TSCA

What do they mean?  TSCA  PMN  SAR  SNUR  OPPT

National Environmental Policy Act  The Toxic Substances Control Act (TSCA) was signed into law on  Provides EPA with authority to require reporting, record- keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures.  Certain substances are generally excluded from TSCA, including, among others, food, drugs, cosmetics and pesticides.  TSCA addresses the production, importation, use, and disposal of specific chemicals including polychlorinated biphenyls (PCBs), asbestos, radon and lead-based paint.

Subchapters of TSCA  SUBCHAPTER I - CONTROL OF TOXIC SUBSTANCES (§§ 2601 to 2629)  SUBCHAPTER II - ASBESTOS HAZARD EMERGENCY RESPONSE (§§ 2641 to 2656)  SUBCHAPTER III - INDOOR RADON ABATEMENT (§§ 2661 to 2671)  SUBCHAPTER IV - LEAD EXPOSURE REDUCTION (§§ 2681 to 2692)  SUBCHAPTER V - HEALTHY HIGH-PERFORMANCE SCHOOLS (§§ 2695 to 2695d)  SUBCHAPTER VI - FORMALDEHYDE STANDARDS FOR COMPOSITE WOOD PRODUCTS (§ 2697)

How many chemical are there? (Aug. 2015) 85,029

Chemicals substances on the Inventory include:  Organics;  Inorganics;  Polymers; and  Chemical substances of unknown or variable composition, complex reaction products, and biological materials (UVCBs).

Chemical substances not on the Inventory are those with uses not regulated under TSCA.  The use of these chemical substances is governed by other U.S. statutes on, for example:  Pesticides,  Foods and food additives,  Drugs,  Cosmetics,  Tobacco and tobacco products,  Nuclear materials, or  Munitions.

What does it mean for a chemical to be on the Inventory?  For purposes of regulation under TSCA, if a chemical is on the Inventory, the substance is considered an "existing" chemical substance in U.S. commerce.  Any chemical that is not on the Inventory is considered a “new chemical substance.”

How do I find out if a substance is on the Inventory?  Someone with a valid commercial need for EPA to verify if a substance is on the inventory can submit a Bona Fide Intent to Manufacture or Import Notice (“bona fide notice”) to obtain a written determination from EPA.  If the chemical is found to be a “new” the manufacturer moved to submit a PreManufacture Notice, or PMN.

What are the outcomes? Limited or no reporting. 90% Chemical completes the review process without being restricted or regulated in any way. 10% Chemical completes the review and is restricted or regulated in any way.

EPA has limited or no reporting requirements for new chemical substances in the following cases:  Low Volume Exemption (LVE) -- 10,000 kilograms or less of the substance will be manufactured each year under the requirements at 40 CFR section ; these requirements were substantially rewritten on March 29,  Research and Development -- the substance is manufactured in small quantities for research and development, and special procedural and recordkeeping requirements are met 40 CFR sections and  Low Releases and Low Exposures (LoREX) -- the substance is expected to have low release and exposure under the requirements at 40 CFR section , published March 29,  Test Marketing Exemption (TME) -- the substance is manufactured for TME, under the requirements at 40 CFR section  Polymer Exemption -- the substance is a that meets certain specified criteria where the substance is not considered chemically active or bioavailable under the requirements at 40 CFR section

Restrict How does the EPA choose? Exempt Limit

Office of Pollution Prevention and Toxics (OPPT)  There is no defined base data set required before PMN, and the TSCA does not require prior testing of new chemicals. Consequently, less than half of the PMNs submitted include toxicological data.  In these cases, OPPT scientists assess the chemical's structural similarity to chemicals for which data are available - called structure-activity relationship (SAR)- to help predict toxicity.  Hazard x Exposure = Risk

Limited test data are submitted or otherwise available on new chemical substances, and as a result EPA often relies on Structure Activity Relationship (SAR) predictions to evaluate potential effects associated with these substances.

Structure Activity Relationship (SAR)

Data obtained from PMN submitters by EPA using the exposure-based finding, can better characterize the tested chemical, confirm or refute a "negative" prediction of no risk or low risk, and supplement and validate the use of SAR in the review of PMNs.

Exposure Assessment An exposure assessment attempts to answer the following questions for a particular substance or chemical:  Who or what is exposed (e.g.,people, aquatic ecosystems) ?  Does the exposure occur through breathing air, drinking water, skin contact or any other routes?  How much exposure occurs?  How often and for how long does exposure occur, that is, what is its frequency and duration ?

