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. e du/thir dc ir c uit_1998/282Filed December 21, 1998

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

No. 97-7494

FERTILIZER INSTITUTE, a Delaware non-profit corporation, Appellant

v.

CAROL M. BROWNER, Administrator, United States Environmental Protection Agency;

THE UNITED STATES ENVIRONMENTAL PROTECTION

AGENCY

On Appeal from the United States District Court
for the District of Delaware (D.C. Civ. No. 96-cv-00273) District Judge: Hon. Joseph J. Farnan, Jr.

Submitted Pursuant to Third Circuit LAR 34.1(a) October 5, 1998

Before: SLOVITER and COWEN Circuit Judges and POLLAK, District Judge*

(Filed December 21, 1998)

Peter L. Gray McKenna & Cuneo, L.L.P. Washington, D.C. 20006

Attorney for Appellant

___________________________________________________ ______________

* Hon. Louis H. Pollak, United States District Cour t for the Eastern District of Pennsylvania, sitting by designation.Lois J. Schiffer

Assistant Attorney General

Steve C. Gold

John T. Stahr Mary F. Edgar Attorneys, Environment and
Natural Resources Division Department of Justice Washington, D.C. 20530

Of Counsel:

Laurel Celeste Attorney, Office of General Counsel
U.S. Environmental Protection
Agency Washington, D.C. 20460

Attorneys for Appellees

OPINION OF THE COURT

SLOVITER, Circuit Judge.

The Fertilizer Institute ("TFI") appeals the decisi on of the district court upholding the Environmental Protecti on Agency's ("EPA") addition of nitrate compounds to t he Toxic Release Inventory ("Inventory"). We will affirm for the
reasons discussed herein.

I.

FACTS AND PROCEDURAL HISTORY

In January 1994, the EPA proposed a rule adding 313 chemicals to the Inventory pursuant to the Emergenc y Planning and Community Right to Know Act of 1986 (t he "EPCRA"). See 42 U.S.C. SS 11023(c)-(d). In Novembe r 1994, the EPA adopted a final rule which included 286 of the 313 chemicals originally proposed. Nitrate compounds we re among the chemicals added based on chronic health effects, specifically because nitrate compounds cau se human infants to develop methemoglobinemia, a condi tion

2that prevents proper transportation throughout the body of

oxygen via red blood cells and causes damage to vit al organs. The EPA characterized this consequence to b e a "severe or irreversible . . . chronic health effect ," one of the criteria in the statute. See 42 U.S.C. S 11023(d)(2 )(B).

In May 1996, TFI, a trade association representing the fertilizer industry whose members use nitrate compo unds, filed a complaint in the district court challenging the EPA's placement of nitrate compounds on the Inventory. TF I gave three reasons for its challenge to the nitrates lis ting: inadequate notice of the EPA's intent to place nitr ates on the list under the EPA's interpretation and applica tion of chronic health effects; inadequate response to the comments submitted by TFI; and misapplication of th e statutory criteria, which resulted in the EPA's ove rstepping its authority under S 11023(d). Both TFI and the EP A filed motions for summary judgment.

Reviewing the overall record, the district court he ld that the EPA provided adequate notice to the parties, in cluding "particularly sophisticated commenters like TFI who are familiar with nitrate compounds." Dist. Ct. Mem. Op . at 19. The district court also concluded that the EPA adeq uately responded to the comments submitted by several organizations, including TFI. Id. at 22. The court observed that the criticisms challenged the EPA's conclusion s, but not the evidence the agency relied on in reaching t hem. Id. at 21-22. Finally, the district court concluded tha t the EPA had shown that the record supported the decision to
include nitrates because of the chronic health effe cts they can produce in infants. Id. at 24-25. Thus, the dis trict court upheld the agency's addition of nitrates to t he Inventory, and granted summary judgment in favor of the

EPA.

TFI filed a timely notice of appeal. We have jurisd iction pursuant to 28 U.S.C. S 1291.

