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DHMH : Request for Comments on Bisphenol-A

DEPARTMENT OF HEALTH AND MENTAL HYGIENE
Request for Comment on Bisphenol A
 
On September 13, 2012, the Secretary of Health and Mental Hygiene submitted to the Legislature a Report on Bisphenol-A Free Infant Formula Containers, in accordance with Senate Bill 151 and House Bill 4 of the 2011 legislative session, Public Health – Containers of Infant Formula Manufactured with Bisphenol–A – Prohibition (the Act).  The law (now § 24-304 of the Health-General Article of the Maryland Annotated Code), signed by the Governor on May 10, 2011, contains the following provisions: 
 
  1. On or after July 1, 2014, the State may not purchase infant formula in containers containing more than 0.5 parts per billion (ppb) of bisphenol-A (BPA);
  2. A person may not manufacture, knowingly sell, or distribute in commerce a container of infant formula containing more than 0.5 ppb of BPA;
  3. Substitutes for BPA used to comply with the above provisions must be safe and legal, and specifically may not be rated as Group A, B, or C carcinogens by the U.S. Environmental Protection Agency, or reproductive toxicants that cause birth defects, reproductive harm, or developmental harm as identified by the United States Environmental Protection Agency; and 
  4. Requires the Department of Health and Mental Hygiene (DHMH) to adopt regulations to carry out the above provisions.   
     
A provision in the Act qualifies the above provisions by allowing the Secretary of Health and Mental Hygiene to suspend these provisions if the Secretary certifies “that the safety concerns for bisphenol-A are resolved by additional research or if implementation of [the provisions] would adversely affect the health or well-being of children or adults…” 
 
Section 2 of the Act requires that DHMH, on or before September 1, 2012, report to the House Health and Government Operations Committee and Senate Finance Committee on the findings of federal research and regulatory activities related to BPA.
 
The report that was submitted to the committees of the General Assembly addressed the following issues:
 
  • Federal research findings related to BPA and its potential alternatives;
  • Recent Federal regulatory activities related to BPA;
  • Recent scientific findings in the peer-reviewed literature on BPA and possible alternatives;
  • Summary of findings relative to the safety concerns for BPA;
  • Update on Maryland’s purchase of BPA-free formula; and
  • Summary and analysis
 
Based on available scientific evidence, DHMH did not reach the conclusion that BPA in infant formula is unsafe.  Given that substantial research is still ongoing, DHMH could not exclude a potential risk. To view the full report, click here
 
DHMH agreed with FDA that families should not change the use of infant formula or foods, as DHMH’s judgment is that the benefit of a stable source of good nutrition outweighs the potential risk to an individual infant from BPA exposure.  DHMH recognizes that manufacturers are moving away from the use of BPA in packaging materials, in part because of public concerns about the potential health effects.
 
Under its latest contract, Maryland’s WIC program will only purchase infant formula that is manufactured in a BPA-free process.  The rest of the market is moving quickly in this direction as well.  Companies are developing new materials for packaging of infant food, which should be studied and reviewed prior to use.
 
One outstanding question that was unanswered in the report is whether the imposition of the 0.5 ppb standard for testing in the formula could produce unforeseen adverse consequences. Given environmental sources of BPA, it is important that the testing method be specific to formula, credible, and reliable.
 
The Secretary proposes to seek public comments and input on the specific question of the use of the numeric standard of 0.5 parts per billion (ppb) in the implementation of the Act.  Specifically, the Secretary poses the following questions:
 
  1. What are the technical issues involved in adopting a numeric standard of 0.5 ppb? 
  2. What are the public health issues involved in adopting a numeric standard of 0.5 ppb?
  3. What would be the alternatives to a numeric standard, and what would be the public health consequences of adopting a different criterion? 

The Secretary has asked the Children’s Environmental Health and Protection Advisory Council (CEHPAC) to review comments and to make recommendations on whether DHMH should take any additional action.  CEHPAC was established in 2000 by legislation.  CEHPAC advises the Governor and the General Assembly on environmental issues that may pose a threat to children. CEHPAC will then vote on recommendations to put forward to the Secretary.  
 
Written comments should be submitted by Friday, October 12 at 5:00 PM. 
 
Comments may be submitted by mail to Michele Phinney, Director, Office of Regulation and Policy Coordination, Department of Health and Mental Hygiene, 201 W. Preston St., Room 512, Baltimore, MD 21201, or by email to dhmh.regs@maryland.gov, or by fax to 410-767-6483.