The United States The United States EnvironmentalEnvironmental Protection Protection

AgencyAgencyA Brief History of EPAA Brief History of EPA

And Personal ExperiencesAnd Personal Experiences

Diane Buxbaum, MPHDiane Buxbaum, MPH

Building an Agency, EPA’s Building an Agency, EPA’s BirthBirth• EPA came into existence in December 2,1970EPA came into existence in December 2,1970

• That was the year of the first Earth Day--a That was the year of the first Earth Day--a day in which there was widespread public day in which there was widespread public concern about issues of environmental concern about issues of environmental healthhealth

• William Ruckelshaus, the first EPA William Ruckelshaus, the first EPA Administrator, sworn in on December 4, Administrator, sworn in on December 4, 1970, had to start from almost “0”1970, had to start from almost “0”

• The stated goal was to “Protect Human The stated goal was to “Protect Human Health and the Environment”Health and the Environment”

Where was the authority Where was the authority before EPA came into beingbefore EPA came into being• Department of the InteriorDepartment of the Interior

– Pesticide ResearchPesticide Research– Water Quality AdministrationWater Quality Administration

• Department of AgricultureDepartment of Agriculture– Pesticide RegistrationPesticide Registration

• DHEWDHEW– National Air Pollution AdministrationNational Air Pollution Administration– Bureau of Water HygieneBureau of Water Hygiene– Bureau of Solid Waste ManagementBureau of Solid Waste Management– Bureau of Radiological HealthBureau of Radiological Health– Pesticide Tolerance ResearchPesticide Tolerance Research

• Executive Office of the PresidentExecutive Office of the President– Federal Radiation ControlFederal Radiation Control– Environmental Radiation StandardsEnvironmental Radiation Standards– Environmental Systems StudiesEnvironmental Systems Studies of the CEQof the CEQ

EPA at the BeginningEPA at the Beginning• Under the Administrator and Deputy Under the Administrator and Deputy

Administrator—Public Affairs, Administrator—Public Affairs, Legislative Liaison, International Legislative Liaison, International Affairs, Equal OpportunityAffairs, Equal Opportunity

• There were AAs for Planning and There were AAs for Planning and Management, Standards and Management, Standards and Enforcement, General Council Enforcement, General Council (lawyers), and Research and (lawyers), and Research and MonitoringMonitoring

With Offices/CommissionsWith Offices/Commissions

• for Water Quality, Air Pollution for Water Quality, Air Pollution ControlControl

• Pesticides, Radiation and Solid WastePesticides, Radiation and Solid Waste

EPA Today, Headquarters, Washington, EPA Today, Headquarters, Washington, DCDC 12 Assistant Administrators 12 Assistant Administrators• Administration and ManagementAdministration and Management• Air and Radiation Air and Radiation • Enforcement and Compliance AssuranceEnforcement and Compliance Assurance• CFO CFO • General CounselGeneral Counsel• Inspector GeneralInspector General• International AffairsInternational Affairs• Environmental InformationEnvironmental Information• Prevention, Pesticides and Toxic SubstancesPrevention, Pesticides and Toxic Substances• Research and DevelopmentResearch and Development• Solid Waste and Emergency ResponseSolid Waste and Emergency Response• WaterWater

10 Regions10 Regions

10 Regions10 Regions• 10 Regional Administrators and 10 Regional Administrators and

OfficesOffices

• A number of ORD LaboratoriesA number of ORD Laboratories– National Center for Computational ToxicNational Center for Computational Toxic

ologyology– National Center for Environmental National Center for Environmental

Assessment NationalAssessment National Center for Environmental Research Center for Environmental Research

– National Health & Environmental Effects National Health & Environmental Effects Research LaboratoryResearch Laboratory

And MoreAnd More

• National Homeland Security ResearcNational Homeland Security Research Centerh Center

• National Exposure Research LaboratoNational Exposure Research Laboratoryry

• National Risk Management Research National Risk Management Research LaboratoryLaboratory

• Plus many more in the hand outPlus many more in the hand out

More on ORD Laboratories—Where they are:More on ORD Laboratories—Where they are:

Research Triangle Park, Research Triangle Park,

Washington DC, Washington DC,

Cincinnati, Ohio, Cincinnati, Ohio,

Athens, Georgia, Athens, Georgia,

Las Vegas, Nevada, Las Vegas, Nevada,

Narragansett, Rhode Island, Narragansett, Rhode Island,

Gulf Breeze, Florida, Gulf Breeze, Florida,

Duluth, Minnesota, Duluth, Minnesota,

Corvallis, Oregon, Corvallis, Oregon,

Ada, Oklahoma, Ada, Oklahoma,

Why Did and Do We Need Why Did and Do We Need EPA?EPA?

