FDA Announces “Operation Stork Speed”
On March 18, 2025, FDA announced that, at the direction of Health and Human Services Secretary Robert F. Kennedy Jr., it is “taking steps to enhance its efforts to ensure the ongoing quality, safety and nutritional adequacy” of infant formula products as part of a broader review of the U.S. food supply, in what is being referred to as “Operation Stork Speed.”
Key measures include:
Nutrient Review: FDA will soon issue a Request for Information to begin a comprehensive review of infant formula nutrients.
Increased Testing: There will be increased testing for heavy metals and other contaminants in infant formula and other foods consumed by children.
Encouraging Innovation: FDA is urging companies to develop new infant formulas and improve transparency in labeling to better inform consumers and will collaborate with the National Institutes of Health on researching the long-term health outcomes associated with formula feeding of infants.
The announcement comes as part of a broader effort to stabilize the supply of infant formula following severe shortages in 2022. FDA has since implemented a national strategy to increase the resilience of the U.S. infant formula market, including measures to prevent future shortages and improve the integrity of the supply chain. Operation Stork Speed builds on these efforts, aiming to ensure that families have access to safe and nutritious formula for their infants.
APHIS Evaluates Petitions Reviewed under 2012 Process, Will Use Process Consistent with USDA Biotechnology Regulations Going Forward
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 27, 2025, that it will no longer use the process it outlined in 2012 for reviewing petitions seeking a determination that a modified plant should not be subject to the regulations for the introduction of organisms altered or produced through genetic engineering (modified organisms) that are plant pests or that there is reason to believe are plant pests. On March 6, 2012, APHIS announced that it would publish two separate Federal Register notices for petitions for which it prepares an environmental assessment. 77 Fed. Reg. 13258. The first notice would announce the availability of the petition, and the second notice would announce the availability of APHIS’ decision-making documents, providing two opportunities for public comment. According to APHIS’ March 2025 announcement, at the time, APHIS anticipated that enabling earlier public engagement on the petition would help scope the subsequent analyses, including whether the petition raised substantive new issues. After evaluating the 34 petitions reviewed under the 2012 process, APHIS states that it “found that the first comment period has not yielded comments that significantly impacted the scoping for APHIS’ evaluation.” Given this experience, APHIS will institute the following process consistent with USDA’s biotechnology regulations:
Once APHIS deems a petition to be complete, it will publish a Federal Register notice that will begin a 60-day comment period on the petition and APHIS’ draft evaluation documents; and
After the comment period closes, APHIS will review the comments and any other relevant information it receives during the comment period, complete its evaluation documents, and make a final determination. APHIS will either approve or deny the petition and publish a Federal Register notice announcing the regulatory status of the modified plant and the availability of the regulatory determination and final supporting documents.
New Guidelines Establishing the Requirements and Procedures That Must Be Observed to Obtain Permission to Advertise Prepackaged Food and Non-Alcoholic Beverages
Following our newsletter dated March 31, 2020 “The new Mexican Official Standard for the labelling of pre-packaged food and non-alcoholic beverages” and other newsletters regarding labelling of products, after five years of the publication of this Mexican Official Standard, on March 11, 2025, the Guidelines regarding advertising of prepackaged food and non-alcoholic beverages were published in the Official Gazette and entered into force on March 12, 2025.
These Guidelines appear to now restrict the advertising of these types of products, imposing advertisers, advertising agencies and media, the obligation to obtain a permit/approval for advertising the products on open television, restricted television, movie theaters, internet and other digital platforms.
Any product is subject to approval by the Federal Comision Against Sanitary Risks (COFEPRIS) when their label includes one or more warning seals of the front labeling system.
The main restrictions, among others, are the following:
It is forbidden to use animated characters, pets or interactive games directed at children to promote the consumption of the products.
To compare the products with natural ones.
To compare with similar products regarding their composition or nutritional contents.
To suggest physical or intellectual abilities from its consumption.
To promote excessive consumption of the product.
To suggest that the products may modify body proportions.
The requirements for obtaining the permit/approval to advertise the products are to fill in a format, pay government fees and attach the “operation notice” (authorization) of the product.
Once submitted the application, COFEPRIS has a term of 20 working days to approve the advertisement and/or 10 days to issue a requirement. Applicant has a term of 5 days to reply or else, the approval will be dismissed.
