ENVE 441

Dr. Robert A. Perkins, PE

ffrap@uaf.edu

http://www.faculty.uaf.edu/ffrap/

17 and 19 April 2007

• Admin, Homework, etc.

• Hazardous Waste Regulations

• Risk Assessment

History

• Love Canal (book)

• Cuyahoga

• Sopranoland

Water Quality

• Cuyahoga River Fire: June 22, 1969

Sopranoland

• Life in New Jersey

Environmental Laws

• Law and Regulations

• How they come about

• The legal process

CONSTITUTION

STATUTES

Three Branches

• The executive (the president, the federal bureaucracy, the military),

• The congress (house and senate) and the

• Courts (supreme and lower courts.)

• All are separate.

Separation of Powers

• Unlike most parliamentary democracies

• Majority power votes the prime minister and cabinet

• Courts often separate

• But often can final appeal back to the parliament

• The congress makes the laws,

• The executive enforces the laws, and the

• Courts interpret the laws.

• Most states have similar constitutions and division of government into branches.

CONSTITUTION

STATUTES

REGULATIONS

COURTS

COMMON LAW

Consider Laws by Branches

• Judicial

• Legislative

• Executive

Agencies as source of law

CONSTITUTION

STATUTES

REGULATIONS

Regulations

• The Congress delegates to an agency (in the Executive Branch) the authority to make certain laws.

• Often those requiring technical details

• According to certain procedures

Genesis of Agency

• Some are created directly by congress– Specific statute– “enabling legislation”– cf. original cabinet duties

• Or Agency formed by Executive Branch– of earlier authorized smaller agencies

Powers Limited

• Legislative– Only the laws (called rules) that are permitted

by the enabling legislation– Must strictly conform to that legislation

• Judicial– All decisions may be appealed to courts– Deference

Rule (Law) Making

• Must conform to the Administrative Procedures Act– exactly

• (State similar)

• http://touchngo.com/lglcntr/akstats/Statutes/Title44/Chapter62.htm

Federal APA

• Informal “Rule Making”• AKA “notice and comment”• Used unless statute says otherwise• No formal public hearing• No formal records of hearing or comments• (But often both are kept)• All parties don’t know what is going on

– One might submit incorrect data, others would not know

Formal

• Must have public hearings

• Must keep records– transcripts

Process

• Often starts with consultation with affected parties– semi-public meetings

• Other input, perhaps in-house

• Priorities

• “Housekeeping”

Federal Register

• http://www.gpoaccess.gov/fr/index.html – today’s FR– or menu at left for “browse”

• http://www.gpoaccess.gov/fr/browse.html • Many items do not need to be published,

but….• As a practical matter, agencies avoid

secrecy, even if it is allowed.

After FR

• Within deadline

• Comment received

• Pubic hearing held– if required

• Rule is redrafted– if major, need to start cycle over with new FR

Rule

• Rule is “promulgated” by agency

• Next it is “codified” with number

• Goes into the Code of Federal Regulations

Digress to Statute

• Note CFR Titles are not same as Statute Titles• http://www.gpoaccess.gov/index.html• Endangered Species Act• PL 93-205• Codified in Title 16, Conservation

– Under 7, 15, 33, 42, 43 as well

• Chapter 35• Sections [ § ] 1531 to 1535

Enabling

• See §1533.a

• (a) Generally (1) The Secretary shall by regulation promulgated in accordance with subsection (b)

• Who is?– See definitions section

CFR

• http://www.gpoaccess.gov/cfr/index.html • Starts with Titles

– Administrative agencies in charge of a title– Title 40 = EPA

• Volumes and Chapters not prominent now• Parts• PART 60--STANDARDS OF PERFORMANCE FOR

NEW STATIONARY SOURCES

• Part 72, Acid Rain

• http://a257.g.akamaitech.net/7/257/2422/08aug20031600/edocket.access.gpo.gov/cfr_2003/julqtr/40cfr72.1.htm

• Note Laws and FR publication

Courts and Regulations

• Immediately after promulgation

• Bring to court to have invalidated, or

• Break the new law

• Go through the hearing process– Usually start with Administrative hearing in

agency

Executive

• Appointed by President

• May be within a cabinet “Department”

• Federal Aviation Administration in the Department of Transportation.

How many Agencies

• Over 100

• May be “executive” or “independent”

• Independent is usually a “commission” with a board and chair.– deep scope over narrow industry– Securities and Exchange Commission– Rates, licenses, etc.

EPA

• Environmental Protection Agency– Independent Agency

– 1970

– Absorbed functions of older agencies

• http://www.epa.gov • http://www.epa.gov/epahome/organization.htm• http://www.epa.gov/epahome/locate1.htm • http://www.epa.gov/epahome/locate2.htm

Science v. Law

• Science: Investigates and attempts to explain natural phenomena. It is cautious, incremental, and truth seeking.

