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Office of the Press Secretary

For Immediate Release March 16, 1995

Launching a new era of partnership between government regulators and the businesses they regulate, the President today announced landmark environmental, drug and medical regulatory reforms that provide flexibility, demand accountability, and provide greater protection to the American people at lower cost.

"The reforms we implement today will significantly reduce paperwork and treat honest business people as partners, not adversaries," the President said during a visit to Custom Print in Arlington, Va. "These regulatory changes are real, deep and fundamental while still protecting public health and safety."

Joined by industry and environmental leaders who support the Administration's regulatory reform efforts, the President visited the small business print shop to emphasize how the reforms will reduce the regulatory burden on businesses, particularly small businesses. He announced a landmark package of 25 environmental reforms, including changes that will reduce the number of forms Custom Print owner Stu McMichael must fill out on toxic emissions from about 20 to one. The President also unveiled a set of reforms that will make America's high-quality drugs and devices available to consumers more quickly and cheaply.

To help facilitate partnerships between the federal government and private industry, the President also announced today a governmentwide policy that allows regulators to waive fines where small businesses have acted properly but violated the rules. In this way, business owners can put their energies into correcting problems, not fighting with regulators.

The Vice President said, "We can throw out tons of old regulations without sacrificing an ounce of real protection. And if regulators and the people they regulate can become partners with the same goal -- clean air or safe workers, for example -- then we get results in place of red tape."

On Feb. 21, the President directed heads of all regulatory agencies to conduct within four months a comprehensive review of the rules they implement to identify obsolete and burdensome regulations. He called for a new approach in the way government regulates the private sector, but said he would oppose any efforts to completely strip away regulations that protect public health and safety. Today's event marks the first results of that comprehensive review ordered by the President.

                    Regulatory Reform Initiative

Cutting Paperwork by 25 percent: EPA will reduce the overall reporting and record keeping burden associated with its rules by 25 percent. We will focus on small businesses and local governments, making changes that will save millions of hours and hundreds of millions of dollars that can be better invested in industrial productivity and actually cleaning up the environment.

One-Stop Emissions Reporting: Businesses will see a substantial reduction and simplification of their reporting burden as a result of the one-stop reporting system. Instead of separate forms for air, water, and waste emissions, a single form will do it all. Much information will also be submitted electronically, speeding up the reporting process.

Grace Period for Small Business: We are going to allow small businesses, which are minor sources of pollution and which receive compliance assistance, a six month grace period to correct violations after a violation has been identified.

Incentives for Self-disclosure and Correction: Companies that take responsibility for finding and fixing environmental violations can depend on more favorable treatment -- in the form of reduced penalties -- from the government than those who do not. Companies that make the responsible decisions to invest in compliance will not be placed at an economic disadvantage by companies that drag their heels.

Extending the Use of Emissions Trading: The marketable allowance trading system used in the Clean Air Act Amendments to solve the acid rain problem is saving the utility industry -- and electricity ratepayers -- as much as $2 billion compared to more traditional regulatory proposals. EPA will extend the use of such market incentives to a broader group for air and water pollution sources, resulting in savings of similar magnitude and letting the market determine the most efficient way for a community to clean the air.

Consolidated Federal Air Pollution Rules: By consolidating all federal air rules for an industry sector into a single rule, we will make it easier for industry and regulators both to understand everything required of a facility and eliminate duplicative and unnecessary record keeping. The resulting savings will be substantial: in the synthetic organic chemical industry alone, this innovation involves consolidating 13 currently separate rules, saving up to $250 million per year.

Greater Flexibility in Funding for States, Tribes and Localities: For the first time, state, tribal and local recipients of EPA grants will be able to combine air, water, and waste funds in a way that gives them the flexibility to find cleaner and cheaper means of achieving their local environmental goals. This will affect more than $600 million in environmental program grants.

Self-Certification: Focusing initially on the pesticide registration program, EPA will install a self-certification program to allow businesses to avoid time-consuming and expensive delays in registering minor and low-risk changes to their pesticides.

                  Regulatory Reform Initiatives

Allow Manufacturing Changes: The FDA will allow drug and biologics manufacturers to change the way they manufacture an approved drug without FDA pre-approved if the risk is negligible. The industry can modernize facilities and processes more easily, and FDA can shift resources to more critical review needs.

Eliminate Some Special Drug Requirements: The FDA would eliminate special requirements for insulin and antibiotic drugs. The industry would no longer be burdened with outdated requirements, and FDA can regulate these products the same way it does other drugs.

Environmental Assessment Exemptions: The FDA would exempt from environmental assessments virtually all applications for human drugs and biologics and animal drugs. The industry would be speared the expense of an analysis the FDA had found not to be needed.

Pre-market Review Exemptions: The FDA would exempt up to 138 categories of low-risk medical devices from pre-market review, adding to 441 categories already reviewed and exempted. The industry would no longer have to wait for pre-market review for devices such as syringes and oxygen masks, and FDA can shift resources to more critical review needs.

Manufacturing Changes Without Prior FDA Approval: The FDA would clarify that pre-market review of medical devices can be affected only if good manufacturing practice violations are related to a specific device. This would alleviate industry concerns that good manufacturing practice violations can slow down approval for devices unrelated to those problems, and ensure that public health is protected.


The Federal government will adopt policies which offer small businesses found to be in violation of regulations an opportunity to avoid punitive actions by correcting the violations within a time appropriate to the hazard in question. This will apply to first time violations where there has been a good faith effort to comply and the violation does not involve significant health or safety threats or criminal wrongdoing.

The federal government will also adopt policies which enable it to waive up to 100 percent of any punitive fine on a small business if the same sum will be used toward correcting the violation leading to the fine. This will apply to first time violations where there has been a good faith effort to comply and where the violation does not involve significant health or safety threats or criminal wrongdoing.

Every regularly scheduled report to the federal government will be required only half as often absent action by the agency head determining that this change is not legally possible, would not properly protect public health and the environment, or would not otherwise be in the best interests of the nation.