Administrative Law Prof Blog

Compounding an error

Another interesting discussion from the Drug and Device Law blog of Jim Beck (Dechert LLP) and Mark Herrmann (Jones Day), "Compounding, Repackaging, or Manufacturing?".

We don't deal with FDA regulatory matters that often, and with the criminal side even less, but the recent decision out of Colorado in U.S. v. Bader, slip opinion here, was too juicy to ignore.

It points out a serious flaw in the FDA's regulatory scheme that we think needs a formal regulatory fix - and soon.

The issue in Bader is the limits on pharmacy compounding.

In Bader a pharmacist purchased bulk human growth hormone ("HGH") - although it could just as easily been some other type of drug (maybe steroids, often used for similar purposes?) - a drug that's subject to severe restrictions when distributed as a drug in the USA.

Anyway, the defendant bought HGH in bulk form and from our point of view, didn't appear to do much to it. As stated in the opinion, he:

    inspected the bulk HGH powder he had received for quality and potency, measured out the proper amount of bulk HGH powder into a single-dose container, separately packaged an appropriate quantity of saline for the consumer to mix with the powder, labeled and packaged the HGH dosage and the saline together, and supplied the two items to the customer. (The customer was responsible for actually mixing the saline and HGH before administering the drug.)

Slip op. at 4.

After that the defendant pharmacist was open for business, able to fill prescriptions in avoidance of otherwise strict regulations, because "the FDA rigorously regulates the importation and distribution of finished drugs that areready for distribution to consumers, but exercises relatively little regulatory oversight over the importation of drug ingredients to be used by pharmacists to create 'compounded' drugs." Slip op. at 3.

So the FDA busted this pharmacist, claiming that what he was doing wasn't "compounding," but merely "repackaging" of a drug that was effectively in consumer-usable form. Id.

Problem is, after all these years, the FDA still doesn't have any formal definition of "compounding" in its regulations. So it had a hard time distinguishing "compounding" from "repackaging."

What follows is a fairly detailed discussion of FDA over-action, Congressional reaction, the 9th Circuit finding the statutory fix unconstitutional, subsequent judicial action, and FDA inaction until the FDA finds itself in an enforcement pickle. A good read and a good example of what can go wrong in the regulatory process. EMM

General versus particularized regulation

An adult business zoning case from Patty Salkin's (Albany) Law of the Land blog: "Municipalities May Regulate Secondary Effects of Adult Business Uses in General, Without Putting Forth Evidence as to the Negative Effects Resulting from Each Individual Business Impacted" addresses the issue of an agency must regulate based on general effects or must examine the effect of each regulated entity individually.

Content-neutral time, place, and manner restrictions like the AZO [the regulation under discussion] are allowed as long as they are “narrowly tailored” to serve a “substantial governmental interest” and do not unreasonably limit the alternative modes of communication available. The Fourth Circuit Court of Appeals stated that the validity of such a regulation depends on its relation to the overall problem which the government seeks to ameliorate. In enacting AZOs the City is entitled to rely on the experience and studies of other cities and states, and is not required to conduct new studies, as long as the evidence relied upon is reasonably believed to be relevant to the problem at hand. Although the Appellants argued that the restriction was unconstitutional because data gathered after the passage of the AZO proved the opposite of what the AZO sought to resolve, the only requirement in reviewing AZOs are that a city show that in enacting its AZO, the city relied on evidence believed to be reasonably relevant to the problem at hand.  When passing an ordinance the City only needs to rely on the secondary effects of adult establishments in the aggregate, not on an individual basis.  The Court stated that what ultimately mattered in cases challenging AZOs is if the City had a sufficient evidentiary basis for adopting the ordinance, and Appellants conceded that the [City] did, so the partial judgment is affirmed.

The second contention that the Appellants put forth, that the AZO was unconstitutional because it does not mandate the ZBA to consider factual evidence concerning the secondary effects of adult businesses, was merely an attempt by the Appellants to avoid the consequences of the AZO’s amortization provision.  When an ordinance targets secondary effects, it does not make sense to require the ZBA to consider evidence that a particular adult establishment is not currently generating the effects that the AZO is trying to resolve.  There is no assurance that the establishments will not begin to generate adverse secondary effects. The Court held that they simply “do not see how the Constitution requires a zoning board to consider whether an adult establishment actually generates secondary effects when decided whether or not to grant a variance.”  The Court concluded that the City may enforce the AZO against an adult establishment without regard to whether that particular establishment generates undesired secondary effects. The district court properly granted summary judgment in favor of the City on the constitutional claim.

Independence News, Inc. v. City of Charlotte, 2009 WL 1533166 (4th Cir. June 3, 2009).

EMM

Private enforcement of regulations

Attorneys Beck and Harrmann at the Drug and Device Law blog have another good case on private enforcement of federal regulations in "Read The Blog, Luke!" (yes, they are a little snippy here, but understandably so), discussing Pantages v. Cardinal Health, No. 5:08-cv-116-Oc-10GRJ, 2009 U.S. Dist. LEXIS 64238 (M.D. Fla. July 27, 2009):

In any event, Judge Jones addressed the "more fundamental problem with Plaintiff's claim for negligence per se" that the parties had overlooked. Id. at *6. "Under Florida law, the violation of a federal regulation does not create civil liability based upon a theory of negligence per se in the absence 'of a legislative intent to create a private right of action.'" Id. Because there is no legislative intent to create a private right of action under the Device Packaging regulation, "Plaintiff's claim fails to state a cause of action for which relief can be granted because Florida law does not recognize a claim based upon a theory of negligence per se for an alleged violation of this particular federal regulation." Id. at *8.

