Meeting Regulatory Requirements
A Guide to Meeting Food Manufacturing Regulatory Requirements in New York State
Do you manufacture, process, pack or hold food products and have questions about what you need to do to be in compliance with New York State and federal regulations?
If your answer is yes, then you may find this webpage useful. It contains several resources that may help you better understand what you need to do to meet regulatory requirements as a food facility operating in New York State. This is by no means a comprehensive list of all resources available, but should point you in the right direction.
Guide Contents
Registering New York State Food Facilities, Products, & Businesses
Available Circulars (NYS Food Safety Rules and Regulations)
Guidance for NYS Food Safety Rules and Regulations for various types of food products/businesses and the related inspection/licensing services pertaining to them.
New York State Home Processor Registration Information Sheet
Details the products that can be commercially produced in a home kitchen and NYS requirements for this type of operation.
Food Establishment Licenses
Describes the following food businesses that require NYS licensing and links to the necessary applications: Food Processors, Retailers, Warehouses, Food Salvagers, Refrigerated Warehouses/Locker and Rendering Plants.
Dairy Businesses
NYS Licensing, inspection, and documentation requirements for any business which deals with milk or milk products from production to consumption (cow, goat, and/or sheep milk).
Maple Syrup and Honey
Requirements and Standards of Identity for NYS Maple Syrup and Honey.
Current Guidance: Manufacture & Sale of Kombucha
NYS requirements for producing and selling kombucha wholesale or retail (includes hazard analysis).
Resources for Food Businesses
Industry information on a variety of food safety topics including processes, sanitation, training, and posters.
FDA & NYSDAM Registration & Licensing Forms; Scheduled Process Forms
Quick links to FDA & NYS product and facility registration forms and applications.
Facility Registration for Federal Compliance
Registration of Food Facilities and Other Submissions
Contains links to registration forms, guides, tutorials, and updated FSMA guidance for the food industry.
Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition), August 2018
Updated information about requirements and exemptions for FDA facility registration and renewal.
Small Entity Compliance Guide: Registration of Food Facilities, May 2018
Details requirements and exemptions for registering a food facility with the FDA.
Federal Regulations for Food Businesses and Specific Products
General:
FDA Food Code
Details updated information on Federal Regulation for all aspects of operating a retail food business, including food service and the preparing of safe food.
FDA & NYSDAM Registration & Licensing Forms; Scheduled Process Forms
Quick links to FDA & NYS product and facility registration forms and applications.
Meat, Egg Products, & Siluriforms:
USDA Food Safety and Inspection Service: Small and Very Small Plant Outreach
Resource for USDA inspected products (e.g. meat/poultry, egg products, siluriforms) and current related regulatory information.
Low Acid Canned Foods and Acidified Foods:
Acidified & Low-Acid Canned Foods Guidance Documents & Regulatory Information
Guidance and resources for registering manufacturing facilities and products that fall under acidified or low-acid classification.
Establishment Registration & Process Filing for Acidified and Low-Acid Canned Foods (LACF)
Forms and instructions for registering products and facilities that fall under acidified or low-acid classification and specific requirements and conditions of these products according to the Code of Federal Regulations.
Resources for FDA's Food Safety and Modernization Act (FSMA): Preventive Controls for Human Food Rule
General Regulation:
Food Safety Modernization Act (FSMA)
Comprehensive information on rules, guidance, training, technical assistance, and compliance/implementation tools.
Code of Federal Regulations Title 21 Part 117: FSMA – Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
Actual regulatory language of the FSMA Preventive Controls for Human Food Rule.
Preventive Controls for Human Food Rule (PCHF)
Resources and guidance explaining FSMA’s PCHF Rule including compliance dates, requirements, technical assistance, and more.
Final Rule on Preventive Controls for Human Food at a Glance
Short summary of FSMA’s PCHF rule in plain language.
FSMA Compliance for Small Businesses:
Small Entity Compliance Guide: What You Need to Know About Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, November 2016
Guidance related to FSMA requirements and exemptions for small businesses/qualified facilities.
Guidance for Industry: Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food And Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, September 2018
Instructions and forms for determining small business status as a “qualified facility” under FSMA regulation.
Qualified Facility Attestation
Instructions for submitting required forms that attest to the status of a business as a “qualified facility” under FSMA regulation.
Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507, June 2019
Information pertaining to the determining that status of a facility as a small business related to the number of people employed by.
FSMA Operational Requirements: Preventive Controls, Hazard Analysis, & Food Safety Plans:
Food Safety Preventive Controls Alliance (FSPCA) Resources
Resources and industry guidance related to Preventive Controls and FSMA requirements.
Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food, January 2018
Guidance for developing a Food Safety Plan in compliance with FSMA Regulation.
Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food: Recall Plan, 2019
New chapter on developing a recall plan in compliance with FSMA’s PCHF rule.
Guidance for Industry and FDA Staff: Questions and Answers Regarding MandatoryFood Recalls, November 2018
Answers to common questions that may arise during a mandatory food recall.
