Reaching Another TSCA milestone, EPA Identifies 40 Chemicals to Prioritize for Risk Evaluation - US Environmental Protection Agency
WASHINGTON (March 20, 2019) — Today, the U.S. Environmental Protection Agency (EPA) is publishing a list of 40 chemicals to begin the prioritization process – the initial step in a new process of reviewing chemicals currently in commerce under the amended Toxic Substances Control Act (TSCA).
“EPA continues to demonstrate its commitment to the successful and timely implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act,” said EPA Administrator Andrew Wheeler. “We are delivering on the promise of Lautenberg to better assess and manage existing chemicals in commerce and provide greater certainty and transparency to the American public.”
“Initiating a chemical for high or low prioritization does not mean EPA has determined it poses unreasonable risk or no risk to human health or the environment; it means we are beginning the prioritization process set forth in Lautenberg,” said Alexandra Dapolito Dunn, Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention.
The Agency is releasing this list in order to provide the public an opportunity to submit relevant information such as the uses, hazards, and exposure for these chemicals. A docket has been opened for each of the 40 chemicals. The publication of this list in the Federal Register initiates a 90-day public comment period. Publication also activates a statutory requirement for EPA to complete the prioritization process in the next nine to 12 months, allowing EPA to designate 20 chemicals as high priority and 20 chemicals as low priority by December 2019.
TSCA requires EPA to publish this list of 40 chemicals to begin the prioritization process to designate 20 chemicals as “high-priority” for subsequent risk evaluation and to designate 20 chemicals as “low-priority,” meaning that risk evaluation is not warranted at this time.
One of the chemicals identified for high-priority evaluation is formaldehyde, a chemical that has been studied by EPA’s Integrated Risk Information System (IRIS) program for many years.
“Moving forward evaluating formaldehyde under the TSCA program does not mean that the formaldehyde work done under IRIS will be lost,” added Dunn. “In fact, the work done for IRIS will inform the TSCA process. By using our TSCA authority EPA will be able to take regulatory steps; IRIS does not have this authority,” she noted.
When prioritization is complete, chemicals designated as high priority will begin a 3-year risk evaluation process to determine if the chemical, under the conditions of use, presents an unreasonable risk to human health and the environment. The designation of a chemical as a low priority means that further risk evaluation is not warranted at this time.
The 20 high priority candidate chemicals include seven chlorinated solvents, six phthalates, four flame retardants, formaldehyde, a fragrance additive, and a polymer pre-curser. EPA has received a manufacturer request for a risk evaluation of two additional phthalates and is currently determining whether the request contains the minimum needed elements to proceed under EPA’s regulations. If complete, EPA has 15 days to provide notice of such a request.
The 20 low priority candidate chemicals have been selected from EPA’s Safer Chemicals Ingredients List, which includes chemicals that have been evaluated and determined to meet EPA's safer choice criteria.
The list of chemicals can be found here: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/list-chemicals-undergoing-prioritization.
Cast Iron Soil Pipe from China Injures U.S. Industry, Says USITC - U.S. International Trade Commission
The United States International Trade Commission (USITC) today determined that a U.S. industry is materially injured by reason of imports of cast iron soil pipe from China that the U.S. Department of Commerce (Commerce) has determined are subsidized and sold in the United States at less than fair value.
Chairman David S. Johanson and Commissioners Irving A. Williamson, Meredith M. Broadbent, Rhonda K. Schmidtlein, and Jason E. Kearns voted in the affirmative.
As a result of the USITC’s affirmative determinations, Commerce will issue antidumping and countervailing duty orders on imports of this product from China.
The Commission’s public report Cast Iron Soil Pipe from China (Inv. Nos. 701-TA-597 and 731-TA-1407 (Final), USITC Publication 4879, April 2019) will contain the views of the Commission and information developed during the investigations.
The report will be available by April 24, 2019; when available, it may be accessed on the USITC website at: http://pubapps.usitc.gov/applications/publogs/qry_publication_loglist.asp.
