Food Contact Material - BPA issues

 LinkedIn: E.C. is 27 countries and 1 market, whereas U.S.A. is 50 states and 1 country (1 market).
The French National Assembly has passed a bill that bans all food contact packaging containing Bisphenol A (BPA) from 2014. EFSA rejected the French bill.

The U.S. FDA agreed to rule on whether to ban BPA use in food and beverage packaging by March 31, 2012 in the District Court for the Southern district of New York (per Chicago Tribune December 7, 2011). Please take note that NRDC sued U.S. FDA in 2010 asking the court to require the agency to respond to 2008 NRDC filed a petition.

Questions:
- Do you think EFSA can ask the French National Assembly to nullify this bill?
- Do you think U.S. FDA can simply walk away ignoring this issue?
- What will happen if either one of them agrees to ban BPA use in food contact packaging



Randall Ehrsam, MA CHENG like this
23 comments • Jump to most recent comments

Follow Michael
Michael Watkins • In my view, FDA is comfortable with the safety of packaging using BPA based materials in contact with food and beverages. Proof of this is found on the FDA website:

“Studies employing standardized toxicity tests used globally for regulatory decision making thus far have supported the safety of current low levels of human exposure to BPA.”

“FDA is not recommending that families change the use of infant formula or foods, as the benefit of a stable source of good nutrition outweighs the potential risk from BPA exposure.”

The National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction, part of the National Institutes of Health, completed a review of BPA in September 2008. Included in this review was the plethora of non-standardized toxicity studies. They use five different terms to describe its level of concern about the different effects of chemicals: negligible concern, minimal concern, some concern, concern, and serious concern. They expressed “some concern for effects on the brain, behavior, and prostate gland in fetuses, infants, and children at current human expo­sures to bisphenol A and “minimal concern for effects on the mammary gland and an earlier age for puberty for females in fetuses, infants, and children at current human exposures to bisphenol A” and “negligible concern” for other outcomes. According to FDA:

“Overall, the current literature cannot yet be fully inter­preted for biological or experimental consis­tency or for relevance to human health. Part of the difficulty for evaluating consistency lies in reconciling findings of different studies that use different experimental designs and different specific behavioral tests to measure the same dimension of behavior.”

Under pressure by NTP, FDA agreed to do additional testing. This testing is underway, and to date, no results have been found to support changing the current FDA position.

FDA has announced it will make a final ruling by March 31, 2012, on whether bisphenol A (BPA) should be banned from use in packaging for food and drinks.

In my view, BPA will not be banned by FDA. However, in the unlikely event that it is, we can close down can plants and ramp up production in glass jar and bottle plants.
3 months ago• Like• Reply privately• Flag as inappropriate 1

Follow Nick (Wai-ho)
Nick (Wai-ho) Tang • Dear Michael

Please note that glass jar and bottle require a cap (metal or plastic). Metal cap (lug cap, PT cap or CT cap) requires coating of plate. Besides BPA, there are BADGE, BFDGE and NOGE to deal with too. On top of this complication, sealing compound has other critical areas to deal with too. They are all Food Contact Materials (In the U.S., it is named as Food Contact Substance).

We should not forget PET, PP.....containers with plastic cap. They are FCM or FCS. The 1935/2004/EC framework has complicated the issues vis-a-vis U.S. FDA GRAS.

Goosh...supplying and buying food packaging material used to be lot of fun. Not any more nowadays, food packaging people are to read and prepare a lot of documents and certification.
3 months ago• Like

Follow Michael
Michael Watkins • Closures for bottles and jars do not necessarily require epoxy coatings. So BPA, BADGE, etc. may be avoided by using jars and bottles. Of course, alternative materials used for closures can also cause chemicals to migrate into food or beverages, as well. Avoiding epoxy could simply trade one problem for another.

You bring up BADGE as well. I thought that the BADGE issue had been addressed several times. In 2004, the European Food Safety Authority (EFSA) reported that:

“…the Panel concluded that BADGE and its chlorohydrins (BADGE.2HCl, BADGE.HCl and BADGE.H2O.HCl) do not raise concern for carcinogenicity and genotoxicity in vivo, respectively.

On the basis of the available experimental data, a Tolerable Daily Intake (TDI) can be established for BADGE and its hydrolysis products. Considering the No-Observed-Adverse-Effect-Level (NOAEL) of 15 mg/kg b.w./day derived from the oral chronic toxicity/carcinogenicity study in the rat with BADGE, and applying an uncertainty factor of 100, a TDI of 0.15 mg/kg b.w. can be established for BADGE. As BADGE is rapidly and extensively metabolised in vivo into the corresponding mono- and bis-diol derivatives BADGE.H2O and BADGE.2H2O, the Panel includes these in the TDI.

For the BADGE chlorohydrins BADGE.2HCl, BADGE.HCl, BADGE.HCl.H2O, in view of the lack of genotoxicity in vivo, the Panel considers that the current restriction of 1 mg/kg of food remains appropriate.”

So I thought this issue had been resolved. Most current concern seems to be on BPA migrating into foods and beverages. I would be curious to know if you or others in this group see BADGE or BADGE derivatives (specifically alpha glycols and chlorohydrins) to be of significant concern anywhere now. Thanks.
3 months ago• Like1

Follow Pramod
Pramod Desai • Traditionally an epoxy phenolic lacquer topped with an organosol are used for lug cap interiors in order to provide chemical resistance to acidic pickles and to anchor the PVC plastisols. Each of the three - ep lacquer, organosol and plastisol or under cloud. Are there any established alternatives? I understand a non-PVC plastisol has been established but I do not know if it is in commercial use.
3 months ago• Like

Follow Nick (Wai-ho)
Nick (Wai-ho) Tang • Thank you for the detail information regarding BADGE matters relating to FCM. It is stated in Directive 1895/2005/EC. BFDGE and NOGE are banned while BADGE is still permissible to be used. This issue is resolved.

Coating of plates for lug cap manufacturing and can is very different. Depending on the pH
of the product packed in glass and the cap size used, the coating (FCM) varies from 1-coat system, 2-coats to as much as 3-coats. BADGE is still in used. BPA has not not the issue as almost all coating used do not carry BPA (as far as I know).

You Everybody should be concerned on OML 10 mg/dm2 of all FCM. All FCM manufacturers, particularly the FCM administrators, are required to track the EC directives on FCM/OML/SML matters and U.S. FDA announcement regarding FCS (Food Contact Substances) that relates to their FCM manufactures and continue to update and to follow the rules. We, the packaging veterans, should keep on highlighting the FCM matters to the new food processing and packaging in-comers, whether they are in the purchasing, manufacturing, sales and marketing – both buyer and seller side.

FCM is becoming part of the food when and after it is packed? Don’t you agree?
3 months ago• Like

Follow Nick (Wai-ho)
Nick (Wai-ho) Tang • Dear Pramod

Yes, there is. It is called "Pano Blue". It looks like a "ring-lined TPE" lug cap. Hope to see that it is "polyester" and the coating is also "polyester". Personally, I am glad that will come out in mass scale and will benfit the "Vacuum Packed in Glass" sector of food packaging and FCM.

