8/8/2019 Small Business Guide & Support Letter

1/3

S. 510 - FDA Food Safety Modernization ActSmall Farm and Small Business Guide

No Change in Agency for Regulated Foods- Only foods already regulated by the Food and Drug Administration (FDA)will be subject to S. 510. Section 403 maintains the existing firewall between FDA and the U.S. Department of Agriculture regulated foods and agricultural products.

No Change in Definition of Facility- Under the Bioterrorism Act of 2002, certain food businesses were consideredfacilities and had to register with FDA. Farms and restaurants were exempted. This definition is not changed in S. 510.If an entity does not need to register now, it will not need to register under S. 510.

Flexibility for Small Businesses - Small businesses are given regulatory flexibility throughout S. 510. For example, smallprocessors are given additional time to comply with new food safety practices and guidelines created by the bill and theSecretary may modify or exempt small processors from new hazard analysis and preventive control requirements based onsize and risk. The legislation also requires the FDA to publish several user-friendly small entity compliance guides toassist firms with the implementation of new practices.

Scale Appropriate Produce Safety Standards - In coordination with the Secretary of Agriculture, FDA developsscience-based standards for the safe production and harvesting of fruits and vegetables. Priority is given to specific fruitsand vegetables that have the highest risk of food borne illness outbreaks. Flexibility is given for different growing,production, and harvesting techniques. FDA has the discretion to limit produce safety standards for small and very smallentities that produce or harvest food which pose little or no serious risk to human health. Consideration is also given toconservation and environmental standards already established by federal natural resource and wildlife agencies.Exemptions are also available for low risk commodities. FDA must minimize the burden of paperwork and, asappropriate, the number of separate standards for separate foods.

Increased Training Opportunities- The bill requires FDA to coordinate with the extension activities of the NationalInstitute of Food and Agriculture (NIFA) of the U.S. Department of Agriculture in educating growers and smallprocessors about any new practices required by S. 510. Necessary funds are authorized to conduct these extensionactivities. The bill also provides for the training and education of state, local, and tribal authorities to facilitate theimplementation of new standards under the FDA Food Safety Modernization Act. Competitive grants are made available,for up to 3 years, to support these efforts to enhance education, training, and technical assistance.

Risk-Based Traceability- The ability to trace back potentially unsafe food in the event of a food-borne illness outbreak isimportant. For the purpose of traceability, farms and small businesses that are not food facilities are not expected tocreate new records. During an active investigation of a foodborne illness outbreak, in consultation with state and localofficials, the Secretary may ask a farm to identify potential immediate recipients of food if it is necessary to protect publichealth or mitigate a foodborne illness outbreak. Limitations are also included for restaurants, commingled agriculturalcommodities, direct to consumer sales, fishing vessels and products carrying an identity preserved label.

Regulatory Flexibility for Organic Foods - Throughout the bill, consideration is given to the unique agriculturalpractices and requirements of organic foods under the Organic Foods Production Act of 1990.

Protections for Farmers Markets, Cottage Industries and Direct Farm-to-Market Sales- Small entities that producefood for their own consumption or market the majority of their food directly to consumers are not subject to registration ornew recordkeeping requirements under S. 510. This includes food sold through farmers markets, bake sales, publicevents and organizational fundraisers.

Farm and Facility Size Exemption- Small food processors that make most of their sales directly to consumers and haveless than $500,000 in annual sales are exempt from preventive controls/HACCP provisions in Section 103 of the bill.Small farms that market most of their sales directly to consumers and have less than $500,000 in annual sales are exemptfrom produce safety standards under Section 105 of the bill. Such food must be sold within the same state or within 275miles from where it was processed or harvested and disclose to consumers the location from which the food originated.

8/8/2019 Small Business Guide & Support Letter

2/3

110 Maryland Avenue NE, Suite 209 Washington, DC 20002-5622p (202) 547-5754 f (202) 547-1837 www.sustainableagriculture.net

ATT: Food Safety; Agriculture

November 24, 2010

Dear Senator:

Our nationwide coalition of family farm, food system, and rural organizations urge your support forthe Managers amendment to S.510, the Food Safety Modernization Act, including the Tester-Haganprovision.

