(VCCEP) Tier 1 Pilot Submission for BENZENE - Tera

products had ceased” [46 Fed. Reg. 27910 (May 22, 1981)]. For further information about the
absence of benzene in consumer products, see Section 7.2.4 below.
The FHSA requires precautionary labeling on the immediate containers of hazardous household
products to help consumers safely store and use these products and to provide consumers
information about immediate first aid steps in the event of an accident. Implementing
regulations require special labeling of certain products containing benzene. Given that
substances containing 5% or more by weight of benzene are “hazardous,” products containing
benzene require special labels, including “danger,” “vapor harmful,” “poison,” and “harmful or
fatal if swallowed” [16 C.F.R. § 1500.14(a), (b)].
The PPPA requires that certain products be packaged in child-resistant packaging to protect
children under five from possible poisoning and death in the event that they open containers of
hazardous products and eat or drink the contents. CPSC regulations impose special packaging
requirements for numerous substances, including solvents for paint or other similar surfacecoating
materials that contain 10% or more by weight of benzene, or combinations of benzene
and certain other solvents, and that have a viscosity of less than 100 Saybolt universal seconds
at 100 °F (see 16 C.F.R. § 1700.14(a)(15)].
4.3 FDA Regulation
FDA regulates a myriad of products ranging from food ingredients and drugs to medical and
surgical devices; therefore, only a sample of FDA’s regulations relating to benzene are
discussed below.
In general, FDA limits the amount, if any, of benzene that can be contained in food and drugs.
Benzene is not an approved food additive that can be added directly to food for human
consumption (see 21 C.F.R. Part 172). Benzene is not an approved substance for use in the
food-contact surface of packaging for processing, transporting, or holding certain foods or for
use in other food-contact surfaces (see, e.g., 21 C.F.R. §§ 176.180, 177.1010). Benzene also
is not approved for use in food packaging cellophane (see 21 C.F.R. § 177.1200).
FDA limits the permissible amount of benzene in bottled water products to 0.005 mg/L [see 21
C.F.R. § 165.110(b)(4)(iii)(B)].
Furthermore, FDA also provides guidance on the amounts of residual solvents that are
considered safe in pharmaceuticals. According to FDA, benzene “should not be employed in
the manufacture of drug substances, excipients, and drug products because of [its]
unacceptable toxicity or [its] deleterious environmental effect.”. If, however, its use is
unavoidable, then the level of benzene should be limited to 2 ppm (FDA, Guidance for Industry,
Q3C—Tables and List).
4.4 OSHA Regulation
The Occupational Safety and Health Administration is the primary federal agency responsible
for establishing and enforcing workplace standards, including exposure limits for many
substances. The National Institute for Occupational Safety and Health (NIOSH) and the
American Conference of Governmental Industrial Hygienists (ACGIH) also develop and
recommend exposure limits for worker protection, although these limits are not enforceable.
Benzene VCCEP Submission
March 2006
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