On January 20, 2001, President Bush’s Chief of Staff Andrew H. Card Jr. sent all federal agency heads and acting agency heads a memorandum that has important implications for scores of health, safety, and environmental standards.
Public Citizen’s Public Safeguards at Risk! report examines significant new federal safeguards likely to be affected by the review and delay requirements of the Card Memorandum. It also examines other significant "Safeguards to Watch" -- final regulations that have recently become effective or proposed rules that are in the pipeline.
The Card "Regulatory Review Plan" Memorandum "postpones" by 60 days the effective date of any new regulation that has been published in the Federal Register and has not yet taken effect, unless it is mandated by a statutory or judicial deadline. This effects scores of new safety standards approved by Clinton agency heads in recent months, including at least 12 rules that will make major improvements in protecting the public, workers, and the environment.
The Card Memorandum also requires agencies to withdraw new proposed and final safety standards that had been sent to, but not yet published by, the Office of Federal Register (OFR) for publication. The Memorandum sets no time limit for this review, and places no restriction on the ability of the incoming officials to make wholesale changes in the rule. At least two significant rules were affected by this requirement -- an Environmental Protection Agency (EPA) rule to improve air quality and eliminate haze and a U.S. Department of Agriculture (USDA) proposed rule requiring hot dog and ready-to-eat meat packagers to test for the dangerous Listeria pathogen.
This action by the Bush Administration may indicate a return to the ways of the Reagan and Bush I Administrations, when important safeguards proposed by the agencies were sent into an Office of Management and Budget (OMB) "black hole," where they were delayed for years, eviscerated or buried under the guise of administration "review."
There are a number of important unanswered questions about how the Card Memorandum will be implemented:
- First, on what basis may the President’s Chief of Staff order a wholesale, 60-day delay in implementation of final rules already published in the Federal Register? Nothing in the Administrative Procedure Act or any other law permits the President to order an across-the-board freeze on the effective date of rules promulgated by agency heads. A delay in the effective date of a rule represents a potentially important change to the agency’s implementation and enforcement plan, and thus any such delay should be preceded by notice and an opportunity for public comment.
- Second, what will be the fate of the rules signed by Department heads under the Clinton Administration and sent to the OFR for publication, but that will now be "withdrawn?" The Public Citizen report identifies three important safeguards that fall into this category: 1) an EPA-proposed standard to improve air quality and eliminate haze, 2) a proposed standard to reduce microbial (Listeria) contamination in food, and 3) a final standard that would require monitoring of the environmental and health effects of some genetically engineered crops. The Card Memorandum directs that such rules be withdrawn from publication for "review and approval" by Bush Administration officials. However, the Memorandum sets no timetable for such review and places no restriction on the ability of the incoming officials to make wholesale changes in the rule.
- Third, what legal authority exists for the President’s Chief of Staff to delay publication of final rules signed by Clinton Administration agency heads, transmitted to the OFR for publication, and made public by OFR? We believe that there is none. While courts have held that an agency may properly withdraw a rule from the OFR prior to its public disclosure, see Kennecott Utah Copper Corp. v. Dep’t of the Interior, 88 F.3d 1191, 1203-1206 (D.C. Cir. 1996), there is no authority that suggests an agency may withdraw a rule after it has been publicly released by OFR. Indeed, the law is clear that once a rule has been signed and released, even if not published in the Federal Register, it may be enforced by the agency so long as the adversely affected party had actual notice of the rule. 5 U.S.C. § 552(a)(1); see also, e.g., Zaharakis v. Heckler, 744 F.2d 711, 714 (9th Cir. 1984). In this respect, the Card Memorandum seems at odds with controlling law.
- Fourth, what role will OMB play in the review process mandated by the Card Memorandum? Nothing in the Card Memorandum rules out the possibility that affected regulations will be subject to review and modification by the OMB, which was notorious during both the Reagan and Bush I Administrations for its secretive, meddlesome, and time-consuming review process. Even for final rules that have been published but have yet to take effect, the additional delay mandated by the Card Memorandum gives disappointed regulated industries the opportunity to seek OMB’s intervention to begin the process of rescinding or modifying the rule.
