Agricultural Law Weekly Review - February 28, 2020

Written by:  

Brook Duer—Staff Attorney
Audry Thompson—Research Assistant

The Agricultural Law Weekly Review provides an update of recent agricultural law developments from the local, state, national, and international levels.  Subscribe to the ALWR at pennstateaglaw.com. 

Food Labeling: Pennsylvania Department of Agriculture Provides Whole Milk Labeling Guidance

On February 19, 2020, the Pennsylvania Department of Agriculture, Bureau of Food Safety issued a guidance document to Pennsylvania dairy processors outlining what methodology can be employed in labeling the fat content of whole milk.  In March 2019, a collection of Pennsylvania dairy farmers formed an advocacy group called “97 Milk, LLC,” which advocates for whole milk consumption and designating whole milk as ‘97% Fat Free.’  However, the guidance document states that, according to FDA, a ‘% Fat Free’ label can only be employed on 1% Low Fat or Skim milk packaging. The document also states: (a) FDA defines whole milk as milk containing between 3.25% and 18% milkfat; and (b) whole milk could be labeled with its fat content as a percentage, if accurate.  

Tax Policy:  Pennsylvania Agriculture Secretary Publishes Support for Slots Tax Re-Direction from Equine Industry to Higher Education Scholarships

On February 22, 2020, Pennsylvania Secretary of Agriculture Russell Redding, who is also the appointed Chairman of the Pennsylvania State Horse Racing Commission, published a guest columnist op-ed in the Daily Local News of Exton, Pennsylvania titled, “Opinion: Even if by a nose, horse racing must become self-sufficient.”  The op-ed advocates for Pennsylvania Governor Tom Wolf’s proposed legislative redirection of $200 million annually in slot machine tax revenue from the Race Horse Development Fund to the proposed Nellie Bly Scholarship Fund.  The Race Horse Development Fund was created by Pennsylvania’s 2004 Gaming Act to receive a portion of the state’s slot machine tax and economically stimulate Pennsylvania’s equine industry by subsidizing purse money at Pennsylvania’s six racetracks.  The proposed Nellie Bly Scholarship Fund would fund scholarships awarded to Pennsylvania residents by the fourteen Pennsylvania State System of Higher Education public universities. 

National Agricultural Policy: USDA Announces Agriculture Innovation Initiative

On February 20, 2020, USDA Secretary Sonny Perdue publicly presented the agency’s “Agriculture Innovation Initiative” at USDA’s annual Agricultural Outlook Forum in Arlington, Virginia, which USDA describes as “a department-wide initiative to align resources, programs, and research” which “will stimulate innovation so that American agriculture can achieve the goal of increasing production by forty percent while cutting the environmental footprint of U.S. agriculture in half by 2050.”  The agenda identifies a three-part plan to achieve this goal by: (i) creating a strategy to align public and private research; (ii) integrating the latest productivity, conservation practices and technologies; and (iii) improve USDA data collection and reporting on conservation practices.  Benchmarks include reducing food loss and waste by fifty percent by 2030, reducing nutrient loss by thirty percent by 2050, and supporting biofuels production, efficiency, and competitiveness to produce ‘market-driven’ blends of E15 in 2030 and E30 in 2050.

Water Issues:  Department of Interior Directs Water Increase to California Central Valley

On February 19, 2020, President Trump signed a Memorandum and Order in a ceremony conducted in Bakersfield, California which implements a U.S. Department of Interior initiative and authorizes the agency to direct water from the San Francisco Bay Delta to California’s Central Valley in order to irrigate farmland.  The action was prevented for several decades by scientific opinions issued by U.S. Fish and Wildlife Service employees that it would harm delta smelt and chinook salmon, both protected by the Endangered Species Act of 1973.  On February 20, 2020, the State of California sued the Department of the Interior in the U.S. District Court for the Northern District of California seeking to reverse the action. On February 25, 2020, the first allocation of water to California’s Central Valley was made.