EMM

A useful recent case for "how much process is due"

From the New York Public Personnel Law blog, "An 'at-will' employee given fair notice and an opportunity to be heard prior to dismissal has received the due process required by the 14th Amendment", discussing Biliski v. Red Clay Consolidated School District (3rd Cir. Docket No. 08-1742):

Edward A. Biliski, a computer technician was employed by the Red Clay Consolidated School District Board of Education. Terminated from his position following “several performance” issues,* Biliski sued, contending the School District had violated his procedural right to due process when it dismissed him.

The District’s defense: Biliski was an “at-will employee and did not enjoy a “constitutionally protectable property interest in his job.”

The Third Circuit ruled that “the process [Biliski] received comported with his rights under the Due Process Clause of the Fourteenth Amendment,” and decided that it was “unnecessary to address whether Biliski possessed a property interest in his continued employment."

Biliski was “under the impression” that he could only be fired for “just cause.” However, said the court, his belief was based on information he was given by co-workers rather than the District. ...

Applying “the interest-balancing framework” that the Supreme Court established in Mathews v. Eldridge, [424 US at 333], to decide whether the totality of the administrative process Biliski received in connection with his termination, including the written presentation of his position to the formal decision-maker, satisfied the “fundamental requirement of due process [, which] is the opportunity to be heard ‘at a meaningful time and in a meaningful manner,’” the Circuit Court decided Biliski received constitutionally sufficient notice of the reasons underlying the District's decision to dismiss him and that the pre-termination proceedings provided to Biliski was constitutionally sufficient.

Considering the several Mathews v. Eldridge factors noted above as relevant here, the court said it was satisfied that Biliski received fair notice of the reasons for the District's action and was give an opportunity to be heard as to why the Board should not terminate his employment.

In other words, given the interests at stake here, Biliski received all the process that was due him.

EMM

Useful web site

From George Mason University, OpenRegs.com. From the site:

OpenRegs.com is an easy-to-navigate regulatory portal. Every day, federal agencies issue dozens of rules that affect you, your business, and your family. We make it easy to keep track of proposed and final regulations and to submit comments to the agencies.

OpenRegs.com is an alternative to the federal government's Regulations.gov regulatory dockets database. That site can be confusing and difficult to use for average citizens and experts alike. The goal of OpenRegs.com is to make the proposed and final regulations published in the Federal Register easy to find and discuss, so that citizens can become better informed and more involved in the regulatory process.

OpenRegs.com also has features not available anywhere else. These include the ability to browse by, and subscribe to, individual agencies and topics codes. Also available are discussion forums for each agency and each regulation, user-submitted related links, and much more. We hope you'll explore the site and join the conversation.

Please note, though, that using OpenRegs.com is not a substitute for visiting Regulations.gov. That site is ultimately the official site. Also, if you want to see comments filed with agencies in a particular regulatory proceeding, you'll have to visit Regulations.gov or the agency's own site. OpenRegs.com should serve as the launching pad, research portal, and discussion community for your regulatory adventures. Enjoy!

Finding Regulations

There are several ways to find regulations on OpenRegs.com. First, you can find regulations by issuing agency. You can also browse by topic in order to find regulations related to a particular subject matter regardless of issuing agency. On the home page, you'll also see links to recently proposed regulations, and proposed regulations the comment periods of which are closing soon. Finally, you can always search to find regs.

Subscribing to Alerts

One of the best features OpenRegs.com offers is the ability to subscribe to alerts by agency or topic. You can choose to receive a notice each time a new proposed or final regulation is published by a particular agency or related to a particular topic regardless of agency. Just click on the "Subscribe to the feed" link on the top right of any agency or topic page.

The discussion forums (fora?) are not popular yet, but considering it just started at the end of June that is hardly surprising. For those interested in specific agencies, this looks like a great service. EMM

New administrative law articles

From the University of Washington's Current Index to Legal Periodicals:

• Berry, Douglas C., David M. Byers and Daniel J. Oates. State regulation of franchising: the Washington experience revisited. 32 Seattle U. L. Rev. 811-901 (2009). [H]|[L]|[W]
• Conley, Marla K. Caring for dolphins, otters, and octopuses: speciesism in the regulation of zoos and aquariums. 15 Animal L. 237-264 (2009). [H]|[L]|[W]
• Eng, Vanessa. Note. Drug safety: it's a learning process. 24 St. John's J. Legal Comment. 159-199 (2009). [H]|[L< /A>]|[W]
• Fitzgerald, Edward A. The Alaskan wolf war: the public trust doctrine missing in action. 15 Animal L. 193-235 (2009). [H]|[L]|[W]
• Ghilain, Katherine. Student article. Improving community character analysis in the SEQRA environmental impact review process: a cultural landscape approach to defining the elusive "community character". 17 N.Y.U. Envtl. L.J. 1194-1242 (2009). [H]|[L]|[W]
• McCammon, Melanie. Note. Environmental perspectives on siting wind farms: is greater federal control warranted? 17 N.Y.U. Envtl. L.J. 1243- 1294 (2009). [H]|[L]|[W]
• Orloski, Michelle. Comment. Preventing Gross injury to local cultural patrimony: a proposal for state regulation of deaccessioning. 81 Temp. L. Rev. 605-634 (2008). [H]|[L]|[W]
• Strocko, Michael. Just a concern for good manners: the Second Circuit strikes down the FCC's broadcast indecency regime. 17 U. Miami Bus. L. Rev. 155-209 (2008). [H]|[L]|[W]
• Tobin, Joseph. Going from the frying pan into the fire? A critique of the U.S. Treasury's newly proposed section 987 currency regulations. 17 U. Miami Bus. L. Rev. 211-267 (2008). [H]|[L]|[W]
• Valencia, Alejandro. The FCC's regulatory mulligan: exploring the options in the wake of a failed D Block auction. 10 N.C. J.L. & Tech. 313- 380 (2009). [H]|[L]|[W]
• Woolhandler, Ann. Delegation and due process: the historical connection. 2008 Sup. Ct. Rev. 223-267. [H]|[L]|[W]
• Zeller, Bruno. Systems of carbon trading. 25 Touro L. Rev. 909-942 (2009). [H]|[L]|[W]
• Resilience & Environmental Law Reform Symposium. Introduction by Marilyn Averill; articles by Robert L. Glicksman, Sandra Zellmer, Lance Gunderson, Mary Jane Angelo, Alyson C. Flournoy, Ahjond S. Garmestani, Craig R. Allen and Heriberto Cabezas. 87 Neb. L. Rev. 821-1054 (2009). [H]|[L]|[W]
  • Averill, Marilyn. Introduction: resilience, law, and natural resource management. 87 Neb. L. Rev. 821-832 (2009). [H]|[L]|[W]
  • Glicksman, Robert L. Ecosystem resilience to disruptions linked to global climate change: an adaptive approach to federal land management. 87 Neb. L. Rev. 833-892 (2009). [H]|[L]|[W]
  • Zellmer, Sandra and Lance Gunderson. Why resilience may not always be a good thing: lessons in ecosystem restoration from Glen Canyon and the Everglades. 87 Neb. L. Rev. 893-949 (2009). [H]|[L]|[W]
  • Angelo, Mary Jane. Stumbling toward success: a story of adaptive law and ecological resilience. 87 Neb. L. Rev. 950-1007 (2009). [H]|[L]|[W]
  • Flournoy, Alyson C. Protecting a natural resource legacy while promoting resilience: can it be done? 87 Neb. L. Rev. 1008-1035 (2009). [H]|[L]|[W]
  • Garmestani, Ahjond S., Craig R. Allen and Heriberto Cabezas. Panarchy, adaptive management and governance: policy options for building resilience. 87 Neb. L. Rev. 1036-1054 (2009). [H]|[L]|[W]

EMM

Theory: Motivations for regulatory overcompliance

From the Review of Law & Economics: "Firms’ Motivations for Environmental Overcompliance" by JunJie Wu (Oregon State) and Teresa M. Wirkkala (ENTRIX, Inc.) Abstract:

This article examines firms’ motivations for environmental overcompliance. A theoretical model is developed to identify the internal and external factors that influence firms’ decisions for environmental overcompliance. An empirical analysis is then conducted to determine the statistical significance of those factors using the primary data collected in an industrial survey in Oregon. The results suggest that diverse factors influence business decisions for environmental overcompliance, including market forces, regulatory pressures, and personal values and beliefs of upper management toward environmental stewardship.

It would be interesting to see if this article's findings apply in other regulatory arenas. EMM

New administrative law articles

From the University of Washington's Current Index to Legal Periodicals:

• Aftergood, Steven. Reducing government secrecy: finding what works. 27 Yale L. & Pol"y Rev. 399-416 (2009). [H]|[L]|[W]
• Bumgardner, Heath D. Comment. A bureaucratic challenge to representation: security clearance requirements and the right to counsel. 19 Geo. Mason U. Civ. Rts. L.J. 625-661 (2009). [H]|[L]|[W]
• Fleder, Samuel David. Comment. Circumvention by delegation? An analysis of North Carolina"s Open Meetings Law and the Byrd loophole. 31 Campbell L. Rev. 535-556 (2009). [H]|[L]|[W]
• Halpert, Mordachi and Boaz Sangero. From a plane crash to the conviction of an innocent person: why forensic science evidence should be inadmissible unless it has been developed as a safety-critical system. 32 Hamline L. Rev. 65-94 (2009). [H]|[L]|[W]
• Pawlenko, Kye. The non-viability of state regulation of workplace captive audience meetings: a response to Professor Secunda. 32 Hamline L. Rev. 191-206 (2009). [H]|[L]|[W]
• Sharkey, Erica. Note. Eureka Stone Quarry, Inc. v. Department of Environmental Protection: the rocky results of air quality violations. 20 Vill. Envtl. L.J. 337-359 (2009). [H]|[L]|[W]

EMM

Why no new stuff?

I'm at the annual meeting of the American Association of Law Libraries in DC. I will be back in my office (and on the reference desk) on Thursday, July 28. EMM

Legislative or administrative decision? And why?

An Idaho case from Patty Salkin's (Albany) Law of the Land blog, "County’s Decision on Whether to Amend Comprehensive Plan Not Reviewable by Court":

The Supreme Court of Idaho held that because there is no statute authorizing judicial review of the legislative decision whether or not to amend a comprehensive plan, the courts may not review the Board’s actions. The Court noted that a county board of commissioners is not an “agency” under the Idaho Administrative Procedures Act (IAPA), and that therefore its actions are not reviewable absent a statute invoking judicial review provisions of the IAPA. The Court said that a request to amend zoning is not an “application for a permit” which would have provided for judicial review, noting that “An application for a zoning change, like a request for an amendment to a comprehensive plan, is not an application for a ‘permit’ and thus no review is authorized…” Lastly, the Court commented that although this legislative decision is not subject to judicial review, it could be subject to scrutiny by means of collateral actions such as declaratory actions.