Food Safety Plan Builder
Online tool to assist and guide food manufacturers through the process of creating a food safety plan in compliance with PCHF rule.
Guidance for Industry: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4); Final Guidance, October 2006
Guidance in defining allergens in food products and regulatory requirements related to the Food Allergen Labeling and Consumer Protection Act.
FSMA Regulation for Fresh Produce:
FSMA Final Rule on Produce Safety
Details on FSMA requirements for produce being sold to the public including: compliance dates, exemptions, variances, environmental impact, technical assistance, inspections, and related guidance and resources.
Draft Guidance for Industry: Guide to Minimize Food Safety Hazards of Fresh-cut Produce, October 2018
Information regarding cGMP requirements and PCHF requirements in an operation that manufactures, processes, packs, or holds fresh-cut produce.
FSMA Regulation for Low-Acid Canned Foods:
Guidance for Industry: Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDA Food Safety Modernization Act, August 2017
Guidance related to FSMA regulation for low-acid canned foods.
Environmental Contaminants in Foods for Babies and Young Children
Closer to Zero: Reducing Childhood Exposure to Contaminants from Foods
A science-based approach to reduce the levels of arsenic, lead, cadmium, and mercury in foods. Aims to set new action levels using four stages: evaluating the science, proposing draft action levels, consulting with stakeholders and then finalizing new action levels.
FDA Industry Letter to Baby and Toddler Food Manufacturers and Processors (March 2021)
Reminds manufacturers who are covered by the PCHF rule, as well as regulations for HACCP or fish and fishery products, to consider chemical hazards that may be present in foods when they conduct their hazard analysis.
Draft Guidance for Industry: Action Levels for Lead in Juice
Part of the FDA's Closer to Zero action plan, this draft guidance proposes to replace the current level of 50 ppb in the Juice HACCP Guidance to 10 ppb for ready to drink apple juice and 20 ppb for other single-strength juice types.
Draft Guidance for Industry: Action Levels for Lead in Food Intended for Babies and Young Children
Part of the FDA's Closer to Zero action plan, this draft guidance reviews FDA’s action levels for lead in processed food intended for babies and young children. The action levels for lead are 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats; 20 ppb for root vegetables (single ingredient); and 20 ppb for dry infant cereals.
HACCP Plans (Hazard Analysis and Critical Control Points)
HACCP Principles & Application Guidelines
Guidelines and Principles needed to develop a HACCP Plan.
Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act, September 2017
Juice HACCP Plan; regulatory requirements and related FSMA exemptions.
Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act
Seafood HACCP Plan; regulatory requirements and related FSMA exemptions.
Retail & Food Service HACCP
Manual for voluntary use of HACCP principles in a retail or food service establishment
Dairy Grade A Voluntary HACCP
Current program documents, references, required forms, and worksheets related to creating a HACCP plan at a dairy establishment.
Listeria Controls for Refrigerated or Frozen Ready-To-Eat Foods
Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods, January 2017
Guidance for manufacturers of RTE foods to comply with FSMA’s PCHF rule and cGMP requirements to minimize the risk of Listeria monocytogenes.
Records
Small Entity Compliance Guide: What You Need to Know About Establishment and Maintenance of Records, April 2014
Guidance for record requirements for small business related to FSMA regulation.
Trainings
The IFS@CU's Fact Sheet “Meeting Regulatory Requirements”
Lists trainings offered through the Institute for Food Safety at Cornell University.
The IFS@CU's GMPs Part 117 Online Course
The Institute for Food Safety at Cornell University offers a Good Manufacturing Practices Course Online that reviews the requirements of 21 CFR Part 117 Subpart B.
Food Safety Preventive Controls Alliance (FSPCA)
Offers courses in Preventive Controls for Human Food, Preventive Controls for Animal Food, Foreign Supplier Verification Programs, and others.
Better Process Control School
Information about Better Process Control School for Acidified and Low-Acid Foods including a list of some of the locations that offer the course.
Institute for Food Safety at Cornell University
Offers Food Safety Training Opportunities for Fruits & Vegetables, Dairy Foods, Food Manufacturing, Packing and Processing, and Regulatory Requirements.
Produce Safety Alliance
Links to Produce Safety trainings throughout the country.
National Good Agricultural Practices Program at Cornell University
Offers online and in-person trainings.
Cornell Dairy Foods Extension Program
Offers individual and certificate programs for science, sanitation and regulation of various dairy foods as well as meat foods.
National Dairy Food Safety Coalition
2-day food safety plan coaching workshop for artisan dairy producers.
Cornell Food Venture Center
Offers an online Better Process Control School for acidified foods.
Regulatory Services and Testing Labs
Cornell’s Food Venture Center Fact Sheet
Lists Regulatory services offered by Cornell’s Food Venture Center Process Authority.
Processing Authorities by State
List of states that have process authority services available.
National Water Quality Testing Labs Map
Map of labs with water quality testing services available.