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.

Click to submit comment

Court Finds that EPA's Conduct in Metolachlor Case is Inexplicable
On August 27, 2001, a federal court in Memphis dismissed all of the claims in a case filed by Cedar Chemical, a metolachlor "Me-Too" registration applicant Cedar had sued EPA and the original metolachlor registrant Syngenta. The court dismissed Cedar's claims against EPA even though EPA itself did not file any motion to dismiss. The court's opinion raises serious questions about EPA's conduct of this litigation. In the court's own words:

Inexplicably, the EPA did not move to dismiss the Cedar complaint....The court expected that EPA would file such a motion at this time, based on statements of its counsel at the August 6, 2001 hearing in these cases. CRE has been following the controversy over the metolachlor because it raises the issue of whether EPA is serious about its pesticide Reduced Risk Initiative. Under its own Reduced Risk Initiative the EPA required Syngenta to eliminate use of metolachlor so benefits of the new "reduced risk product" would be realized. Granting the metolachlor "Me-Too" applications would gravely, perhaps mortally, injure this important program which encourages companies to voluntarily introduce more environmentally friendly pesticide products. Like the court, CRE finds EPA's conduct in the Cedar case to be inexplicable. The Agency has some explaining to do.

Click for Court's Opinion

Click to submit comment

EPA Solicits Comment Regarding Preparation of Third U.S. Climate Action Report
The Environmental Protection Agency (EPA) is currently seeking comments from the general public regarding issues related to the third U.S. Climate Action Report (CAR) which the U.S. is to submit to the United Nations Framework Convention on Climate Change (UNFCCC) no later than November 30, 2001.

Click to view notice in Federal Register

Comment on Item

View past CRE Regulatory Action of the Week items

CRE Responds to ANSI Invitation to Recommend Process Changes
ANSI invited CRE to propose changes in the process by which Standards Development Organizations (SDOs) produce consensus standards. The ANSI letter came in response to detailed comments by CRE recommending that SDOs incorporate the policies and procedures found in the federal "good government" laws when developing standards intended for regulatory application. It is CRE's view that SDO use of the good government laws when developing standards intended for regulator use will: 1) improve the quality and utility of the standards; and 2) make it easier for regulatory agencies to adopt the consensus standards. CRE's recommendations to ANSI will be considered by the Executive Standards Council (ExSC) at their next regularly scheduled meeting.

Read the ANSI letter to CRE

Read the CRE letter to ANSI

Comment on Item

ANSI Responds to CRE "Good Government" Recommendations
CRE, in response to an invitation from ANSI, recommended changes in the process by which Standards Development Organizations (SDOs) produce consensus standards intended for regulatory application. CRE recommended to ANSI's Executive Standards Council (ExSC) that SDOs developing standards intended for regulatory use incorporate the policies and procedures found in the federal "good government" laws. After consideration, the ExSc declined to adopt CRE's recommendations.

Read the ANSI ExSC Response

Comment on Item

How Many DC Lobbyists Would Survive in Italy?
The New York Times reports that Italy's highest Court of Appeal has opined that influence-peddling is not a crime—the only punishable offense is exaggerating one's power to influence. More specifically, Italian law punishes the false boast of claiming the ability to exert influence, not the act of influencing.

"Rome Journal: Official Favors Make Italy Go Round," New York Times, April 20, 2001

Comment on Item

Banning Soft Drinks In Schools Will Not Solve The Childhood Obesity Problem

Read more

EPA Policy Office Gets More Control Over Rule Making Process
An April 10th memorandum from Administrator Whitman announces very significant changes in the EPA's rule making process:

A task force chaired by Tom Gibson--Associate Administrator of Policy, Economics and Innovation (OPEI)-will conduct a 45-day review of EPA's rule making process to strengthen the role of science, economics and policy analysis:

OPEI will now coordinate the internal process for preparing EPA rules for OMB review; and

OPEI will be EPA's liaison with OMB on all matters dealing with regulatory policy. These changes add up to a much greater OPEI role in EPA's rule making process. The CRE website will closely follow this development and will keep the public informed.

Click to read the full text of the Whitman memo

Comment on Item

CRE Report Card Requests FTC Provide Methodology for Analyzing Pharmaceutical Data
CRE prepared a Report Card on a Federal Trade Commission proposal to collect extensive information from brand name and generic drug manufacturers concerning agreements developed pursuant to the Hatch-Waxman Act. The information is intended to help the FTC evaluate whether any manufacturers have entered into anticompetitive agreements to delay market entry of generic drugs. A key conclusion of CRE's analysis is that the Commission should make available for public comment their intended methodology for analyzing the data.

Read CRE's transmittal letter to the FTC

Read CRE's Report Card on the FTC's Proposed Collection of Information Regarding the Hatch-Waxman Act

Comment on Item

EPA Requests Information on Indoor Air Quality Practices in Schools
The Environmental Protection Agency (EPA) has announced a new information request that seeks to gain information regarding the number of public and private schools that have implemented sound indoor air quality (IAQ) management practices. The information request, entitled "Indoor Air Quality Practices in Schools Survey," seeks to collect data that are essential for measuring the effectiveness of EPA's outreach efforts against the Agency's established GPRA goal. EPA hopes to achieve the implementation of sound IAQ practices in 15 percent (16,650) of the nation's public and private schools by 2005.

Click to view full notice in Federal Register

Comment on Item

Administration To Unveil New Ergo Policy In September
CRE Web site reporter Don Fulsom reports on the Bush administration's efforts to formulate a new ergonomics policy. This is the second in a series of articles on the politically volatile issue of ergonomics in the workplace.

Read the CRE Guest Column Article

Comment on item

Clinton Environmental Review Executive Order Being Applied To Trade Agreements
Clinton Executive Order 13141 requires environmental review of some trade agreements. The United States Trade Representative and the Center for Environmental Quality have promulgated guidelines implementing the Executive Order. 65 FR 79442. The USTR is now applying the Executive Order and the guidelines to specific trade agreements. Specifically, the USTR is soliciting public comment on environmental issues raised by the multilateral trade negotiations on agriculture and services in the World Trade Organization. The comment period ends July 27, 2001. 66 FR 20846.

CRE believes that Executive Order 13141 provides an important regulatory precedent. CRE is now looking at ways to expand the Executive Order to include analysis required in Good Government laws such as the new Data Quality Act, the Paperwork Reduction Act, and the Regulatory Flexibility Act. CRE believes that the important concerns underlying the Good Government laws apply with equal force to trade agreements.

Read a more detailed discussion of trade-agreement environmental review under the Clinton Executive Order and the USTR Guidelines.

Read the USTR notice seeking comment on application of the Order and guidelines to the WTO agreement.

Read Executive Order 13141.

Read the USTR Guidelines implementing the Executive Order.

Comment on Item

View past CRE Regulatory Action of the Week items

Unleashing Innovation: The Right Approach to Global Climate Change
The Business Roundtable has completed a report which is based on a recently completed survey of BRT member companies and identifies 38 specific opportunities to improve regulatory, tax, and trade policies to encourage elaborate innovation and implementation of new energy-conserving technologies.

Read Item

Click to submit comment

EPA to Emphasize Regulatory Effectiveness
Inside EPA, in its May 18^th edition, quotes EPA officials as saying that one of its priorities is to develop a system to assess the potential effectiveness of a rule. CRE applauds EPA for this effort. CRE, from its inception, has thought the effectiveness of rules, not their abolition, should be the thrust of regulatory agency programs. However, the term effectiveness has different meanings to different individuals. It is for this reason that CRE has adopted the totality of the requirements set forth in the "Good Government Laws" to define effectiveness. More precisely, a strict adherence to the Paperwork Reduction Act, the Data Quality Act, the Regulatory Flexibility Act, the Unfunded Mandates Act, and Executive Order 12866 "Regulatory Planning and Review," will provide an operating definition of the term effectiveness.

Comment on Item

Congress Should Fund The Administrative Conference Of The United States
The Administrative Conference of the United States (ACUS) has not been funded since fiscal year 1995. No other entity performs the ACUS' invaluable, bipartisan, statutorily mandated function of systematically reviewing and promoting changes in the federal government's administrative process. The American Bar Association recently recommended that the President "take steps to re-establish a government entity" to perform this function. This recommendation could easily be implemented by Congress's appropriating funds for the ACUS.

Everyone who wants to improve the administrative process should join CRE in asking Congress to fund the ACUS. This is a CRE priority issue.

Read more.

Comment on Item

Bush Administration Delays And Reviews New DHHS Rules
On March 19, 2001, Tommy Thompson, the new Secretary of the Department of Health and Human Services, delayed for sixty days the effective dates of two DHHS rules. Both rules were published during the last days of the Clinton Administration. The purpose of the delay is to allow the Bush Administration to review the rules in accordance with the so-called Card memorandum, which was issued on Inauguration Day. The Federal Register notice of the action delaying the rules is at 66 FR 15352.

The first rule concerns clinical research on pregnant women and human fetuses. This rule was published in the Federal Register on January 17, 2001. The Federal Register notice of the rule explained that it "enhances the opportunity for participation of pregnant women in research by promoting a policy of presumed inclusion, by permitting the pregnant woman to be the sole decision maker with regard to her participation in research, and by exempting from the regulations six categories of research." 66 FR 3878.

