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CRE closely monitors litigation over federal regulations in which CRE participants or Board of Advisors Members are parties. Recent significant litigation that CRE has covered includes:

Harkonen v. OMB and DOJ
The irony involved in this case is inescapable: DOJ indicted and tried Harkonen for alleged inaccuracies in a press release, yet DOJ claims that Congress and OIRA have immunized it from any IQA challenge to significant and harmful inaccuracies in its own press release that was widely disseminated on the Internet.

Reply Brief of Dr. W. Scott Harkonen

New Information Quality Act Case Filed In Ninth Circuit Regarding A Department Of Justice Press Release On A Wire Fraud Conviction

Harkonen Amicus

Pharmaceutical Research and Manufacturers of America Amicus Brief

Brief of Dr. Harkonen

Addendum A

Volume 1

Volume 2

Amicus Brief FDA

9th Circuit Decision

CRE Analysis of Harkonen

Medical Marijuana Litigation
In 2001, despite significant evidence to the contrary, the U.S. Department of Health & Human Services (HHS) began posting to its web site information that marijuana has no medical value. In response to this blatant disregard for scientific evidence, ASA filed a Data Quality Act (DQA) petition on October 4, 2004, requesting that HHS correct its information being disseminated regarding the medical use of marijuana. The DQA requires federal agencies, like HHS, to ensure that the information it distributes is fair, objective and meets certain quality guidelines. Congress passed the DQA primarily in response to increased use of the Internet, to prevent the harm that can occur when government websites, which are easily and often accessed by the public, disseminate inaccurate information.

  • Click to read full article

  • ASA Oral Aguments From Court Transcript

    CMS Sued Over Lack of Transparency
    Multinational Legal Services, CRE’s legal affiliate, acted as counsel to a home medical equipment trade association and an oxygen supply company in their lawsuit against the Centers for Medicare and Medicaid Services for: 1) not conducting a notice-and-comment rulemaking on the agency’s financial qualification standards; and 2) failing to disclose the standards at all. Durable Medical Equipment (DME) suppliers are required to meet the unstated standards in order for their bids to be even considered by CMS in their DMEPOS competitive bidding program.

  • Click to read the complaint
  • Click to read about lawsuit on CRE’s Interactive Public Docket

  • Briefs for the U.S. Court of Appeals for the DC Circuit

  • Click to read Multinational Legal Service’s Appellate Brief
  • Click to read CMS’s Opposition Brief
  • Click to read Multinational Legal Service’s Reply Brief

  • DC District Court Briefs

  • Click to read CMS’s Brief at the District Court
  • Click to read Multinational Legal Service’s Opposition Brief at the District Court
  • Click to read CMS’s Reply Brief at the District Court

  • CRE Files Notice of Intent to Sue DOE for Violation of the Data Quality Act
    CRE filed notice of its intent to sue the Department of Energy (DOE) for violation of its nondiscretionary duty to publish proposed Data Quality Act guidelines for public notice and comment. DOE is the only Cabinet-level agency that has failed to comply with its duties under the Data Quality Act, despite a prior request by CRE for publication of proposed guidelines. DOE's proposed guidelines must be sent to OMB by August 1st, and they must be published in final form by October 1st. Consequently, DOE's inexplicable violation of the statutory deadlines for publishing proposed guidelines has already significantly diminished the public's right to submit meaningful comment. Given CRE's historical involvement in the Data Quality Act, this may be the first in a number of judicial actions that CRE will file. For example, CRE may sue agencies whose Data Quality guidelines do not comply with OMB's government-wide guidelines.

  • Click to review CRE's Notice of Intent to Sue DOE
  • Click to review CRE's earlier request to DOE regarding publication of Data Quality Act guidelines
  • CRE Regulatory Services

  • Legal Challenge to EPA Dioxin Reassessment is Settled
    Plaintiffs and EPA have agreed to settle the legal challenge to the agency's Dioxin Reassessment. However, plaintiffs note there is still potential for a challenge to the Reassessment under the Data Quality Act. With this litigation-related barrier removed, EPA may move rapidly to release the final Dioxin Reassessment for interagency review. The Chairman of EPA's Appropriations Committee in the House has requested that the agency defer release of the Dioxin Reassessment until the National Academy of Sciences has had time to complete an important related study. CRE is informed that the Risk Assessment may state that dioxin has adverse effects at or below background levels. If that is indeed the conclusion of the Reassessment, this will have major implications for the national food supply.

