Food & Water Watch, Inc. v. U.S. Envtl. Prot. Agency
This text of 291 F. Supp. 3d 1033 (Food & Water Watch, Inc. v. U.S. Envtl. Prot. Agency) is published on Counsel Stack Legal Research, covering District Court, N.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
Opinion
EDWARD M. CHEN, United States District Judge
The Toxic Substances Control Act ("TSCA")'s Section 6(a) requires Defendant *1036United States Environmental Protection Agency ("EPA") to regulate the use of certain chemical substances that it determines pose an unreasonable risk to health or the environment.
Plaintiffs petitioned the EPA under Section 21 to regulate the fluoridation of drinking water supplies under Section 6(a) because, they maintain, the ingestion of fluoride poses an unreasonable risk of neurotoxic harm to humans. After the EPA denied Plaintiffs' petition, Plaintiffs filed this suit seeking judicial review of the EPA's determination. The EPA argues that Plaintiffs' lawsuit should be dismissed because their administrative petition failed to address conditions of use other than the fluoridation of drinking water, failed to specifically identify the chemicals at issue, and failed to justify treatment of those chemicals on a categorical basis. For the reasons stated herein, the Court finds a citizen petition need not evaluate all conditions of use; that Plaintiffs sufficiently identified the chemicals they sought to regulate; and that Plaintiffs presented an adequate basis, in their administrative petition, for requesting categorical treatment of the chemicals they identified. Defendant's motion is DENIED .
I. FACTUAL & PROCEDURAL BACKGROUND
Plaintiffs are a group of non-profit organizations and associations and individual parents who sue on behalf of themselves and their minor children.1 They allege that fluoridation chemicals (specifically, hydrofluorosilicic acid, sodium silicofluoride, and sodium fluoride) are added to public water supplies across the United States in an attempt to reduce tooth decay. Compl. ¶ 3. The practice began in the 1940s "on the mistaken premise that fluoride's primary benefit to teeth comes from ingestion. "
On November 22, 2016, Plaintiffs petitioned the EPA to issue a rule under Section 6(a) of the Toxic Substances Control Act ("TSCA"),
Defendant attaches Plaintiffs' petition as Exhibit 1 to the Rave Declaration. See Docket No. 28-1 (hereinafter "Admin. Pet.").2 In the first paragraph of the cover letter, the petition states that the signatories "hereby petition the U.S. Environmental Protection Agency to protect the public and susceptible subpopulations from the neurotoxic risks of fluoride by banning the addition of fluoridation chemicals to water." Admin. Pet. at 1. The petition is approximately 30 pages long and summarizes scientific studies Plaintiffs maintain demonstrate the neurotoxic effects of ingesting fluoride in low doses, as well as the heightened risks to vulnerable subpopulations. According to the Table of Contents, petitioners attached 45 pages of appendices identifying hundreds of scientific studies upon which their petition relies, but the EPA did not submit them to the Court with its motion.
The EPA denied the petition on February 17, 2017.
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EDWARD M. CHEN, United States District Judge
The Toxic Substances Control Act ("TSCA")'s Section 6(a) requires Defendant *1036United States Environmental Protection Agency ("EPA") to regulate the use of certain chemical substances that it determines pose an unreasonable risk to health or the environment.
Plaintiffs petitioned the EPA under Section 21 to regulate the fluoridation of drinking water supplies under Section 6(a) because, they maintain, the ingestion of fluoride poses an unreasonable risk of neurotoxic harm to humans. After the EPA denied Plaintiffs' petition, Plaintiffs filed this suit seeking judicial review of the EPA's determination. The EPA argues that Plaintiffs' lawsuit should be dismissed because their administrative petition failed to address conditions of use other than the fluoridation of drinking water, failed to specifically identify the chemicals at issue, and failed to justify treatment of those chemicals on a categorical basis. For the reasons stated herein, the Court finds a citizen petition need not evaluate all conditions of use; that Plaintiffs sufficiently identified the chemicals they sought to regulate; and that Plaintiffs presented an adequate basis, in their administrative petition, for requesting categorical treatment of the chemicals they identified. Defendant's motion is DENIED .