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UNITED STATES INTERNATIONAL TRADE COMMISSION
Washington, DC 20436
FACTUAL HIGHLIGHTS
Cast Iron Soil Pipe from the China
Investigation Nos. 701-TA-597 and 731-TA-1407 (Final)
Product Description: The merchandise covered by these proceedings is cast iron soil pipe, whether finished or unfinished, regardless of industry or proprietary specifications, and regardless of wall thickness, length, diameter, surface finish, end finish, or stenciling. The scope of these investigations includes, but is not limited to, both hubless and hub and spigot cast iron soil pipe. Cast iron soil pipe is non-malleable iron pipe of various designs and sizes. Cast iron soil pipe is generally distinguished from other types of non-malleable cast iron pipe by the manner in which it is connected to cast iron soil pipe fittings.
Status of Proceedings:
1. Type of investigation: Final phase antidumping duty and countervailing duty investigations.
2. Petitioners: Cast Iron Soil Pipe Institute, Mundelein, IL.
3. USITC Institution Date: Friday, January 26, 2018.
4. USITC Hearing Date: Tuesday, February 12, 2019.
5. USITC Vote Date: Wednesday, March 20, 2019.
6. USITC Notification to Commerce Date: Wednesday, April 3, 2019.
U.S. Industry in 2017:
1. Number of U.S. producers: 2.
2. Location of producers’ plants: California, North Carolina, and Texas.
3. Production and related workers: [1]
4. U.S. producers’ U.S. shipments: 1
5. Apparent U.S. consumption: 1
6. Ratio of subject imports to apparent U.S. consumption: 1
U.S. Imports in 2017:
1. Subject imports: $13.2 million.
2. Nonsubject imports: $757,000.
3. Leading import source: China.
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l[1] Withheld to avoid disclosure of business proprietary information.
OFAC: Announcements - Office of Textiles and Apparel
3/18/2019 – U.S.-Korea FTA: Advice on Modifications to Certain Textile and Apparel Rules of Origin, Institution of Investigation and Notice of Opportunity to Provide Written Comments, United States International Commission. Deadline for filing written submissions: March 29, 2019.
3/06/2019 – December 2018 Textile and Apparel Import Report
Four South Carolina Men Sentenced for International Wildlife Smuggling - Department of Justice
Columbia, South Carolina --- United States Attorney Sherri A. Lydon announced today that Steven Verren Baker, 38, of Holly Hill, South Carolina, was sentenced to 27 months in federal prison after pleading guilty to participating in a Conspiracy to Smuggle Wildlife. Senior United States District Judge Joseph F. Anderson, Jr., of Columbia, imposed the sentence and ordered Baker to forfeit $263,225.00 in proceeds.
On February 27, 2019, Joseph Logan Brooks, 29, formerly of Holly Hill, was sentenced to five months incarceration and five months home confinement for his participation in the conspiracy. Likewise, on March 1, 2019, fellow conspirator Matthew Tyler Fischer, 26, of Holly Hill, was sentenced to six months home confinement and two years’ probation. William Fischer, age 48, of Harleyville, South Carolina, was sentenced to two years’ probation and ordered to pay a $1,000 fine for a misdemeanor Wildlife Trafficking violation. All three participated in or facilitated Baker’s efforts.
Matthew Harrison Kail, age 30, of Pomona Park, Florida, and William Thomas Gangemi, age 26, of Freehold, New Jersey, have both pleaded guilty and are awaiting sentencing.
Evidence presented previously established that Baker was the ringleader of an international syndicate of wildlife smugglers exchanging turtles protected by international agreements back and forth between the United States and China. The activity took place from January through June 2016. Baker obtained protected turtles from Hong Kong to distribute here in the United States, and he shipped protected turtles from the United States to Asia.
The transactions were set up using the Facebook text messaging feature. Shipments were made internationally through the United States Postal Service. Several packages were intercepted entering the United States at John F. Kennedy International Airport.
The United States Fish and Wildlife Service, the United States Postal Inspection Service, and the South Carolina Department of Natural Resources investigated the case. Assistant United States Attorney Winston David Holliday, Jr., of the Columbia office is prosecuting the case.