  • Click to review read Settlement Agreement
  • Click to read the letter to EPA from Congressman Walsh
  • Submit a comment

  • Appeals Court Ruling May Aid Challenge to EPA Dioxin Review

    Tozzi v. EPA, (D.D.C. Civ. No. 98-00169)

    • Paperwork Reduction Act challenge to EPA's proposed "Sector Facility Indexing Project", which would have employed a "toxicity weighting factors" model that EPA's own Science Advisory Board had rejected. The agency had intended to place this reformulated TRI data on the Internet, ostensibly to allow easy "toxicity" comparisons of releases across five industry sectors.
    • Three days prior to oral argument in the case, EPA withdrew its plan to use the toxicity weighting factors. The case was subsequently dismissed.
    • For further discussion of this case, see CRE's Regulation by Information section.

    Tozzi v. DHHS, (D.D.C. Civ. No. 99-1170)

    • APA suit seeking declaratory and injunctive relief to prevent HHS from using improper criteria in listing a substance in the National Toxicology Program's forthcoming 9th Report on Carcinogens.
    • Suit alleges that NTP is wrongly relying on animal and mechanistic data in its proposed listing of dioxin as a "known" (as opposed to "reasonably anticipated") human carcinogen. Both sides agree that the epidemiologic data alone will not support such a listing.
    • Following briefing, oral argument on the parties' cross-motions for summary judgment was held June 14, 2000.
    • The district court ruled on September 30, 2000, that the case was judicially reviewable and that some of the Plaintiffs have standing to proceed. In a 12-page opinion (free plug-in) the court deferred to the agency's interpretation of the listing criteria, however, and granted summary judgment to defendants.
    • Plaintiffs are appealing the decision to the D.C. Circuit Court of Appeals.
    • For further discussion of this case, including copies of key briefing, see CRE's Key Briefing.

    Tozzi v. EPA, (D.D.C. Civ. No. 00-0173)

    • Challenge to EPA's final rule on TRI reporting requirements for persistent bioaccumulative toxic (PBT) chemicals. The new rule establishes an extraordinarily low reporting threshold of 0.1 gram for dioxin and 16 related compounds.
    • The suit before U.S. District Court Judge Royce Lamberth alleges that (1) EPA violated the Paperwork Reduction Act by, inter alia, publishing a final rule that did not specify how releases would be calculated for dioxin and dioxin-like compound; (2) EPA failed to articulate an "intelligible principle" for the selection of the specific reporting threshold, and thus usurped legislative power in violation of the non-delegation doctrine; and (3) EPA failed to meet statutory criteria under EPCRA . 313 for TRI listings.
    • The parties have completed briefing, and awaiting the court's ruling on, the government's motion to dismiss the first count relating to the Paperwork Reduction Act.
    • Plaintiffs' suit charges that EPA and OMB violated the act by not allowing the public to comment on the complete information collection request that OMB approved in connection with EPA's final rule. If successful, the suit would establish major precedent for reviewing Paperwork Act determinations, review which many had considered unavailable in light of a judicial preclusion provision in the statute. 
    • Briefing on cross-motions for summary judgment on the "substantive" claims (nos. (2) and (3) above) has been put off until Judge Lamberth rules on the government's motion to dismiss the Paperwork Reduction Act claims.
      • For further discussion of this case, including copies of key briefing, Click Here
    • Counsel for plaintiffs filed papers with EPA and the court arguing that EPA's June 15, 2000, guidance on TRI reporting is both legally and factually insufficient.

    Tozzi v. EPA (D.D.C. Civ. No. 00-2604)

    • APA challenge to EPA's use of "draft" proposed guidelines for cancer risk assessment in lieu of the agency's formally adopted 1986 guidelines.
    • Plaintiffs include a pesticide manufacturer, whose product was classified as a "likely" human carcinogen under the new guidelines, and a plastic medical device manufacturer, whose PVC products are implicated by EPA's dioxin reassessment. The dioxin reassessment is based on the agency's new cancer risk assessment guidelines.
    • Plaintiffs also have brought a claim under the Congressional Review Act because EPA never submitted the new guidelines for review by Congress, as required under that statute.
    • The complaint was filed October 27, 2000, and the case has been assigned to U.S. District Judge Thomas Penfield Jackson in Washington, D.C.
    • For further discussion of this case, including copies of key briefing, click here.

    Data Quality: Partners of Washington, D.C. Law Firm Author Article on Impacts of Tozzi v. DHHS Case: CRE Sees Major Implications for Data Quality Act
    Partners at Bergeson & Campbell, P.C., a D.C. law firm specializing in chemical, medical device, and diagnostic product approval and regulation, recently authored an article entitled "The Tozzi Decision: Another Arrow in Manufacturers' Quiver in Product Defense Wars." Although the article emphasized the importance of the court's decision for designations in the National Toxicology Program's Report on Carcinogens Program, CRE believes that it will have even greater significance for judicial review under the Data Quality Act. For example, the opinion provides precedent for standing when information disseminated by a federal agency is causing harm to a company or person to whom the information relates.

  • Click to read the Bergeson & Campbell article on Tozzi v. DHHS from the EPA Administrative Law Reporter
  • Click to submit a comment

    Deeper Judicial Scrutiny Needed For Agencies' Use Of Science
    A recent decision of the United States Court of Appeals for the District of Columbia Circuit may offer a potentially significant expansion of judicial review of regulatory science. The case involved the Department of Health and Human Services’ (HHS) designation of dioxin as a “known” human carcinogen. The court’s decision to review the Agency’s scientific report under the Administrative Procedure Act w as correct, but the opinion curiously omits discu ssion of a numb er of important rev iewability precedents. The case is a salutary development regarding the availability of judicial review, but, upon reaching the merits, the court retreated to an excessively deferential stance. It is also one among many regulatory science cases which dem onstrate that under the current doctrine of APA review o f regulatory sc ience, the d egree of jud icial scrutiny — i.e., the “hardness” of the look — is not applied in a consistent manner.

  • Click to read full article
  • Click to submit a comment

    FDA Sees EU Dioxin Limits as Source of Trade Dispute
    The FDA has announced that the European Union's new and extraordinarily low limits for dioxin levels in animal feed, which are set to be enforced starting July 1, 2002, could lead to a major U.S.-EU trade dispute. The potential trade war raises the stakes in pending litigation over EPA's dioxin risk assessment because EPA's proposed classification of dioxin as "carcinogenic to humans" could undermine the U.S. negotiating position in talks with the EU. CRE issued a supportive letter to FDA echoing the agency's concerns and urging further involvement.

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  • View past CRE Regulatory Action of the Week items

    Latham & Watkins Analysis of Supreme Court's Mead Decision Suggests Leveled Playing Field for Federal Agencies and Regulated Businesses in Administrative Law Cases
    The law firm of Latham & Watkins has written an insightful analysis that concludes that the Supreme Court's recent decision in United States v. Mead Corp. has dramatically restricted the judicial deference that courts must accord to agencies in determining the meaning of federal statutes. With certain limited exceptions, an agency's interpretation will now receive heightened deference only if the court finds the agency's interpretation to be persuasive. This significant break from the Chevron doctrine is anticipated to level the playing field between federal agencies and private parties in most administrative law cases, leading to new challenges of agency actions.