The second rule concerns the Anesthesia Services Condition of Participation for Hospitals, the Surgical Services Condition of Participation for Critical Access Hospitals, and the Ambulatory Surgical Center Conditions of Coverage-Surgical Services, under the Medicare and Medicaid programs. The rule changes the physician supervision requirements for certified registered nurse anesthetists furnishing anesthesia services in hospitals, CAHs, and ASCs. This rule was published in the Federal Register on January 18, 2001, 66 FR 4674.

Comment on Item

Education Department Announces Availability of Test Measurement Resource Guide
The Department of Education's Office of Civil Rights has announced the availability of a final document entitled, "The Use of Tests as Part of High-Stakes Decision-Making for Students: A Resource Guide for Educators and Policymakers." According to the Federal Register notice, the resource guide is designed "to provide educators and policymakers with an informative and practical tool that will assist in their development and implementation of policies that involve the use of tests in making high-stakes decisions for students." The notice also mentions that the guide provides information about relevant Federal non-discrimination standards and professionally recognized test measurement principles, as well as a collection of resources related to the non-discrimination and test measurement principles discussed in the guide.

Click to view full notice in the Federal Register, including information on how to obtain a copy of the document.

Comment on Item

CRE Exploratory Committee: Update
As a result of the CRE white paper, Market Driven Consortia, Implications forthe FCC's Cable Access Proceeding, CRE established an Exploratory Committee to assess process options for developing open cable platform standards. Specifically, the Exploratory Committee will develop recommendations as to whether standars for broadband internet-cable connections should be established through a standards development organization (SDO) or through a market-driven consortia (MDC).

Click here to read more.

Comment on Item

EPA Wants Public Comment On Managing Diazinon Risk
EPA is soliciting public comment on how to manage the risk from the organophosphate pesticide diazinon. The agency requests comment on this issue by April 2, 2001. This request for public comment is part of a joint initiative by EPA and the Department of Agriculture to increase transparency in the tolerance reassessment process for organophosphate process. Copies of the revised risk assessment and related documents for diazinon can be accessed at https://www.epa.gov/pesticides/op/.

Click to full notice in Federal Register.

Click to submit comment

Federal Focus, Inc. Issues Draft Executive Order on Agricultural Biotechnology
Federal Focus, Inc., a nonprofit science and research foundation located in Washington D.C., recently issued a draft Executive Order on regulation of agricultural biotechnology products. The draft Executive Order includes specific recommendations for improving transparency in federal agency decision making and bolstering public confidence in the regulatory process for biotechnology. Public concerns in this area must be taken seriously, but inquiry into the health and environmental effects of this new technology must be based firmly upon science; otherwise the significant potential benefits of biotechnology may be lost needlessly. CRE believes that the proposed Executive Order is both insightful and timely, particularly as the Administration continues its reassessment of agri-biotech regulation.

Click to view the Federal Focus draft Executive Order on agricultural biotechnology.

Click to submit comment

Comment Period Extended to Respond to Issue of Adverse Environmental Effects of Pollutants Associated with the Formation of Acid Rain Including Fine Particulate Matter
The Environmental Protection Agency (EPA) has extended the period for submission of public comments regarding the issue of adverse environmental effects associated with pollutants related to the formation of acid rain, including fine particulate matter. Two events have prompted this action. First, EPA received a petition from seven States urging EPA to promulgate revised secondary national ambient air quality standards (NAAQS) for pollutants associated with acid rain. Second, the Department of the Interior (DOI) requested that EPA also address many of these same adverse environmental effects associated with these same types of air pollutants.

Click to full notice in Federal Register

Click to submit comment

NIH and Warren Grant Magnuson Clinical Center Seek Comments on Satisfaction Surveys Related to Health Care Services
NIH and the Warren Grant Magnuson Clinical Center recently issued a public comment request in the Federal Register related to satisfaction surveys for customers and other partners (66 Fed. Reg. 10023, Feb. 13, 2001). The surveys will question are variety of interested parties, including patients, family members, visitors, intramural collaborators, vendors, regulators, and small businesses, and will may be administered via written forms, faxed documents, electronic submissions, or telephone inquiries. The goal of the information collection is to determine satisfaction with Clinical Center services, to assist in the design of new services or modification of existing services, and to evaluate implemented changes. Comments may be submitted to OMB and the agencies through March 15, 2001.

Click to full notice in Federal Register

Click to submit comment

EPA Reschedules Public Information and Confidentiality Meeting
The Environmental Protection Agency (EPA) has rescheduled its public meeting on advance notice of proposed rulemaking (ANPRM) and potential revision of the confidential business information (CBI) regulations for March 7, 2001. The meeting was changed from its original date of January 18, 2001 due to requests from the public to allow additional time for stakeholder participation and to avoid potential travel difficulties in the Washington, D.C. area because of events revolving around the Presidential Inaugural during the week of January 20, 2001. The meeting will take place from 9 a.m. to 4:30 p.m. in the EPA auditorium, 401 M Street, SW., Washington, D.C.

Click to view full notice in Federal Register

Click to submit comment

EPA Solicits Public Comment on Possible Deficiencies in Operating Permits Program
The Environmental Protection Agency (EPA) has announced a 90-day comment period for members of the general public to submit comments on deficiencies that they perceive exist in State and local agency operating permits programs required by title V of the Clean Air Act. The deficiencies that the public claims exist can be of two types: deficiencies in the substance of the approved program or deficiencies in how a permitting authority is implementing its program. EPA will review the comments and determine whether it agrees or disagrees with the purported deficiencies. It will then publish notices of those findings. In cases where EPA determines there is a deficiency, it will publish a notice of deficiency and will establish a time frame for the authority to correct the deficiency. Comments identifying possible deficiencies must be received by March 12, 2001.

Click to view complete notice in Federal Register

Comment on Item

OMB Seeks to Clarify Implementation of FAIR Act
As established by Congress, the Federal Activities Inventory Reform Act of 1998 (the "FAIR Act") allows for a challenge-and-appeal process regarding the list that agencies must submit annually to The Office of Management and Budget (OMB) of their activities that "are not inherently governmental functions" and that are performed by Federal employees. A recent General Accounting Office (GAO) report reveals, however, that confusion exists among those submitting challenges and appeals regarding the scope of the challenge-and-appeal process. In an effort to eliminate this confusion, OMB is proposing a revision of its guidance on the implementation of the FAIR Act.

Click to read more

View past CRE Regulatory Action of the Week items

U.S. Chamber Supports CRE Petitions to OMB to Control Federal Agency Abuse of "Information Demand" Letters
CRE is concerned that agencies, including EPA, the Labor Department, and others may be improperly invoking the Paperwork Reduction Act's statutory "enforcement exemption" to avoid prior OMB review and approval of agency information demands. CRE petitioned OMB in October 2000 to: (1) review recent information demand letters issued by EPA; and (2) conduct a rulemaking to establish what evidence of a violation an agency must have before the agency properly may invoke the PRA "enforcement exemption". On December 5, 2000, the U.S. Chamber of Commerce wrote to OMB in support of both CRE petitions.

Click to view the U.S. Chamber of Commerce's letter to OMB.

Click to view the CRE petitions.

Click to view the MLS legal memorandum.

CDC Solicits Comment on Proposed Data Collection for the National Exposure Registry
The Centers for Disease Control and Prevention (CDC) has announced an opportunity for public comment concerning a data collection project that will focus on expanding the National Exposure Registry (NER). As defined in the Federal Register notice, the NER is "a program that collects, maintains, and analyzes information obtained from participants (called registrants) whose exposure to selected toxic substances at specific geographic areas in the United States was documented." Through this collection, the CDC seeks to update five of its existing sub-registries and to establish a new asbestos sub-registry. Participants in the data collection will be interviewed initially with a baseline questionnaire. Then an identical follow up telephone questionnaire will be administered every three years until the criteria for terminating a specific sub-registry is met. Written comments concerning this information request should be received by February 8, 2001.

Click to view full notice in Federal Register including contact information

Click to submit comment

CRE Announces Initiative for Applying Data Quality Law to the Financial Sector
CRE considers the Data Quality statute recently enacted by Congress to be a "Good Government" law which should be given wide applicability. While government risk assessment would be subject to the Data Quality law, environmentalists have historically criticized risk assessment legislation for targeting environmental areas. There has been some justification for such criticisms in the past, so for that reason, CRE is emphasizing initial applicability of the Data Quality law to the Financial Sector. As a prototype case, CRE is focusing its Data Quality Initiative on the risk assessment being conducted by the Office of Federal Housing Enterprise Oversight (OFHEO) of the systemic risk posed by Fannie Mae and Freddie Mac to the nation's financial system and to U.S. housing finance markets. CRE has already submitted comments to OFHEO and looks forward to further cooperative efforts. CRE anticipates broadening the Data Quality Initiative to other agencies in the near future.

Click here to read more about the CRE Data Quality Initiative for the Financial Sector, its application to the OFHEO systemic risk assessment, and CRE's comments to OFHEO.

