Status and Future Directions of the - US Environmental Protection ...
Status and Future Directions of the - US Environmental Protection ...
Status and Future Directions of the - US Environmental Protection ...
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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