I don't have enough information. Let us find together.
3 months ago• Like

Follow Pramod
Pramod Desai • Dear Wai-ho, Nick Tang thanks for the info. But are you referring to Pano caps which are distinct from Lug caps. Anyway, for low pH pickles, the base coat of an epoxy-phenolic lacquer will be a must. Or has a polyester replaced this EP family of lacquers for chemical resistance too? And what about pvc plastisols? Kindly advise.
3 months ago• Like

Follow Nick (Wai-ho)
Nick (Wai-ho) Tang • Pano makes lug caps too. Their latest award "Pano Blue" cap is a step version of lug cap possibly a 63 mm size. I don’t understand why blue colour. Believe this is polyester TPE on polyester coating (laminated). I have to find out. This is new and requires market experience.

Are you food packers packing mango chutney or are you supplying lug caps to food companies packing this product. This product, my experience, is very corrosive. If you are a lug cap producer, you may want to work with Hoba PPG and ask them for their 3-coat system. If you are WCEA India licensee , you know the spec already.

Please be careful when selecting plastisol - sealing compound:- ADC (Azodicarbonamide), Phthalate, 2-EHA, possibly ESBO (there is no concern yet).

Mango Chutney is an exporting item to Europe in millions of packages. Well, you and/or your customer may have to go through rounds of cap and package analysis by outside institute to certify non presence of the banned ingredients as well as passing the FCM (coating and plastisol) Overall Migration Limit test.
3 months ago• Like1

Follow Drs. Rogier
Drs. Rogier van Duin NPDP • Substitution of the epoxy-phenolic basecoat by a polyester based lacquer is possible nowadays. For this there are two obstacles, price of polyester is higher than epoxy and intercoat adhesion of the PVC organosol. We at Diostyl Coatings have several options.
3 months ago• Like2

Follow Nick (Wai-ho)
Nick (Wai-ho) Tang • Drs. Rogier

Are your options PVC? Almost most (or all) of the lug cap manufactrurers are into PVC, polyester system is not economical to change at the moment because of the economical scale of using. Personally, I don't see the immediate move from PVC into polyester. Nor it will within a near 2 years' time. It takesd longer than 2-3 years for the polyester system to gain market experience. This will allow PVC system to adjust and adopt into the complete complaince.

What is more important now is the OML for the FCM for lug cap (coating and plastisol "sealing compound") - 20 dm2/kg. Do you, at Diostyl Coatings, have these including plastisol "sealing compound"? Please let all the lug cap manufacturers in the world note your achievement. Orders willfly in quickly.
3 months ago• Like

Follow Nick (Wai-ho)
Nick (Wai-ho) Tang • There are, at least, two world renowned and reputable coating manufacturers that can supply BPA-free coating for food cans. Do it right the first time for this time and be the first one to take off while everybody is waiting EFSA or U.S. FDA decision.
1 month ago• Like

Follow Nick (Wai-ho)
Nick (Wai-ho) Tang • Forbes Magazine March 5 reported Campbell Soup is phasing out BPA and is using BPA alternatives for their soup cans. What does this mean? Do you think competitors will simply sit and wait? What do you think U.S. FDA will decide this month on BPA? What do you think EFSA will say?
1 month ago• Like

Follow Randy
Randy Ross • Our company supplies soup cans for a number of large packers of soup. Through a co pack agreement some of our cans are used with the Campbell’s products and we do engage them from time to time. Campbell’s will begin what I believe will be a 2 to 4 year transition in can coatings. While the industry has 40 years experience with epoxy liners, the new liners are still maturing. Some soup ingredients can be quite a challenge, that said, over time, and at additional expense the industry will move to Poly, Vinyl or Acrylic liners depending on the products packed. In the mean time Campbell’s will introduce a high end line of soups in pouches to pacify the non science panic mongers.
1 month ago• Like

Follow Drs. Rogier
Drs. Rogier van Duin NPDP • Why go for vinyl or acrylic if polyesters have the future? Acrylics might be associated with taste differences. And Vinyls coatings release hydrochloric acids. And if you want to go green, some raw materials for polyesters now are from renewable sources.
1 month ago• Like

Follow Randy
Randy Ross • I would agree that vinyls have their issues, but all the non epoxy's do. If you look, vinyl is being used in hot filled tomato's quite extensively. Poly's have issues with some of the input ingredents, so at the moment you will find all three being used.
1 month ago• Like

Follow John
John Greenwald • Any alternate coating (to epoxy) for food has to be carefully considered in regard to potential future concerns regarding all ingredients and by-products. BPA has been extensively tested and found safe to use by all major global regulatory agencies. Yet the drum beat for removal continues. I predict attention will soon shift to whatever new coating type becomes popular. There exists a considerable fear of chemicals in the general population.
1 month ago• Like

Follow Randy
Randy Ross • Mr. Greenwals speaks the truth. We may be jumping out of the frying pan, but into ?
1 month ago• Like

Follow Michael
Michael Watkins • Randy,
Twenty years ago, vinyls were "evil" with dioxin scares in Europe, etc. Coke and others had significant programs to remove vinyls from all beverage cans. Now we will see vinyls in food cans? I always thought vinyls were unjustly maligned - and I was not in the vinyl business. Will the industry now ignore the anti-vinyl propaganda of the 1990s? Thanks.
1 month ago• Like

Follow John
John Greenwald • Vinyl coatings did get a bad rap, largely due to the liver cancer in vinyl polymer plants caused by HUGE exposure to vinyl chloride monomer. That said, vinyls still have environmental issues due to high organic solvent content and HCl emissions. Epoxies can and largely have been converted to water-borne which benefits cost and environmental issues. Acrylics will have limited use due to high flavor issues with residual monomers and polyesters will degrade under common food processing and storage conditions.
1 month ago• Like

Follow Alan
Alan Randall • John's comments regarding vinyl, epoxy and acrylic technologies are right on target. It appears that in addition to being "green", any chemical products or chemical by-products identified, by any of the number of extraction requirements globally, will need to be considered. We may be simply moving from one "forest" of (extraction) peaks to a totally unknown forest of peaks. For each peak identified the standardized toxicity tests used globally for regulatory decision will need to be performed. Any carcinogenicity and genotoxicity or similar issue will need to be identified. This is in addition all of the flavor, pack test and other performance testing required to introduce a new coating to the market. The amount of time needed to bring a new coating to this market will increase substantially. Epoxy and vinyl technologies offer a lot of technical advantages and have been well studied. If the public fear of BPA containing materials does drive the industry to new technologies, based on the amount of environmental and performance testing required, what form will the future food or beverage container take?

LinkedIn discussion of FDA and EFSA positions and likely outcomes

Food Contact Material - BPA issues
E.C. is 27 countries and 1 market, whereas U.S.A. is 50 states and 1 country (1 market).
The French National Assembly has passed a bill that bans all food contact packaging containing Bisphenol A (BPA) from 2014. EFSA rejected the French bill.

