Regulatory Register - Winter 2022

In this issue USDA Joins Global Dairy Net Zero Initiative, Launches Agriculture Innovation Mission for Climate, Page 3 U.S. Supreme Court Blocks OSHA ETS, Page 5 FDA Drug Residue Report Indicates Progress, Page 6

REGULATORY REGISTER

Volume 24, Issue 1 Winter 2022

ENVIRONMENT NMPF Joins Letter Requesting 90-Day WOTUS Comment Extension NMPF, along with several other agriculture groups including the American Farm Bureau Federation and National Pork Producers’ Council, in a joint letter sent Dec. 21 requested a 90-day extension to the Environmental Protection Agency (EPA) and the Department of the Army’s comment period for the proposed definition of Waters of the U.S. (WOTUS) under the Clean Water Act. “To our considerable alarm, the proposed rule appears to codify an entirely novel and expansive approach to the definition of WOTUS that was neither contemplated or applied under the pre-2015 guidance and rules,” the letter stated, arguing that 60 days isn’t enough to thoroughly analyze the proposed rule, new economic analysis and technical support document.

The proposed rule “exercises the agencies’ discretionary authority to interpret “Waters of the United States” to mean the waters defined by the longstanding 1986 regulations, with amendments to certain parts of those rules to reflect the agencies’ interpretation of the statutory limits on the scope of the “waters of the United States” and informed by Supreme Court case law.” The agencies believe a return to the pre-2015 definition will provide a known and familiar framework for co-regulators and stakeholders.

The proposed rule comes after the Navigable Waters Protection Rule was ordered and vacated in the case of Pascua Tribe v. U.S. Environmental Protection Agency in August 2021.

NMPF and fellow agriculture groups have yet to hear back from EPA regarding the extension.

EPA Delays Pyrethrins Decision Until 2024; Looks to Rodenticides NMPF scored a significant victory for its members in December with an EPA delay on its decision on the use of pyrethrins in agriculture. The agency is also following a similar process in its view of rodenticides, with NMPF seeking additional information while successfully advocating for a comment-period delay.

The EPA published on Dec. 2 a delay to its decision on the use of pyrethrins in agriculture until at least 2024 after NMPF filed joint comments with other agricultural organizations, including the American Farm Bureau Federation and the National Pork Producers Council, advocating for the continued use of pyrethrins on agriculture operations.

“The pyrethrin + products are fundamentally important to the U.S. livestock and poultry sectors for the control of many airborne and other animal house insect pests, especially house and stable flies,” the groups wrote on Nov. 3. “These insects are highly detrimental to the health and welfare of the animals, the persons working in the houses, and lead to risks of spread of food safety pathogens.”

Pyrethrins are the most effective and safe product to use for adult fly control on agriculture operations.

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PYRETHRINS ARE THE MOST EFFECTIVE AND SAFE PRODUCT TO USE FOR ADULT FLY CONTROL ON AGRICULTURE OPERATIONS.

After initiating a registration review in Dec. 2011, EPA proposed the prohibition of multiple applications of pyrethrins, including the use in animal barns, even after recognizing that this could negatively impact pest control, citing “potential risks of concern for residential handlers and adults and children who are exposed after application.” The joint comments emphasized the important role pest management plays in biosecurity and disease control, noting and that there is little to no public exposure to pyrethrins when applied properly.

As it’s been doing with pyrethrins, EPA is currently conducting a registration review process for rodenticides with a proposed interim decision to be issued in 2022. The office of Pesticide Programs, Biological and Economic Analysis Division is currently analyzing the use and benefits of rodenticides and has issued questions to gather information to support the review. NMPF sent a joint letter with fellow animal agriculture groups on Dec. 21 asking for a 30-day extension. A 20-day extension was granted, making answers to the agency due Feb. 4, 2022. NMPF will be providing input to the agency.