  • Read Item
  • Click to submit comment

  • Dioxin Reassessment Plaintiffs Assert DC Circuit's Favorable Rulings in Tozzi v. DHHS Undermine EPA's Position on Standing and Reviewability
    Plaintiffs challenging EPA's dioxin reassessment, including CRE Board Member Jim Tozzi, have filed a notice of recent authority alerting Judge Thomas Penfield Jackson to striking similarities in the recent decision in Tozzi v. DHHS. On November 23, 2001, the DC Circuit held that plaintiffs in the DHHS case, including a PVC medical device manufacturer, had standing to challenge the National Toxicology Program's listing of dioxin as a known human carcinogen. The Appeals Court also ruled that the NTP report was reviewable agency action. The same PVC company, and virtually the same reviewability issues, are present in the Tozzi v. EPA suit.
  • Read about this suit
  • Read about Tozzi v. DHHS
  • Click to submit comment

  • D.C. Court Of Appeals Rules In Tozzi v. DHHS That When An Agency Issues A Pejorative Statement, The Statement Is Judically Reviewable: Major Implications For The Data Quality Act
    This case holds that a corporation can sue when an agency makes a pejorative statement against a corporation, product, or person, before such a statement is incorporated in a final rule. This opinion will have a major impact on the Data Quality Law because an agency denial of a petition for correction will be reinforced by the standing and reviewability criteria in this opinion. Notwithstanding the courts deference to an agency's interpretation of its own rules, the opinion sets a major precedent on both a government-wide basis and for EPA's upcoming dioxin reassessment in particular.

  • Read Item
  • Read Bureau of National Affairs Article
  • Comment on Item
  • View past CRE Regulatory Action of the Week items

  • TRI Suit Extended Pending EPA Discussions on PBT Reporting
    Parties to a federal lawsuit challenging EPA's new reporting requirements for releases of 17 persistent bioaccumulative toxic (PBT) chemicals have agreed to defer court briefing while discussions about supplemental reporting continue with the agency. The plaintiffs, including CRE Board Member Jim Tozzi, have agreed to postpone their summary judgment filing until November 1, 2001 in the hope that talks with the agency may yield an agreement on broader use of toxic equivalents or "TEQ" methodology under the agency's new reporting rule. In another development, EPA stated in a letter to Congress that the agency is "working in partnership with the American Chemistry Council and the Chlorine Chemistry Council" to provide improved public access to TEQ data.

  • Read discussions on TEQ reporting.
  • Click to read a summary of the latest regulatory news.
  • Click to submit comment

  • Oral Argument Set in NTP Dioxin Listing Appeal
    The U.S. Court of Appeals for the D.C. Circuit has directed attorneys in Tozzi v. DHHS to limit their September 17, 2001 oral arguments to 10 minutes for each side. At issue in the case is whether NTP violated its own criteria for listing substances as "known" human carcinogens during the dioxin review for the agency's biennial Report on Carcinogens. CRE Board Member Jim Tozzi and other plaintiffs are appealing a lower court's ruling that the agency was within its rights to consider all test data -- including animal data -- as "relevant" to the known human carcinogen determination. The appeals court is also expected to question counsel about the plaintiffs' legal standing and the court's power to review so-called "informational" government statements.

  • Read more about NTP lawsuit.
  • Read about other litigation.
  • Click to submit comment

  • The Mead Decision Changes Judicial Review of Agency Action
    In his dissent to the recent United States Supreme Court's opinion in United States v. Mead Corp., 120 S. Ct. 2164, 2188 (2001), Justice Scalia stated that this opinion will have "enormous" consequences because it "is one of the most significant opinions ever rendered by the Court dealing with the judicial review of administrative action." Mead was applied for the first time to EPA in Tozzi v. EPA.

  • Read the Legal Memorandum.
  • Read Tozzi v. EPA.
  • Read Mead
  • Comment on Item

    Court to Hear Paperwork Act Argument in Request to Block TRI Reporting
    U.S. District Judge Royce Lamberth will hear arguments on Friday, June 29, 2001 in the Toxic Release Inventory reporting case Tozzi v. EPA. Plaintiffs seek to enjoin EPA from requiring reporting of certain chemical data, which must be submitted by July 1, on the grounds that EPA violated the Paperwork Reduction Act, and other laws, in connection with the agency's 1999 PBT chemical reporting rule. Judge Lamberth's ruling will have government-wide implications; at stake is whether agencies can bypass the PRA by submitting incomplete clearance packages to OMB for review.

