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CRE Watch List 2003 - 1999

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FCC Decision on Broadcast Rules Suggests Need for Oversight
The FCC has issued new rules governing media ownership by broadcast companies. These new rules have the effect of significantly relaxing media ownership restrictions. The FCC News Release announcing the decision stated that the new rules were "based on empirical evidence" and were the result of an "unprecedented public record" of more than 520,000 comments. Commissioner Adelstein's dissenting statement noted that "99.9 percent"of people who made their views known to the Commission were opposed to the new rules. The Commissioner's statement also discussed his view that the new rules were "based on oftentimes arbitrary numbers." Given the economic significance of the new broadcast ownership rules and the disputes over the quality of the data and analysis underlying the Commission's decision, the rulemaking is a key illustration why OMB should, under its existing authority, review major rulemakings by the FCC and other independent agencies. OMB has particular expertise in regulatory analysis and is responsible for ensuring that agencies adhere to the "good government" laws, such as the Data Quality Act and Paperwork Reduction Act, which govern the regulatory process. Although there is great controversy over whether the public interest will be well served by the new broadcast ownership rules, there should be little dispute that the public would have been better served by OMB oversight of the rulemaking.

Click to read the FCC News Release

Click to read Statement by Commissioner Adelstein

Click to read CRE's Blueprint for OMB Review of
Independent Agency Regulations

Click here for CyberActivist.US

OMB Analytic Tool Reveals Poor Cost-Effectiveness of NHTSA Tire Standards Proposal
OMB, in the President's FY '03 Budget, used a league table to rank the cost-effectiveness of ten health and safety regulations. OMB noted that the tables are "most useful" when based on information about potential or proposed rules. Thus, CRE is undertaking a series of analyses utilizing league tables to evaluate the cost-effectiveness of proposed regulations. CRE's first league table analysis is of NHTSA's proposed tire performance standards for FMVSS No. 139. The analysis found that NHTSA's proposed tests are less cost-effective than any rule included in OMB's league table.

Click to read CRE letter to NHTSA

Click to read CRE paper on OMB use of league tables

Click to read CRE league table analysis of NHTSA tire standards proposal

CRE Regulatory Services

FCC Seeks to Update Record on Rules Adopted in 1996 Local Competition Docket
In an effort to refresh and update the record on issues pertaining to the adopted rules in Docket No. 96-98, Implementation of the Local Competition Provisions of the Telecommunications Act of 1996, the Federal Communications Commission (FCC) has requested that parties that originally filed petitions for reconsideration in 1996 addressing issues that are not subject to pending litigation now file a supplemental notice indicating which issues they still wish to be reconsidered. The FCC believes that since many of these petitions were filed several years ago, the passage of time and intervening developments may have rendered the record developed by these petitions stale. Also, the FCC believes that some issues raised in petition for reconsideration may have become irrelevant in light of intervening events. The FCC notes that to the extent that parties do not indicate an intent to pursue their respective petitions for reconsideration, the petitions will be deemed withdrawn and will be dismissed.

Click to read the notice in Federal Register

Comment on Item

DOT Honors Safety Commitment
The Federal Motor Carrier Safety Administration carried through on its commitment to improve highway safety by terminating allowable overloading of manufactured home tires. In ending overloading, the Department also took another important step in implementing Secretary Mineta's and FMCSA Administrator Clapp's new tire safety campaign.

Click to read FMCSA regulation

Click to submit comment

DOT: Is It a Department of Deception?
The Federal Motor Carrier Safety Administration (FMCSA) continues to deceive the public about ending the allowable overloading of tires used on commercial vehicles. Despite at least three Federal Register notices committing the agency to specific dates for ending tire overloading - and numerous deaths attributed, in part, to the overloading of tires - DOT may go back on its word to end the overloading of tires used to transport manufactured housing. The latest overloading extension would come despite the Department's previously published conclusion that such overloading needed to be terminated due to its association with a tire failure rate that was "too high." MBS has written to DOT to protest this perversion of the regulatory process which threatens public safety.

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EPA Issues Exemption from Requirement for a Plant Pesticide
The Environmental Protection Agency (EPA) has established an exemption from the requirement of a tolerance for residues of the plant-pesticides Bacillus Thuringiensis Cry1F protein and the genetic material necessary for its production in corn on field corn, sweet corn, and popcorn when applied/used as a plant-pesticide.

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OSHA Seeks Comment on Request for Increase in Burden-Hour Estimates for Information Collected Using OSHA-7 Form
The Occupational Safety and Health Administration (OSHA) is soliciting comments regarding its request for an increase in the existing burden-hour estimate for, as well as an extension of OMB approval of, the OSHA-7 Form. OSHA's request is to increase the current total burden hour estimate from 8,155 hours to 14,819 hours, an increase of 6,664 hours. According to OSHA, this time increase is due to an increase of complaints received from 28,713 to 55,130.

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WATCHLIST
CPSC Submits Request for Reinstatement of Approval of Information Collection Requirements in the Safety Standard for Bicycle Helmets
The Consumer Product Safety Commission (CPSC) has announced that it has submitted to the Office of Management and Budget (OMB) a request for reinstatement of approval for a collection of information in the safety standard of bicycle helmets. According to the Commission, the information, which is collected from manufacturers, importers, and private labelers of bicycle helmets, is used "to help protect the public from risks of injury or death due to head injury associated with bicycle riding". In particular, the Commission believes that this information "helps the Commission determine whether bicycle helmets subject to the standard comply with all applicable requirements". The Commission received only one comment from its original notice announcing its intention to seek this reinstatement of approval for the information collection.

Click to view full notice in Federal Register

Comment on Item

OSHA Seeks Comment on Extension of Information-Collection Requirements of Voluntary Protection Program
The Occupational Safety and Health Administration (OSHA) is soliciting public comments regarding its request for an extension of the information-collection requirements of the Voluntary Protection Program. In particular, OSHA specifies that it is looking for comments on the following issues: "Whether the proposed requirements are necessary for the proper performance of the Agency's function; the accuracy of the Agency's estimate of the burden (time and costs) of the information-collection requirements; the quality, utility, and clarity of the information collected; and ways to minimize the burden on employers who must comply."