I. FACTUAL & PROCEDURAL BACKGROUND
Plaintiffs are a group of non-profit organizations and associations and individual parents who sue on behalf of themselves and their minor children.1 They allege that fluoridation chemicals (specifically, hydrofluorosilicic acid, sodium silicofluoride, and sodium fluoride) are added to public water supplies across the United States in an attempt to reduce tooth decay. Compl. ¶ 3. The practice began in the 1940s "on the mistaken premise that fluoride's primary benefit to teeth comes from ingestion. "
On November 22, 2016, Plaintiffs petitioned the EPA to issue a rule under Section 6(a) of the Toxic Substances Control Act ("TSCA"),
Defendant attaches Plaintiffs' petition as Exhibit 1 to the Rave Declaration. See Docket No. 28-1 (hereinafter "Admin. Pet.").2 In the first paragraph of the cover letter, the petition states that the signatories "hereby petition the U.S. Environmental Protection Agency to protect the public and susceptible subpopulations from the neurotoxic risks of fluoride by banning the addition of fluoridation chemicals to water." Admin. Pet. at 1. The petition is approximately 30 pages long and summarizes scientific studies Plaintiffs maintain demonstrate the neurotoxic effects of ingesting fluoride in low doses, as well as the heightened risks to vulnerable subpopulations. According to the Table of Contents, petitioners attached 45 pages of appendices identifying hundreds of scientific studies upon which their petition relies, but the EPA did not submit them to the Court with its motion.
The EPA denied the petition on February 17, 2017.
The remainder of the EPA's denial sets forth a substantive response to the scientific studies submitted by the petitioners. See, e.g.,
Plaintiffs now seek an order compelling the EPA to initiate the process for the rule they requested. See
II. STATUTORY CONTEXT
This motion turns on interpretation of the Toxic Substances Control Act, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Pub. L. No. 114-182,
The relationship between three provisions of the Act are at issue here. Section 6(a), codified at
A. Section 6(a): Regulation of Chemical Substances Posing Unreasonable Risk of Harm
The TSCA requires the EPA to regulate the use of certain chemical substances that pose an unreasonable risk of harm health *1039or the environment. Under Section 6(a) of the TSCA, codified at
[i]f the Administrator determines in accordance with subsection (b)(4)(A) that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or that any combination of such activities, presents an unreasonable risk of injury to health or the environment, the Administrator shall by rule and subject to section 2617 of this title, and in accordance with subsection (c)(2), apply one or more of the following requirements to such substance or mixture to the extent necessary so that the chemical substance or mixture no longer presents such risk....
• prohibiting, restricting, or limiting the amount of such substance that may be manufactured, processed, or distributed in commerce,id. § 2605(a)(1) ;
• prohibiting, restricting, or limiting such manufacture, processing, or use in connection with "a particular use" or "a particular use in a concentration in excess of a level specified by the Administrator,"id. § 2605(a)(2)(A) ;
• labeling requirements for such substance,id. § 2605(a)(3);
• record-keeping requirements for manufacturers or processors of the substance,id. § 2605(a)(4);
• commercial-use regulations,id. § 2605(a)(5);
• disposal requirements,id. § 2605(a)(6); and,
• notice requirements,id. § 2605(a)(7).
The EPA may limit the application of such requirements to "specified geographic areas."
After the LCSA amendments in 2016, there are now three possible pathways to obtaining a Section 6(a) rule regulating substances:
1) After an EPA risk evaluation of a chemical which the EPA has sua sponte designated as "high priority," see15 U.S.C. § 2605 (c)(1), which results in a finding of unreasonable risk;
2) After an EPA risk evaluation of a chemical at the request of a manufacturer, see15 U.S.C. § 2605 (b)(4)(C)(ii), which results in a finding of unreasonable risk; or,
3) Upon granting a Section 21 citizen petition, see15 U.S.C. § 2620 (a), § 2620(b)(3).
