6. REGULATION
          6.1. United States
              6.1.2. EPA
 6.1.2.1. HPV Data

Chemicals that are manufactured or imported into the US at levels of 1 million pounds or more annually are known as High Production Volume (HPV) chemicals. There were around 3000 substances that met the criteria for HPV chemicals in 1990. These were assessed for toxicity data in six basic areas. Of these materials 43% have no basic toxicity data available. Only 7% have a full set of basic data. [i]

The 1990, 1994, and 1998 HPV lists were cross-referenced with a list of fragrance chemicals. Using the EPA's Master Summary for the Chemical Hazard Data Availability, the availability of basic toxicity data in six basic toxicity areas chemicals was assessed. Four hundred seven chemicals were found.

Areas of Assessment of Chemical Hazard Data

  • Acute toxicity - immediate toxic effects

  • Chronic toxicity - long term toxic effects

  • Teratogenicity or developmental and reproductive toxicity - impact on reproduction and/or developing fetus

  • Mutagenicity - does it cause direct damage to DNA in cells

  • Ecotoxicity - is it toxic to the environment

  • Environmental fate - is it broken down or does it accumulate in the environment

Data was only available for the 351 chemicals that are on the 1990 HPV list. Of these 351 chemicals, 63 are a part of an effort the EPA is involved in to develop basic toxicity data on materials that are internationally HPV.

Less than 18% of the materials have all the sets of basic toxicity data and more than 10% have none. Over 45% are missing three or more sets of data. Less than 23% have been assessed for chronic toxicity and reproductive data is missing on over half of the materials. About 50% of these materials have potential for high exposure in consumer products.

Tables 1 and 2 summarize the findings.

 Table 1: Summary of available data for HPV flavor/fragrance materials

Total number of areas data are available

 

 

          6 of six

62

17.6%

          5 of six

70

19.9%

          4 of six

59

16.8%

          3 of six

49

13.9%

          2 of six

48

13.6%

         1 of six

27

7.7%

         0 of six

36

10.2%

 

Table 2: Specific areas data are available for HPV flavor/fragrance chemicals

Acute

300

85.4%

Chronic

79

22.5%

Reproductive

166

47.2%

Mutagen

222

63.2%

Eco

221

62.9%

Fate

230

65.5%

 

The EPA has asked industry to provide toxicity data in the six basic areas. The fragrance industry has volunteered to provide toxicity data on 66 materials.  This indicates either primary usage or high volume usage in fragrance or flavors. Fifty-four of these materials are on the 1990 HPV list and have been assessed for available data. The available data on HPV flavors/fragrance materials which has been sponsored is summarized in the tables below.

Clearly there is less data publicly available on materials that are primarily used by the fragrance and flavors industries. Only 2 have available data in all six areas and a third has no data available. Over 72% are missing three or more sets of data. Only two materials have chronic toxicity data and over 70% are missing reproductive data. Tables 3 and 4 summarize the findings.

Table 3: Summary of available data for industry sponsored
 HPV flavor/fragrance materials

6 of six

2

3.7%

5 of six

3

5.5%

4 of six

10

18.5%

3 of six

8

14.8%

2 of six

10

18.5%

1 of six

3

5.5%

0 of six

18

33.3%

 

Table 4: Specific areas data are available for industry sponsored
HPV flavor/fragrance chemicals

Acute

36

68.5%

Chronic

2

3.7%

Reproductive

16

29.6%

Mutagen

23

42.6%

Eco

21

38.9%

Fate

20

37%