Click to read more

Click to view full notice in the Federal Register

Comment on Item

HHS Announces Organization of Advisory Committee on Regulatory Reform
The Department of Health and Human Services (HHS) announced formation of an Advisory Committee on Regulatory Reform to ensure that the Department's programs and activities are effective and efficient. The Committee, which will be governed by the requirements of the Federal Advisory Committee Act (FACA), will assemble experts from various sectors in the health care field in order to identify potential regulatory reforms which could reduce burdens and costs while maintaining or enhancing performance. The meetings of the advisory committee will be open to the public. CRE strongly supports HHS's efforts to undertake a critical reevaluation of its programs with broad public input.

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NHTSA Denies GM Application for Exemption of Noncompliance for Headlamps
The National Highway Traffic Safety Administration (NHTSA) has denied an application from General Motors Corporation that would have exempted it from remedying certain headlamps on 1999 Buick Century and Buick Regal models that do not meet certain photometric standards. GM sought this exemption on the basis that the noncompliance is inconsequential to motor vehicle safety.

Click to read more

Click to view full notice in the Federal Register.

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SEC Solicits Comments on Proposed Rule Change Requested by the American Stock Exchange
The Securities and Exchange Commission (SEC) is seeking comment on a proposal by the American Stock Exchange to add a rule that would provide various types of disclaimers to the Goldman Sachs Technology Composite Index and sub-indexes thereof licensed for use in connection with certain Index Fund Shares traded on the Exchange. The American Stock Exchange believes that this proposed rule, called Rule 1005A, is similar to Rules 1004, 1005, and 1006 which provide various disclaimers for Standard and Poor's, Dow Jones, and Nasdaq Indexes, respectively.

Click to read more

Click to view full notice in the Federal Register.

Comment on Item

EPA Failure to Provide Public Notice and Comment on HPV Chemical Testing Rule's Paperwork Burden Leads to CRE Letter to OMB
EPA has submitted an Information Collection Request to OMB covering toxicology data collection from both voluntary and mandatory TSCA testing programs. The Agency excluded the proposed new mandatory HPV test rule's paperwork burden from the ICR even though EPA intends to use the ICR's OMB Control Number for the HPV test rule(s). CRE recommends that the existing OMB Control Number be used only for voluntary TSCA testing programs and that EPA develop and provide for public comment a new ICR specific to mandatory TSCA programs, including HPV test rule(s), prior to taking any final action on the mandatory HPV chemical testing program. CRE also recommends that EPA develop a separate ICR for exposure data from voluntary and mandatory TSCA testing programs.

Click to read CRE letter to OMB.

Click to read attachment to CRE letter.

Click to see CRE's EPA HPV Chemical Testing Special Project.

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CRE Files Human Test Data Petition at EPA
EPA's Pesticides Office has refused to consider clinical human test data in establishing No Observed Adverse Effects Levels during pesticide review and registration. On August 30, 2001, CRE petitioned EPA to return to its prior practice of considering clinical human test data when establishing pesticide NOAELs. CRE's petition explains that the Pesticides Office cannot refuse to consider clinical human test data without a rulemaking in accordance with all applicable laws and executive orders.

Click to read CRE's Human Test Data petition.

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Public Commenters Ask: Is EPA Destroying Its Reduced-Risk Pesticides Initiative?
In a recent RegWeek article, CRE reported on EPA's unwillingness to cancel an existing registration for the pesticide Metolachlor, despite a requirement for the phase out of that pesticide as part of the registration of a new, reduced-risk alternative, S-Metolachlor. In addition, the agency is considering granting other companies the right the market the original, less environmentally-friendly product. CRE asked its readers for their thoughts, and there was clear consensus that EPA's approach: (1) threatens the agency's credibility in terms of protecting human health and the environment, and (2) provides a strong disincentive for companies to develop new, safer products. Such results are clearly at odds with goals of the Reduced-Risk Pesticides Initiative. EPA is strongly urged to reconsider its present course.

Click to read CRE's analysis of public comments received on the Metolachlor/S-Metolachlor issue.

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Henshaw, Scalia Nominations Move Forward in Senate
CRE Web site reporter Don Fulsom reports on the latest Capitol Hill developments on ergonomics-related matters. This is one in a series of articles on the politically volatile issue of ergonomics in the workplace.

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Click to submit comment

Industry, Labor Groups Clash at Ergonomics Forum
CRE Web site reporter Don Fulsom reports on the opening of the Labor Department's public forums on ergonomics. This is one in a series of articles on the politically volatile issue of ergonomics in the workplace.

Comment on Item

OSHA Ergonomics Forum: Humanistic Versus Ergonomics Intervention in the Work Place
Dr. Alf Nachemson of Sweden, an internationally recognized expert in back pain, stated that humanistic intervention in the workplace has a greater impact than ergonomics intervention. Mr. Richard Trumka of the AFL-CIO stated that OSHA's emphasis on defining the term ergonomics was a way of minimizing the issue.

Comment on Item

American Chemistry Council Identifies Serious Deficiencies in EPA's HPV Rulemaking
The American Chemistry Council (ACC) has identified serious deficiencies in EPA's proposed HPV rulemaking. Although ACC made clear their strong support for the voluntary HPV Challenge Program, the Council's comments point out major problems with the proposed rule which EPA needs to address prior to taking any regulatory action.

Read more on AAHRPP.

Read the AAHRPP Press Release.

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Federal Government and Others Move Ahead With Reviews of Human Volunteer Research
A variety of entities are currently reviewing this subject and considering recommendations. These entities include Federal agencies, Federal advisory committees, international bodies, and Congress. The resulting recommendations are bound to raise numerous issues in areas such as regulatory impacts, practicality, ethics, and legality. CRE will follow developments in this area through periodic updates and links to other key sites. Commentaries may be submitted to CRE for posting on the "Commentaries" page, at CRE's discretion regarding pertinence and quality of content.

