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Hello, I'm Eric Nelson, Director of the Division of Compliance
at the Center for Veterinary Medicine.
In the United States, the Food and Drug Administration
has the principal role in regulating feed
to ensure its safety for animals and people.
FDA's programs have evolved along with developments
in the animal feed and livestock production industries
in the United States.
One of FDA's earliest animal feed regulations
was designed to ensure safe drug use in feed.
The result was the Good Manufacturing Practice regulations.
Later came regulations to address issues of Salmonella in feed,
mycotoxin contamination,
and, more recently, concerns about BSE.
Over the past several years,
CVM and FDA have begun to think more strategically about feed safety.
CVM has led a program to review the entire regulatory scheme for feed
through its Animal Feed Safety System initiative.
And following the melamine contamination crisis
and other significant food-borne human health issues,
the Administration and Congress gave food and feed safety issues
more emphasis
and FDA more programs to work with.
Here's some of that history.
In the United States,
FDA derives most of its authority
to regulate food and animal feed
from the Federal Food, Drug,
and Cosmetic Act.
Section 201 of the Act states,
"The term 'food' means articles
used for food or drink
for man or other animals,
and articles used for components
of such articles."
Therefore, the law describes food
in such a way
that the definition includes
animal feed and pet food
and gives FDA the authority
to regulate both food and feed.
Within FDA, the regulatory work
concerning animal feed
and pet-food safety
is handled principally by the Center
for Veterinary Medicine.
For the most part, the animal-feed
and pet-food regulatory system
FDA and CVM has developed
over the years
is made up of programs and policies
responding to and addressing specific,
identified hazards.
For example, CVM developed
current Good Manufacturing Practice
regulations
as a mechanism to ensure the safety
of medicated feed,
and FDA/CVM developed regulations
for preventing the establishment
and spread
of bovine spongiform encephalopathy
in the United States.
In the area
of feed contaminants, also,
CVM has policies for limiting
mycotoxins in feed ingredients.
In addition, CVM has issued
action levels and guidance levels
to address concerns about mycotoxins
in feed and feed ingredients.
Overall, the feed safety system
has worked well in the United States,
but challenges to the feed safety
have come from unexpected sources,
such as dioxins or melamine
in feed ingredients.
Partially because
of unexpected challenges,
but more because
of identified weaknesses
in the animal-feed
and pet-food regulatory system,
FDA in 2003 established the Animal
Feed Safety System Initiative.
The goal of the Initiative
is to provide FDA
with a broader view
of animal feed safety
by making
the Animal Feed Safety System
comprehensive and risk-based
and one not focused
on specific, identified threats.
The melamine contamination crisis,
which occurred in 2007,
highlighted the evolving nature
of international commerce in food,
including animal feed and pet food,
and the need for a review
of the policies used to protect
against food and feed risks.
The crisis highlighted the fact
that large amounts
of food and feed ingredients
are traded internationally
and that the imported products
are broadly distributed
throughout the food chain.
For example, the discovery
of melamine contamination
resulted in recalls by 100 companies
of more than 60 million servings
of pet food
and the contamination
affected feed supplies
at hog farms in eight states
as well as 30 broiler farms
and eight breeder poultry farms.
As a result
of the heightened awareness
of the need for increased food and feed safety protection,
the U.S. Congress passed legislation in 2007 to give FDA more mechanism
to keep pet food and animal feed safe.
Those new mechanisms
apply to the regulation of ingredient standards and definitions
and early warning system for pet foods
and a safety reporting portal
through which consumers and companies
can report safety problems concerning food,
including food for animals.
The crisis also prompted regulatory officials in the U.S. government
to review the approach to food safety used in the United States.
The work being done under the AFSS fits well
within the newer food safety laws, programs, and policies developed
as the United States addressed the crisis created
by the discovery of melamine contamination
of imported feed ingredients.
Animal feed includes livestock feed, pet foods, and exotic animal diets.
The FD&C Act prohibits interstate distribution
of adulterated or misbranded articles.
Adulterated feed articles
are those considered defective or improperly produced.
They are unsafe, unapproved,
filthy, putrid, decomposed,
or produced under unsanitary conditions.
Misbranding applies to labels that contain false information
or potentially misleading information.
For example, it could be a claim
that a product is an excellent source for nutrients
when, in fact, the product contains very little
of an animal's nutrient requirement.
A product is also considered misbranded
if required information is not on the label.