Each pathway is discussed below.
B. EPA's Sua Sponte Designation of High-Priority Chemicals
Both parties agree that the LCSA's most significant amendments to the TSCA relate to Section 6(b), codified at
Once the EPA has designated a chemical substance "high-priority," it must initiate a Section 6(b) "risk evaluation."
*1040
The procedure for and scope of a "risk evaluation" are discussed below. If, upon completion of a Section 6(b) risk evaluation, the EPA determines that a chemical substance presents an unreasonable risk, it must initiate rulemaking to address that risk under Section 6(a).See
C. Section 6(b) Risk Evaluations
The purpose of a risk evaluation is to:
determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator, under the conditions of use.
Within six months of initiating a Section 6(b) risk evaluation, the EPA must publish a scope document that describes "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider."
The statute requires the EPA to "establish, by rule, a process to conduct [such] risk evaluations" no later than June 22, 2017.
As explained in the final rule, the EPA ultimately sided with those commenters who argued that a risk evaluation need not cover all conditions of use. Thus,
EPA went back to the direction on risk evaluation provided in section 6(b) of the statute and legislative history, and developed an approach to the term, 'the conditions of use' that is firmly grounded in the law, while accounting for the various policy considerations necessary for effective implementation of section 6. EPA's final approach is informed in part by the legislative history of the amended TSCA, which explicitly states that the Agency is given the discretion to determine the conditions of use that the Agency will address in its evaluation of the priority chemical, in order to ensure that the Agency's focus is on the conditions of use that raise the greatest potential for risk. See, June 7, 2016 Cong. Rec. S3519-S3520.
In its final rule, the EPA affirmed that, in identifying "the conditions of use" of a chemical substance, it "will be guided by its best understanding, informed by legislative text and history, of the circumstances of manufacture, processing, distribution in commerce, use and disposal Congress intended EPA to consider in risk evaluations."
[I]n developing the scope of the risk evaluation, TSCA section 6(b)(4)(D) requires EPA to identify 'the conditions of use that the Agency expects to consider in a risk evaluation,' suggesting that EPA is not required to consider all conditions of use. Consequently, EPA may, on a case-by-case basis, exclude certain activities that EPA has determined to be conditions of use in order to focus its analytical efforts [in a risk evaluation] on those exposures that are likely to present the greatest concern, and consequently merit an unreasonable risk determination.
For those "conditions of use" that the EPA elects to include within the scope of a risk evaluation, the EPA has also explained that it may "conduct its risk evaluations in stages." 82 Fed. Reg. at 33729. Accordingly, "in cases where EPA has sufficient information to determine whether or not the chemical substance presents an unreasonable risk under particular conditions of use, the Agency may issue an early determination for that subset of conditions of use, while EPA continues to evaluate the remaining conditions of use." Id. Thus, even when the EPA has determined to perform a risk evaluation on some but not all conditions of use, it affords itself the discretion to issue partial risk determinations on particular conditions of use while it continues to assess other conditions of use within its defined scope.
D. Manufacturer Requests
In addition to the Section 6(b) risk evaluation required for chemicals sua sponte designated by the EPA as "high priority," the TSCA also requires a Section 6(b) risk evaluation to be performed upon the request of the manufacturer of a chemical substance. See
The EPA has, pursuant to § 2605(b)(4)(C)(ii), promulgated a rule governing the required form, manner, and criteria for a manufacturer's request for risk evaluation. In its proposed rule, the EPA required manufacturers to address all conditions of use in their requests for a risk evaluation. See Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act,
In response, the EPA modified its position. The final rule thus states that "EPA agrees with many of these concerns in opposition to the proposed approach."