Wildlife Issues: Canada Geese Depredation Order Expanded by Thirty Days

On February 25, 2020, the U.S. Fish and Wildlife Service published a final rule at 85 FR 10621, effective March 26, 2020, updating a 2006 rule that had established a depredation order allowing take of resident Canada geese at agricultural facilities in enumerated Atlantic Flyway states by authorized methods by authorized personnel between May 1 and August 31.  The new final rule states the time period designated in 2006 no longer adequately protects crops planted in early spring.  The amended time period is now April 1 through August 31 at agricultural facilities in the following states: Connecticut, Delaware, Florida, Georgia, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, North Carolina, Pennsylvania, Rhode Island, South Carolina, Vermont, Virginia, and West Virginia. 

Food Policy: FDA Reopens 2005 Standard of Identity Proposed Rule Comment Period

On February 21, 2020, the U.S. Food and Drug Administration (FDA) published notice in the Federal Register at 85 FR 10107 that it was reopening the comment period on a 2005 proposed rule titled, “Food Standards; General Principles and Food Standards Modernization.”  While the initial rule was jointly published with USDA, the reopened comment period, closing on April 21, 2020, solicits comments addressed only to the “FDA-specific aspects of the proposed rule.”  The 2005 regulatory amendment was intended to commence a process “to modernize FDA definitions and standards of identity (and standards of quality and fill of container).” 

From National Ag Law Authorities & Sources: 

Tiffany Dowell, Landowner Liability Protection Resources (Feb. 17, 2020).

Ellen Essman, Ohio Tackles “TMDL” for Lake Erie’s Western Basin (Feb. 19, 2020).

Kristine A. Tidgren, IRS Allows Some Farmers to Revoke Election out of UNICAP (Feb. 25, 2020).

Penn State Research & News:

Jeff Mulhollem, Feed supplement for dairy cows cuts their methane emission by about a quarter (Feb. 20, 2020).

Jeff Mulhollem, Forest 'duff' must be considered in controlled burning to avoid damaging trees (Feb. 21, 2020).

AGENCY PRESS RELEASES—STATE/FEDERAL

Pennsylvania Department of Agriculture Press Releases:
Department of Agriculture Offers Milk Processors New Labeling Advice, Opportunity to Rebrand Whole Milk (Feb. 19, 2020).

Pennsylvania Adds 39 Farms, 2,848 Acres to Nation-Leading Farmland Preservation Program (Feb. 20, 2020).

Top-Performing Bulls to Sell in Pennsylvania Livestock Evaluation Center Auction (Feb. 21, 2020).

Agriculture Secretary Announces Research Funding to Combat Chronic Wasting Disease in PA Deer (Feb. 25, 2020).

U.S. Department of Agriculture Press Releases:
USDA and EPA Announce Continued Commitment to Support Rural Water Systems (Feb. 20, 2020).

USDA Invests Nearly $24 Million for Broadband in Utah’s Uintah Basin (Feb. 20, 2020).

USDA Invests $5 Million in Broadband for Rural Georgia Communities (Feb. 21, 2020).

USDA Invests $3.3 Million in High-Speed Broadband for Rural Beaverhead County (Feb. 24, 2020).

USDA and USTR Announce Progress on Implementation of U.S.-China Phase One Agreement (Feb. 25, 2020).

USDA Expands Market for U.S. Wheat: Adds Idaho, Oregon, and Washington to List of States that Can Export Wheat to Kenya (Feb. 25, 2020).

USDA Invests $9.1 Million in Broadband for Rural South Carolina Communities (Feb. 25, 2020).

Secretary Perdue Announces New FSIS Leadership (Feb. 25, 2020).

USDA Invests $2.3 Million in Broadband for Rural Eastern Nevada (Feb. 25, 2020).

STATE ACTIONS—EXECUTIVE/LEGISLATIVE

Pennsylvania Executive Agencies—Actions and Notices: 

Department of Agriculture

50 Pa.B. 1122 “Fiscal Year 2019-2020 Annual Plan for Awarding Grants under the Pennsylvania Agricultural Fair Act,” Notice (Feb. 22, 2020).

Fish and Boat Commission

50 Pa.B. 1194 “Classification of Wild Trout Streams; Additions, Revisions and Removal,” Notice (Feb. 22, 2020).

50 Pa.B. 1194 “Additions to List of Class A Wild Trout Waters,” Notice (Feb. 22, 2020).

50 Pa.B. 1195 “Classification of Wild Trout Streams; Proposed Additions and Revisions; April 2020,” Notice (Feb. 22, 2020).

