The Occupational Safety and Health Administration (OSHA) issued a press release detailing changes to an existing policy on the instance-by-instance issuance of citations. According to OSHA, this change is "to make [OSHA's] penalties more effective in stopping employers from repeatedly exposing workers to life-threatening hazards or failing to comply with certain workplace safety and health requirements."

“Department of Labor announces enforcement guidance changes to save lives, target employers who put profit over safety; seeks to hold employers to greater account for safety, health failures.” - January 26, 2023, DOL press release

According to the press release, the impact of the change will be limited to specific conditions where the rule's language supports a citation for each instance of noncompliance, which include violations such as "lockout/tagout, machine guarding, permit-required confined space, respiratory protection, falls, trenching and for cases with other-than-serious violations specific to recordkeeping." According to John Surma of Ogletree Deakins, "...related enforcement memoranda suggest this is not how the practice is expected to be utilized."

Since 1990, the practice of issuing citations on an "instance-by-instance" basis (IBI citations) has been limited to "egregious willful citations." OSHA Instruction CPL 02-00-080, published on October 21, 1990, states that "[t]he large proposed penalties that accompany violation-by-violation citations are not, therefore, primarily punitive nor exclusively directed at individual sites or workplaces; they serve a public policy purpose; namely, to increase the impact of OSHA's limited enforcement resources."

It is important to point out that the instance-by-instance citation policy was rarely used. As John Surma of Ogletree Deakins notes, "When it was used, it was often limited to cases involving serious injury or death where prior serious injury- or death-related inspections were conducted and citations issued. Even more limiting, OSHA often limited this practice to cases where the citations were fully resolved through settlement or adjudication."

The current announcement was related to an enforcement memorandum that included four factors for determining whether instance-by-instance citations should be issued. The factors to be considered include the following:

• The employer has received a willful, repeat, or failure to abate violations within the past five years, where that classification is current.
• The employer has failed to report a fatality, inpatient hospitalization, amputation, or loss of an eye under the requirements of 29 CFR 1904.39.
• The proposed citations are related to a fatality/catastrophe.
• The proposed recordkeeping citations are related to injury or illness(es) resulting from serious hazards.

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The enforcement memorandum provided the following guidance:

• Instance-by-instance citations may be applied when the text of the relevant standard allows (such as, but not limited to, per machine, location, entry, or employee) and when the instances of violation cannot be abated by a single method of abatement.
• When an inspection may result in instance-by-instance violations, each instance should be documented thoroughly, e.g., material being processed, equipment, facility conditions, human factors, personal protective equipment, etc.
• The case file must contain a fully documented justification for IBI citations.

In addition to issuing new guidance on when to issue IBI citations, OSHA also issued an enforcement memorandum reminding regional administrators and area directors of their authority not to group violations. The practice of grouping violations typically involves issuing a citation with multiple subparts that carry no penalty but state alternative theories or factual bases to justify the issuance of the citation. Those subparts carry no additional penalty, but they may require abatement of violations beyond the scope of the first listed instance.

That enforcement memorandum set forth the factors that generally are considered when considering when to group citations and then why grouping should not be considered:

Grouping violations should be considered when:

• Two or more serious or other-than-serious violations constitute a single hazardous condition that is overall classified by the most serious item
• Grouping two or more other-than-serious violations considered together creates a substantial probability of death or serious physical harm, or
• Grouping two or more other-than-serious violations result in a high gravity other-than-serious violation.

According to John Surma of Ogletree Deakins: "In cases where grouping does not elevate the gravity or classification and resulting penalty, violations should not be grouped if the evidence allows for separate citations.

Thus, whereas the prior guidance concerning IBI citations was limited to inspections where egregious willful citations were issued, this guidance would apply the practice to even the lowest level of citable violation: that which is considered other-than-serious.