3II.

DISCUSSION

A.

Standard of Review

In considering summary judgment decisions, we revie w the case de novo, applying the same standard that t he
district court did. See Carlisle Area Sch. v. Scott P., 62 F.3d 520, 526 (3d Cir. 1995). In the context of agency d ecision making, we review the agency record directly. See T roy Corp. v. Browner, 120 F.3d 277, 281 (D.C. Cir. 1997 ).

Courts review agency decision making with deference

. The Administrative Procedure Act provides that a co urt should "set aside agency action, findings, and conc lusions found to be arbitrary, capricious, an abuse of disc retion, or
otherwise not in accordance with law." 5 U.S.C. S 7 06(2)(A). Grounds for concluding that the agency acted arbitr arily and capriciously include its reliance on factors ou tside those Congress intended for consideration, a comple te failure by the agency to consider an important aspe ct of the problem, or an agency's explanation contrary to, or implausible in light of, the evidence. See Motor Ve hicle Mfrs. Ass'n of the United States, Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983); see also Pennsylvania Dep't of Pub. Welfare v. United States Dep't of Health and H uman Servs., 101 F.3d 939, 943 (3d Cir. 1996) (reversal appropriate if action "irrational, not based on rel evant factors, or outside statutory authority").

We have often stated that in assessing the record, the court should not substitute its own judgment for th e scientific expertise possessed by the agency. See, e.g., Southwestern Pa. Growth Alliance v. Browner, 121 F. 3d 106, 117 (3d Cir. 1997). Furthermore, the courts ar e deferential to an agency's interpretation of a stat ute in situations in which "Congress has been either`silen t or ambiguous' " on the question under consideration. I d. at 116 (quoting Chevron, U.S.A., Inc. v. Natural Resou rces Defense Council, Inc., 467 U.S. 837, 843 (1984)).

4B.

The EPCRA

The Emergency Planning and Community Right to Know Act authorizes the EPA to add chemicals and compoun ds to the Inventory under three general criteria, broadly described as acute effects, chronic effects, and environmental effects. Only the first two are relev ant to the analysis here. The relevant provision states:

A chemical may be added if the Administrator determines, in his judgment, that there is s ufficient evidence to establish any one of the followi ng:

(A) The chemical is known to cause or can reasonably be anticipated to cause significa nt
adverse human health effects at concentratio n levels that are reasonably likely to exist beyond f acility site boundaries as a result of continuous, or fre quently recurring, releases.

(B) The chemical is known to cause or can reasonably be anticipated to cause in humans --

(I) cancer or teratogenic effects, or

(ii) serious or irreversible --

(I) reproductive dysfunctions,

(II) neurological disorders,

(III) heritable genetic mutations, or

(IV) other chronic health effects.

S 11023(d)(2) (emphasis added). Subsection (A) gove rns chemicals that have acute effects and imposes two determinations on the EPA: significant adverse huma n health effects and a minimum level of exposure. In contrast, the chronic effects standard of subsectio n (B) requires only a determination of "serious or irreve rsible . . . chronic health effects," and does not refer to any level of

exposure.

We consider TFI's challenge to the EPA's addition o f nitrate compounds to the Inventory under the "chron ic health effects" language of subsection (B)(ii)(IV).

51. The Meaning and Application of "Chronic Effects"

First, TFI asserts that the EPA changed its definit ion and then applied the new definition of "chronic health effects" when adding nitrates to the Inventory, but without explaining the reasons for doing so. TFI compares t he language in the EPA's Hazard Assessment Guidelines for Listing Chemicals on the Toxic Release Inventory, R evised Draft (26 May 1992) ("Draft HAG"), with the determi nation
made in the final rule. The Draft HAG states that c hronic health effects "result from long-term exposure to a chemical." Draft HAG at 29 (emphasis added). By con trast, the EPA's listing for nitrates is premised on the l ong-term (i.e., chronic) consequences of methemoglobinemia.