Although, we consider all these requirements to be an unnecessary burden to the industry, this Guidelines provide definitions of terms such as, “pets”, “celebrities”, “children’s characters”, “digital downloads”, “cartoons” and “indirect advertising”, that were missing in the Mexican Official Standard for the labelling of pre-packaged food and non-alcoholic beverages.
HHS Job Cuts: FDA, CDC, NIH and CMS Impacted Amidst Significant Restructurings
On March 27, 2025, the United States Department of Health and Human Services (HHS) announced a “dramatic restructuring” that will result in a reduction in agency workforce combined with significant internal restructuring.1 The department plans to cut approximately 20,000 positions, bringing its headcount in line with HHS’s pre-2002 level of around 62,000 employees. The anticipated restructuring involves consolidating 28 divisions into 15, citing prior budget and staffing increases of 38 percent and 17 percent, respectively.2
In connection with this restructuring, the Administration announced the following changes:
Creation of the Administration for a Healthy America (AHA), which will consolidate the Office of the Assistant Secretary for Health (OASH), the Health Resources and Services Administration (HRSA), the Substance Abuse and Mental Health Services Administration (SAMHSA), the Agency for Toxic Substances and Disease Registry (ATSDR) and the National Institute for Occupational Safety and Health (NIOSH);
Transfer of the Administration for Strategic Preparedness and Response (ASPR) to the Centers for Disease Control (CDC);
Creation of a new Assistant Secretary for Enforcement to oversee the Departmental Appeals Board (DAB), Office of Medicare Hearings and Appeals (OMHA) and Office for Civil Rights (OCR);
Merging the Assistant Secretary for Planning and Evaluation (ASPE) with the Agency for Healthcare Research and Quality (AHRQ) to create a new Office of Strategy to provide research enhancing HHS’s various initiatives;
Reorganizing the Administration for Community Living (ACL) programs that support older adults and people of all ages with disabilities into other parts of HHS; and
10 HHS Regional Offices will be consolidated into 5.3
These cuts and restructurings follow the February 11, 2025, Executive Order which placed much of the federal government’s human resource management under the purview of the Department of Government Efficiency (DOGE)4 and the February 12, 2025 termination of “Fork in the Road,” a deferred resignation program for government employees.5 This latest announcement adds to the growing number of federal staff reductions—62,000 jobs were cut across 17 different agencies in February alone.6 With HHS’s designation of a new Assistant Secretary of Enforcement to combat purported fraud, waste and abuse across its divisions, more job cuts could be on the horizon.
As a result of this latest announcement, the anticipated amount of job cuts and resulting reduced employee pools are as follows: the U.S. Food and Drug Administration (FDA) will cut 3,500 employees (about 20 percent of its workforce); the Centers for Disease Control and Prevention (CDC) will cut 2,400 employees; the Centers for Medicare and Medicaid Services (CMS) will cut 300 employees; and the National Institutes of Health (NIH) will cut 1,200 employees. These cuts, along with another 2,600 employees slated for dismissal, amount to a total of 10,000 HHS jobs cut. These cuts, combined with another 10,000 employees who have left the agency due to buyouts or other voluntary resignations, add up to the 20,000 total employee reduction.7
Potential Impacts
The sweeping job cuts, department re-organization and consolidation are in line with Secretary Kennedy’s vision of “doing more with less” resources, while a former HHS employee anonymously expressed concerns that “the cuts will weigh heavily on caseworkers and account management teams,” ultimately leading to a declination in “[s]ervice standards for Medicare Advantage beneficiaries,” due to both “a reduction in the people that handle their cases” and “diminished oversight of the Medicare Advantage plans.”8
Healthcare providers and other organizations that rely on regular interaction with HHS and its subagencies should be on the lookout for disruptions or delays in service as HHS implements these cuts and departmental reorganizations. For example, several senior FDA drug reviewers have already announced their resignations, and more are expected, raising the distinct possibility that the FDA’s ability to perform its public health functions will be impaired.9 The full impact of the March 27th announcements will not be known for some time, but potentially impacted stakeholders should keep a watchful eye over the coming months as HHS implements the announced changes.
[1] U.S. Dep’t of Health and Human Servs., HHS Announces Transformation to Make America Healthy Again (Mar. 27, 2025), https://www.hhs.gov/about/news/hhs-restructuring-doge.html.
[2] U.S. Dep’t of Health and Human Servs., Fact Sheet: HHS’ Transformation to Make America Healthy Again (Mar. 27, 2025), https://www.hhs.gov/about/news/hhs-restructuring-doge-fact-sheet.html.
[3] Id.
