The American Herbal Products Association (AHPA) submitted nearly 200 pages of comments and suggested revisions to the Food and Drug Administration (FDA) in response to the first two proposed rules issued to implement portions of the FDA Food Safety Modernization Act (FSMA).

The rules that FDA first proposed on Jan. 16, 2013, would create new regulations for human food manufacturers (Current Good Manufacturing Practice (cGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food) and subject certain farming activities to risk-based standards (Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption).

If implemented in the form proposed, the FSMA regulations for produce would impact the botanical products industry because FDA proposed that many of the botanicals used by AHPA members be classified as produce subject to these production standards. The proposed hazard analysis and risk-based preventive controls regulations for human food would not apply to cGMP-compliant dietary supplement manufacturers but would apply to suppliers of dietary ingredients and other component ingredients that are used by dietary supplement manufacturers.

In the comments, AHPA stressed that these proposed rules are the most far-reaching regulations FDA has ever promulgated, and that they will likely impact the entire U.S. food production system. Given the scope and potential impact of the proposed rules, AHPA urged FDA to publish a second set of proposed rules to collect additional comments.

"These proposals would likely increase costs and burdens significantly throughout the food production system. There is a very real risk that small-volume crops and products, as well as small companies, will be pushed entirely out of the marketplace, to the detriment of consumers and producers," said Staci Eisner, chair of AHPA's Government Relations committee. "The broad and deep impact of the new, proposed regulations necessitates regulatory restraint. AHPA's comments suggest ways FDA can streamline and focus the proposed rules to significantly minimize the burdens and costs while also preserving the new protections for food safety."

AHPA's comments are aimed at assuring that, once implemented, these rules do not unnecessarily burden AHPA members or their suppliers.

"AHPA's comments focus on minimizing costs of implementation by reducing redundancies and maximizing regulatory flexibility, and clarifying the specific language of these rules to eliminate as much confusion as possible when the rules are implemented," said AHPA President Michael McGuffin.

Comments on both proposed rules
Due to the complex interrelations between the two proposed rules, AHPA submitted comments that apply to proposed rules and individual comments on each rule separately.

In addition to urging regulatory restraint, AHPA's comments on both rules maintained that:

Comments on proposed produce safety rule
Regarding the proposed rule for produce, AHPA provided FDA with 60 pages of comments and suggested revisions.

These comments include a recommendation for FDA to invert the underlying assumption used to determine what the proposed rule would cover.  The proposed produce safety rule is predicated on the assumption that all covered produce will be required to comply unless the farmer identifies the commercial processor who will be responsible for reducing any associated microbial risks.

"This approach is not the most efficient or effective way to implement the new rule," AHPA commented. "It unnecessarily increases the scope and cost of the burden, and places a requirement to control the supply chain on entities (i.e., farmers) who are ill-equipped to enforce such control."

AHPA recommended moving the burden of determining whether compliance is necessary from the beginning of the supply chain, i.e., the farmer, to the end of the supply chain, i.e., the person who sells covered produce to retailers, such as grocers, or the final food processor in the supply chain.

AHPA also expressed concern that the proposed definitions of "produce," "fruit," and "vegetable" do not accurately capture the spectrum of commodities intended by Congress or FDA to fall within the scope of the proposed rule.

"The proposed definitions, as currently written, would encompass a wide variety of non-produce botanical crops used for human consumption, such as those used as or in production of spices, flavors, colorants, dietary ingredients, and excipients," AHPA commented.

Comments on Proposed Hazard Analysis and Risk-Based Preventive Controls Rule
AHPA submitted 130 pages of comments and suggested revisions covering a wide-range of issues. Among the comments are requests for FDA to:

FDA did not propose requiring product testing, environmental monitoring, or supplier approval and verification (SAV) in the proposed rule, but the agency requested comments from the industry on these topics. AHPA expressed general opposition to prescriptive requirements for product testing, environmental monitoring (other than temperature monitoring for foods that require refrigeration or freezing), and SAV because of the costs for consumers and the industry.

Regarding testing and monitoring, AHPA noted that they should be required only under carefully delineated circumstances when a hazard is fairly likely and acute (i.e., it may cause serious adverse health consequences or death). Regarding SAV, AHPA maintained that appropriate supplier approval and verification can be accomplished through review of the supplier's specifications and/or test results; certifications by third-party auditors; paper-based audits; or some combination of these. AHPA asserted that companies should have the flexibility to determine the best methods to ensure the suitability of the raw materials and ingredients they buy.

Next stepsFDA received thousands of comments on the proposed rules according to FDA's Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor.

"We now turn to the deliberations needed to craft a final rule," Taylor recently wrote in FDA's blog. "While some concerns may be addressed through more precise language, others may need more changes, and a few may require substantial changes in what we've proposed."

Taylor also said that FDA will engage stakeholders in the eventual implementation of the final rules.

"The AHPA FSMA comments were a huge effort led by Staci Eisner, chair of the AHPA Government Relations Committee, and AHPA President Michael McGuffin," said Tony Young, AHPA's general counsel. "Their combined experience in the manufacture of botanical raw materials and finished botanical products gave them great insight to aid AHPA in providing meaningful comments to FDA."