounts of naturally occurring metal  compounds change form, generally from metal sulfides to  metal oxides.  In the 1999 metals mining guidance, EPA  announced that it would treat these changes as the manufacturing of toxic chemicals, a reportable event.  See 1999 Guidance, at 3-11.  Barrick objects that the 1999 Guidance is  inconsistent with   313(c) of the statute and 40 C.F.R.    372.65(c), which do not permit the agency to treat as  "manufacturing" the conversion of one metal compound into  another within the same compound category.  No further  detail is needed to understand why there is final agency  action here and why this claim is ripe.  Here too, EPA  counsel conceded at oral argument that the position on this  subject expressed in the 1999 Guidance is the agency's final  position.  The 1999 Guidance itself (at 3-11) says just that:


8
Metal mining facilities should be aware of chemical con-versions that may take place during beneficiation.  The following types of conversions constitute manufacturing:


9
. Conversion of one metal compound to another within the same compound category.  For example, alead mine may convert galena (lead sulfide in ore) to lead oxide during beneficiation.


10
Thus, if Barrick refuses to abide by the 1999 Guidance, the  company will be subject to an enforcement action.


11
3. Barrick's third and last claim relates to the fact that its  mine produces metal bars--dore--that are gold and silver but  also contain tiny amounts of naturally occurring elements and  compounds from rock, compounds and elements that EPA  lists as "toxic chemicals."  Under the statute, "the term  process means the preparation of a toxic chemical, after its  manufacture, for distribution in commerce."  42 U.S.C.    11023(b)(1)(C)(ii).  Barrick thus believes that a "toxic  chemical" cannot be "processed" unless it has first been  "manufactured."  From this it concludes that in producing its  dore it has not processed toxic chemicals and therefore has no  reporting obligation under the statute.  EPA's opposite conclusion, Barrick contends, is embodied in its statement in the  preamble to the 1997 rule expanding coverage to the mining  industry, in the 1999 Guidance and in a letter, dated March  18, 1999, from the Chief of EPA's Toxic Release Inventory  Branch to another mining company.  The preamble states  that the term "manufacture" is not limited to human activity."Manufacture" of a toxic chemical includes its "production"  and "EPA interprets 'production' to include creation."  62  Fed. Reg. at 23,857.  Thus, according to the preamble "chemicals which exist in nature have been 'manufactured' at some  point."  Id. The 1999 Guidance states the same conclusion  without giving the reasoning:


12
Non-Target Metals and Metal Compounds.  When processing the target metals and metal compounds at your facility, the ore you are beneficiating may also contain  other non-target EPCRA Section 313 metals and metal compounds.  If any portion of these non-target metal sand metal compounds remain in the metal concentratedistributed into commerce, you must consider them to-ward the processing threshold of 25,000 pounds.  If the EPCRA Section 313 chemicals are completely removed from your product prior to distribution into commerce, the chemicals are not considered processed and do nothave to be considered toward the processing threshold.


13
1999 Guidance, at 3-15.  The March 18, 1999, "guidance"  letter from the branch chief also states the same conclusion.  In order to comply with EPA's interpretation, Barrick claims  that in 1999 it wound up reporting that it had " 'processed'  the naturally occurring metal impurities that it could not  completely remove from its dore."  Reply Brief of Appellant  Barrick at 21.


14
Nothing in EPA's brief or in its oral argument indicates  that the EPA's position on this subject is tentative.  The  March letter is firm and conclusive, as is the 1999 Guidance. Both state what must be done to comply with EPA's toxic  release inventory program.  Legal consequences flow from  the position expressed--Barrick must keep records and report to EPA unless it wishes to risk an enforcement action. That the agency action is embodied in interpretative statements in a rulemaking preamble, in a guidance document, and  in a letter from a branch chief is not disqualifying.  As we  have said, the final agency action in Ciba-Geigy, 801 F.2d at  436 n.8, consisted of a "series of steps taken by EPA"  culminating in a letter from an EPA official stating the  agency's position.6  We have no doubt that EPA, in responding by letter to industry inquiries, assists companies in bringing themselves into compliance.  But it scarcely follows that a  company may not obtain judicial review of the agency's  interpretation of the statute or regulation.  There is of course  the matter of timing.  We have already decided that the first  two objections Barrick raised are ripe for review and we see  no basis for ruling any differently on this claim.  It too  presents a pure question of law and withholding review has  sufficient adverse effects on Barrick's business.


15
For the reasons stated, the judgment of the district court is  reversed and the case is remanded for further proceedings.


16
So ordered.



Notes:


1
 The guidance went through several iterations from 1997 to  1999, some of which were published in the Federal Register.  See,  e.g., 62 Fed. Reg. 63,548 (1997).  According to Barrick, the January  1999 version is "comprehensive and authoritative" and represents  the agency's principal set of reporting instructions for mining  companies. Brief of Appellant Barrick at 5.


2
 EPA's 1999 metals mining guidance commanded:  "you must  report ...  the waste rock."  1999 Guidance, at 3-28.  Other  portions of the 1999 Guidance, not challenged in this case, are  framed as recommendations.


3
 EPA's brief contained a quite different argument--namely  that the 1999 Guidance was not final because it was not "binding"  and it was not binding because it merely explained "EPA's current  view of how the statutory and regulatory requirements of the [toxic  reporting] program apply to the metal mining industry and do not  impose any binding new requirements."  Brief for Federal Apellees  at 16.  It appears that EPA has abandoned this line of argument in  light of our intervening decision in Appalachian Power Co. v. EPA.If it has not, if EPA still wishes us to consider the argument despite  the quite different position it took at oral argument, we reject it for  the reasons given in Appalachian Power, 208 F.3d at 1020-23.There is not the slightest doubt that EPA directed regulated  entities to comply with the 1999 Guidance regarding their treatment  of waste rock, see supra note 1, and the other two interpretations  Barrick protests--conversion of one metal compound into another  within the same compound category, and impurities in dore, see  infra pp. 6-8.


4
 In a case (unlike this one) in which our jurisdiction was  restricted to reviewing final "regulations," we held that a statement  in a preamble to a proposed rule could not be reviewed.  See  Florida Power & Light Co. v. EPA, 145 F.3d 1414, 1418-20 (D.C.  Cir. 1998);  see also Molycorp, Inc. v. EPA, 197 F.3d 543 (D.C. Cir.  1999).


5
 Barrick claimed not only that EPA had issued a substantive  rule without engaging in rulemaking but also that it had misinterpreted its regulation (40 C.F.R.   372.38(a)) and had acted arbitrarily by saying, with respect to the de minimis exception, that  waste rock is not manufactured, but saying elsewhere that all  "chemicals which exist in nature have been 'manufactured' at some  point," 62 Fed. Reg. at 23,857.


6
 The final agency action in Her Majesty the Queen v. EPA, 912  F.2d 1525, 1530-32 (D.C. Cir. 1990), consisted of a letter from an  EPA official reiterating the agency's interpretation of a provision in  the Clean Air Act.