The definitions of "legislative decisions" and "administrative decisions vary from jurisdiction to jurisdiction. YMMV. EMM

The Recurring Question of Chevron Deference & Agency Jurisdiction

From Jonathan Adler at The Volokh Conspiracy, "The Recurring Question of Chevron Deference & Agency Jurisdiction". Opening paragraph:

Unless you’re an avid follower of federal energy law, there’s no reason you would have noticed the U.S. Court of Appeals for District of Columbia’s recent decision in Connecticut Department of Public Utility Control v. Federal Energy Regulatory Commission. In this case, a panel held that the Federal Energy Regulatory Commission (FERC) has jurisdiction to review the installed capacity requirement set by a regional transmission organization that administers regional electricity transmission. Those not focused on energy regulation (myself included) might be tempted to ask, “Who cares?” But not so fast. CDPUC v. FERC raised an interesting an important administrative law question that has bedeviled and divided federal appellate courts for years: Whether courts should grant Chevron deference to agency statutory interpretations that implicate the an agency’s regulatory jurisdiction.

Nemo debet esse iudex in propria causa (no one should be judge in his own cause). As Lord Coke said, "even an act of Parliament made against natural equity, as to make a man a judge in his own case, is void in itself". Co. Lit. §212. Yes, I know that the British courts no longer follow this maxim as to acts of Parliament, but it remains applicable otherwise. Prof. Adler points out,

Yet in some prior cases, the D.C. Circuit has expressly declined to defer to agency interpretations of statutory provisions defining the scope of an agency’s jurisdiction. As the court explained in its 1987 decision in ACLU v. FCC:

it seems highly unlikely that a responsible Congress would implicitly delegate to an agency the power to define the scope of its own power. When an agency's assertion of power into new areas is under attack, therefore, courts should perform a close and searching analysis of congressional intent, remaining skeptical of the proposition that Congress did not speak to such a fundamental issue.

My own view is that the D.C. Circuit had it right in 1987 is wrong today.

See "The Rest is Silence: 'Chevron' Deference, Agency Jurisdiction, and Statutory Silences" by Nathan Sales and Jonathan Adler on SSRN. Abstract:

Should agencies receive Chevron deference when interpreting the reach of their own jurisdiction? This article argues that, in general, they should not. We begin by identifying and detailing the various different types of jurisdictional questions that may arise in statutory interpretation. The article then surveys how the Supreme Court and lower federal courts have analyzed these different aspects of the jurisdiction problem, with a particular attention to statutory silences. The Court's Chevron jurisprudence strongly suggest that deference to agency determinations of their own jurisdiction should be disfavored, particularly where a statute is silent (and not merely ambiguous) about the existence of agency jurisdiction. In particular, we argue that courts should deny Chevron deference regardless of whether an agency is asserting or disclaiming jurisdiction. This no-deference rule should apply in both existence- and scope-of-power cases, but courts should continue to show deference where agencies assert the existence of a factual predicate that triggers jurisdiction. We support our proposal with arguments drawing on both traditional administrative law norms and public choice analyses of the incentives faced by agencies and other relevant actors. While there are strong counterarguments to our proposal - particularly the potential difficulty in distinguishing between jurisdictional and non-jurisdictional questions - this article maintains that denying deference in the jurisdictional context is desirable and consistent with Chevron principles.

Recommended. EMM

An interesting APA case

On the Statutory Construction Blog, David Hricik (Mercer) point out an interesting Federal Circuit opinion in "Holy Trinity Wise but Would be Ignored Today?". The case is Nat'l Cable Telecomm. Ass'n v. FCC, No. 08-1016 (Fed. Cir. May 26, 2009). Dave is quite right that the statutory interpretation arguments would be difficult to summarize, and I commend them to you.

The dispute is over new FCC regulations prohibiting exclusive cable deals in multifamily housing. These regulations are a reversal of the 2003 Inside Wiring Order. From an administrative law perspective, the Court deals with three objections. I'm going to omit all of the cites and internal quotes. First, beginning on page 13:

For their primary APA claim, petitioners argue that in deciding "to bar [exclusivity contracts] now, after affirmatively permitting them in 2003," the Commission failed to explain its change of heart and thus acted arbitrarily and capriciously. Of course, it is axiomatic that agency action must either be consistent with prior action or offer a reasoned basis for its departure from precedent. Yet it is equally axiomatic that an agency is free to change its mind so long as it supplies a reasoned analysis, showing that prior policies and standards are being deliberately changed, not casually ignored. Petitioners believe that the Commission has neither reasonably disavowed the logic of the 2003 Inside Wiring Order nor explained how that logic could fail to produce the same outcome on the record now presented. Finding the Commission's extensive discussion of its change in approach more than equal to our forgiving standard of review, we disagree. ...

Indeed, even were the analysis in the 2003 Inside Wiring Order more extensive, and even had it expressly committed the Commission to petitioners' preferred logic, the 2007 Order's analysis would still easily satisfy our deferential standard of review. As the Supreme Court recently put it, "[the Commission] need not demonstrate to a court's satisfaction that the reasons for the new policy are better than the reasons for the old one; it suffices that the new policy is permissible under the statute, that there are good reasons for it, and that the agency believes it to be better." In other words, the existence of contrary agency precedent gives us no more power than usual to question the Commission's substantive determinations. We still ask only whether the Commission has adequately explained the reasons for its current action and whether those reasons themselves reflect a clear error of judgment. Here, the Commission could hardly have made its "good reasons" for its current policy clearer: it believes that individual consumers are more likely to capture the benefits of competition in the absence of exclusivity agreements. ... Given this explanation, together with the rest of the Commission's extensive analysis of exclusivity contracts, we can easily see a clear articulation of the concerns driving its change in policy, as well as the basis for the new, reasonable inferences the Commission drew from a significantly updated record. This marks the limits of our review.

