Attachment_9.pdf

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FSMA Facts which requires importers to take steps to help ensure that imported human and animal food are as safe as that which is produced domes cally, as well as a pro-gram for the accredita on of third-party auditors, also known as cer fica on bodies, to conduct food safety audits and issue cer fica ons of foreign facili es and the foods for humans and animals they produce.

Acts of inten onal adultera on may take several forms, including those where the inten on is to cause large-scale public health harm; acts of disgruntled employees, consumers, or compe tors; and economi-cally mo vated adultera on. Acts of disgruntled em-ployees, consumers, or compe tors are generally di-rected at a acking the reputa on of the company and not at causing public health harm. The primary pur-pose of economically mo vated adultera on is to ob-tain economic gain, and not to impact public health, although public health harm may occur.

Inten onal adultera on of the food supply with intent to cause public health harm is unlikely to occur. How-ever, inten onal adultera on could have catastrophic results including human illness and death, loss of pub-lic confidence in the safety of food, and significant adverse economic impacts, including trade disrup on, all of which can lead to widespread public fear. Efforts to protect against inten onal adultera on require a shi in perspec ve from what is taken for tradi onal food safety. The FDA proposes an approach that tar-gets certain processes within a facility that are most likely to be vulnerable, rather than targe ng specific foods or hazards. The Agency recognizes the inherent challenges faced when crea ng prac cal and reasona-ble regula ons to address this kind of inten onal adultera on and seeks public input to help refine the approach and scope of the rule.

Summary FDA’s proposed rule on food defense would require domes c and foreign facili es to address vulnerable processes in their opera ons to prevent acts on the food supply intended to cause large-scale public harm. The proposed rule, which is required by the FDA Food Safety Moderniza on Act, would require the largest food businesses to have a wri en food defense plan that addresses significant vulnerabili es in a food opera on.

The FDA is proposing that the requirements be effec-ve 60 days a er the final rule is published in the Fed-eral Register. Recognizing that small and very small businesses may need more me to comply with the requirements, the FDA is proposing ered compliance dates based on facility size. The proposed rule was published on December 24, 2013, and comments are due by June 30, 2014. The FDA will hold a public mee ng on February 20, 2014, to explain the proposal and provide addi onal opportunity for input.

Background The FDA Food Safety Moderniza on Act (FSMA) was signed into law on January 4, 2011, to be er protect human and animal health by helping to ensure the safety and security of the food and feed supply.

FSMA embraces preven ng food safety problems as the founda on of a modern food safety system and recognizes the need for a global approach to food and feed safety. The FDA has proposed five addi onal rules that are founda onal to this preven ve ap-proach encompassed by FSMA. In addi on to the rule on inten onal adultera on, the FDA has proposed preven ve controls for human food and separately for animal food; standards for produce safety. FDA has also proposed two rules related to imports: the Foreign Supplier Verifica on Program for importers, U.S. Department of Health & Human Services / U.S. Food & Drug Administra on 1

Proposed Rule on Protec ng Food against Inten onal Adultera on

Food Defense Plan Each facility covered by this rule would be required to prepare and implement a wri en food defense plan, which would include the following:

Ac onable process steps: Iden fy any ac onable process steps, using one of two procedures. The FDA analyzed data from vulnerability assessments conducted using the CARVER+Shock methodology and iden fied four key ac vity types, as described above. The FDA has determined that the presence of one or more of these key ac vity types at a process step indicates a significant vulnerability to inten onal adultera on aimed at large-scale pub-lic harm. Facili es may iden fy ac onable process steps using the FDA-iden fied key ac vity types or conduct their own facility-specific vulnerability assessments.

Focused mi ga on strategies: Iden fy and imple-ment focused mi ga on strategies at each ac on-able process step to provide assurances that the significant vulnerability at each step will be signifi-cantly minimized or prevented and that food manufactured, processed, packed, or held by the facility will not be adulterated.

Monitoring: Establish and implement procedures, including the frequency with which they are to be performed, for monitoring the focused mi ga on strategies.

Correc ve ac ons: Using correc ve ac ons if focused mi ga on strategies are not properly implemented.

Verifica on: Verifica on ac vi es would ensure that monitoring is being conducted and appropri-ate decisions about correc ve ac ons are being made. It would also help ensure that the focused mi ga on strategies are consistently implement-ed and are effec vely and significantly minimizing or preven ng any significant vulnerabili es. In addi on, the rule includes requirements for peri-odic reanalysis of the food defense plan every three years or under certain condi ons.

U.S. Department of Health & Human Services / U.S. Food & Drug Administra on 2

Proposed Rule on Protec ng Food against Inten onal Adultera on

Who is Covered?