 Chemical Properties and Fate  Estimating Concentrations in the Environment Using Models  Assessing Exposures  Assessing Exposures Using Monitoring Data  Assessing Exposures Using Models

What they were thinking… Congress intended that a greater priority for testing exists for high exposure chemicals. Exposure-based testing is usually required via a negotiated section 5(e) consent order.

“Unreasonable Risk"  The term "unreasonable risk" is not defined in the Toxic Substances Control Act (TSCA). The legislative history, however, indicates that unreasonable risk involves the balancing of the probability that harm will occur and the magnitude and severity of that harm against the effect of a proposed regulatory action on the availability to society of the expected benefits of the chemical substance.  In the context of the New Chemicals Program, EPA considers unreasonableness of risk both in the context of individual chemical substances and in considering whether to exempt categories of chemical substances.

Individual Substance  EPA's determination that manufacture, processing, use, distribution in commerce, or disposal of an individual substance which has been the subject of a notice under section 5 of the TSCA may present an unreasonable risk of injury to human health or the environment is based on consideration of:  (i) the size of the risks identified by EPA;  (ii) limitations on risk that would result from specific safeguards (generally, exposure and release controls) sought based on Agency review and  (iii) the benefits to industry and the public expected to be provided by new chemical substances intended to be manufactured after Agency review.

Exposure ParameterTSCA 5(e) Exposure-Based Policy Criterion Production Volume100,000 kg/yr Significant or Substantial Human Exposure: High Number of Workers Exposed > 1,000 workers Significant or Substantial Human Exposure: Acute Worker Exposure, Inhalation > 100 workers exposed to > 10 mg/day Significant or Substantial Human Exposure: Chronic Worker Exposure, Inhalation > 100 workers exposed to 1-10 mg/day for > 100 days/yr Significant or Substantial Human Exposure: Chronic Worker Exposure, Dermal > 250 workers exposed by routine dermal contact for > 100 days/yr Significant or Substantial Human Exposure: Consumer Presence in consumer product where exposures are likely Significant Human Exposure: Ambient General Population > mg/kg/day exposure via drinking water, air, or groundwater Substantial Human Exposure: Ambient General Population > 10,000 kg/yr release to environmental media Substantial Environmental Release > 1,000 kg/yr total release to surface water calculated after wastewater treatment

In considering risk, EPA considers factors including:  environmental effects  distribution  fate of the chemical substance in the environment  disposal methods  waste water treatment  use of protective equipment and engineering controls  use patterns  market potential of the chemical substance

EPA may issue a TSCA section 5(e) Order to prohibit or limit activities associated with the substance, if EPA determines that:  There is insufficient information to evaluate the human health and environmental effects of the substance, and  The substance may present an unreasonable risk of injury to human health or the environment (the "risk- based" finding), or  The substance will be produced in substantial quantities and may be anticipated to enter the environment in substantial quantities or there may be significant or substantial human exposure (the "exposure-based" finding).

“Insufficient Information"  In practice, these section 5(e) Orders are almost always issued as "Consent Orders" that are signed by both EPA and the chemical manufacturer.  Given the "insufficient information" finding, most Section 5(e) Orders require the PMN submitter to develop and submit to EPA certain toxicity or fate tests before exceeding a specified production volume ("test trigger") designed to allow sales of the chemical to generate enough revenue to pay for the testing.

Exposure-based section 5(e) Orders consist primarily of a requirement to conduct triggered testing (plus recordkeeping and "risk notification" in case the test data indicates a risk.)  Risk-based TSCA section 5(e) Orders, depending on the type of concerns identified by EPA for a given PMN substance, typically also require exposure controls such as:  Gloves  Goggles  Respirators  Specified disposal technologies  Restrictions on releases to water  Hazard communication such as material safety data sheets (MSDS), labels, and training.

Significant New Use Rules (SNURs):  The SNUR defines a significant new use so as to require reporting to EPA before any manufacturer or processor of the same chemical undertakes activities inconsistent with requirements of the section 5(e) Order.  Thus, EPA has an opportunity to review those activities before they occur because, under section 5(a)(1)(B) of TSCA, any company wishing to undertake the activities designated in the SNUR must submit a SNUN to EPA at least 90 days before doing so. These SNURs appear in 40 CFR Part 721.

TSCA section 5(f) Actions:  If EPA determines that a new chemical will present unreasonable risk before a TSCA section 6 rule can be promulgated, EPA may  (1) limit the amount or impose other restrictions on the substance via an immediately effective proposed rule, or  (2) completely prohibit the substance by issuing a proposed order or applying to a US District Court for an injunction.