Background Materials

United States Government Resources

Private and Non-Government Resources

Commentaries

Comment on Item

CRE Announces New Special Projects Section
CRE now has a Special Projects section of the Watch List. These Special Projects demonstrate in-depth work on issues of importance to the regulated community. The Special Projects section provides a reference guide to relevant documents throughout the CRE website. CRE's first Special Project is EPA's HPV Chemical Testing Rule.

See Special Projects

Comment on Item

An HHS Advisory Commission Recommends Federal Regulatory Authority Over Privately Funded Research
The National Bioethics Advisory Commission states that as many as 50,000 U.S. researchers participate in conducting clinical studies in humans. They believe that the current regulatory system that applies to federally funded research be expanded to include privately funded research. CRE has been following developments in the human research area (see related CRE activities.) CRE is in the process of writing a number of white papers on this issue.

Read article in The Washington Post, "U.S. Oversight Urged for Human Research," May 16, 2001.

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SBA Opposes EPA's 100/lb TRI Reporting Limit for Lead
The Small Business Administration's Office of Advocacy sent a letter to EPA Administrator Whitman opposing the Agency's January 17 Final Rule lowering the TRI reporting threshold for lead to 100 pounds. Key concerns expressed by SBA were: 1) disagreement with EPA's certification under the Regulatory Flexibility Act that the rule would not impose a significant burden on a small businesses; 2) EPA has not established a factual basis for designating lead as a persistent bioaccumulative toxic; and 3) EPA has not demonstrated significant benefit for lowering the lead reporting threshold to 100 pounds.

Read SBA's letter.

Comment on Item

Health and Environmental Groups Oppose EPA Chemical Testing Programs
The Physicians Committee on Responsible Medicine has written to EPA Administrator Whitman on behalf of a number of national organizations in opposition to three major EPA chemical testing initiatives. The letter raised a number of issues which could constitute violations of the Paperwork Reduction Act. Specifically, the letter charges that some of the tests are redundant and that at least some of the tests will not produce useful results, i.e. lack practical utility. The PCRM also claims that EPA staff is, "worried about how to handle the expected deluge of incoming data." Agencies are required by the PRA to a plan for the efficient and effective management and use of data prior to seeking OMB approval for the proposed information collection.

Read the Environmental News Network article, "Health groups challenge EPA animal testing," May 1, 2001.

Comment on Item

CRE Criticizes EPA's Use Of Unvalidated Test Methods
CRE has submitted comments criticizing EPA's use of unvalidated test methods in the Preliminary Human Health Risk Assessment for the herbicide atrazine. Test methods that have not been properly validated should not and cannot be used to regulate. CRE is interested and involved in the proper validation of test methods by federal agencies because this important issue cuts across many agencies and regulatory programs. For example, test validation is the subject of the proposed settlement agreement in NRDC's suit on EPA's estrogenic substances screening program. NRDC v. Whitman. EPA is now soliciting public comment on this proposed settlement and a related consent decree. In addition, People for the Ethical Treatment of Animals is suing EPA for allegedly using unvalidated test methods under TSCA in the case Helstosky v. EPA in the United States Court of Appeals for the D.C. Circuit.

Click here to access CRE's atrazine comments.

Click here here to access EPA's Federal Register notice.

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OMB Seeks Comment on Draft Report to Congress on the Costs and Benefits of Federal Regulations
As required by statute, OMB has recently produced a Draft Report to Congress on the Costs and Benefits of Federal Regulations, which includes recommendations for reform in the regulatory process. Divided into three chapters, the Draft Report estimates the costs and benefits of regulations in the aggregate, by agency and agency program, and by major rule. OMB also is required to analyze the impacts of federal regulation on state, local, and tribal governments, small businesses, wages, and economic growth. OMB is accepting public comment on the Draft Report until July 2, 2001. CRE strongly supports OMB's efforts to improve transparency and efficiency in the regulatory process and urges interested parties to submit comments to OMB.

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EPA Non-Compliance with the Paperwork Reduction Act Triggers CRE Request to Re-Propose the HPV Chemical Testing Rule
EPA failed to comply with the requirements of the Paperwork Reduction Act (PRA) in publishing a Notice of Proposed Rulemaking (NPRM) which would mandate hazard screening tests on High Production Volume (HPV) chemicals. EPA's HPV NPRM: 1) incorrectly stated that the rule did not involve new information collection activities; 2) mischaracterized the Information Collection Request as an extension of an existing ICR; and 3) failed to justify a proposed new use of the data under the data quality provisions of the PRA and OMB guidance documents. CRE responded to the NPRM's shortcoming with comments asking that the rule be re-proposed.

Read CRE comments on EPA's HPV Rulemaking

Click to submit comment

CRE Files Petition with OMB to Stay Implementation of HIPAA Electronic Transaction Standards Issued by HHS
CRE has petitioned OMB to stay implementation of the Electronic Transaction Standards because of non-compliance with Paperwork Reduction Act and the Administrative Procedure Act

Read Executive Summary

(petition text and attachments available)

Click to submit comment

Agriculture Department Issues Tentative Decision on Milk Pricing Formulas
The decision would decrease slightly the wholesale prices of butter, nonfat dry milk, and cheese.

Click to read more.

Click to view full notice in the Federal Register.

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FDA Issues Draft Guidance on Procedures for Labeling Whether Foods Have or Have Not Been Bioengineered
The Food and Drug Administration (FDA) has announced the availability of a new draft guidance intended to assist food manufacturers in its labeling of whether food is developed using bioengineering or not. The guidance, which is entitled "Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering," is being published in response to requests on the part of food manufacturers, who wish to voluntarily label their foods (human and animal) as being made with or without bioengineering or the use of bioengineering ingredients, as a means to ensure that their labeling is truthful and not misleading. The guidance is also part of the previous administration's initiatives to strengthen science-based regulation of bioengineered foods and consumer access to information.

Click to view full notice in the Federal Register.

Comment on Item

Paperwork is Drowning the Medical Profession
An insightful article recently appeared in the Washington Post describing the increasingly onerous paperwork and regulatory burdens imposed upon the medical profession. While measures to prevent fraud and abuse are necessary, CRE agrees that current administrative requirements are exerting negative pressures on the practice of medicine. Thus, CRE has been asking for reforms under the Paperwork Reduction Act as a high priority for the new Administration

Click to read more, including a summary of points from The Washington Post article.