Moreover, the enforcement memorandum on grouping violations extends the program's reach far beyond the application of IBI citation issuance to a limited set of other-than-serious recordkeeping violations to many other categories of other-than-serious violations. Whereas the press release of January 26, 2023, suggests that IBI citations will only be issued concerning OSHA recordkeeping citations, the corresponding enforcement memoranda indicate that it could be used for all other-than-serious citations that meet the stated criteria.

In addition to the significant increase in penalties for OSHA citations that recently became effective, employers are much less likely to see citations grouped—with the consequence of significantly increased penalties multiplied by the number of instances cited. It is fair to assume that the number of cases that will be contested, due to the increased overall penalty exposure, will increase dramatically, depending upon how widespread this practice is utilized and the time to resolution of OSHA citations increased."

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Blaine J. Hoffmann has been in the occupational safety & health industry for over 27 years. He is the producer and host of The SafetyPro Podcast and the founder of the SafetyPro Podcast Community Site.

As part of the Consolidated Appropriations Act 2023, the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) was signed into law. MoCRA implements new compliance requirements on the cosmetics industry and expands the U.S. Food and Drug Administration’s (“FDA”) authority to oversee and regulate cosmetics.

The following new requirements on “responsible persons” and “facilities” will be imposed by MoCRA:

• Facility Registration and Product Disclosure. All facilitates (domestic or foreign) that manufacture or process cosmetic products for distribution in the United States must register with FDA by December 29, 2023. Registration is biennial. Further, responsible persons must annually submit cosmetic product listings to FDA and disclose key product information, such as ingredients.

• Adverse Event Recording and Serious Adverse Event Reporting. Generally, responsible persons must keep records of any adverse events related to products used in the United States for six years and submit any “serious adverse events” to FDA within 15 days of the responsible person’s receipt of the report. MoCRA broadly defines what constitutes a serious adverse event compared to other FDA regulatory product categories (e.g., dietary supplements).

• Labeling Requirements. To improve the reporting of adverse events, responsible persons must include contact information on product labels. Additionally, product labels must identify any fragrance allergens in the product. Labels for products intended solely for licensed professionals must also indicate that only licensed professionals may use the product.

• Safety Substantiation Requirement. Responsible persons must ensure that a product is “safe” and keep records “adequately substantiating” the product’s safety. Products without adequate safety substantiation may be considered adulterated under the FDCA. MoCRA also states that Congress feels animal testing should not be used for safety testing on cosmetic products and should be phased out except for appropriate allowances.

   

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MoCRA significantly expands FDA’s enforcement authority over the cosmetics industry.

• Issue Mandatory Recalls. FDA now has mandatory recall authority if the agency concludes there is a reasonable probability that a cosmetic is adulterated or misbranded and the use of the cosmetic will cause serious adverse health consequences or death.

• Access Records. The FDA can access records relating to any cosmetic product if the agency reasonably believes that a product (or one of its ingredients) is adulterated and presents a threat of serious adverse health consequences or death.

• Suspend Facilities. FDA may suspend a facility’s registration if the agency determines that a cosmetic product manufactured or processed by that facility has a reasonable probability of causing serious adverse health consequences or death, and there is a reasonable belief that other products from the same facility may be similarly affected.

• Federal Preemption. MoCRA explicitly preempts state or local laws that differ from the federal cosmetics framework regarding facility registration and product listing, good manufacturing practices (“GMPs”), records, recalls, adverse event reporting, or safety substantiation.

MoCRA directs FDA to promulgate rules regarding the following three issues. Importantly, the cosmetics industry will have opportunities to provide comments on the proposed rules.

• GMPs. FDA must establish GMP regulations consistent with national and international standards. Cosmetic products manufactured or processed under conditions that do not meet FDA’s forthcoming GMP regulations may be considered adulterated. The agency must issue a proposed rule by December 29, 2024, and a final rule by December 29, 2025.

• Fragrance Allergens. FDA must publish regulations to identify fragrance allergens. Cosmetic product labels that do not include fragrance allergen disclosures required by such regulations may be considered misbranded under the FDCA. The agency must issue a proposed rule by June 29, 2024, and a final rule no later than 180 days after the public comment period.