With some excep ons, this proposed rule would apply to both domes c and foreign facili es that man-ufacture, process, pack, or hold food and are required to register as a food facility under sec on 415 of the FD&C Act. This rule does not apply to farms or other food facili es not required to register under sec on 415 of the FD&C Act. More informa on about exemp-ons from this proposed rule can be found in the chart at the end of this fact sheet.

Highlights of the Proposed Rule The subject of this proposed rule is to protect food from inten onal adultera on when the intent is to cause large-scale public harm. The FDA has iden fied four key ac vi es within the food system that are most vulnerable to such forms of adultera on. They include:

bulk liquid receiving and loading;

liquid storage and handling;

secondary ingredient handling (the step where ingredients other than the primary ingredient of the food are handled before being combined with the primary ingredient); and mixing and similar ac vi es.

Facili es would be required to review their produc-on system to determine if they have any of these ac vity types or complete their own vulnerability as-sessment. Once that is completed, they would need to iden fy ac onable process steps, which are points, steps, or procedures in a food process that will re-quire focused mi ga on strategies to reduce the risk of inten onal adultera on. Facili es are also required to complete a wri en food defense plan. Once in place, this proposed rule would establish measures that a food facility would be required to implement to protect against the inten onal adultera on of food.

Effec ve and Compliance Dates and Defini ons for Small and Very Small Businesses The FDA is proposing the effec ve date for businesses subject to the new requirements to be 60 days a er the final rule is published. Recognizing that small and very small businesses may need more me to comply with the requirements, the compliance dates are adjusted accordingly.

Compliance Dates:

Very Small Businesses—a business that has less than $10,000,000 in total annual sales of food would have to comply within three years a er the publica on of the final rule.

Small Businesses—a business employing fewer than 500 persons would have to comply two years a er the publica on of the final rule.

Other Businesses—a business that is not small or very small and does not qualify for exemp ons would have to comply one year a er the publica-on of the final rule.

Economic Impact of the Proposed Rule The proposed rule is aimed at preven ng inten onal adultera on from acts intended to cause massive public health harm, including acts of terrorism. Such acts could cause illness, death, economic disrup on of the food supply including disrup on of trade, and loss of public confidence in the food supply. The cost of the proposed rule to both domes c and foreign firms, annualized over 10 years at a 7 percent discount rate, is between $260 million and $470 million. The first-year cost is between $520 million and $860 million.

The average annualized cost per firm is about $37,000, with ini al costs of $70,000. (This is an aver-age per-firm cost, and firms may have more than one facility. The annualized cost for a one-facility firm with 100 employees is about $13,000.) The expected bene-fit of preven ng a catastrophic terrorist a ack on the US food supply is about $130 billion, which means that the benefits of this rule outweigh the costs to Americans if the rule has a 1 in 730 or be er annual

U.S. Department of Health & Human Services / U.S. Food & Drug Administra on 3

Proposed Rule on Protec ng Food against Inten onal Adultera on

Training: Personnel and supervisors assigned to the ac onable process steps would be trained in food defense awareness and in their responsibili es for implemen ng focused mi ga on strategies.

Recordkeeping: Establish and maintain certain records, including the wri en food defense plan;

records documen ng monitoring, verifica on ac vi es and correc ve ac ons, and documenta-on related to training of personnel.

Appendix to the Dra Qualita ve Risk Assessment of Risk of Ac vity/Food Combina ons for Ac vi es (Outside the Farm Defini on) Conducted in a Facility Co‐Located on a Farm The FDA requested comment on a dra qualita ve risk assessment when it announced the proposed rule for preven ve controls for human food. The dra qualita ve risk assessment is designed to provide a science-based risk analysis of those on-farm ac vity/ food combina ons that would be considered not rea-sonably likely to introduce uninten onal hazards that are reasonably likely to cause serious adverse health consequences.

With the announcement of this proposed rule, the FDA is publishing for comment Appendix 4 to the dra RA (the dra RA Appendix). The purpose of the dra RA Appendix is to provide a science-based risk analysis of those food produc on ac vi es conducted on-farm that would be considered low risk with respect to the risk of inten onal adultera on caused by acts of terrorism. We are considering the results of this analysis in determining any specific exemp ons or modified requirements. We request comment on whether we should exempt on-farm manufacturing, processing, packing, or holding of the foods iden fied as having low-risk produc on prac ces when con-ducted by a small or very small business if such ac vi-es are the only ac vi es conducted by the business that are subject to sec on 418 of the FD&C Act.