The second argument is on page 19:

Mounting a separate complaint, real estate petitioners argue that the Commission acted arbitrarily by rejecting their proposed alternative remedies, including case-by-case adjudication. This argument runs aground on bedrock administrative law, which puts the choice between proceeding by general rule or by individual, ad hoc litigation primarily in the informed discretion of the administrative agency. ... [W]e see considerable wisdom in the Commission's determination to avoid the burden that would be imposed by numerous individual adjudications, a judgment petitioners have given us no reason to doubt.

The third administrative law issue begins on page 19:

The final issue presented concerns the Commission's decision to apply its rule to existing contracts. According to petitioners, this amounts to directly retroactive action barred by the APA's requirement that legislative rules be given future effect only ...

First, we think it readily apparent that the Commission's action has only future effect as the APA and our precedents use that term. The exclusivity ban purports to alter only the present situation, not the past legal consequences of past actions. Petitioners insist that under our precedent, [t]he critical question is only whether the Commission's rule "changes the legal landscape". Of course, if that were all it took to render a rule impermissible under the APA, it would spell the end of informal rulemaking. We have thus repeatedly made clear that an agency order that only upsets expectations based on prior law is not retroactive. That describes precisely this case. Here the Commission has impaired the future value of past bargains but has not rendered past actions illegal or otherwise sanctionable. It is often the case that a business will undertake a certain course of conduct based on the current law, and will then find its expectations frustrated when the law changes. Such expectations, however legitimate, cannot furnish a sufficient basis for identifying impermissibly retroactive rules. ...

Legitimate expectations, it noted, were left largely undisturbed, because [t]he lawfulness of exclusivity clauses ha[d] been under [the Commission's] active scrutiny for a decade, and both the Commission and several individual states had already taken similar actions. Finally, the Commission explained that incumbent operators would continue to reap the benefits of their natural monopolies, as they will still be able to use their equipment in MDUs to provide service to residents who wish to continue to subscribe to their services.

Once again, we think [the Commission's] extensive discussion easily satisfies the Commission's obligation under our deferential standard of review [i.e., Chevron — Editor]. The Commission balanced benefits against harms and expressly determined that applying the rule to existing contracts was worth its costs. Indeed, it devoted as much analysis to this narrow issue as it did to the entire question of exclusivity contracts in the 2003 Inside Wiring Order on which petitioners claim they reasonably relied. Thus, although petitioners believe that the 2003 order promised them that their exclusivity deals would remain valid, we agree with the Commission that any cautious administrative lawyer would have understood that the Commission could later take precisely the action it decided against in 2003. That agencies may change their minds is, after all, a matter of hornbook law — all the more so where, as here, the initial decision not to act was based on the insufficiency of the record. We thus see nothing unreasonable in the Commission's balancing of the benefits and costs and, following familiar principles of judicial review, we decline to rebalance those factors for ourselves.

EMM

Standing - particularized injury

From Patty Salkin's (Albany) Law of the Land blog, "Town Residents Who Were Not Adjacent Property Owners Lacked Standing to Challenge Public Boat Launching Site":

Following a request by the Board of Selectmen to improve the Westport Island’s only public boat-launching site, the planning board approved the project. The proposal ... was expected to increase daily trips to and from the site by 36 vehicles during peak season. ... [O]pponents asked the planning board to grant them party status because the frequently travel on the road where the boat launch is located and they were concerned about safety issues with increased traffic. ... Although the residents alleged they were aggrieved because their personal property was threatened due to the increased risk of traffic accidents at the frequently traveled intersection, the board rejected this argument finding that they failed to prove any “potential injury different from that suffered by the general public traveling over [the] Route.”

The Supreme Court of Maine noted that just because ... they live on the Island and frequently travel by the site, and because they attended the planning board hearings, does not demonstrate that the residents are “aggrieved parties” for purposes of appeal to the zoning board within the meaning of the zoning ordinance. The Court said that in addition to demonstrating party status during the administrative proceeding, to be an “aggrieved party” they must also demonstrate that they suffered a particularized injury or harm. Relying only on their status as members of the driving public, is not enough to grant standing since they have no property affected directly or indirectly by the boat ramp permit and no other economic interest that could give them standing. The Court also noted that their alleged harm was not particularized given the fact that 1,600 people drive by the site daily.

EMM

New administrative law articles

From the University of Washington's Current Index to Legal Periodicals:

• Botein, Michael. Federal regulation of FIOS and Lightspeed: a tale of two jurisdictional dilemmas. 53 N.Y.L. Sch. L. Rev. 1041-1055 (2008/09). [H]|[L]|[W]
• Crawford, Susan P. Transporting communications. 89 B.U. L. Rev. 871-937 (2009). [H]|[L]|[W]
• Krishtul, Anna Pikovsky. Comment. The FDA's recent about-face: Plan B age restriction is unlawful rulemaking and violates minors' due process rights. 81 Temp. L. Rev. 303-330 (2008). [H]|[L]|[W]
• Madara, Matthew R. Note. Constitutional law--sacrificing the good of the few for the good of the many: denying the terminally ill access to experimental medication. 31 W. New Eng. L. Rev. 535-580 (2009). [H]|[L]|[W]
• Silvers, Damon and Heather Slavkin. The legacy of deregulation and the financial crisis--linkages between deregulation in labor markets, housing finance markets, and the broader financial markets. 4 J. Bus. & Tech. L. 301-347 (2009). [H]|[L]|[W]
• Zaring, David. Personal liability as administrative law. 66 Wash. & Lee L. Rev. 313-367 (2009). [H]|[L]|[W]
• Proposed Regulatory Systems. Articles by Gerald Korngold, John Patrick Hunt and Thomas E. Plank. 60 S.C. L. Rev. 727-805 (2009). [H]|[L]|[W]
  • Korngold, Gerald. Legal and policy choices in the aftermath of the subprime and mortgage financing crisis. 60 S.C. L. Rev. 727-748 (2009). [H]|[L]|[W]
  • Hunt, John Patrick. One cheer for credit rating agencies: how the market-to-market accounting debate highlights the case for rating- dependent capital regulation. 60 S.C. L. Rev. 749-778 (2009). [H]|[L]|[W]
  • Plank, Thomas E. Regulation and reform of the mortgage market and the nature of mortgage loans: lessons from Fannie Mae and Freddie Mac. 60 S.C. L. Rev. 779-805 (2009). [H]|[L]|[W]
• Sustainable Energy: The Intersection of Innovation, Law, and Policy. Keynote address by John Hanger; articles by Gary E. Marchant, Amy L. Edwards, David M. Driesen and Robert A. Reiley. 18 Widener L.J. 817-935 (2009). [H]|[L]|[W]
  • Hanger, John. Keynote address at the Widener Law Journal Symposium. 18 Widener L.J. 817-829 (2009). [H]|[L]|[W]
  • Marchant, Gary E. Sustainable energy technologies: ten lessons from the history of technology regulation. 18 Widener L.J. 831-858 (2009). [H]|[L]|[W]
  • Edwards, Amy L. When brown meets green: integrating sustainable development principles into brownfield redevelopment projects. 18 Widener L.J. 859-881 (2009). [H]|[L]|[W]
  • Driesen, David M. Sustainable development and air quality: the need to replace basic technologies with cleaner alternatives. 18 Widener L.J. 883-895 (2009). [H]|[L]|[W]
  • Reiley, Robert A. Financial incentives and the leadership role taken by Pennsylvania and other states to bring green energy to the free market. 18 Widener L.J. 897-935 (2009). [H]|[L]|[W]
• Symposium on Health Care Technology: Regulation and Reimbursement. Foreword by Maxwell J. Mehlman; articles by Michael Ash and Stephen Arons, Timothy S. Hall, Karen A. Jordan and Richard S. Saver. 31 W. New Eng. L. Rev. 293-451 (2009). [H]|[L]|[W]
  • Mehlman, Maxwell J. Foreword. 31 W. New Eng. L. Rev. 293-303 (2009). [H]|[L]|[W]
  • Ash, Michael and Stephen Arons. Economic parameters of end-of-life care: some policy implications in an era of health care reform. 31 W. New Eng. L. Rev. 305-332 (2009). [H]|[L]|[W]
  • Hall, Timothy S. Regulating direct-to-consumer advertising with tort law: is the law finally catching up with the market? 31 W. New Eng. L. Rev. 333-352 (2009). [H]|[L]|[W]
  • Jordan, Karen A. Opening the door to hard-look review of agency presumption. 31 W. New Eng. L. Rev. 353-410 (2009). [H]|[L]|[W]
  • Saver, Richard S. At the end of clinical trial: does access to investigational technology end as well? 31 W. New Eng. L. Rev. 411-451 (2009). [H]|[L]|[W]