EPA intends to conduct a full risk evaluation that encompasses both the conditions of use that formed the basis for the manufacturer request, and any additional *1043conditions of use that EPA identifies, just as EPA would if EPA had determined the chemical to be high priority. However, rather than require the manufacturer to identify any additional conditions of use that EPA will evaluate, EPA will determine the additional conditions of use during the process of determining whether to grant or deny the manufacturer request.
Accordingly, under the final rule, a manufacturer need not address all conditions of use, but rather only those that interest it. See
E. Section 21: Citizen Petitions
The TSCA's Section 21 (
When the EPA denies a petition or fails to act within 60 days of the petition, a petitioner may "commence a civil action in a district court of the United States to compel the Administrator to initiate a rulemaking proceeding as requested in the petition."
As passed in 1976, the reviewing court was to compel the EPA to initiate the action requested by the petitioner under Section 6(a) if the petitioner demonstrated by a preponderance of the evidence that "there is a reasonable basis to conclude that the issuance of such a rule or order is necessary to protect health or the environment against an unreasonable risk of injury."
If the court determines that the petitioner has satisfied that burden, then it "shall order the Administrator to initiate the action requested by the petitioner."
III. DISCUSSION
Defendant argues that Plaintiffs' lawsuit must be dismissed for three reasons. The Court first addresses Defendant's argument that the petition must be dismissed because it does not address all "conditions of use" for fluoride, but rather, only the one that interests petitioner, the fluoridation of drinking water supplies. The Court then reviews Defendant's argument that dismissal is required because the petition does not adequately identify the chemical substances Plaintiffs seek to regulate and because the petition does not provide adequate grounds to justify treating "fluoridation chemicals" as a category. For the reasons below, the Court rejects each of Defendant's arguments.
A. Plaintiffs Are Not Required to Identify All Conditions of Use for a Chemical Substance in Their Petition
The central dispute is whether Section 21 requires Plaintiffs to address all conditions of use in their petition as the EPA contends, or whether citizen petitions, such as the one filed in this case, may address only the conditions of use the petition seeks to regulate.
Statutory interpretation begins with the text of the statute. See Los Angeles Lakers, Inc. v. Fed. Ins. Co. ,
1. Statutory Text and Structure
The text of Section 21 imposes only a procedural requirement that a petition must be filed with the Administrator and a substantive requirement that the petition "set forth the facts which it is claimed establish that it is necessary to issue, amend, or repeal a rule under section 2603, 2605, or 2607 of this title or an order under section 2603 or 2604(e) or (f) of this title." See
*1045Additional substantive requirements, if any, could arise therefore only through Section 21's incorporation of Section 6. In other words, Section 21 requires a petition to present "the facts" which "establish that it is necessary" to issue a Section 6(a) rule. See
According to Section 6(a), a rule is required when "in accordance with subsection (b)(4)(A)" the EPA determines that a chemical substance "presents an unreasonable risk of injury to health or the environment."
Defendant rejects this literal and natural reading, claiming that a citizen petitioner must instead present the EPA with all information about all uses of a chemical substance (i.e. , about all the "conditions of use"), even those uses which are of no interest to the petitioner and which the petitioner does not contend pose an unreasonable risk.
This argument has no basis in the statutory text. Not only does it ignore Section 6(a)'s use of the singular article "an" in describing unreasonable risks, Section 21 does not itself use the term "conditions of use." See
With respect to Section 6(b), there is no good reason to believe that the term's appearance therein is to be imported into Section 21 such that it obligates all citizen petitioners to address all conditions of use.6 Section 21 refers only generally to Section 6; it does not specifically refer to *1046Section 6(b). See
That makes sense in light of the fact that there are three different pathways to a Section 6(a) rule. The predicate for a rule is a finding of unreasonable risk. Section 6(b) governs two processes that may result in an unreasonable risk finding: risk evaluations based on EPA's sua sponte designation of a "high priority" chemical" and risk evaluations at the request of a manufacturer. Section 21 governs the third pathway, one that appears to be independent of the Section 6(b) risk evaluation process. Indeed, the TSCA explicitly requires a Section 6(b) "risk evaluation" to be performed for "high priority" chemicals and in response to manufacturer requests, but does not state that the same requirement applies to citizen petitions. See U.S.C. § 2605(b)(4)(C). Thus, the statutory text and structure suggest that Section 21 does not require a citizen petitioner to perform the functional equivalent of a Section 6(b) risk evaluation with respect to conditions of use that the petitioner does not seek to regulate.