For Addi onal Informa on FR No ce FDA Food Safety Moderniza on Act web site Fact Sheet: Preven ve Controls for Human Food Fact Sheet: Standards for Produce Safety Fact Sheet: Foreign Supplier Verifica on Program for Importers of Food Fact Sheet: Accredita on of Third Party Auditors Fact Sheet: Preven ve Controls for Animal Food The Food Safety Law and the Rulemaking Process:

Pu ng FSMA to Work Video: The Rulemaking Process: A Primer by FDA Video: FDA Food Safety Moderniza on Act: A

Primer by FDA

Updated: 3/28/14

U.S. Department of Health & Human Services / U.S. Food & Drug Admin-

Proposed Rule on Protec ng Food against Inten onal Adultera on chance of preven ng such an a ack. The document is available at h p://www.fda.gov/downloads/Food/ GuidanceRegula on/FSMA/UCM378630.pdf.

Rulemaking Process and How to Submit Comments The proposed rule, “Focused Mi ga on Strategies to Pro-tect Food against Inten onal Adultera on,” is published in the Federal Register so that the public can review it and submit comments. FDA considers comments received during the comment period on the proposed rule and then considers revising the rule, based on its review of the comments, before issuing a final rule. The proposed rule and suppor ng documents are filed in the FDA’s official docket on h p://www.regula ons.gov and also can be accessed at www.fda.gov/fsma. Comments are due by June 30, 2014.

The FDA will hold a public mee ng on February 20, 2014, in College Park, MD. The FDA will conduct addi-onal outreach during the comment period, which may include addi onal public mee ngs.

Assistance to Industry The FDA will publish within six months of publica on of the final rule a guidance document that provides the requirements in plain language to help businesses, par-cularly small businesses, comply with the iden fica-on of ac onable process steps and implementa on of focused mi ga on strategy requirements.

https://www.federalregister.gov/articles/2013/12/24/2013-30373/focused-mitigation-strategies-to-protect-food-against-intentional-adulteration� http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm� http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM360735.pdf� http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM359258.pdf� http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM362557.pdf� http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM362557.pdf� http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM362557.pdf� http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM362557.pdf� http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM362561.pdf� http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM368997.pdf� http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM277713.pdf� http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm249243.htm#rulemaking� http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm249243.htm#primer� http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm249243.htm#primer� http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm249243.htm#primer� http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm249243.htm#primer� http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM378630.pdf� http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM378630.pdf� http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM378630.pdf� http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM378630.pdf� http://www.regulations.gov� http://www.fda.gov/fsma�

U.S. Department of Health & Human Services / U.S. Food & Drug Administra on 5

Proposed Rule on Protec ng Food against Inten onal Adultera on

Exemp ons and Modified Requirements for Focused Mi ga on Strategies to Protect Food against Inten onal Adultera on*

Type of facility or opera on Exempt Status

A very small business (a business that has less than $10,000,000 in total annual sales of food, adjusted for infla on)

Exempt, but would be required to provide to FDA, upon request, documenta on relied on to demonstrate that the business is very small.

The holding of food, except the holding of food in liquid storage tanks

Exempt

The packing, re-packing, labeling or re-labeling of food where the container that directly contacts the food remains intact

Exempt

Ac vi es that fall within the defini on of “farm” Exempt

Manufacturing, processing, packing, or holding of food for animals

Exempt

Alcoholic beverages under certain condi ons Exempt

* This chart does not contain all of the informa on necessary to determine the proposed requirements for compliance in a par cular circumstance. Consult the proposed rule for specific requirements.

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/HRV (Za stvaranje Adobe PDF dokumenata najpogodnijih za visokokvalitetni ispis prije tiskanja koristite ove postavke. Stvoreni PDF dokumenti mogu se otvoriti Acrobat i Adobe Reader 5.0 i kasnijim verzijama.)

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<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> /RUM <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> /RUS 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<FEFF005900fc006b00730065006b0020006b0061006c006900740065006c0069002000f6006e002000790061007a006401310072006d00610020006200610073006b013100730131006e006100200065006e0020006900790069002000750079006100620069006c006500630065006b002000410064006f006200650020005000440046002000620065006c00670065006c0065007200690020006f006c0075015f007400750072006d0061006b0020006900e70069006e00200062007500200061007900610072006c0061007201310020006b0075006c006c0061006e0131006e002e00200020004f006c0075015f0074007500720075006c0061006e0020005000440046002000620065006c00670065006c0065007200690020004100630072006f006200610074002000760065002000410064006f00620065002000520065006100640065007200200035002e003000200076006500200073006f006e0072006100730131006e00640061006b00690020007300fc007200fc006d006c00650072006c00650020006100e70131006c006100620069006c00690072002e> /UKR <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> /ENU (Use these settings to create Adobe PDF documents best suited for high-quality prepress printing. Created PDF documents can be opened with Acrobat and Adobe Reader 5.0 and later.)

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