[4] Exec. Order No. 14,210, 90 Fed. Reg. 9669 (Feb. 14, 2025); see also Exec. Off. of the President, Implementing The President’s “Department of Government Efficiency” Workforce Optimization Initiative (Feb. 11, 2025), https://www.whitehouse.gov/presidential-actions/2025/02/implementing-the-presidents-department-of-government-efficiency-workforce-optimization-initiative/.
[5] U.S. Off. of Pers. Mgmt., Fork in the Road: Program Closed, https://www.opm.gov/fork/ (last visited Mar. 27, 2025).
[6] Janet Nguyen, Federal workers’ salaries represent less than 5% of federal spending and 1% of GDP, Marketplace (Mar. 6, 2025), https://www.marketplace.org/2025/03/06/federal-workers-salaries-represent-less-than-5-of-federal-spending-and-1-of-gdp/.
[7] Phil Taylor, HHS plans 10,000 more job cuts, taking target to 20,000, pharmaphorum (Mar. 27, 2025), https://pharmaphorum.com/news/hhs-plans-10000-more-job-cuts-taking-target-20000.
[8] Meg Tirrell et al., HHS cuts 10,000 employees in major overhaul of health agencies, CNN (Mar. 27, 2025, 6:46 PM), https://www.cnn.com/2025/03/27/health/hhs-rfk-job-cuts/index.html.
[9] See @steveusdin1, X (Mar. 27, 2025, 4:54 PM), https://x.com/steveusdin1/status/1905377827836624915.
Nebraska Considers Sales Tax on Candy and Soft Drinks
Earlier this year lawmakers in Nebraska proposed a bill (LB170) which would end the state’s sales tax exemption for soda and candy. Currently, all food and beverages except prepared foods and vending machine items are exempt from the sales tax.
The proposed bill defines candy as a “preparation of sugar, honey, or other natural or artificial sweeteners in combination with chocolate, fruits, nuts, or other ingredients or flavorings in the form of bars, drops, or pieces” but excludes “any preparation that contains flour or that requires refrigeration” to avoid discouraging consumption of healthier snacks like granola and protein bars. (See Deep Dive: Nebraska Legislature committee to discuss ‘Sugar Tax’). Soft drinks are defined as “nonalcoholic beverages that contain natural or artificial sweeteners” but excludes “beverages that contain milk or milk products, soy, rice, or similar milk substitutes or that contain greater than fifty percent of vegetable or fruit juice by volume.”
The bill is intended to reduce the state’s budget deficit. It is opposed by affected industry including the Nebraska Beverage Association.
Illinois Moving Forward with BVO Ban
Illinois is moving forward with the Illinois Food Safety Act to ban brominated vegetable oil (BVO), potassium bromate, propylparaben, and Red No. 3, despite FDA’s BVO ban that went into effect in July 2024 with a one-year compliance period. We previously blogged about Illinois’ bill and the FDA revocation of BVO.
According to Illinois Secretary of State Alexi Giannoulias, FDA’s ban left enforcement gaps, including lingering sales of BVO-containing products. The Illinois bill would ensure that “families aren’t stuck with unsafe leftovers while the feds catch up.” The Illinois ban is intended to enforce the BVO ban at the retail level and “tackle additional chemicals, potentially setting a precedent for stricter state oversight.”
Illinois is not the only state pushing for stricter food additive bans. California banned four additives in 2023, and other states including New York and New Jersey have proposed similar laws. According to the Environmental Working Group, states are “tired of waiting” for FDA to review additives and are “forcing the FDA’s hand.” However, states could face lawsuits claiming federal preemption for the banned chemicals.
FDA Announces a “Chemical Contaminants Transparency Tool” to Evaluate Potential Health Risks of Contaminants in Human Foods.
On March 20, 2025, the Food and Drug Administration (FDA) announced the availability of a Chemical Contaminants Transparency Tool, a database intended to provide users with a list of contaminant levels in the food supply.
Contaminant levels, such as tolerances, action levels, and guidance levels, are used by FDA to evaluate potential health risks in food. If contaminant levels exceed the permissible threshold, FDA will deem the food to be unsafe.
The database compiles existing information from several sources, including compliance policy guides, guidance for industry, and the Code of Federal Regulations, into a single reference. Information includes the contaminant’s name, commodity, contaminant level type, level value, and its reference source. There are currently 301 records available on the database.
