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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.
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.
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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.”
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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.”
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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.”
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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.”
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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.
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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.”
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.
2009 -- A LOOK BACK
Government Assessment on BPA
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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.
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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.”
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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.”
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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 Legislation
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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.
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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.
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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.
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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
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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.
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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
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Illinois -- On April 2, 2009, the proposed BPA bill
failed to pass, getting 55 of the 60 votes needed.
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Washington -- Both BPA bills (HB 1180 and SB 5282) failed
to pass before the end of the legislative session on April 27, 2009.
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Maryland
-- On April 10, 2009, Maryland’s
HB 15 was voted unfavorable by the Senate Finance Committee on a vote of
7-4.
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Vermont -- There were two
bills in Vermont
impacting BPA. Neither bill cleared
their respective chambers before the Vermont
crossover deadline in late March.
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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.
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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.
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New York -- The proposed BPA ban did not pass
Local Legislation --
BPA Bills That Passed
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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.
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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.
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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
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Albany County, NY -- The proposed bill called for a ban of the
sale of children’s beverage containers with BPA. It did not pass.
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Schenectady County, NY -- The bill did not pass.
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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.
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Rockland County, NY -- The BPA ban in children’s beverage
containers bill did not pass, but was sent back to Committee in December
2009.
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