Comment on Item

EPA Announces Meeting on Community Right-to-Know Toxic Chemical Release Reporting
The Environmental Protection Agency (EPA) has announced that it will hold an open stakeholder meeting on January 29, 2001 to solicit input on the types of information that EPA can provide to aid users better understand Toxics Release Inventory (TRI) data that is reported under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). One goal in particular of the meeting is to identify ways that EPA can help users of the data understand the different factors to consider when using the TRI data. The meeting will take place from 9:00 a.m. to 5:00 p.m. at the U.S. Environmental Protection Agency, Washington Information Center, Conference Room 3 North, 401 M St., SW., Washington, D.C.

Click to view full notice in Federal Register

Click to submit a comment

EPA Seeks Comments on Information Request Regarding Standards for Reformulated and Conventional Gasoline
The Environmental Protection Agency (EPA) has announced that it is requesting public comments on an information collection request regarding standards for reformulated and conventional gasoline. This request, which affects refiners, oxygenate blenders, importers of gasoline, and parties in the gasoline distribution network, is required under regulations established in the Clean Air Act and serves as a way to demonstrate compliance and aid in enforcement. Comments regarding this request must be submitted on or before January 29, 2001.

Click to view full notice in Federal Register

Click to submit a comment

EPA Dioxin Risk Assessment Triggers Calls for Banning Polyvinyl Chloride Plastics
As CRE has stated for years, the EPA dioxin risk assessment will have a major impact on regulatory actions at the federal, state, and local levels. Since the release of the EPA document in draft form this past spring, a number of groups -- including the Center for Health, Environment and Justice -- have begun calling for a wide range of regulatory actions including closing incinerators, production of chlorine-free paper, and bans on the use of polyvinyl chloride plastics. CRE believes that such actions are unjustified due to scientific and legal flaws in the draft risk assessment, and regulators should bear such concerns in mind prior to implementation of costly, burdensome, and unsupported dioxin control measures.

Click to sumbit a comment

President Bush Defers Action on New and Pending Agency Regulations
In a memorandum issued January 20, 2001 to Heads and Acting Heads of Executive Branch Departments and agencies, the President has issued a Regulatory Review Plan, which will allow the senior official appointed by the Bush Administration to review and approve new and pending regulatory actions. Under the Regulatory Review Plan, no new rules shall be sent to the Federal Register until such review has taken place. Rules already sent to the Federal Register are to be withdrawn, and regulatory actions already published, but which have not yet taken effect, shall have their implementation temporarily postponed for 60 days. There is an exclusion for regulations promulgated pursuant to statutory or judicial deadlines or for "emergency or other urgent situations relating to health and safety." The memorandum requests independent agencies to voluntarily comply with the Regulatory Review Plan as well.

Click here to review the Regulatory Review Plan Memorandum

Comment on Item

EPA Announces Meeting of NACEPT Standing Committee on Compliance Assistance
The Environmental Protection Agency (EPA) has announced an open meeting of the National Advisory Council for Environmental Policy and Technology (NACEPT) Standing Committee on Compliance Assistance. The meeting is scheduled for Wednesday, January 10, 2001 from 8:30 a.m. to 5:00 p.m., and Thursday, January 11, 2001 from 8:30 a.m. to 4:45 p.m. The meeting will be held at the Washington Monarch Hotel, 2401 M St. NW, Washington, D.C. The meeting will focus primarily on strategic compliance assistance (CA) policy issues, including integrating CA into the Agency's mission, CA measurement and CA priority setting.

Click to view full notice in Federal Register including contact information:

Click to submit comment

NIH Solicits Comment on Proposed Information Request Regarding a Nested Case-Control Study of Lung Cancer and Diesel Exhaust Among Non-Metal Miners
The National Institutes of Health (NIH) is currently seeking comment on a proposed information request regarding a nested case-control study that will examine lung cancer in non-metal minors and its association, if any, with diesel exhaust exposure. According to the Federal Register notice, the information will be used in a study by the National Cancer Institute and the National Institute for Occupational Safety and Health "to examine risk of mortality from lung cancer for various measures of diesel exhaust exposure...." Interested persons are invited to submit comments regarding this information request on or before January 11, 2001.

Click to view full notice in Federal Register including contact information:

Click to submit comment

HHS Announces Meeting of National Bioethics Advisory Commission
The Department of Health and Human Services (HHS) has announced an open meeting of the National Bioethics Advisory Commission (NBAC) scheduled for January 18, 2001 from 8:30 a.m. to 5:00 p.m. and January 19, 2001 from 8:00 a.m. to 12:00 p.m. The meeting will be held at the Sheraton Premiere at Tysons Corner, 8661 Leesburg Pike, Tysons Corner/Vienna, VA. The Commission will discuss its ongoing project on ethical and policy issues in international research. Opportunities for statements by the public will be provided on January 18 from 1:00 p.m. to 1:30 p.m.

Click to view notice in Federal Register including contact information

Click to submit comment

EPA's Science Advisory Board Solicits Nominations for Members and Consultants
The Environmental Protection Agency's (EPA) Science Advisory Board (SAB) is currently requesting nominations for members and consultants. According to the Federal Register notice, the SAB is composed of "Non-federal Government scientists and engineers who are employed on an intermittent basis to provide independent advice directly to the EPA Administrator on technical aspects of public health and environmental issues confronting the Agency." Any interested person or organization is welcome to nominate qualified persons to serve on the SAB. Nominees must be qualified by education, training, and experience to evaluate scientific, engineering and/or economic information on issues referred to and addressed by the Board.

Click to view full notice in Federal Register including contact information

Click to submit comment

Agriculture Department Announces Meeting of Advisory Committee on Agricultural Biotechnology
The Department of Agriculture has announced that an open meeting of the Advisory Committee on Agricultural Biotechnology (ACAB) is scheduled for November 29-30, 2000 in the Empire Room at the Omni Shoreham Hotel, 2500 Calvert Street, NW, Washington, DC from 8:30 a.m. until 6:30 p.m. on November 29 and from 8:30 a.m. until 5:30 p.m. on November 30. Topics to be discussed include: (1) The USDA's public seed breeding program and plant germplasm repositories; (2) impacts of gene flow from transgenic crops to other plants and current and potential USDA roles in addressing them; and (3) biotechnology budget priorities for FY 2002.

Click to view notice in Federal Register

Labor Seeks Information Regarding Disclosure Obligations of Fiduciaries of Employee Benefit Plans Governed by ERISA
Due to recent events including certain rulings by the Supreme Court and several federal circuit courts and recent changes in the laws governing the substantive requirements for employee benefit plans, some uncertainty has arisen as to how plan fiduciaries may best conduct their affairs so as to satisfy their fiduciary and disclosure obligations under the Employee Retirement Income Security Act of 1974 (ERISA). In an effort to clarify this uncertainty the Department of Labor has decided to request information from the public regarding this issue.

Click to view notice in Federal Register

Click to read original original ^®

National Committee on Vital and Health Statistics to Hold Meeting
The Department of Health and Human Services (HHS) has announced an open meeting of the National Committee on Vital and Health Statistics. The meeting will be held at the Hubert H. Humphrey Building, 200 Independence Avenue SW., Room 705A, Washington, DC 20201 on November 28, 2000 from 9 a.m. to 5 p.m. and on November 29, 2000 from 10:15 a.m. to 3:30 p.m. The Committee plans to hear presentations and hold discussions on several health data policy topics. These topics include implementation of the administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), a briefing on selected HHS data policy initiatives, and an analysis of State privacy laws. For a complete description of the Committee's agenda, please see the full notice in the Federal Register by clicking below.

Click to view notice in Federal Register

ATSDR Proposes Information Collection for Hanford Nuclear Reservation in Washington State
The Agency for Toxic Substances and Disease Registry (ATSDR) has submitted an information collection request under review by the Office of Management and Budget (OMB) of the Hanford Nuclear Reservation which is located in south central Washington State and which is on the Environmental Protection Agency's (EPA) National Priorities List (NPL).

Click to view notice in Federal Register

Click to read original original ^®

Agency for Toxic Substances and Disease Registry Releases List of Sites for which it Completed Public Health Assessments from April through June 2000
The Agency for Toxic Substances and Disease Registry (ATSDR) has announced the nineteen sites for which it has completed public health assessments during the period from April 1, 2000 through June 30, 2000. The list includes sites that are on or proposed for inclusion on the National Priorities List (NPL). The list also includes sites for which assessments were prepared in response to public requests. For a complete list of the sites and for information on obtaining the completed assessments, please click on the link to the Federal Register notice below.

Click to view notice in Federal Register

FDA Releases Draft Guidance on Mammography Quality Standards Act
The Food and Drug Administration (FDA) has announced the availability of the draft guidance entitled "Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #4." According to the FDA this document is intended to help facilities meet the Mammography Quality Standards Act of 1992's final regulations, which became effective April 28, 1999. The FDA also states that this draft guidance is neither final nor in effect at this time. Written comments concerning this draft guidance must be received by December 12, 2000.

