Senate Bill S8211

                                 
BILL NUMBER: S8211

SPONSOR: SEPULVEDA
 
TITLE OF BILL:

An act to amend the agriculture and markets law, in relation to prohib-
iting certain food additives and food color additives, and providing for
a private right of action

 
PURPOSE:

To prohibit the manufacture, sale, delivery or distribution of food
additives, food color additives or any food or food product containing:
brominated vegetable oil, potassium bromate, propylparaben, red dye 3
and titanium oxide.

 
SUMMARY OF PROVISIONS:

Section One: The section heading of section 199-a of the agricultural
and markets law is amended and a new subdivision 5 is added: (a) bans
the use of brominated vegetable oil, potassium bromate, propylparaben,
red dye 3 and titanium oxide after January 1, 2025 as food additives or
              

food color additives or for use in any food or food product.

(b) within 90 days of the effective date of this subdivision the commis-
sioner of agriculture is directed to amend the exemption list to indi-
cate that the substances prohibited in this subdivision shall not be
deemed to be safe for human consumption. The Commissioner may bring an
action to enforce compliance under section 202(c) of the Agriculture and
Markets law and the recognition by the federal food and drug adminis-
tration of any of these substances as safe may not be alleged as a
defense.

(c) Provides for a private right of action to enforce compliance.

Section 2: Provides for an effective date.

 
EXISTING LAW:

Section 199-a of the agriculture and markets law

 
JUSTIFICATION:

The California Food Safety Act which was signed into law in 2023 banned
four of the five additives contained in this legislation.  Originally,
California Chapter 328 also banned titanium oxide but it was amended by
the California Senate.

The pharmaceutical industry noted many concerns regarding these addi-
tives in October 2023 and alerted the public through it's publication
Pharma News Intelligence:

 
"BROMINATED VEGETABLE OIL

According to the FDA, brominated vegetable oil is a type of vegetable
oil with bromine that prevents citrus flavoring from rising to the top
of some beverages. Brominated vegetable oil (BVO) may also be listed as
a specific type of oil, such as brominated soybean oil.

The Environmental Working Group (EWG) categorizes BVO as a higher
concern in food. According to an article by ThermoFisher, in 1958, the
FDA deemed BVO as "generally recognized as safe" (GRAS). Federal regu-
lations enforced by the FDA allow companies to include small amounts of
BVO in their products as long as they do not exceed 15 parts per million
(ppm). The FDA website notes that very few companies still use BVO in
their product formulations, with most companies - excluding some who use
it as a stabilizer for fruit flavoring in beverages - opting for an
alternative.

The Center for Food Safety in Hong Kong notes that BVO is not approved
as a food additive in the European Union, Australia, New Zealand, Main-
land China, Singapore, and Japan; however, certain levels are approved
in America and Canada.  The global bans are based on several studies
that have evaluated the safety of BVO and found that it can negatively
affect human health.  For example, a 1997 case study published in the
Journal of Toxicology:  Clinical Toxicology revealed that a patient who
consumed 2-4 liters of cola daily eventually presented with neurological
symptoms, including headache, fatigue, ataxia, and memory loss. The
patient also presented with right eyelid ptosis and continued deteri-
oration, causing immobility. Researchers conducted an in-depth evalu-
ation, noting serum bromide levels of 3180 mg/L, which caused them to
issue a diagnosis of severe bromism. Clinicians reported that hemodialy-
sis helped clear clinical symptoms and reduce serum bromide levels.

Although BVO is currently approved as a food additive under a particular
concentration, the FDA is working with the National Institutes of Envi-
ronmental Health Sciences (NIEHS), a subset of the National Institutes
of Health (NIH), to adjust their guidelines as recent evidence demon-
strated the potentially harmful effects of BVO.

The updated considerations will be based on a Food and Chemical
Toxic~lozv study, which showed that oral exposure to BVO increased the
tissue levels of bromine and detrimental thyroid effects.

The study evaluated the effects of consuming BVO through a 90-day
dietary exposure experiment on Sprague-Dawley rats at various rates,
including 0%, 0.002%, 0.02%, 0.1%, and 0.5% BVO by weight.

According to the research, a statistically significant increase in serum
bromine was detected in rats given the highest dose of BVO, regardless
of sex.  Additionally, the researchers found that male rats given the
highest two doses of BVO and females given the highest concentration had
an increased incidence of thyroid follicular cell hypertrophy.

Other impacts on the thyroid included an increased serum TSH level in
both genders receiving the highest dose and a decrease in T4 for high-
dose males.  An earlier rats fed 0%, 0.25%, 0.5%, 1.0%, and 2.0% BVO for
two weeks before mating determined that chronic exposure to BVO can have
behavioral and reproductive effects.

The study found that excessive consumption of BVO yielded significant
reproductive issues, with rats fed 2% being completely infertile.
Beyond infertility at the highest rate of BVO consumption, researchers
also noted that a 1.0% BVO diet caused difficulty reproducing and other
health concerns, including reduced maternal body weight and smaller
litter sizes.

Despite no evidence of offspring malformations, 1% BVO was linked to
higher postnatal mortality rates and behavioral impairments in surviving
offspring.

As the dose declined, the risk of postnatal death and behavioral impair-
ments declined; however, they were not eliminated.

