implementation status fsma final rule produce safety

7/25/2019 Implementation Status Fsma Final Rule Produce Safety

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Food Safety

Modernization Act

San Jose, Costa Rica

May 11, 2016

Allan Gonzlez, M.Sc.Analista Regulatorio InternacionalOficina Regional para LatinoamricaAdministracin de Alimentos y Medicamentos (FDA)Embajada EEUU, San Jos, Costa Rica


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FDA and Latin America Regional Office

Overview and status of implementation of FSMA

Final Rule: Produce Safety

Agenda


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What is FDA? Public Health with regulatory aspect, with

jurisdiction over the following products which are consumed in U.S.

Human Drugs

Prescription, over the counter(OTC), generic

Vaccines, blood products

and other biological products

Blood Supply

Medical Devices

From simple items such astongue depressors, to complextechnologies such aspacemakers

Products that emit radiationMicrowave ovens, tanningbeds, laser pointers

Food

Food safety, food additives(including radiation used totreat food), infant formulas,dietary supplements, foodutensils, containers

Cosmetics

Veterinary Products

Livestock feed, pet food,animal drugs

Tobacco Products

Color additives (for food,drugs, cosmetics)


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Important aspects of Food Safety

System in the US.

Shared responsibility between FDA, USDA andEPA

FDA regulates food "interstate commerce"

Transparency of regulations and standards

The same rules for domestic and internationalproduction

All regulations have scientific / risk / and preventive

basis Consistency and predictability of performance


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FDA is responsible for the safety of 80% of all food consumed inthe US. It Includes supply of domestic and imported foods

Exceptions

Meat and meat products

Poultry and poultry products

Frozen and processed eggs,

dried, liquid

Animal and plant health

FDA vs. USDA Jurisdict ion:

http://www.f

da.gov/downloads/ICECI/Inspections/IOM/UCM127390.pdf

USDA

Regulated

Important aspects of the US Food

Safety System
http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM127390.pdfhttp://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM127390.pdfhttp://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM127390.pdf


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Human food groups under FDA

jurisdiction

Dairy products

Milk Cheese

Butter and other dairyproducts (ice cream, yogurt,cream)

Vegetables and derivatives Vegetables

Fruits

Nuts

Juices

Spices and seasonings, foodadditives

Infant formula

Fish and Seafood Fish

Seafood

Crustaceans

Surimi based on themGrains y derivatives

Bread

Cereals

Flours /Confectionary

Dietary Supplements

Bottled water and drinks


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FDA International Offices

Beijing

Santiago

Mexico City

San Jose

New Delhi

Mumbai

London

Brussels

Headquarters

Silver Spring, MD


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Regional Offices Functions

To establish links with competent authorities tobetter understanding of the regulatory systemsand information exchange

To collaborate and coordinate with competentrelevant authorities and institutions in areas ofoutreach and training to help ensure safety and/ or effectiveness of FDA-regulated products.

To help to obtain a better chance of compliancefor products that are exported to the US.

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Functions of Regional Offices

To work with the regulated industry in compliance

To increase the ability to make more timely andproductive inspections

To coordinate and collaborate with sister agencies

of US Gob. (FAS, APHIS, FSIS, EPA, Commerce)with representatives in the region, in areas ofmutual interest: dissemination, training, technicalassistance.

To provide technica assistance

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FDA - Latina America Regional

Office

OIP-LAO-MexicoPhilip Budashewitz

Patricia Oliva Romero (Admin.)

Medical Devices and Cosmetics:

Rafael Nevarez

Ana Patricia Pineda

Human and Animal Food

Ana Lilia Sandoval

Office coverage: Mexico

Phone number: +52 55 5028-5440

OIP-LAO-ChileJulio Salazar

Soledad Muoz (Admin.)

Gonzalo Ibanez

Office coverage:

South America

Phone number: +52 2 2330-3035

OIP-LAO-Costa RicaEdmundo Garcia

Marcia Miller (Admin.)

Kenneth Nieves

Allan Gonzlez

Office coverage:

Central Americ and Caribbean

Phone number: +506-2519-2224

FDA- Latin America Regional Office

Edmundo Garcia, DirectorPhilip Budashewitz, Deputy DirectorInboxo for assistance: [email protected]

Telephone number: +(506) 2519-2224
mailto:[email protected]:[email protected]


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Latin America Regional Office:

Coverage and Profile

FDA-LAO provides attention to 44 countries

and territories, includding Mexico, Central

America, South Americ and the Caribbean

~ 30% all products regulated by FDA comefrom Latin America and the Caribbean.