Click to view notice in Federal Register

Click to read original original ^®

MBS Report on Regulatory Mandates in the Medicare Modernization Act of 2000
Multinational Business Services, Inc. (MBS) prepared a section-by-section review of the Clinton Administration's proposal to establish a Medicare prescription drug benefit, the "Medicare Modernization Act of 2000" (MMA). Specifically, MBS was tasked with identifying the specific number of new Federal regulatory mandates that would be required to implement the MMA, as well as who would be responsible for complying with (and paying for implementation of) those requirements. MBS's 64-page report identifies 412 new regulatory requirements in the MMA, 182 of which would have to occur in order to implement the prescription drug benefit. Taxpayer dollars would be required to implement these 182 new requirements, as well as to fund the administrative and operational expenses of the benefit management entities that would be established under the proposal.

Executive Summary

Jim Tozzi Statement

Download Report Cover & Table of Contents (pdf)

Download Report (pdf)

Download Chart

(pdf) (view @ 200% or > in Acrobat)

Free Acrobat Plug-in

OMB Seeks Comment on Standards for Defining Metropolitan Areas
OMB recently issued a Federal Register notice seeking public comment on the final report and recommendations of the Metropolitan Area Standards Review Committee concerning changes to the standards for defining metropolitan areas (65 Fed. Reg. 51060, August 22, 2000). The purpose of the standards is to provide nationally consistent definitions for collecting, tabulating, and publishing federal statistics for a set of geographic areas. While the new definitions will not be used as part of Census 2000, they may be used in future censuses and other important statistical activities of the federal government. As these activities have the potential to have a serious impact upon the public, CRE encourages interested parties to submit their comments to OMB.

Click to read more.

OMB Publishes Changes to OMB Circular A-76 Revised Supplemental Handbook
The Office of Management and Budget (OMB) has published three technical changes to the OMB Circular A-76 Revised Supplemental Handbook. The changes are: 1) to expand the Federal Activities Inventory Reform (FAIR) Act's inventory challenge and agency response periods from calendar days to working days; 2) to delete Part 1, Chapter 3, paragraph K.1.e., of the Revised Supplemental Handbook to avoid any conflict with the provision at Part 1, Chapter 3, paragraph K.7 that there is a single cost comparison appeal period; and 3) to strengthen OMB's longstanding policy of limiting the participation of directly affected individuals on an A-76 cost comparison Source Selection Team.

Click to view notice in Federal Register

Click to read original original ^®

Corps of Engineers and EPA Clarify that Mechanized Excavation Activities are Likely to Result in Discharge of Dredged Material Subject to Regulation
According to the Federal Register notice, the proposed rule by the U.S. Army Corps of Engineers and the Environmental Protection Agency (EPA) would "establish a rebuttable presumption that mechanized landclearing, ditching, channelization, in-stream mining, or other mechanized excavation activity in waters of the United States result in more than incidental fallback, and thus involve a regulable discharge of dredged material".

Click to view notice in Federal Register

Click to read original original ^®

President's Information Technology Advisory Committee Announces Meeting
The President's Information Technology Advisory Committee (PITAC) has announced that it will hold open session meetings from 3:00 p.m. to 5:00 p.m. on September 19, 2000 and from 8:00 a.m. to 3:00 p.m. on September 20, 2000 at the National Science Foundation, 4201 Wilson Boulevard, Arlington, VA 22230. The Agenda for the meeting on the 19th, which will be held in room 375, will include sessions entitled: (1) Administration's Agenda for International IT Current Overview (G-8 Discussion); (2) Internet for Economic Development Initiative; and (3) International IT Efforts and the NGO Community. According to PITAC's notice in the Federal Register, the meeting on the 20th, which will be held in room 1235, will include, "(1) Updates and reports from the PITAC's panels on learning, digital libraries, healthcare; the digital divide; and international issues; (2) a discussion on 21st century technologies; (3) a discussion on IT and the Humanities; and (4) a discussion of PITAC next steps and future studies". The discussion on IT and the Humanities will be hosted by William Ferris, Chairman of the National Endowment for the Humanities. Seating for the meetings is limited, and is available on a first-come, first-served basis.

Click to read full notice in Federal Register.

Justice Announces Proposed Consent Decree with American Chemical Services, Inc., et al.
The Justice Department has announced the lodging of a proposed consent decree in United States v. American Chemical Service, Inc., et al., No. 2:00CV438 (N. D. Indiana), and State of Indiana v. American Chemical Service, Inc., et al., No. 2:00CV437 (N. D. Indiana), on July 14, 2000 with the United States District Court for the Northern District of Indiana. The proposed consent decree relates to the implementation of the Environmental Protection Agency's (EPA) selected remedial action for the American Chemical Service Superfund Site, Griffith, Lake County, Indiana. Under the proposed consent decree the United States' and the State of Indiana's civil claims against the 39 defendants named in this action (including the two owners/operators) would be resolved.

Click to read full notice in Federal Register, including details of proposed decree.

HCFA Proposes New System of Records
The Health Care Financing, Department of Health and Human Services (HHS), Administration (HCFA) has proposed the establishment of a new system of records to help in its study of the effectiveness of lung volume reduction surgery. According to HCFA the primary purpose of the proposed system of records�called "National Emphysema Treatment Trial (NETT) System, HHS/HCFA/CHPP, 09�70�0531"�will be "to maintain data that will allow HCFA to collect and provide secure data on participants in the randomized phase of the study, pay claims, and to monitor and evaluate the clinical trial."

Click to read full notice in Federal Register.

FDA Announces Withdrawal of Food Additive Petition
The Food And Drug Administration (FDA) has announced that Minnesota Mining and Manufacturing has withdrawn its petition that proposed to amend the food additive regulations to provide for the safe use of a perfluoroalkyl acrylate copolymer as a component of paper and paperboard in contact with nonalcoholic foods at high temperatures, including the use in microwave heat susceptor packaging. The withdrawal of the petition is without prejudice to a future filing.

Click to view notice in Federal Register.

Agriculture Increases Desirable Carryout of Raisins Produced from California Grapes
In a final ruling the Agricultural Marketing Service, USDA, has increased the desirable carryout used to compute the yearly trade demand for raisins covered under the Federal marketing order for California raisins. According to the Department of Agriculture, this increase in desirable carryout�a term defined as the amount of raisins from one season needed during the first part of the next season for market needs�will ultimately make more raisins available to handlers for immediate use early in the season when supplies are tight and will allow desirable carryout to more accurately reflect actual carryout inventory.

Click to read full notice in Federal Register.

Regulatory Implications of Mixing Criminal Liability and Product Liability
CRE believes that Congress should not enact legislation that injects criminal liability into the current legal liability regime governing automobile safety and product liability. Legislation pending in the Congress raises very significant legal and policy issues, both for the automobile industry at which the current legislation is aimed, and as a problematic precedent that could expand to affect many other U.S. industry sectors. CRE believes Congress should not rush to judgment, because this issue needs substantial further public debate.

Read Item

FDA Amends Food Additive Regulations
In a final ruling the Food and Drug Administration (FDA) has amended the food additive regulations to provide for the safe use of ionizing radiation as as means of reducing Salmonella in fresh shell eggs. This action comes in response to a petition filed by Edward S. Josephson of the University of Rhode Island's Food Science and Nutrition Research Center.

Click to read full notice in Federal Register.

MSHA Protects Miner Safety with Help from Depts. of Labor and HHS
The main safety concern regarding mine workers has always been exposure to coal mine dust. The Federal Coal Mine Health and Safety Act of 1969 (Coal Act) established the first comprehensive dust standard by setting a limit of 2.0 milligrams of respirable coal mine dust per cubic meter of air (mg/m3). Later, the Coal Act was amended by the Federal Mine Safety and Health Act of 1977 (Mine Act) which further standardized mine worker conditions by requiring that "each operator shall continuously maintain the average concentration of respirable dust in the mine atmosphere during each shift to which each miner in the active workings of such mine is exposed at or below 2.0 milligrams of respirable dust per cubic meter of air."

Click to view notice in Federal Register

Click to read original original ^®

EPA Proposes to Clean up the Diesel Engine's Act with New Emission Standards
If implemented as proposed, the program would bring heavy-duty diesel emissions on par with those of new vehicles powered by gasoline, but at what cost?

Click to view notice in Federal Register

Click to read original original ^®

SBC Communications Inc. Opposes Breakup of Bundling by FCC
SBC Communications Inc. filed comments with the Federal Communications Commission opposing a proposal to encourage competition in local phone service. The FCC proposed requiring incumbent phone companies provide competitors with access to individual elements of the local phone company's network. SBC opposes this proposal since: 1) it would require them to allow use of their network by competitors at "reasonable rates"; and 2) the proposal would allow competitors to pick and choose specific network elements rather than requiring the competitor to purchase a bundle of services.

Click here to read excerpts from SBC Communications

EPA Responds to CRE Challenge of Inconsistency in Cancer Hazard Descriptors.
EPA's Director of Science Coordination and Policy stands behind EPA's revised cancer guidelines, stating, "It is erroneous to think that all hazard classification systems and definitions should be the same."

Read EPA Letter to CRE

OMB Requests Public Comment on Disclosure of Lobbying Activities Form
OMB has recently requested public comment on its proposed renewal without change of Standard Form LLL (Disclosure of Lobbying Activities). The request was published in the June 19, 2000 Federal Register (65 Fed. Reg. 38005) and comments are due to the agency by August 18, 2000.

