AHPA suggests revisions, clarifications in thick sheaf of comments on FSMA

04-Dec-2013 - Last updated on 04-Dec-2013 at 16:56 GMT

In a reflection of the broad nature of its membership, the American Herbal Products Association has submitted comments on two proposed Food Safety Modernization Act rules that run to nearly 200 pages. In part, the comments suggest ways to lessen the burden on small manufacturers who might otherwise be driven out of business by compliance costs.

The comments suggest revisions in two rules that are part of the rollout of FSMA, often referred to as the biggest change in the food safety regime in the United States since the advent of the Food, Drug and Cosmetic Act itself. The rules, first proposed on Jan. 16, 2013, are the Current Good Manufacturing Practice (cGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food (HARPC) and the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.

According to AHPA, the new rules could have a dramatic effect on its members’ businesses, because 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 GMP-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 organization’s goal is to minimize redundancies that could add up to big costs for smaller companies, said AHPA president Michael McGuffin.

"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," he said.

In commenting on both rules taken together, AHPA suggested that the definitions of “farm,” “mixed-use facility” and “harvesting” be clarified, and that the different safety considerations of ready-to-eat foods and non-RTE foods be taken into account. Also, the group urges that the safety burden be placed wherever possible on processors rather than farmers.

Comments on Proposed Produce Safety Rule

AHPA devoted 60 pages of comments specifically on the proposed produce safety rule. A basic underlying tenet of the comments is that FDA is placing the safety burden on the farmer, who is ill-equipped (except, perhaps, for vertically integrated operations) to control the conditions under which food is held and packaged after it leaves the field. The burden for determining compliance should be placed upon the entities that provide foods to customers and consumers, AHPA maintains.

Also, the comments seek additional clarification on the categories of food the rule covers. The present categories of “produce,” “fruit” and “vegetable” don’t really cover the waterfront as it exists, the group said. The rules as written could bring a number of botanical ingredient suppliers in under an umbrella that should apply more to suppliers of bulk whole foods.

"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.

HARPC comments

AHPA devoted 130 pages of comments to the proposed HARPC rule. The comments suggest clarifications in definitions of what type of facilities (such as very small operations) are exempt from certain requirements. AHPA also suggested that production codes be required in packaging and in records maintained by food facilities.

FDA engagement

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

In a blog post, Taylor wrote that "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.