• Talc. FDA must issue regulations to establish required standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.

In addition to the above rulemakings, FDA must issue a report within the next three years on the use of per- and polyfluoroalkyl substances (“PFAS”) in cosmetic products.

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Blaine J. Hoffmann has been in the occupational safety & health industry for over 27 years. He is the producer and host of The SafetyPro Podcast and the founder of the SafetyPro Podcast Community Site.

The U.S. Environmental Protection Agency (EPA) announced on January 9, 2023, the availability of the final revision to the risk determination for trichloroethylene (TCE) risk evaluation issued under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 1222. EPA determined that TCE, as a whole chemical substance, presents an unreasonable risk of injury to human health when evaluated under its conditions of use (COU). EPA states that the revision to the risk determination reflects its announced policy changes to ensure the public is protected from unreasonable chemical risks in a way supported by science and the law.

TCE is a volatile organic compound (VOC) used primarily in industrial and commercial processes. Consumer uses include cleaning and furniture care products, arts and crafts, spray coatings, and automotive care products like brake cleaners.

In its revised risk determination, EPA found that TCE presents an unreasonable risk to the health of workers, occupational non-users (ONU) (workers nearby but not in direct contact with this chemical), consumers, and bystanders. EPA identified risks for adverse human health effects unrelated to cancer, including neurotoxicity and liver effects, from acute and chronic inhalation and dermal exposure to TCE. EPA also identified risks for cancer from chronic inhalation and dermal exposures to TCE.

EPA states that it used the whole chemical risk determination approach for TCE in part because there are benchmark exceedances for multiple COUs spanning across most aspects of TCE’s life cycle, from manufacturing (including import), processing, commercial use, consumer use, and disposal for the health of workers, ONUs, consumers, and bystanders, and because the health effects associated with TCE exposures are “severe and potentially irreversible” (including developmental toxicity, reproductive toxicity, liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, and cancer).

"This decision should not be viewed as an indication that the EPA believes there is widespread non-compliance with applicable Occupational Safety and Health Administration (OSHA) standards.” - EPA

EPA notes that the revised risk determination for TCE does not reflect an assumption that workers always and appropriately wear personal protective equipment (PPE), even though some facilities might use PPE as one means to reduce workers’ exposure. EPA states that this decision “should not be viewed as an indication that the EPA believes there is widespread non-compliance with applicable Occupational Safety and Health Administration (OSHA) standards.” In fact, according to EPA, it received public comments from industry respondents about occupational safety practices currently in use at their facilities. It will consider these comments and other information on the use of PPE, engineering controls, and different ways the industry protects its workers as potential ways to address unreasonable risk during the risk management process. EPA will consider this information as part of the risk management process.

EPA acknowledges that occupational safety protections could be in place at some workplace locations. Not assuming the use of PPE in its baseline exposure scenarios, however, reflects EPA’s recognition that specific subpopulations of workers exist that may be highly exposed because:

• OSHA standards do not cover them (e.g., self-employed individuals and public sector workers who are not covered by a state plan).

• Their employers are out of compliance with OSHA standards.

• OSHA’s chemical-specific permissible exposure limits (PEL) (primarily adopted in the 1970s) are described by OSHA as being “outdated and inadequate for ensuring the protection of worker health.”

• The OSHA PEL alone may be inadequate for ensuring worker health protection, as is the case for TCE, according to the EPA.

EPA states that as it moves forward with risk management rulemaking for TCE, it will “strive for consistency with existing OSHA requirements or best industry practices when those measures would address the identified unreasonable risk.” EPA will propose occupational safety measures in the risk management process that would meet TSCA’s statutory requirement to eliminate an unreasonable risk of injury to health and the environment.

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Blaine J. Hoffmann has been in the occupational safety & health industry for over 27 years. He is the producer and host of The SafetyPro Podcast and the founder of the SafetyPro Podcast Community Site.