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DEFENSA DE "OCURRIDOS NATURALMENTE"
en los casos de la Proposición 65

Actualizado: mayo de 2024

The below is a brief submitted to a judge requesting to be informally briefed on the naturally occuring defense on a shellfish California Proposition 65 case.

Proposition 65 requires clear and reasonable warnings absent an exemption under Cal. Code of Regs. tit. 27 § 25249.10 (preemption, ≤12 months since listing of a chemical, no significant risk), or a determination that the listed chemical is naturally occurring, § 25501(a)(1), People ex rel. Brown v. Tri-Union Seafoods, LLC (2009) 171 Cal.App.4th 1549, 1556 [90 Cal.Rptr.3d 644].

Prop. 65 does not exempt a product when it is polluted by natural or synthetic toxins

Prop. 65 does not exempt any food or product, including water, when it is polluted by natural or synthetic substances. 

“Naturally occurring” = no known human activity

“Regs., tit. 27, § 25501, subd. (a).) A chemical is naturally occurring only to the extent it does not result from known human activity. (Id., subd. (a)(3).) Thus, where a food contains a chemical that is “in part naturally occurring and in part added as a result of known human activity,” only the portion attributable to human activity counts toward the exposure.” Tri-Union, at 1556.

Defendant’s burden to prove “naturally occurring” defense

To come within the “naturally occurring” rubric, a defendant must prove that the chemical “is a natural constituent of a food” or “is present in a food solely as a result of absorption or accumulation of the chemical which is naturally present in the environment in which the food is  raised, or grown, or obtained … .” § 25501, subd. (a)(1), Tri-Union, at 1556.

Distinguir el caso Tri-Union sobre el atún y el mercurio del caso sobre el plomo y el cadmio en los mariscos

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Al comparar las fuentes de contaminación que afectan a diferentes especies marinas, el caso de la contaminación por metilmercurio en el atún, Tri-Union , es muy diferente debido a una variedad de factores, incluido el hecho de que existe una distinción notable entre un pez grande, migratorio y de aguas profundas, como el atún, donde hay muy poco o nada de mercurio antropogénico en las profundidades del océano, y los mariscos sésiles (que permanecen fijos en un lugar).

La exposición de los mariscos a los contaminantes se limita a aguas específicas y poco profundas, por ejemplo, de la bahía de Chesapeake, el río Rappahannock, etc. Estas áreas se ven afectadas por fuentes puntuales identificables de contaminación, lo que facilita un rastreo más claro de las fuentes de contaminación.

Otros factores son que la producción de metilmercurio es principalmente resultado de la actividad microbiana en ambientes acuáticos donde las bacterias anaeróbicas convierten el mercurio inorgánico en metilmercurio, mientras que el plomo y el cadmio se producen industrialmente; el plomo y el cadmio tienen una gama de aplicaciones más amplia y un volumen de uso mucho mayor en comparación con el mercurio.

Una vez liberado, el mercurio puede transportarse a grandes distancias a través de la atmósfera antes de depositarse en los océanos; las emisiones de metilmercurio emanan de fuentes no puntuales (NPS) frente a fuentes puntuales en el caso del plomo y el cadmio; los peces grandes atraviesan entornos oceánicos vastos y variados como depredadores superiores; esta amplia distribución y su posición en la cadena alimentaria hacen que sea un desafío identificar las fuentes exactas de contaminación por mercurio, etc.

Compare el caso del atún Tri-Union con el caso de los mariscos

01

Productos químicos, Grupo IARC

Tri-Union tuna fish case is based on one chemical, methylmercury, which is an IARC Group 2B possible carcinogen, also recognized for developmental toxicity [28][29].

 

Mercury and inorganic mercury are not classifiable as to their carcinogenicity to humans (Group 3).


Methylmercury production is primarily a result of microbial activity in aquatic environments where anaerobic bacteria convert inorganic mercury into methylmercury. This process occurs naturally and may be enhanced by anthropogenic mercury emissions [33].

​​

02

No se discutió ninguna sinergia

The case did not offer any consideration of synergetic effect from the presense of other chemicals. 

03

Escala industrial del mercurio

La producción mundial de mercurio se estimó en tan solo 1200 toneladas métricas en 2023 [23]. Nuevamente, se trata de la cantidad de mercurio, no de metilmercurio, que es más difícil de estimar, tras su conversión en el medio ambiente.

04

Emisión de mercurio

Experts testified that since the industrial revolution, atmospheric mercury has increased by a factor of three (Tuna Companies), or within a spread of two to four (State). Tri-Union, at 1563.

05

Aumento antropogénico del mercurio

Court accepted the Tuna Companies' experts conclusion that there has been no increase in the amount of methylmercury in ocean fish over the past 100 years. Tri-Union, at 1562.

