Hazardous Substances Laws and Regulations

Hazardous Waste & How it is Regulated

J. Craig SmithBryan C. Bryner

Smith Hartvigsen, PLLC

Toxic Substances Control Act

(TSCA)

Law and Regulations

• Law: 15 U.S.C.A. § 2601-2692– Statute is not substantive– Generally requires EPA to establish

substantive rules

• EPA Regulations: 40 CFR 700-766 (all matters); 40 CFR 195 (radon)

Objective of TSCA• Require manufacturers and processors of chemicals and

mixtures to develop adequate data with respect to the effect of chemical substances and mixtures on health and the environment.

• Regulate chemical substances and mixtures which present an unreasonable risk of injury to health or the environment,

• Allow EPA to take action with respect to chemical substances and mixtures which are imminent hazards

• Assure that innovation and commerce in such chemical substances and mixtures do not present an unreasonable risk of injury to health or the environment

• Exercise authority over chemical substances and mixtures in such a manner as not to impede unduly or create unnecessary economic barriers to technological innovation.

What it Does

• Gives EPA the ability to track the 75,000 existing industrial chemicals currently produced or imported into the United States.

• Authorizes EPA to require testing of old and new chemical substances

• Authorizes EPA to regulate the manufacturing, processing, import and use of chemicals.

Overview• Title I: Control of Toxic Substances

– Enacted 1976• Title II: Asbestos Hazard Emergency Response

– Enacted 1986, amended 1990– Authorizes the EPA to impose requirements for asbestos

abatement in schools and requires accreditation of persons who inspect for asbestos-containing materials.

• Title III: Indoor Radon Abatement– Enacted 1988– Requires the EPA to publish a guide to radon health risks and

perform studies of radon levels in schools and federal buildings• Title IV: Lead Exposure Reduction

– Enacted 1992– Requires the EPA to identify sources of lead contamination in

the environment, regulate amounts of lead allowed in products, including paint and toys, and establish state programs to monitor and reduce lead exposures

Title I RequirementsSection 4: Testing Requirements of Existing Chemicals

• Purpose: to develop a database of information about chemicals that will allow the EPA to determine if the manufacture, distribution in commerce, processing, use, or disposal the chemicals “does or does not present an unreasonable risk of injury to health or the environment”

• How chemicals are recommended for testing– Interagency Testing Committee has a list (“Master

Testing List”) of up to 50 chemicals that have highest priority

– Recommendations by other EPA offices, federal agencies, and international organizations


(cont.)

• EPA will require producers to conduct tests on existing chemicals if it makes a finding that:– Their manufacture, distribution, processing, use, or

disposal may present an unreasonable risk of injury to health or the environment OR they are to be produced in substantial quantities and the potential for environmental release or human exposure is substantial or significant

• Guidelines set for evaluating what level of release or exposure is “substantial”

– Existing data are insufficient to predict the effects of human exposure and environmental releases; AND

– Testing is necessary to develop such data


(cont.)

• If EPA makes the above findings, it then promulgates a rule (pursuant to rulemaking procedures under administrative procedures act) for manner and method of conducting testing

• Testing is not/has not been done on all chemicals since all do not meet these requirements, or testing has not been recommended for the chemicals

Title I RequirementsSection 5: Premanufacture Notification & Pre-Screening

of New Chemicals

• Purpose: identify potential hazards of new chemicals and control them before use of the chemical becomes widespread

• Also applies to significant new use of existing chemical


of New Chemicals (cont.)

• Producers must submit a Pre-Manufacture Notice (PMN) to EPA at least 90 days prior to producing or otherwise introducing a new chemical product into the U.S.

• EPA has 90 days after notification to evaluate the potential risk posed by the new chemical– Evaluation base on

• Available data, if any• If no available data, similar chemical structure used in similar

ways; OR• Premarket testing of chemical if it may present an

unreasonable risk OR chemical is to be produced in substantial quantities and potential for environmental release or human exposure is substantial or significant


of New Chemicals (cont.)