• Government regulation: Seeks to affect human behavior and settle human disputes. It is episodic and preemptory and seeks resolution rather than truth.

• Government regulators are often forced to intervene, and make a decision before knowledge is complete.

• American regulation is bound up in the concept of "rule of law." – Not negotiation between affected parties– Must have a “bright line”

– American regulation must make rules based on the legislative intent and must explain the reasons or facts that form a basis for these rules.

– This allows opponents of the rules numerous opportunities to contest facts.

– Often the facts are weak and both sides have great opportunities to construe what facts there are in a manner suitable to their case.

– This forces the regulators to defend their decisions based on the weak facts and sometimes "distort the current knowledge," often by putting more weight on evidence that the underlying science can bear.

• "The statute laws often describe a desirable social outcome, and may demand more of science that it can provide."

• [Material above and quotes from the Regulatory Toxicology chapter by Richard Merill in Casarett and Doull's Toxicology.]

Guidance Documents

• Such a laboratory procedures• Often a consensus standard put together by experts

in the field and provide minimum standards for many investigations.

• Since the guidance documents are not law, other reasonable procedures may be substituted but, as a practical matter, the standard methods are often really a requirement, rather than guidance.

• May inhibit innovation and progress– vendors

Burden of Proof

• Who has the responsibly for demonstrating a substance is harmful or safe?

• Established by the statute. – food additives, the manufactures must prove they are

safe before they are put in food.

– OSHA must demonstrate that a substance is harmful before its use is restricted.

• How about EPA?– Many different statutes

Risk Allowed

• Some laws specify no risk is allowed. – Any chemical that causes cancer in laboratory animals

is not permitted as a food additive.

• A negligible risk will permitted– A 1 in one million increase in cancer rate is considered

negligible.

• Tradeoff approaches. – Often use the word "feasible," which implies risk is

permitted, if it is economically impractical to remove or reduce the risk.

Take Home Ideas

• Many practical engineering decisions governed by regulations

• Regulations are made by an agency, but must conform to the intent of a statute law

• Regulations (“rules”) are promulgated by a definite process defined by law.

• FR, CFR• Laws and Regulations are not “science”

AMFAARPAA

AJAASBCAA

ESAA-AECAFFRAA

FEAPRAIRA

NWPAACODRA/NMSPAA

FCRPAMMPAA

120

110

100

90

80

70

60

50

40

30

20

10

0

1870 1880 1890 1900 1910 1920 1930 1940 1950 1960 1970 1980 1990 2000

EPACTFFCACERFACRAA

PPAPPVAIEREAANTPAGLCPAABACZARAWRDAEDPOPARECACAAAGCRAGLFWRAHMTUSANEEA

SDWAASARA

BLRAERDDAAEAWANOPPAPTSAUMTRCAESAAQGANCPA

TSCAFLPMARCRANFMACZMAA

NEPAEQIACAAEPAEEAOSHAFAWRAANPAA

FRRRPASOWADPA

WSRAEARCFHSA

AQA

NAWCA

WQA

NWPA

MPRSAAARPA

HMTA

FCMHSA

NHPA

WLDAFWCAA

FWAAEA

AEPA FIFRA PAA

FAWRAMBCANPSWA

IANBRA

AARHAYA

TAFWCA

BPA

NLRAWPA

AQAFOIA

WRPAAFCA

FHSANFMUA

BLBAFWPCAMPRSACZMA

NCAFEPCAPWSAMMPA

ESATAPA

RCRAAWLDI

APASWDA

CERCLACZMIA

COWLDAFWLCA

MPRSAA

CAAACWA

SMCRASWRCASDWAA

Growth in Environmental LawsN

um

ber

of

Law

s

RCRA & CIRCLA

• CERCLA 1980– "superfund law." – Comprehensive Environmental Response,

Compensation, and Liability Act,– Overhauled in 1986 by SARA

• Superfund Amendments and Reauthorization Act

• RCRA 1976– Resource Conservation and Recovery Act– Modified in 1984 by the Hazardous and Solid

Waste Amendments (HSWA)

• RCRA is the "hazardous waste law." It provides cradle to grave control of hazardous waste

RCRA

• Subtitle D– Municipal Solid Waste

• Subtitle C– Hazardous Waste

RCRA Law

• A solid waste - or a combination of solid wastes - that, because of its quantity, concentration, or physical, chemical, or infectious characteristics, may:

• Cause, or significantly contribute to, an increase in mortality or an increase in a serious irreversible illness, or incapacitating, reversible illness; or

• Pose a substantial present or potential hazard to human health or the environment when improperly treated, stored, transported, disposed of, or otherwise managed.

Hazardous?

• Many definitions, lists, etc.