The imported products from the region are: 48% Food 47% Medical devices 5% Drugs, biological products,

tobacco, feed (*FY14 data) Clinical research sites: Argentina, Brazil

and Mexico are the largest in the region


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FSMA

Food Safety Modernization Act

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Why a new law is needed?

Foodborne illnesses are a significant burden

In U.S.:

Aproximately 48 million (1 in 6 Americans) get sick ayear

128,000 are hospitalized

3,000 die

http://www.cdc.gov/foodborneburden/index.html

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http://www.cdc.gov/foodborneburden/index.htmlhttp://www.cdc.gov/foodborneburden/index.htmlhttp://www.cdc.gov/foodborneburden/index.html


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Food Safety Modernization Act

Food Drug andCosmetics Act (1938).Amendment (1973).

President Obama signedFood SafetyModernization Act onJanuary 4, 2011.

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Rules

1. Preventive Controls for Human Food

2. Preventive Controls for Animal Food

3. Produce Safety

4. Foreign Supplier Verification Programs

5. Accredited Third-Party Certification

6. Sanitary Transportation of Human and Animal Food

7. Focused Mitigation Strategies to Protect Food Against

Intentional Adulteration


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FSMA Main Topics

Prevention

Inspections,Compliance,and Response/Application

Import Safety

EnhancePartnerships


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New resources for FDA under FSMA

Authority to order product recalls.

Suspension of registration (inscription)

Biannual Renewal of Registrations

Fees for re-inspections and recalls

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Import Safety: the most revolutionary

change of FSMA

It is required that foreign foods exported to the EEU are as safe and reliableas those produced domestically.

US importers will now be responsible for ensuring that their foreignsuppliers have adequate preventive controls implemented

FDA can rely on third parties to certify that food companies meet USrequirements

Mandatory certification may be required for high-risk foods

Voluntary Qualified Importer Program (VQIP) - expedited review

Product entry may be denied if FDA access to a company to carry out aninspection is refused.

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Ph I S i S d d


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Regulation Proposal Final

Preventive Controls for HumanFood*

Jan. 16, 2013 Set 17, 2015

Preventive Controls for Animal Food* Oct. 29, 2013 Set 17, 2015

Produce Safety* Jan. 16, 2013 Nov 13, 2015

Foreign Supplier VerificationPrograms*

Jul. 29, 2013 Nov 13, 2015

Accredited Third-Party Certification Ju. 29, 2013 Nov 13, 2015

Sanitary Transportation of Humanand Animal Food

Feb. 5, 2014 Abr 06, 2016

Intentional Adulteration Dec. 24, 2013 May 31, 2016

*Addi tional proposals published in September 2014

Phase I: Setting Standards


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Final Rule on Produce Safety

http://www.fda.gov/fsma


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Background - 1

FDA issued proposed rule on Jan. 16, 2013.

Proposed standards for the growing, harvesting,packing, and holding of produce

FDA issued supplemental notice of proposed rulemaking on Sept. 29,2014.

Described FDAs thinking on specific issues relatedto:

coverage of rule, water quality, raw manure, wildlife

conservation, and withdrawal of qualified exemption


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Background - 2

Final comment period closed on December 15, 2014Extensive stakeholder outreach and input

Four public meetings; various outreach efforts

About 36,000 submissions, including over 15,000 unique

comments, in response to both 2013 and 2014documents

Input from various sectors of stakeholder community


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Regulatory Framework

Framework considers many factors associated withproduce and the farming community, including

Diversity of operations

Broad range of crops and practices

Integrated approach that draws on current scientificinformation, outbreak data, past experiences

Focuses on identified routes of contamination,rather than commodity-based

Includes Current Good Manufacturing Practice-like provisions; numerical criteria; and monitoringprovisions


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Produce Rule Documents

Final rule

Qualitative Assessment of Risk (QAR)

Regulatory Impact Analysis (RIA)

Environmental Impact Statement (EIS) and Record of Decision (ROD)

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Coverage of RuleCovers

Domestic and imported produce

Produce for human consumption

Does not cover

Produce for personal or on-farm consumption

Produce not a raw agricultural commodityCertain specified produce rarely consumed raw

