EPA’s Existing Chemicals Programs and

Initiatives

Presented to the North and South Carolina Chapter

American Industrial Hygiene Association

Charles Auer, Director, Chemical Control Division

March 15, 2002

Why is the HPV Challenge Needed?

• 43% of the U.S. HPV chemicals have no publicly available studies for any of the 6 basic endpoints

• Only 7% of the U.S. HPV chemicals have a full set of publicly available studies for the 6 basic endpoints

HPV Challenge ProgramGoals and Approach

HPV Challenge goal is public availability of a baseline set of health and environmental effects data on approximately 2800 HPV chemicals; goal is not testing chemicals

Defined list of chemicals and battery of tests – Screening Information Data Set (SIDS)

Submit detailed summary information in a uniform database format (“robust summaries”)

FR Notice issued December 26, 2000 (65 FR 81686)

HPV Challenge ProgramDesign Features

Voluntary program for companies to make basic hazard data on their HPV chemicals publicly available by 2005

Strongly encourage greater international testing efforts under OECD HPV/SIDS, ICCA

Public involvement at every step Incorporate animal welfare considerations

and encourage use of SAR/category approach

SIDS Data Elements Chemical Identity

Chemical Name CAS Registry Number

Physical/Chemical Properties Melting Point Boiling Point Vapor Pressure Partition Coefficient Water Solubility

SIDS Data Elements (cont.)

Environmental Fate and Pathways Biodegradation

Aerobic Abiotic Degradability

Hydrolysis Photolysis

Fate and Environmental Distribution Assessment

SIDS Data Elements (cont.)

Ecotoxicity Acute Toxicity

Fish Daphnia Algae

Chronic Toxicity (when indicated) Daphnia

SIDS Data Elements (cont.)

Mammalian Toxicity Acute Toxicity

Oral preferred if not available (except for gases)

Repeated Dose Toxicity Combined Repeat Dose and Reprotox

Screen (OECD 422) OR 28-day study (OECD 407)

SIDS Data Elements (cont.)

Mammalian Toxicity (Con’t) Genotoxicity

Gene mutation Chromosomal aberrations

Reproductive/Developmental Toxicity Combined Reproductive and

Developmental Toxicity Screen (OECD 420) OR

Combined Repeat Dose and Reprotox Screen (OECD 422)

SIDS Data Elements (cont.)

Report Other Available Hazard/Exposure Data - the OECD SIDS “Dossier” includes reporting for:

Irritation Sensitization Carcinogenicity Other physical/chemical properties Human Experience Exposure/Use Information Etc.

HPV Challenge Program Success

423 companies and 131 consortia have pledged to voluntarily provide data on over 2100 chemicals by 2005!

HPV Challenge Program

Companies now submitting test plans and robust summaries of existing data

Data are publicly accessible through posting on Internet:– www.epa.gov/chemrtk

HPV Challenge Program

Companies exploring voluntary submission of exposure data to provide context for hazard data.

Companies should delay start of new testing for 120 days after posting of test plan to allow public comment.

Test Plan Performance 121 Test Plans covering 776 chemicals

have been received by EPA. Test Plans cover 65 chemical categories and 56 single chemicals

116 Test Plans have been posted on EPA’s web site for public comment

Test Plans are generally being sent to EPA on the schedule committed to by the sponsors.

Test rule to ensure equity ( 65 FR 81658)

Why the HPV Challenge Program is Important to Your

Work?

By 2005 : basic information available to

industry, government and the public on all HPVchemicals.

fully searchable database. as data are assessed, priority

chemicals are identified for additional testing, assessment, or management.

Why is the Voluntary Children’s Chemical

Evaluation Program (VCCEP) Needed?

“... review and report on what new testing may be needed to address the special impact industrial chemicals may have on children.”

VCCEP developed via a public stakeholder process.

VCCEP is not a testing program – hazards, exposures, and risks of chemicals to children are evaluated and if necessary information gaps are to be filled.

FR Notice announcing the “Voluntary Children’s Chemical Evaluation Program” issued December 26, 2000 (65 FR 81699).

The Pilot attempts to define a workable common ground that meets the needs of diverse stakeholders.

Key Features of the VCCEP

Goal is publicly available data.

Strong chemical selection criteria – biomonitoring data.

Tiered testing scheme. Implementation process builds on and

models the HPV Challenge when ever possible.

Commitments made tier by tier in the Pilot.

Key Features of the VCCEP (cont.)

Role for exposure information gathering and assessment.

Additional data development decisions (such as testing) based on whether chemical is adequately characterized given the available data.

Peer Consultation promotes joint stewardship of the program and a strong science foundation.

23 Pilot ChemicalsAcetone TolueneBenzene [Chlorobenzene]Vinylidene chloride n-DodecaneMethyl ethyl ketone p-DioxaneTrichloroethylene Decanealpha-Pinene Tetrachloroethyleneo-Xylene [m-Dichlorobenzene]Ethylbenzene Undecanep-Dichlorobenzene Decabromodiphenylether[Ethylene dibromide] Pentabromodiphenyl etherEthylene dichloride Octabromodiphenyl etherm-Xylene

[ ] = unsponsored

1st Tier Toxicity Studies(HPV Challenge Health-related

Studies)

Acute toxicity Repeated dose toxicity with

reproductive and developmental toxicity screens

Bacterial reverse mutation assay In vitro or in vivo chromosomal

aberrations

2nd Tier Toxicity Studies Sub chronic (90 day) toxicity Prenatal developmental toxicity Reproductive and fertility effects Metabolism and

pharmacokinetics Immunotoxicity In vivo chromosomal aberrations

or in vivo micronucleus test

3rd Tier Toxicity Studies

Carcinogenicity Neurotoxicity screening

battery Developmental neurotoxicity

Exposure Assessments Biomonitoring data used for chemical selection

contribute to an overall assessment. Depth of exposure information increases with each

tier:– Tier 1: screening level data– Tiers 2 and 3: advanced assessments using

exposure studies, monitoring data, and modeling Transparency Exposure assessments need to address standard

issues:– Populations– Routes of exposure– Extent, duration and frequency of exposures

Peer Consultation Forum for scientists and experts from

stakeholder groups to exchange scientific views on sponsor’s assessments.

