E. Lynn Grayson

Nanomaterial Reporting Rule Update

6a01310fa9d1ee970c01b7c901cfe4970bBy E. Lynn Grayson 

EPA recently extended the effective date of the final reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale. EPA has delayed the effective date of the January 12, 2017 final rule from May 12, 2017 to August 14, 2017.

Industry sought to repeal the rule, or at a minimum, obtain an extension of the effective until EPA adopts guidance explaining how to comply with the new two-fold requirements including: 1) companies that make, import or process a distinct or “discrete” form of a nanoscale chemical at some time in the future are to provide information to EPA (135 days before they make, import or process the chemical or within 30 days of deciding to manufacture or process the chemical); and 2) companies must comply with a one-time obligation to report information known or reasonably attainable regarding any nanoscale chemicals made or processed at any time during the past three years. Based upon the information EPA receives, the Agency could decide to require new toxicity, exposure or other data or it could decide to impose restrictions on commercial activity.

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DTSC Seeks Comments on New Safer Consumer Products Guidance

6a01310fa9d1ee970c01bb096080e5970dBy E. Lynn Grayson

The California Department of Toxic Substances Control (DTSC) has issued draft guidance titled Alternatives Analysis Guide and is seeking comments through January 20, 2017. California’s Safer Consumer Products (SCP) Program challenges product designers and manufacturers to reduce toxic chemicals in their products. According to DTSC, the SCP regulations establish innovative approaches for responsible entities to identify, evaluate, and adopt better alternatives. The SCP approach requires an Alternatives Analysis (AA) that considers important impacts throughout the product’s life cycle and follows up with specific actions to make the product safer. DTSC prepared the Draft Alternatives Analysis Guide to help responsible entities conduct an AA to meet the regulatory requirements. Public comments are specifically requested to provide DTSC with insight on the clarity and usefulness of the Draft Alternatives Analysis Guide.

DTSC’s SCP Program regulations took effect October 1, 2013 and are being implemented based on the various regulatory requirements. The goals of the program are to: 1) reduce toxic chemicals in consumer products; 2) create new business opportunities in the emerging safer consumer products industry; and 3) help consumer and businesses identify what is in the products they buy for their families and customers.

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FDA Limits Inorganic Arsenic in Infant Rice Cereals

By E. Lynn Grayson

The U.S. Food and Drug Administration (FDA) has proposed limiting the amount of inorganic arsenic allowed in infant rice cereal to 100 parts per billion (ppb). This action is consistent with the level set by the European Commission (EC) for rice intended for the production of food for infants and young children. Rice cereal is a leading source of arsenic exposure in infants. The FDA testing found that the majority of infant rice cereals currently on the market either meet, or are close to, the proposed action level.

The FDA announced the availability of the following documents: 1) a draft guidance for industry entitled Inorganic Arsenic in Rice Cereals for Infants: Action Level; 2) a supporting document entitled Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infant; and 3) a risk assessment report entitled Arsenic in Rice and Rice Products Risk Assessment Report. The draft guidance identifies an action level for inorganic arsenic of 100 ppb and outlines the FDA’s intended sampling and enforcement approach. The supporting  document reviews data on inorganic arsenic levels in rice cereals for infants, health effects, achievability of the proposed limitation and explains the FDA’s rationale for identifying the 100 ppb action level. The risk assessment report includes quantitative and qualitative components assessing the cancer risks of long term exposure to inorganic arsenic in rice and rice products.

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