The new administration should obey the law and follow the legal procedures for any reconsideration or change to health, safety, and environmental standards.
Safeguards Affected by the Card Memorandum
Food Safety
-- The Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA), in response to hundreds of cases of Listeria poisoning and deficient testing of Listeria in hot dog and ready-to-eat meat packing plants, sent a proposed rule for printing in the Federal Register that would require processors to test their products for this dangerous pathogen. Listeria can cause serious injury, miscarriage, and death, and can survive refrigeration in contaminated lunchmeats and hot dogs. Listeria poisoning is often fatal for the elderly and persons with weak immune systems.
- Control of Deadly Micro-organisms in Food
Unfortunately, officials at the USDA were forced by the Card Memorandum to withdraw this important proposed rule. At a minimum, this action will delay needed requirements for pathogen testing. It is also possible that the withdrawn regulation could be substantially weakened by the Bush administration before it is resubmitted for publication.
- Genetically Modified Crops
-- On January 17, 2001, the EPA sent a final rule on genetically engineered plants to the Federal Register for printing; this rule would have established a mandatory EPA safety review process for plants that are genetically engineered to resist pests. To protect the public from the known and unknown health and environmental risks associated with genetically modified crops, it is urgent that the EPA monitor their safety.
However, officials at the EPA were forced by the Card Memorandum to withdraw their important rule announcing the their intention to monitor the health and environmental safety of genetically modified crops. It is very possible that when (and if) this rule is resubmitted to the Federal Register, it will contain provisions that favor biotech profits over consumer and environmental protections. For example, the rule may be revised to exempt several classes of genetically modified crops from EPA monitoring.
-- The USDA’s Organics Rule set national standards for the production, handling, and processing of organically grown agricultural products. This final rule establishes a national-level accreditation program to be administered by the Agricultural Marketing Service, an arm of the USDA, for State officials and private persons who want to be accredited as certifying agents.
- National Organics Standards
This rule was published in the Federal Register on December 21, 2000 and can be found at 65 FR 80548. , but could be delayed an additional 60 days under the Card Memorandum.
Environmental Protections
- Clean Air
-- On January 12, 2001, the EPA publicly announced that it had approved a proposed regulation that could help improve air quality and eliminate haze in many of the country's national parks and other wilderness areas. The proposed rule tells states which of the nation’s hundreds of older industrial polluters must retrofit their plants with new pollution-control technology. In addition to reducing air pollution in national parks and wilderness areas, this proposed "Best Available Retrofit Technology" (BART) rule would produce healthier air in cities and protect sensitive ecosystems from acid rain.
This important rule was sent to the Federal Register for publication, and the full text of the regulation was even posted on the EPA website in an "unofficial" version at https://www.epa.gov/ttn/oarpg/t1/fr_notices/bartrule.pdf. Unfortunately, the Card Memo requires the EPA to withdraw this proposed rule. At a minimum, this action will delay needed improvements in air quality. It is also possible that the withdrawn regulation will be substantially weakened by the Bush administration before -- and if -- it is resubmitted for publication in the Federal Register.
- Protection of Federal Forests
-- The USDA issued a final rule to establish prohibitions on road construction, road reconstruction, and logging in inventoried roadless areas on National Forest System lands. The intent of this final rule is to provide lasting protection for inventoried roadless areas within the National Forest System in the context of multiple-use management.
The final rule was published in the Federal Register on January 12, 2001, and can be found at 66 FR 3244. This regulation was scheduled to take effect on March 13, 2001, but could be delayed an additional 60 days due to the Card Memorandum. The logging industry may try to greatly increase its logging and construction activities in now-roadless areas during this period of delay.