Nor is there any reason to think that the term "under the conditions of use," as it appears in Section 21's judicial review provisions, see
This reading also coheres with the statutory requirement that the "conditions of use" for a chemical substance are to be "determined by the Administrator,"
Moreover, the statutory timelines present another problem for the EPA's interpretation. The EPA has three-and-a-half years to complete a Section 6(b) risk evaluation; yet it must act on a citizen petition under Section 21 within 90 days. If the EPA is correct that a citizen petitioner must present all scientific information related to all conditions of use of a chemical substance, then the EPA would essentially be required to perform a potentially wide ranging plenary review within three months perhaps approximating what the EPA would otherwise have three-and-a-half years to complete. Thus, far from easing the EPA's burden, its interpretation requiring Section 21 petitions to tender and the EPA to evaluate all conditions of use would expand that burden exponentially. The structure of the statute thus suggests that a Section 21 petition is not intended to require citizen petitions to present all conditions of use, thus burdening the EPA with an expansive evaluative task which must be completed within 90 days.
Thus, the text and structure of the statute do not support the EPA's contention that Section 21 requires a citizen petitioner who seeks to regulate a chemical substance to address all conditions of use. Rather, a natural reading suggests that a Section 21 petitioner need only present "the facts" which "establish that it is necessary" to issue a rule under Section 6(a), see
*10482. Purpose of the Statute
The EPA's interpretation would also undermine the role of Section 21 citizen petitions and the purpose of the TSCA.
The purpose of citizen petitions is to ensure the EPA does not overlook unreasonable risks to health or the environment. See Env. Def. Fund v. Reilly ,
The EPA's interpretation would undermine the purpose of Section 21 by permitting it to deny even a petition that successfully identifies an unreasonable risk of harm to health or the environment under a single condition of use simply because the petition does not also address all other conditions of use. The EPA would be permitted not to act despite knowledge of an unreasonable risk of harm, while simultaneously inoculating itself from judicial review of its refusal to act because of the petition's supposed deficiency. That a known unreasonable risk of harm could be ignored by the EPA is contrary to the TSCA's very purpose, as well as the statute's express command that the EPA "shall" promulgate regulations when "an" unreasonable risk is found. See
Further, the EPA's interpretation creates a disparity between citizen petitions and manufacturer requests. Under the EPA's published rules, a manufacturer's request for a Section 6(b) risk evaluation may be limited to only those particular conditions of use of interest to the manufacturer. See
Thus, the purpose of the statute is more consonant with a reading that Section 21 does not require a petitioner to address all conditions of use.
3. Legislative History
Although the text, structure, and purpose of the TSCA clearly demonstrate that *1049a Section 21 petition does not need to address all conditions of use, the Court's interpretation is also bolstered by the legislative history. See Hernandez ,
The EPA argues that the Committee Report carries no weight because it referred to an earlier draft of the legislation that did not include the "conditions of use" language. That is incorrect. It is true that the phrase "conditions of use" did not appear directly in the citizen petition section of that draft. However, the draft referred to whether a citizen petition demonstrated that a chemical would not meet "the safety standard." S. 697 (114th Cong. 1st Sess., Jun. 17, 2015). The term "safety standard," in turn, was defined in the draft to mean "a standard that ensures, without taking into consideration cost or other nonrisk factors, that no unreasonable risk of injury to health or the environment will result from exposure to a chemical substance under the conditions of use ...."
Accordingly, the legislative history also supports the view that citizen petitioners are not required to address all conditions of use.
