Food Safety Modernization Act

Supplemental Proposed Rules(Commenting period, Round 2 closes

December 15, 2014!!)

FSMA Background

• Gives FDA broad new powers to prevent food safety problems, detect and respond to food safety issues.

• Authorizes new regulations for farmers who grow certain kinds of fresh produce (fruits and vegetables) and for certain facilities that process food for people to eat.

• Supplemental Proposed Rules reflect changes from the first round of comments.

Produce Rule

• New standards for the growing, harvesting, packing, and holding of produce for human consumption

• Applies to fruits and vegetables normally consumed raw, such as apples, carrots, lettuce, onions, and tomatoes

Farm Definition

• Farm physical location (to include both contiguous and non-contiguous parcels)

• Ownership structure (include food hubs and other cooperatives, individual and joint ownerships, as well as leasing situations)

• Farm Activities (harvesting and holding)

Covered Produce vs. All Produce

• Sales threshold to determine if farm is regulated under FSMA

• From ALL food to ALL produce – now to only covered produce?

Modified Requirements and Withdrawing Exemptions

• Clarity and consistency of process of withdrawing and reinstating exemption, including clear timeframe

• Process needs to allow for opportunity to rectify situation and avoid withdrawal of exemption

Agricultural Water Standards

• Must take science- and risk-based approach in establishing standards

• Testing regime: frequency, source, data sharing, baseline survey

• Align with current GAP standards

Biological Soil Amendments

• Raw manure application changed from 9 months to zero

• Research and risk assessment needed• Interim standard that aligns with both the

NOP regulations and GAP standards of 90/120 days

Conservation and Wildlife

• Support and encourage co-management• Promote conservation practices• Define co-management– farm system management approaches that respond

to site-specific conditions by integrating cultural, biological and mechanical practices that promote ecological balance and public health by conserving and improving biodiversity, soil, water, air, energy, and other natural resources, while also reducing pathogen hazards associated with food production.

Paperwork & Recordkeeping

• Limit to those kept in the ordinary course of business

• Preserving records for one year• Accepting written paperwork, not only

electronic

Preventive Control Rule• A food facility manufactures, processes, packs,

or holds human food• Certain on-farm activities may classify a farm

as a “facility” & the farm would be subject to the requirements of the PCR

• Two main parts:– New requirements for hazard analysis and risk-

based preventive controls, and– Revisions to existing Current Good Manufacturing

Practice (GMP) requirements.

Farm Definition

• FSMA’s framework directs FDA to narrowly define facility and broadly define farm

• Prevent farms from being incorrectly labeled as facilities and subject to duplicate regulations

Retail Food Establishment

• A Retail Food Establishment is not regulated by the PCR

• Definition should include the sale and distribution of food through a community supported agriculture program, roadside stand, farmers market, or other direct-to-consumer platforms

Very Small Business Definition

• Retain the threshold of at least $1,000,000,• Apply it not to sales of “human food” but to

sales of food regulated

Supplier Verification

• Violates Congress’ express prohibition that the FDA not require domestic farms and facilities to undergo third-party audits

• Should be removed from the proposed rule

COMMENT TODAY!

• FDA open commenting period closes

DECEMBER 15, 2014

• Visit www.newenglandfarmersunion.orgfor information and tips on commenting.