Comment on Item

CRE Telecommunications Standards Program
CRE has published a landmark white paper, Market-Driven Consortia: Implications for the FCC's Cable Access Proceedings, weighing the use of consensus standards versus privately developed non-consensus standards in regulatory applications. To follow-up on the conclusions in the white paper, CRE organized an Exploratory Committee which includes representatives of a variety of industry stakeholders.

Click to read more.

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FDA Allergenic Products Advisory Committee
The Food and Drug Administration (FDA) is currently requesting nominations for voting members to serve on a host of committees including the Allergenic Products Advisory Committee. The complete list of committees for which FDA is requesting nominations is as follows: The Allergenic Products Advisory Committee, the Biological Response Modifiers Advisory Committee, the Blood Products Advisory Committee, the Transmissible Spongiform Encephalopathies Advisory Committee, and the Vaccines and Related Biological Products Advisory Committee. The function of the Allergenic Products Advisory Committee, which has three vacancies occurring August 31, 2001, is to review and evaluate "available data concerning the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological products or materials that are administered to humans for the diagnosis, prevention, or treatment of allergies and allergic diseases." Applicants for this committee should have expertise in the following fields: immunology, pediatrics, internal medicine, biochemistry, statistics, and related scientific fields.

Click to view full notice in the Federal Register.

Comment on Item

Administration Finalizes Guidelines for Environmental Review of Trade Agreements
The Clinton Administration has finalized guidelines for Executive Order 13141 which makes explicit "the United States' commitment to a policy of careful assessment and consideration of the environmental impacts of trade agreements, including, in certain instances, written environmental reviews." As described in the Federal Register notice, the Order "institutionalizes the use of environmental reviews as an important tool to help identify potential positive and negative environmental effects of certain major trade agreements, and to facilitate consideration of appropriate responses where effects are identified." The Order will be implemented by the Office of the United States Trade Representative (USTR) and the Council on Environmental Quality (CEQ).

Click to view full notice in the Federal Register.

Comment on Item

FMCSA Implements Strong Sanctions Against Delinquent Motor Carriers
The final rule by the Federal Motor Carrier Safety Administration (FMCSA) amends the penalty provisions of the rules of practice of the Federal Motor Carrier Safety Regulations by implementing severe penalties against motor carriers who fail to pay civil penalties assessed by the FMCSA.

Click to read more.

Click to view full notice in the Federal Register.

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FDA Announces New User Fee Rates for Prescription Drugs
The Food and Drug Administration (FDA) has established new rates for prescription drug user fees for fiscal year (FY) 2001. Retroactive to October 1, 2000 and in effect through September 30, 2001, these new rates affect three different types of user fees: (1) certain types of applications and supplements for approval of drug and biological products, (2) certain establishments where such products are made, and (3) certain products. The new rates are as follows:

Applications requiring clinical date: $309,647

Applications not requiring clinical data: $154,823

Supplements requiring clinical data: $154,823

Establishments: $145,989

Products: $21,892

Fees for FY 2001 for the first category, applications and supplements, were set by the Prescription Drug User Fee Act of 1992 (PDUFA), as amended, subject to adjustment for inflation. Fees for the other two categories, establishments and products, are calculated so that total revenues from each category will approximate FDA's estimate of the revenues to be derived from applications.

Click to view full notice in the Federal Register.

Comment on Item

Federal Financial Agencies Seek Comment on Proposed Capital Rule
The Office of the Comptroller of the Currency (OCC), the Federal Reserve, and the Federal Deposit Insurance Corporation (FDIC) recently issued a proposed regulation to increase capital requirements for banks and bank holding companies which make equity investments in nonfinancial companies. Based upon the higher level of risk associated with such investments, the federal banking agencies plan to apply a series of marginal capital charges on covered equity investments. Such capital requirements would increase with the level of a banking organization's overall exposure to equity investments relative to Tier 1 capital. CRE believes that capital requirements are a significant issue. While generally providing a soundness check for a given investment, they also affect the overall availability of financial capital for productive activity. Therefore, capital requirements must be set at the optimum level which properly balances these important functions. Thus, CRE strongly encourages interested parties to submit comments on the proposed rule by the deadline of April 16, 2001.

Click here to readmore, including the full Federal Register notice and how to submit comments to USDA.

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USDA Issues ANPRM and Public Comment Request on Possible Responses to Changing Agricultural Marketing Practices Including Biotechnology
USDA's Agricultural Marketing Service (AMS) and Grain Inspection, Packers and Stockyards Administration (GIPSA) issued an Advanced Notice of Proposed Rulemaking (ANPRM) in the Federal Register calling for public comments on how the Department can best facilitate the marketing of agricultural commodities, including the products of biotechnology. Part of the Administration's Biotechnology Initiative, USDA issues a series of questions through which it seeks to define its role in key areas, such as commodity testing, product segregation procedures, and quality assurance. USDA seeks to maintain the marketing and export of U.S. grains, oilseeds, fruits, vegetables, and nuts, keeping in mind consumer preferences, trading partner requirements, and the anticipated benefits of value-added crops produced by biotechnology. Comments are due to the agency by February 28, 2001.

Click to readmore, including the full Federal Register notice and how to submit comments to USDA.

Click to submit comment

DOT Agency — Federal Motor Carrier Safety Administration — Issues Long-Term Strategy and Performance Plan
The Department of Transportation's Federal Motor Carrier Safety Administration (FMCSA) recently issued a draft document outlining its Long-Term Strategy and Performance Plan (66 Fed. Reg. 10049, Feb. 13, 2001). FMCSA was created as part of the Motor Carrier Safety Improvement Act of 1999 (P.L. 106-159), with the goals of improving commercial motor vehicle, operator, and carrier safety, and reducing the number and severity of large truck-involved crashes on U.S. highways. FMCSA became a new Administration within DOT in January 2000, and the draft strategy report and performance plan outline the agency's program for achieving the goals of the Act for the period between fiscal years 2002 and 2009. CRE supports FMCSA's efforts to improve public safety on our nation's roadways, as well as the agency's focus on excellence and stakeholder involvement, as expressed in its Strategic Plan.