Four Examples of Hundreds that I Four Examples of Hundreds that I am certain you can think ofam certain you can think of

• 1) The almost extinction of the Brown 1) The almost extinction of the Brown Pelican, Pelican, Pelicanus occidentalis, Pelicanus occidentalis, due due to DDT caused egg thinning. Many to DDT caused egg thinning. Many other species of birds were also other species of birds were also affectedaffected

The Brown PelicanThe Brown Pelican

Hunting in the past caused losses Hunting in the past caused losses of pelican populations, but the of pelican populations, but the most dramatic reductions were most dramatic reductions were caused by pesticides such as caused by pesticides such as DDT and endrin.  The threat of DDT and endrin.  The threat of DDT is particularly insidious DDT is particularly insidious because it drastically lowers the because it drastically lowers the number of offspring of pelicans number of offspring of pelicans by interfering with the formation by interfering with the formation of calcium, which results in the of calcium, which results in the production of brittle, thin-shelled production of brittle, thin-shelled eggs that end up being crushed eggs that end up being crushed by an incubating parent. by an incubating parent. 

   In 1972, the Environmental In 1972, the Environmental

Protection Agency (EPA) Protection Agency (EPA) banned the use of DDT in the banned the use of DDT in the U.S. and put heavy restrictions U.S. and put heavy restrictions on the use of certain other on the use of certain other pesticides.  One year later, a pesticides.  One year later, a pelican recovery plan was put pelican recovery plan was put into action. Populations have into action. Populations have since significantly recovered.since significantly recovered.

•2) A Second Example, The Donora, 2) A Second Example, The Donora, Pennsylvania Fog of 1948 Pennsylvania Fog of 1948– The small company town was blanketed The small company town was blanketed

for 4 days with toxic fumes from the US for 4 days with toxic fumes from the US Steel smelting plantSteel smelting plant

– It was Halloween, and there was a It was Halloween, and there was a temperature inversion—warmer dirty air temperature inversion—warmer dirty air held down by cooler airheld down by cooler air

– 20 people died, 14,000 were affected, and 20 people died, 14,000 were affected, and if it had not cleared when it did many if it had not cleared when it did many more would have diedmore would have died

• Who Knows of any other deadly fogs?Who Knows of any other deadly fogs?

– 1952 London a fog so thick that people 1952 London a fog so thick that people could not even see their own feet lasted could not even see their own feet lasted 4 days and was responsible for the 4 days and was responsible for the deaths of about 12,000 peopledeaths of about 12,000 people

This is an actual photo of London in This is an actual photo of London in 19521952

• 3) A Third Example—Burning Rivers3) A Third Example—Burning Rivers

– In 1969 the Cayuga River in Ohio, where In 1969 the Cayuga River in Ohio, where industrial wastes were dumped burnedindustrial wastes were dumped burned

– YES THE RIVER BURNED YES THE RIVER BURNED due to the chemicals and solvents dumpeddue to the chemicals and solvents dumped

in the riverin the river

• A Fourth Example: Love Canal, Buffalo, NYA Fourth Example: Love Canal, Buffalo, NY– Hooker Chemical (a subsidiary of Occidental Hooker Chemical (a subsidiary of Occidental

Petroleum) had sold property to the Niagara Petroleum) had sold property to the Niagara City school board to build a school in 1953– City school board to build a school in 1953– The same property where they had dumped The same property where they had dumped 20,000 tons of toxic chemicals and covered 20,000 tons of toxic chemicals and covered the wastes, perhaps to hide their actionthe wastes, perhaps to hide their action

They did add a disclaimer about the site in the sale, They did add a disclaimer about the site in the sale, even though they knew it was for a school, no one even though they knew it was for a school, no one actually seemed to realize the toxic waste was thereactually seemed to realize the toxic waste was there

– Soon homes were being built around the siteSoon homes were being built around the site– In 1977 and before, toxic wastes were In 1977 and before, toxic wastes were

discovered leaking out of Love Canaldiscovered leaking out of Love Canal

• An aerial view of the Love Canal SiteAn aerial view of the Love Canal Site

So What Happened?So What Happened?