For instance, if a feed product contains a substance
that is toxic to cows
but the label has no such warning against feeding the product to cows,
the product would be considered misbranded.
Labeling includes more than what's attached to the product's container
and includes advertising and point-of-sale information
and can include information on an Internet site.
Food, including food for animals,
does not have to go through pre-market approval by FDA
to be sold in the United States.
For example, potato chips, cereal, soup, and pet food.
However, for animal feed,
the components used in the feed
should be acceptable for use in feed prior to marketing.
And any new feed ingredient must go through some approval process.
It is the responsibility of the manufacturer
to ensure products that are marketed in the United States
are safe and otherwise acceptable for their intended uses.
Under the FD&C Act, components of feed can include food additives,
additives Generally Recognized as Safe, or GRAS,
drugs suitable for use in feed for animals,
and color additives.
For a food additive that can be used in animal feed,
we rely on a company to provide us
with the data needed to review the safety of the additive.
The data are compiled into a food additive petition.
Included in a petition are, among other things,
data to address the safety to animals, people, and the environment
and information demonstrating the additive does
what the petitioner says it will accomplish.
FDA reviews the data.
Once we've approved a food additive,
a regulation is published in the Code of Federal Regulations
stating that the substance has been approved.
Safe food additives are legally defined in the Act
as substances for which a regulation has been established.
Substances that are approved as safe food additives
cover a wide range of functions,
such as nutrients, nutrient protections,
and antimicrobial actions.
They are approved for intended purposes.
A GRAS substance is GRAS only for its intended use.
A substance is generally recognized as safe for a specific intended use
and should be used at levels to support that intended use.
A substance approved as GRAS for an intended purpose
is not considered GRAS for other purposes.
The GRAS substance must have evidence of safety.
The quantity and quality of scientific evidence
is essentially the same as required for approval
of a food additive petition.
Furthermore, the safety evidence must be generally known
and accepted by qualified experts.
Alternately, a GRAS determination can be made
through experience based on common use in food
prior to 1958.
A GRAS substance is no more or less safe than an approved food additive
for an intended use.
The difference between an approved food additive
and a GRAS substance is the fact that a GRAS approval
is based on knowledge commonly available.
Companies can make their own determinations
about the safety of a GRAS substance
and then submit information to FDA for review.
FDA will evaluate
whether the submitted notice provides sufficient basis
for a GRAS determination
or if information in the notice or otherwise available to FDA
raises questions about whether the product is GRAS.
Whatever the recognition process is,
the intended use is the deciding factor.
Drugs can be added to feed only after FDA/CVM has reviewed the drug
for safety, efficacy, and other criteria
and approved the drug for its intended use in the specified animal.
More information about FDA's animal drug approval process
is available on our website at the address given on the slide.
Color additive approvals are handled
by the Center for Food Safety and Applied Nutrition,
who consults with us on certain aspects of submitted petitions.
Let's shift from how components in feed are approved
to how they are marketed.
This is a source of concern for the feed ingredient industry.
Once a food additive is published in the CFR as approved,
any firm can manufacture the additive
if it can meet all of the standards set forth in the regulation.
Disputes about patent infringements are not handled by the FDA.
Once a firm has finished the review process,
the company's marketers will start to think
about what they can say about the products.
They may try to make drug claims,
but they are prohibited from doing so under the law.
The FD&C Act defines a drug as a substance used to cure,
prevent, mitigate, treat disease
or a substance other than food
used to alter the structure or any function of the body.
Unsuitable claims, for example,
are claims of improved animal productivity,
including growth promotion claims and gains in feed efficiency
and claims about structure or function effects.
The Food Safety Modernization Act was signed into law in January 2011.
CVM has a big part in implementing this new legislation,
and we are strongly supporting it.
We consider the legislation historic.
It calls for a new, prevention-oriented
food safety system.
It also includes a broad prevention mandate and accountability.
It gives FDA new tools, including mandatory recall of products
that a company fails to voluntarily recall,
as well as better access to records,
a more flexible standard for administratively detaining products
that are potentially in violation of the law,
and the ability to suspend registration of a facility
if FDA determines that food from that facility
poses a reasonable probability
of serious adverse health consequences or death.
FDA is also required to establish a system
that will enhance its ability to track and trace
domestic and imported foods.
It also creates a new system of import oversight.
Importers are now responsible for ensuring
that their foreign suppliers
have adequate preventative controls in place.
FDA can rely on third parties
to certify that foreign food facilities meet U.S. requirements.
Thank you.