See Auer, 519 U.S. at 461, 117 S.Ct. 905. As revealed above, the EPA's characterization of the tailings as a byproduct (i.e., something manufactured other than a mixture) is not plainly erroneous or inconsistent with the regulatory language. Accordingly, the Court upholds the EPA's interpretation with regard to this issue.
Having done so, the Court must now determine whether EPA's interpretation should have been made through the APA's notice and comment rulemaking procedures. Interpretive rules do not require notice and comment rulemaking so long as the interpretation is within the scope of the regulatory and statutory language. See American Mining Congress v. Mine Safety & Health Admin., 995 F.2d 1106, 1113 (D.C. Cir. 1993). In this case, the interpretation of the de minimis exemption as applied to tailings is within the scope of the regulation, which notes that the exemption applies to toxic chemicals present "in a mixture." Toxic chemicals removed from a mixture are no longer eligible for the exemption. As such, the Court concludes that notice and comment rulemaking was not required.
Based on the foregoing, the Court concludes that the EPA's exclusion of waste rock from the de minimis exemption does not comport with the language of the 1988 regulation, which is silent as to whether the substance must be involved in a "threshold activity." Because the tailings are removed from and not "present in a mixture," however, EPA's decision to exclude tailings for the de minimis exemption is proper and did not require compliance with notice and comment rulemaking.
Barrick also claims that the EPA has unlawfully expanded the EPCRA definition of "manufacturing" to include an intra-category chemical change of a toxic chemical and the definition of "processing" to encompass the distribution of irremovable naturally-occurring impurities contained in the dore. Plaintiff asserts that these expansive interpretations of the statutory definitions violate the clear language of the statute, and, in any event, are valid only if issued via notice and comment rulemaking.
A court is required to give effect to an agency regulation that is a reasonable interpretation of an ambiguous statute. Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). If the statutory language is clear on its face, the Court's inquiry must stop there. Id. at 842-43, 104 S.Ct. 2778. If, however, the statute is ambiguous with respect to a particular issue, the Court must decide whether the agency's interpretation is a permissible construction of the statute. Id. at 843, 104 S.Ct. 2778. As previously stated, an agency's further interpretation of its own regulation is "controlling unless `plainly erroneous or inconsistent with the regulation.' " See Auer, 519 U.S. at 461, 117 S.Ct. 905.
The toxic chemicals subject to the requirements of the EPCRA are listed in title 40, section 372.65(c) of the Federal Code of Regulations. See 42 U.S.C. § 11023(c) (referencing the list now contained in the C.F.R.). The list contains both elements (e.g., copper) and chemical compounds consisting of multiple elements (e.g., copper sulfate). In some cases, all compounds of the same chemical are listed as one "chemical category." For example, all compounds of arsenic are considered one "chemical category" on the list. Each chemical category is a separate entry on the "toxic chemical" list and is considered a different "toxic chemical." Where a chemical category, rather than a single element, makes up a reportable "toxic chemical," a person must aggregate the quantities of all of the different compounds that fall into that same chemical category and determine if the total amount meets the threshold quantity for reporting purposes.
The statutory definition of "manufacture" is "to produce, prepare, import, or compound a toxic chemical." 42 U.S.C. § 11023(b)(1)(C)(i). The 1988 rulemaking expanded this definition by adding the following sentence:
Manufacture also applies to a toxic chemical that is
produced coincidentally during the manufacture,
processing, use, or disposal of another chemical or
mixture of chemicals, including a toxic chemical that
is separated from that other chemical or mixture of
chemicals as a byproduct, and a toxic chemical that
remains in that other chemical or mixture of
chemicals as an impurity.
40 C.F.R. § 372.3. The 1999 Metal Mining Guidance further elaborated on this definition, stating that the "conversion of one metal compound to another within the same compound category" may constitute "manufacturing." See Metal Mining Guidance at 3-11. The Metal Mining Guidance notes that the conversion of lead sulfide to lead oxide, both metal compounds that belong in the "lead" chemical category on the toxic chemical list, would constitute manufacturing. See id.
During the autoclaving step of gold extraction, trace amounts of arsenic sulfide become arsenic oxide. Burke Decl. ¶ 11. Barrick contends, however, that this "intra-category" transformation of one metal compound to another does not produce a "toxic chemical" because the two compounds belong to the same "chemical category" on the toxic chemical list. No new "toxic chemical" is created. Barrick contends that such intra-category changes are incidental and do not constitute the production, preparation, importation or compounding of a toxic chemical. Therefore, Barrick argues that EPA's interpretation conflicts with the language and structure of the EPCRA and is invalid. Finally, Barrick argues that even if this Court concludes that the EPA's interpretation is consistent with the EPCRA, the interpretation is a legislative rule and a "substantive legal addition" to the TRI program and therefore is void unless promulgated through notice-and-comment rulemaking. See Appalachian Power Co. v. EPA, 208 F.3d 1015, 1024 (D.C. Cir. 2000); Paralyzed Veterans of America v. D.C. Arena L.P., 117 F.3d 579 (D.C. Cir. 1997).