- Energy Conservation -- The Department of Energy (DOE) recently published three final rules setting efficiency standards for clothes washers, air conditioners, and other commercial and household appliances. The DOE determined that these revised energy conservation standards will result in significant conservation of energy.
Part or all of each of these three rules would have taken effect in February 2001, but now the effective dates could be delayed an additional 60 days due to the Card Memorandum. These rules were published in the Federal Register on January 12, 2001 and January 22, 2001, and can be found at 66 FR 3314, 66 FR 7170, and 66 FR 3336.
- Arsenic in Drinking Water -- The EPA has issued a final regulation to reduce the public health risks from arsenic in drinking water. When it takes effect, this standard will provide additional protection for 13 million Americans against cancer and other health problems, including cardiovascular disease, diabetes, and neurological effects.
The final rule was published in the Federal Register on January 22, 2001, and can be found at 66 FR 6976. This important regulation was supposed to take effect on March 23, 2001, but could be delayed an additional 60 days under the Card Memorandum.
- Public’s Right-to-Know about Industrial Releases of Toxic Lead
-- The EPA created new regulations supporting the public’s "right-to-know" about industrial releases of lead -- a highly toxic chemical -- into the environment. The rule is an important part of the Agency’s overall efforts to expand the public’s right to know about toxic chemicals in their communities.
The rule was published in the Federal Register on January 17, 2001, and can be found at 66 FR 4500. It was scheduled to take effect on February 16, 2001, but could be delayed an additional 60 days under the Card Memorandum.
- Pollution from Diesel Engines
-- The EPA recently published a final rule setting lower diesel particulate standards for heavy-duty vehicles. According to EPA scientists, the pollution emitted by diesel engines contributes to premature mortality, aggravation of respiratory and cardiovascular disease, aggravation of existing asthma, acute respiratory symptoms, chronic bronchitis, and decreased lung function. According to the agency, numerous studies also link diesel exhaust to increased incidence of lung cancer. Because of its significant public health effects, the new diesel standard has long been a priority for environmental and public health organizations.
The rule was published in the Federal Register on January 18, 2001, and can be found at 66 FR 5002. It was scheduled to take effect on March 19, 2001, but could be delayed an additional 60 days due to the Card Memorandum.
- Protecting Wetlands
-- The EPA and the Army Corps of Engineers have signed a final regulation to strengthen wetlands protection. The new regulation will reduce the loss of America’s wetlands by clarifying the types of activities that are likely to result in a discharge, unless there is an "incidental fallback" of dredged material under the Clean Water Act. The rule indicates that the EPA and the Corps regard the use of mechanized earth moving equipment to conduct landclearing, ditching, channelization, in-stream mining, or other earth moving activity as the discharge of dredged material.
This rule was published in the Federal Register on January 17, 2001, and can be found at 66 FR 4550. It was scheduled to take effect on February 16, 2001, but could be delayed an additional 60 days under the Card Memorandum.
- Lead Poisoning
in Children -- To help prevent lead poisoning in children under the age of six, the EPA recently established standards for lead-based paint hazards in most pre-1978 housing and child-occupied facilities. This EPA action, authorized by the Toxic Substances Control Act (TSCA), set residential lead dust cleanup levels, made changes to existing dust and soil sampling requirements and changed state program authorization requirements.
The regulation was published in the Federal Register on January 5, 2001, and can be found at 66 FR 1206. It was scheduled to take effect on March 6, 2001, but could be delayed an additional 60 days due under Card Memorandum.
- Snowmobiles in National Parks
-- The National Park Service (NPS) has issued an important environmental standard that would phase out snowmobile use in several national parks. Snowmobile use can cause irreparable harm to the parks, and threatens the preservation of these national treasures for future generations.
The NPS published a final rule in the Federal Register on January 22, 2001, which can be found at 66 FR 7259. The effective date of this regulation was originally set for February 21, 2001. However, the implementation of this rule will take now effect after the end of the 2001 snowmobile season, because it will be delayed 60 days under the Card Memorandum.
Medicaid
HMO Protections for Medicaid Patients -- The 1997 Balanced Budget Act required the Department of Health and Human Services (HHS) to write regulations permitting states flexibility to require Medicaid recipients to enter into managed care without getting their consent and without first getting a Medicaid waiver. In return, families and persons with disabilities were supposed to be provided with some important protections, including having a choice between at least two plans, having emergency room treatment paid-for if it met the "prudent layperson" standard, and having a strong appeals process when care is delayed or denied.
The regulations were published in the Federal Register on January 19, 2001, and can be found at 66 FR 6227. These regulations will be effective on April 19, 2001, but could be delayed an additional 60 days due to the Card Memorandum.
Workplace Health and Safety
Workplace Dangers -- The Occupational Safety and Health Administration (OSHA) recently issued a final rule protecting iron workers from the hazards of steel erection work. The most common hazard faced by workers is a fall from great heights. The final rule, the product of labor-management negotiation, is expected to prevent 30 deaths and 1,142 injuries, and save over $40 million annually.
The rule was published in the Federal Register on January 18, 2001 and can be found at 66 FR 5196. Its scheduled effective date is July 18, 2001, but could be delayed an additional 60 days under the Card Memorandum.
- Mine Safety
-- The Mine Safety and Health Administration (MSHA) published new rules reducing permitted levels of worker exposure to underground diesel particulate matter (dpm) in mines. Dpm – a small particle found in diesel exhaust -- is known to cause cancer and damage to the respiratory system. Underground miners are exposed to far higher concentrations of dpm than any other group of workers. According to MSHA, the best available evidence indicates that such high exposures put these miners at excess risk of a variety of adverse health effects, including lung cancer.
The new proposed regulations were announced on January 19, 2001, and can be found at 66 FR 5526 and 66 FR 5706. The rules were scheduled to take effect on March 20, 2001, but could be delayed an additional 60 days under the Card Memorandum.
Safeguards to Watch
The following important safeguards are not expected to be affected by the Card Memorandum. However, watch for regulated industries to attempt to use their influence with the Bush Administration to rescind, delay, weaken, or block them.
Food Safety and Quality
Juice Safety -- The Food and Drug Administration (FDA) recently published final safety standards to ensure the safe and sanitary processing of fruit and vegetable juices. The regulations mandate the application of Hazard Analysis and Critical Control Point (HACCP) principles to the processing of these foods. HACCP is a preventive system of hazard control. FDA is taking this action because there have been a number of food hazards associated with juice products and because a system of preventive control measures is the most effective and efficient way to ensure that these products are safe. This rule should reduce the amount of E. coli in fruit juices. Children are especially susceptible to E. coli poisoning, because they drink a high amount of fruit juice relative to their body weight, and their immune systems are weaker than those of adults.
The rules were published in the Federal Register on January 19, 2001, and can be found at 66 FR 6138. This important safety standard is scheduled to take effect on January 22, 2002, and it is hoped that the Bush administration will not delay its implementation.
- Quality of Poultry
-- The FSIS published a final rule to limit the amount of water retained by raw, single-ingredient, meat and poultry products as a result of post-evisceration processing, such as carcass washing and chilling. Raw livestock and poultry carcasses and parts will not be permitted to retain water resulting from processing unless it can be demonstrated, with data collected that any retained water is an inevitable consequence of food safety requirements. In addition, the producer will be required to disclose on the labeling of the meat or poultry products the maximum percentage of retained water.
The final rule was published on January 9, 2001 in the Federal Register and can be found at 66 FR 1750. The rule will take effect on January 9, 2002. It is hoped that the Bush administration will not delay the implementation of this regulation, which is not set to take effect for almost a full year.