The U.S. FDA agreed to rule on whether to ban BPA use in food and beverage packaging by March 31, 2012 in the District Court for the Southern district of New York (per Chicago Tribune December 7, 2011). Please take note that NRDC sued U.S. FDA in 2010 asking the court to require the agency to respond to 2008 NRDC filed a petition.

Questions:
- Do you think EFSA can ask the French National Assembly to nullify this bill?
- Do you think U.S. FDA can simply walk away ignoring this issue?
- What will happen if either one of them agrees to ban BPA use in food contact packaging .
2 months ago
Like CommentFollow Flag More
Randall Ehrsam likes this
11 comments

Follow Michael
Michael Watkins • In my view, FDA is comfortable with the safety of packaging using BPA based materials in contact with food and beverages. Proof of this is found on the FDA website:

“Studies employing standardized toxicity tests used globally for regulatory decision making thus far have supported the safety of current low levels of human exposure to BPA.”

“FDA is not recommending that families change the use of infant formula or foods, as the benefit of a stable source of good nutrition outweighs the potential risk from BPA exposure.”

The National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction, part of the National Institutes of Health, completed a review of BPA in September 2008. Included in this review was the plethora of non-standardized toxicity studies. They use five different terms to describe its level of concern about the different effects of chemicals: negligible concern, minimal concern, some concern, concern, and serious concern. They expressed “some concern for effects on the brain, behavior, and prostate gland in fetuses, infants, and children at current human expo­sures to bisphenol A and “minimal concern for effects on the mammary gland and an earlier age for puberty for females in fetuses, infants, and children at current human exposures to bisphenol A” and “negligible concern” for other outcomes. According to FDA:

“Overall, the current literature cannot yet be fully inter­preted for biological or experimental consis­tency or for relevance to human health. Part of the difficulty for evaluating consistency lies in reconciling findings of different studies that use different experimental designs and different specific behavioral tests to measure the same dimension of behavior.”

Under pressure by NTP, FDA agreed to do additional testing. This testing is underway, and to date, no results have been found to support changing the current FDA position.

FDA has announced it will make a final ruling by March 31, 2012, on whether bisphenol A (BPA) should be banned from use in packaging for food and drinks.

In my view, BPA will not be banned by FDA. However, in the unlikely event that it is, we can close down can plants and ramp up production in glass jar and bottle plants.
2 months ago• Like1

Follow Nick (Wai-ho)
Nick (Wai-ho) Tang • Dear Michael

Please note that glass jar and bottle require a cap (metal or plastic). Metal cap (lug cap, PT cap or CT cap) requires coating of plate. Besides BPA, there are BADGE, BFDGE and NOGE to deal with too. On top of this complication, sealing compound has other critical areas to deal with too. They are all Food Contact Materials (In the U.S., it is named as Food Contact Substance).

We should not forget PET, PP.....containers with plastic cap. They are FCM or FCS. The 1935/2004/EC framework has complicated the issues vis-a-vis U.S. FDA GRAS.

Goosh...supplying and buying food packaging material used to be lot of fun. Not any more nowadays, food packaging people are to read and prepare a lot of documents and certification.
2 months ago• Like

Follow Michael
Michael Watkins • Closures for bottles and jars do not necessarily require epoxy coatings. So BPA, BADGE, etc. may be avoided by using jars and bottles. Of course, alternative materials used for closures can also cause chemicals to migrate into food or beverages, as well. Avoiding epoxy could simply trade one problem for another.

You bring up BADGE as well. I thought that the BADGE issue had been addressed several times. In 2004, the European Food Safety Authority (EFSA) reported that:

“…the Panel concluded that BADGE and its chlorohydrins (BADGE.2HCl, BADGE.HCl and BADGE.H2O.HCl) do not raise concern for carcinogenicity and genotoxicity in vivo, respectively.

On the basis of the available experimental data, a Tolerable Daily Intake (TDI) can be established for BADGE and its hydrolysis products. Considering the No-Observed-Adverse-Effect-Level (NOAEL) of 15 mg/kg b.w./day derived from the oral chronic toxicity/carcinogenicity study in the rat with BADGE, and applying an uncertainty factor of 100, a TDI of 0.15 mg/kg b.w. can be established for BADGE. As BADGE is rapidly and extensively metabolised in vivo into the corresponding mono- and bis-diol derivatives BADGE.H2O and BADGE.2H2O, the Panel includes these in the TDI.

For the BADGE chlorohydrins BADGE.2HCl, BADGE.HCl, BADGE.HCl.H2O, in view of the lack of genotoxicity in vivo, the Panel considers that the current restriction of 1 mg/kg of food remains appropriate.”

So I thought this issue had been resolved. Most current concern seems to be on BPA migrating into foods and beverages. I would be curious to know if you or others in this group see BADGE or BADGE derivatives (specifically alpha glycols and chlorohydrins) to be of significant concern anywhere now. Thanks.
2 months ago• Like1

Follow Pramod
Pramod Desai • Traditionally an epoxy phenolic lacquer topped with an organosol are used for lug cap interiors in order to provide chemical resistance to acidic pickles and to anchor the PVC plastisols. Each of the three - ep lacquer, organosol and plastisol or under cloud. Are there any established alternatives? I understand a non-PVC plastisol has been established but I do not know if it is in commercial use.
2 months ago• Like

Follow Nick (Wai-ho)
Nick (Wai-ho) Tang • Thank you for the detail information regarding BADGE matters relating to FCM. It is stated in Directive 1895/2005/EC. BFDGE and NOGE are banned while BADGE is still permissible to be used. This issue is resolved.

Coating of plates for lug cap manufacturing and can is very different. Depending on the pH
of the product packed in glass and the cap size used, the coating (FCM) varies from 1-coat system, 2-coats to as much as 3-coats. BADGE is still in used. BPA has not not the issue as almost all coating used do not carry BPA (as far as I know).

You Everybody should be concerned on OML 10 mg/dm2 of all FCM. All FCM manufacturers, particularly the FCM administrators, are required to track the EC directives on FCM/OML/SML matters and U.S. FDA announcement regarding FCS (Food Contact Substances) that relates to their FCM manufactures and continue to update and to follow the rules. We, the packaging veterans, should keep on highlighting the FCM matters to the new food processing and packaging in-comers, whether they are in the purchasing, manufacturing, sales and marketing – both buyer and seller side.

FCM is becoming part of the food when and after it is packed? Don’t you agree?
1 month ago• Like

Follow Nick (Wai-ho)
Nick (Wai-ho) Tang • Dear Pramod

Yes, there is. It is called "Pano Blue". It looks like a "ring-lined TPE" lug cap. Hope to see that it is "polyester" and the coating is also "polyester". Personally, I am glad that will come out in mass scale and will benfit the "Vacuum Packed in Glass" sector of food packaging and FCM.

I don't have enough information. Let us find together.
1 month ago• Like

Follow Pramod
Pramod Desai • Dear Wai-ho, Nick Tang thanks for the info. But are you referring to Pano caps which are distinct from Lug caps. Anyway, for low pH pickles, the base coat of an epoxy-phenolic lacquer will be a must. Or has a polyester replaced this EP family of lacquers for chemical resistance too? And what about pvc plastisols? Kindly advise.
1 month ago• Like

Follow Nick (Wai-ho)
Nick (Wai-ho) Tang • Pano makes lug caps too. Their latest award "Pano Blue" cap is a step version of lug cap possibly a 63 mm size. I don’t understand why blue colour. Believe this is polyester TPE on polyester coating (laminated). I have to find out. This is new and requires market experience.