• In 1980 EPA and New York State paid In 1980 EPA and New York State paid to relocate the residents of Love Canalto relocate the residents of Love Canal

• In 1980 EPA pressed for passage of In 1980 EPA pressed for passage of the Superfund legislationthe Superfund legislation

• In 1982, the Superfund paid for the In 1982, the Superfund paid for the cleanup of Love Canalcleanup of Love Canal

More HistoryMore History

• Well, the rules or laws under which EPA Well, the rules or laws under which EPA functions are numerous—I will only functions are numerous—I will only mention a few—actually, you can read it in mention a few—actually, you can read it in the handouts and go on line to get more the handouts and go on line to get more informationinformation

•CAA, Clean Air Act of 1970CAA, Clean Air Act of 1970

•FIFRA, Federal Insecticide, FIFRA, Federal Insecticide, Rodenticide and Fungicide Act of 1972Rodenticide and Fungicide Act of 1972

More History (I heard the More History (I heard the moans)moans)

•EPA bans DDT in 1972EPA bans DDT in 1972

•Federal Water Pollution Control Act of Federal Water Pollution Control Act of 1972 and amendments -- became 1972 and amendments -- became what is known as the Clean Water Actwhat is known as the Clean Water Act

•TSCA, Toxic Substances Control Act or TSCA, Toxic Substances Control Act or 19761976

And MoreAnd More

• RCRA, the Resource Conservation and Recovery Act of RCRA, the Resource Conservation and Recovery Act of 1976—deals with solid and hazardous wastes and 1976—deals with solid and hazardous wastes and recyclingrecycling

• Superfund of 1980, Comprehensive Environmental Superfund of 1980, Comprehensive Environmental Response Compensation and Liability ActResponse Compensation and Liability Act

• UST, Underground Storage Tank standards 1988UST, Underground Storage Tank standards 1988

And MoreAnd More

• Montreal Protocol ratified 1988 to ban Montreal Protocol ratified 1988 to ban ozone depleting chemicalsozone depleting chemicals

• PPA, Pollution Prevention Act of 1990PPA, Pollution Prevention Act of 1990

• SPCC, Spill Prevention, Control and SPCC, Spill Prevention, Control and Countermeasure Control, 1991Countermeasure Control, 1991

• EPA proposes Hudson River PCB Cleanup EPA proposes Hudson River PCB Cleanup plan in 2000plan in 2000

This has been just a partial This has been just a partial listlist

•The passage of these laws was The passage of these laws was not the end, many of them have not the end, many of them have been amended—updated, some been amended—updated, some many times, since they were first many times, since they were first passedpassed

And now to a more personal And now to a more personal aspect. Some of my work at aspect. Some of my work at EPA.EPA.• I will cover only two programs that I I will cover only two programs that I

have dealt with, even though I have have dealt with, even though I have worked in others—the Good worked in others—the Good Laboratory Practice program and the Laboratory Practice program and the Healthcare/Academic Institution Healthcare/Academic Institution Compliance InitiativesCompliance Initiatives

Good Laboratory Practice Good Laboratory Practice ProgramProgram

• I was the lead Inspector for 6 years, I was the lead Inspector for 6 years, overseeing scientific studies overseeing scientific studies undertaken to register pesticides undertaken to register pesticides under the Good Laboratory under the Good Laboratory Regulations of FIFRARegulations of FIFRA

• GLP regulations came into being GLP regulations came into being because it turned out that some because it turned out that some studies that had been submitted to studies that had been submitted to EPA in the 70’s were totally falseEPA in the 70’s were totally false

What we did when we What we did when we inspectedinspected

• We would go to a facility and begin We would go to a facility and begin by finding out how the substance by finding out how the substance being tested arrived being tested arrived

• We followed the substance from We followed the substance from arrival to test application, to storage arrival to test application, to storage and or disposaland or disposal

• We followed how the lab was run and We followed how the lab was run and how data were maintainedhow data were maintained

• It was not only interesting, it brought It was not only interesting, it brought me into the research lab and out me into the research lab and out literally in the field again after many literally in the field again after many years absenceyears absence

• It was FUN!It was FUN!

• There was a facility where I was lead There was a facility where I was lead inspector in New Jersey -- It became inspector in New Jersey -- It became the first case with major violations the first case with major violations found under these regulationsfound under these regulations

• But Craven Labs in Texas was hands But Craven Labs in Texas was hands down the big winner of being “bad” in down the big winner of being “bad” in 19901990

• What was interesting to me was seeing What was interesting to me was seeing the science being done in various the science being done in various mostly excellent research facilitiesmostly excellent research facilities

• What was very satisfying was finding What was very satisfying was finding the bad actors whose studies were the bad actors whose studies were poorly designed and/ or carried out, and poorly designed and/ or carried out, and seeing them either clean up or get out seeing them either clean up or get out of the pesticide testing fieldof the pesticide testing field