Environmental Protection
- Large-Scale Factory Farm Pollution -- The EPA proposed strict new controls to reduce water pollution from large industrial feedlot operations. The factory farming of livestock has produced large amounts of waste that enter aquatic ecosystems. This run-off has contributed to outbreaks of pfiesteria and other water-borne diseases. The new rules will apply to 39,000 concentrated animal feeding operations, while only 2,500 operations currently have permits under the Clean Water Act. The rule will limit the spreading of manure, issue co-permits for subcontractors, eliminate current loopholes in the permits presently used in some states, and require livestock facilities to take the necessary action to prevent the discharge of animal waste from their lagoons and storage pits.
The proposed rules were published in the Federal Register on January 12, 2001, and can be found at 66 FR 2960.
Medical Privacy and Patient Safety
- Medical Privacy
-- The Health Insurance Portability and Accountability Act of 1996 (HIPAA) requires the Department of Health and Human Services to publish rules protecting the privacy of health information. As required by HIPAA, the final regulation covers health plans, health care clearinghouses, and those health care providers who conduct certain financial and administrative transactions (e.g., electronic billing and funds transfers) electronically. All medical records and other individually identifiable health information held or disclosed by a covered entity in any form, whether communicated electronically, on paper, or orally, is covered by the final rule. These standards will improve the efficiency and effectiveness of public and private health programs and health care services by providing enhanced protections for individually identifiable health information.
Although this rule was scheduled to take effect on February 26, 2001, it is not expected to be affected by the Card Memorandum because it was promulgated pursuant to a deadline set in the HIPPA Act. However, there has been no definitive word from the Bush administration confirming that this rule will not be affected. The final rule was published in the Federal Register on December 28, 2000 and can be found at 65 FR 82462.
- Protecting Patients Receiving Gene Therapy
-- The FDA has proposed a rule that would improve public access to valuable information about clinical research on gene therapy and xenotransplantation (the transplantation of a gene from another species into a human patient). These areas of clinical research present particular public health risks, and last year gene therapy was associated with the death of a young study participant in Pennsylvania.
Under a rule protecting "trade secrets" and "confidential commercial information," biotech firms and other actors in the pharmaceutical industry are currently able to prevent disclosure to the FDA of crucial data related to a drug’s safety and efficacy. The proposed protection would improve the current standard for disclosure regarding these biotech techniques. If adopted, the FDA’s new standard would help ensure that patients, doctors, and the public are aware of the risks faced by those who undergo experimental procedures involving the genes of humans and other species.
The proposed rule was published in the Federal Register on January 18, 2001 and can be found at 66 FR 4688. It is urgent that these protections be finalized.
Workplace Health and Safety
- Ergonomics Protections -- OSHA issued a final Ergonomics Program standard to protect employees in general industry from musculoskeletal disorders (MSDs) of the upper extremities, back, and lower extremities. Every year, nearly 600,000 MSDs serious enough to cause time off work are reported to the Bureau of Labor Statistics by general industry employers. Evidence suggests that an even larger number of MSDs not causing time away from work occur in these workplaces every year. Besides the discomfort and dislocation to workers, an immeasurable amount of productivity is sacrificed every year due to easily preventable injuries.
The final rule was published in the Federal Register November 14, 2000, and can be found at 65 FR 68262. The much-needed new standards were effective as of January, 16, 2001, but are likely to face congressional scrutiny and substantial resistance from industry.
- Injury Tracking and Reporting -- OSHA recently published a rule in the Federal Register that improved the system employers use to track and record workplace injuries and illnesses. OSHA can use this rule to track the quality of existing standards and develop new ones. They can also use the rule to monitor compliance rates at hazardous workplaces.
It was published in the Federal Register on January 19, 2001, and can be found at 66 FR 5916. It is scheduled to take effect on January 1, 2002, and it is hoped that the Bush Administration will not delay its implementation.
- Protections for Medical Professionals
-- OSHA revised its bloodborne pathogens standard to clarify the need for employers to select safer needle devices as they become available and to involve employees in identifying and choosing the devices. The updated standard also requires employers to maintain a log of injuries from contaminated needles. Pricks from infected needles are the most common mode of workplace transmission of HIV and hepatitis viruses.