50 Pa.B. 1199 “Proposed Changes to List of Class A Wild Trout Waters; April 2020,” Notice (Feb. 22, 2020).

Susquehanna River Basin Commission

50 Pa.B. 1232 “Grandfathering Registration Notice,” Notice (Feb. 22, 2020).

50 Pa.B. 1232 “Commission Meeting [Friday, March 13, 2020],” Notice (Feb. 22, 2020).

Pennsylvania Legislature:

H.B. 2289 “An Act amending the act of June 1, 1937 (P.L.1168, No.294), known as the Pennsylvania Labor Relations Act, further providing for definitions; providing for notice and regulations; further providing for unfair labor practices and for representatives and elections; providing for initial collective bargaining agreement; and further providing for prevention of unfair labor practices and for penalties,” Referred to Labor and Industry [House] (Feb. 18, 2020).

S.B. 1041 “An Act amending the act of March 4, 1971 (P.L.6, No.2), known as the Tax Reform Code of 1971, in sales and use tax, further providing for definitions [Preserving the Sales Tax Exemption for Multi-Purpose Agriculture Vehicles],” Referred to Finance [Senate] (Feb. 19, 2020).

S.B. 1036 “An Act amending the act of March 4, 1971 (P.L.6, No.2), known as the Tax Reform Code of 1971, in sales and use tax, further providing for definitions [Clarification of Sales Tax Exemption for Cervidae Livestock Operations],” Referred to Finance [Senate] (Feb. 19, 2020).

H.B. 1755 “An Act amending the act of May 15, 1945 (P.L.547, No.217), known as the Conservation District Law, providing for legislative report,” Referred to Agriculture and Rural Affairs [Senate] (Feb. 19, 2020).

H.B. 1737 “An Act amending the act of May 19, 1995 (P.L.33, No.3), known as the Economic Development Agency, Fiduciary and Lender Environmental Liability Protection Act, further providing for definitions [Environmental liability exemption for land banks],” Referred to Environmental Resources and Energy [Senate] (Feb. 19, 2020).

H.B. 1584 “An Act amending Title 30 (Fish) of the Pennsylvania Consolidated Statutes, in Pennsylvania Fish and Boat Commission, repealing provisions relating to waterways patrolmen and employees,” Referred to Game and Fisheries [Senate] (Feb. 19, 2020).

H.B. 1536 “An Act amending Title 75 (Vehicles) of the Pennsylvania Consolidated Statutes, in general provisions, further providing for definitions; in licensing of drivers, further providing for suspension of operating privilege; in rules of the road in general . . . [Vulnerable Highway User Protections],” Referred to Transportation [Senate] (Feb. 19, 2020).

H.B. 2315 “An Act amending the act of March 4, 1971 (P.L.6, No.2), known as the Tax Reform Code of 1971, in personal income tax, further providing for operational provisions and providing for contributions for the Pennsylvania Fish and Boat Commission and the Pennsylvania Game Commission,” Referred to Game and Fisheries [House] (Feb. 24, 2020)

FEDERAL ACTIONS—EXECUTIVE/LEGISLATIVE

Federal Executive Agencies—Actions and Notices: 

Agricultural Department

85 FR 9451 “Submission for OMB Review; Comment Request [Food and Nutrition Service: Summer Food Service Program Integrity Study]” Notice (Feb. 19, 2020).

85 FR 9721 “Agency Information Collection Activities [USDA Registration Form to Request Electronic Access Code],” Notice (Feb. 20, 2020).

85 FR 10647 “Submission for OMB Review; Comment Request [Rural Housing Service: Planning and Performing Construction and Other Development],” Notice (Feb. 25, 2020).

Agricultural Marketing Service

85 FR 9399 “Quality Systems Verification Programs,” Proposed Rule—Comment Period (Feb. 19, 2020).

85 FR 9699 “Marketing Order Regulating the Handling of Spearmint Oil Produced in the Far West; Salable Quantities and Allotment Percentages for the 2020-2021 Marketing Year,” Proposed Rule—Comment Period (Feb. 20, 2020).

85 FR 10096 “Tomatoes Grown in Florida; Proposed Amendments to the Marketing Order No. 966 and Referendum Order,” Proposed Rule (Feb. 21, 2020).