EMM

SSRN Administrative Law Abstracts for July 20, 2009

Tomorrow's Research Today ADMINISTRATIVE LAW ABSTRACTS Accepted Paper Series Vol. 13, No. 14: Jul 20, 2009 WILLIAM FUNK, EDITOR Professor of Law, Lewis & Clark Law School funk@lclark.edu Click here to browse ALL abstracts for this journal   Links: Subscribe ~ Unsubscribe | Distribution | Network Directors | Advisory Board | Submit ~ Revise Your Papers   Table of Contents Are 'Better' Security Breach Notification Laws Possible? Jane K. Winn, University of Washington - School of Law Standing for the Public: A Lost History M. Elizabeth Magill, University of Virginia School of Law The President as Scientist-in-Chief Michele E. Gilman, University of Baltimore - School of Law Jurisdiction as Competition Promotion: A Unified Theory of the FCC's Ancillary Jurisdiction John F. Blevins, South Texas College of Law Accountability in the Administrative Law Judiciary: The Right and the Wrong Kind Edwin Felter, affiliation not provided to SSRN The Australian Crowns - Changing the Rules of Succession Anne Twomey, University of Sydney - Faculty of Law Is a Competent Federal Government Attainable or Oxymoronic? Peter H. Schuck, Yale University - Law School ^top ADMINISTRATIVE LAW ABSTRACTS "Are 'Better' Security Breach Notification Laws Possible?"  Berkley Technology Law Journal, 2009 JANE K. WINN, University of Washington - School of Law Email: jkwinn1@u.washington.edu Security breach notification laws (SBNLs) have clearly succeeded in bringing the issue of inadequate information security to the attention of American consumers, but it is not clear whether have succeeded in creating stronger incentives for American businesses to invest in better security for databases of sensitive personal information. This paper reviews the development of new governance approaches to regulation, including “responsive regulation,” “smart regulation” and “better regulation” and then applies new governance criteria to SBNLs to show why they are unlikely to have much impact on the information security policies of many American businesses. This paper reviews the practical problems that any business faces when trying to secure large quantities of sensitive personal information, and outlines what a “better regulation” approach to information security regulation targeting sensitive personal information might include. "Standing for the Public: A Lost History"  Virginia Law Review, 2009 M. ELIZABETH MAGILL, University of Virginia School of Law Email: mem2a@virginia.edu This article recaptures a now-anachronistic approach to standing law that the Supreme Court followed in the middle decades of the 20th Century and explains how and when it died. It then speculates about why the federal courts retreated from the doctrine when they did. The now-anachronistic view of the permissible scope of standing, which is called here 'standing for the public,' permitted Congress to authorize parties who had no cognizable legal rights to challenge government action, in order to, as the Supreme Court itself said 'represent the public' and bring the government’s legal errors before the courts. Ironically, the federal courts retreated from this approach to standing law in the 1960s and 1970s, the very period that is best known for its doctrinal innovations that liberalized standing law. The article tells the (complicated) tale of how the courts erased the standing for the public principle from the case law, places those actions action in context by looking at contemporaneous developments in the legal profession and Congress, and speculates about why this approach to standing law died when it did. "The President as Scientist-in-Chief"  Willamette Law Review, Vol. 45, No. 3, 2009 MICHELE E. GILMAN, University of Baltimore - School of Law Email: mgilman@ubalt.edu During the Bush Administration, many scientists, both inside and outside of government, asserted that the President was distorting scientific knowledge to achieve political ends. In controlling the scientific output of government agencies, President Bush acted consistently with unitary executive theory. Under this theory, the President can direct the output and discretion of government agencies. This article examines the tension between a unitary executive and government agencies engaged in scientific research and policy making. In particular, the article assesses the legality of two high profile instances in which President Bush allegedly distorted scientific data to achieve his policy objectives: global climate change and human embryonic stem cell research. The article assesses whether a Scientist-in-Chief model of executive control fosters the values of accountability and efficiency that underpin unitary executive theory. The article also explores various checks on the Scientist-in-Chief, including Congress, the courts, the states, and the media. The article concludes that a Scientist-in-Chief model of executive authority undermines democratic accountability and scientific deliberation. Notably, President Obama has expressly disavowed the Scientist-in-Chief model of his predecessor. "Jurisdiction as Competition Promotion: A Unified Theory of the FCC's Ancillary Jurisdiction"  Florida State University Law Review, Vol. 36, 2009 JOHN F. BLEVINS, South Texas College of Law Email: jblevins@stcl.edu The FCC’s “ancillary jurisdiction” refers to the agency’s residual authority to regulate matters over which it lacks explicit statutory authority under the Communications Act of 1934. Because many of today’s most controversial and consequential policy debates involve new technologies not explicitly covered by that statute, the scope of the FCC’s ancillary jurisdiction has taken on a critical new importance in recent years. In particular, the future of federal Internet policy depends on resolving the questions surrounding ancillary jurisdiction. In this article, I provide a new theory of the FCC’s ancillary jurisdiction, arguing that it is best understood as an authority to promote market competition. More specifically, ancillary jurisdiction has primarily addressed and promoted competition in markets where vertical leveraging is a concern – particularly those involving dominant incumbent infrastructure providers. My argument has both a positive and normative dimension. Descriptively, I offer the novel argument that the competition-promotion framework provides the most persuasive and coherent account of the seemingly incoherent line of cases reviewing the FCC’s ancillary jurisdiction. Normatively, I argue that the FCC’s ancillary jurisdiction should be exercised in this manner, in large part to protect the doctrine’s viability in the face of increasing criticism and to shape it in a way that both promotes competition and limits agency capture. "Accountability in the Administrative Law Judiciary: The Right and the Wrong Kind"  Denver University Law Review, Vol. 86, No. 1, 2008 EDWIN FELTER, affiliation not provided to SSRN Email: ed.felter@state.co.us This article discusses and evaluates several forms of accountability in the administrative law judiciary, and compares them with prevalent forms of accountability in the judicial branch. Felter argues that codes of judicial conduct, as well as formal enforcement mechanisms, work together to maintain a balance of independence and accountability in the administrative law judiciary. The article analyzes the "right kinds" of accountability as distinguished from the "wrong kind" of accountability, i.e., political accountability. The article maintains that decisional independence is the cornerstone of any properly functioning adjudication