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Notice of Intent to List Chemicals by the Labor Code Mechanism: Aloe Vera, Whole Leaf Extract and Goldenseal Root Powder

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) intends to list Aloe vera, whole leave extract and Goldenseal root powder as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 651). This action is being proposed pursuant to the “Labor Code” listing mechanism2. OEHHA has determined that these chemicals meet the criteria for listing by this mechanism.

Chemical

CAS No.

Endpoint

References

Aloe vera, whole leaf extracta

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Cancer

IARC (2015);
Grosse et al. (2013)

Goldenseal root powderb

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Cancer

IARC (2015);
Grosse et al. (2013)

aAloe vera, whole leaf extract, consists of the liquid portion of the Aloe vera leaf and is a natural consituent3 of the Aloe barbadensis Miller plant.

b Goldenseal root powder is a natural constituent4 of the goldenseal plant (Hydrastis canadensis)

Background on listing by the Labor Code mechanism: Health and Safety Code section 25249.8(a) incorporates California Labor Code section 6382(b)(1) into Proposition 65. The law requires that certain substances identified by the International Agency for Research on Cancer (IARC) be listed as known to cause cancer under Proposition 65. Labor Code section 6382(b)(1) refers to substances identified as human or animal carcinogens by IARC. As the lead agency for the implementation of Proposition 65, OEHHA evaluates whether a chemical’s listing is required by Proposition 65.

OEHHA’s determination: Aloe vera, whole leaf extract, and goldenseal root powder each meet the requirements for listing as known to the state to cause cancer for purposes of Proposition 65.

IARC has published on its website a list entitled “Agents classified by the IARC Monographs, Volumes 1-112" (IARC, 2015). IARC concludes that Aloe vera, whole leaf extract, and goldenseal root powder are each classified in Group 2B (the agent is “possibly carcinogenic to humans”), and that there is “sufficient evidence of carcinogenicity in experimental animals” for each (Grosse et al., 2013). Therefore both substances qualify for listing via Labor Code section 6382(b)(1).

An explanation of the carcinogenicity classifications used by IARC, and the Monographs development and peer review by the international working groups of scientific experts convened by IARC, may be found at the following URL: http://monographs.iarc.fr/ENG/Preamble/CurrentPreamble.pdf .

Identity of chemicals: Aloe vera, also known as Aloe barbadensis Miller, is one of approximately 420 species of Aloe plants. Other common names of Aloe vera are Barbados aloe, Mediterranean aloe, True aloe, and Curaçao aloe. Whole leaf extract of Aloe vera is commonly referred to as whole leaf Aloe vera juice or Aloe juice. Whole leaf extract of Aloe vera is the liquid portion of the Aloe vera leaf (e.g., what remains after removal of fibrous material, such as lignified plant fibers), and is a natural constituent of the Aloe barbadensis Millerplant. Aloe vera whole leaf extract is not the same as Aloe vera decolorized whole leaf extract, Aloe vera gel, Aloe vera gel extract, or Aloe vera latex, which would not be covered by this proposed listing.

Goldenseal is also known as Hydrastis Canadensis, orangeroot, Indian turmeric, and curcuma, but it should not be confused with turmeric (Curcuma longa Linn.). Goldenseal root powder is the powdered dried roots and underground stems of goldenseal plants. Goldenseal root powder is a natural constituent of the goldenseal plant.

Opportunity for comment: OEHHA is providing this opportunity to comment as to whether the chemicals identified above meet the requirements for listing as causing cancer specified in Health and Safety Code section 25249.8(a) and Labor Code section 6382(b)(1). Because these are ministerial listings, comments should be limited to whether IARC has identified the specific chemical or substance as a known or potential human or animal carcinogen. Under this listing mechanism, OEHHA cannot consider scientific arguments concerning the weight or quality of the evidence considered by IARC when it identified these chemicals and will not respond to such comments if they are submitted.

OEHHA must receive comments by 5:00 p.m. on Tuesday, May 26, 2015 June 9, 2015. We encourage you to submit comments in electronic form, rather than in paper form. Comments transmitted by e-mail should be addressed to P65Public.Comments@oehha.ca.gov, and should include “NOIL” and the chemical name in the subject line. Comments submitted in paper form may be mailed, faxed, or delivered in person to the address below.

Mailing Address: Ms. Esther Barajas-Ochoa
Office of Environmental Health Hazard Assessment
P.O. Box 4010, MS-19B
Sacramento, California 95812-4010

Fax: (916) 323-2265

Street Address: 1001 I Street
Sacramento, California 95814

Comments received during the public comment period will be posted on the OEHHA web site after the close of the comment period.

If you have any questions, please contact Esther Barajas-Ochoa at Esther.Barajas-ochoa@oehha.ca.gov or at (916) 445-6900.

Link to Public Comments

Wednesday, June 17, 2015

Downloads

Footnotes and References

Footnotes

1Health and Safety Code section 25249.5 et seq.

2Health and Safety Code section 25249.8(a).

3Title 27, Cal. Code of Regs., section 25501(a)(1)

4Title 27, Cal. Code of Regs., section 25501(a)(1)

 

References

Grosse Y, Loomis D, Lauby-Secretan B, El Ghissassi F, Bouvard V, Benbrahim-Tallaa L, Guha N, Baan R, Mattock H, Straif K, on behalf of the International Agency for Research on Cancer Monograph Working Group. (2013). Carcinogenicity of some drugs and herbal products. The Lancet Oncology. Published online July 5, 2013, doi: 10.1016/S1470-2045(13)70329-2.

International Agency for Research on Cancer (IARC, 2015). Agents Classified by the IARC Monographs, Volumes 1-112. Last update: March 23, 2015. [Accessed April 1, 2015].