• If EPA finds a reasonable basis to conclude the substance will present an unreasonable risk, EPA will promulgate requirements to protect adequately against such risk; OR

• EPA may determine that the proposed activity does not present an unreasonable risk.

Title I RequirementsSection 6: Regulatory Controls

• Regulation is usually on a case-by-case basis• Regulation may be imposed on categories of chemicals• If hazards presented by existing or new chemicals are unreasonable

risks, EPA may– Prohibit or limit the amount of production or distribution of a substance

in commerce;– Prohibit or limit the production or distribution of a substance for a

particular use;– Limit the volume or concentration of the chemical produced;– Prohibit or regulate the manner or method of commercial use;– Require warning labels and/or instructions on containers or products;– Require notification of the risk of injury to distributors and, to the extent

possible, consumers;– Require record-keeping by producers;– Specify disposal methods; and– Require replacement or repurchase of products already distributed

• EPA must use “least burdensome” regulatory approach

Title I RegulationsTSCA Chemical Substance Inventory

• Database of every “existing” chemical– Approximately 75,000 chemicals– Lists TSCA restrictions on manufacture or use of each

chemical– More than 500 individual chemicals are subject to

specific EPA administrative orders requiring workplace or manufacturing controls

• Any chemical not in the Inventory is classified as “new”

• After filing PMN and EPA approval of new chemical, it is added to the Inventory

Title I RegulationsReporting & Record Keeping Requirements

• If you manufacture, process or import an existing chemical, you must report and/or record– Chemical identities– Categories of use– Amounts manufactured and processed– Descriptions of byproducts– Environmental and health effects– Number of individuals & employees exposed– Manner of disposal

Title I Regulations

• Exemptions from TSCA regulation– Chemicals regulated by other laws

• Drugs, cosmetics, foods, food additives (FFDCA)• Pesticides (FIFRA)• Nuclear materials• Tobacco

Federal Insecticide, Fungicide and Rodenticide Act

(FIFRA)

Legal Authority

• 7 U.S.C. §§ 136-136y

• EPA Regulations: 40 C.F.R. §§ 152-180

Overview & Objectives

• FIFRA is a product licensing statute: pesticide products must obtain an EPA registration before manufacture, transport, and sale

• Gives EPA ability to regulate pesticide use through labeling, packaging, composition, and disposal

Regulation

• Pesticides may not be sold unless they are (1) registered and (2) labeled

• Registration– Manufacturers must submit scientific data on

pesticide toxicity and environmental behavior– Special data required if pesticide is used on food or

feed crops– Pesticide and its acceptable uses not cause harm to

human health with reasonable certainty or pose unreasonable risks to the environment

Regulation (cont.)• Registration (cont.)

– Pesticide classified as either:• General use pesticide

– Safe enough to be used and handled by the general public

• Restricted use pesticide– Can only be applied by certified users because they are

considered more dangerous– Most states have developed programs approved by the

EPA to train and certify applicators for restricted use pesticides

– All pesticides must be re-registered on a 15-year cycle

Regulation• Registration (cont.)

– Other types of registration• Temporary registrations:

– no significant risk to the environment and registration would be in the public’s best interest

• Minor use registrations: – pesticide applications on crops with fewer than 300,000

acres of total production in the United States

• Experimental use:– Allow companies to conduct research with pesticides in

order to develop the required data for the registration process

– Allow agricultural research institutions to conduct other scientific experiments with the pesticides


– Other types of registration (cont.)• Special local registrations:

– Allow states to add permissible uses to pesticide labels for special local needs within a state

• Emergency use:– Allow states or federal agencies to use new

pesticides registrations or add uses to existing registrations for a specific length of time to control an emergency situation


– Labeling requirements• Once registered, the manufacturer must prepare a

label that meets EPA approval that explains the permissible uses and required conditions for use of the pesticides, including protections for workers

• Pesticide label requirements preempt state and local laws

• Application of a pesticide inconsistent with the label instructions is a violation of federal law

Emergency Planning and Community Right-To-Know Act

(EPCRA)

Authority

• Law: 42 U.S.C. § 116 et seq.