EPA contends that its interpretation of "manufacture" to include all creation of any new chemical compounds within a listed chemical category is reasonable. The statutory definition of "manufacture" is silent as to how it should be applied to chemical categories, and EPA argues that its 1988 rule therefore defined manufacture to include all creation, including creations of chemical byproducts, impurities, or other chemicals. See 40 C.F.R. § 372.3. EPA asserts that because its interpretation is rational and advances EPCRA's objective of making more information about toxic releases publicly available, its interpretation is entitled to deference under both Auer and Chevron.
The statute broadly defines "toxic chemical" as "a substance on the list described in section [313(c)]." 42 U.S.C. § 11049(10). EPA contends that this definition is ambiguous with respect to the status of chemical categories that are listed because a category is not a "substance" but includes a number of substances. The 1988 rule clarifies the statutory definition of "toxic chemical" to encompass either the listed chemical or the listed chemical category.
EPA submits that it has jointly considered its interpretations of "manufacture" and "toxic chemical," each of which is a reasonable interpretation of ambiguous statutory language, and concluded that changes of chemicals from one chemical compound to another within the same chemical category of toxic chemicals constitute manufacturing that is reportable under the statute. The EPA has applied this interpretation consistently since a 1990 Question and Answer document and has adopted this approach in its response to comments in the 1997 notice and comment rulemaking that incorporated metal mining facilities in the TRI program. The EPA contends that its interpretation of the 1988 regulation is rational and serves the informative purpose of the EPCRA.*fn10
Finally, EPA argues that its interpretation does no more than clarify a phrase in the 1988 regulations, consistent with its past practice; thus, its regulatory interpretation is not "legislative," and need not be made through notice and comment rulemaking. See Paralyzed Veterans of America, 117 F.3d at 588; American Mining Congress, 995 F.2d at 1112.
The Court finds that under the ambiguous language of both the statute and the regulation, the EPA's interpretation of "manufacture" to include intra-category changes is reasonable, and therefore entitled to deference under Chevron and Auer. Moreover, the EPA's interpretation is not a change to the statute that need have been made through notice and comment rulemaking. Even in an intra-category change, a toxic substance is "produced" through the process of autoclaving the ore — an action that fits within the statutory definition of "manufacture."
Furthermore, the Court finds the EPA is consistent in its treatment of the term "toxic chemical." As in determining threshold quantities, the EPA considers elements making up a chemical category in the aggregate — if any of the substances belonging to the chemical category is manufactured, then the category as a "toxic chemical" has been manufactured. That one metal compound within a chemical category changes to another within the same category does not alter the end result: namely, a metal compound within a chemical category (and thus a "toxic chemical") has been produced.*fn11
Finally, the Court concludes that the EPA's interpretation is not a legislative rule because it is a consistent elaboration on the definitions in the statute and regulation. A toxic chemical has been produced in the autoclave process. That it arose through an intra-category change as opposed to another method is irrelevant — the statute and the regulation recognize no such distinction. The EPA "arguably could have relied on the regulation itself" rather than on the Metal Mining Guidance to conclude that an intra-category changes was a "manufacture." See Paralyzed Veterans of America, 117 F.3d at 588. Therefore, the EPA was not required to follow the formal notice and comment rulemaking procedures.
The Court next turns its attention to plaintiff's challenge to the EPA's interpretation of "processing." In the DOA letter issued in March, 1999, EPA generally takes the position that if dore shipped from a mine contains any amount of a listed toxic chemical, then Barrick has "processed" the chemical, and the entire amount of that chemical in the process stream must be considered in making the threshold determinations. See Pl's Mem. Ex. C, Tab C, DOA Letter, at 2.*fn12 Barrick asserts that under this definition, because the dore contains unwanted trace amounts of certain impurities that Barrick is unable to fully remove, Barrick must report the entire amount of those chemicals, including the amounts that Barrick has removed and does not distribute in commerce. Because the EPA fails to assert (nor can the Court find) that the predicate act of "manufacturing" has occurred, the Court concludes that impurities contained within the ore mined by plaintiffs is not "processed" for purposes of the EPCRA.
