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87<br />

CAS # 1990 Manufacturer<br />

STEPAN CHEMICAL COMPANY<br />

70084-98-9 UNION CAMP CORPORATION<br />

76<br />

1998<br />

Manu.<br />

2002<br />

Manu.<br />

<strong>Status</strong> <strong>and</strong> <strong>Future</strong> <strong>Directions</strong> <strong>of</strong> <strong>the</strong> HPV Challenge Program – Final Draft – 10/19/04<br />

Trade<br />

Association<br />

70693-50-4 CIBA-GEIGY CORPORATION TEXTILE PRODUCTS * * ACC, API<br />

70851-08-0 RHONE POULENC INCORPORATED<br />

71077-05-9 TEXACO CHEMICAL COMPANY ACC, API, SOCMA<br />

72162-28-8 GE PLASTICS * * API<br />

73665-18-6 KOPPER COMPANY INCORPORATED *<br />

83864-02-2 EI DUPONT DE NEMOURS & CO INC * ACC<br />

84501-86-0 WERNER G SMITH INC * *<br />

90640-80-5 KOPPER COMPANY INCORPORATED *<br />

90640-86-1 KOPPER COMPANY INCORPORATED * *<br />

119345-02-7 DOW CHEMICAL <strong>US</strong>A ACC, API, SOCMA<br />

125997-20-8 GREAT LAKES CHEMICAL CORPORATION - RESEA<br />

------------------------------------------------------------------------------------<br />

The The table table reveals reveals that for that <strong>the</strong> for 330 <strong>the</strong> orphan 330 orphan chemicals, chemicals, HPV <strong>the</strong>re Challenge are: 151 Program cases where Unsponsored a company Chemicals,”<br />

member from <strong>the</strong> ACC trade association could have sponsored a chemical; 83 cases where a<br />

<strong>the</strong>re company are: 151 cases member where from a company <strong>the</strong> API member trade association from could outlines have EPA’s sponsored initial thinking a chemical; for obtaining <strong>and</strong> 91hazard<br />

<strong>the</strong> ACC cases trade where association a company could member have sponsored from <strong>the</strong> a SOCMA screening-level trade association data for could <strong>the</strong> have 330 orphan sponsored chemicals a<br />

chemical (note that <strong>the</strong> API company list was not a complete list <strong>of</strong> members).<br />

chemical; 83 cases where a company member from <strong>and</strong> making <strong>the</strong> data publicly available in <strong>the</strong> HPV<br />

<strong>the</strong> API The trade figure association below, which could is have a flowchart sponsored on a <strong>the</strong> following Information page entitled System. “Preliminary (HPVIS is Strategy a data-searchable for<br />

Addressing HPV Challenge Program Unsponsored Chemicals,” outlines EPA’s initial thinking for<br />

chemical; obtaining <strong>and</strong> 91 hazard cases where screening-level a company data member for <strong>the</strong> from 330 orphan application chemicals for HPV <strong>and</strong> Challenge making Program <strong>the</strong> data data that<br />

<strong>the</strong> SOCMA publicly available trade association in <strong>the</strong> HPV could Information have sponsored System. is (HPVIS discussed is a later data-searchable in this report.) application EPA continues for to<br />

HPV Challenge Program data that is discussed later in this report.) EPA continues to recognize<br />

a chemical <strong>the</strong> HPV (note Challenge that <strong>the</strong> API Program company as a list dynamic was not <strong>and</strong> a fluid recognize program, <strong>the</strong> <strong>and</strong> HPV any Challenge strategy Program for addressing as a dynamic<br />

complete orphan list chemicals <strong>of</strong> members). must be flexible to accommodate <strong>and</strong> changing fluid program, Program <strong>and</strong> circumstances any strategy for <strong>and</strong> addressing EPA<br />

<strong>and</strong> stakeholder needs.<br />

orphan chemicals must be flexible to accommodate<br />

The figure below, which is a flowchart on <strong>the</strong> following<br />

page entitled “Preliminary Strategy for Addressing<br />

changing Program circumstances <strong>and</strong> EPA <strong>and</strong><br />

stakeholder needs.<br />

EPA’s High Production Volume Challenge Program<br />

Approximately 241 meet <strong>the</strong> HPV<br />

Challenge Program “No Longer<br />

HPV” criterion <strong>and</strong> will not be a<br />

direct focus <strong>of</strong> follow-up work<br />

under <strong>the</strong> HPV Challenge<br />

Program at this time.<br />

8.<br />

ITC-coordinated TSCA<br />

8(d) Unpublished<br />

Health <strong>and</strong> Safety Data<br />

Rule <strong>and</strong> TSCA 8(a)<br />

PAIR Rule to ga<strong>the</strong>r<br />

exposure data for<br />

future test rule findings.<br />

9.<br />

Are studies<br />

available/submitted to<br />

EPA adequate to meet<br />

SIDS endpoints?<br />

Yes<br />

<strong>Status</strong> <strong>and</strong> <strong>Future</strong> <strong>Directions</strong><br />

Preliminary Strategy for Addressing HPV<br />

Challenge Program Unsponsored Chemicals<br />

Make data publicly<br />

available in HPVIS.<br />

3.<br />

Yes<br />

Does <strong>the</strong><br />

chemical meet<br />

“No Longer HPV”<br />

criterion?<br />

5.<br />

Yes<br />

Can test<br />

rule exposure-based<br />

findings be made with<br />

currently available<br />

information<br />

No<br />

10.<br />

Can test rule<br />

exposure-based<br />

findings be made with<br />

PAIR <strong>and</strong>/or o<strong>the</strong>r<br />

currently available<br />

information?<br />

No<br />

Yes<br />

11.<br />

Propose <strong>and</strong> finalize Third HPV Test<br />

Rule for Chemicals for which findings<br />

can be made. Consider risk-based<br />

findings for chemicals where needed.<br />

571 Unsponsponsored<br />

Chemicals based on 1990 HPV<br />

Challenge Programming List<br />

No<br />

2. Yes<br />

Is chemical<br />

included in First<br />

HPV Test<br />

Rule?<br />

No<br />

No<br />

~330 orphan<br />

chemicals<br />

12.<br />

Seek o<strong>the</strong>r data<br />

development<br />

mechanism for<br />

chemicals with<br />

continuing hazard<br />

<strong>and</strong> fate data gaps.<br />

1.<br />

EPA <strong>and</strong> o<strong>the</strong>rs may engage<br />

in activities to secure<br />

additional HPV sponsors.<br />

4.<br />

Finalize <strong>the</strong> First HPV Test<br />

Rule. Identify SIDS endpoint<br />

studies not addressed in <strong>the</strong><br />

First HPV Test Rule.<br />

6.<br />

Yes<br />

Are <strong>the</strong>re any<br />

publicity available<br />

studies that are adequate<br />

to fulfill HPV Challenge<br />

Program needs?<br />

No<br />

7.<br />

Propose <strong>and</strong> finalize<br />

Second HPV Test Rule<br />

addressing inadequate<br />

studies for specific<br />

endpoints. Also include<br />

in this test ruls studies<br />

that address endpoints<br />

left uncovered in <strong>the</strong><br />

First HPV Test Rule for<br />

which <strong>the</strong>re are<br />

inadquate studies.<br />

88

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