• What was very fulfilling was knowing What was very fulfilling was knowing that I was helping to see that pesticides that I was helping to see that pesticides with the least negative environmental with the least negative environmental impacts were getting registeredimpacts were getting registered

Hospital and College/University Hospital and College/University Compliance InitiativesCompliance Initiatives• In 1999 a very enthusiastic new employee, In 1999 a very enthusiastic new employee,

a hazardous waste inspector, was looking a hazardous waste inspector, was looking around for a new sector that needed to be around for a new sector that needed to be brought into environmental compliancebrought into environmental compliance

• EPA had inspected and worked with the EPA had inspected and worked with the biggies like the Dows and DuPont's and biggies like the Dows and DuPont's and the GMs and GEs and the Mercks and the the GMs and GEs and the Mercks and the Orthos, platers, printers and dry cleanersOrthos, platers, printers and dry cleaners

• It came to this person that colleges and It came to this person that colleges and universities had laboratories and garages universities had laboratories and garages and heating plants, etc.---maybe this was and heating plants, etc.---maybe this was the new sectorthe new sector

Well, it got bigger and I became Well, it got bigger and I became the Compliance Assistance the Compliance Assistance CoordinatorCoordinator• We have almost 400 academic We have almost 400 academic

institutions in Region 2 – New York, New institutions in Region 2 – New York, New Jersey, Puerto Rice and the US Virgin Jersey, Puerto Rice and the US Virgin IslandsIslands

• But when you went to the colleges/ But when you went to the colleges/ universities, some of them had hospitals universities, some of them had hospitals associated with them—the SUNYs and associated with them—the SUNYs and CUNYs here in NY, Rutgers in NJ, etc.CUNYs here in NY, Rutgers in NJ, etc.

• So we added about 500 hospitals to So we added about 500 hospitals to form a new hospital initiativeform a new hospital initiative

This is what was found at one This is what was found at one academic institutionacademic institution

And this at anotherAnd this at another

And the following at And the following at hospitalshospitals

The picric acid at one facility The picric acid at one facility had to be taken out by the had to be taken out by the bomb squad and blown upbomb squad and blown up

And this, as wellAnd this, as well

Picric Acid (Cont’d)Exhibit VII-18

And what have we And what have we accomplishedaccomplished

• We have, in our College/University and We have, in our College/University and Hospital Initiatives, been able to Hospital Initiatives, been able to encourage facilities to participate in our encourage facilities to participate in our Voluntary Audit Policy Program -- to carry Voluntary Audit Policy Program -- to carry out self audits and disclose the violation out self audits and disclose the violation found to us (tell us what you are doing found to us (tell us what you are doing wrong)—we often give them time to fix it wrong)—we often give them time to fix it upup

• And we inspectAnd we inspect

• As of December 2005As of December 2005

• 129 inspections of both sectors129 inspections of both sectors

• 99 enforcement actions99 enforcement actions– 38 formal enforcement actions valued 38 formal enforcement actions valued

at over 4.3 million dollars at over 4.3 million dollars

•Resulting in settlements of almost Resulting in settlements of almost 1.2 million dollars1.2 million dollars

• 59 Audit Agreements with larger facilities59 Audit Agreements with larger facilities

• 247 Voluntary Disclosures247 Voluntary Disclosures

• And over 3300 violations correctedAnd over 3300 violations corrected

A Few Examples of Properly A Few Examples of Properly Managed Pollutants-Results Managed Pollutants-Results Count!`Count!`• From RCRA over 200,000 lbs/yr of From RCRA over 200,000 lbs/yr of

hazardous waste now managed properlyhazardous waste now managed properly

• From SPCC over 1,244,000 gallons of oil From SPCC over 1,244,000 gallons of oil are managed properlyare managed properly

• 760 residential units comply with lead laws 760 residential units comply with lead laws under TSCAunder TSCA

• Under the CAA, at least 156,000 lbs of Under the CAA, at least 156,000 lbs of chlorofluorocarbons are being handled chlorofluorocarbons are being handled correctlycorrectly

Contact InformationContact Information

Diane Buxbaum, MPHDiane Buxbaum, MPHHospital and Academic Institution Hospital and Academic Institution

Compliance Initiatives CoordinatorCompliance Initiatives CoordinatorEPA Region 2EPA Region 2Buxbaum.diane@epa.govBuxbaum.diane@epa.gov

www.epa.govwww.epa.gov is EPA’s web site is EPA’s web sitehttp://www.epa.gov/region02/http://www.epa.gov/region02/ is Region 2’s is Region 2’s

web siteweb site