• Regulations: 40 CFR 300, 355, 370, 372

Objective

• Two main objectives– To help communities plan for emergencies

involving hazardous substances– Provide local governments and the public with

information about possible chemical hazards in their communities

What it Does

• Establishes requirements for Federal, state and local governments, Indian Tribes, and industry regarding emergency planning and “Community Right-to-Know” reporting on hazardous and toxic chemicals

• Increases the public’s knowledge and access to information on chemicals at individual facilities, their uses, and releases into the environment

EPCRA Regulations-Four types of chemicals regulated under EPCRA

• Extremely Hazardous Substances– More than 300 named substances

• Hazardous Substances– About 720 named substances– Identified in CERCLA regulations

• Hazardous Chemicals– No list of “hazardous chemicals”– Defined by OSHA regulations as chemicals which

represent a physical or health hazard• Toxic Chemicals

– Approximately 650 toxic chemicals named/listed

EPCRA RegulationsSections 301 to 303: Emergency Planning

• Local governments– Establish Local Emergency Planning Committees

(LEPCs) with stakeholder participation• Prepares and develops chemical emergency response plans• Review emergency plans at least annually

– LEPC membership must include (at a minimum)• Elected state and local officials• Police, fire, civil defense, and public health professionals• Environment, transportation, and hospital officials• Representatives from community groups and the media

EPCRA RegulationsSections 301 to 303: Emergency Planning (cont.)

• Local Governments (cont.)– Utah LEPC’s

• Each of Utah’s 29 counties• Salt Lake City• Sandy City• West Valley City

– Community Emergency Response Plan• Identification of facilities and transportation routes of extremely

hazardous substances• Description of emergency response procedures, on and off site• Designation of a community coordinator and facility emergency

coordinator(s) to implement the plan• Outline of emergency notification procedures• Description of how to determine the probable affected area and

population by releases• Description of local emergency equipment and facilities and the persons

responsible for them• Outline of evacuation plans• A training program for emergency responders (including schedules)• Methods and schedules for exercising emergency response plans


• State governments– Required to oversee and coordinate local planning

efforts– Establish State Emergency Response Commission

(SERC)• Establishes procedures for receiving and processing public

requests for information collected under EPCRA• Reviews local emergency response plans• Designates local emergency planning districts• Appoints a Local Emergency Planning Committees (LEPC)

for each district• Supervises the activities of the LEPC


• State governments (cont.)– Utah SERC

• Dr. Dianne Nielsen, Executive Director

Utah Dept. of Environmental Quality

186 North 1950 West, Rm. 203

Salt Lake City, UT 84116-3085

• Mr. Craig Deardon, SERC Co-Chair &Commissioner

Utah Department of Public Safety

4501 S. 2700 W.

Salt Lake City, UT 84119-5977


• Facilities that maintain Extremely Hazardous Substances (EHSs) on-site in quantities greater than corresponding Threshold Planning Quantities (TPQs)– Must cooperate in emergency plan preparation– Designate a facility emergency coordinator to

participate in the planning process– Notify their SERC and LEPC within 60 days of

becoming subject to the emergency planning requirements (such as from a shipment or production of an EHS)

EPCRA RegulationsSection 304: Emergency Notification

• Facilities must immediately report accidental releases of EHS and “hazardous substances” in quantities greater than corresponding Reportable Quantities (RQs) (defined under CERCLA) to– SERC– LEPC; and– National Response Center

EPCRA RegulationsSection 304: Emergency Notification (cont.)

• What chemicals must be reported– Extremely Hazardous Substances– Hazardous Substances

• Emergency Notification requirements– The chemical name– An indication of whether the substance is extremely hazardous– An estimate of the quantity released into the environment– The time and duration of the release– Whether the release occurred into air, water, and/or land– Any known or anticipated acute or chronic health risks

associated with the emergency, and where necessary, advice regarding medical attention for exposed individuals

– Proper precautions, such as evacuation or sheltering in place– Name and telephone number of contact person

EPCRA RegulationsSection 304: Emergency Notification (cont.)

• Written follow-up notice– A written follow-up notice must be submitted to the

SERC and LEPC as soon as practicable after the release.