4. Consistency With EPA Regulations
The Court's interpretation is also consistent with the EPA's regulations with respect to manufacturer requests and sua sponte risk evaluations under Section 6(b). (The EPA has not proposed or adopted any rule specifically addressing Section *105021.) As explained above, EPA initially took the position that a Section 6(b) risk evaluation must address all conditions of use, but its final rule permits it to focus on fewer than all conditions of use. Compare 82 Fed. Reg. at 7565with 82 Fed. Reg. at 33728-29. The EPA argued that its final rule was grounded in the statutory text. See 82 Fed. Reg. at 33729 (explaining that the statutory text "suggest[s] that EPA is not required to consider all conditions of use" and thus EPA "may" "exclude certain activities that EPA has determined to be conditions of use" from the scope of a Section 6(b) risk evaluation). Similarly, the EPA backed away from a requirement that a manufacturer must address all conditions of use when requesting a Section 6(b) risk evaluation. See 82 Fed. Reg. at 33736.
If the term "under the conditions of use" does not impose an affirmative requirement that every manufacturer request or sua sponte review address all conditions of use in the Section 6(b) context, then there is no reason to think it does so in the context of Section 21 citizen petitions.
5. Deference to EPA's Interpretation
The EPA's litigation argument herein that citizen petitions must identify all conditions of use before they can be considered is not entitled to Chevron deference. As a threshold matter, as explained above, the statutory text, structure, and purpose strongly indicate that a Section 21 petition need not address all conditions of use. Arguably, there is thus no need to refer to the agency's interpretation given the clear statutory text. Cf. Trumpeter ,
Even if there is ambiguity, the agency's interpretation would not be entitled to Chevron deference. "Generally, Chevron deference is reserved for legislative rules that an agency issues within the ambit of the authority entrusted to it by Congress. Such rules are characteristically promulgated only after notice and comment." Tablada v. Thomas ,
At best, the EPA's interpretation may be entitled to Skidmore deference "proportional to its power to persuade." Tablada ,
Finally, the EPA's policy arguments in support of its interpretation are unavailing. It argues that citizen petitioners must present information about all conditions of use, otherwise, citizen petitioners would place a drain on agency resources and cut in line ahead of "high priority" chemical substances or those identified by manufacturers. Even so, that would not necessarily be inconsistent with the statute's purpose. A citizen petition must persuade the EPA that a chemical substance poses an unreasonable risk of harm before the EPA is required to issue a rule. It is not unreasonable that Congress would require the EPA to act in response to a known unreasonable risk of harm, regardless of whether the finding is prompted by a citizen petition, a manufacturer request, or a sua sponte evaluation by the agency. In any event, the statute contemplates the possibility that some citizen petitions may present evidence of harms that are nevertheless less pressing than other matters pending before the EPA. Reviewing courts are thus required to weigh the relative harm addressed by a citizen petition, as well as consider, and accommodate, any EPA resource constraints in fashioning relief. See
For those reasons, the EPA's interpretation in this litigation is entitled to minimal, if any, weight, and the Court rejects it.13
*10526. Conclusion
In sum, the statutory text does not support the EPA's interpretation. Rather, a natural reading of the language suggests a citizen petitioner need only present facts demonstrating that a chemical substance poses an unreasonable risk due to one or more conditions of use that are of concern to the petitioner. This construction is consistent with the language, structure, and purpose of the statute, the legislative history, the EPA's interpretation of similar provisions, and the policies Congress sought to advance. The Court therefore concludes that Section 21 does not require a petition under Section 6(a) to address all conditions of use, but rather, only those that the petitioner seeks to regulate. The EPA's motion to dismiss for failure to address all conditions of use is DENIED .
B. Plaintiffs Adequately Identified the Chemical Substances at Issue
Defendant also argues Plaintiffs' petition "does not provide enough information to allow the Agency or the Court to evaluate 'fluoridation chemicals' under th[e] statutory scheme because it does not identify the specific chemical substances at issue...." Mot. at 8. According to Defendant, the petition merely "allege[s] neurological effects of exposure to unspecified 'fluoridation chemicals.' " Mot. at 12.