Click here to read more, including a link to the FMCSA document, and information on houw to submit comments to the agency.

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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

OMB Issues Guidance on Racial and Ethnic Federal Data
The Office of Management and Budget (OMB) has announced the availability of a new document intended to give Federal agencies and other interested parties a general framework for interpreting recent Federal data on race and ethnicity. The document entitled, "Provisional Guidance for the Implementation of the 1997 Standards for Federal Data on Race and Ethnicity," seeks to clarify changes that were made to the document, "Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity," which was revised in 1997 from its original version published in 1977. The specific changes that the guidance seeks to clarify are changes in racial categorization and terminology and the requirement that agencies provide the opportunity for individuals to choose more than one racial category if they wish to reflect multiple racial heritages. Due to the volume of the guidance it is not being reproduced in the Federal Register. However, it is available at the following web address: http://www.whitehouse.gov/OMB/inforeg/index.html#SP

Click to view full notice in Federal Register

Click to submit comment

EPA Finalizes Amendments to NESHAP for the Pulp and Paper Industry
The Environmental Protection Agency (EPA) has implemented its proposed amendments to the pulp and paper national emissions standards for hazardous air pollutants (NESHAP). The final amendments, which the EPA proposed on January 25, 2000, include changes to the pulping process vent standards, the biological treatment system standards, monitoring requirements, and test methods and procedures to address technical issues identified after promulgation of the 1998 Pulp and Paper NESHAP. The Pulp and Paper NESHAP is the air component of the integrated air and water rules for the pulp and paper industry. The effective date of the final rule is February 20, 2001.

Click to view complete notice in Federal Register

Comment on Item

NCI Solicits Comment on Proposed Information Request Regarding Accountability of its Investigational Agents
The National Cancer Institute (NCI) has announced a proposed information collection in order to fulfill drug accountability standards as required by the Food and Drug Administration (FDA). As a sponsor of investigational drug trials, NCI has the responsibility of assuring the FDA that systems of drug accountability are being maintained by investigators in its clinical trials program. In order to comply to these requirements, NCI has developed two forms, the Drug Accountability Report Form and the Transfer Investigational Drug Form. According to the Federal Register notice, the Drug Accountability Report Form is designed "to account for drug inventories and usage by protocol," and the Transfer Investigation Drug Form "permits intra-institutional transfer of agents to NCI approved protocols for use by the investigator or other NCI registered investigators on approved protocols." The data obtained using these forms is intended "to ensure the investigational agents are used according to protocol guidelines and to ensure the patient's safety and protection." Comments regarding this collection are due by February 12, 2001.

Click to view full notice in Federal Register including contact information

Click to submit comment

EEOC Final Rule to Protect Older Workers' Rights
The Equal Employment Opportunity Commission (EEOC) has published a final ruling designed to protect the rights of older workers. The regulation states that, under the Older Workers Benefit Protection Act of 1990, "employees cannot be required to tender back the consideration received under a waiver agreement before being permitted to challenge the waiver agreement in court, and addressing related issues." The regulation is effective January 10, 2001.

Click to view full notice in Federal Register

Comment on Item

CDC Solicits Comment on Proposed Data Collection Regarding Musculoskeletal Disorders Project
The Centers for Disease Control and Prevention(CDC) has announced an opportunity for public comment concerning a proposed data collection for a project that will focus on the prevention of work-related musculoskeletal disorders (MSDs). Specifically, the proposed project seeks "to quantify the risk for upper limb and low back MSDs at varying levels of exposure to physical job stressors (repetitive, forceful exertion, awkward postures, vibration, manual handling, etc.)." According to the Federal Register notice, the study data will be used "to test and expand existing guidelines for limiting exposure to physical job stressors, and for developing new guidelines where none exist." The study is designed to enroll up to two thousand workers who will participate in three annual data collection surveys. Written comments concerning this information request should be received by February 8, 2001.

Click to view full notice in Federal Register including contact information

Comment on Item

Washington Post Issues Scorecard on Villa Tozzi Wine
While CRE is accustomed to issuing Scorecards on federal regulations, CRE is pleased to announce that a recent vintage of wine produced and marketed by a Member of CRE's Board of Advisors recently received a positive Scorecard of its own. Wine critic Michael Franz of the Washington Post recently reviewed Villa Tozzi Montepulciano d'Abruzzo 1997 ($8, Italy, distributed by Wine Source) and called it "a remarkable over-achiever that shows all the aromatic and flavor components that one would expect to find in an Italian wine costing $20."

Labor Submits OSHA Information Request to OMB
The Department of Labor has submitted a public information request by the Occupational and Safety Hazard Administration (OSHA) to the Office of Management and Budget (OMB) entitled OSHA Date Collection System. The review requests CY 2000 injury and illness data from 81,425 establishments throughout the United States. According to the Federal Register notice, the data are needed for two purposes: (1) "to carry out intervention and enforcement activities in order to guarantee workers a safe and healthful workplace"; and (2) "for measurement purposes in compliance with the Government Performance and Results Act of 1995 and multiple research purposes." This type of review is an extension of a currently approved collection.

Click to view notice in Federal Register.

IRS Clarifies Tax Reporting Requirements
The Internal Revenue Service (IRS) has proposed regulations aimed to clarify three specific issues regarding tax reporting requirements: (1) who the payee is for information reporting purposes if a check or other instrument is made payable to joint payees; (2) provide information reporting requirements for escrow agents and other persons making payments of behalf of another person; and (3) clarify that the amount to be reported paid is the gross amount of the payment. The IRS is also proposing regulations that remove investment advisers from the list of exempt recipients. Comments regarding these proposed regulations must be received by January 17, 2001. There will be a public hearing scheduled for February 7, 2001 at 10 a.m. Requests to speak at the public hearing must be submitted by January 24, 2001.