Are you food packers packing mango chutney or are you supplying lug caps to food companies packing this product. This product, my experience, is very corrosive. If you are a lug cap producer, you may want to work with Hoba PPG and ask them for their 3-coat system. If you are WCEA India licensee , you know the spec already.

Please be careful when selecting plastisol - sealing compound:- ADC (Azodicarbonamide), Phthalate, 2-EHA, possibly ESBO (there is no concern yet).

Mango Chutney is an exporting item to Europe in millions of packages. Well, you and/or your customer may have to go through rounds of cap and package analysis by outside institute to certify non presence of the banned ingredients as well as passing the FCM (coating and plastisol) Overall Migration Limit test.
1 month ago• Like1

Follow Drs. Rogier
Drs. Rogier van Duin NPDP • Substitution of the epoxy-phenolic basecoat by a polyester based lacquer is possible nowadays. For this there are two obstacles, price of polyester is higher than epoxy and intercoat adhesion of the PVC organosol. We at Diostyl Coatings have several options.
1 month ago• Like2

Follow Nick (Wai-ho)
Nick (Wai-ho) Tang • Drs. Rogier

Are your options PVC? Almost most (or all) of the lug cap manufactrurers are into PVC, polyester system is not economical to change at the moment because of the economical scale of using. Personally, I don't see the immediate move from PVC into polyester. Nor it will within a near 2 years' time. It takesd longer than 2-3 years for the polyester system to gain market experience. This will allow PVC system to adjust and adopt into the complete complaince.

What is more important now is the OML for the FCM for lug cap (coating and plastisol "sealing compound") - 20 dm2/kg. Do you, at Diostyl Coatings, have these including plastisol "sealing compound"? Please let all the lug cap manufacturers in the world note your achievement. Orders willfly in quickly.
1 month ago• Like

Follow Nick (Wai-ho)
Nick (Wai-ho) Tang • There are, at least, two world renowned and reputable coating manufacturers that can supply BPA-free coating for food cans. Do it right the first time for this time and be the first one to take off while everybody is waiting EFSA or U.S. FDA decision.

Ottawa conference seeks global consensus on risks of bisphenol A

The Globe and Mail: "The World Health Organization has asked experts on the chemical to come to Ottawa this week for a five-day symposium that will help it evaluate the potential risks from BPA. Much of the attention will be focused on the migration of the compound from cans into food and beverages, and whether there are subpopulations, such as pregnant women and their fetuses, more at risk from these exposures."

The WHO meeting is being held in Canada, in part because it is the leading jurisdiction in the world on BPA regulation. The federal government was the first in the world to add the man-made chemical to a national toxic substances list last month, after having earlier banned baby bottles made from the compound, another international first.

The intense scrutiny of tin cans is a new stage in the ongoing safety debate over BPA, a key material in the manufacture of many plastics.

Worries about the chemical have already led several major food companies serving the Canadian market, including organic food purveyor Hain Celestial and ketchup king H.J. Heinz, to publicly commit to eliminating BPA.

The WHO gathering is supported by two heavyweight international regulators, the U.S. Food and Drug Administration, which is currently conducting its own review of BPA, and the European Food Safety Authority, which recently concluded food exposures aren’t a concern.

The goal of the meetings “is to bring together some of the foremost experts in the world to review the most recent scientific information available on BPA and try to establish an international consensus on the safety of BPA, with a particular focus on food applications,” Health Canada says.

Group sues FDA over inaction on BPA ban request

JSOnline: "The Natural Resources Defense Council filed a lawsuit Tuesday against the Food and Drug Administration for its failure to act on the group's petition to ban bisphenol A from food packaging.

BPA is a chemical used to make hard plastic and to line the cans of most food products. The advocacy group sent a petition to the FDA in 2008 asking that it ban the use of BPA in food packaging. By law, the FDA had 90 days to respond to the petition."

"And 20 months later, the FDA has not responded to that petition, so we are asking the court to intervene and require the FDA to take action," said Sarah Janssen, a senior scientist with the council.

If the suit is successful, the court can order the FDA to respond to the petition and hold the agency in contempt of court if it fails to do so, said Aaron Colangelo, a senior attorney with defense council.

The FDA does not comment on pending lawsuits, said Michael Herndon, an agency spokesman.

NRDC Statement

More on plastics warnings

Chattanooga Times Free Press: "In a little publicized update in January, the U.S. Food and Drug Administration (FDA) advised mothers to breastfeed their infants during their first year of life if possible.

The advisory reflected concern that bisphenol A (BPA), a chemical frequently found in many foods and infant products might cause hormonal abnormalities in children exposed to the substance at an early point of their development.

BPA is a component of many plastics used in water and soda containers, liners for canned goods including infant formula, vat-liners in wine production and dental sealants. Billions of pounds of BPA, which has been employed in producing plastics for decades, are manufactured worldwide each year. BPA is linked to plastic through a weak chemical bond that is easily broken by heat and exposure to ultraviolent radiation. BPA acts as a weak estrogen in animals and therein lies the concern.

The developing fetus is exposed to BPA through the blood of its mother. The newborn infant may be exposed through maternal milk, infant formula, and canned food. Though BPA is broken down within the human body, the chemical is often detected in human blood, urine, milk and cord blood."

NAMPA Review Newsletter January 2010

NAMPA News

FDA JANUARY 15, 2010, ANNOUNCEMENT

On January 15, 2010, the U.S. Food and Drug Administration (FDA) issued an interim update on its review of bisphenol A (BPA). FDA’s fundamental position regarding BPA is that FDA approved uses are safe and BPA has not been proven to be harmful to children or adults in these current approved uses. On the basis of some recent studies, however, FDA has modified its stance to reflect “some” concern, similar to the view expressed by the National Toxicology Program (NTP). As a result, FDA is seeking additional research to answer questions and clarify uncertainties about potential BPA risks. More information on the additional studies and FDA’s position is available here.

FDA also expressed its support for industry stakeholders to undertake additional reasonable steps to reduce human exposure to BPA. More information on these steps is offered by the U.S. Department of Health and Human Services (HHS) here. FDA clearly specified in its announcement that it was not recommended that families change their use of infant formula or foods. NAMPA’s response to the FDA announcement is available at metal-pak.org.
________________________________________
LETTER FROM THE CHAIRMAN

FDA and BPA -- What’s at Stake for FDA?

Could you imagine a time where the science behind DNA testing was called into question? If so, what would that mean to the Justice system that has convicted and freed people in criminal cases for well over a decade? Well this is the type of question that FDA must be receiving in response to its recent statements on BPA. The hallmark of the regulatory system in the United States is the risk assessment process that has been in use for over 40 years and has been the basis for the determination of what is safe and unsafe regarding pharmaceuticals, food additives, and food contact materials. The basis of the process is to use well established and validated tests to determine if the risks posed by a particular substance are acceptable. If at some point new tests are discovered, those tests must also be validated and held to an acceptable standard of quality and scientific rigor. FDA has made thousands upon thousands of determinations of safety using this well established and internationally recognized system.