It is well-established that an agency may not depar t from "established precedent without announcing a princip led

reason for such a reversal." Donovan v. Adams Steel Erection, Inc. 766 F.2d 804, 807 (3d Cir. 1985) (ci ting Local 777, Democratic Union Org. Comm. v. NLRB, 603 F.2d 862 (D.C. Cir. 1978)). Nor may an agency "chang[e] cour se by rescinding a [promulgated] rule" without providing "a reasoned analysis for the change." Motor Vehicle Mf rs. Ass'n, 463 U.S. at 42. Either of these actions woul d be arbitrary and capricious.

However, we are not persuaded that the EPA has abandoned its prior practices here in the way that the precedents require to trigger an explanation. In Ad amsSteel, the agency departed from a series of agencyestablished and court-established precedential stan dards, and in Motor Vehicle Mfrs. Ass'n, the agency depart ed from an already promulgated rule, as distinguished from the unpromulgated Draft HAG, upon which TFI relies. Significantly, TFI did not challenge the evidence o n which the EPA relied either in the rulemaking or in the d istrict
court. We conclude that the EPA was free to exercis e its discretion and expert judgment in relying on a defi nition of other chronic effects that does not require long-te rm exposure. We agree with the D.C. Circuit's conclusi on that the EPA did not abandon any long-held policy in promulgating this rule. See Troy Corp., 120 F.3d at 287.

However, TFI also contends that the EPA has used th e phrase "other chronic effects" inconsistently withi n the final

6rule at issue. TFI apparently argues that because t he EPA

now views persistence beyond the period of exposure as a characteristic of chronic effects, four chemicals t hat it listed under acute effects (subsection (A)) (methyltrichlo rosilane, trimethyltrichlorosilane, brucine, and phosphine) s hould have been listed under chronic effects (subsection (B)), because they may cause permanent injury. TFI Br. at 22.

The EPA concedes that it withdrew voluntarily two of the chemicals (methyltrichlorosilane and trimethyltrichlorosilane) from the Inventory. EPA B r. at 31 (citing Deletion of Certain Chemicals, 63 Fed. Reg. 19838 (1998)). With regard to the two remaining chemicals , it considered factors such as the manifestation period and
duration of the effect and concluded that these che micals "kill too quickly for their effects to be considere d `chronic.' " EPA Br. at 31. Applying this distinction involves p recisely the type of scientific expertise that this court wi ll not second guess. See Southwestern Pa. Growth Alliance, 121

F.3d at 117.

But TFI presses the inconsistency argument further, referring to related litigation over the 1994 rule. See Troy Corp., 120 F.3d 277, aff'g in part and rev'g in par t National Oilseed Processors Ass'n v. Browner, 924 F. Supp. 1 193 (D.D.C. 1996). In Troy Corp., the court considered, inter alia, industry objections to the EPA's listing of b ronopol as
a chronic toxicant. The studies on which the EPA ba sed that listing showed that bronopol produced severe gastrointestinal irritation in tested animals, sugg esting that
it was an acute toxicant. The EPA relied on the dur ation of exposure in placing the chemical under (B), even th ough that subsection does not have an exposure requireme nt. The Troy Corp. court was concerned because previous ly in dealing with hydrogen sulfide the agency had looked not to the length of the exposure but to the length of the effect. The Troy Corp. court, therefore, directed the EPA t o reconsider whether its listing of bronopol in the I nventory was inconsistent with its approach in the earlier c ase. Id. at
291.

Here, the EPA listed nitrates based on the chronic effect, not the duration of the exposure, which is consiste nt with its approach to hydrogen sulfide. Had it based this listing

7on duration of exposure, TFI would have been able t o argue

that the EPA was being inconsistent with the hydrog en sulfide listing. Therefore, the EPA was not arbitra ry and capricious in its listing of nitrates under subsect ion (B).

