1. FDA ensure that there are no further delays in fully implementing the pedigree provisions contained in their December 1999 Final Rule.



2. The Office of Pharmacy Affairs require that 340B covered entities make public, in a manner consistent with patient privacy, records documenting that discounted drugs have been administered to only eligible patients.



3. Manufacturers shall disclose the identities of their authorized distributors.

The Cost of E-Government
Watchdog organizations are debating whether e-government projects will save the government money. Expected cost-savings from streamlining technical processes and eliminating duplicative computer systems has been a key justification for undertaking e-government initiatives. However, a leading expert opined that, "successful e-government projects might end up costing taxpayers money" by stimulating public demand for services provided by federal agencies. Similar views were expressed by officials from EPA and SBA. Although the discussion of e-government at the forum sponsored by Council for Excellence in Government focused on "big picture" issues, such as the nature of potential savings from e-government, CRE believes that the specific policies which guide the selection and implementation of e-government projects need to be fully analyzed in order to assess project costs, benefits and efficiency.

FTC Seeks Additional Regulatory Authority to Prevent Unsolicited E-mail
The Federal Trade Commission is asking Congress for increased regulatory authority over unsolicited e-mail, commonly known as "spam." Specific powers sought by the Commission include the authority to develop new regulations defining and banning deceptive or abusive e-mail messages and to issue "discovery subpoenas" to internet service providers when investigating entities accused of sending spam. One Senator is pushing the FTC to engage in "high visibility" enforcement actions should Congress pass anti-spam legislation. However, FTC Chairman Muris explained that the Commission already made prosecution of fraudulent spam a high priority and the agency has already acted against a number of spammers. As Commissioner Swindle noted, "We have had recently a number of relatively good hangings, but the spam goes on." The Commissioner is quoted as stating, that what was needed was "solid, narrowly defined laws that don't do more damage than they do good ... and we have to have technology improvements."

Federal Court Rules That Escaping Aquaculture Salmon Are Pollutants Requiring Clean Water Act Permit
A federal judge in the United District Court for Maine recently ruled that commercially raised Salmon which escape from their pens into the ocean are "pollutants" requiring permits under the Clean Water Act. In this decision, United States Public Interest Research Group v. Atlantic Salmon of Maine (D. Me. 2003), the judge fined the aquaculture companies in question because they did not have CWA Permits, and ordered them to shut down their operations by emptying their pens. The judge found in his opinion that the commercially raised salmon were genetically different from wild salmon and damage them genetically by inbreeding with the wild salmon. The activist group PIRG brought the case under the CWA's citizen suit provision.

CyberActivist.US: Using the Internet to Enhance Public Participation in the Regulatory Process
The Center for Regulatory Effectiveness has initiated a new website, CyberActivist.US, designed to provide a new, substantive and transparent mechanism for expanding the opportunities –– and quality –– of stakeholder participation in the public policy process. The website site contains a number of discussion topics and you are encouraged to participate. The current discussion topics range from our soliciting the views on a policy statement issued by the Federal Trade Commission to a Data Quality Act petition filed with DOT by an informed citizen.

The site has several purposes. First, our large federal readership will be able to view, on a real-time basis, the concerns of influential stakeholders on ongoing rulemakings, including those for which the public comment period has expired. Our Federal readers will also be able to vent public policy issues in a worldwide forum.

Second, stakeholders will be able to initiate discussions on regulatory issues that are not presently the subject of a regulatory proceeding.

Third, stakeholders will be able to build cyber-coalitions on topics of interest to them.

The strength of CyberActvism.US is in its informed and diverse multinational readership. We are launching CyberActivism.US at this time because of the spectacular traffic enjoyed by our anchor site, TheCRE.com.

CRE Files Comments on Atrazine IRED
CRE's comments on EPA's "Interim" Interim Registration Eligibility Decision for atrazine raised several test validation issues. The Agency's "Final" IRED is due in October after SAP review of the amphibian endocrine effects issue.

