Description
This guidance provides information to manufacturers on the action level of 10 parts per billion (ppb) or 10 micrograms/kilogram (µg/kg) for inorganic arsenic in apple juice that is intended to help protect public health by reducing exposure to inorganic arsenic and that is achievable by industry with the use of current good manufacturing practices. This guidance presents the background and rationale for FDA’s action level.
Scope & Applicability
Product Classes
3The primary product category addressed by the guidance.; The specific food product category subject to the action level guidance
Product category with a finalized action level for inorganic arsenic.
FDA is setting an action level for inorganic arsenic in single-strength apple juice
Stakeholders
2Responsible for declaring acceptable market names on labels.
Entity responsible for submitting NDINs
Regulatory Context
Attributes
3Action level for inorganic arsenic in rice cereals
LOQ defined as 2.8 ppb for arsenic species in the FY11 dataset
Lowest analyte concentration reliably differentiated from noise; analyte being measured should be absent or below the limit of detection in the laboratory reagent blank
Identified Hazards
Hazards
3risk assessment for pharmaceuticals affecting the immune system
quantitative assessment of the risk for cancer associated with exposure to inorganic arsenic
considerations including additional information on neurodevelopmental effects
Related CFR Sections (3)
- 21CFR109.6§ 109.6 Added poisonous or deleterious substances.
(a) Use of an added poisonous or deleterious substance, other than a pesticide chemical, that is also a food additive, will be controlled by a regulation issued under section 409 of the act when possible. When such a use cannot be approved under the criteria of section 409 of the act, or when the adRead full regulation →
- 21CFR109.4§ 109.4 Establishment of tolerances, regulatory limits, and action levels.
(a) When appropriate under the criteria of § 109.6 , a tolerance for an added poisonous or deleterious substance, which may be a food additive, may be established by regulation in subpart B of this part under the provisions of section 406 of the act. A tolerance may prohibit any detectable amount ofRead full regulation →
- 21CFR117.37§ 117.37 Sanitary facilities and controls.
Each plant must be equipped with adequate sanitary facilities and accommodations including:Read full regulation →
See Also (4)
- Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young Children (Status: Final)
- Guidance for Industry: Action Level for Inorganic Arsenic in Rice Cereals for Infants (Status: Final)
- Draft Guidance for Industry: Action Levels for Lead in Juice (Status: Draft)
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)