  • Read about this litigation, including key briefs
  • Comment on Item

    Scientists File Brief in Support of Tozzi Challenge to NTP Dioxin Listing
    A group of prominent health scientists has filed an amicus or "friend of the court" brief with the D.C. Circuit in support of appellants who are challenging NTP's classification of dioxin as a "known human carcinogen".

  • To Amicus Brief, Discussion and related links

    Tozzi Plaintiffs File DC Circuit Brief in NTP Dioxin Case
    CRE Advisory Board Member Jim Tozzi and several other plaintiffs have appealed to the DC Circuit to reverse a lower court ruling that allowed the National Toxicology Program to classify dioxin as a "known human carcinogen". In a 51-page brief filed April 30, 20001, the Tozzi plaintiffs argued that the agency wrongly relied on animal and human in vitro studies to make up for a lack of sufficient epidemiologic evidence, which the agency had always required for "known" listings in previous editions of the Report on Carcinogens. Plaintiffs also argue that the HHS Secretary arbitrarily revised the agency's listing rationale at the last moment to avoid a defeat in court.

    The Tozzi v. DHHS case takes on added significance in light of recent dioxin related activities at EPA as well. With a majority of EPA's Science Advisory Board voting against classification of dioxin as a human carcinogen (see related article), NTP's dioxin listing may have a strong impact on EPA's final dioxin reassessment, which is nearing completion. Briefing in the NTP case will continue over the summer, and oral argument has been scheduled for September 17, 2001. EPA may decide to defer finalization of its report until the DC Circuit rules on NTP's dioxin listing.

  • Read DC Circuit Brief in NTP case.
  • Read more about NTP lawsuit.
  • Comment on Item
  • View past CRE Regulatory Action of the Week items

    Court Lifts Seal in Tozzi v. HHS Case
    On April 17, 2001, a federal court ordered the public disclosure of certain key documents relating to NTP's upgrade of dioxin to "known human carcinogen" in the 9th RoC. The documents reflect that the agency's new rationale for the upgraded listing, revealed to the plaintiffs only minutes before oral argument, was the brainchild of the Office of the HHS Secretary and that the Secretary arbitrarily supplanted the listing criteria adopted by NTP scientists. The materials had been held under seal for nearly a year.

  • Read DC Circuit Brief in NTP case.
  • Read more about NTP lawsuit.
  • Comment on Item

    Tozzi Lawyers Respond to EPA Motion to Dismiss Dioxin Reassessment Suit
    Quoting recent criticism of EPA from the agency's own Science Advisory Board, attorneys for CRE Board Member Jim Tozzi argue that EPA has failed to provide a rationale for changing its 1986 carcinogen risk assessment policy, and that the Tozzi suit challenging EPA's forthcoming dioxin reassessment should be allowed to move forward. Plaintiffs' latest brief also asserts that EPA is using the agency's so-called "cancer guidelines" as rules that are binding on reviewing scientists and that the agency is applying multiple and inconsistent review standards in an arbitrary and capricious manner. The court should allow plaintiffs to proceed with discovery to explore these questions of fact, plaintiffs argue. Plaintiffs also respond to EPA's arguments on standing and the Congressional Review Act.

  • Read about this litigation, including this and other key briefs.
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    EPA Moves to Dismiss Tozzi Suit Over Dioxin Reassessment
    In a 33-page brief by the Department of Justice's Environmental Defense Section, EPA has moved to dismiss the suit filed late last year by CRE Advisory Board Member Jim Tozzi and other plaintiffs. The government's motion challenges plaintiffs' claims that the dioxin reassessment and the pyrethrins cancer hazard classification at issue are "final agency actions". The agency further asserts that its cancer risk assessment guidelines are merely non-binding guidance that EPA may amend without notice-and-comment rulemaking. The government's brief also attacks plaintiffs' standing and denies that the Congressional Review Act allows for judicial review. Charles Fromm, counsel for plaintiffs, acknowledged that DoJ had filed a forceful brief, but he noted that recent DC Circuit decisions cast some doubt on the agency's position.