Click to view notice in Federal Register

Click to read original original ^®

CRE Receives Comments on EPA National Primary Drinking Water Regulations for Radionuclides
As part of a court agreement, EPA plans to issue a regulation under the Clean Water Act dealing with radionuclides by November 21, 2000. Pursuant thereto, EPA published proposed National Primary Drinking Water Regulations for Radionuclides in the Federal Register on April 21st (65 Fed. Reg. 21575). Because drinking water standards affect all Americans and have serious public health implications, they are of considerable importance.
CRE recently received comments from Radiation, Science, and Health (RSH), an international nonprofit organization of independent experts on radiation and public policy, which were sent to EPA in response to the call for comments on the radionuclides rule. This organization raises a number of scientific objections to EPA's proposed regulation, including use of outdated data. It also asserts that regulation of low-level sources of radiation, below naturally-occurring background rates, is unnecessary, and it points to recent scientific studies which suggest that low doses of scientific radiation are, in fact, beneficial. CRE is posting the RSH comments to offer one viewpoints on the EPA rule and to encourage discussion and debate on this important topic.

Read Item

Rule by FAA Receives No Comments from Manufacturer Or Public
A notice of a proposed rule by the Federal Aviation Administration (FAA) to counter a possible unsafe condition on certain Swedish-made airplanes received no comments from the aircraft company nor from the public. The rule, which is now final, applies to certain SAAB 2000 series airplanes which have shown fatigue cracking in the internal backup struts in the forward part of the nacelle structure. The rule requires repetitive detailed visual and dye penetrant inspections of the backup struts in the left and right nacelles to detect discrepancies, and corrective actions, if necessary. These possible unsafe conditions were originally brought to the FAA's attention by Luftfartsverket (LFV), the airworthiness authority of Sweden.

Click to read Federal Register Notice Item

FTC Endorses Self-Regulation Proposal from Internet Advertisers
The Federal Trade Commission endorsed a self-regulation proposal from an organization of Internet advertisers. The industry proposal would govern the online collection of information about web surfers.

Read Item

SSA Official Responds to CRE Regarding Opportunities for Public Comment
CRE has received a response from the author of the SSA regulation on "Administrative Procedure for Imposing Penalties for False or Misleading Statements." (See article immediately below: "SSA Bypasses Regulatory Procedures in order to Get Tough with Benefits Cheaters") The response points out that the agency did not intend to diminish opportunity for public comment through issuance of an interim final rule, and that comments to the agency are welcome through September 8, 2000. SSA reiterates that all comments received will be addressed when the final rule is issued. (See related Federal Register notice for details on submitting comments)

Click to read response from the Social Security Administration

EPA to Begin Accepting Applications for Brownfields Pilots
The Environmental Protection Agency has announced that it is accepting applications for Brownfields Job Training and Development Demonstration Pilots through October 16, 2000. The goals of the pilots are twofold: to facilitate cleanup of brownfields sites contaminated with hazardous substances and to prepare the trainees for future employment in the environmental field. EPA intends to select ten Pilots by December 2000.

Read Item

Wood Products Maker Settles Charges with Government for $11.2 Million
The Bureau of National Affairs (BNA) has reported that Willamette Industries of Portland, Oregon, has agreed to pay $11.2 million to settle allegations of violating Clean Air Act new source review permitting procedures. In its Daily Environment Report for July 21, 2000, the BNA reported that the agreement also requires the company to install pollution control devices at 13 of its facilities which the government estimated to cost an additional $74 million (the company, however, estimates the cost to be $28 million) as well as to pay $8 million to fund supplemental environmental projects. The report also mentions that Willamette is the fourth wood products industry company to settle violations since the government initiated its sector-based investigation and reached its first settlement in.

Comment on Item

NHTSA Takes Lead in Addressing Driver Distraction
The National Highway Traffic Safety Administration will be holding two public events that focus on the potential safety implications associated with driver distraction while using advanced in-vehicle technologies. The first event is an international Internet Forum which is expected to begin on July 5, 2000 and end August 11, 2000. According to the NHTSA's description, "the Forum will provide an opportunity for technical experts as well as the general public to download technical papers, relate their experiences regarding the use of in-vehicle devices and their impact on safety in general and driving performance in particular, and participate in exchange of views on related technical issues."

Click to view notice in Federal Register

Click to read original original ^®

SSA Bypasses Regulatory Procedures in Order to Get Tough with Benefits Cheaters
The Social Security Administration (SSA) has bypassed the notice and public comment procedures specified in the Administrative Procedures Act (APA) in issuing an interim final ruling regarding administrative procedures for imposing penalties on people for false or misleading statements regarding monthly social security benefits. The SSA justifies its action by arguing that had it followed the notice and public comment procedures the issuance of final rules would have been delayed until well past the statutory effective date and the regulatory issuance date specified by Congress.
As a rule, the CRE does not agree with the practice of bypassing regulatory procedures. However, in this case, the CRE believes the SSA is justified in doing so, given the circumstances and in light of the nature of the final rule.

Click to read notice in the Federal Register

FCC CABLE ACCESS PROCEEDING FCC Chairman Announces Plans for Cable TV-Internet Access Proceeding The Center for Regulatory Effectiveness is creating an exploratory committee to determine whether an ANSI Accredited Standards Committee (ASC) or an MDC should be established for the purpose of developing standards for interconnecting cable televisions systems with the internet and other networks. Stakeholders interested in participating in the exploratory committee should contact the CRE. Read More Read CRE Letter to FCC Chairman Kennard on Cable Access. Read CRE White Paper: Market Driven Consortia, Implications for the FCC's Cable Access Proceeding HTML version PDF version

EPA Responds to CRE Challenge of Inconsistency in Cancer HazardDescriptors
EPA's Director of Science Coordination and Policy stands behind EPA's revised cancerguidelines, stating, "It is erroneous to think that all hazard classification systems anddefinitions should be the same."

Read EPA Letter to CRE

Bell Atlantic Opposes Breakup of Bundling by FCC
The Bell Atlantic telephone companies, better known simply as "Bell Atlantic", have submitted comments to the Federal Communications Commission opposing their providing of unbundled network elements to competitors. The proposal by the FCC, which is part of the implementation of the Local Competition Provision of the Telecommunications Act of 1996, seeks to promote competition among telecommunications carriers by requiring existing companies such as Bell Atlantic to provide access to individual elements of their network to any requesting carrier. Bell Atlantic opposes this proposal for two main reasons. First, it requires them to provide to any competitor at reasonable rates technology�also known as network elements such as switches, transports, and local loops�which they essentially built. Second, it allows competitors access to these network elements on an unbundled basis, which eliminates the obligation of any competitor to buy the whole bundle of network elements when the competitor only wants to purchase one of the elements.

Click here to read comments from Bell Atlantic.

Is the EPA setting the stage for another loss in court?
Recent studies have indicated that EPA has lost more cases in court than they have won. Is EPA positioning itself for another loss in court as a result of violating the Federal Advisory Committee Act (FACA)? FACA is one of the "good government" statutes that CRE monitors to assess agency compliance. The current EPA review of a triazine raises precedential issues regarding FACA, consequently CRE has communicated its concerns to EPA.

Click here to read CRE Letter to EPA.

Click here to read EPA's response to CRE.

Click here make a comment.

Associated General Contractors of America and U.S. Army Corps of Engineers Announce Partnering Initiative
The Associated General Contractors of America (AGC) and the U.S. Army Corps of Engineers has recently announced a joint initiative to promote partnering in the construction industry. The partnering initiative is a voluntary system for handling construction problems through cooperation, open communications, and a commitment to problem solving. Along with arbitration and mediation, it is hoped that partnering can help prevent litigation in construction disputes and otherwise benefit the project in question. A joint website has been set up to highlight case studies of best practices and to provide additional partnering resources. CRE strongly supports such cooperative efforts which prevent unnecessary litigation and preserve resources for projects that further the agency\'92s mission. CRE hopes that the partnering principle can be extended to other federal agencies to promote cooperative efforts which would forestall unnecessary regulation and litigation.

Click here to read more on this issue and to link to the AGC/Corps Partnering Website.

Senate Unanimously Approves Truth in Regulating Act of 1999
The Senate has recently approved important regulatory reform legislation designed to help Congress and the public gain information used as the basis for agency regulatory actions. The Truth in Regulating Act of 1999 (S. 1198) establishes a 3-year pilot program to support congressional oversight to ensure that important regulatory decisions are effective, efficient, and fair. Specifically, the legislation will allow Committee Chairmen or the Ranking Members to request a General Accounting Office (GAO) review of the risk assessment or cost-benefit analysis of a major regulation (i.e. an "economically significant rule" with an impact of $100 million or more). GAO must submit a report to Congress on the regulation within 180 days.
CRE applauds this movement for increased congressional oversight of the regulatory process and the transparency and public accountability benefits likely to result from passage of S. 1198.

Click here to view a Senate press release on the Truth in Regulating Act of 1999 (S. 1198).

Click here to view a summary of S. 1198.

In an effort to raise awareness of children's online privacy protection, the Federal Trade Commission is seeking to identify organizations to participate in and co-sponsor a campaign designed to promote the FTC's implementation of the Children's Online Privacy Protection Act (COPPA)

Click to view notice in Federal Register

Click to read original original ^®

FCC Invites Comment on Information Collection Regarding Creation of Wireless Medical Telemetry Service
As part of its continuing effort to reduce paperwork burden, the Federal Communications Commission is requesting comments from the general public and other federal agencies regarding an FCC proposal to appoint a frequency coordinator to maintain a database of all Wireless Medical Telemetry Service (WMTS) equipment in operation. This proposal, argues the FCC, would aid WMTS users in avoiding interference.