The rule was published in the Federal Register on January 18, 2001, and can be found at 66 FR 5318. A deadline for the rule was set by the Needlestick Safety and
Prevention Act, so it is not expected to be affected by the Card Memorandum.
- Protection from Tuberculosis
– A final OSHA health standard to control occupational exposure to tuberculosis (TB) is long overdue. TB is a communicable, potentially lethal disease that afflicts the most vulnerable members of our society: the poor, the sick, the aged, and the homeless. As many as 13 million U.S. adults are presently believed to be infected with TB; over time, more than 1 million of these individuals may develop active TB disease and transmit the infection to others. OSHA estimates that more than 5 million U.S. workers are currently exposed to TB in the course of their work. OSHA’s proposed plan to control the spread of TB would require employers to protect employees through infection prevention and control measures that have been demonstrated to be highly effective in reducing or eliminating job-related TB infections.
This proposed rule appeared in the Federal Register on October 17, 1997, and can be found at 62 FR 54160. Now, after three years, two full public comment periods, and a series of hearings, it is critical that OSHA finalize its tuberculosis rule.
Automotive Safety
--The National Highway Traffic Safety Administration (NHTSA) of the Department of Transportation (DOT) proposed a safety standard to upgrade vehicle fuel systems in November 2000. This was the first major improvement to this standard since 1976. The new rule is intended to decrease the number of vehicle fires, which claim 57 lives and incur 119 serious injuries each year following vehicle crashes. The rule would limit the amount of fuel that is allowed to spill from the vehicle’s fuel system in three different crash scenarios.
- Prevention of Deadly Vehicle Fires
The proposed rule appeared in the Federal Register on November 11, 2000 and can be found at 65 FR 67693.
- Reducing Neck and Head Injuries in Crashes
-- NHTSA recently published a long-awaited standard to upgrade the requirements for head restraints (the name of the uppermost part of passenger seats) in cars, light trucks, trucks and buses, thus providing badly needed protection for the neck and head -- critical areas often injured in crashes. This is an important improvement and modernization of a safety standard that was issued in 1969. An estimated 805,581 whiplash injuries occur each year, at a cost of $5.2 billion annually. NHTSA buttressed the standard with new strength requirements, limited the size of gaps and openings in head restraints, and applied the rule to outward-facing back seats. DOT forecasts that changes made by the rule would reduce the number of neck injuries by at least 14,000 each year.
The proposed rule appeared in the Federal Register on January 4, 2001 and may be located at 66 FR 968.
- Protections to Prevent Tire and Other Defects
-- in a sweeping bill passed last fall in response to the Ford/Firestone fiasco, Congress required NHTSA to undertake many new safety regulations. Under the law, NHTSA must update obsolete standards on tires and improve tire labeling, do dynamic rollover testing and a consumer information program, and issue a rule requiring manufacturers to submit crucial early warning information on safety defects. The agency also must require tire inflation gauges inside vehicles before 2002, set out the needed definition for the law’s criminal penalty section, and improve the safety of child restraints. NHTSA’s records show that the Ford/Firestone tragedy has caused nearly 150 deaths and over 500 serious injuries nationally. The new law’s multi-pronged approach and early warning section will give the agency a much more active role in preventing future tragedies from auto safety defects.
The law was named the Transportation Recall Enhancement, Accountability and Documentation (TREAD) Act, and was codified in numerous sections of 49 U.S.C. 30101 et seq. Many -- but not all -- of the directives in the bill are subject to a statutory deadline. The "early warning" regulations, which were required within 120 days of passage of the law and must be completed by June 30, 2002, were published after the Card Memorandum was issued. The TREAD Act also requires NHTSA to release an improved tire safety standard by June, 2001.
The law was the target of intense industry lobbying, and there are many regulatory questions left to be answered as the process moves forward. Stay tuned for more industry efforts to derail it or to water it down.
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Written by: Public Citizen
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