Dupont Ordered to Perform Non-Validated Tests
On April 18, 2003, a West Virginia state court ordered DuPont to pay for blood tests of perfluorooctanate acid (PFOA) in residents near the company's Washington, West Virginia plant. DuPont is appealing this order, which was issued in class action litigation alleging exposure and harmful effects from PFOA releases from the plant. CRE understands that the test that DuPont must use to comply with the order has never been properly validated and that there are questions regarding its accuracy and reliability. Under similar circumstances, and in response to a Data Quality Act petition filed by CRE and agricultural groups, EPA stated that non-validated tests for atrazine's endocrine effects could not be used for any regulatory purpose and additional tests for these effects should be performed once properly validated test protocols have been developed. To their credit, DuPont and 3M are working with CDC to validate a reproducible and reliable tests to measure PFOA in human blood. CRE believes that, until such tests have been developed, any PFOA testing done pursuant to the state court order could not be considered accurate, reliable and reproducible; therefore, such tests could not be consistent with the Data Quality Act.

Teflon Under Fire
On April 14th, EPA announced that it was accelerating its TSCA review of perfluorooctanoic acid (PFOA), a chemical used to make Teflon and other purposes. EPA's announcement follows an April 11th petition by the Environmental Working Group (EWG) which asks EPA to investigate whether DuPont violated TSCA Section 8(e) by failing to provide EPA information DuPont allegedly had regarding the reproductive effects of PFOA. The information allegedly includes blood tests that Dupont performed during the 1980s on pregnant employees at a West Virginia plant. In a press release, DuPont denies the Petition's allegations. DuPont contends, "There is no evidence or data that demonstrates PFOA causes adverse human effects, including developmental or reproductive effects, in any segment of human population." DuPont further notes that the information at issue "is an informal recording of the presence of low levels of PFOA in eight blood samples taken from female employees in or near the fluoropolymer manufacturing area at DuPont's Parkersburg, W. Va., site in the early 1980s." While "the information records one confirmed birth defect, there is no indication that it was caused by exposure to PFOA." EPA cautions that there is much uncertainty regarding this issue, and that it "does not believe there is any reason for consumers to stop using any consumer or industrial related products." EPA and the industry have agreed that the industry will submit new data to EPA by June 15.

USTR Ordered to Appoint Environmentalist to FACA Panel
A federal district court in Seattle recently ordered USTR to appoint an environmental group representative to the Industry Sector Advisory Committee on Chemicals and Allied Products for Trade Policy Matters ("ISAC-3"). This is a FACA Advisory Group that was established to ensure that U.S. trade policies and negotiation objectives adequately reflect U.S. commercial and economic interests. An environmental group, the Washington Toxics Coalition, sued the Government claiming that an environmental group representative was required in order to ensure that ISAC-3 was "fairly balanced" as required by FACA.

Federal Register in Brief; Precedential Regulatory Process Changes HUD Use and Update of Regulatory Calendar
Recently over 100 agencies, or components thereof, published their semi-annual agenda of regulations under development. For easy access by the regulated community, CRE has linked them on its home page in the entry entitled Regulations Under Development - By Agency. HUD in the notice below has notified the public of a change in the scheduled release date for a particular entry. Unfortunately there is no way to change the entry on the calendar. The e-rulemaking project, in concert with the Regulatory Information Service Center, should consider making the calendar available online with a continued update capability.

FTC Regulatory Review
Under the current Chairman Tim Murris the Federal Trade Commission (FTC) has breathed new life into the office of planning. FTC has long been recognized for its economic expertise. The office of planning and other FTC professionals have instituted a very active participation program in Federal and State regulatory activities. The office has participated in numerous rulemakings. The activities of this office will now be included on the CRE website.

Criticism of EPA is Elevated to an Unproductive Level
In a September 10th public comment, an EPA critic chided the collective agency as "dictatorial fascists" in response to a proposed rule, "Control of Emissions From Spark-Ignition Marine Vessels and Highway Motorcycles." This proposed rule supplements an earlier action to establish regulations for vehicular air pollution as required by the Clean Air Act. The first part of the effort included off-highway motorcycles. The critical author determines that the proposed rule will negatively impact Harley Davidson, whose engines emissions would violate the rule. The author threatens legal action from the Motorcycles Riders Foundation (MRF) and the ACLU if EPA adopts the rule. The EPA acknowledges that the rule will affect the industry, especially small businesses. The critic's rhetoric detracts from the otherwise sound prediction.