This argument is not persuasive. The EPA did not deny Plaintiffs' petition on the grounds that it was not sufficiently specific for the EPA to evaluate. Rather, the EPA denied the petition on the merits. See 82 Fed. Reg. at 11,881, col. 3. (concluding petition did "not set forth a scientifically defensible basis to conclude that any persons have suffered neurotoxic harm as a result of exposure to fluoride in the U.S. through the purposeful addition of fluoridation chemicals to drinking water or otherwise from fluoride exposure in the U.S."). Like the EPA, the Court will be able to understand from the petition and supporting materials what chemicals are at issue.
Moreover, Plaintiffs' petition does identify the chemical substances they seek to regulate. A "chemical substance" is "any organic or inorganic substance of a particular molecular identity, including-(i) any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature and (ii) any element or uncombined radical." See
Plaintiffs' petition sufficiently identifies the chemicals at issue. This is not a case where Plaintiffs seek to regulate a chemical in litigation that the EPA did not realize was at issue in the administrative petition. Defendant's motion to dismiss on that basis is DENIED.
C. Plaintiffs' Reference to the Category "Fluoride" Does Not Require Dismissal
Relatedly, Defendant argues that Plaintiffs' petition fails to justify treatment of the three "fluoridation chemicals" as a "category" under
a group of chemical substances the members of which are similar in molecular structure, in physical, chemical, or biological properties, in use, or in mode of entrance into the human body or into the environment, or the members of which are in some other way suitable for classification as such for purposes of this chapter....
Plaintiffs' petition plainly presents a basis for why the chemical substances are "similar" "in use" and "in mode of entrance into the human body": they are all allegedly used for fluoridation of water, and are all ingested through water consumption. Moreover, Plaintiffs claim that these chemicals all have similar "physical, chemical, or biological properties," insofar as they are all used for the same purpose (fluoridation of water to prevent tooth decay) and pose a similar risk of harm (neurotoxic effects). Thus, the petition plainly presents a basis for why it is made with respect to a "category" of chemicals under § 2625(c).
Defendant also argues the use of a category was problematic because Plaintiffs requested regulation of "several different chemicals" but "fail[ed] to distinguish between them," thus conveying "inadequate information about the properties or conditions of use of the individual chemical substances for EPA or the Court to determine whether they should be considered as a category for purposes of risk evaluation and any necessary regulation." Mot. at 13. This argument contradicts the record. The EPA did not deny Plaintiffs' petition because it had inadequate information to evaluate the petition, but rather because the petition did "not set forth a scientifically defensible basis" to conclude that "the purposeful addition of fluoridation chemicals to drinking water" causes harm. See 82 Fed. Reg. at 11,881, col. 3. Moreover, as discussed above, Plaintiffs were not required to identify all conditions of use for each of the compounds where they sought *1054to regulate only one condition of use, fluoridation of drinking water.
At best, the EPA raises the question whether Plaintiffs will meet their burden in this litigation by showing by a preponderance of the evidence that each chemical substance in the category of "fluoride" or "fluoridation chemicals" poses an unreasonable risk of harm, as appears to be required under
IV. CONCLUSION
Plaintiffs are entitled to judicial review of their petition on the merits because they complied with the two minimal statutory requirements: they filed their petition with the Administrator, and they set forth the facts they believe justify a rule under Section 6(a) regulating the fluoridation of drinking water supplies. Plaintiffs were not required to address other uses of fluoridation chemicals in their petition to the EPA. Moreover, Plaintiffs sufficiently identified the chemical substances at issue in their petition and explained why they seek to regulate that category of substances. Whether they can meet their ultimate burden on the merits with respect to each chemical substance remains to be seen, but they are at least entitled to attempt to make that showing. Defendant's motion to dismiss is DENIED .
This order disposes of Docket No. 28.
IT IS SO ORDERED .
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