Enter BPA, a well studied chemical, where every established and validated test continues to yield the same conclusion -- BPA is safe. Where the difficulty lies for FDA is that there are millions of dollars of research going on with BPA with so many methods of testing that it has become impossible to understand the outcomes of all of these tests. FDA is now questioning whether these tests should also be considered despite the fact that these tests are not internationally recognized and may not have real relevance to human health. Armed with the knowledge that every single substance known to man can cause some adverse affect if the right test is designed to find that affect, even if the test has no relevance to human health (remember that water is toxic in the right tests), what is FDA to do?

If FDA allows non-validated, non-repeatable, inappropriate exposure route tests to be considered in the BPA risk assessment, what are the consequences for FDA’s risk assessment of other substances? Does the FDA announcement of January 15, 2010, start the Administration down a path where it will become difficult to turn back? By declining to insist that all studies be held to the same high standard of quality and reproducibility, FDA’s decision leads us into a quagmire. Indeed, the decision may invite doubt over every risk assessment conducted by FDA that relied upon proper validated studies as a basis. FDA and the rest of the world have been consistent in their processes and messaging over the last 15 years -- if you want your data to be considered, you need to follow the established rules of science. Now it looks like that process could be changing. What does that mean for every other safety decision from FDA? That is anyone’s guess now.
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WHO’S WHO IN THE FEDERAL BPA REVIEW

FDA’s January 15, 2010, announcement marked not only the latest in a series of federal actions on BPA, it also revealed the key players within the government who have been tasked with evaluating BPA. For those who did not have an opportunity to listen in on the various briefings offered earlier this month, below is a quick rundown of the key players involved in the ongoing review of BPA by various agencies, along with some recent public statements made by each on BPA

- Margaret Hamburg, M.D., Commissioner, FDA. Hamburg, a Harvard-trained physician and former New York City health commissioner, is an expert in community health and bioterrorism defense. She was recently quoted in Chemistry World on January 21, 2010: “‘At this time we share the perspective of the NTP of some concern of health effects of BPA,’ FDA commissioner Margaret Hamburg said. 'In the interim, as a precaution, the FDA is taking reasonable steps to help reduce human exposure to BPA,’ she added

- Josh Sharfstein, Ph.D., Principal Deputy Commissioner, FDA. Sharfstein came onto the national scene as the commissioner of the Baltimore Health Department with a 2007 investigation into the safety of over-the-counter cold medicines for young children, which caused major companies to pull drugs from the shelves. Dr. Sharfstein had the following comment in Health Day on the day of FDA’s announcement: “In a word, FDA does support the use of bottles with BPA because the benefit of nutrition outweighs the potential of risk of BPA,” said Dr. Joshua Sharfstein, principal deputy commissioner of the FDA. “If we thought it was unsafe, we would be taking strong regulatory action

- Linda Birnbaum, Ph.D., D.A.B.T., A.T.S., Director, National Institute of Environmental Health Sciences (NIEHS). Dr. Birnbaum, the first toxicologist to head NIEHS, came to the Institute from the U.S. Environmental Protection Agency (EPA). For 16 years, she served as director of EPA's Experimental Toxicology Division. During her last year at EPA, she coordinated efforts across the Agency probing the contamination of Libby, Montana, with asbestos from a vermiculite mine.

Dr. Birnbaum has been an outspoken critic of BPA, providing frequent comment to the media, including a recent statement to the Milwaukee Journal-Sentinel where she said that people should avoid ingesting the chemical, especially pregnant women, babies, and children. She urged people to seek alternatives. Asked if consumers should be worried about BPA, Birnbaum said, “Absolutely.” In a WebMD article about the January 15 event, Dr. Birnbaum is quoted as follows: “There are critical periods of development when exposure to BPA may lead to certain health effects, including behavioral effects, diabetes, reproductive disorders, development of certain kinds of cancers, asthma, cardiovascular disease, and effects that can go from one generation to the next

- William Corr, J.D., Deputy Secretary, HHS. Corr has spent more than two decades in and around government and health policy and plays a key role in shaping the Obama Administration’s efforts to modernize and expand health coverage. He is a former aide to former Senator Thomas A. Daschle and now serves under HHS Secretary Kathleen Sebelius.

Corr was quoted in the publication Health Day, on January 15, 2010: “Recent reports show subtle effects of low doses of BPA in laboratory animals and that has raised concerns so we now are taking a much closer look at BPA.” “BPA has not been proven to harm either children or adults,” Corr said. He further stated: “But the data deserves a much closer look because children are being exposed at early stages of development

- Robin Ikeda, M.D., M.P.H., Acting Deputy Director for Non-Communicable Disease, Environmental Health and Injury Prevention, Centers for Disease Control and Prevention (CDC). In this position, she is responsible for providing guidance and leadership to the CDC’s scientific and programmatic portfolios. Prior to these appointments, from April 2006 to September 2009, Dr. Ikeda served as NCIPC’s Associate Director for Science

- Mr. Marc Smolonsky, Associate Deputy Secretary, HHS. During the Stakeholders call on January 15, Smolonsky, who served as moderator for the call, told participants: “But thanks to new technology and advances in science we now have new research findings about BPA that shows subtle effects of low doses of BPA in laboratory animals, and this has raised new concerns. At this time, I want to be clear that BPA has not been proven to harm either children or adults. However especially given that children in the early stages of development are exposed to BPA, the data and new research deserves a closer look.”
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ANTICIPATED BPA ACTION PLAN FROM EPA

In September 2009, EPA Administrator Lisa P. Jackson announced the Agency’s intent to issue action plans on certain chemicals of concern, and specifically mentioned BPA as such a chemical. In December 2009, the EPA rolled out four of these action plans, but BPA was not one of the chemicals listed. Nonetheless, EPA is expected to issue an action plan for BPA in the near term, reportedly to address issues related to environmental impacts.

This EPA initiative announces actions that are almost breathtaking in scope, and its development and implementation of the action plan items will set a number of new precedents. EPA has never previously announced so many actions under the Toxic Substances Control Act (TSCA), nor has it ever cited use of Section 6 so widely. Moreover, that it was issued in this form after being reviewed by the Office of Management and Budget (OMB) is significant and portends potentially great and largely unfettered EPA activity in the months to come. A final point is to recognize EPA’s decision to rely on the Office of Pollution Prevention and Toxics’ (OPPT) Design for the Environment (DfE) program to assist in conducting alternatives assessments for two of the chemical classes in the December 2009 notice (phthalates and PBDEs). The DfE program’s previous alternatives assessments have been open to participation by industry as well as other stakeholders in a forum that allows for complex issues and difficulties to be explained and addressed.

The action plans announced in December summarize available hazard, exposure, and use information; outline the risks that each chemical may present; and identify specific steps EPA is taking to address those concerns. According to EPA, “[a]s those actions begin, there will be opportunities for public and stakeholder comment and involvement.” EPA states that its actions “represent its determination to use its authority under the existing Toxic Substances Control Act (TSCA) to the fullest extent possible, recognizing EPA’s strong belief that the 1976 law is both outdated and in need of reform.”