Click to view notice in Federal Register

Click to read original original ^®

EPA Solicits Comments on its Information Collection Procedures
As part of its job in administering a number of environmental protection statutes, the Environmental Protection Agency is required to collect data from thousands of facilities in many economic sectors. Before submitting its continuing Information Collection Request to the Office of Management and Budget, the EPA is soliciting comments on its proposed information collection procedures for affected businesses. Comments must be submitted on or before June 12, 2000.

Click to view notice in Federal Register

Click to read original original ^®

Bank of America Supports An Expansive Definition of Personal Data Which Can Be Released
Bank of America, the largest bank in the United States with $633 billion in total assets, has submitted 21 pages of comments supporting many of the rules that would implement the provisions of Title V of the Gramm-Leach Bliley Act. The rules were proposed jointly by four federal banking agencies: the Office of the Comptroller of the Currency, the Board of Governors of the Federal Reserve System, the Federal Deposit Insurance Corporation, and the Office of Thrift Supervision.

Read item

OSHA Promulgates Interim Final Rule to Comply with Electronic Freedom of Information Act (EFOIA)
The Occupational Safety and Health Administration has issued an interim final rule amending the agency's FOIA regulation in order to comply with "EFOIA" - the Electronic Freedom of Information Act" ("EFOIA"). The interim rule will go into effect on May 22, 2000. OSHA will accept public comments through June 26.

Click to read original original ^®

Labor Department Explains Notices of Workers' Eligibility for Benefits from Two Assistance Programs
The Labor Department has clarified two notices that appeared in the April 21, 2000 addition of the Federal Register which seemed to describe that workers from one company were benefitting from two different assistance programs. One of the notices grants to the workers of the company in question, the Thaw Corporation of Washington, eligibility to apply for NAFTA Transitional Adjustment Assistance, while the other notice grants the same workers eligibility to apply for Worker Adjustment Assistance. The reason for these two notices, according to the Labor Department's Grant D. Beale, Program Manager of the Division of Trade Adjustment Assistance, is simply that the company applied for and qualified for both programs as a way to cover their bases. The workers would have to choose between one of the two benefit programs which Mr. Beale said were essentially the same, the NAFTA program having been enacted later than the Worker Adjustment Assistance program.

For further explanation of these two programs, please see: https://www.wdsc.org/layoff/trade.htm

EEOC's Obligation to Implement a U.S. Supreme Court Decision Dealing with Quotas for Federal Contracts
In 1995 the U.S. Supreme Court issued its decision in Adarand Constructors, Inc. v. Pena, which places severe restrictions on the ability of the federal government to collect data from federal contractors to enforce quotas. Despite the passage of five years, and despite a petition by CRE, EEOC has yet to comply with the strictures laid down by the U.S. Supreme Court (as well as subsequent federal court decisions). This CRE issue paper delineates EEOC's legal obligations and identifies mechanisms for challenging EEOC's noncompliance.

Click here to Read Issues Paper.

New York Adopts Law to Guarantee Public Access to Scientific Data Used by State Regulatory Agencies
The state of New York has recently adopted a new law to guarantee public access to scientific data state agencies have used as the basis of new rules and regulations. The law provides that where a study serves as the basis for a regulation, the agency must publish key information about the study in the State Register, including the title of the study, the Principal Investigator, an abstract of the study, and information related to the agency's Data Access Officer. Where underlying study data are "readily available," the agency must also make this information available to the public. New York's law represents a significant advancement of Data Access at the state level.

Click here to read more about the New York Data Access law.

DOT Electronic Docket Greatly Improves Rulemaking Transparency
CRE commends the Department of Transportation for placing all of their rulemaking dockets (https://dms.dot.gov) on the internet. As a result of DOT's action, the public can now review public comments on all rulemakings and submit new comments electronically. CRE urges other federal agencies to look to the DOT Docket Management System as a model for placing agencies' dockets on the internet.

Read item

Comment on Item

U.S. Patent and Trademark Office Clarifies Selection Criterion for Advisory Board Membership

Click Here to Read More

EPA Studies Demonstrate A Major Reduction in Dioxin Levels
EPA, much to its credit, has continued to review dioxin exposure levels during preparation of its revised dioxin risk assessment. Studies indicate a greater than 20-fold reduction in dioxin levels since roughly 1970, to levels approximating those prior to the early 1930s. CRE has recommended incorporation of these new data, and opportunity for public comment and peer review.

Corps of Engineers to Cease Publication of Regulatory Guidance Letters In the Federal Register A New Way to Save Money?
The U.S. Army Corps of Engineers announced that they will cease publishing Regulatory Guidance Letters in the Federal Register. The Federal Register announcement stated that "to insure widest dissemination while reducing costs to the Federal Government" the RGLs would be published on their web site at the convenient address: https://www.usace.army.mil/inet/functions/cw/cecwo/reg.

Click to view notice in Federal Register

Click to read original original ^®

Federal Banking Agencies Have Issued Proposed Rules Which Deal with the Privacy of Consumer Financial Information. The Question is, Do the Proposed Rules Go Too Far or Not Far Enough?
CRE is Requesting Comments from the Public to Ensure that Federal Banking Regulatory Agencies, in Issuing the Final Rules, Comply With Statutory Authorities that Protect the Consumer's Right to Privacy But Not at an Excessive Cost.

Click to view notice in Federal Register

Click to read original original ^®

President Clinton Signs Executive Order Directing Environmental Review as Part of Trade Agreements. Call for Public Comments Issued.
President Clinton has signed a new Executive Order directing the U.S. Trade Representative to work with the Council on Environmental Quality to incorporate environmental considerations, such as sustainable development, into the USTR's negotiating objectives for trade agreements. The President's action was announced recently in the Federal Register.

Click to view notice in Federal Register

Click to read original original ^®

Cell Phone Tower Health and Safety Issues on Agenda at NIOSH Board of Scientific Counselors Meeting March 10.
The Board of Scientific Counselors (BSC) of the National Institute for Occupational Safety and Health (NIOSH) will meet on March 10, 2000 to provide advice to the agency on its research activities.

Click to view notice in Federal Register

Click to read original original ^®

USDA-HHS Advisory Committee Issues Recommendations for U.S. Dietary Guidelines. Meeting Announced and Call for Public Comments Issued.
The Dietary Guidelines Advisory Committee has issued its recommendations to the Secretaries of Agriculture and Health and Human Services for changes to the current U.S. Dietary Guidelines. The recommendations contain ten guidelines to improve the well being of the public through promotion of a healthy diet and lifestyle.

Click to read original original ^®

SBA Issues Annual Report on Implementation of the Regulatory Flexibility Act for FY 1999
The Chief Counsel for Advocacy at the Small Business Administration (SBA) has recently issued the agency's Annual Report on Implementation of the Regulatory Flexibility Act (RFA) for FY 1999. The report also encompasses the 1996 Small Business Regulatory Enforcement Fairness Act (SBREFA), which amended the RFA of 1980. Also, for the first time, the SBA report has been shifted to cover the fiscal year, rather than the calendar year, in order to harmonize the report with the requirements of the Government Performance and Results Act (GPRA).

According to the SBA report, RFA interventions by the SBA, small businesses, and relevant agencies are making a real difference. Changes instituted pursuant to these laws resulted in revisions to final regulations that year which reduced potential regulatory costs by nearly $5.3 billion. These savings were accomplished without compromising any public policy objectives.

While the RFA was designed to make agencies take into account the cost of regulations to small businesses, the Act was significantly strengthened with the passage of SBREFA, which authorized judicial review of agency compliance with the RFA. SBREFA also required EPA and OSHA to convene Small Business Advocacy Review Panels to obtain real world input as to the burden impacts of their proposed regulations.

The goal of the RFA has been to get agencies to internalize the process of finding the least burdensome regulatory alternative. The significant FY 1999 savings reflect vigilance on the part of the SBA Office of Advocacy, small businesses, and others, but it also demonstrates that the agencies have a way to go to fully internalize the principles of the RFA and SBREFA. CRE commends the Office of Advocacy on its efforts in this regard.

Click here to read the Executive Overview of the SBA report.

Visit the SBA Office of Advocacy Website at https://www.sba.gov/advo/.

Click here to review the entire SBA report.

CRE Recommendations Proposed in Regulatory Information Presentation Act of 1998
CRE has long recommended in its various Regulatory Report Cards that the public would benefit by clearer analyses and better documentation of compliance with Good Government laws when agencies propose rules and report other regulatory actions in the Federal Register. On June 25, 1998 (105th Cong., 2d Sess.), Rep. Helen Chenoweth introduced H.R. 4162, the "Regulatory Information Presentation Act of 1998." That legislation would direct the Office of the Federal Register to develop a uniform format which agencies would use to present, in a consistent and informative manner, the analytical information supporting a proposed and final rulemaking action determined to be "significant" or "major". CRE is pleased to note that Congress has also taken notice of this issue and encourages adoption of H.R. 4162 or similar legislation.