We believe the HELP Committee and the bills sponsors have thoughtfully considered the impact of the measure on the family farmers, natural resource conservation, organic farming, local and regionalfood enterprises. The Senate bill is a vast improvement over the House measure, and we urge youto pass it and send it to the House for their final consideration during this session of Congress.

Sadly, the bill as a whole and the Tester-Hagan amendment in particular have been recently thesubject of wild and inaccurate claims. Within agriculture, the amendment has been attacked by industry trade associations as too permissive and the bill by some food freedom advocates as an toohighly regulated. We believe the bills managers have achieved a responsible balance between theseextremes. Many of the letters and communications in opposition to the bill or the amendment haveplayed fast and loose with the actual facts, trying to break apart the carefully considered andnegotiated bipartisan package.

The ultimate outcomes of the legislation will depend on decisions to be made during theimplementation phase by the FDA, and no one can be sure what those outcomes will be. Onbalance, we believe the farm sector is better off with rather than without the bill. The alternative

from the farm perspective FDA regulation in the absence of congressional directives is the morerisky and less palatable choice.

The Tester-Hagan provision in the Managers amendment assures food safety while granting freedom of choice that Americans deserve and expect as well as the opportunity for success thatfarms and food producers need. Specifically, the Tester-Hagan provision of the Managersamendment mandates additional levels of food safety assurances not currently in place for smallscale on-farm and independent processors by requiring them to submit proof to FDA of compliance

with either State and local requirements where they exist or alternatively with FDA food safety planrequirements appropriate to the scale of operation and distribution, and also to provide theircustomers with the name and address of the farm or business.

The Tester-Hagan provision complements other parts of the Managers Amendment that advancethe continuous improvement of best practices by providing increased training and scale appropriateoversight and verification. The Managers package successfully guides FDA away from a one-size-fits-all regulatory structure that would defeat the dual goal of improving real world food safety outcomes and advancing public health by growing the fresh healthy food, healthy farm, healthy community connection.

8/8/2019 Small Business Guide & Support Letter

3/3

The Tester-Hagan provision harmonizes with the FDA's integrated national food safety system initiative which relies on an effective network of local, state, and federal authority andpersonnel to assure maximum safety of all food reaching the plates of Americans. Although theintegrated approach has been made more urgent by increasing globalization and complexity in thefood system, this approach is relevant to the entire food system, as it relies heavily on coordination

between local, regional, and Federal agencies, empowering each in ways that increase theireffectiveness in their specific jurisdictions. This model of distributed responsibility is reflected in thedetails of the amendment.

In light of the disinformation campaign about the amendment, we feel it necessary to mention thefollowing salient features of the Managers amendment with Tester-Hagan included:

FDA's current authority is in no way diminished; Qualified food facilities, including farms, still must register with FDA; Qualified facilities must submit evidence to FDA of either Federal or State and local food

safety compliance;

FDA and State and local authorities may still inspect or conduct investigations of qualifiedfacilities; FDA may issue recall notices or quarantines if an FDA investigation reveals a food safety

problem in a qualified facility; FDA can issue a recall and require additional federal measures to assure any problems are

corrected; and If FDA determines, in the absence of a formal investigation, that there are material

conditions in a qualified facility that threaten food safety, then FDA can issue a recall (if appropriate) and require additional federal measures to assure any problems are corrected.

As a result, FDA and the States have ample authority to ensure food safety at the local level.

Contrary to some of the rhetoric seen in recent industry letters, the sky is not falling. Inclusion of the Tester-Hagan language in the Manager's amendment is an important step in the reorienting of our food system toward a balanced approach to feeding the world safe and healthy food whilesupporting rural and urban communities. It will be more effective, in costs and outcomes, than theone-size-fits-all approach large-scale processors would prefer to foist on family farmers and localfood entrepreneurs, and will contribute to the economic recovery that we all anxiously seek.

Thank you for your consideration of our views on this important matter. Your support of theManagers Amendment to S510 will help make food safer without undermining FDA's authority and

without creating an unacceptable barrier to the growth of new farming and food businessopportunities to provide high quality, healthy food and economic growth and jobs.

Sincerely,

Ferd HoefnerNSAC Policy Director