85 FR 10398 “Peanut Standards Board; Request for Nominations,” Notice (Feb. 24, 2020).

Animal and Plant Health Inspection Service

85 FR 10562 “National Veterinary Accreditation Program,” Rule (Feb. 25, 2020).

Environmental Protection Agency

85 FR 10642 “Receipt of a Pesticide Petition Filed for Residues of Pesticide Chemicals in or on Various Commodities,” Proposed Rule—Comment Period (Feb. 25, 2020).

Farm Credit Administration

85 FR 10035 “Oversight of the Federal Agricultural Mortgage Corporation,” Rule (Feb. 21, 2020).

Farm Service Agency

85 FR 9722 “Information Collection Requests; Farm Loan Programs: Inventory Property Management, Direct Loan Servicing-Regular, General Program Administration, and Guaranteed Farm Loan Program,” Notice—Comment Period (Feb. 20, 2020).

Federal Crop Insurance Corporation

85 FR 9452 “Notice of Request for Extension of a Currently Approved Information Collection [Ineligibility for Programs under the Federal Crop Insurance Act,’” Notice—Comment Period (Feb. 19, 2020).

85 FR 9451 “Notice of Request for Extension of a Currently Approved Information Collection [Area Risk Protection Insurance],” Notice—Comment Period (Feb. 19, 2020).

Federal Emergency Management Agency

85 FR 9675 “Suspension of Community Eligibility [Florida],” Rule (Feb. 20, 2020).

85 FR 10458 “Agency Information Collection Activities: Proposed Collection; Comment Request; National Flood Insurance Program Policy Forms” Notice—Comment Period (Feb. 24, 2020).

Fish and Wildlife Service

85 FR 10621 “Migratory Bird Permits; Regulations for Managing Resident Canada Goose Populations; Agricultural Facilities in the Atlantic Flyway,” Rule (Feb. 25, 2020).

Food and Drug Administration

85 FR 9783 “Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability; Reopening of Comment Period,”

Notice—Comment Period (Feb. 20, 2020).

85 FR 10172 “Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary National Retail Food Regulatory Program Standards,” Notice—Comment Period (Feb. 21, 2020).

85 FR 10107 “Food Standards; General Principles and Food Standards Modernization; Reopening of the Comment Period,” Proposed Rule (Feb. 21, 2020).

85 FR 10057 “Definition of the Term ‘Biological Product’” Rule (Feb. 21, 2020).

85 FR 10632 “Unilever; Filing of Food Additive Petition,” Proposed Rule (Feb. 25, 2020).

Food and Nutrition Service.

85 FR 9453 “Agency Information Collection Activities: Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Program Regulations-Reporting and Record-Keeping Burden,” Notice—Comment Period (Feb. 19, 2020).

Food Safety and Inspection Service

85 FR 10401 “Notice of Request for a New Information Collection: Voluntary Destruction of Imported Meat, Poultry, and Egg Products,” Notice—Comment Period (Feb. 24, 2020).

85 FR 10402 “Notice of Request for Renewal of an Approved Information Collection (Sanitation SOPs and Pathogen Reduction/HACCP),” Notice—Comment Period (Feb. 24, 2020).

85 FR 10648 “Notice of Request for Renewal of an Approved Information Collection (Procedures for the Notification of New Technology and Requests for Waivers),” Notice—Comment Period (Feb. 25, 2020).

Health and Human Services Department

85 FR 9474 “Meeting of the Tick-Borne Disease Working Group,”  Notice (Feb. 19, 2020).

Justice Department

85 FR 9807 “Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act and Request for Comments on Draft Restoration Plans and Environmental Assessments,” Notice (Feb. 20, 2020).

85 FR 9806 “Notice of Lodging of Proposed Consent Decree Under the Clean Water Act,” Notice (Feb. 20, 2020).

Land Management Bureau

85 FR 10188 “Notice of Availability of the Wyoming Draft Supplemental Environmental Impact Statement for Greater Sage-Grouse Conservation,” Notice (Feb. 21, 2020).

85 FR 10184 “Notice of Availability of the Utah Draft Supplemental Environmental Impact Statement for Greater Sage-Grouse Conservation,” Notice (Feb. 21, 2020).

85 FR 10186 “Notice of Availability of the Oregon Draft Supplemental Environmental Impact Statement for Greater Sage-Grouse Conservation,” Notice (Feb. 21, 2020).