Hoping for participation by State experts. Not a consensus based approach. Managed by an independent third party

that summarizes the consultation’s results and forwards them to EPA.

Balanced science-based participation. First Peer Consultation for Tier 1

assessments anticipated mid-2002

Participation Tremendous support from

chemical manufacturers 20 of 23 chemicals sponsored Over 35 sponsor companies 11 consortia (some sponsor

multiple chemicals)

Why is VCCEP Important to Your Work?

Complements HPV Challenge with detailed testing and assessment.

Ability to develop key exposure data.

Peer consultation may provide effective new way of working.

Information Access

For more information about HPV and VCCEP and its pilot (including past Federal Register Notices, HPV Test Plan Review information, VCCEP Peer Consultation information, guidance materials and other technical materials) see:

www.epa.gov/chemrtk

PerFluoroOctyl Sulfonates (PFOS) and Related Chemicals

PerFluoroOctyl Sulfonates; acids, salts, halides,etc.

Over 300 chemicals, including polymers.

Man-made: do not occur in nature. Produced since 1950’s for use in

surface treatment, paper protection, and performance chemical (surfactant and insecticide) products.

PFOS Concerns Persistent:

– Very stable chemical that does not break down or degrade in the environment; once it’s there, it stays

Bioaccumulative:– PFOS can build up over time; its half-life in

human blood may be from 1 to 4 years– Organisms higher-up in the food chain are

exposed to the full dose of what has built up in their food

PFOS Concerns Toxic:

- In repeat dose systemic and reproductive toxicity studies, serious effects seen»Post-natal deaths in rats at 3.2 and 1.6

mg/kg/day» In repeat-dose treated Rhesus monkeys,

death within 3 weeks at 10 mg/kg/day; within 7 weeks at 4.5 mg/kg/day. Adverse effects in cynomolgus monkeys at 0.75 mg/kg/day

PFOS Concerns

Exposure: Detected in blood not only in workers

handling the chemical, but in the general US population and in wildlife worldwide– High as 12.83 ppm in manufacturing workers– In pooled serum from general population, 30-40

ppb; small sample of children, mean 54 ppb– In birds, wild mammals, and fish, in ppb range

PFOS Withdrawal Strategy 3M Corporation conducted studies, shared

results with EPA, and discussed concerns. In May, 3M publicly announced voluntary

phase-out of perfluorooctanyl chemistries, most by end of 2000, others by end of 2002.

3M continues aggressive research program.

EPA followed up voluntary action with regulation.

PFOS Withdrawal Strategy EPA proposed and took public comment on a Significant New

Use Rule (SNUR) to manage 90 PFOS chemicals discontinued by 3M

Public meeting on March 27, 2001, raised clarification questions, more information provided from several industry sectors through October 2001

Follow-up actions published in the Federal Register Monday, March 11, 2002

Follow Up Actions Final SNUR 67 FR 11008

concerns 13 known discontinued PFOS chemicals making any new manufacture or importation a significant new use; and

Supplemental Proposed Rule 67 FR 11014 includes 75 additional chemicals, proposing to exclude from the definition of “significant new use” specifically defined, low volume, controlled exposure uses in:

semiconductor manufacture; aviation hydraulics; photography;

Related Chemistry Concerns

PFOA and related substitutes, such as fluorinated “telomers”, may present similar concerns:– Known persistence.– Evidence of toxicity data in public literature.– PFOA also found in human blood, although at lower

levels than PFOS

EPA working with industry to answer key questions and

develop comprehensive database – PFOA: similar bioaccumulative potential? fate and

transport?– similar widespread exposure? Toxicity? – Telomers: fate and transport? similar widespread

exposure? Toxicity? what degradates are formed from the telomers? What is the degradates bioaccumulation potential?

Ongoing EPA Actions PFOS:

– Complete action on proposed SNUR for 88 3M phaseout PFOS chemicals.

– Consider need/options for action on other 200-plus PFOS chemicals.

PFOA:– Preliminary hazard assessment released

March 2002– Assess new data as received.– Identify needs/options for action.

Ongoing EPA Actions Telomers:

– Begin EPA review of existing data.– Review submissions from voluntary

industry testing program in 2001-2002.

– Address existing, as yet unsubstantiated market claims that telomerization products are safer than fluorochemicals produced through other processes.

State, Tribal, and Local Challenges-

Why PFOS Issue is Important to You? Hazard assessment outcomes on fluorochemicals

may influence future discharge and permitting decisions at manufacturing plants and facilities.

Changes in fire fighting foam formulations over the next 10 years may affect municipal, tribal, and volunteer fire departments using synthetic foams (different foam types require different equipment).

Alternatives will be developed to meet the many other uses of PFOS: What is their safety and effectiveness?

For Further Information on PFAS Staff Technical Contact:

Mary F. Dominiak, 202-564-8104, dominiak.mary@epa.gov

For data CDs from PFOS/PFOA/telomer file (AR-226), or for copies of comments on SNUR (OPPTS-50639): TSCA NCIC, 202-260-7099, Monday-Friday, noon to 16:00 Eastern time; oppt.ncic@epa.gov