EPA also intends to establish a “Chemicals of Concern” list and will commence a process that may result in regulations requiring “significant risk reduction measures” to protect human health and safety. The Chemicals of Concern list will rely on EPA’s authority under TSCA Section 5(b)(4)(A)(i), which authorizes EPA by rule to “compile and keep current [a] list of chemical substances with respect to which the Administrator finds that the manufacturer, processing, distribution in commerce, use, or disposal, or any combination of such activities, presents or may present an unreasonable risk of injury to health or the environment.” This section of TSCA, previously described as the “Risk List,” has not otherwise been used by EPA. The listing requires a rulemaking and a finding that a chemical “presents or may present an unreasonable risk,” and EPA’s announcement emphasizes the “may present” arm of the findings. When the Bush Administration raised the possibility of using the Section 5(b)(4) listing under the Chemical Assessment and Management Program (ChAMP), industry raised a number of “black list” concerns in its comments. Thus, any such list is likely to be targeted as a presumptive “hit” list not unlike the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) authorization candidate list. More information is available on the action plans and the Chemicals of Concern list here.
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2009 -- A LOOK BACK

Government Assessment on

- California Proposition 65 -- In July 2009, the California Developmental and Reproductive Toxicant Identification Committee (DARTIC) concluded that BPA is not toxic and does not pose a risk to consumers. Committee members determined that BPA is not a developmental or reproductive toxicant, and as a result, the Committee voted unanimously not to include BPA on Proposition 65

- German Federal Institute for Risk Assessment (BfR) -- On October 2, 2009, the German equivalent of the U.S. FDA, BfR, reiterated its conclusions that BPA does not pose a health risk to people. In a Frequently Asked Questions document, BfR stated, “Following careful examination of all studies, in particular the studies in the low dose range of bisphenol A, BfR comes to the conclusion in its scientific assessment that the normal use of polycarbonate bottles does not lead to a health risk from bisphenol A for infants and small children

- Food Standards Australia New Zealand (FSANZ) -- In March 2009 and again in May 2009, FSANZ issued unequivocal statements that low levels of exposure to BPA do not pose a significant health risk. FSANZ stated that it has assessed the risk to infants from exposure to BPA and “concurred with the conclusions reached by the US FDA and the EFSA that the levels of exposure are very low and do not pose a significant health risk

- Health Canada -- In March 2009, Health Canada released research findings that showed levels of BPA in soft drinks were far below established regulatory levels. In July 2009, Health Canada released results of several other studies investigating BPA exposure levels in baby food in glass jars with metal lids, powdered infant formula, and bottled water, which also showed extremely low levels well below regulatory thresholds. Health Canada noted that these studies confirmed its previous assessment conclusion that the current dietary exposure to BPA through food packaging uses is not expected to pose a health risk to the general population.

Legislative Proposals

Federal

- Ban Poisonous Additive Act of 2009 (S. 593) -- On March 13, 2009, Senators Feinstein (D-CA) and Schumer (D-MA) and Representative Markey (D-MA) proposed a federal BPA-ban bill that included food packaging. The bill specified a 180-day implementation period, but included the option of a one-year waiver if an alternative for the food packaging was not available. With the waiver, the food package would require labeling to inform the consumer of BPA. Additional one-year waivers are included in the proposed legislation, although the language is not clear whether the number of one-year waivers is limited. NAMPA’s statement on Feinstein’s bill is included on its website

- BPA-Free Kids Act of 2009 (S. 793) -- Senator Schumer introduced the BPA-Free Kids Act of 2009 on March 31, 2009. Schumer’s bill focused solely on baby bottles, sippy cups, and children’s tableware; it did not include canned food or beverages. NAMPA’s statement on Schumer’s bill is included on its website

- Food Safety Enhancement Act -- The House passed H.R. 2749, the Food Safety Enhancement Act of 2009, on July 30, 2009. The bill includes the following provision related to BPA in food and beverage containers:

Sec. 215 (a) Notice of Determination -- No later than December 31, 2009, the Secretary of Health and Human Services shall notify the Congress whether the available scientific data support a determination that there is a reasonable certainty of no harm, for infants, young children, pregnant women, and adults, for approved uses of polycarbonate plastic and epoxy resin made with bisphenol A in food and beverage containers, including reusable food and beverage containers, under the conditions of use prescribed in current Food and Drug Administration regulations.

The Senate did not take up its version of the bill in 2009. In August 2009, there was a science briefing with Hill staff on BPA and food packaging

- House Bill 4341 -- On December 16, 2009, Congressman Ryan (D-OH) introduced legislation that would require warning on the label of any food container that is composed in whole or in part of BPA or could release BPA into food.

State Legislation -- BPA Bills That Passed

- Minnesota -- The proposal, which has been amended to include only sippy cups and baby bottles, passed on a floor vote (126 to 5) on May 5, 2009. The Governor signed the bill on May 7, 2009

- Connecticut -- In August 2009, Governor Jodi Rell signed into law a measure banning the manufacture and sale of reusable food and beverage containers, including baby bottles, sippy cups, sports bottles, and thermoses, as well as infant formula and baby food containers, containing BPA, effective October 2011.

State Legislation -- BPA Bills That Did Not Pass

- Illinois -- On April 2, 2009, the proposed BPA bill failed to pass, getting 55 of the 60 votes needed

- Washington -- Both BPA bills (HB 1180 and SB 5282) failed to pass before the end of the legislative session on April 27, 2009

- Maryland -- On April 10, 2009, Maryland’s HB 15 was voted unfavorable by the Senate Finance Committee on a vote of 7-4

- Vermont -- There were two bills in Vermont impacting BPA. Neither bill cleared their respective chambers before the Vermont crossover deadline in late March

- California -- SB 797, which would prohibit the manufacture, sale, or distribution in commerce of any bottle, cup, or liquid food or beverage in a can or jar that contains BPA at a level above 0.1 ppb, failed to pass.

- Massachusetts -- NAMPA and other trade groups testified against HB 2068 on May 5, 2009. The bill did not pass. The Massachusetts Department of Health issued a public health advisory on BPA

- New York -- The proposed BPA ban did not pass

Local Legislation -- BPA Bills That Passed

- Suffolk County, NY -- On April 2, 2009, County Executive Steve Levy signed the Suffolk County BPA bill, representing the first-in-the-nation ban on baby bottles and cups that contain BPA. Although this legislation does not directly impact metal packaging, NAMPA opposed this legislation because it was not supported by the science

- Annapolis City Council -- The Annapolis BPA bill that would have required facilities to provide warnings to its patrons regarding BPA was reintroduced as a voluntary program and passed on April 13, 2009. The final ordinance provides that retailers that sell any form of food or beverage in a container that may contain BPA can voluntarily notify customers by posting a visible sign on the premises. It is unclear whether retailers are opting into the program

- Chicago -- On May 13, 2009, the Chicago City Council voted to ban BPA in baby bottles and sippy cups.

Local Legislation -- BPA Bills That Did Not Pass

Albany County, NY -- The proposed bill called for a ban of the sale of children’s beverage containers with BPA. It did not pass

- Schenectady County, NY -- The bill did not [ass

- Duchess County, NY -- The bill, which called for no sale of children’s beverage containers containing BPA, was vetoed by the County Executive in December 2009

- Rockland County, NY -- The BPA ban in children’s beverage containers bill did not pass, but was sent back to Committee in December 2009.

FDA responds to JS Media article

Your Opinions - JSOnline: "FDA does regulate chemical

The article 'FDA says it's unable to regulate BPA' does not accurately describe the current regulatory status of the chemical bisphenol A (Page 1A, Jan. 17)."

BPA is, in fact, a chemical regulated by the agency. Its use in food packaging is authorized by a food additive regulation that dates from the 1960s. The Food and Drug Administration has the authority under this regulatory structure to make changes to the status of the chemical, including revoking its use if warranted by scientific evidence through rule-making.

Last week, the FDA announced that it has some concern about BPA, and new studies are underway to clarify uncertainties and resolve important outstanding scientific questions. As an agency dedicated to protecting the public health, the FDA would like to have a nimble regulatory structure in place when these answers arrive.

For that reason, the FDA would prefer to regulate BPA through the food contact substance notification program. Under this alternate regulatory structure, the FDA would have the ability to get more information about BPA's use and move faster to make changes to the status of the chemical, if warranted by scientific evidence.

Dr. Joshua M. Sharfstein

Principal deputy commissioner of food and drugs

U.S. Food and Drug Administration

Silver Spring, Md.

NAMPA Response to FDA statement January 2010

http://tinyurl.com/ylm8chg

The North American Metal Packaging Alliance, Inc. (NAMPA) supports the U.S. Food and Drug Administration’s (FDA) announcement today to continue its ongoing scientific research and evaluation of bisphenol A (BPA). At the same time, FDA officials reiterated that consumers can continue to use safely existing products that contain BPA

“The FDA announcement clearly noted that BPA exposure is not proven to harm children or adults -- which is consistent with other international regulatory bodies,” said Dr. John Rost, NAMPA Chairman. “Our members stand ready to help FDA in any process changes they feel are needed to better ensure the safety of packaged foods.”

Despite FDA concern, American Chemistry Council insists Bisphenol A is safe for everyone

Herbal-Bulgaria.com: "The FDA, for its part, has been engaged in a conspiracy of silence to avoid admitting that BPA is dangerous for human health. This conspiracy was recently shattered when the FDA’s own science advisors blasted the agency for ignoring over 100 published studies showing BPA was dangerous. The FDA, you see, had discarded those 100 studies and, instead, based its conclusions on just two studies that happened to be funded by the chemical industry.

That’s how the FDA operates across the board: Ignore all the science you don’t like, and cherry-pick the science you want to believe, even if it’s all been funded by the chemical companies. By relying on that gimmick, the FDA was able to maintain its intellectually dishonest position that BPA posed no risk to human health.

There’s also evidence of corruption and fraud in the FDA’s position on BPA. Did you know, for example, that the chairman of the FDA panel making a key decision on BPA “safety” — Martin Philbert — also sits at the top of a company that received a secret $5 million payment (http://www.naturalnews.com/026400_Bisphenol-A_BPA_food.html)."

U.S. regulators pressed to speed up BPA decision

Dr. Buttar's Blog: "The U.S. Food and Drug Administration should immediately ban the use of the chemical bisphenol A in food and beverage containers, a U.S. environmental health advocacy group urged on Thursday.

The nonprofit Environmental Working Group renewed a call for regulators to curb the use of bisphenol A, or BPA, citing a new study suggesting the widely used chemical poses a health risk.

The FDA is considering whether any action needs to be taken. Asked about the group’s letter, an FDA spokesperson said that an announcement on BPA is forthcoming.

Bisphenol A has been used for decades to harden plastics and turns up in many food and beverage containers including some baby bottles, the coating of food cans and some medical devices. It appears to mimic the hormone estrogen in the body.

People consume BPA when it leaches from plastic into baby formula, water or food in a container.

“How much more does the FDA need to know to be convinced it must protect the national food supply from further contamination?,” Environmental Working Group president Ken Cook said in a letter to FDA Commissioner Margaret Hamburg.

“We urge you to act now to prohibit the use of BPA in food and food containers,” Cook wrote."

FDA Calls BPA Risky, but Puts off Regulation

OMB Watch: "On Friday, the Food and Drug Administration made its long-awaited announcement on the safety of bisphenol-A, a chemical ingredient in hard plastics, food can liners, and other common products. The verdict? “[R]ecent studies provide reason for some concern about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants and children. FDA also recognizes substantial uncertainties with respect to the overall interpretation of these studies and their potential implications for human health effects of BPA exposure.”

While it’s good to hear FDA finally admit that BPA could be a health threat, its plan going forward lacks the aggressiveness many were expecting. Instead of announcing a regulatory path to limit consumer exposure to BPA, FDA reiterated warnings that parents throw away their children’s hard plastic baby bottles or cups if they are scratched and that that consumers avoid putting hot liquids in BPA containers.

Urvashi Rangan of Consumers Union hit the nail on the head when he called FDA’s message “confusing.” How can the agency say that something as seemingly-benign as a scratched bottle poses a potential threat, but not take precautionary steps? Food Safety News reports:"

FDA officials - including Sharfstein; Lynn Goldmann, a consultant to the FDA; and Jesse Goodman, the FDA's acting chief scientist - told the Journal Sentinel they were frustrated by the antiquated framework of the FDA's regulatory process.

Officials say they would like chemical manufacturers to report information about the chemical to them, including how much BPA they produce and where and how it is used.

But because BPA was classified years ago as an indirect food additive, it is not subject to the kind of scrutiny that other chemicals are. Without critical data about BPA, it is impossible to regulate the chemical, officials said.

Sharfstein told the paper, "We may have to go after legislation to change it.”

EFSA to evaluate FDA decision on bisphenol A

FoodQualitynews.com: "The European Food Safety Authority (EFSA) said it would be contacting the US Food and Drug Administration (FDA) this week to discuss its verdict that bisphenol A (BPA) is now of “some concern”.

The European food safety watchdog was just one of a number of bodies to react after the FDA revealed its step-change decision on Friday that it wanted to see an end to the use of the chemical in the manufacture of baby bottles and would back efforts to replace or minimise its use elsewhere in food can linings.

“We have a co-operation agreement with the FDA and will be liaising with them over this decision,” an EFSA spokesman told FoodProductionDaily.com. He added that EFSA was in constant contact with its US counterparts.

“We will be reviewing the information they have and taking it into account with regard to our position on BPA. The CEF panel is due to meet before the end of the month to consider what, if any, implications it has for EFSA’s position,” said the spokesman.

EFSA is presently carrying out an evaluation of the effects of BPA on neuro-development and is due to publish its findings in spring 2010."

