BPA CONTROVERSY

BPA (Bisphenol A)

-is an important industrial chemical compound used to

make polycarbonate plastic and certain type of epoxy resins.

- used in many products such as refillable beverage containers,

compact disks, some plastic eating utensils, and impact-resistant safety and sports equipment.

これ　は　 BPA 　です。

HISTORY ( 歴 史 )

1905 – synthesize by Thomas Zincke of University of Marburg, Germany.

1953 – Dr. Hermann Schnell of Bayer and Dr. Dan Fox of GE independently develop manufacturing procedure on developing Polycarbonate using BPA as starting material.

…. 1958 – commercial production of such plastic

started in the USA.

1959 – commercial production started in Europe

1963 – declared as a GRAS by the FDA

Has been extensively studied for the past 50 years.

How do we get exposed…?

Diet Almost 93% of the 2517 Americans tested are

exposed to it. Children have the highest level followed by

teens and then adult.

Environmental About 6 billion pounds of BPA products are

produced each year, 2 hundred thousand pounds of the chemical is released into the atmosphere

Dietary Intake for BPA

0.05mg/kg BW.D

…Safe or Dangerous or

Safe?

WHY is it controversial?!

Health Concerns Carcinogenicity

Alleged to cause prostate, breast and uterus cancer

Reproductive and Developmental Toxicity Autism, ADHD, early puberty, heart ailments and

obesity, neurobehavioral problems Low-Dose Hypothesis

The experimental design used to proved its safety.

THE PRO SIDE : BPA is SAFE!

1) BPA is not carcinogenic and does not selectively affect reproduction

or development. The No-Observed-Adverse- Effect-Level (NOAEL) for

BPA,confirmed in multiple laboratory animal tests, is 50 mg/kg

body weight/day;

2) The estimated dietary intake of BPA from polycarbonate plastic

and epoxy resin food contact applications, based on the results of multiple migration studies with

consistent results, is less than 0.000118 mg/kg body weight/day;

and

3) This potential human exposure to BPA is more than 400 times lower than the maximum acceptable or “reference”

dose for BPA of 0.05 mg/kg body weight/day established by the U.S. Environmental Protection Agency, which is derived from the NOAEL.

1st Round!

PRO Cagen, et al. (1999) and Ashby, et. al (1999)

- Both study resulted in a No-Observed-adverse-effect level which disclaimed the Low-Dose Hypothesis

Low Dose Hypothesis

a hypothesis that has been advanced claiming that exposure to

extremely low doses of certain substances could cause adverse

health effects in humans.

(series of experiments in 1997 and 1998)

But according to U.S. NTP….

“There is credible evidence that low doses of BPA can cause effects on specific endpoints. However, due to the inability of other credible studies in several different laboratories to observe low dose effects of BPA, and the consistency of these negative studies, the Subpanel is not

persuaded that a low dose effect of BPA has been conclusively established as a general or reproducible finding. In addition, for those studies in which low dose effects have been observed, the mechanism(s) is uncertain (i.e., hormone related or otherwise) and the biological relevance is unclear.” (emphasis added)

…. In 1995, the Bisphenol A Toxicology Task Force of

the Society of the Plastics Industry, Inc. completed a comprehensive review of available data on BPA (BATTF, 1995) which is consistent with BPA (EU

RAR, 2002) stating that there is no evidence to say that low dosage of BPA can cause reproductive

and developmental problems.

Study by US NTP, 1982 and EU RAR, 2002 which studied cancer bioassays of rats that

were exposed with BPA for a lifetime suggested that there was no convincing

effects to say BPA’s carcinogenicity.

According to studies by different government agencies in Europe, USA, Japan and private sectors there is minimal leaching that occurs

in BPA products and it cannot exceed the dietary intake levels.

1. U.S. Food and Drug Administration (FDA) on baby bottles, water bottles and cut portions of baby bottles under “typical/normal use” conditions (Biles et al, 1997);

2. U.K. Ministry of Agriculture, Fisheries and Food (MAFF) on baby bottles subjected to 20-50 cycles of cleaning, sterilizing and simulated use (Mountfort et al, 1997; MAFF, 1997);

3. U.K. Department of Trade and Industry (DTI), Consumer Affairs Directorate on baby bottles handled under “realistic worst-case conditions of use” (Earls et al, 2000);

4. Japanese National Institute of Health Sciences (NIHS) on tableware and baby bottles under conditions representative of normal consumer use (Kawamura et al, 1998); and

5. Society of the Plastics Industry, Inc. (SPI) on polycarbonate discs under the most rigorous conditions recommended by FDA (Howe and Borodinsky, 1998).

However . . .

THE CON SIDEBPA effects in mice

and ratsHuman health trends

Prostate hyperplasia and cancer

Mammary hyperplasia and cancer

CancerProstate cancer

increaseBreast cancer increase

Abnormal urethra/obstruction

Sperm count decreaseEarly puberty in females

Ovarian cysts/uterine fibroids

Abnormal oocyte chromosomes

Male and female

reproductive system

HypospadiasSperm count decrease

Early sexual maturation

PCOS/uterine fibroidsMiscarriage

Body weight increaseInsulin resistance

Metabolic disease

Obesity increaseType 2 diabetes

Hyperactivity/impaired learning

Abnormal play behavior

Abnormal socio-sexual behavior

Brain and behavior

ADHDAutism

The question with the experiments: these publications did not acknowledge

source of funding (Cagen, et al. and Ashby, et al. 1999)

both of these industry-funded studies also failed to find any effects of the positive control estrogenic drug diethylstilbestrol (DES) as reported by Vom Saal, et al. (1998)

…. Failure of FDA to identify the faulty studies.

Dr. George Pauli’s statement in 1999, 2005 The use of CD-SD mice as subjects in studies

that resulted into a NOAEL. Use of questionable studies to say that BPA

is safe. (Tyl, et al. 2008 study) Inconsistency of the scientists Unreported contamination of specimens

In a review as of 2005, out of 115 studies investigating “low doses” of BPA in experiments conducted with laboratory animals, over 90% of government-funded studies conducted by academic and government scientists with no financial conflicts concerning BPA reported finding harm, while 100% of industry-funded studies reported no harm.

NTP STUDY 2008 vs. FDA 2008 draft risk assessment of BPA

FDA

Used in its draft which still insist that BPA safety are experiments conducted by Tyl, et. al (2002) and Tyl, et. Al (2008), which used GLP. 2002, use of CD-SD mouse 2008, inconsistent report of the scientists

about the age of the mouse used in the experiment.

Released on August 18, 2008 days after NTP released its own draft that involved a 2 year review of published studies concerning BPA by the Center for the Evaluation of Risk to Human Reproduction (CERHR)

NTP 2008

The NTP concluded that there was some concern for adverse effects of BPA on some

aspects of the reproductive system (in particularly the prostate) and development (in

particular neuro-behavioral development), with the primary threat occurring during early

life (NTP, 2008).

The fear Factor~!

North American Metal Packaging Alliance, Inc.

May 28, 2009, 10:00 a.m. - 3:10 p.m. EDTRE: BPA Joint Trade Association Meeting on Communications StrategyMeeting Goal: Develop potential communication/media strategies around BPA

PRO SIDE CON SIDESociety of Plastics Industry, Inc.Bisphenol A Group Sector of European Chemical Industry CouncilU.S. FDAJapan NIHSAmerican Chemist Council

University scientists like Dr. vom SaalCanadian GovernmentAlaska Community on ToxicsEnvironmental Working Group

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