06

Tres estudios probaron la contribución antropogénica del mercurio

Every study (3 of them) that had tested whether methylmercury in tuna has anthropogenic contribution had concluded it was naturally occurring: a change is not expected in methylmercury levels in the deep ocean because there is very little anthropogenic mercury in the deep ocean. Fitzgerald, 23 Tr. 2853:2-7; Morel, 25 Tr. 3181:22. Tri-Union, at 1388.

07

El promedio era aceptable hace 20 años

The case was filed in 2004, and considered averaging.

08

Estudios de peces del museo

Museum Fish Studies: three studies existed prior to the case and compared methylmercury concentrations in museum fish caught prior to the industrial age with modern fish samples;  demonstrated that methylmercury concentration in ocean fish has not increased over time, notwithstanding increased contributions of mercury into the atmosphere due to manmade pollution. One study of museum and modern fish analyzed a fish that lives 2,000 to 3,000 meters deep in the ocean and has high levels of methylmercury. Anthropogenic pollution would not be expected at such depths because very little of the mercury deposited from the atmosphere into the oceans settles to the deep ocean. Tri-Union, at 1564.

09

Contaminación del NPS por mercurio

Methylmercury emissions emanate from nonpoint sources (NPS). [1][6][17]. NPS pollution refers to diffuse contamination or pollution of water or air that does not originate from a single discrete source. Tuna, being a top predator, accumulates higher levels of methylmercury due to bioaccumulation [1][6]. This also makes it improbable to identify the source.

10

Mercurio viaja largas distancias

Once released, mercury can be transported over long distances through the atmosphere before being deposited in oceans and other water bodies. [1][6]

01

Productos químicos, Grupo IARC

Los casos de mariscos generalmente involucran dos sustancias químicas tóxicas producidas industrialmente, ninguna de las cuales surge naturalmente a partir de la actividad microbiana en ambientes acuáticos, como ocurre con el metilmercurio:

El cadmio (Cd) es un carcinógeno del Grupo 1 según la IARC (1993), la OEHHA (2005) y la EPA de EE. UU. (2005), dos niveles más peligroso que el metilmercurio. El cadmio también es un conocido tóxico para la reproducción y el desarrollo. Afecta la salud reproductiva masculina y femenina, perjudicando la espermatogénesis, la calidad del semen y el equilibrio hormonal. La exposición al cadmio es especialmente perjudicial para las mujeres embarazadas y puede provocar resultados adversos en el embarazo y problemas de desarrollo en la descendencia .

El plomo (Pb) es un probable carcinógeno clasificado como Grupo 2A por el IARC [29] y se sabe que causa toxicidad reproductiva y del desarrollo. Se ha documentado ampliamente que perjudica la fertilidad, reduce la calidad del esperma y afecta tanto al sistema reproductivo masculino como al femenino. La exposición al plomo se asocia con abortos espontáneos, muerte fetal intrauterina y trastornos del desarrollo infantil 6 8 .

02

Efecto sinérgico significativo del Pb y el Cd

Cd and Pb synergy. Studies “suggest that exposure to Cd and Pb mixtures produces more pronounced effects compared to the response observed after exposure to single metal solutions” [31]. The combination of cadmium and lead is more toxic to the kidneys than either heavy metal alone or in combination with methylmercury [32].

03

Escala industrial de plomo y cadmio

In 2023, approximately 4.5 million metric tons of lead was produced [24]. Lead historically had a broader range of applications and a higher total volume of use compared to mercury, particularly due to its use in gasoline, paints, pipes, batteries, plumbing systems, which resulted in widespread environmental contamination [20].

Production of cadmium was estimated to be around 22,600 metric tons in 2023 [25]. Cadmium is present in fossil fuel combustion, phosphate fertilizers, chemicals, petroleum, iron, steel, textile, leather and cement production, mining, roofs, plastic waste, rechargeable nickel-cadmium batteries, PVC (plastic) products, non-ferrous metal smelters, in the electronic waste, as well as in pigments, coatings, etc. [22].

04

Emisiones de plomo y cadmio

According to the NCBI report, the sum of industrial lead emissions is approximately 700 times the sum of natural emissions into the atmosphere [26]. “230-fold increase in lead deposition rates in Greenland ice cores over the last 3,000 years, from 0.03 ng/cm2 per year in prehistoric ice cores (800 BC) to about 7 ng/cm2 per year in contemporary ice cores… Comparable increases in the Northern Hemisphere have since been documented in pond and lake sediments, the oceans, pelagic sediments” [30].

05

Aumento antropogénico del plomo

Studies “have shown the pandemic scale of lead contamination… Lead concentrations in the atmosphere are now 100 times natural concentrations,.. in remote surface waters of the North Pacific and the North Atlantic are at least 10 times natural concentrations,.. in terrestrial organisms are 100 times natural concentrations” [27].