USDA Joins Global Dairy Net Zero Initiative, Launches Agriculture Innovation Mission for Climate at UN COP26 Meetings USDA on Dec. 4 joined the Pathways to Dairy Net Zero initiative as a formal supporter as part of its support of climate-related initiatives during the United Nations COP26 meetings. USDA also formally launched the Agriculture Innovation Mission (AIM) for Climate during the event.

These global agriculture efforts align with the approach U.S. dairy is taking to reduce its environmental impact through its Net Zero Initiative, which aims to achieve net-zero greenhouse gas emissions by 2050 and will help the U.S. dairy industry be an environmental solution now and in the future.

Pathways to Dairy Net Zero is a groundbreaking, multi-stakeholder initiative that aims to accelerate climate change action across the dairy sector that’s wellaligned with U.S. dairy’s Net Zero Initiative launched last year.

AIM for Climate accelerates climate-smart agriculture and food systems innovation over the next five years by embracing practical solutions identified through investments in research and pilot programs, which also is very similar to dairy’s Net Zero approach.

“Dairy farmers are proud to be part of the U.S. Dairy Net Zero Initiative to do our part in driving toward a global climate solution,” said Jim Mulhern, president, and CEO of NMPF. “USDA’s formal support for the Pathways to Dairy Net Zero, which NMPF also supports, will help to further catalyze this global effort by dairy sectors and governments around the world to foster sustainable production practices. We commend USDA’s global leadership in charting an incentivebased approach to encouraging sustainably managed livestock systems that can help feed a growing global population while minimizing environmental impacts.”

“With the world’s lowest greenhouse gas footprint per gallon of milk, U.S. dairy leads the world in sustainability. Yet we’re also deeply committed to making further progress as we work together with others in the U.S. and around the world to create environmental solutions that make U.S. dairy ever more competitive globally,” said Krysta Harden, president and CEO of USDEC. “Working together and with a firm commitment to the positive role that innovation and productivity can play in the sustainability arena, we’ll be able to help create the sustainable future so important to us all.”

COVID-19 AND SUPPLY CHAIN ISSUES

NMPF Acts as White House Conduit on Food, Agriculture COVID Issues The White House Domestic Policy Council (DPC) and the National Economic Council (NEC) in the last week of December requested weekly updates on food and agricultural supply chain challenges. FDA and USDA are responsible for submitting information to the DPC/NEC each Monday.

Federal rules and regulations prohibit federal agencies from soliciting information from more than nine private sector entities unless they follow a stringent and arduous process. Because that isn’t timely, the government has once again reached out to the Food and Agriculture Sector Coordinating Council (FASCC) to conduct the information collection. NMPF Staff Counsel and SVP Clay Detlefsen serves as the Chair of the FASCC and is leading the effort.

Below are the questions posed by DPC and NEC to frame industry’s responses: · What challenges are currently being experienced with regard to supply chain continuity? · Are there newly emerging or anticipated concerns with maintaining supply chain continuity (e.g. supplies or inventory that are currently adequate but may become an issue, etc.)? · Are there areas where federal government assistance could be helpful (e.g., vaccine/booster education, transportation, etc.) · What challenges are being seen regarding maintaining employees? · Are there any issues with obtaining PPE (masks, gloves, etc.)? · Other areas of concern?

NMPF is very pleased with the private-sector responses supplied thus far. The responses go far beyond COVID and delve into many of the challenges the food and agriculture entities have faced for years which the pandemic has only exacerbated. Worker shortages; transportation challenges including trucking and ports; ingredient and packaging shortages have all been raised. In addition, a great deal of concern has been expressed about the OSHA ETS and the lack of availability for testing.

NMPF with continue to be the conduit and will submit weekly reports for the foreseeable future.

U.S. Supreme Court Blocks OSHA ETS, Encouraging Dairy The U.S. Supreme Court on Jan. 13 blocked the Biden Administration from enforcing a vaccinationor-testing requirement crafted by the Occupational Health and Safety Administration. The court’s decision stayed the OSHA ETS COVID vaccination and testing requirements for employers with 100 or more employees and the Biden Administration abandoned pursuit of the mandate Jan. 26.