85 FR 10183 “Notice of Availability of the Northwest Colorado Draft Supplemental Environmental Impact Statement for Greater Sage-Grouse Conservation,” Notice (Feb. 21, 2020).

85 FR 10184 “Notice of Availability of the Nevada and Northeastern California Draft Supplemental Environmental Impact Statement for Greater Sage-Grouse Conservation,” Notice (Feb. 21, 2020).

85 FR 10185 “Notice of Availability of the Idaho Draft Supplemental Environmental Impact Statement for Greater Sage-Grouse Conservation,” Notice (Feb. 21, 2020).

Rural Business-Cooperative Service

85 FR 9725 “Guarantee Fee Rates for Guaranteed Loans for Fiscal Year 2020, Maximum Portion of Guarantee Authority Available for Fiscal Year 2020, Annual Renewal Fee for Fiscal Year 2020,” Notice (Feb. 20, 2020).

Rural Utilities Service

85 FR 10555 “Special Servicing of Telecommunications Programs Loans for Financially Distressed Borrowers,” Rule—Comment Period (Feb. 25, 2020).

U.S. House Agriculture Committee Actions: 

H.R.5915 “Making Essentials Available and Lawful (MEAL) Act of 2020,” Referred to Committee on Agriculture and Committee on Ways and Means (Feb. 14, 2020).

H.R.5920 “MONARCH Act of 2020,” Referred to Committees on Agriculture; Natural Resources; and Appropriations (Feb. 14, 2020).

S.2107 “Protecting America's Food and Agriculture Act of 2019,” Presented to President (Feb. 20, 2020).

U.S. Senate Agriculture, Nutrition, And Forestry Committee Actions: 

No new actions Feb. 19–25, 2020

S.3292 “A bill to amend the Federal Crop Insurance Act to reduce Federal spending on crop insurance, and for other purposes” Read twice and referred to the Committee on Agriculture, Nutrition, and Forestry (Feb. 13, 2020).

S.3293 “A bill to amend the Richard B. Russell National School Lunch Act to establish the Food and Nutrition Education in Schools Pilot Program, and for other purposes” Read twice and referred to the Committee on Agriculture, Nutrition, and Forestry (Feb. 13, 2020).

Follow us on Twitter @AgShaleLaw to receive #AgLaw HotLinks

Feb. 19–25, 2020 #AgLaw links:

Larger Soybean and Cotton Plantings Due to Trade Deal? Successful Farming

DFA, Dean reach $425m deal, Feedstuffs

Pompeo pledges $1 billion in US support for European energy initiative, The Hill

GAO opens investigation into USDA trade aid, Feedstuffs

USDA to unveil plan to cut farms' environmental impact in half by 2050, Politico

House members continue to prod FDA on milk labeling, Feedstuffs

Bayer/Monsanto to Appeal Dicamba Verdict – Says Soil Root Rot Cause of Damages, Brownfield

Connect with us on Facebook.  Every week we post the CASL Ledger detailing all of our publications and activities from the week. 

Want to get updates, but prefer to listen? 

Check out the Agricultural Law Podcast.  Subscribe at iTunes, Spotify, or Stitcher.

Want a monthly recap of some of the biggest legal developments in agriculture? 

Check out our January 2020 Agricultural Law Brief. 

To receive this monthly update via email, subscribe here.

FSMA Update: Mitigation Strategies to Protect Food against Intentional Adulteration

Written by Errin McCaulley - Research Assistant

On May 27, 2016, The Food and Drug Administration (FDA) released its last final rule under the Food Safety Modernization Act (FSMA) titled Mitigation Strategies to Protect Food against Intentional Adulteration (81 Fed. Reg. 34,165). This final rule mandates compliance requirements that are similar to a  Hazard Analysis and Critical Control Point (HACCP) program, albeit more flexible. Whereas traditional HACCP programs focus on the analysis of hazards in food production, such as biological and chemical hazards, and the identification of critical control points (CCPs) to mitigate these hazards, the final rule on intentional adulteration is concerned with vulnerabilities which, if exploited, could result in the deliberate tampering of food products.