Click to read more and to access the text of H.R. 4162

Select Docket Filings
The CRE is instituting a new feature which will bring key filings in important rulemakings to our readers. This new feature will focus on filings and issues concerning the regulatory process. CRE readers interested in having a filing included in this section should submit a abstract to the CRE.

Submit Filing Abstract

Off-Register Regulation
Off-Register Regulation refers to the government issuing regulations without going through the publication of a Federal Register notice and providing the opportunities that the notice and comment process allows for public participation, compliance with all good government authorities including the Paperwork Reduction Act, the Regulatory Flexibility Act, the Unfunded Mandates Reform Act, and the Executive Order on Regulatory Planning and Review, as well as Congressional oversight. The three types of Off-Register Regulation identified by the CRE are:

Regulation by Litigation

Regulation by Information

Regulation by Appropriation

Supreme Court Ruling in Air-Bag Case Could Reshape Corporate Liability

Promoting the quality, objectivity, utility, and intergrity of federal government information

Use of the Internet as a "Backdoor" Federal Register

Alleged Overstatement of Corporate Profits Could Lead to SEC Regulation

EPA's Better America Bond

Side Air Bags

Council gives AP Environmental Science Textbooks a C Average for being Light on Science

CRE/Judicial Conference

Tozzi Bio

FCC Order 96-449

DC Circuit Opinion No. 91-1248

Brief for FCC No. 97-1838

CRE Data Qualitry Petition to DOD

FDIC Working Paper (Flannery and Samoly)

Hanson and Morgan paper

OMB Environmental Review

PRA Power Play

IWC Letter 1

IWC Letter 2

Tozzi Affidavit

DLC

Letter to the President

Bill of Law

CRE Petition - Original

CRE Petition w/ attachments

Banking Agency Transmittal Letters

McInerney Letter

Tozzi Articles

Tozzi National Press

Tozzi Affidavit

SEC PRA SEC Letters

• Link 1
• Link 2

Toward a Federal Data Agenda for Communications Policymaking

Everybody wants to get into the [Data Quality] Act

White House Drops Effort to Standardize Agency Risk Assessments

Stay current on government regulations

Price Control Elements in the Medicare Modernization Act of 2000

The CRE Disclosure Alternative To The SEC's Auditor Independence Rule With Sunset Provision

Resource Requirements Needed to Carry Out the Mandates in Section 511 of the Proposed Medicare Modernization and Prescription Drug Act of 2002

The MBS Report on Regulatory Mandates in the Medicare Modernization Act of 2000

DQA at FCC

2005 Edition Journal of Public Health

Agency (FCC) reliance on data submitted to the agency by outside parties ("third-party" data)

Regulatory Impact Analysis ? Experiences and Contributions for Better Regulatory Quality

NHTSA on DQA

NOAA IWC Letter

Agency (FCC) reliance on data submitted to the agency by outside parties ("third-party" data)

Stage 2 Lawsuit: Pre-Filing Review Copy

The cost benefit analysis

United States Data Quality Act

Dirty Deals: The Drug Diversion Trade

Regulatory Requirements of H.R. 1415

Regulatory Requirements of H.R. 3605/S. 1890

The MBS Report on Mandatory Duties Under The Paperwork Reduction Act

Ensuring Accountability for Developing Well-Founded Federal Regulations

Product Development Opportunites Through Federal Research

A Blueprint for Constructing a Credible Environmental Risk Assessment Policy in The 104th Congress

Activists File Rare Data Act Challenge Against EPA Refinery Air Rule

Brazilian Regulatory Conference

FCC Invokes the Data Quality Act (please see Footnote 467 and pp. 76-79)

Aquatic Mammals

John Brunious Funeral

John Brunious Funeral Preservation Hall

CRE on the BBC

Wine, Jazz and Data Quality

Public Eye Watching the Watchdogs

CRE: Watchdog for Congress

DQA Applies to ICR

DQA Applies to Third Party Data

DQA Applies PRA Certification.

Litigation

Views of Third Parties on CRE

A Difficult Decade: Continuing Freedom of Information Challenges for the United States and its Universities

RFA Judicial Review

Litigation 2

T.H.

Forbes on Blogs

Texas Research Permit

PRA Certification

SBA Letter

Houston DQA Petition

Data Quality Act Challenge

OMB Rejects FCC Data-Collection Rules

CRE and EDSP

CRE testified before the FDIC in support of Wal-Mart’s application for an in-house bank

Litigation 3

GAO on Carbon Sequestration

• CLIMATE CHANGE: Federal Actions Will Greatly Affect the Viability of Carbon Capture and Storage As a Key Mitigation Option

Brazil Seminar Video

Written Remarks Brazil

Post Liquor Article

Tozzi Brazil Presentation

EFAB

National Archives Interview March 2009: Centralized Regulatory Review PA 1957

1 2 3 4 5

6 7 8 9 10

11 12 13

The Implications of the NOAA National System of Marine Protected Areas on the Outer Continental Shelf Lands Act

Comments on NOAA’s Proposed National System of Marine Protected Areas (MPAs)

The Implications Of The NOAA National System Of Marine Protected Areas On The Outer Continental Shelf Lands Act

Small Business Enhanced Competitive Bidding: Paperwork Reduction Act Comments on CMS' DMEPOS Competitive Bidding ICR

NOAA Pre-dissemination Review ICR

NOAA Pre-dissemination review #2

NOAA Pre-dissemination review #3

Scalia on Tozzi

Obama Retakes The Global Stage

“The Man Who Sold the World”, by William Kleinknecht (Nation Books) Centralized Oversight Of The Regulatory State Deregulator Extrordinare

HomeCare Magazine

CRE + NGO (1)

Washington Post--Peter Behr

Jenner Block

Venable

Stealth Lobbying Kills Secondary Smoke Proposal Los Angeles Times

Chamber

How Medicare Suppliers And Beneficiaries Can Complain About Durable Medical Equipment, Prosthetics, Orthotics, And Supplies ("DMEPOS") Concerns

White House Blog

An Excerpt from the White House Open Government Initiative Blog A Primer on the Data Quality Act

Tozzi v HHS

• Raul
• Beregeson
• Citations
• Decision

Preservation Hall Jazz Band September 1985 performance at Wolf Trap

DOT requires third party data to meet DQA guidelines

The Need for the DQA

DOT states in Rule Third party data to meet DQA

CRE CRA Watchdog

A Practical Guide To Reducing Merchant Payment Card Processing Costs

Open Government Initiative

• The Obama Administration's Open Government Directive
• Why an Open Government Matters
• Open Government Directive Memorandum
• Open Government Policy
• Reinventing Technology Assessment

Prime Time Master

Prime Time Inside EPA

DC Circuit: CRE On White House Website

CRE on White House Website

• The Obama Administration's Open Government Directive
• Why an Open Government Matters

FDA Unveils Draft Proposals on Agency Disclosure Policies for Public Comment

Prime Time Rehearing

Prime Time District Court Decision

Prime Time Abbreviated

EPA Trains its Staff in DQA Compliance

Tozzi on the Chamber

U.S Government Launches Data.gov Open Government Initiative

ICANN and the DQA

DQA Petitions

Spotila Letter

Cass Sunstein on Tozzi at ACUS  (audio file)

TPSAC Tozzi - 3.59:40

Rep. Issa Letter

Tozzi/Reaganomics

CPR on IPD

Am I Blue

IWC # 1

CRE as a Gateway

ACUS - Page 1, Page 2, Page 3

The Most Excellent Center for Regulatory Effectiveness

Counterfeit Coalition

Tozzi v HHS NTP History

Tozzi in Websters Online

Tozzi TPSAC March 2010 (3:08:23)

CRE Press Release Coverage

BOEMER Gives Wind Power Zoning Priority (USA)

ACUS on CRE

IQA and Scientific Integrity Memo
IPD Launch Medical News Part 1, Part 2

AAAS Recognition of CRE

FCC PRA
ACUS Government, Public

OIRA 30th Anniversary
Waynesburg, Ohio Notables

• Joe Cicchetti
• Frank Elsass
• Russell Furney worked with Enrico Fermi
• Shawn Mathey

Press Release of OIRA's 30th Birthday

Science Magazine DAA DQA

Science Magazine Initial + Response

ORIA 30th Bio

Increasing Public Access to Federal Contract Information - Reinvigorating the Data Access Act: Center for Regulatory Effectiveness in Science Magazine

OIRA's 30th Anniversary

Vickrey

The Council on Competitiveness and Regulatory Review: A “Kindler, Gentler Approach” to Regulation? Administrative Law Review, with Delissa Ridgway and Michael Waldman, Volume 6:639

Tozzi, J. and E. Clarke, (1983) "On Information and the Regulation of Public utilities", A. Danilsen and D. Kamershen (Ed.) Current Issues in Public Economics, 133-147. Lexington: Lexington Books.

Comments on New Information Collection Request, “Parts 3900–3930—Oil Shale Management—General.’’