NHTSA Rulemaking Upgrading Tire Performance Standards Has Not Complied with the National Technology Transfer and Advancement Act
The National Highway Traffic Safety Administration has not complied with the National Technology Transfer and Advancement Act and OMB Circular A-119 in their rulemaking to upgrade tire performance standards. The Act and Circular require that agencies use voluntary technical standards in regulations unless doing so would be contrary to law or impractical. However, even though a number of private consensus and consortia standards are available for adoption by NHTSA, including a draft international standard the agency participated in developing, NHTSA has proposed using a government-unique standard in the tire standard regulation.

EPA Settlement with Sierra Club Draws Criticism from SBA
In a Federal Register Notice issued on Monday, August 26, 2002, the EPA solicited public comment on a ruling involving an initial agreement that has been reached between the EPA and the Sierra Club concerning the final rule of a case under Section 112 of the Clean Air Act, which in part calls for the EPA to reduce the period between Part 1 and Part 2 applications from 24 months to 12 months for promulgating MACT standards. The Office of Advocacy of the SBA sent a letter to an EPA official opposing the settlement, arguing that reducing the time period between Part 1 and Part 2 applications would impose a heavy economic burden upon small businesses and small agencies, overburdening the latter with an anticipation of "completing 'case by case' MACT determinations". The Office of Advocacy goes on to state that "the action would force an estimated 80,000 facilities...many of which are small businesses, to complete the burdensome, needless, and counterproductive Part 2 applications", arguing that the complexity of completing Part 2 applications requires a level of expertise exceeding the capabilities of small businesses that are likely to be affected by the settlement.

CEQ Releases Policy Statement on Amendment to Environmental Quality Improvement Act
The CEQ released a policy statement promulgating new policies and procedures for the Office of Environmental Quality Management Fund (OEQ Management Fund), which was created in 1982 as an amendment to the Environmental Quality Act, discussing the purpose, definitions, policy and procedures of the policy changes. The outlines provided in the Amendment regarding the OEQ Management fund would serve as a useful model for other Federal Agencies, specifically with respect to procedures relating to drafting charters and charter amendments.

FCC Announces Start of Biennial Regulatory Review
In a September 26th announcement, FCC opened the public comment solicitation period in its 2002 Biennial Review of Telecommunications Regulations, which was officially released on September 23, 2002. The review, a broader version of the two previous reviews from 1998 and 2000, will be within the purview of five FCC bureaus and offices: International Bureau; Wireline Competition Bureau; Office of Engineering and Technology; Wireless Telecommunications Bureau; Consumer and Governmental Affairs Bureau. The fate of four FCC broadcast ownership rules are a key component of the review. The FCC also solicits opinions of the issue of determining information deemed "necessary in the public interest".

Regulatory Flexibility Executive Order Applies to Independent Agencies
Executive Order 13272, signed on August 13, 2002, sets new requirements for Federal agencies to comply with the Regulatory Flexibility Act, "as amended (5 U.S.C. 601 et seq.) (The Act)." This order is a strong statement from the Executive Branch in imposing procedural requirements on independent agencies. CRE recommends that Executive Order 13272 be complemented by adopting CRE's Blueprint for OMB review of independent agency regulation.

New Rule on Propane Canisters to take Effect in the State of New York
The appendment to a rule setting new limits on the size of propane canisters, which is currently permitted by Pamphlet No. 58 of the National Fire Protection Association, is scheduled to take effect January 3, 2003. The rule is a variation on the International Fire Code, which allows the use of propane canisters weighing up to 12 and 50 pounds. NAPA (The National Asphalt Pavement Association) is currently negotiating with the New York Department of State to bring New York up to code with other states currently using rules contained within the International Codes. For details relating to old and revised language used in the rule, contact Richard Brescia of the New York Propane Gas Association: (518)449-3333.

National Academies Committee Finds No Evidence of Adverse Health Effects from EPA Biosolids Regulations
In July, a committee of the National Research Council (NRC) of the National Academies of Science (NAS) issued a report containing the findings from an exhaustive 18-month review of EPA's regulatory requirements for land application of biosolids. The committee, noting that there had been anecdotal allegations of disease, stated as its foremost finding that there was no documented evidence that the EPA regulations have failed to protect public health. Nevertheless, to more fully meet public concerns about land application practices and to address data gaps, the committee recommended that EPA work to update the scientific basis for its regulations. On September 6th, the National Academies disseminated an op-ed piece by the Committee Chair for the report which re-emphasized the finding of no evidence of adverse health effects and which observed that the op-ed appeared necessary because some press accounts of the report had focused only on criticisms of EPA's past efforts and did not fully reflect the committee's findings and recommendations.