EPA is Improperly Using Proposed, Unvalidated Tests to Assess and Regulate Herbicides and Other Substances
CRE previously pointed out to EPA that the Agency must use its currently operative cancer risk assessment guidelines and tests unless and until EPA promulgates final, validated new cancer guidelines and tests in accordance with the requirements of the APA and the Congressional Review Act. This issue is not limited to cancer risk assessments. EPA has recently ignored its currently operative non-cancer risk assessment guidelines and tests and used new, proposed, unvalidated guidelines and tests to assess developmental, reproductive and other non-cancer endocrine effects. CRE has prepared a White Paper explaining why the law, sound science, and good government require EPA to use its currently operative (and validated) non-cancer guidelines and tests unless and until EPA promulgates (and validates) new ones.

ATF Requests Comments on Letterhead Applications and Notices Filed by Brewers
In an effort to reduce paperwork and respondent burden, the Bureau of Alcohol, Tobacco and Firearms (ATF) is soliciting comments concerning the Letterhead Applications and Notices Filed by Brewers. In order to operate a brewery in the United States, brewers are required to file a notice of intent, which is similar to a permit and, when approved by ATF, is a brewer's authorization to operate. In an effort to make this application process simpler for brewers, ATF has recently rewritten the form in plain language style to make it more easily understood. In addition, the revised form now combines many letterhead instructions and attachments where previously the brewer would have to generate the attachments for the application. The CRE applauds the efforts made by ATF both to make this application process simpler and to seek public comment on this matter. Written comments should be received on or before December 18, 2000.

Department of Education Invites Comments on Proposed Information Request Regarding Centers for Independent Living Program
The Leader, Regulatory Information Management Group, Office of the Chief Information Officer, Department of Education is seeking public comment on a proposed information request regarding the Centers for Independent Living (CIL) Program, which is a program designed to promote independent living for individuals with disabilities. The information request will include questionnaire surveys of all CIL directors and a nationally representative sample of current and former consumers of CIL services. The study will examine two major areas: (1) consumer satisfaction and outcomes of services, and (2) systems advocacy and change. Interested persons are invited to submit comments regarding the CIL Program information request on or before December 11, 2000.

EPA Solicits Comments on Two Draft Pesticide Science Policy Documents Concerning Pesticide Risk Assessment in Drinking Water
The two documents together describe the Environmental Protection Agency's (EPA) approach to conducting a screening-level risk assessment of pesticide residues in water.

Click to view notice in Federal Register.

EPA Announces Availability of Revised Pesticide Science Policy Document
The Environmental Protection Agency (EPA) has announced the availability of a revised version of the pesticide science policy document entitled "The Role of Use-Related Information in Pesticide Risk Assessment and Risk Management." Copies of this document may be obtained in three ways: electronically, fax-on-demand, and in person. For complete details on how to obtain a copy and for further contact information, please click on the Federal Register notice given below.

OMB Establishes New Rates for Hospital and Medical Care Treatment Provided by the United States
The Office of Management and Budget (OMB) has established three sets of rates for use in connection with the recovery, from tortiously liable third persons, of the cost of hospital and medical care and treatment furnished by the United States through three separate Federal agencies. These rates have been established in accordance with the requirements of OMB Circular A-25, requiring reimbursement of the full cost of all services provided. To view the details of the specific rates, please click on the full Federal Register notice below.

Center for the Evaluation of Risks to Human Reproduction (CERHR) Announces the Availability of Seven Expert Panel Reports on Phthalate Esters and Solicits Public Comments on these Reports
According to the Federal Register notice, these seven phthalate esters were selected for the initial evaluation by the CERHR "based on their high production volume, extent of human exposures, use in children's products, published evidence of reproductive or developmental toxicity, and public concern." According to the notice, phthalate esters are used as plasticizers in a wide range of polyvinyl chloride-based consumer products. CERHR invites public comment on the expert panel reports including any recent relevant toxicology data and human exposure information. Written comments must be received by December 11, 2000.

CRE Issues Report on SEC Auditor Independence Rule
CRE has published a "Report Card" on the Securities and Exchange Commission's proposed Auditor Independence Rule, a rule which would prohibit accounting companies from performing many non-audit services for their audit clients. The CRE report identifies numerous instances in which the SEC did not comply with "good government" statutes, which help assure the effectiveness of regulations before they are issued. The report specifies actions that the SEC should take to correct the deficiencies.

Legal Opinion Concludes Tech Transfer Act is Reviewable in Court
Multinational Legal Services, counsel to CRE, has issued a legal memorandum concluding that the SEC and other agencies are subject to court challenge for violating provisions of the National Technology Transfer and Advancement Act. That statute requires that federal agencies adopt available voluntary consensus standards, in lieu of government-unique standards, unless the voluntary standards are impractical or contrary to law, in which case the agency must explain its decision to OMB. The legal memorandum was filed with the SEC in connection with the SEC's proposed rule on auditor independence.

MSHA Requests Comment on Proposed Information Collection Related to Gamma Radiation Exposure Record
According to the notice in the Federal Register, MSHA is particularly interested in four types of comments: 1) those which "evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility"; 2) those which "evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used"; 3) those which "enhance the quality, utility, and clarity of the information to be collected"; and 4) those which "minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g. permitting electronic submissions of responses."

Click to view notice in Federal Register.

Justice, Treasury, and OMB Extend Deadline for Public Comment Regarding Proposed Financial Privacy and Bankruptcy Study
The proposed study which the three agencies are seeking comment on concerns how the filing of bankruptcy affects the privacy of individual consumer information that becomes part of a bankruptcy case.

Click to view notice in Federal Register.

EPA's GPRA Plans Jeopardized By "Me-Too" FIFRA Registrations
EPA's Annual Performance Plan and Congressional Justification for FY 2001 contains a Strategic Goal of "Safe Food, including an "Objective" to "Reduce Agricultural Pesticides Risk." (EPA Performance Plan, p. III-1.) EPA's Plan further explains, "Progressively replacing older, higher-risk pesticides is one of the most effective methods for curtailing adverse impact on health and the ecosystem while preserving food production rates."CRE understands that a number of companies are considering replacing their currently registered "higher-risk" pesticides / herbicides with new, more environmentally friendly and equally effective products. Other less scrupulous companies may try to take advantage of these good corporate citizens by filing me-too FIFRA registration applications for the "higher-risk" applications. EPA should deny me-too pesticide / herbicide applicants conditional registration when the original registrant has canceled, or has agreed to cancel, the product and to replace it with an equally effective new product posing less risk.