– The follow-up notice must update information included in the initial notice and provide information on actual response actions taken and advice regarding medical attention necessary for citizens exposed.

• Information about accidental chemical releases must be available to the public.

EPCRA RegulationsSections 311 and 312:

Hazardous Chemical Reporting

• Facilities manufacturing, processing, using or storing designated “hazardous chemicals” must maintain Material Safety Data Sheets (MSDSs) for each substance

• One-time submission of MSDS or detailed list of the chemicals to:– SERC– LEPC– Local fire department


Hazardous Chemical Reporting (cont.)

• Provide annual inventory report by March 1 for all chemicals submitted, to same entities– Tier I form

• Facility must report the amounts and general location of chemicals in certain hazard categories

• Ex: “facility stores 10,000 pounds of substances that cause chronic health effects”

– Tier II form• Same information, but it must name the specific chemical• Ex: “facility has 500 pounds of benzene,” and it would indicate the

physical and health hazards associated with benzene• Tier II required by Utah instead of Tier I

– Utah Department of Environmental Quality manages EPCRA data for Utah SERC



• What facilities are regulated?– Any facility required under OSHA regulations to

maintain MSDSs for hazardous chemicals stored or used in the work place

– Facilities with chemicals in quantities that equal or exceed the following thresholds must report

• Extremely Hazardous Substances (EHSs): either 500 pounds or the Threshold Planning Quantity (TPQ), whichever is lower

• All other hazardous chemicals: 10,000 pounds



• MSDS– Detailed information sheets that provide data on

health hazards and physical hazards of chemicals along with associated protective measures

– Over 500,000 products have MSDSs which are normally obtained from the chemical manufacturer

• Information about chemical inventories at facilities and MSDSs must be available to the public

EPCRA RegulationsSection 313: Toxic Chemicals Reporting

• Toxics Release Inventory (TRI) is a publicly available EPA database that contains information on toxic chemical releases and waste management activities reported annually by certain industries as well as federal facilities

• Facilities must complete and submit a Toxic Chemical Release Inventory Form annually by July 1 for each of the more than 600 Toxic Release Inventory (TRI) chemicals that are manufactured or otherwise used above the applicable threshold quantities

• Covered facilities:– Have 10 or more full-time employees or the equivalent;– Are in a covered NAICS code; and – Exceed any one threshold for manufacturing (including

importing), processing, or otherwise using a toxic chemical listed in 40 CFR Section 372.6

Enforcement and Penalties• Civil Penalties

– Failure of facility to cooperate and participate in emergency planning

– Failure to notify for accidental release– Failure to submit MSDS/list of chemicals– Non-compliance with annual inventory

• Criminal Penalties – Failure to notify for accidental releases

• Authorizes Citizen Suits against facilities• Authorizes civil actions by state and local

governments against facilities.

LUST Program--

RBCA

Background

• State and federal environmental regulations require owners and operators of underground storage tank facilities to investigate and remediate spills of petroleum products to the underlying soil and groundwater– Contaminate drinking water sources– Contaminate soils and water vapors

Background (cont.)

• Background– 629,000+ underground storage tanks

nationwide – nearly all contain petroleum– 4,024 active USTs in Utah– 4,341 number of confirmed releases– 3,886 cleanups completed– 455 LUST cleanups to be completed in

backlog– Utah obtains more than 50% of the

population’s drinking water from groundwater

Background (cont.)• Regulatory and Legal History

– 1984 Amendments to RCRA:• Required EPA to develop a comprehensive regulatory

program for USTs storing petroleum or certain hazardous substances

• Directed EPA to publish regulations that would require owners and operators of new tanks and tanks already in the ground to prevent, detect, and clean up releases

– 1986 Amendments to RCRA• Created the Leaking Underground storage Tank Trust Fund,

which is to be used for two purposes:– To oversee cleanups by responsible parties– To pay for cleanups at sites where the owner or operator is

unknown, unwilling, or unable to respond, or which require emergency action.