The ruling, which was in line with NMPF concerns, means that employers with 100 or more employees do not need to follow the OSHA ETS COVID vaccination and testing requirements.

This means employers can continue to implement COVID safety precautions as they determine for their business, subject to any state or local requirements.

“We are pleased with the Supreme Court’s decision on a stay of the ETS,” said NMPF President and CEO Jim Mulhern in a statement. “NMPF has long been concerned about the practical application of the OSHA regulation at a time when testing supplies are scarce and food and agriculture supply chains are already disrupted by a lack of worker availability. We have voiced those concerns in meetings and other communications to federal officials over the last several months. The court’s decision will bring relief to dairy employers who strive 24/7 to put nutritious products on consumer plates.”

Parts of the mandate requiring record-keeping and masks had been scheduled to go into effect on Monday, with full requirements going into effect by Feb. 9.

The Supreme Court decision in effect ends the Biden Administration’s attempt to establish a sweeping nationwide vaccine mandate. It also ends a brief but intense storm of activity for NMPF, which was discussing the requirement with federal officials even before it was announced.

The ETS itself was issued last Nov. 4.

Prior to the issuance of that rule in October, NMPF and several other agricultural entities met virtually with the White House Office of Management and Budget (OMB) to express our concern about the

unseen rule. NMPF expressed concern about the availability of COVID tests and suggested that the government use the Defense Production Act (DPA) as was done previously in a number of COVID-related challenges, to ensure an adequate supply of tests. The government failed to do so in a meaningful way, a mistake given current difficulty in acquiring both rapid home tests and PCR lab tests. NMPF and the others also suggested suspending the application of the OSHA ETS to essential critical infrastructure workers as defined by DHS-CISA (which NMPF played a critical role in defining) should the rule create workforce problems.

Meanwhile, to prepare for the possibility that the mandate would take effect and be upheld in court, NMPF created a Toolbox on its website explaining ETS basics as litigation exploded. The 5th Circuit Court of Appeals issued a nationwide stay on OSHA’s implementation and enforcement of the ETS on Nov. 6. Within days of that action, every Court of Appeals in the country had at least one case before it – 34 in all.

On Nov. 16, all the cases were consolidated into one and the litigation was assigned to the 6th Circuit Court of Appeals.

The 6th Circuit ultimately ruled with a three-judge panel that the 5th Circuit’s stay needed to be lifted.

Immediately thereafter that decision was appealed to U.S. Supreme Court, which blocked the ETS pending resolution in the 6th Circuit.

On Jan. 26, OSHA revoked the ETS while stating it would pursue a permanent final rule to be released in May. Such a rule would need to be drastically different from the broad unconstitutional rule that OSHA previously issues and even then, it is likely to be challenged in court. Employers with 100 or more employees may now proceed with addressing COVID-19 in the workplace as they see fit subject only to state and local laws.

In a related matter, the government has asked NMPF at the end of December for assistance in determining the state of food and agriculture entities and their workforces given ongoing complications due to COVID-19 and the recent spike due to the Omicron variant.

ANIMAL HEALTH Annual FDA Drug Residue Report Indicates Continued Progress Only 1 out of 12,050 milk tankers tested positive for antibiotic residues last year, according to the 2021 National Milk Drug Residue Database annual report released on Dec. 15 by the U.S. Food and Drug Administration.

The data illustrates the continued long-term national pattern of improvements in milk quality practices by the industry.

Of the approximately 3.5 million milk pick-up tankers tested in the past year, only 290 (0.08%) yielded a positive result. The number of samples tested (tankers, packaged products, producer samples) and reported positive decreased from 536 in 2020 to 451 in 2021; only a single pasteurized packaged dairy product (31,0009) tested was found to have an antibiotic residue with the 1000 pounds of product destroyed and not sold to the public.