The EPCRA defines "process" as:
[t]he preparation of a toxic chemical, after its
manufacture, for distribution in commerce —
(I) in the same form or physical state as, or in a
different form or physical state from, that in which
it was received by the person so preparing such
(II) as part of an article containing the toxic
42 U.S.C. § 11023(b)(1)(C)(ii). Barrick correctly argues and the EPA does not contest that under the statutory definition, a toxic chemical cannot be "processed" unless it has first been "manufactured," as defined by EPCRA. See id. Because naturally-occurring elements found in the ore (to include those qualifying as toxic chemicals under the EPCRA) are not produced, prepared, imported, or compounded, Barrick asserts that they are not "manufactured" within the meaning of the EPCRA. Barrick therefore concludes that because the impurities naturally occurring in the ore it mines have not been "manufactured" under EPCRA, they cannot be "processed" under EPCRA. The EPA in its preamble to the 1997 rulemaking takes a contrary position. The preamble states that because "production" includes creation by natural (and industrial) processes, even those chemicals existing in nature have been "manufactured" at some point. See 62 Fed. Reg. 23834, 23856-57 (May 1, 1997). This would include all chemicals (e.g., metals and impurities) naturally occurring in ores.*fn13 Id. Consistent with the 1997 rulemaking preamble, the EPA initially maintained in its summary judgment briefs that naturally-occurring metals and impurities in the ore were "manufactured" via natural processes. The EPA asserted that such impurities were thereafter "processed" (i.e., "prepared" for distribution in commerce) during both the extraction of the ore from the plaintiff's mines and beneficiated in preparation.*fn14 Since the filing of its briefs, however, a federal district court judge in the District Court of Colorado has ruled that "naturally occurring undisturbed ores are not manufactured" within in the meaning of EPCRA. March 30, 2001 "Order of Clarification" in National Mining Ass'n, et al. v. EPA, Civ Action No. 97 N 2665 (D.Colo.) (clarifying a January 16, 2001, "Order and Memorandum or Decision").*fn15 The EPA has embraced the Colorado district court's decision and concomitantly abandoned in this case its argument that "toxic chemicals at plaintiff's mining facilities that remain in the ground, in their natural, undisturbed state, have been `manufactured' by natural creative processes." Def's Notice of Supp.App. at 2. While the EPA correctly points out that the court's ruling in National Mining is limited in that it did not "address the issue of whether the term `manufacture' includes extraction and beneficiation activities," see National Mining, Order of Clarification at 3, the Court finds its concession with regard to naturally occurring impurities to be dispositive of the issue now before it.
Having conceded that impurities occurring naturally in undisturbed ores are not "manufactured," the EPA offers no alternative legal theory by which the Court can find that the naturally-occurring impurities in the ore have been manufactured within the meaning of EPCRA. By its own admission, the "processing" of toxic chemicals is predicated upon their having been "manufactured." The EPA asserts only that the impurities in the ore are "processed" (after being manufactured) during extraction and beneficiation.
Absent further clarification by the EPA, this Court may have independently concluded that impurities in the mined ore are still "manufactured" during the extraction and/or beneficiation processes in that they are "prepared" within the meaning of the statutory definition. See 42 U.S.C § 11023(b)(1)(C)(i). The EPA, however, has foreclosed this interpretation of the statute by limiting the scope of the term "prepare" as it appears in the definitions of "manufacture" and "process." The EPA maintains that the term "prepare" in the definition of "manufacture" means "to create," while the same term means "to make ready" for purposes of "processing" under the EPCRA. Def's Memo in Supp. of EPA's Cross-mot Summ. J. at 33. Given this clarification, this Court can find no basis for concluding that Barrick has created and therefore "manufactured" the impurities contained in the ore.
Based upon the foregoing, the Court concludes that the EPA's interpretation that impurities occurring naturally in the ore Barrick mines have been "processed" is unreasonable in light of the clear statutory definition of "process," stating that a toxic chemical can only be processed after being manufactured. Therefore, to the extent that the EPA's guidance documents assert that the failure to remove these impurities during the processing of dore results in their having been processed for purposes of EPCRA, they contravene the statutory definition of "processing" and are invalid under the statute.
It is therefore, this 2nd day of April, 2003,
ORDERED, that plaintiff's motion for summary judgment  is granted in part and denied in part; and it is
FURTHER ORDERED, that defendant's cross-motion for summary judgment  is granted in part and denied in part; and it is
FURTHER ORDERED, that defendant's interpretation excluding plaintiff's waste rock from being eligible for the de minimis exemption is invalid; and it is
FURTHER ORDERED, that defendant's interpretation excluding plaintiff's tailings from being eligible for the de minimis exemption is valid; and it is
FURTHER ORDERED, that defendant's interpretation excluding plaintiff's tailings from being eligible for the de minimis exemption need not have been promulgated via notice and comment rulemaking; and it is
FURTHER ORDERED, that defendant's interpretation that an intra-category change of a toxic chemical falls within the definition of "manufacture" is valid; and it is
FURTHER ORDERED, that defendant's interpretation that an intra-category change of a toxic chemical falls within the definition of "manufacture" need not have been promulgated via notice and comment rulemaking; and it is
FURTHER ORDERED, that defendant's interpretation that plaintiff has "processes" naturally occurring impurities found in its dore is invalid; and it is
FURTHER ORDERED, that plaintiff's motion to amend the complaint  is denied without prejudice.