FDA rules on Bisphenol A (BPA) January 2010

FDA Website: "Bisphenol A (BPA) is an industrial chemical that has been present in many hard plastic bottles and metal-based food and beverage cans since the 1960s."

Studies employing standardized toxicity tests have thus far supported the safety of current low levels of human exposure to BPA. However, on the basis of results from recent studies using novel approaches to test for subtle effects, both the National Toxicology Program at the National Institutes of Health and FDA have some concern about the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children. In cooperation with the National Toxicology Program, FDA’s National Center for Toxicological Research is carrying out in-depth studies to answer key questions and clarify uncertainties about the risks of BPA.

In the interim:

FDA is taking reasonable steps to reduce human exposure to BPA in the food supply. These steps include:

-Supporting the industry’s actions to stop producing BPA-

containing baby bottles and infant feeding cups for the U.S. market;

-Facilitating the development of alternatives to BPA for the linings of infant formula cans; and

-Supporting efforts to replace BPA or minimize BPA levels in other food can linings.

FDA is supporting a shift to a more robust regulatory framework for oversight of BPA.

FDA is seeking further public comment and external input on the science surrounding BPA.

FDA is also supporting recommendations from the Department of Health and Human Services for infant feeding and food preparation to reduce exposure to BPA.

FDA is not recommending that families change the use of infant formula or foods, as the benefit of a stable source of good nutrition outweighs the potential risk from BPA exposure.

FDA Blows It on BPA

Windows Live: "The U.S. Food and Drug Administration will miss its third self-imposed deadline on letting consumers know whether it is safe to use products made with bisphenol A, a chemical ingredient in the lining of most food and beverage cans.

FDA spokesman Michael Herndon said Tuesday the agency would not be making a decision before the end of the year, a pledge it made when it missed its Nov. 30 deadline."

Bisphenol A becomes test of leadership for FDA

Food navigator USA: "The straight-talking Commissioner vowed to sort out the thorny question of BPA in weeks not months – garnering almost universal praise that here at last was somebody who not only understood the importance of the issue but was prepared to bang some heads together to solve the problem. It was a bold declaration designed to challenge the perception of a food safety body too readily influenced by the industries it was charged with regulating.

And in a world where perception can be reality, it could also explain why BPA has so far failed to trigger the same level of anxiety in Europe. The European Food Safety Authority (EFSA) certainly has its critics but few would dispute the organisation is impartial and not afraid to ruffle industry feathers if that is where the evidence leads. While the FDA has wrestled with its lack of credibility, EFSA has been able to calmly assert that it sees no need to review its stance on BPA. It has provided a clear and consistent position that inspires consumer confidence and stability for industry."

Erectyle Dysfunction and Male Sexual Problem caused by BPA

Homeopathy Remedies: "research from The Kaiser Permanente publish in the Journal Human Reproduction, The men working in facilities with chemical BPA exposure had four times the Risk of Erectile Dysfunction and seven times more Risk of Difficulties with Ejaculation than their counterparts who weren’t regularly exposed to BPA. They also had Lowered Sexual Desire dramatically and overall less satisfaction with their sex life than men without the chemical exposure."

The research followed by 230 chinese men who were exposed to BPA in their workplace for five years and compared them to 404 others worker in a factory where no BPA exposure.

Dr. Li, a reproductive and perinatal epidemiologist at Kaiser Permanente’s Division of Research in Oakland, California, also pointed out other disturbing implications of the new study:

BPA may have health effects that go far beyond male sexual problems like Erectile Dysfunciton (ED). In fact, male sexual problems could prove to be early indicators of BPA-related effects on the body that are more difficult to study, such as cancer or metabolic diseases.

BPA or Bisphenol-A is a chemical compound containing two phenol functional group, belonging to the phenol class of aromatic organic compounds.

Bhispenol-A was first synthesized by AP. Dianin in 1891.

The testifying of FDA Associate Commissioner for Science Norris Alderson before the Senate insisted that products made with bisphenol A (BPA) are SAFE!, even though a number of studies have implicated it as a carcinogen and hormonic mimic.

New $30m study into the safety of BPA

Foodproductiondaily: "Opening yet another chapter in the long running saga about the safety of Bisphenol A (BPA), the US National Institutes of Health is to launch a new $30m study into the safety of the chemical used in metal cans linings, many plastics bottles and sipper cups.

The funds, from the American Recovery and Reinvestment Act, will be spent over two-years on human and animal studies to remedy the research gaps identified by expert scientific panels.

The Food and Drug Administration (FDA) has pledged to release its own assessment of BPA's safety by the end of next month. Until then it maintains that the current guidelines for the use of BPA are sufficient and that the chemical is safe when used in accordance with existing regulations.

But the Environmental Working Group (EWG) believes the FDA already has enough evidence to restrict the exposure of pregnant women and children to BPA.

EWG scientist, Anila Jacob told USA Today: “We can always learn more about BPA, but we have scores of studies showing that low-dose exposure can increase risks."

Meanwhile, in a statement published on the website of The American Council on Science and Health (ACSH), John Doull, Professor of Toxicology, University of Kansas Medical Center, warned that banning BPA devalues science.

Appropriate regulations

“Banning bisphenol A…ignores our proven ability to use science, experience and judgment to establish appropriate regulations for all chemicals including bisphenol A,” he wrote.

“It is clear from the extensive scientific data on bisphenol A that an outright ban cannot be justified from a public health point of view. Our time-tested methods for human health risk assessment permit our regulatory agencies to establish rigorous limits on exposure that provide a wide margin of safety,” added Doull.

It will study low-dose exposures to BPA and effects on behavior, obesity, diabetes, reproductive disorders, asthma, cardiovascular diseases and various cancers. Researchers will also question whether the effects of BPA exposure can be passed from parents to their children."

FDA Slammed Over Pace Of BPA Study

Newsinferno: "JSOnline reported that millions of dollars are being unnecessarily dumped into more studies into the effects of BPA; given that an astounding number of studies—over 900—have been conducted and confirm the negative risks, the 33 BPA experts from the scientific community, find the multi-million dollar study redundant.

Most of the scientists hail from universities and recently sent a letter to Margaret Hamburg, the commissioner of the U.S. Food and Drug Administration (FDA), with accusations that the agency is dragging on the issue and endangering consumer health, said JSOnline."

FDA Science Board Meeting Presentations

Including BPA reviews

Click here

U.S. FDA to reconsider BPA safety issue

Plastics News: "FDA said CFSAN was currently reviewing more than 100 studies, many of which evaluate the potential risk for low-dose exposure to BPA. One of the recommendations of the FDA Science Board subcommittee last October had been to review such studies.

An FDA spokesman said the review will focus on the potential adverse human health effects that were considered to be of some concern in the National Toxicology Program report in September 2008.

That NTP report was dismissed by previous leadership at FDA. Among other things, NTP had suggested that parents might want to reduce the exposure of infants to products that contain BPA.

The agency had received stinging criticism in October for rejecting a report by an FDA Science Board subcommittee which said that FDA’s position that BPA is not harmful ignores critical studies and that the margins of safety the agency defines as adequate “are, in fact, inadequate.”

Eleven safety agencies around the world have said that BPA is safe for use in food contact applications."