development and may therefore have short- and long-term consequences for infant health, (3) animals may not be the most appropriate model on which to base decisions of safety, (4) “one size fits all” food safety models may not work for all new additions to formulas, (5) infant formulas could be considered as more than just food, and (6) potential benefits, along with safety, should be considered when adding a new ingredient to formulas.

INTRODUCTION

A discussion on guidelines to ensure the safety of ingredients new to infant formulas requires a broad understanding of the concepts and models of safety regulations and an in-depth review of infancy as a unique period that requires unique safety measures. This chapter describes fundamental concepts of safety regulations, statistical considerations in assessing food safety, models of safety assessment (including the Novel Foods model of Health Canada), and special considerations for ensuring the safety of infants and regulating infant formulas.

U.S. REGULATORY AGENCIES

Several federal, state, and local agencies monitor the safety and quality of substances that are ingested and inhaled by the general public. Each agency operates within its own domain using its own set of rules and procedures, but the agencies work collaboratively on some issues to ensure the safety and quality of food, water, and air. The Food and Drug Administration (FDA) has the primary responsibility for regulating ingredients new to infant formulas and other agencies serve in peripheral roles.

FUNDAMENTAL CONCEPTS OF SAFETY REGULATIONS

The terms safety, hazard, risk, harm, and benefit are central to the full understanding of safety assessment. Safety refers to a reasonable certainty of no harm (21 U.S.C §348) (e.g., for food ingredients in the U.S. regulatory system) or, in some systems (e.g., for pharmaceutical drugs in the U.S. regulatory system), a reasonable balance between costs (harm) and benefits. Safety is an intellectual concept; it is not an inherent biological property of a substance. Safety is described by noting a range along a continuum, not an absolute point or value. The relationship between biology and safety is mediated through concepts of harm, benefit, and risk. As such, the concept of safety and its assessment is influenced by many different organizations, individuals, and intellectual disciplines.

A hazard generally refers to some substance or combination of substances (organic or inorganic, or in some cases psychological) that may, under some circumstances or for some individuals, produce undesired health-related outcomes. Nearly any substance can have the potential to produce an undesired health outcome to some individual under some circumstance. Exposure to a hazard, however, does not guarantee that an undesired outcome will occur.

The likelihood that such an outcome will occur given exposure to a hazard is what is referred to as the risk of that hazard. The risk of a hazard is not a general (main effect) property of the substance, but rather it is an interaction between the nature of the hazard, the circumstances of the exposure (e.g., the magnitude, the timing, and the specific features of the individual, such as health status, age, and susceptibility), and other such conditions that moderate the actual health impact of the hazard.

Harm refers to the nature of the undesired outcome (usually a health outcome) associ-



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