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.

CRE Opens Electronic Regulatory Forum

��Each year, the federal government proposes a number of regulations of economic significance impacting a variety of business sectors. The economic assumptions, cost-benefit analyses, and other underpinnings of these rules are often open to question. However, the complexity of the issues and the short span of most public comment periods often leave interested parties in a difficult position when responding to these agency proposals. Several users of the CRE website have asked CRE to provide assistance in this area, so as to improve overall regulatory policy.

��In response to these requests, CRE is please to announce a new service on its website which will allow the regulated community and the interested public to exchange information about important regulations proposed by federal agencies. The CRE Electronic Regulatory Forum will allow for enhanced review of such agency actions and submission of better comments to the

��In this way, interested parties need not draft their comments in isolation or in reliance on a small number of colleagues. The CRE Electronic Regulatory Forum will help identify other interested parties, share information and analyses, and test various hypotheses. This ongoing exchange of information will be posted on the CRE Website and will also be open to federal regulators during and after the formal public comment period announced in the Federal Register.
However, the key to this endeavor is participation by interested parties, as CRE cannot exhaustively research and analyze every issue itself. CRE also requires input on topic worthy of coverage. CRE hopes that this service will be a useful resource to visitors to the site.

About the CRE Electronic Regulatory Forum

A CRE Electronic Regulatory will be opened periodically for important proposed regulations as identified by CRE or suggested by users of the CRE Website.
A brief background description will be provided on the regulation under consideration, including information such as:
- The Federal Register citation for the proposed rule.
- Information on opportunities for public comment on the proposed regulation.
- Other relevant information.
CRE will then provide a public discussion forum which will provide information on the scientific, economic, and policy underpinnings of the proposed rule in question.
- A specific area for concern will be the economic analyses and assumptions offered by the agencies in justifying proposed rules.
CRE will also provide website links or other citations to materials which would be of interest on a given issue.

CRE Electronic Regulatory Forum: OSHA's Proposed Ergonomics Rule

Click here to read more and to access the CRE Electronic Regulatory Forum on OSHA's proposed ergonomics rule.

OSHA Data Initiative Offers Opportunity to Enhance Data Quality
OSHA recently announced in the Federal Register (65 Fed. Reg. 39944, June 28, 2000) an opportunity for the public to comment on its Data Initiative, which is designed to collect employer-specific data on injuries and illnesses in the workplace. Previously, OSHA data collection efforts had been industry-wide, and this aggregation of information tended to mask the experiences of individual employers.

Click to view notice in Federal Register.

When it Comes to Monopoly-Busting, There is No Resting in Peace for the Feds (Even if the Target Happens to be Involved in a Piously Inclined Business)
In this case, the federal agency doing the penalizing is the Federal Trade Commission. They contend that Service Corporation International (SCI) violated federal law prohibiting unfair methods of competition when SCI acquired the LaGrone Funeral Home in Roswell, New Mexico in 1994. At the time of the acquisition there were only two funeral homes in operation in Roswell, one of which-the Ballard Funeral Home-was already owned by SCI. According to the FTC the acquisition of the LaGrone Funeral Home gave SCI a monopoly on funeral home services in Roswell, thus violating federal anti-competition laws. According to the FTC notice, prices for funeral services increased in Roswell after the acquisition.

Click to view notice in Federal Register.

OMB Announces Information Collection and Request for Public Comments
The two collections that OMB seeks comment on are (1) reports from auditors to auditees concerning audit results, audit findings, and questioned costs, and (2) reports from auditees to the Federal Government providing information about the auditees, the rewards they administer, and the audit results. Both of these types of reports are used by non-federal entities, pass-through entities, and Federal agencies to ensure that Federal rewards are expended in accordance with applicable laws and regulations.

Click to view notice in Federal Register.

CRE Issues Report Card On SEC Auditor Independence Rule
On July 12, 2000, the Securities and Exchange Commission issued a proposed rule that would impose sweeping changes on the accounting industry. The SEC's Revision of the Auditor Independence Requirements, 65 Fed. Reg. 43148 (July 12, 2000), would generally prohibit accounting companies from simultaneously performing both audit and non-audit services for the same SEC registrant company.

USTR and CEQ Seek Second Set of Comments on Environmental Guidelines
On February 22, 2000 the USTR and CEQ solicited comments in the Federal Register on issues the agencies should consider when developing guidelines for implementing the Order. The notice invited comment on general views on how the environmental process should work, mechanisms for involving the public, the timing and process for conducting written reviews, and appropriate methodologies for assessing environmental impacts in the context of trade negotiations. The agencies received twenty-two sets of comments from a broad range of the public, including representatives of industry, agriculture, and environmental organizations.

Click to view notice in Federal Register.

EPA Establishes Error Reporting and Correction Process for "TRI" Database
The CRE has a continuing interest in improving the quality of data and information that Federal agencies disseminate to the public, including through the Internet. The CRE is pleased to report that the Environmental Protection Agency (EPA) has established a publicly-available error notification and correction process for the Toxic Release Inventory (TRI) database.

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.

FCC Chairman Announces Plans for Cable TV-Internet Access Proceeding
Federal Communications Chairman William E. Kennard announced that he will propose that the FCC open a formal proceeding on the issue of whether regulation is needed to ensure that multiple internet service providers have access to a cable system operator's platform. Chairman Kennard's announcement was made on the home page of the FCC's internet site. In his announcement, the Chairman expressed his preference for an open cable platform to be achieved through market forces.

Click to view notice in Federal Register.

Analysis of the Regulatory Requirements of the Health Security Act
The Center for Regulatory Effectiveness has completed a comprehensive analysis of the Clinton Administration's proposed Health Security Act (HSA). Issues addressed by the analysis include: 1) the number of federal employees that would be need to manage the new federal programs that would be created by the legislation; 2) the number of state employees that would be required by the HSA; and 3) the number of new pages that would be added to the Code of Federal Regulations by the HSA. The CRE analysis also includes a complete roster of the regulatory mandates contained in the proposed legislation.

