ENVE 441

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ENVE 441

• Dr. Robert A. Perkins, PE
• ffrap_at_uaf.edu
• http//www.faculty.uaf.edu/ffrap/

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17 and 19 April 2007

• Admin, Homework, etc.
• Hazardous Waste Regulations
• Risk Assessment

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History

• Love Canal (book)
• Cuyahoga
• Sopranoland

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Water Quality

• Cuyahoga River Fire June 22, 1969

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Sopranoland

• Life in New Jersey

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Environmental Laws

• Law and Regulations
• How they come about
• The legal process

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CONSTITUTION
STATUTES
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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.

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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

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• 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.

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CONSTITUTION
STATUTES
COURTS
REGULATIONS
COMMON LAW
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Consider Laws by Branches

• Judicial
• Legislative
• Executive

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Agencies as source of law
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CONSTITUTION
STATUTES
REGULATIONS
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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

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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

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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

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Rule (Law) Making

• Must conform to the Administrative Procedures Act
• exactly
• (State similar)
• http//touchngo.com/lglcntr/akstats/Statutes/Title
  44/Chapter62.htm

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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 dont know what is going on
• One might submit incorrect data, others would not
  know

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Formal

• Must have public hearings
• Must keep records
• transcripts

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Process

• Often starts with consultation with affected
  parties
• semi-public meetings
• Other input, perhaps in-house
• Priorities
• Housekeeping

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Federal Register

• http//www.gpoaccess.gov/fr/index.html
• todays 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.

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After FR

• Within deadline
• Comment received
• Pubic hearing held
• if required
• Rule is redrafted
• if major, need to start cycle over with new FR

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Rule

• Rule is promulgated by agency
• Next it is codified with number
• Goes into the Code of Federal Regulations

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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

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Enabling

• See 1533.a
• (a) Generally (1) The Secretary shall by
  regulation promulgated in accordance with
  subsection (b)
• Who is?
• See definitions section

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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

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• Part 72, Acid Rain
• http//a257.g.akamaitech.net/7/257/2422/08aug20031
  600/edocket.access.gpo.gov/cfr_2003/julqtr/40cfr72
  .1.htm
• Note Laws and FR publication

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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

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Executive

• Appointed by President
• May be within a cabinet Department
• Federal Aviation Administration in the Department
  of Transportation.

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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.

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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

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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.

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• 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

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• 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.

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• "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.

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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

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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

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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.

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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

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Growth in Environmental Laws
Number of Laws
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RCRA CIRCLA

• CERCLA 1980
• "superfund law."
• Comprehensive Environmental Response,
  Compensation, and Liability Act,
• Overhauled in 1986 by SARA
• Superfund Amendments and Reauthorization Act

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• 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

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RCRA

• Subtitle D
• Municipal Solid Waste
• Subtitle C
• Hazardous Waste

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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.

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Hazardous?

• Many definitions, lists, etc.
• CWA 40CFR116.4
• Many others CAA, OSHA,
• RCRA has two methods

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Regulations

• Two methods
• Listed
• U, P, F, K lists
• http//www.faculty.uaf.edu/ffrap/EQE_649/Module_03
  /Submodule3B/Submodule3B_1.htm
• Characteristic

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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.

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• F Wastes - Waste from nonspecific sources
• K Wastes - Waste from specific sources

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Characteristic Wastes

• Ignitability
• Reactivity
• Corrosivity
• Toxicity
• TCLP,
• Toxicity Characteristic Leaching Procedure

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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.

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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/hrsi
  nt.htm
• Record of Decision
• Remedial Design and Remedial Action

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Take Home Thoughts

• RCRA v. CERCLA
• Listed v. Characteristic Wastes
• HRS, NPL
• State v. Federal

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Risk Assessment

• Terms
• Risk
• Safe
• Hazardous

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Two Tracks

• Carcinogens
• Non-carcinogens

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Non-Carcinogenic Hazards

• Hazard quotient ( HQ )

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UF1  Uncertainty Factor due to extrapolation from
animal data UF2  Uncertainty Factor due to
application to sensitive human populations UF3
 Uncertainty Factor due to use of sub-chronic
instead of chronic NOAEL UF4  Uncertainty Factor
due to use of LOAEL instead of NOAEL MF
 Modifying Factor allows for professional
judgment of additional uncertainties
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• 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?

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Exposure Point Concentration
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C Concentration of chemical in medium (i.e., mg
of Z / L of water, or mg of Z / kg of beans CR
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.
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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.
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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.
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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.
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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
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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)