  • Read about this litigation, including key briefs
  • Comment on Item
  • Tozzi Plaintiffs Seek Injunction Against EPA Dioxin Reassessment
    CRE Advisory Board Member Jim Tozzi and other plaintiffs have asked a federal court to enjoin EPA from releasing as final the agency's controversial dioxin reassessment. The Tozzi suit alleges that EPA is violating federal law by basing the reassessment on cancer risk guidelines that the agency has never finalized. While EPA has already agreed to give Tozzi 10 days notice before publishing its report, Plaintiffs' motion for injunction states that, notwithstanding the agency's commitment, completion of the report may be imminent and should be enjoined while the case is pending. The brief invokes recent D.C. Circuit decisions in support of the alleged APA and Congressional Review Act violations and describes the threatened harm to one of the Plaintiffs, a PVC medical device manufacturer. The filing concludes, "The public would be ill served by premature release of a risk assessment whose underpinnings (i.e., the draft cancer risk assessment guidelines) are considered by the agency as unworthy of being finalized."

  • Read about this litigation, including key briefs
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  • Dropping Its Earlier Reliance on Animal Data, NTP Lists Dioxin as "Known Human Carcinogen"
    Citing a rationale that was never presented to agency reviewing committees, the NIEHS on January 19 moved to amend the Ninth Report on Carcinogens to list dioxin as a "known human carcinogen". The agency's action makes public a document that was previously placed under seal, at the request of the agency, in litigation challenging the upgraded listing. The final status of the listing is on appeal to the D.C. Circuit.

  • Read Item
  • Read about related litigation
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  • Tozzi and Others Sue EPA Over Dioxin Risk Assessment
    CRE Advisory Board Member Jim Tozzi and other plaintiffs filed a new suit against EPA based on the agency's violation of two "good government" laws. The suit challenges EPA's use of "draft guidelines" for carcinogen risk assessments in lieu of agency guidelines that were formally adopted in 1986. According to plaintiffs, EPA's use of the new guidelines violates the Administrative Procedure Act, and the guidelines are also without effect because they were never submitted to Congress pursuant to the Congressional Review Act. The Tozzi plaintiffs specifically are challenging EPA's use of the draft guidelines to classify a botanical pesticide as a "likely" human carcinogen and to support the agency's controversial dioxin reassessment.

  • Read More About This Suit, Including Briefs
  • Read More About Other Tozzi Litigation

    D.C. Circuit Rejects NTP Motion for Summary Affirmance in Tozzi Suit
    Plaintiffs challenging NTP's listing of dioxin as a known human carcinogen scored a partial victory on December 15, 2000, when the D.C. Circuit held that the government had not met its burden of showing that a lower court ruling in the government's favor warranted summary affirmance. Plaintiffs Jim Tozzi and others are appealing a September 30 ruling holding that NTP properly interpreted the criteria for listing substances in the 9th Report on Carcinogens.

  • Read D.C. Circuit Order
  • Read More About This Suit, Including Briefs
  • Court Reviews RoC, Holds Plaintiff in Tozzi v. HHS Has Standing
    Judge Emmet Sullivan ruled that a PVC manufacturer had standing to challenge a proposed upgraded listing for dioxin in the 9th Report on Carcinogens. The court's September 30, 2000 opinion also ignored government arguments that the RoC is not judicially reviewable. This aspect of the decision sets important precedent for review of risk assessments and similar so-called "informational" agency actions. The court sided with the agency on its interpretation of the RoC listing criteria, however, a decision plaintiffs are appealing.

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  • D.C. Circuit Briefing in NTP Tozzi Suit Now Available
    CRE has posted recently filed briefs to the D.C. Circuit in the case of Tozzi v. DHHS. The briefs were filed in connection with the appeal from a ruling September 30, 2000, in which a lower court deferred to NTP's interpretation of criteria for listing substances in the Report on Carcinogens.

  • Read More About This Suit, Including Briefs
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    EPA's TRI Reporting Guidance Does Not Cure Paperwork Act Violations, Tozzi Plaintiffs Assert
    Counsel for plaintiffs suing EPA and OMB over the agencies' violations of the Paperwork Reduction Act filed papers notifying EPA and the court that EPA's recent guidance on TRI reporting is both legally and factually insufficient.

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