The full report is available here.

Antimicrobials Used in Food-Producing Animals at Historic Low Sales and distribution of medically important antimicrobials for use in food-producing animals decreased 3 percent in 2020, the second-lowest year on record, according to the FDA’s annual report on animal antibiotics used in agriculture, released Dec. 14. Sales and distribution of all antimicrobials for use in food-producing animals declined by 9 percent, the lowest year on record.

The report, first released in 2009, monitors market changes related to antimicrobial drug products for food-producing animals and slow the development of antimicrobial resistance.

Use of medically important antimicrobials has dropped 38 percent since 2015, the peak year of antimicrobial sales. The full report breaks down antimicrobial drug sales by class and medical importance, noting that the antimicrobials sold doesn’t equate to antimicrobials used.

NMPF supports FDA’s work to increase the oversight of antimicrobial usage and has made veterinarian- client-patient relationships a cornerstone of the FARM program to help ensure judicious use.

FARM PROGRAM FARM Presents Survey Results at Town Hall FARM Program stakeholders identified care for sick animals, calves, and non-ambulatory cattle as dairy’s greatest priority to maintain focus on for Version 5 of FARM’s Animal Care Program as determined by an industry wide survey distributed through the fall with results presented at a virtual town hall Dec. 14.

60% of survey respondents supported implementing specific timeframes for improving aspects of their facilities, such as all age classes of animals being able to easily stand up, lie down, adopt normal resting postures and have visual contact with other cattle without risk of injury.

The survey was intended to collect feedback from farmers, veterinarians, cooperatives, processors, and others within the dairy supply chain as planning commences for Version 5 of FARM Animal Care, which will launch July 1, 2024. The survey questions were developed following a series of focus groups hosted last August by the FARM Program. FARM received 682 complete responses; staff were able to identify potential refinement opportunities for the next program cycle in addition to the top animal care priorities from stakeholders.

The survey also showed general support for making minor modifications and adding clarity to the FARM Animal Care Program while avoiding large overhauls.

Most survey respondents, including farmers, showed they would willingly support small changes to better address animal care vulnerabilities. Respondents also were in consensus that standards that aren’t direct measures of good animal welfare practices should be updated to prioritize an outcomes-based approach.

For more information, visit the Version 5 development page.

LABELING

NMPF Files Comments to Cell-Based Meat Docket NMPF filed comments to USDA’s Food Safety Inspection Service’s Advanced Notice of Proposed Rulemaking entitled “Labeling of Meat or Poultry Comprised of or Containing Cultured Animal Cells,” emphasizing consumers right to know that they are consuming cell-based/lab-grown products through the label on the product. The comments, filed Nov. 9, highlighted: • The need to enforce already existing standards; • That the word “cultured” should not be used to describe these products, as the term is associated with cultured dairy products including yogurt, and kefir, among others; • Products containing lab-grown animal cells should clearly state that; • USDA should coordinate policies with FDA while developing these standards; and • “Cell-based,” “lab-grown,” or “synthetic” would all be appropriate labels for these products.

FSIS should move expeditiously through the normal rulemaking process and not waste years developing rules while not making the same blunders that FDA has. The full comments can be found here.

Bioengineering Rule in Effect with New Year The National Bioengineered Food Disclosure Standard, which establishes a mandatory standard for disclosing foods that are or may be bioengineered, became mandatory Jan. 1.

The standard, first announced in December 2018, defines bioengineered foods as those that contain detectable genetic material that’s been modified through certain lab techniques and cannot be created through conventional breeding or found in nature.

Regulated entities have many options for the disclosure

including text, symbol, electronic or digital link, and/ or text message. The rule is intended to provide clarity for consumers.

In a regulatory victory for NMPF, the rule reiterated that meat or milk from animals consuming bioengineered grains does not make that meat or milk a bioengineered food. USDA stated that under any voluntary disclosure, it would be inappropriate to label that same meat or milk as being “derived from bioengineering.”