Farms with produce sales of $25,000 per year

Eligible for exemption (with modified requirements)

Produce that will receive commercial processing (kill-stepor other process that adequately minimizes hazards)

Qualified exemption


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Farms

Farm definition was revised to clarify that the relevant entity is thefarm business

First defined as part of Implementation of the Bioterrorism Act of 2002,for registration and recordkeeping regulations (21 CFR Part 1,subparts H and J)

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Primary Production Farm

An operation under one management in one general, but

not necessarily contiguous, physical location

Devoted to the growing of crops, the harvesting of crops, theraising of animals, or any combination of these activities

In addition to these activities, a primary production farm can:

Pack or hold RACs (regardless of who grew or raised them)

Manufacture/process, pack, or hold processed foods so long as:

all such food is consumed on that farm or another farm underthe same management; or

the manufacturing/processing falls into limited categories

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Secondary Activities Farm

An operation not located on a primary production farmdevoted to harvesting, packing, and/or holding RACs

The primary production farm(s) that grow, harvest,and/or raise the majority of those RACs must own or

jointly own a majority interest in the secondary activitiesfarm

The definition also allows certain, limited additionalmanufacturing/processing, packing, and holding

Same as those for a primary production farm

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Activities That Do Not Fall


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Activities That Do Not FallUnder Farm Definition

Manufacturing/processing that goes beyond activities within the farmdefinition

Examples include:

Pitting dried plums, chopping herbs Making snack chips from legumes

Roasting peanuts or tree nuts

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Qualified Exemption

Farms are eligible for a qualified exemption (andmust meet certain modified requirements) if:

Less than $500,000 annual food sales; and

Majority of food sales to qualified end-users, i.e., Consumer of the food; or

Restaurant or Retail food establishment located in the samestate or Indian reservation, or located within 275 miles offarm

(The term consumer does not include a business.)

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Variances - Flexibility

A state, tribe, or foreign country may petition FDAfor a variance from some or all provisions

if necessary in light of local growing conditions

Practices under the variance need to provide thesame level of public health protection as the ruleand not increase the risk that produce is adulterated

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Alternatives Flexibility

Farms may establish alternatives to certain,specified requirements only

Farm must have scientific information that thealternative provides the same level of publichealth protection as the relevant requirementand does not increase the likelihood of

adulteration

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Standards for Produce Safety

Focus on conditions and practices identified as potentialcontributing factors for microbial contamination

Agricultural water

Biological soil amendments of animal origin

Worker health and hygiene

Equipment, tools, buildings and sanitation

Domesticated and wild animals

Growing, harvesting, packing and holding activitiesSprouts requirements

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Agricultural Water - 1

Safe and adequate sanitary quality of waterInspection of water system under farms control

Water treatment, if a farm chooses to treat water

Tiered approach to water testingSpecific microbial criteria for water used for certain

purposes

Corrective measures

Records requirements

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Agricultural Water-2

Water used during growing activities for produce other

than sproutsFrequency of testing dependent on water source

Lower frequency for untreated groundwater

Higher frequency for untreated surface water

Microbial Water Quality Profile (MWQP)

Initial survey to develop MWQP

Minimum of 2 years, but no more than 4 years

Annual survey to update MWQP using a rolling dataset Re-characterize MWQP under certain conditions

Enables farms to understand their water source to determineappropriate use

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Agricultural Water - 3

Stringency of microbial criteria is dependent on use:

For activities e.g. post-harvest wash, sprout irrigation No detectable generic E. coli

For growing activities such as non-sprout irrigation

GM of 126 CFU/100 mL or less generic E. coli and STV of 410CFU/100 mL or less generic E. coli

Allows for microbial die-off in-field, between last irrigation andharvest, of up to 4 consecutive days

Allows for microbial reduction or removal post-harvest, including

through commercial practices or storage

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Biological Soil Amendments


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Biological Soil Amendmentsof Animal Origin - 1

Standards for treated and untreatedRestrictions on application method depending on

treatment status

Application-to-harvest interval for certain untreated

BSAs of animal origin is [reserved] Currently working on risk assessment

Processes for meeting treated standard for BSAs ofanimal origin, including two examples for composting

The microbial standards are not testing requirements

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Training Requirements

Requirements include:

All personnel who contact covered produce orfood-contact surfaces

Establishes minimum content expectationsfor training

Training for supervisors

Record requirements

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Worker Health and Hygiene

Pathogens may be transmitted from workers to food


Preventing contamination by ill persons

Hygienic practices Farms must make visitors aware of policies and

give them access to toilet and hand washingfacilities.

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Equipment Tools Buildings


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Equipment, Tools, Buildingsand Sanitation


Equipment/tools: designed and constructed to allowadequate cleaning and maintenance.

Food contact surfaces of equipment and tools must

be inspected, maintained, cleaned, and sanitized asnecessary.

Buildings: size, design and construction must facilitatemaintenance and sanitary operations.

Toilet and hand-washing facilities must be adequate,and readily accessible during covered activities.

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Growing Harvesting Packing


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Growing, Harvesting, Packing,

and HoldingActivities


Separate covered and excluded produce not grown inaccordance to the rule

Identify and not harvest covered produce that is reasonably likely

to be contaminated Not distributing covered produce that drops to the ground before

harvest

Food-packing material appropriate for use

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Domesticated and Wild Animals

Unified requirements for grazing, working, and wild animals:Assess, as needed, relevant areas during growing for

potential animal contamination;

If significant evidence of potential contamination is

found (e.g., animal excreta, animal observation ordestruction),

Evaluate whether covered produce can be harvested

Take steps throughout the growing season to ensure that

covered produce that is reasonably likely to be contaminatedwill not be harvested

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Impact on Wildlife


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Impact on Wildlifeand Animal Habitat

Codified provision (developed in consultation withUSDA's NRCS and the U.S. Fish and WildlifeServices):

Regulation does not authorize taking ofendangered or threatened species; or requiremeasures to destroy animal habitat or excludeanimals from outdoor growing areas

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Requirements for Sprouts -1

Sprout requirements include:- Treating seed and beans before sprouting

- Testing spent sprout irrigation water (or sprouts, insome cases) for certain pathogens

- Monitoring the growing, harvesting, packing, andholding environment for Listeria species or Listeriamonocytogenes

- Discontinuing use of seeds or beans when spent

irrigation water (or sprouts) is associated with afoodborne illness or a positive pathogen finding

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Requirements for Sprouts - 2

Significant changes in final rule include:

Staggered compliance dates based on operation size begin 1 year aftereffective date of the rule; no additional time for water provisions

Exclude soil- or substrate-grown sprouts harvested without their roots

Criteria established for spent irrigation water testing to account for

emerging pathogensEstablish a written sampling plan and a corrective action plan for

testing of spent irrigation water (or sprouts)

New provisions to prevent contaminated product entering commerce(incl. hold-and-release -- must not allow sprouts to enter commerce

until negative pathogen testing results are received)

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Staggered Compliance Dates

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* Farms with


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Environmental Impact Statementand Record of Decision

EIS assessed potential environmental impacts of therule

- Final EIS considers public comment on Draft EIS.

- Potentially significant impacts identified on groundwater

and soil subsidence (resources already significantlyimpacted).

- Evaluated potential environmental impacts of thoseprovisions designed to fulfill FDAs public health goals

ROD considers decisions in the rule and identifiesagency-preferred alternative for each potentiallysignificant provision

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C t d B fit


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Costs and Benefits

Annualized benefits (at 7%) of avertingapproximately 331,964 produce-related illnesses= $925M ($976M at 3%)

Annualized costs (at 7%) = $366M ($387M at 3%)

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Guidance

Implementation and Compliance Guide

Sprout Guidance

Small Entity Compliance Guide

Updated GAPs Guidance

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Education Outreach Training and


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Education, Outreach, Training andTechnical Assistance Partnerships

Alliances

Produce Safety Alliance

Sprout Safety Alliance

Food Safety Preventive Controls Alliance

FDA/USDA-NIFA Collaboration: National FoodSafety Training, Education, Extension,

Outreach, and Technical Assistance ProgramTraining through Cooperative Agreements

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FDAs Role in Education Outreach


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FDA s Role in Education, Outreach,Training, and Technical Assistance

FDA Guidance documents

National Technical Assistance Network

Information Center

Partnerships will be essential

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F M I f ti


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For More Information

Web site: www.fda.gov/fsma

Subscription feature availableTo submit a question about FSMA, visit www.fda.gov/fsma and go to

Contact Us

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Thank you very much foryour attention!

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