Researchers in the study concluded, "A clear dose-response was observed
in di- and tetrabromostearic acid levels in the heart, liver, and ingui-
nal fat. These data expand upon previous observations in rats and pigs
that oral exposure to BVO is associated with increased tissue levels of
inorganic and organic bromine and that the thyroid is a potential target
organ of toxicity."

 
POTASSIUM BROMATE

The Michigan State University Center for Research on Ingredient Safety
notes that potassium bromate is often added to baked food to oxidize
dough quickly.

The chemical properties of this compound can enhance gelatinization in
starches, improve volume and structure in proteins, and form protein-fat
structures in lipids to improve quality. FDA regulations allow 0.0075
parts of potassium bromate for every 100 parts of flour for uncooked
products; however, fully baked products should only contain 20 parts per
billion (ppb) of the compound.

The New Jersey Department of Health and Senior Services notes that
potassium bromate should be handled like a carcinogen. It is a laborato-
ry agent, oxidizing agent, and food additive.

The acute health effects of potassium bromate exposure include irritated
or burning skin and eyes, coughing, wheezing, and shortness of breath.
Prolonged exposure to potassium bromate has been linked to kidney,
thyroid, and gastrointestinal cancer in animals, suggesting similar
effects on human health.

The compound has also been linked to neurological changes, including
headache, irritability, cognitive impairment, and personality changes.

Despite the potential risks, Michigan State maintains that, at low
levels, potassium bromate is safe and should not affect human health.
However, studies on rats have shown that high doses or increased expo-
sure to potassium bromate can cause DNA mutations, damage cells, and
cause cancer.

In Europe, potassium bromate is banned as a food additive. However, the
university notes that the differences between European and American
regulations are due to the fundamental strategies of the regulatory
organization.

European organizations function based on the precautionary principle.
These organizations ban and regularly use potentially toxic chemicals
based on the possibility that any health risks may occur. However, in
the US, the FDA uses risk assessments and evaluations from studies to
determine how to regulate products.

 
PROPYLPARABEN
An article in Current Environmental Health Reports explains that para-
bens are compounds that can be preservatives with antimicrobial and
antifungal properties that can extend the shelf-life of many foods.
Propylparaben (PP) is a common type of paraben that has been added to
personal care products, pharmaceuticals, cosmetics, and food.

Although multiple studies have linked paraben concentrations in urine to
endocrine system disruption, researchers at the Vale School of Public
Health published an article in September 2023 that noted no association
between the two.

According to Chemical Safety Facts, a website run by the American Chem-
istry Council, some studies have insinuated that parabens cause endoc-
rine disruption and increase cancer risk by mimicking estrogen.  Howev-
er, the site quickly notes that these studies on animal models have used
higher and prolonged exposures that are unlikely to occur naturally.

Public perception of propylparaben safety is clouded by the results of a
controversial 2004 study that connected parabens and breast cancer.
Philippa Darbre, professor emeritus in the School of Biological Sciences
at the University of Reading in Great Britain, who led the study, main-
tains that it did not make definitive conclusions on the link between
"It would be wonderful if a single chemical could be identified as a
sole problem and then replaced by something 'safe,' but this is unlikely
to happen," Darbre told the Washington Post. "What often happens now is
that one chemical with 'bad press' is replaced by a new chemical with
less data.

 
RED DYE 3

According to an article by the Center for Science in the Public Interest
(CSPI), Red Dye 3, also called Red 3, FD&C Red 3, and Red Dye No. 3, is
a type of food coloring commonly found in candies, cakes, and other
foods in the US.

Consumer Reports notes that Red 3 has been approved in the US as a food
additive since 1907. The compound, also known as erythrosine, is used in
various processed foods in the United States.

In an interview with Contemporary Pediatrics, Jamie Alan, PharmD, PhD,
and associate professor, Department of Pharmacology and Toxicology,
Michigan State University, discussed the potential health effects of Red
Dye No. 3.  Alan noted that some studies have associated increased
consumption of Red Dye 3 with exacerbated attention deficit hyperactivi-
ty disorder (ADHD) symptoms in kids.

However, Red Dye No. 3 is often consumed with other dyes and chemicals,
making determining what compound impacts symptoms difficult.

The Southern Vermont Medical Center notes that Red Dye No. 3 can be
occasionally consumed safely; however, consumers may consider reading
ingredient lists to minimize consumption. Beyond the inability to defin-
itively link Red Dye No. 3 to health outcomes, an article in the Inter-
national Journal of Occupational and Environmental Health notes that
other dyes, including Red 40, Yellow 5, and Yellow 6, have also been
linked to intentionally carcinogenic effects.


A 2022 review published in Environmental Health analyzed the potential
impacts of synthetic dyes on children and noted a need to reevaluate
advised dietary intake and sponsor additional research on the matter."

In view of these many concerns and uncertainties regarding these food
additives it is essential that the New York state legislature act to
protect the public health and safety and ban these additives from
products manufactured, sold, or distributed in New York.

 
LEGISLATIVE HISTORY:

New Bill

 
FISCAL IMPLICATIONS:

None

 
LOCAL FISCAL IMPLICATIONS:

None

 
EFFECTIVE DATE:
Immediately