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BEYOND A POINT OF PROTECTION

Updated: Jul 9, 2020

Through the passage of Proposition 65[i], the people of the State of California demanded to be warned prior to exposure to carcinogens or reproductive and developmental toxins. Proposition 65 protects consumers by requiring a warning prior to contact with elevated levels of some such toxins in consumer products, providing citizens of California with a point of protection. The impact of Proposition goes beyond consumer protection by incidentally reducing workers exposure to listed chemicals during the manufacturing process and environmental pollution from listed chemicals, such as, phthalates that end up in the waste stream.


Proposition 65 achieves these incidental public benefits because, instead of providing consumer warnings, manufacturers often choose to reformulate to reduce listed chemicals in consumer products to amounts below the No Significant Risk Levels (NSRLs) and Maximum Allowable Dose Levels (MADLs).The Office of Environment and Health Hazard Assessment (OEHHA) of the Environmental Protection Agency of the State of California lists chemicals known to the state to cause cancer and reproductive and developmental harm. OEHHA established NSRL and MADL levels for many of these listed chemicals.


In particular, OEHHA listed six phthalate chemicals used as plasticizers to soften polyvinyl chloride (PVC) as reproductive toxins, developmental toxins or carcinogens.These are DEHP (di(2-ethylhexyl)phthalate), BBP[ii] (butyl benzyl phthalate),[iii] DBP (di-n-butyl phthalate),[iv] DnHP (di-n-hexyl phthalate),[v] DIDP (di-isodecyl phthalate),[vi]and DINP (diisononyl phthalate).[vii] Through enforcement of Proposition 65, many manufacturers of consumer products containing vinyl have adopted reformulation standards for these listed phthalate chemicals that mirror levels at which phthalates are ban in children’s products by federal and state laws, i.e., 1,000 parts per million or 0.1 % phthalate content.


Since phthalates are not covalently bound to polymer chains, their molecules, embedded between the polymer chain molecules, evaporate into airborne particles, settle into dust or leach out, easily escaping into air, soil and water.[viii] The occupational and environmental impact of reducing phthalate chemicals in products is well documented.


Removing phthalates from the manufacturing process protects factory workers from exposure while making, assembling and packaging products. Employment in the PVC fabrication industry may be associated with both obstructive and restrictive ventilatory effects leading to a potential toxicological effect of vinyl and PVC[ix]. Manufacturing vinyl by softening PVC with listed phthalate chemicals to make the PVC more flexible for use in consumer products puts factory workers at risk. Reformulating vinyl products to remove listed phthalate chemicals to comply with California’s Proposition 65 has the added public benefit of eliminating factory workers’ exposure domestically and abroad.


Reformulation eliminates phthalates from industrial waste. DEHP has been measured in, among other places, river and bay sediments in the USA[x], rivers and lake sediments in Europe[xi], sediment near direct discharge points from industry in Sweden and Malaysia[xii], and marine sediment near industrial discharges around coastal Taiwan, China[xiii]. DEHP tends to be absorbed into sediment, which serves as a phthalate sink[xiv]. Product reformulation to comply with California’s Proposition 65 reduces accumulation of listed phthalates in sediment from industrial discharge into bodies of water.


The disposal of phthalate laden products delivers phthalates into our soil and water. The principal source of the listed phthalate chemical DEHP release on land is disposal of waste to landfills.[xv,xvi] Phthalates leach from consumer products made from PVC plasticized with phthalates and, when tossed into the trash, lace leachate from landfills.[xvii] When phthalates are removed, they are not present in consumer products to leach into soil and groundwater through leachate from landfills after disposal.


Phthalates, as plasticizers, have been contained in plastics at high percentages. About one third of all plastic waste ends up in soils or freshwater. Most of this plastic disintegrates into particles smaller than five millimeters, known as microplastics, and these break down further into nanoparticles (less than 0.1 micrometer in size).[xviii] As the plastic disintegrates, phthalates, highly susceptible to leaching since they fail to covalently bind to the polymer matrix, are released into the environment.