EPA LUST Regulations: 3 Sections

• Technical Requirements– Technical Requirements

• Technical design criteria for USTs to reduce the chance of releases from USTs, detect leaks and spills when they do occur, and secure a prompt cleanup

• Financial Responsibility Requirements– Ensure that, in the event of a leak or spill, an owner or

operator will have the resources to pay for costs associated with cleaning up releases and compensating third parties

EPA LUST Regulations: 3 Sections (cont.)

• State Program Approval Objectives– Because of the large size and great diversity of the regulated

community, state and local governments are in the best position to oversee USTs

– RCRA allows state UST programs approved by EPA to operate in lieu of the federal program

– State program approval (SPA) regulations set criteria for states to obtain the authority to operate in lieu of the federal program. State programs must be at least as stringent as EPA’s

• Utah has an approved state program since 1995

– Owners and operators in states that have an approved UST program do not have to deal with two sets of statutes and regulations (state and federal) that may be conflicting

– Once their programs are approved, states have the lead role in UST program enforcement


• Exemptions from federal (not necessarily state) regulations– Farm and residential tanks of 1,100 gallons or less

capacity holding motor fuel used for noncommercial purposes;

– Tanks storing heating oil used on the premises where it is stored;

– Tanks on or above the floor of underground areas, such as basements or tunnels;

– Septic tanks and systems for collecting storm water and wastewater;

– Flow-through process tanks;– Tanks of 110 gallons or less capacity; and– Emergency spill and overfill tanks


• RBCA Process– Overview

• Flexible, science-based, decision management framework that may be customized for use by individual regulatory agencies.

• RBCA process entails: (1) identification of applicable risk factors on a site-specific basis and 2) implementation of appropriate corrective measures in a timeframe necessary to prevent unsafe conditions


• RBCA Process (cont.)– RBCA involved three key elements:

• Rick-Based Site Prioritization:– Characterize risk drivers at each site and prioritize response

actions based on the timing and magnitude of potential impacts to human health and the environment.

• Site-Specific, Risk-Based Remediation Goals:– Determine risk-based concentration limits for affected

environmental media designed to prevent impacts on human health and the environment.

– To provide for economical use at both small and large facilities, RBCA employs a tiered approach to the development of risk-based cleanup goals, designed to match the site assessment effort to the relative complexity of each site

– Tier 1 remediation goals represent generic concentration limits, based on conservative default assumptions

– Under Tiers 2 & 3, the user may derive site-specific concentration limits, based on additional site data and increasingly sophisticated methods of data analysis

EPA LUST Regulations: 3 Sections

(cont.)• RBCA Process

– RBCA involved three key elements: (cont.)• Remedy Selection:

– Minimize risk by preventing exposure to unsafe levels of site chemicals

– Options for management of contaminated soil and groundwater include removal/treatment, containment, natural attenuation, institutional controls, or some combination thereof.

Utah Underground Storage Tank (UST) Program

• Created by amendments to the Solid and Hazardous Waste Act in 1986

• Utah Underground Storage Tank Act enacted in 1989

• UST Program administered by – Utah Department of Environmental Quality– Division of Environmental Response and Remediation

(DERR)– UST/LUST Branch– http://undergroundtanks.utah.gov

Utah Underground Storage Tank (UST) Program (cont.)

• LUST section of DERR oversees remediation of contamination from USTs

• Petroleum Storage Tank (PST) Trust Fund– PST Fund functions similarly to insurance with the

owner/operator having a “deductible”– Fund is used to help finance corrective actions

Utah Underground Storage Tank (UST) Program (cont.)

• Corrective Action: Utah Cleanup Rules (Utah Admin. Code R311-211, Corrective Action Utah’s Cleanup Rules – UST and CERCLA Sites)– Cleanup to generally applicable standards is not always

reasonable for petroleum releases from underground storage tanks

– Utah’s Cleanup Rules allow a risk-based analysis to determine a site-specific cleanup standard when the generally applicable cleanup standards are not reasonable

– Reasonableness is based on consideration of impact or potential impact to public health and the environment, the cost of the cleanup, and the available technology

– Generally adopts the EPA RBCA method, but has modified it into a 2-tiered approach, rather than 3-tiered

Documents

Hazardous Substances Laws and Regulations