NAS to Host Symposium on the Role of Scientific and Technical Data and Information in the Public Domain
On September 5-6, 2002, the National Academy of Science will host a Symposium on the Role of Scientific and Technical Data and Information in the Public Domain. The meeting will bring together experts from the public and private sectors who are involved in creation, dissemination, and use of scientific and technical data, in order to discuss various legal, economic, and technological issues related to such information. The meeting is free and open to the public, but advance registration is required. CRE urges interested parties to attend this important meeting.

Regulatory Watchdogs
To better inform its readers as to significant organizations influencing rulemakings, CRE has established a list of regulatory watchdog websites. CRE will update this list annually. We define a regulatory watchdog as an organization whose primary activity is to either participate directly in a wide range of regulatory proceedings or, through their website, to significantly influence the participation of other persons in such rulemakings. To qualify for CRE's listing, in general, the fundamental theshhold a website must meet is that it have traffic in the top one-half of one percent of all websites. Inclusion on CRE's list of Regulatory Watchdogs does not necessarily indicate endorsement or support of their positions.

Since these watchdog organizations play such an important role, CRE is starting "Watchdog Watch" This new feature will provide analyses of statements made by these groups on their websites.

The Heartland Institute Reports on "Fat Tax" and America's War on Obesity
The Heartland Institute has published articles following various efforts by public health experts and public interest groups to reign in America's appetite for fatty foods, with a 2001 U.S. Surgeon General's report declaring obesity to be a "public health epidemic." For example, Heartland recently reported on the idea of a "fat tax" to compensate society for added costs of medical care related to obesity, an idea which they say goes back to 1967. It is also noted that trial lawyers are eager to advance this agenda (and earn considerable fees) by bringing lawsuits against the food industry, based upon the model of the States' Tobacco Litigation. Fat, in moderation, is essential to a healthful diet, so the idea of taxes, bans, or lawsuits related to specific food items can only lead to a regulatory morass. The public deserves reliable scientific information so that they can make informed nutrition choices, but ultimately, some modicum of personal responsibility and common sense must hold sway.

SBA Issues Letter to EPA Regarding Failure to Comply with Regulatory Flexibility Act
The Small Business Administration's (SBA) Office of Advocacy recently issued a letter to EPA challenging the agency's failure to meet the requirements of the Regulatory Flexibility Act (RFA) in its proposed rule on Control of Emissions from Land-based Recreational Engines. EPA issued an earlier related rulemaking on tailpipe emissions for such vehicles; however, the latest proposed regulation would finalize completely new and specific requirements for fuel tanks. EPA has failed to comply with the RFA by either: (1) providing small entities an opportunity to comment on the burdens imposed by such requirements or (2) undertaking the necessary economic analyses to certify that the rule would not have a significant economic impact on small entities. CRE agrees with SBA that EPA should take the necessary steps to comply with all Good Government laws, including the RFA, when conducting rulemakings.

FTC Determines Attorneys to be Subject to Notice Requirements of Gramm-Leach-Bliley
The Federal Trade Commission (FTC) has determined that law firms must comply with the notice provisions included in the 1999 Gramm-Leach-Bliley financial modernization legislation. According to the FTC, attorneys may provide "financial services" under the Act, thereby triggering the notice provisions related to the privacy of consumer financial information. The American Bar Association (ABA) and other legal groups have reacted strongly against this interpretation which they deem to be at odds with congressional intent and which may have potentially serious negative impacts upon attorney-client privilege.

Agencies Clear Way For Trading Securities Future Products
A last minute burst of regulatory activity by the SEC and the CFTC opens the door for trading of securities futures products. Pressure by key Congressman motivates agencies to meet target date; however the two commissions have a narrow window of time to resolve a number of difficult problems before the more important second phase may begin. Retail trading of securities futures products is slated to commence as early as December 21. If the two agencies can reach agreement in a timely manner, marketers are expected to roll out their new products early next year.