Not only does Proposition 65 protect consumers, the statute creates secondary occupational and environmental benefits. The ability to comply with Proposition 65 by manufacturing products without listed chemicals, obviating the need for consumer warnings, incentivizes the consumer product manufacturing industry to make products without using listed chemicals. Eliminating listed chemicals from products means that the toxic chemicals are neither manufactured nor introduced in the manufacturing process. This eliminates toxins from the air workers breathe and the effluent discharged into rivers and coastal waters from industrial waste. Toxic chemicals do not then leach from products after consumers discard them whether they end up in a landfill or a body of water. Product reformulation, instead of providing consumer warnings at the point of contact with listed chemicals in consumer products, has a greater impact by removing listed chemicals, such as phthalates, from the manufacturing cradle to the grave of product disposal.


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[i] Proposition 65 is codified at California Health & Safety Code § 25249.5, et seq.

[ii] Listed by OEHHA as a carcinogen on January 1, 1988, and as a developmental toxin and male reproductive toxin on October 24, 2003

[iii] Listed by OEHHA as a developmental toxin on December 2, 2005.

[iv] Listed by OEHHA as a developmental toxin and female and male reproductive toxin on December 2, 2005.

[v] Listed by OEHHA as a female and male reproductive toxin on (December 2, 2005.

[vi] Listed by OEHHA as a developmental toxin on April 20, 2007.

[vii] Listed by OEHHA as a carcinogen on December 20, 2013.

[viii] Int J Environ Res Public Health. 2014 Jun; 11(6): 5628–5639.

[ix] Id.

[x] IARC Working Group on the Evaluation of Carcinogenetic Risks to Humans (2000: Lyon, France), citing: Peterson, J.C. & Freeman, D.H. (1982) Phthalate ester concentration variations in dated sediment cores from the Chesapeake Bay. Environ. Sci. Technol., 16, 464–469; Ray, L.E., Murray, H.E. & Giam, C.S. (1983) Analysis of water and sediment from the Nueces Estuary/ Corpus Christi Bay (Texas) for selected organic pollutants, Chemosphere, 12, 1039–1045; Hollyfield, S. & Sharma, V.K. (1995) Organic contaminants and characteristics of sediments from Oso Bay, South Texas, USA. Environ. Geol., 25, 137–140.

[xi] Id., citing: Schwartz, H.E., Anzion, C.J.M., Van Vliet, H.P.M., Copius-Peereboom, J.W. & Brinkman, U.A.T. (1979) Analysis of phthalate in sediment from Dutch rivers by high performance liquid chromatography. Int. J. environ. Anal. Chem., 6, 133-134; Giam, C.S. & Atlas, E., Chan, H.S. & Neff, G.S. (1980) Phthalate esters, PCB and DDT residues in the Gulf of Mexico atmosphere. Atmos. Environ., 14, 65-69; Preston, M.R. & Al-Omran, L.A. (1989) Phthalate ester speciation in estuarine water, suspended particulates and sediments. Environ. Pollut., 62, 183-193; Ritsema, R., Cofino, W.P., Frintrop, P.C.M & Brinkman, U.A.T. (1989) Trace-level analysis of phthalate esters in surface water and suspended particulate matter by means of capillary gas chromatography with electron-capture and mass-selective detection. Chemosphere, 18, 2161-2175.

[xii] IARC, supra, citing: Turén, 1986; Tan, G.H. (1995) Residue levels of phthalate esters in water and sediment samples from the Klang River Basin. Bull. Environ. Contam. Toxicol., 54, 171-176.

[xiii] IARC, supra, citing: Jeng, W.-L. (1986) Phthalate esters in marine sediment around Taiwan. Acta oceangr. Tawain, 17, 61-68.

[xiv] IARC, supra, citing: WHO, 1992.

[xv] Agency for Toxic Substances and Disease Registry (ATSDR) Public Health Statement Di(2-ethylhexyl)phthalate (DEHP) CAS#: 117-81-7 (2002).

[xvi] IARC, supra, citing: Swedish Environmental Protection Agency (1996) Disposal of PVC Waste. Report on a Government Assignment (no. 4594), Stockholm; Bauer, M.J. & Herrmann, R. (1997) Estimation of the environmental contamination by phthalic acid esters leaching from household wastes. Sci. total Environ., 208, 49-57.

[xvii] IARC, supra, citing: Ghassemi, M., Quinlivan, S. & Bachmaier, J. (1984) Characterization of leachates from hazardous waste landfills. J. environ. Sci. Health, A19, 579-620.

[xviii] UN environment programme (03 Apr 2018) Plastic Planet: How tiny plastic particles are polluting our soil.



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