06

Un gran número de estudios confirman las fuentes antropogénicas

No such studies are found for lead and cadmium in shellfish, but a body of the opposite studies, and for a reason: the cultivation of shellfish occurs in coastal and estuarine environments where the waters are shallow. Shellfish, which are filter feeders, accumulate toxins from sediments and the surrounding water [3][4][5].

 

“Estuarine and coastal marine environments are affected by a wide range of pollutants owing to increased anthropogenic activity from a burgeoning population in the coastal zone.” [19]. “There are many well-documented cases of destruction of productive oyster bottoms by human activities.” [18]. The issue of lead and cadmium contamination in shellfish is a recognized public health concern which is widely known; many companies properly place both on-label and online warnings for consumers, for decades now, regarding the risks associated with consuming shellfish. Despite progress in reducing lead exposure in U.S. communities, elevated blood lead levels remain an issue for children [21]

07

Las regulaciones posteriores a Beechnut prohíben promediar los teratógenos

20 years of added science since the Tri-Union suggests no averaging for teratogens is appropriate. In addition, the levels of contamination involved in shellfish cases, amount to dangers of immediate health consequences, especially for developing fetuses, from a single exposure.

08

Estudios precolombinos

We were unable to find such “museum” peer-reviewed studies for lead and cadmium in shellfish, while the scientific evidence of anthropogenic pollution by lead and cadmium is unsurmountable, see for instance: “Studies incorporating rigorous trace-metal analysis have shown that the natural background lead concentration of North American Indians in pre-Columbian times was 0.3 mg per 70-kg adult [citations]. The body of an average North American urban adult contains 100–1,000 times as much lead.” [27].

09

Contaminación por plomo y cadmio en PS

Lead and cadmium contamination in shellfish is associated with point source pollution, which can be traced back to specific, identifiable sources [3][4][5].

10

El plomo y el cadmio se depositan localmente

Lead and cadmium can enter aquatic environments through direct and identifiable discharges from industrial processes, mining operations, wastewater treatment plants, rooftops, traffic, fuel combustion, power plants. [3][4][5]

Citations

[1] https://ipen.org/sites/default/files/documents/BRI-IPEN-report-update-102214%20for%20web_0.pdf

[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7661403/

[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10196716/

[4] https://oap.ospar.org/en/ospar-assessments/intermediate-assessment-2017/pressures-human-activities/contaminants/metals-fish-shellfish/

[5] https://oap.ospar.org/en/ospar-assessments/quality-status-reports/qsr-2023/indicator-assessments/heavy-metals-biota-sediment/

[6] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7731724/

[7] https://www.epa.gov/salish-sea/toxics-food-web

[8] https://www.epa.gov/system/files/documents/2023-10/tasc-r9-1.0.14-carson-river-mercury-booklet_07-25-2023-final-508.pdf

[9] https://pubs.acs.org/doi/10.1021/es305071v

[10] https://www.mdpi.com/2304-8158/12/16/3094

[11] https://www.nrdc.org/stories/water-pollution-everything-you-need-know

[12] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10258679/

[13] https://quizlet.com/889918142/apes-unit-8-mcq-flash-cards/

[14] https://www.sciencedirect.com/science/article/abs/pii/S026974912100107X

[15] https://www.sciencedirect.com/science/article/pii/S004896972204164X

[16] https://quizlet.com/677899252/apes-module-7-water-and-land-pollution-flash-cards/

[17] https://www.epa.gov/nps/basic-information-about-nonpoint-source-nps-pollution

[18] http://sarasota.wateratlas.usf.edu/upload/documents/Chapter-18-Environmental-Factors-Affecting-Oyster-Populations.pdf

[19] https://www.jstor.org/stable/25735588

[20] https://www.epa.gov/archive/epa/aboutepa/lead-poisoning-historical-perspective.html 

[21] https://pubmed.ncbi.nlm.nih.gov/34570188/ 

[22] ​https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7312803/ 

[23] chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.epa.gov/system/files/documents/2023-12/2023-mercury-inventory-report_final.pdf 

[24] https://www.statista.com/statistics/264871/production-of-lead-worldwide/ 

[25] https://pubs.usgs.gov/periodicals/mcs2024/mcs2024-cadmium.pdf 

[26] https://www.ncbi.nlm.nih.gov/books/NBK236466/

[27] https://www.ncbi.nlm.nih.gov/books/NBK236466/ 

[28] ​https://www.atsdr.cdc.gov/toxprofiles/tp46-c7.pdf 

[29] https://monographs.iarc.who.int/list-of-classifications/ 

[30] Chemical Contaminations in the Chesapeake Bay Sea Grant Maryland National Oceanic Atmospheric 

[31] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6351928/

[32] https://pubmed.ncbi.nlm.nih.gov/31420836/ 

[33] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8745031/ 

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