FDA Takes Action Against Marketer of Unapproved Products Claiming to Treat Addiction, Chronic Pain and Other Serious Conditions - U.S. Food & Drug Adminstration
The U.S. Food and Drug Administration today posted a warning letter to Nutra Pharma Corp. for illegally marketing unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain, including pain associated with cancer, diabetes, shingles, fibromyalgia and other serious conditions.
“One of our most important obligations is to protect consumers from those who would prey on them with bogus claims and fraudulent products. We’ve dedicated new resources to our enforcement work and I consider these activities the cornerstone of our consumer protection mission and one of our most significant institutional obligations. We’re especially focused on those who would exploit Americans harmed by the opioid crisis with the false promise of products that can treat pain or addiction, but that offer no such benefit,” said FDA Commissioner Scott Gottlieb, M.D. “Today, we posted a warning letter to a company preying on patients who may be seeking alternative treatments for chronic pain, cancers, arthritis and autoimmune and neurological disorders. Health fraud scams like these are inexcusable. These patients deserve proven treatments not false promises that can deter them from seeking otherwise effective care, and that can also contain ingredients or contaminations that can threaten their health. We have great concern for the millions of Americans who live with chronic pain or cancer, and for whom traditional treatment options have been exhausted, as well as those battling opioid addiction. They deserve new advances in care that can address pain without the risk of addiction, not the deception of bogus products that offer no proven benefit. We’ll continue our efforts to protect consumers from such false claims, while also working to advance the development of new treatment options, including non-addictive products for pain management and innovative products for the treatment of opioid use disorder.”
The FDA issued a warning letter to Nutra Pharma for their products: “Nyloxin Oral Spray,” “Nyloxin Topical Gel,” “Nyloxin Topical Roll-On,” “Nyloxin Topical Roll-On ES,” “Nyloxin Professional Size Pump Topical Gel” and “Regular Strength Sample Pack.” These products also may confuse consumers because its name is similar to FDA-approved drugs.
Examples of claims made include:
“Nyloxin . . . treats conditions that cause chronic pain.”
- “[C]obra venom saw its primary use in the treatment of cancer and arthritis. Reportedly the venom was used to treat liver cancer, lung cancer, esophageal cancer, skin cancer, and leukemia.”
- “Today, cobra venom is being studied for treating various forms of pain, cancers, autoimmune and neurological disorders.”
- “Researchers in China are examining the possibility that cobra venom can be used to treat drug addiction.”
- “Treatment of the Cobrotoxin in 90 cases with heroin dependence.”
Health fraud scams like these can pose serious health risks. These products have not been demonstrated to be safe or effective and may keep some patients from seeking appropriate, FDA-approved therapies. Selling these unapproved products with claims that they can treat chronic pain is a violation of the Federal Food, Drug, and Cosmetic Act.
In addition to supporting the development of alternatives to opioid analgesics for chronic pain, reducing the number of Americans who are addicted to opioids and cutting the rate of new addiction is one of the Administration’s highest priorities. This work includes promoting more widespread innovation and access to medication-assisted treatment (MAT) for the more than 2 million of Americans with an opioid use disorder (OUD). The FDA is taking steps to make safe and effective MAT available to those who suffer from OUD and to reduce the stigma that is sometimes associated with use of these therapies. Using products with unsubstantiated claims may prevent those addicted to opioids from seeking approved treatments that have been demonstrated to be safe and effective, delay their path to recovery and put them at greater risk of death. In fact, patients receiving FDA-approved medication-assisted treatment cut their risk of death from all causes in half, according to the Substance Abuse and Mental Health Services Administration.
The FDA has requested responses from Nutra Pharma within 15 working days. The warning letter also states that failure to correct violations may result in legal action without further notice, including, without limitation, seizure and injunction.
In December 2017 the FDA proposed a risk-based enforcement approach that prioritizes enforcement and regulatory actions involving drug products labeled as homeopathic that have the greatest potential to cause risk to patients. Given the concerns about the proliferation of potentially ineffective and harmful products labeled as homeopathic, the FDA previously stated it would consider taking additional enforcement and/or regulatory actions, consistent with its current compliance policies, in the interest of protecting the public. Homeopathic products have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality.
Health care professionals and consumers are encouraged to report any adverse events related to these products to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.