Because this final rule deals with potential acts, such as terrorism, and not identified or present hazards, as in HACCP, FDA added flexibility throughout this final rule to ease the burden of compliance. This final rule is intended to prevent the intentional introduction of harmful agents into the food supply during the manufacturing/processing, packing, or holding of human food. FDA requires, absent certain exemptions, that all facilities that must register under 21 U.S.C. § 350d (§ 415 FD&C Act) are required to implement this final rule. FDA did, however, provide for a handful of exemptions (see 81 Fed. Reg. 34,220-21) which will be codified as 21 C.F.R. § 121.5.

The requirements of FSMA’s last rule are not as robust as either the Preventive Controls for Human Food (PCHF) or Preventive Controls for Animal Food (PCAF) final rules which preceded it; rather, FDA responded to numerous comments and added flexibility throughout this final rule.

First, covered facilities must create a “food defense plan” as drafted by a “qualified individual” (21 C.F.R. § 121.126). The food defense plan must contain the written vulnerability assessment, the written procedures for (1) “food defense monitoring,” (2) “food defense corrective actions,” and (3) “food defense verification” (Definitions of quoted terms can be found at 34,219 of this final rule).

Second, a qualified individual must carry out a vulnerability assessment for each type of food manufactured, processed, packed, or, in the event of liquid storage tanks, held at the facility and identify “significant vulnerabilities” at each “actionable process step” (21 C.F.R. § 121.130). A vulnerability assessment must consider (1) the potential impact a contamination of the assessed food could have on the public health, (2) the physical accessibility of the food product being assessed, and (3) a determination of an attacker’s ability to carry out a contamination of the assessed food product. FDA, in response to several comments, stressed that the focus of a vulnerability assessment is upon the potential inside attacker, such as an employee, rather than an attacker from outside the facility.

Third, a qualified individual must craft mitigation strategies aimed at minimizing the vulnerabilities identified during the assessment and ensure their implementation (21 C.F.R. § 121.135). This provision also requires a written explanation as to how the mitigation strategy sufficiently minimizes the vulnerability. In response to several comments, FDA clarified that, while perhaps not fulfilling all requirements for mitigation strategies, facilities that are already parties to a security program, such as Customs-Trade Partnership Against Terrorism (C-TPAT) or Chemical Facility Anti-Terrorism Standards (CFATS), may be able to use certain procedures from these programs as mitigation strategies.

Fourth, along with the creation of mitigation strategies, facilities are also required to establish and implement the “management components” for mitigation strategies which include written procedures for (a) “food defense monitoring” (21 C.F.R. § 121.140), (b) “food defense corrective actions” (21 C.F.R. §121.145), and (c) “food defense verification” (21 C.F.R. § 121.150). In response to concerns raised by several comments regarding food defense verification, FDA modified the proposed rule’s language to emphasize that the purpose of verification in this final rule is not to verify the effectiveness of the mitigation strategies, but rather to ensure that the procedures a facility puts in place, such as food defense monitoring, are being carried out properly.

The last major requirement of this final rule concerns the reanalysis of the food defense plan (21 C.F.R. § 121.157). A qualified individual must carry out a reanalysis of the food defense plan as a whole at least once every three years. A reanalysis of the food defense plan in part is required in the event a mitigation strategy is implemented improperly, a change is made to the facility, such as construction, and a new vulnerability could reasonably arise. Further events which would require either a complete or partial reanalysis of the food defense plan are listed in § 121.157.

The final rules under FSMA, including this most recent one, require record retention for a period of no less than two years. Under this final rule, except for the food defense plan, all records may be kept off-site from the facility, as long as their retrieval is possible within twenty-four hours, and electronic medium is permitted. Finally, after reviewing numerous comments regarding records, FDA is allowing the use of existing records, to avoid the need for duplication, and facilities that already take part in a security program, such as C-TPAT or CFATS, may use applicable records, either combined or separate, to form the records required under this final rule.

The effective date of this rule is July 26, 2016. The compliance dates are as follows: facilities, excluding “small” (<500 full-time equivalent employees) and “very small” (<$10,000,000 in annual sales of human food for last three years, including market value of human food manufactured, processed, packed, or held without sale), have three years from the effective date to comply (July 26, 2019); small businesses have four years from the effective date to comply (July 26, 2020); and very small businesses are exempt from the requirements of this rule, although FDA may, upon request, require documentation from a very small business which show the facility meets the requirements of the exemption.