Reyes

Profile - The OMB's Jim Tozzi, 1 ENVTL. F. 11, 11 (May 1982)

Office of Management and Budget: If There's a New Rule, Jim Tozzi Has Read It, WASH. POST, July 10, 1981

Erik D. Olson, The Quiet Shift of Power: Office of Management & Budget Supervision of Environmental Protection Agency Rulemaking under Executive Order 12,291, 4 VA. J. OF NAT. RESOURCES L. 1, 6 (1984)

Paperwork Reduction Act of 1980: Hearing Before the H. Comm. on Gov't Operations, 96th Cong. 88-98 (1980)

The 20 Years War, 15 NAT'L J. 1238 (1983)

Note to Regulatory Relief Community

Ciao Jim Tozzi

Nixon Legacy Forum

CRE NATIONAL PRESS RELEASES

Peer Review Library

Tozzi Photo

Tozzi Resume

The Rise of the Social Entrepreneur

Environmental Forum 2004 (Tozzi pg 38)

Tozzi Blog

Tozzi ACUS 1.13.45

CRE Comments on the MMS Proposed OCS Leasing Plan and its EIS

OIRA Thirtieth Anniversary Conference (ALR TOC)

The Twenty Years War

The Twenty Years War Appendix

CTP Letter

CTP Response Letter

Congressional Hearing (Tozzi) Regulatory Budget

Tozzi at Preservation Hall

U.S. Environment Agency Misses Dioxin Deadline

Jim Miller on Jim Tozzi

OMB violation of the PRA

• Part 1
• Part 2

Tozzi on ACUS

ACUS Meeting: PRA

State DQA

e-cig on CRE

e-cig on CRE #2

CRE and RPC

Tozzi/craftsman

Federal Register on CRE

Ketchup

ACUS 2011 Annual Report

OIRA Personnel Levels

Three OIRA Social Entrepreneurial Actions

ACUS 2011 Annual Report

OIRA Personnel Levels

Three OIRA Social Entrepreneurial Actions

DOD Payday Lenders

Responding to America’s First Energy Crisis

H.R. 5952

Presidential Review

Whistleblowing

BLM Non-compliance

DQA Petitions
ACUS on PRA

• Video (12.48)
• Tozzi Comment 1
• Tozzi Comment 2

PRECEDENT ICR Prohits Stronger Reg Gov Use of Third Party Dara (5,17)

UNEP Success

OMB Denial of an ICR

CRE on DOE Website

NOAA Pre-dissemination Review ICR NOAA Pre-dissemination review #2 NOAA Pre-dissemination review #3

• DOT
• NMFS also/or NMFS
• MMS
• EPA
• Agriculture
• FDA

A Library of Agency Pre-dissemination Review Programs

Agency Documents for Predissemination Review Library

DQA Atrazine

Tozzi Master Craftsman

ACUS Public Members 2012

Zoom Info Tozzi

Cyber Litigation

Harvard Law Review on Tozzi

ABA on Tozzi

CRE Mission Statement

Tozzi Resume

Regulations.gov Proposal

Data Access Determination

CRE Mission and Staff Background

Policy Entrepreneurs A new book came out on lobbying and policy entrepreneurs; Tozzi was placed in the later category. For further details , go to the link below, click on title of Book and put Tozzi in the search engine when it comes up. https://www.amazon.com/Lobbying-Policymaking-R-Kenneth-Godwin/dp/1604264691 Policy Entrepreneurs Policy Entreprenuers and Regulatory Agencies OIRA' s Reach Policy Entrepreneurs Clinton Health Care Plan (fn 15) Policy Entreprenuers (Levinson) NOAA Pre-dissemination Review ICR NOAA Pre-dissemination review #2 NOAA Pre-dissemination review #3 DOT https://www.thecre.com/pdf/benchmark.pdf NMFS https://www.thecre.com/forum1/wp-content/uploads/2011/04/esapestartpredissemination.pdf also/or https://www.thecre.com/forum1/?p=120 MMS https://www.thecre.com/forum1/wp-content/uploads/2011/04/esapestartpredissemination.pdf EPA https://govpulse.us/entries/2007/08/03/E7-15123/draft-epa-s-2007-report-on-the-environment-highlights-of-national-trends Agriculture https://thecre.com/quality/comments_agriculture.html FDA https://www.thecre.com/pdf/2008_CRE_BPA_Recommendations.pdf Policy Entrepreneurs Univ PA Law School IPD NGO Federal Agency Recognition of CRE Public Comments on Settlements NOLA Motion NOLA Settlement Tozzi Summary Bio Third-Party Evaluation That's Life My Way Corporate America Use of Interactive Public Dockets An Initial Step by the Private Sector to Use Interactive Public Dockets Columbia School of Journalism on Koch Use of Websites Policy Entrepreneur Live Washington Post Physician Fees Three CRE Principals for Engaging Outside Regulatory Support Private Influence On Environmental Policy: The Case Of The National Industrial Pollution Control Council CRE Contract Process Third-Party Evaluation-credibility Reagan Retrospective Review Reagan Retrospective Review 2 CRE Credibility Administrative Conference of the United States (2010-2017) Federal Register White House American Association for the Advancement of Science (AAAS) American Men and Women of Science Department of Defense (FedLaw website) Public Eye ABC News The Federalist Society The Community Of Herbal Product Users National Press Congressional Press Trade Press Tozzi on ACUS (2) CRE NGO Interventions NRDC (1) NRDC (2) EFAB Press Pickup DOJ Counterfeit Post Attachment 1 Attachment 2 DOJ Counterfeit Post (DOJ) Attachment 1 Attachment 2 Tozzi Resume Google Tozzi OIRA The Environmental Forum, May 1982 The Environmental Forum, May 1983 The Environmental Forum, September/October 2004 The Environmental Forum, January/ February 2012 Administrative Law Review (Special Edition) 37 (2011)] Tozzi DQA Data Access Act OMB Disapproves FCC ICR CRE in Federal Register A Proposal to the Committee on Administration & Management of The Administrative Conference of the United States Effective Information Management in the Regulatory State IPD Recognition Prime Time Interpretation Tozzi at CFPB (2:28:20) Al Schmid BAT Sustainable Investment Global Economic Intersection The Telegraph Reuters T.V. The Sacramento Bee Ecopreneurist Penn Blog EPA Peer Review EPA Peer Review 2 CRE Third Party Validation Three Determinants of the Administrative State Tozzi Dissertation ASA DQA Success Story CRE on DOJ Comments to the Science Advisory Board The Need for Government-Sponsored Scientific Studies of The Adverse Health Effects of Counterfeit Cigarettes I Have Heard That Song Before Tozzi Regulatory Arsenal CRE on DOJ Part III Ecopreneurist Jim Tozzi Jim WikiTV Recent International Interventions UNEP IWC Seismic Ban World Health Organization Madagascar Applicability of the Data Quality Act to International Regulatory Bodies (pdf) Applicability of the Data Quality Act to International Regulatory Bodies (doc) DQA Storage (DQA Petitions HHS) Matthew Pre-filing Review Brief Pre-filing Review Brief 2 Am I Blue Blanche Thomas with Papa French and his New Orleans Jazz N. B. Joe Lastie Program CRE/JT JT Pub JT Pub (mn) APSA Tozzi Mary Magdalene Jim Tozzi Center for Regulatory Effectiveness Building a Nationwide Constituency for OIRA ABA Nov 2015 Jim Tozzi ACUS OIRA Tozzi Government Controls Imposed by the White House Plan CRE Press Coverage 2016 Seven Game Changers Jim Tozzi Precedents Seven Deadly Regulatory Reforms GW 30th Anniversary OIRA Ecopreneurship OMB Menthol Policy Entrepreneurs Reg Blog GW Speakers Navigating Medical Marijuana: Advocates Return to D.C. This Weekend NMFS Acoustic Guidance Violates the Peer Review Requirements of the Information Quality Act Jim Tozzi Durante Kratom Nixon Foundation PFC Review Board Member, Jim Tozzi's Role in Stopping the DEA from Classifying Drug in Schedule 1 Status A Trump SWAT Team for Regulation OIRA Syllabus Reagan Regulatory Swat Team Google Ranking Oral Histories: Jim Tozzi National Archives Nixon Foundation: Energy Regulation GW University EPA - In process A number of the above activities were described in press articles Aspirin 2 Aspirin 1 Schmid PPB Q&A API Q&A CRE NO Street Band NO Street Band 2 CRE Third Party Validation CRE Illicit Tobacco Credentials University of Washington School of Law American University School of Law OMB Contact Transparency in Science Gov't Starts Making WH Visitor Logs Public Bulgaria Meade and Tozzi Tozzi TV Bio Interactive Public Docket (Audiopedia) WikiTV Original Clinton Healthcare Plan Applicability of Data Quality Act to Foreign Institutions Why Are Executive Orders Important? ABA How The CRE's Jim Tozzi used the Data Quality Act to defeat the 2016 DEA ban. It is still relevant. ACUS 1 Jim Tozzi and "Regulation of Social Media" Summer Brown-Bag Series: Section of Administrative Law & Regulatory Practice Regulatory Policy Committee From Cherry Blossoms To Climate: EPA As Peace Corps For Environment? Tozzi Washing Post # 2 Tozzi GW Pierce Program Summary Gray Panel Sher Brazil Blog Article Columnista Current Events: Management of the Administrative State This Month’s Political Science Paper and Management of the Administrative State ACUS