• CWA 40CFR116.4• Many others: CAA, OSHA, • RCRA has two methods

Regulations

• Two methods

• Listed

• U, P, F, K lists– http://www.faculty.uaf.edu/ffrap/EQE_649/

Module_03/Submodule3B/Submodule3B_1.htm

• Characteristic

Listed Wastes

• U Wastes - discarded commercial products, off-specification chemicals, and container and spill residues of commercial chemical products.

• P Wastes - Same as U wastes except these are classified as acutely hazardous due to their acute toxicity or reactivity.

• F Wastes - Waste from nonspecific sources

• K Wastes - Waste from specific sources

Characteristic Wastes

• Ignitability

• Reactivity

• Corrosivity

• Toxicity – TCLP, – Toxicity Characteristic Leaching Procedure

RCRA v. CERCLA

• RCRA usually deals with current or ongoing pollution events and usually there is some sort of viable economic entity that is responsible and heavily involved.

• CERCLA usually deals with past events, sometimes long ago, and either there is not an economically viable entity available, or finding that entity, and making them pay, is part of the process.

CERCLA, Superfund Action

• Process– Hazard Identification – Preliminary Assessment and Site Investigation

(PA/SI)• Generates HRS, Hazard Ranking Score• National Priorities List

– Remedial Investigation• Risk Assessments• http://www.epa.gov/superfund/programs/npl_hrs/hrsint.htm

– Record of Decision – Remedial Design and Remedial Action

Take Home Thoughts

• RCRA v. CERCLA

• Listed v. Characteristic Wastes

• HRS, NPL

• State v. Federal

Risk Assessment

Terms

• Risk

• Safe

• Hazardous

Two Tracks

• Carcinogens

• Non-carcinogens

Non-Carcinogenic Hazards

• Hazard quotient ( HQ )

UF1  Uncertainty Factor due to extrapolation from animal data

UF2  Uncertainty Factor due to application to sensitive human

populationsUF3  Uncertainty Factor due to use of sub-chronic instead of chronic

NOAELUF4  Uncertainty Factor due to use of LOAEL instead of NOAEL

MF  Modifying Factor allows for professional judgment of additional uncertainties

• Direct ingestion of contaminated food. • Direct ingestion of water • Inhalation of a chemical vapor • Inhalation of chemical particulates or

aerosols • Dermal contact with chemical or

contaminated dust, water • Others?

Exposure Point Concentration

C = Concentration of chemical in medium (i.e., mg of Z / L of water, or mg of Z / kg of beansCR = Contact rate with medium, or the amount of medium contacted per period of time (i.e., L of water drank / day, or kg of beans eaten / day.)EF = Exposure frequency, or how often the medium is contacted (days of contact / calendar year)ED = Exposure duration, or how long the exposure (contact with the contaminant) occurs ( years until receptor moves away, or years until contaminant disappears)BW = Body weight of receptor (kg, default to 70 kg for adults)AT = Averaging time (days) if we are considering carcinogenic effects of chemical Z, the AT is 365 days / year times 70 years.

Here is the result of an animal study of the carcinogenic chemical Z. This study used 1400 rats and fed them Z each day for two years, then killed the animals and examined them for tumors. The study used 100 males and 100 female rats at each of six doses plus an unexposed control group. The study cost $1,400,000.

At the lowest dose tested, 10 mg / kg day, the study found 2% of the rats had tumors - 3 males and one female. If you are doing a risk assessment in anticipation of using chemical Z in toothpaste, what sort of risk would you be comfortable with? 1 tumor in 10,000 or 1 in 100,000? If we knew the dose of Z that produced tumors in one of 100,000 rats, we could work backwards and estimate how much Z can safely be put in toothpaste. How many rats would you need? How about 800,000, I'd guess. That would be 100,000 males and that many females in each of four groups. With some economy of scale, you might treat them for $500 each, then the testing would cost only $400,000,000.

Besides the obvious practical problem, money, space, time, and finding enough pathologists to perform necropsies on 800,000 rats, there are several theoretical problems. As you move to lower and lower doses, the curve flattens out and large changes in dose result in small changes in effect. Lower doses are inherently more difficult to measure and analyze.

We just stretch a straight line from the lowest data point we have, 2% at 10 mg/kg-day, to 0% at 0 dose. (We converted from a log to a arithmetical axis.) From here it is easy to compute the dose that could cause a tumor in 1 out of 100,000 male rats. It would be :

Baseline Risk Assessment

• Consider each receptor type• Compute Exposure Point Concentration• Determine Intake• Calculate Slope Factor

– May be different for each route• Apply SF to Intake to determine Risk. May add risks from

routes, and chemicals to determine risk of not cleaning up site.

• Later you will compute the same if the site is cleaned up. • (Cannot add carcinogen risk and non-carcinogen)