2. Statutory Construction

TFI next contends that in listing nitrates the EPA interpreted the statutory language of "serious or irreversible," 42 U.S.C. S 11023(d)(2)(B)(ii)(IV), in a way that makes the term "chronic" superfluous, which would b e an impermissible statutory construction. See Babbitt v . Sweet Home Chapter of Communities for Greater Or., 515 U. S. 687, 698 (1995); United Steel Workers v. North Star Stee l Co., 5 F.3d 39, 42 (3d Cir. 1993). Specifically, it argues that "the fact that an adverse effect may persist past the pe riod of exposure is simply another way of stating that the effect is
`serious or irreversible.' " TFI Br. at 25.

As the EPA notes, not all chronic effects are irrev ersible,
and to demonstrate that the word "chronic" retains meaning distinct from "irreversible" it gives the e xample of a stomach ulcer that might develop over a long peri od of time and last a long time but be medically reversib le. Similarly, not all "chronic effects" are necessaril y serious, because, as the EPA notes, a minor effect might las t a long
time.

The mere existence of some overlap between terms do es not mean that the EPA's interpretation of the statu tory language is so unreasonable that it cannot be accep ted. See Sweet Home Chapter, 515 U.S. at 698 (agency interpretation creating overlap with other words in statute a function of act's purposes not agency unreasonabl eness). The deference that we owe to an agency's interpreta tion of its own statute, particularly one this technical, r equires at

least that much.

3. Notice of the Definition of "Chronic Effects"

Finally, TFI contends that during the rulemaking pr ocess the EPA failed to notify the public that the basis for its listing of nitrate compounds as "chronic" was that they produce health effects that persist past the period of exposure. It argues that had it known that the EPA was

8applying what TFI asserts is the "new `chronic effe cts'

definition," TFI would have commented.

In responding, the EPA first notes that TFI did not raise this issue in the district court. Instead, there it raised lack of notice that effects other than methemoglobinemia were the basis for listing nitrates. TFI has not dispute d in its reply brief that the direction of its lack of notic e argument
in the district court was different than that it ma kes here. This alone would support ruling against TFI. In any event, the record supports the conclusion that TFI was ade quately apprised of the definition that the EPA used.

The rulemaking process requires an agency "to fairl y apprise interested parties of all significant subje cts and issues involved," American Iron & Steel Inst. v. EP A, 568 F.2d 284, 291 (3d Cir. 1977) (internal quotation ma rks omitted), so that they can participate in the proce ss. This policy is not undermined when an agency promulgates a final rule that does not mirror precisely the propo sed rule outlined in the notice. A "substantially different" rule is permissible as long as the participants had suffici ent notice at the start of the process. Id. at 293; accord Ass ociation of Oil Pipelines v. FERC, 83 F.3d 1424, 1432 (D.C. Cir . 1996).

The EPA argues that the notice sufficiently apprise d interested parties of its persistent effects ration ale for listing nitrates under the chronic effects category , and that it merely applied what was a commonly used interpre tation of "chronic effects." In its notice, it referred in terested
commenters to the scientific literature on which it s conclusions were based. The EPA notes that at least one commenter understood that EPA would consider an eff ect chronic based on the effect's duration, and that
commentator directed comments to that issue. Just a s TFI could understand that it was not the methemoglobine mia condition itself, but the extended consequences of that condition, that warranted a listing under chronic e ffects, it could conclude that the EPA was relying on the pers istent consequences after exposure.

TFI was apprised sufficiently of the EPA's usage of persistence beyond exposure as the basis for the ni trates listing. Therefore, this final challenge fails.

9III.

CONCLUSION

We have considered all of TFI's other contentions a s well
and conclude that it has failed to demonstrate that the EPA acted arbitrarily and capriciously in listing nitra tes on the Toxic Release Inventory because of their "serious o r irreversible . . . chronic health effects." Thus, w e will affirm the district court's grant of summary judgment for the EPA.

A True Copy:

Teste:

Clerk of the United States Court of Appeals
for the Third Circuit

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