SILVER SPRING, Md.,
April 8, 2021 /PRNewswire/ --
Protecting one of our most vulnerable populations, babies and young
children, is among the U.S. Food and Drug Administration's highest
priorities. Today, we're announcing a new action plan, Closer to
Zero, that sets forth our approach to reducing exposure to
toxic elements in foods commonly eaten by babies and young children
to the lowest possible levels. Although the FDA's
testing shows that children are not at an immediate
health risk from exposure to toxic elements at the
levels found in foods, we are starting the plan's work
immediately, with both short- and long-term goals for achieving
continued improvements in reducing levels of toxic elements in
these foods over time.
We recognize that Americans want zero toxic elements in the
foods eaten by their babies and young children. In reality, because
these elements occur in our air, water and soil, there are limits
to how low these levels can be. The FDA's goal, therefore, is to
reduce the levels of arsenic, lead, cadmium and mercury in
these foods to the greatest extent possible. We are also sensitive
to the fact that requiring levels that are not currently feasible
could result in significant reductions in the availability of
nutritious, affordable foods that many families rely on for their
children. Our plan, therefore, outlines a multi-phase,
science-based, iterative approach to achieving our goal of getting
levels of toxic elements in foods closer to zero over time.
Closer to Zero includes research and evaluation of
changes in dietary exposures to toxic elements, setting action
levels (recommended limits of toxic elements in foods that can be
achieved by industry and progressively lowered as appropriate),
encouraging adoption of best practices by industry, and monitoring
progress.
Our action plan will occur in three phases. As part of the first
phase, we'll immediately begin our work setting action levels using
a four-pronged approach:
1.
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Evaluate the
scientific basis for action levels. The cycle of continual
improvement starts with the FDA evaluating existing data from
routine testing of the food supply, research and data on chemical
analytical methods, toxicological assays, exposure and risk
assessments, and other relevant scientific information. Through a
process that may include advisory committees, public workshops, and
consultation with scientific experts, federal agency partners, and
other stakeholders, the agency will establish interim reference
levels (IRLs) for certain toxic elements as appropriate. An IRL is
a measure of exposure from food that the FDA may use to determine
if the amount of exposure to an individual element across foods
could result in a specific health
impact.
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2.
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Propose action
levels. The IRLs may be among the key factors that inform
the development of the FDA's proposed action levels for certain
toxic elements in categories of baby foods (e.g., cereals, infant
formula, pureed fruits and vegetables, etc.) and other foods
commonly eaten by babies and young children.
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3.
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Consult with
stakeholders on proposed action levels, including the achievability
and feasibility of action levels. For each toxic
element—for every identified category of food—the FDA will gather
data and other information through a process of consultation that
could include workshops, scientific meetings, and collaboration
with federal partners to assess, among other things, the
achievability and feasibility of the proposed action levels and the
timeframes for reaching them.
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4.
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Finalize action
levels. The FDA will use the information gathered from
stakeholders, updated scientific research, and routine monitoring
data to make any needed adjustments and finalize action
levels.
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Once the FDA has
published final action levels, the agency will establish a
timeframe for assessing industry's progress toward meeting the
action levels and recommence the cycle to determine if the
scientific data support efforts to further adjust the action levels
downward.
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Our action plan will start with prioritizing our work on those
elements for which we have the most data and information – arsenic
and lead – while research continues on other elements, progressing
through each element over time across various categories of foods
consumed by babies and young children. During the plan's first year
(phase one), we will be proposing action levels for lead in
categories of foods consumed by babies and young children,
consulting with and gathering data from stakeholders and federal
partners on issues such as the feasibility of meeting action levels
for lead, and sharing resources with industry on best practices for
reducing or preventing lead contamination. We will also complete
updated sampling assignments testing toxic element levels in baby
foods and evaluate the science related to arsenic exposure from
foods beyond infant rice cereal. Phases two, three and beyond are
outlined in our plan.
Through this plan, we'll also take measures to ensure that
limiting exposure to toxic elements in foods does not have
unintended consequences—like limiting access to foods that have
significant nutritional benefits by making them unavailable or
unaffordable for many families, or unintentionally increasing the
presence of one toxic element when foods are reformulated to reduce
the presence of another. In addition, our goal of moving closer to
zero reflects the reality that fruits, vegetables, and grains do
take up toxic elements in the environment as they grow. With a
cycle of continual improvement and collaboration, we aim to push
the levels of toxic elements in these foods closer and closer to
zero over time.
While our testing of toxic elements in foods has shown there
have already been significant reductions of toxic elements found in
foods, the FDA is confident that our new plan will help further
advance our work in this area. As part of our ongoing efforts to
reduce exposure to toxic elements from foods, we'll be continuing
our research and collaborations on this topic, finalizing action
levels for arsenic in apple juice and issuing draft action levels
for lead in juices in the near future, evaluating the potential
impact of new technologies, interventions, or mitigation controls
to reduce exposure, and reevaluating risks based on declining
levels of toxic elements in foods. We view this work and our
Closer to Zero plan as part of a larger effort to improve
maternal and infant nutrition and health. We plan to combine our
efforts to reduce exposure to toxic elements in baby foods with
other FDA initiatives to improve the health of mothers, infants,
and children.
Again, it's important to note that the FDA's testing shows
that children are not at an immediate health
risk from exposure to toxic elements at the levels
found in foods. However, we know that additional progress can
be made and are confident that a science-driven, transparent
and inclusive process will help lead to even further
reductions in exposure to these toxic elements. We look
forward to providing additional updates on our plan as new data,
information, progress updates and additional material are made
available.
Additional Resources:
- Closer to Zero: Action Plan for Baby Foods
- FDA Shares Action Plan for Reducing Exposure to Toxic Elements
from Foods for Babies and Young Children (Constituent Update)
- Metals and Your Food
- FDA Announces New Actions Aimed at Further Reducing Toxic
Elements in Food for Babies, Young Children (March 5, 2021)
- FDA Response to Questions About Levels of Toxic Elements in
Baby Food, Following Congressional Report (Feb. 16, 2021)
Media Contact: Kim
DiFonzo, 240-651-4191
Consumer Inquiries: 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, products that give off electronic radiation, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration