NECAFS Annual Conference and Meeting

January 22 - 24, 2024

Westin Portland Harborview Hotel
157 High Street
Portland, ME

Conference Agenda

Register Now

Registration fee: $260 (If you need financial support from NECAFS, please see Financial Support section below.)

HOTEL ROOM BOOKING LINKS

Government rate $117 per night: https://www.marriott.com/events/start.mi?id=1693596408216&key=GRP

Non-government rate $129 per night: https://www.marriott.com/events/start.mi?id=1693596278207&key=GRP

AGENDA

January 22nd - 4:00 - 6:00pm
• Welcome Reception

January 23rd - 8:00 - 5:00pm
• Integrated Research and Extension for Enhanced Food Safety
• NE Produce Safety Regulator and Program Staff Meeting
• (Please note, parts of this session are closed and are for state produce safety program inspectors and program staff only.)

January 23rd - 5:30 - 6:30pm
• Poster Session and Reception

January 24th - 8:00 - 3:00pm
• Integrated Produce Safety Regulatory, Educational, and Research Meeting
• Preventive Controls Workgroup Meeting

Financial Support

NECAFS strives to make this meeting accessible to anyone from the Northeast region who wants to attend. If you do not have a grant or another funding source available to pay for your costs, NECAFS can cover the cost of your registration, hotel, and travel.

It's that easy, but if you still have questions, email Elizabeth Newbold.

Summary of 2023 NECAFS Annual Conference and Meeting - Hartford, CT

The 2023 NECAFS Annual Conference and Meeting was held in Hartford, CT, January 18th & 19th. The agenda and meeting materials are provided below.

Summary Evaluation Report for 2023 NECAFS Annual Conference and Meeting

Combined Meeting Notes

NE Regulator and Program Staff Meeting Agenda

Educators Meeting Agenda

Produce Safety Workgroup Meeting Agenda

Preventive Controls Workgroup Meeting Agenda

Full Agenda with Slides
DateSessionMaterials
Jan. 18, 2023Welcome and Plenary Session

NECAFS Background & History, Current Work Plan, and Connection to Past Annual Meetings and to the current work of THIS YEAR’s Annual Meeting (Slides)

  • Chris Callahan, Northeast Center to Advance Food Safety (NECAFS)
  • Annie Fitzgerald, NECAFS
  • Sean Fogarty, NECAFS
  • Anna Loewald, NECAFS
  • Elizabeth Newbold, NECAFS

State Department of Agriculture Introductions

Lightning round of overview from State Produce Safety Programs (Slides)

  • Massachusetts
  • Maryland
  • New Hampshire
  • Rhode Island
  • New York
  • Connecticut
  • Maine
  • Delaware
  • Pennsylvania
  • West Virginia
  • New Jersey
  • Vermont

 

Educators Meeting

Federal Updates

FDA Produce Safety Network

  • Ben Marshall, Center for Food Safety & Applied Nutrition, FDA (Slides)

USDA Food Safety Outreach Program

  • Jodi Williams, National Institute of Food & Agriculture, USDA (Slides)

Produce Safety Alliance

  • Donna Clements, Cornell University, Produce Safety Alliance (Slides)

Food Safety Preventive Controls Alliance

  • Donna Schaffner, Rutgers Food Innovation Center (Slides)

FDA Preventive Controls

  • Glenn Bass, Office of Regulatory Affairs, FDA

Presentation: Educational Projects with Unique Approaches

Sanitizing and Cleaning Resources for Your Business (SCRUB)

  • Andy Chamberlin, University of Vermont (Slides)

Experiential Learning Opportunities for Limited Resource Growers through Mobile Farm Innovation in Mississippi, Alabama, and Georgia

  • Billy Mitchell, work was completed with National Farmers Union (Slides)

Development of an alternative FSMA compliant produce safety curriculum for plain sect and other smaller fresh produce growers

  • Jeff Stoltzfus, Pennsylvania State University (Slides)

Educational Barriers of Producers and Processors

On-Farm Produce Safety: A Review of Needs Assessments of Small- and Medium-Sized Growers in the United States

  • Elizabeth Newbold, University of Vermont, NECAFS (Slides)

Understanding the Food Safety Needs of Small and Very Small Processors in the Northeast United States: A Food Safety Communicator Perspective

  • Andrea Gilbert-Eckman, University of Maryland and Annie Fitzgerald, University of Vermont, NECAFS (Slides)
Jan. 19, 2023Plenary Session

Breakfast and Education Introductions

Lightning round of introductions from extension and community-based organizations (Slides)

  • Chesapeake Produce Safety Education Project
  • Community Involved in Sustaining Agriculture
  • Cornell University
  • Franklin County Community Development Corporation
  • New England Farmers Union
  • Penn State University
  • Rutgers University
  • University of Connecticut
  • University of Delaware
  • University of Maine
  • University of Massachusetts Amherst
  • University of Maryland
  • University of New Hampshire
  • University of Rhode Island
  • University of Vermont
 Produce Safety Workgroup Meeting

Regulatory Findings

Summary of Regional 2022 Inspectional Observational Data

  • Kristina Sweet, Vermont Agency of Agriculture (Slides)

Roll out of Harvest/Postharvest Water Educational Inspections and Proposed Agricultural Water Preharvest Rule

  • Ben Marshall, Center for Food Safety & Applied Nutrition, FDA (Slides)
 Preventive Controls for Human Food Workgroup Meeting

Processors’ Food Safety Toolkit

Overview and early usage trends

  • Annie Fitzgerald, University of Vermont and Beth Demmings, Cornell University (Slides)

Regional PCHF Course Evaluation Tool

Launch of regionally developed tool to collect PCHF evaluation and processor educational needs data 

  • Nicole Richard, University of Rhode Island (Slides)

Exploring Projects with Creative Approach to Implementation and Their Successes

Improving the Development of Food Safety Plans through the Advanced Preventive Controls School Initiative

  • Byron Chaves-Elizondo, University of Nebraska-Lincoln (Slides)

Development and Implementation of a Hands-on Food Safety and Regulatory Curriculum for Members of Shared-use Commercial Kitchens in Florida

  • Matt Krug, University of Florida (Slides)

Building Capacity: Customized Food Safety Educaiton and Outreach in Rhode Island

  • Nicole Richard, University of Rhode Island (Slides)

Food Safety Management and Document Development for PCHF Rule Qualified Exemption-Eligible Food Facilities

  • Abby Snyder, Cornell University (Slides)

Multi-Modal Dairy Food Safety Plan Education to Support Small and Medium Dairy Producers

  • Sam Alcaine, Cornell University

Session Video Recordings

All videos from the meeting are available on the NECAFS YouTube channel.

 

 

Summary of 2022 NECAFS Annual Conference and Meeting - Virtual

The 2022 NECAFS Annual Conference and Meeting was held jointly virtually, January 18th, 19th, & 20th, jointly with the Northeast Regulator One-Day Working Meeting. The agenda and meeting materials are provided below.

Summary Evaluation Report for 2022 NECAFS Annual Conference and Meeting

Full Conference Agenda

Full Agenda with Slides
DateSessionMaterials
Jan. 18, 2022Regulator One Day MeetingWelcome and Introductory Remarks
  • Ananda Fraser, Rhode Island Division of Agriculture

Drafting a Memorandum of Understanding Between States and Lead State Determination Tool Development

  • Steve Pilis, Massachusetts Department of Agricultural Resources
  • Abigail Phillips, Rhode Island Division of Agriculture

Breakout Group Sessions

  • Facilitators: Aaron Finley, Gina Clithero, Abby Phillips, Steve Pilis, Erik Stenfors, Anna Wicks, Amanda Ziegler

Summary of Regional Misunderstanding and Noncompliance Issues Observed During Inspections

  • Kristina Sweet, Vermont Agency of Agriculture

NASDA Update Presentation

  • Bob Ehart, NASDA
  • Joe Reardon, NASDA

FDA Presentation – Office of Regulatory Affairs and State Field Work

  • Wendy Johnecheck, FDA Office of Regulatory Affairs
  • Kimberly Langello, FDA Emergency Response Coordinator
  • Nicole Vaught, FDA Emergency Response Coordinator

Breakout Group Session by Authority

  • FDA Authority (ME, PA, NJ)
  • State Authority (everyone else)

Closing Remarks

  • Ananda Fraser, Rhode Island Division of Agriculture
Jan. 19, 2022Welcome and Plenary Session

NECAFS Background & History, Current Work Plan, and Connection to Past Annual Meetings and to the current work of THIS YEAR’s Annual Meeting (Slides)

  • Chris Callahan, Northeast Center to Advance Food Safety (NECAFS)
  • Annie Fitzgerald, NECAFS
  • Sean Fogarty, NECAFS
  • Elizabeth Newbold, NECAFS
 Produce Safety Workgroup MeetingWelcome and Review Group’s Previous Discussion
Recap of 2021 Produce Safety Workgroup discussion and NECAFS activities (Slides)
  • Chris Callahan, NECAFS

Regional Consolidation of Inspectional Observations (Slides)

  • Kristina Sweet, VT Agency of Agriculture

Initiatives to Address Worker Training in 2021 (Slides)

  • Laura Pineda-Bermudez, Cornell University
  • Shauna Henley, University of Maryland

Regulatory Overview of Worker Training

  • Chris Callahan, NECAFS
  • Michael Botelho, Massachusetts Department of Agricultural Resources

Inspector Panel - Articulation of Worker Trainings Issues Seen On-Farm across Northeast

  • Speakers: Steve Schirmer, NY State Dept. of Ag and Markets, Tucker Diego, VT Agency of Agriculture, Michael Botelho, Massachusetts Department of Agricultural Resources, Kim Carlen, Pennsylvania Department of Agriculture
  • Moderator: Betsy Bihn, Produce Safety Alliance, Cornell University

Breakout Group Sessions

  • Facilitators: Antonio Acosta, Gina Clithero, Cathy Davies, Hans Estrin, Angela Ferelli Gruber, Sean Fogarty, Wes Kline, Kristin Krokowski, Michael Lawrence, Brenda Morris, Juan Silva, Seth Wilner, Claire Zabel
 Preventive Controls for Human Food Workgroup MeetingState Preventive Controls for Human Food Inspector Panel
Roll out of Preventive Controls inspections, what they are seeing on the ground, areas of noncompliance and misunderstanding
  • Speakers: John Morris, Maine Department of Agriculture, Conservation & Forestry, Monica Robotin, Connecticut Department of Consumer Protection
  • Moderator: Jason Bolton, University of Maine

Snapshot of Food Processing and Safety in the Northeast (Slides)
Articulation of processor and food processing landscape in the Northeast. What are the group’s data needs?

  • Annie Fitzgerald, Northeast Center to Advance Food Safety

Food Safety Preventive Controls Alliance Update

General FSPCA Updates (Slides)

  • Donna Schaffner, Rutgers University

FSPCA Curriculum Update

  • Martin Bucknavage, Penn State University

Working Group Introduction and Updates (Slides)
Presentation on Preventive Controls for Human Food working group structure, history, and projects

  • Nicole Richard, University of Rhode Island

Evaluation subgroup update

  • Nicole Richard, University of Rhode Island

Resources subgroup update

  • Beth Demmings, Cornell University
  • Annie Fitzgerald, Northeast Center to Advance Food Safety

Awareness subgroup update

  • Amanda Kinchla, University of Massachusetts Amherst
Jan. 20, 2022Plenary SessionFDA CFSAN Northeast Update (Slides)
  • Adriana Jimenez Lopez, Produce Safety Network, Food and Drug Administration
Food Safety Outreach Program update (Slides)
  • Jodi Williams, FSOP Program Leader
 Produce Safety Workgroup Meeting

Bridging the Gap between Research and Application

Summary Overview of NECAFS Work (Slides)

  • Elizabeth Newbold, NECAFS, Lisa McKeag, University of Massachusetts, Robert Hadad, Cornell University

Risk-Based Thinking and Applying Process to Example Scenario

  • Donald Schaffner, Rutgers University
  • Ben Chapman, North Carolina State University

Breakout Group Sessions (Slides)
What would you do and justify your answer using science?

  • Facilitators: Antonio Acosta, Ollie Cultrara, Cathy Davies, Hans Estrin, Angela Ferelli Gruber, Sean Fogarty, Wes Kline, Kristin Krokowski, Michael Lawrence, Brenda Morris, Seth Wilner, Wendy Johnecheck, Claire Zabel
 Preventive Controls for Human Food Workgroup MeetingNeeds Assessment, Review of findings
  • Andrea Gilbert, University of Maryland
  • Annie Fitzgerald, Northeast Center to Advance Food Safety
Group Discussion for Long-Term Planning of the Preventive Controls for Human Food Workgroup
Discuss current workgroup activities, needs, new activities, and structural changes
  • Jill Fitzsimmons, University of Massachusetts Amherst

Session Video Recordings

All videos from the meeting are available on the NECAFS YouTube channel.

 

 

Summary of 2021 NECAFS Annual Conference and Meeting - Virtual

The 2021 NECAFS Annual Conference and Meeting was held jointly virtually, February 16th, 17th, & 18th, jointly with the Northeast Regulator One-Day Working Meeting. The agenda and meeting materials are provided below.

Summary Evaluation Report for 2021 NECAFS Annual Conference and Meeting

Full Conference Agenda

Combined Meeting Minutes

Material Provided at Conference
2020 Regional Summary of PSA Grower Training Pre- and Post-Test Results
2020 Food Safety Resource Clearinghouse User Analytics
List of Actively Funded Research Projects in the Northeast
Number of Trainings in the Northeast in 2020 (PSA Grower Training, FSPCA QI Trainings, OFRR)

 

Full Agenda with Slides
DateSessionMaterials
Feb. 16, 2021Regulator One Day MeetingWelcome and Introductory Remarks
  • Michael Botelho

Mandatory Farm Registration

  • State presentations
    • Delaware – Anna Wicks
    • Rhode Island – Ananda Fraser
    • Maryland – Deanna Baldwin
    • Connecticut – Resha Jacquier

Group Exercise and Break Outs on Topics where Guidance is Lacking

  • Farm Definition Presentation
    • New York – Aaron Finley
  • Q & A Farm definition – what are states doing while the farm definition is under review?
    • Facilitated by Ananda Fraser
  • Break out group discussions
    • Sales value determination
    • Unintended consequences

Program Standards

  • State Presentations to discuss the necessary flexibility needed to accommodate the differing authorities across the states and how those differences need to inform program standards
    • Maryland – Deanna Baldwin
    • New Jersey – Chris Kleinguenther
  • NASDA and AFDO presentation on program standards
    • NASDA – Jim Melvin
    • AFDO – Brenda Morris

Research and Education Needs

  • Review of compiled misunderstanding and deficiencies seen on farms
    • Maine, Leah Cook
  • Group discussion
    • How can communication be informed and improved to better facilitate all perspectives and flow of knowledge both education and research?
    • Facilitated by Leah Cook

Concurrent Meetings

  • Program Lead and PI Working Meeting
  • Program Staff Networking Discussion
Feb. 17, 2021Welcome and Plenary Session

Summary of next steps articulated at past Annual Meetings, NECAFS 2020 project outputs and collaboration exercises

  • Chris Callahan and Elizabeth Newbold, NECAFS (Slides)
 Produce Safety Workgroup MeetingWelcome and Review Group’s Previous Discussion
  • Recap of 2020 Produce Safety Workgroup discussion and NECAFS activities
  • Overview of Plan for this year’s Produce Safety Workgroup Meeting

Review of audit data from USDA

Report-out from regulator one-day working meeting, a consolidation of inspectional observations from across the region

  • Leah Cook, Maine Dept of Ag, Conservation and Forestry (Slides)

Break Outs Groups

  • Step 1. WHAT IS HAPPENING AND WHY? Emerging and reoccurring produce safety issues. Intent is to identify what is the issue, what does it look like, and why is it happening?

Break Out Groups

  • Step 2. WHAT SHOULD WE DO ABOUT IT? Planning for collaborative improvement.  Intent is to develop action plans that help growers better respond to the specific issues identified.

Break Out Groups

  • Step 3. HOW ARE WE GOING TO DO WHAT WE NEED TO DO? Establishing a communication and collaboration framework for research and education activities. Intent is to describe how we build something that will provide sustained engagement around the topics identified as key produce safety issues.
 Preventive Controls for Human Food Workgroup MeetingGeneral FSPCA Updates
  • Mellonie O'Neil, Rutgers University
FSPCA Curriculum Update
  • Martin Bucknavage, Penn State (Slides)

FDA Update: Overview and description of PC inspectional roll-out in the Northeast

PC Needs Assessment: Review of findings and gaps in data

  • Andrea Gilbert, University of Maryland (Slides)

Review of PC Sub-group Goals

  • Nicole RichardUniversity of RI (Slides)

Supgroup Updates

  • Awareness, Luke LaBorde, Penn State and Amanda Kinchla, UMass (Slides)
  • Evaluation, Nicole Richard, University of RI (Slides)
  • Resources, Beth Demmings, Cornell University and Annie Fitzgerald, University of Vermont - NECAFS (Slides)
Feb. 18, 2021Federal UpdatesFDA CFSAN Northeast Update
  • Adriana Jimenez Lopez, Produce Safety Network (Slides)
USDA Food Safety Research
  • Patricia Millner, USDA ARS

Session Video Recordings

All videos from the meeting are available on the NECAFS YouTube channel.

Summary of 2020 NECAFS Annual Conference and Meeting - Philadelphia, PA

The 2020 NECAFS Annual Conference and Meeting was held February 10-12 in Philadelphia, PA, jointly with the Northeast Region Produce Safety Workgroup.  The agenda and meeting materials are provided below.

Summary Evaluation Report of 2020 Annual Conference and Meeting

Full Conference Agenda

Combined Meeting Minutes

DateSessionMaterials
Feb. 11, 2020Breakfast and Welcome Remarks
  • Elizabeth Newbold, NECAFS
  • Luke LaBorde, Penn State
  • Nicole Martz, PA Department of Agriculture
  • Jeff Warner, Director for the Bureau of Food Safety, PA Department of Agriculture (Slides)
 Welcome and Plenary SessionSummary of next steps articulated at past Annual Meetings, NECAFS 2019 project outputs and collaboration exercises
  •  Chris Callahan and Elizabeth Newbold, NECAFS (Slides)
 Project Updates from the RegionSummary of projects across the region

Project specific presentations

  • Amanda Kinchla, UMass, “Risk assessment on DIY washing machines for post harvest leafy green drying” (Slides)
  • Robert Hadad, Cornell, “Educating Produce Growers & Workers in the Farm Food Safety Aspects of Efficient Reasonable Cleaning of Wash-Line Equipment” (Slides)
  • Kevin Cody, Tufts, “Preparing Diverse Beginning Farmers for Growth: New Entry Expands FSMA Training and On-Farm Technical Assistance Through Tiered FSMA Support Mechanisms that Don't Leave New/Beginning Farmers Behind” (Slides)
  • Robson Machado, University of Maine, “Info toons and video as delivery tools for food safety training” (Slides)
 Produce Safety Workgroup Meeting

Produce Safety Alliance Update

  • Gretchen Wall, Produce Safety Alliance, Cornell University (Slides)

Summary of On-Farm Readiness Review Evaluations

  • Meredith Melendez, Rutgers University (Slides)

Growers Perspective – OFRR and Farm Inspections

  • Andre Cantelmo, Heron Pond Farm (Slides)

Produce Safety Research Consortium

  • Socrates Trujillo & Marianne Solomotis, Food and Drug Administration (Slides)

Group Discussion

  • Chris Callahan, University of Vermont & Betsy Bihn, Cornell University (Slides)
 Preventive Controls for Human Food Workgroup Meeting

Needs Assessment Review and Summary Results

FDA Update

FSPCA Update

  • Bill Lachowsky, Rutgers University (Slides)

Supgroup Updates

  • Awareness, Luke LaBorde, Penn State (Slides)
  • Evaluation, Nicole Richard, University of RI (Slides)
  • Resources, Beth Demmings, Cornell University (Slides)
Feb. 12, 2020Federal Updates
  • Stephen Hughes, FDA Produce Safety Network (Slides)
  • Wendy Johnecheck and Erin Nagel, FDA Office of Regulatory Affairs (Slides)
  • NECAFS on behalf of Deirdra Chester, USDA FSOP (Slides)
  • Ellen Johnson, North Central Regional Center (Slides)
  • Keith Schneider, Southern Regional Center (Slides)
  • Stephanie Brown, Western Regional Center (Slides)
  • Josiah Griffin, Indigenous Food and Agriculture Initiative (Slides)
  • Chelsea Matzen, Local Food Safety Collaborative (Slides)
  • Jim Melvin, NASDA (Slides)
 Produce Safety Needs Assessment Workgroup Meeting

Summary of Local Food Safety Collaborative Needs Assessment Survey Report

  • Betsy Bihn & Laura Pineda-Bermudez, Cornell University (Slides)

NECAFS Food Safety Needs Assessment Systematic Review

  • Hannah Doyle, University of Vermont (Slides)
 Buyer Workgroup Meeting

Welcome and Introduction to Meeting and Review of 2019 Albany Meeting and Developing a Handbook of Produce Safety Standards for Buyers

  • Elizabeth Newbold, University of Vermont (Slides)

Vermont Produce Program: Buyer Outreach Initiative

  • Gina Clithero & Kristina Sweet, Vermont Agency of Agriculture (Slides) (Handout)

Development of State Implementation Matrix

  • Sedona Chavez, Center for Ag and Food Systems at Vermont Law School (Slides)

Session Video Recordings

All videos from the meeting are available on the NECAFS YouTube channel.

Summary of 2019 NECAFS Annual Conference and Meeting - Albany, NY

The 2019 NECAFS Annual Conference and Meeting was held February 4-6 in Albany, NY, jointly with the Northeast Region Produce Safety Workgroup.  The agenda and meeting materials are provided below.

File Summary Report of 2019 Annual Conference and Meeting Evaluations

Overall Agenda

Combined Notes

Date / TimeSessionMaterials
February 4Welcome ReceptionNone
   
February 5Plenary

NECAFS Highlights, Look Ahead, and Meeting Expectations - C. Callahan

Slides

Notes

 State and Regional Updates

Summary of Regional State Updates (Report) - E. Newbold

Slides

Notes

  

Project Specific Presentations

Rhode Island - L. Pivarnik, S. McCormick, A. Fraser

National Young Farmers Coalition - C. Fraver - Slides

Cornell Cooperative Extention - B. Williams

Penn State Extention - M. Gorgo-Gourovitch

Notes (included in State and Regional Update notes)

 Produce Safety Workgroup

Joint Session Agenda

Notes

  

Regulatory Focus Agenda

Notes

  

Educational Focus Agenda

Notes

 Preventive Controls for Human Food Workgroup

Agenda

Slides

Notes

   
February 6Federal Updates

FDA Updates - S. Hughes

USDA AMS Updates - K. Peterson

USDA NIFA Updates - J. Williams

Notes

 Buyer Workgroup

Agenda

Notes

 Educational Approaches to Training Delivery

Agenda

Notes

 Summary of Workgroup Outputs and Next StepsNotes

 

Highlight Video

Summary of 2018 NECAFS Annual Conference and Meeting - Baltimore, MD

The 2018 NECAFS Annual Conference and Meeting was held Jan. 23-25 in Baltimore, MD, held jointly with the Northeast Region Produce Safety Workgroup.  Agenda for the Conference and Meeting included:

Tuesday, January 23rd

  • Focused meeting day, in two parallel tracks, dedicated to:
    • Produce Safety, and
    • Preventive Controls for Human Food

Wednesday, January 24th

  • Joint conference session:
    • Keynote speaker
    • Updates from each state regulatory, research and extension
    • Three panel sessions featuring producers, processors and buyers. 

Wednesday Evening, January 24th 

  • Poster session that
    • Highlighted poster presentations on extension, education and outreach activities across the region

Thursday, January 25th

  • NECAFS Steering Team Meeting

Evaluation from 2018 Annual Conference and Meeting

Attendees at the 2018 NECAFS Annual Conference and Meeting completed program evaluations.  This evaluation asked questions about the Annual Conference and Meeting as well as overall NECAFS programming.  Please download the full report here.

File NECAFS Summary Evaluation Report

Video from 2018 Annual Conference and Meeting

All videos from the meeting are available on the NECAFS YouTube channel.

Summary of 2017 NECAFS Annual Conference and Meeting - Boston, MA

The 2017 NECAFS Annual Conference and Meeting was held January 10, 2017 in Boston, MA.  Below is a full summary report and presenations from the meeting.

Full Report

PDF icon Intro and Agenda Presentation

PDF icon FDA Presentation

PDF icon MD and MA Presentation

PDF icon VT Presentation

 

NECAFS Annual Conference and Meeting

Held annually, the NECAFS Annual Conference and Meeting provides an opportunity for regional partners to connect in person to discuss current training, education and outreach trends and activities related to the FSMA associated Produce Safety Rule and the Preventive Controls for Human Food Rule.