system. The price of decisional independence is accountability to concepts and mechanisms other than the political system. The article maintains that the first mechanism of accountability for all judicial and quasi-judicial officers is the requirement of "reasoned elaboration," which is the prerequisite to second form of accountability, judicial review. The next mechanism is accountability to the relevant code of judicial conduct. The article discusses and analyzes appropriate and inappropriate judicial performance evaluations. It distinguishes developmental evaluations (for the purpose of performance improvement, but not to affect pay or employment status) from judgmental evaluations. Developmental evaluations are sometimes in the form of anonymous surveys of practitioners and litigants, peer review quality assurance processes and/or both. Judgmental evaluations, which often are legally required and can affect pay and employment status, can be evaluations by a supervisory judge or by a performance commission. The article concludes with an argument against political evaluations of judges because these evaluations are generally based on the wrong reasons, e.g., the political clamor of the day. "The Australian Crowns - Changing the Rules of Succession"  Quadrant, Vol. 53, No. 6, pp. 44-47, 2009 Sydney Law School Research Paper No. 09/49 ANNE TWOMEY, University of Sydney - Faculty of Law Email: a.twomey@usyd.edu.au The United Kingdom Government proposes to consult other Commonwealth nations about removing some of the discriminatory aspects of the rules concerning succession to the throne. This article considers the potential effect upon the Crown in Australia of British legislation changing the rules of succession to the throne. It addresses the question of who has the power to change the rules of succession with respect to the Crown in Australia and proposes a solution based on federal principles. "Is a Competent Federal Government Attainable or Oxymoronic?"  George Washington Law Review, Vol. 77, 2009 PETER H. SCHUCK, Yale University - Law School Email: peter.schuck@yale.edu This is a review of two books on public policymaking performance and civil service reform at the federal level: A GOVERNMENT ILL EXECUTED: THE DECLINE OF THE FEDERAL SERVICE AND HOW TO REVERSE IT by Paul C. Light (Harvard U. Press 2008) and PROMOTING THE GENERAL WELFARE: NEW PERSPECTIVES ON GOVERNMENT PERFORMANCE, edited by Alan S. Gerber & Eric M. Patashnik (Brookings Institution Press, 2006). ^top Solicitation of Abstracts Administrative Law publishes abstracts of working papers as well as articles accepted for publication in the field of administrative law and regulation. To submit your research to SSRN, log in to the SSRN User HeadQuarters, and click on the My Papers link on the left menu, and then click on Start New Submission at the top of the page. Distribution Services If your Institution is interested in learning more about increasing readership for its research by becoming a Partner in Publishing or starting a Research Paper Series, please email: Management@SSRN.com. Distributed by: Legal Scholarship Network (LSN), a division of Social Science Electronic Publishing (SSEP) and Social Science Research Network (SSRN) Directors LSN SUBJECT MATTER EJOURNALS A. MITCHELL POLINSKY Stanford Law School, National Bureau of Economic Research (NBER) Email: polinsky@stanford.edu BERNARD S. BLACK University of Texas at Austin - School of Law, McCombs School of Business, University of Texas at Austin, European Corporate Governance Institute (ECGI) Email: bblack@law.utexas.edu RONALD J. GILSON Stanford Law School, Columbia Law School Email: rgilson@leland.stanford.edu Please contact us at the above addresses with your comments, questions or suggestions for LSN-Sub. Advisory Board Administrative Law WILLIAM R. ANDERSEN University of Washington School of Law MICHAEL ASIMOW University of California, Los Angeles - School of Law HAROLD H. BRUFF University of Colorado Law School RONALD A. CASS Chairman, Center for the Rule of Law; Dean Emeritus, Boston University School of Law RONALD M. LEVIN Washington University School of Law RICHARD J. PIERCE George Washington University Law School SUSAN ROSE-ACKERMAN Henry R. Luce Professor of Jurisprudence, Law School and Department of Political Science, Yale Law School EDWARD L. RUBIN Dean, Vanderbilt University - School of Law PETER H. SCHUCK Yale University - Law School SIDNEY A. SHAPIRO University Distinguished Professor of Law, Wake Forest University School of Law CASS R. SUNSTEIN Felix Frankfurter Professor of Law, Harvard University - Harvard Law School ^top Subscription Links: Subscribe to Journal | Unsubscribe from Journal | Join Site License | Financial Hardship   Subscription Management You can change your journal subscriptions by going to the SSRN User HeadQuarters. Please enter the email address where you received this email in the 'Your Email Address' field and click 'Submit'. Click on 'Email me this information' on the next screen, and your User ID and Password will be emailed to you. Once you have successfully logged in, you will be able to change your journal subscriptions. If you have questions or problems with this process, please email UserSupport@SSRN.com or call 877-SSRNHelp (877.777.6435 or 585.442.8170). Outside of the United States, call 00+1+585+4428170.   Site License Membership Many university departments and other institutions have purchased site licenses covering all of the journals in a particular network. If you want to subscribe to any of the SSRN journals, you may be able to do so without charge by first checking to see if your institution currently has a site license. To do this please click on any of the following URLs. Instructions for joining the site are included on these pages. Accounting Research Network NEW Cognitive Science Network NEW NEW Corporate Governance Network NEW Economics Research Network Entrepreneurship Research & Policy Network Financial Economics Network Health Economics Network Information Systems & eBusiness Network Legal Scholarship Network Management Research Network Political Science Network Social Insurance Research Network HRN Classics Research Network HRN English & American Literature Research Network HRN Philosophy Research Network If your institution or department is not listed as a site, we would be happy to work with you to set one up. Please contact site@ssrn.com for more information.   Individual Membership (for those not covered by a site license) Join a site license, request a trial subscription, or purchase a subscription within the SSRN User HeadQuarters: http://www.ssrn.com/subscribe   Financial Hardship SSRN understands there is financial hardship in certain countries (for example the former Soviet Union and Eastern Bloc). If you are undergoing financial hardship and believe you cannot pay for a journal, please send a detailed explanation to Subscribe@SSRN.com ^top To ensure delivery of this journal, please add LSN@publish.ssrn.com (William Funk) to your email contact list. If you are missing an issue or are having any problems with your subscription, please Email usersupport@ssrn.com or call 877-SSRNHELP (877.777.6435 or 585.442.8170). REDISTRIBUTION Individual and professional subscriptions to the journal are for single users. It is a violation of copyright to redistribute this document electronically or otherwise without the explicit permission of Social Science Electronic Publishing, Inc. Site licenses for organizations are available by contacting Site@SSRN.com ^top Copyright © 2009 Social Science Electronic Publishing, Inc. All Rights Reserved