According to the news release, under the direction of Secretary Kennedy, the Chemical Contaminants Transparency Tool is one new initiative intended to modernize chemical safety. The intention behind the database is to offer the American public “informed consent about what they are eating.”
EPA Extends 2024 RFS Compliance Reporting Deadline
The U.S. Environmental Protection Agency (EPA) issued a final rule on March 14, 2025, extending the Renewable Fuel Standard (RFS) compliance reporting deadline for the 2024 compliance year. 90 Fed. Reg. 12109. As reported in our January 8, 2025, blog item, EPA published a proposed rule on December 12, 2024, that would partially waive the 2024 cellulosic biofuel volume requirement and revise the associated percentage standard under the RFS program due to a shortfall in cellulosic biofuel production. 89 Fed. Reg. 100442. As a result of this proposed change, EPA proposes to extend the RFS compliance reporting deadline for the 2024 compliance year. In its March 14, 2025, final rule, EPA does not make final the proposed partial waiver or most of the other proposed amendments to other RFS provisions, instead stating that it may address them in a later action. According to EPA, it expects that the effective date of the revised 2024 cellulosic biofuel standard will not occur until after the March 31, 2025, original 2024 RFS compliance reporting deadline. To provide obligated parties with sufficient time to carry out and adjust their compliance strategies once EPA issues the final revised 2024 cellulosic biofuel standard, it is extending the 2024 RFS compliance reporting deadline from March 31, 2025, to the next quarterly compliance reporting deadline after the effective date of the final rule establishing the revised 2024 cellulosic biofuel standard. EPA states that by operation of law, the 2024 attest engagement deadline would also be extended to the next June 1 annual attest engagement reporting deadline after the revised 2024 RFS compliance reporting deadline. EPA also made several minor amendments and technical corrections to other RFS provisions. The rule was effective March 13, 2025.
Behavioral Health Law Ledger | March 2025
Welcome to the Ledger
The March 2025 issue of Greenberg Traurig’s quarterly Behavioral Health Law ledger explores two behavioral health legal developments: proposed legislation in several states that would affect behavioral and mental health operations, including reimbursement for mental health services and enforcement of fraud and abuse laws for substance use disorder facilities; and a rise in hospital closures, including psychiatric hospitals.
Pending Legislation Review: State Legislation that May Impact Behavioral Health
Multiple states have introduced legislation with may affect behavioral and mental health operations on a state level.
Legislation on Behavioral Health Operations
Colorado
Colorado Senate Bill 25-042 proposes to empower Colorado’s Behavioral Health Administration to address reimbursement shortages for behavioral health services and to fill in gaps in Colorado’s continuum of care for behavioral health crises. On an operational level, this would increase the number of reimbursable days for inpatient mental health services from 15 days to 60 days. In addition, this bill proposes to amend how involuntary mental health holds are handled and would change the discharge requirements for patients admitted on involuntary mental health holds.
Possible effects: Should this bill pass, we anticipate changes relating to reimbursement for mental health services in Colorado, which may improve accessibility gaps that persist. Nevertheless, even if the bill does not pass, this legislation demonstrates Colorado legislators’ focus on behavioral health in the state and continues the trend of improving access to, and reimbursement for, behavioral health services state-wide.
California
California Senate Bill 35 proposes to revise existing enforcement and increase scrutiny on substance use disorder (SUD) recovery facilities within California. Operationally, this bill would authorize the suspension and/or revocation of SUD facilities’ licenses for facilities who engaged in patient brokering and other kickback schemes. This bill would also empower city and district attorneys to enforce these measures, thereby potentially increasing local enforcement and scrutiny.
Possible effects: This is the second bill on scrutiny into SUD recovery facilities to be introduced since the passage of California’s Ethical Treatment for Persons with Substance Use Disorder Act (Cal. Health & Safety Code § 11857 et seq.) in 2022. Should this bill pass, it would strengthen enforcement of fraud and abuse laws for SUD facilities. However, even if the bill does not pass, this proposed legislation demonstrates a continued focus on and prioritization of SUD facility compliance within California.
Legislation on Mental Health Services and Education
Eighteen states have proposed legislation regarding education around maternal mental health. These states are Alabama, Arizona, California, Connecticut, Georgia, Maryland, Massachusetts, Minnesota, Mississippi, New Hampshire, New Jersey, New Mexico, Oklahoma, Tennessee, Virginia, and West Virginia.
These proposed bills include legislation to provide coverage for perinatal and post-partum depression screening, extending delivery and post-natal care to fee-for-service models to improve care outcomes, improving patient and practitioner education on maternal mental health, and legislation commissioning studies on SUDs and behavioral health concerns within maternal mental health.