FIFRA/FFDCA/FQPA

 FIFRA  FQPA  FFDCA  OPP  DDT

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)  The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was signed into law on  All pesticides distributed or sold in the United States must be registered (licensed) by EPA.  Before EPA may register a pesticide under FIFRA, the applicant must show, among other things, that using the pesticide according to specifications "will not generally cause unreasonable adverse effects on the environment.''

Food Quality Protection Act (FQPA)  The Food Quality Protection Act (FQPA)was signed into law on  The enactment of the Food Quality Protection Act (FQPA) of 1996, Congress presented EPA with an enormous challenge of implementing the most comprehensive and historic overhaul of the Nation's pesticide and food safety laws in decades.  The FQPA amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food Drug, and Cosmetic Act (FFDCA) by fundamentally changing the way EPA regulates pesticides.

Federal Food, Drug, and Cosmetic Act  The Federal Food, Drug, and Cosmetic Act (FFDCA) was signed into law on  Set tolerances, or maximum residue limits, for pesticide residues on foods.  In the absence of a tolerance for a pesticide residue, a food containing such a residue is subject to seizure by the government. Once a tolerance is established, the residue level in the tolerance is the trigger for enforcement actions. That is, if residues are found above that level, the commodity will be subject to seizure.

What do they mean?  FIFRA defines the term ''unreasonable adverse effects on the environment'' to mean:  (1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or  (2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 408 of the Federal Food, Drug, and Cosmetic Act.

The Office of Pesticide Programs (OPP) The Office of Pesticide Programs (OPP) regulates the use of all pesticides in the United States and establishes maximum levels for pesticide residues in food, thereby safeguarding the nation's food supply.

 FIFRA is a product licensing statute; pesticide products must obtain an EPA registration before manufacture, transport, and sale  registration based on a risk/benefit standard  strong authority to require data--authority to issue Data Call-ins  ability to regulate pesticide use through labeling, packaging, composition, and disposal  emergency exemption authority--permits approval of unregistered uses of registered products on a time limited basis  ability to suspend or cancel a product's registration: appeals process, adjudicatory functions, etc.

Registration of New Pesticides  Data Requirements for Registration  The categories of data required include:  the product’s chemistry  environmental fate  residue chemistry  dietary and non-dietary hazards to humans  hazards to domestic animals and non-target organisms (40 CFR Part 158).

“Product Chemistry"  Under the "product chemistry" category, applicants must supply technical information describing the product’s:  active and inert ingredients  manufacturing or formulating processes  physical and chemical characteristics.

 Data from "environmental fate" studies are used to assess the effects of pesticide residues on the environment, including the effect on non-target organisms and their habitat.  Residue chemistry information includes the expected frequency, amounts, and time of application, and test results of residue remaining on treated food or feed.

 Information under "hazards to humans, domestic animals, and non-target organisms" includes specific test data assessing acute, subchronic, and chronic toxicity, skin and eye irritation potential, and potential exposure by various routes (i.e., oral, dermal, inhalation).  All studies must be conducted under conditions that meet Good Laboratory Practice (GLP) standards (40 CFR Part 160). Guidelines for studies of product chemistry, residue chemistry, environmental chemistry, hazard evaluation and occupational and residential exposure can be found in 40 CFR Part 158.

Labeling Requirements  Labeling requirements control when and under what conditions pesticides can be:  applied,  mixed,  stored,  loaded or used,  fields can be reentered after application,  and crops can be harvested.  Requirements are also imposed on container specifications and disposal.

Development of DDT  DDT (dichloro-diphenyl- trichloroethane) was developed as the first of the modern synthetic insecticides in the 1940s. It was effective for insect control in crop and livestock production, institutions, homes, and gardens.  DDT's quick success as a pesticide and broad use in the United States and other countries led to the development of resistance by many insect pest species. s/Info/DDT.html

Rachel Carson's Silent Spring The publication in 1962 of Rachel Carson's Silent Spring stimulated widespread public concern over the dangers of improper pesticide use and the need for better pesticide controls.

 It was initially used with great effect to combat malaria, typhus, and the other insect-borne human diseases among both military and civilian populations.

 In 1972, EPA issued a cancellation order for DDT based on its adverse environmental effects, such as those to wildlife, as well as its potential human health risks.  Since then, studies have continued, and a relationship between DDT exposure and reproductive effects in humans is suspected, based on studies in animals.  In addition, some animals exposed to DDT in studies developed liver tumors. As a result, today, DDT is classified as a probable human carcinogen by U.S. and international authorities.

DDT and the Bald Eagle By 1963, with only 487 nesting pairs of bald eagles remaining, the species was in danger of extinction. Loss of habitat, shooting, and DDT poisoning contributed to the near demise of our national symbol. ecovery/biologue.html