Click to view The Regulatory Requirements of the Health Security Act: Volume 1.
Click to view The Regulatory Requirements of the Health Security Act: Volume 2, Part 1.
Click to view The Regulatory Requirements of the Health Security Act: Volume 2, Part 2.
Click to view The Regulatory Requirements of the Health Security Act: Volume 2, Part 3.

Associated General Contractors of America and U.S. Army Corps of Engineers Announce Partnering Initiative
The Associated General Contractors of America (AGCA) 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. It stresses teamwork to achieve mutual objectives and goals. Along with arbitration and mediation, it is hoped that partnering can help prevent litigation in construction disputes and otherwise benefit the project in question.

CRE Proposes a Limited Extension of the Form Permitting Data to be Used for Small Disadvantaged Business Procurement Credits Until the Administration Proposes Regulations Implementing the Supreme Court Decision in Adarand Constructors, Inc.

Clinton Administration Proposes Enhanced Consumer Privacy Legislation for the Financial Services Industry
In a recent "Regulatory Action of the Week," CRE reported on the proposed rule issued jointly by a number of federal banking agencies designed to implement the consumer privacy protections of the 1999 Gramm-Leach-Bliley Act. (See CRE past Regulatory Action of the Week Items, "Federal Banking Agencies Have Issued Proposed Rules Which Deal with the Privacy of Consumer Information.")

Transportation Department Publishes List of Actions Under Review
The Department of Transportation has published in the Federal Register a list of existing regulations that it plans to review in the next year. Due to its very aggressive review policy the Department will review six regulations, the most of any federal department this year. The reviews are required under section 610(a) of the Regulatory Flexibility Act (5 U.S.C. 601) which states that agencies must have a plan for the periodic review of its existing regulations which have a substantial economic impact on a significant number of small entities.

Click the six specific rules. (Sequence Numbers 2007, 2101, 2155, 2258, 2266, 2295)

Social Security Administration (SSA) Successfully Fulfills Requirements for Computer Matching Program
On March 28, 2000 the Social Security Administration (SSA) announced in the Federal Register a computer matching program that it plans to conduct. This computer matching program will involve the disclosure by State Health/Income Maintenance Agencies to the SSA of records of Medicaid enrollees that have been inactive for at least one year. In order to become eligible to participate in this computer matching program, the SSA had to successfully complete the requirements of federal agencies involved in computer matching programs--which it did with flying colors. For this the SSA should be recognized and commended.

EPA Safeguards Confidential Business Information
EPA has announced that a private contractor, Syracuse Research Corporation, will be given access to the confidential business information of private companies. (See 65 Fed. Reg. 11,777.) The companies are required to report the confidential information to EPA under the Toxic Substances Control Act ("TSCA") and the information is supposed to be analyzed by EPA subject to EPA's "TSCA Confidential Business Information Security Manual." EPA's Federal Register notices indicates that contractor's employees will be "briefed on appropriate security procedures" and required to sign nondisclosure agreements.

Department of Justice Antitrust Procedures in Grain Case Offers Template for Resolving Microsoft Litigation
The Antitrust Procedures and Penalties Act [15 USC 16(b)-(h)] provides a set of procedures for resolving antitrust suits which includes the opportunity for public comment on the proposed settlement prior to filing the settlement with the court. The proposed Final Judgement for the Department of Justice's antitrust case against Cargill, Inc. and Continental Grain offers an example of this public process. The resolution of this case, which concerned Cargill's acquisition of Continental's grain trading business, may offer a template for ensuring that the public has the opportunity to comment on and participate in crafting a Final Judgement resolving the Microsoft litigation.

Click to read the Department of Justice's proposed Final Judgement and Competitive Impact Statement, 64 FR 44046
Click to read the Department of Justice's court submission including public comments and the Department's Response, 65 FR 15982

A Private Sector Proposal to the FTC to Protect the Online Privacy of Children
The Federal Trade Commission has initiated a rulemaking proceeding to determine whether FTC should grant its seal of approval to a private company's "self-regulatory guidelines" to ensure compliance with the Children's Online Privacy Protection Act (15 U.S.C. § 6501 et seq.).

US Civil Rights Commission Surveys: Another Case of Paperwork Reduction Act Evasion
On February 16, 2000, the US Civil Rights Commission published four "emergency" requests for OMB clearance of proposed information collections under the Paperwork Reduction Act. See 65 Fed. Reg. 7825-28. All four requests seek data that the Commission will use to conduct annual surveys on employment discrimination. By seeking these four clearances on an "emergency" basis, the Commission is evading full public (and OMB) scrutiny as required by the Act.

Click to view notice in Federal Register.

Proposed NASD/SEC Regulation to Raise the Day Trading Margin Requirement From $2,000 to $25,000
The National Association of Securities Dealers ("NASD"), a "self-regulating" entity, has filed with the Securities and Exchange Commission ("SEC") a proposed rule that would impose more stringent requirements on day trading customers.

Click to view notice in Federal Register.

USDA-HHS Advisory Committee Issues Recommendations for U.S. Dietary Guidelines.

Meeting Announced and Call for Public Comments Issued.

PostalWatch attacks new regulation on Commercial Mail Receiving Agencies

Oversight group enlists input of CRE on Postal Service's failure to comply with Paperwork Reduction Act and other federal statutes.

Cancer Risk Assessment Guidelines

U.S. Environmental Protection Agency

Risk Assessment for Dioxin and Related Compounds

U.S. Environmental Protection Agency

Risk Characterization Handbook

U.S. Environmental Protection Agency

OMB Report to Congress on the Costs and Benefits of Federal Regulation

On January 7, 2000, OMB issued a Federal Register notice requesting public comments on its Draft Report to Congress on the Costs and Benefits of Federal Regulations (1999) (65 Fed. Reg. 1296). OMB plans to submit a final report to Congress in February, pursuant to the requirements of section 638(a) of the Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1999.

Discrete Compound Interest Tables

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