Together, these bills represent a continued state-level shift towards prioritizing mental health on a populational level. Should these bills pass, we anticipate potential changes in reimbursement and covered services on a state level, as well as further research into this field.
Rise in Hospital Closures May Reduce Accessibility of Behavioral Health Services
In 2025, there has been a large increase in closures of hospitals, including psychiatric hospitals. To date in 2025, at least 13 hospitals have closed their doors or announced imminent closures. In almost every case, the hospital administrators have stated that the decision to cease operations was caused by financial and operational considerations, including reimbursement challenges and ongoing labor shortages.1 At least one other hospital has shuttered its inpatient psychiatric wing following ongoing concerns regarding its patient census and reimbursement.2
Of the 13 hospitals to have closed or announced imminent closure, two are in Colorado, where an additional hospital-based behavioral health provider is also closing (or at least reorganizing and relocating its operations elsewhere). On March 1, 2025, Johnstown Heights Behavioral Health ceased operations. West Springs Hospital closed effective March 10, 2025. Each of these hospitals cited ongoing financial and operational struggles that influenced these closures. Finally, West Pines Behavioral Health, a hospital-based behavioral health provider, has announced it will close its Lutheran Hospital campus operations effective March 31, 2025.3 Much of its staff and operations appear to have been relocated to the new West Pines Behavioral Hospital, which is a fairly new adult (with adolescent and senior inpatient services coming in the near future) psychiatric hospital in Westminster through the partnership of Acadia Healthcare and Intermountain Health that was initially licensed as a psychiatric hospital in December 2024.4 Including the new addition of West Pines Behavioral Hospital, there are now eight psychiatric hospitals in Colorado, two of which are run by the state of Colorado, and all eight of which are on the front range urban corridor of Colorado.
These closures come on the heels of the Center for Healthcare Quality and Payment Reform’s February 2025 Report stating that “[m]ore than 700 rural hospitals—one-third of all rural hospitals in the country—are at risk of closing because of the serious financial problems they are experiencing. Over 300 of these rural hospitals are at immediate risk of closing because of the severity of their financial problems.” In light of ongoing nationwide financial struggles of health care providers, including psychiatric hospitals and those serving rural populations, behavioral health patients may face reduced accessibility for behavioral and mental health care, especially on Colorado’s western slope, despite increasing need for such service access in recent years.
1 See 10 hospital closures in 2025 – Becker’s Hospital Review | Healthcare News & Analysis.
2 See Endeavor cuts jobs amid service reductions – Becker’s Hospital Review | Healthcare News & Analysis.
3 See generally Nearly 500 behavioral health workers in Colorado have been laid off in the past 3 months | The Colorado Sun.
4 See Colorado to get more mental health bed options, new hospital amid “near crisis” | the Colorado Sun.
CLP Changes And What They Mean For Commercial Operations — A Conversation with Karin Baron and Lioba Oerter [Podcast]
This week I had the pleasure of speaking with Lioba Oerter, Director of Expert Services, 3E Expert Service Processing Centre (ESPC), and Karin F. Baron, Director of Hazard Communication and International Registration Strategy at B&C and our consulting affiliate, The Acta Group, about the significant changes to product classification, labeling, and packaging (CLP) in the European Union (EU). Lioba and I shared a podium recently and found we also have a shared belief that these forthcoming CLP changes will have a profound commercial impact on product classification, labeling, and packaging globally and that with everything going on in the world these days, this impact may be a bit underappreciated. Karin and I spoke about these matters last year, and I welcomed an opportunity to consider them again with Karin and Lioba in light of the new CLP developments as of December 2024. Karin, Lioba, and I discuss the CLP changes, including those recently made, why they came to be, what they mean for commercial operations, and conclude with some tips on staying ahead of this coming storm.
What’s the (Re)issue? Patent Term Extensions for Reissue Patents
Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original patent should be used to calculate the extension, not the reissue date. Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., Case No. 23-2254 (Fed. Cir. Mar. 13, 2025) (Dyk, Mayer, Reyna, JJ.)
Merck owns a patent that is directed to a class of 6-mercapto-cyclodextrin derivatives. Four months after the patent issued, Merck applied to the US Food & Drug Administration (FDA) for approval of sugammadex, which it intended to market as Bridion®. During FDA’s review of Merck’s new drug application (NDA), Merck filed a reissue application that included narrower claims. The reissue application issued and included all the original claims and 12 additional claims. FDA regulatory review continued throughout the examination of the reissue application and extended almost two years beyond the date the patent reissued. In all, the FDA regulatory review lasted nearly 12 years.
The Hatch-Waxman Act provides owners of patents related to pharmaceutical products a process to extend the term of their patent rights to compensate for time lost during regulatory review of their NDAs. The act contains a clause providing that “the term of a patent . . . shall be extended by the time equal to the regulatory review period . . . occur[ring] after the date the patent is issued.” Having been unable to market the invention covered by the patent for almost 12 years because of FDA’s regulatory review, Merck filed a PTE application for its reissue patent seeking a five-year extension (the maximum allowed under the act) based on the patent’s original issue date. The US Patent & Trademark Office (PTO) agreed and granted the five-year extension.
Between the reissue date and the PTO’s grant of the five-year extension, Aurobindo and other generic manufacturers had filed abbreviated new drug applications (ANDAs) seeking to market generic versions of Bridion®. Merck sued for infringement. At trial, Aurobindo argued that the PTO improperly calculated the PTE by using the original issue date instead of the reissue date because only 686 days of FDA’s regulatory review occurred after the reissue date, as opposed to the almost 12 years which had passed since the initial issue date. The district court disagreed, finding that Aurobindo’s proposed construction “would undermine the purpose of the Hatch-Waxman Act.” Aurobindo appealed.
Aurobindo argued that the act’s reference to “the patent” referred to the reissue patent because that is the patent for which the patentee was seeking term extension. Merck argued that the act’s text, read in light of other patent statutes and the history of patent reissue, required the opposite conclusion (i.e., a PTE based on the original issue date).
The Federal Circuit agreed with Merck, explaining that while the language of the PTE text may be ambiguous, that ambiguity may be resolved by considering the PTE text in light of the history of the Hatch-Waxman Act and its place within the statutory scheme. The purpose of the act is “to compensate pharmaceutical companies for the effective truncation of their patent terms while waiting for regulatory approval of new drug applications,” and “the statute should be liberally interpreted to achieve that end.”
Having found that the Hatch-Waxman Act contemplates PTE for patents claiming drug products for which exclusivity was delayed by FDA review, the Federal Circuit found no reason to deny Merck compensation for the PTE period calculated by the PTO based on the original patent issue date.
China Releases New Rules Regarding the Use of Facial Recognition Technology
On March 21, 2025, the Cyberspace Administration of China and the Ministry of Public Security jointly released the Security Management Measures for the Application of Facial Recognition Technology (the “Measures”), which will become effective on June 1, 2025. Below is a summary of the scope and certain of the key requirements of the Measures.
Scope of Application of the Measures
The Measures apply to activities using facial recognition technology to process facial information to identify an individual in China. However, the Measures do not apply to activities using facial recognition technology for research or algorithm training purposes in China.
Facial information refers to biometric information of facial features recorded electronically or by other means, relating to an identified or identifiable natural person, excluding information that has been anonymized.
Facial recognition technology refers to individual biometric recognition technology that uses facial information to identify an individual’s identity.
Specific Processing Requirements for Facial Recognition Technology
The Measures include specific processing requirements which must be complied with when activities are in scope of the Measures. These include:
Storage: The facial information should be stored in the facial recognition device and prohibited from external transmission through the Internet, unless the data handler obtains separate consent from the data subject or is otherwise permitted by applicable laws and regulations.
Privacy Impact Assessment (“PIA”): The data handler should conduct a PIA before processing the data.
Public Places: Facial recognition devices can be installed in public places, subject to the data handler establishing the necessity for maintenance of public security. The data handler shall reasonably determine the facial information collection area and display prominent warning signs.
Restriction: The data handler should not use facial recognition as the only verification method if there is any other technology that may accomplish the same purpose or meet the equivalent business requirements.
Filing Requirement: If the data handler processes facial information of more than 100,000 individuals through facial recognition technology, it should conduct a filing with the competent Cyberspace authority at the provincial level or higher within 30 business days upon reaching that threshold. The filing documents should include, amongst other things, basic information of the data handler, the purpose and method of processing facial information, the security protection measures taken, and a copy of the PIA. In cases of any substantial changes of the filed information, the filing shall be amended within 30 business days from the date of change. If the use of facial recognition technology is terminated, the data handler shall cancel the filing within 30 business days from the date of termination, and the facial information involved shall be processed in accordance with the law.