Voglio sapere a riguardo di…

khammond on DSKJM1Z7X2PROD with PROPOSALS2

69128

Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules
foods Ref. 28. To identify commodities for the Food Traceability List, the commodities and associated commodity-hazard pairs produced by the Model were ranked. Commodities with associated commodity-hazard pairs with criteria scores in the moderate to strong range were considered for inclusion on the list.
Based on data in the Model, we tentatively identified foods for inclusion on the Food Traceability List Ref. 27, which was announced in conjunction with issuance of the Food Traceability proposed rule 85 FR 59984, September 23, 2020. When the FDA issues a final rule, we will also publish the Food Traceability List.
The proposed Food Traceability List Ref. 27 includes the following types of produce:
Cucumbers fresh, includes all varieties of cucumbers;
Herbs fresh, includes all types of herbs, such as parsley, cilantro, basil;
Leafy greens fresh, includes all types of leafy greens, such as lettuce, e.g., iceberg, leaf and romaine lettuces, kale, chicory, watercress, chard, arugula, spinach, pak choi, sorrel, and endive;
Melons fresh, includes all types of melons, such as cantaloupe, honeydew, and watermelon;
Peppers fresh, includes all varieties of peppers;
Sprouts fresh, includes all varieties of sprouts;
Tomatoes fresh, includes all varieties of tomatoes; and Tropical tree fruits fresh, includes all types of tropical tree fruit, such as mango, papaya, mamey, guava, lychee, jackfruit, and starfruit.
On-farm contamination of produce is well documented in the literature. The peer-reviewed FDA Qualitative Assessment of Risk to Public Health from On-Farm Contamination of Produce QAR Ref. 11 provides a scientific evaluation of the potential adverse health effects resulting from human exposure to microbiological hazards in produce, with a focus on public health risk associated with the on-farm contamination of produce. With respect to water used during growing, harvesting, and post-harvesting activities, the QAR concludes as follows:
Agricultural water can be a source of contamination of produce.
Public Drinking Water Systems domestically regulated by the Environmental Protection Agency EPA have the lowest relative likelihood of contamination due to existing standards and routine analytical testing.

VerDate Sep<11>2014

19:13 Dec 03, 2021

Jkt 256001

Though less likely to be contaminated than surface water, groundwater continues to pose a public health risk, despite the regulation of many U.S. public wells under the Ground Water Regulation.
There is a significant likelihood that U.S. surface waters will contain human pathogens, and surface waters pose the highest potential for contamination and the greatest variability in quality of the agricultural water sources.
Susceptibility to runoff significantly increases the variability of surface water quality.
Water that is applied directly to the harvestable portion of the plant is more likely to contaminate produce than water applied by indirect methods that are not intended to, or not likely to, contact produce.
Proximity of the harvestable portion of produce to water is a factor in the likelihood of contamination during indirect application.
Timing of water application in produce production before consumption is an important factor in determining likelihood of contamination.
Commodity type growth characteristics, e.g., near to ground and surface properties e.g., porosity affect the probability and degree of contamination.
Microbial quality of source waters, method of application, and timing of application are key determinants in assessing relative likelihood of contamination attributable to agricultural water use practices.
The QAR Ref. 11 concludes that while different commodities may have different risk profiles at different stages of production, all commodities have the potential to become contaminated through one or more of the routes identified, especially if practices are poor and/or conditions are insanitary.
Based on the foregoing, we continue to conclude that there is an ample history of microbiological contamination of produce on farms to justify requirements for pre-harvest agricultural water in part 112 to help prevent contamination and illness.
IV. Legal Authority We are issuing this proposed rule under FDAs authorities in sections 402, 419, and 701a of the FD&C Act and sections 311, 361, and 368 of the PHS
Act.
Section 419a of the FD&C Act 21
U.S.C. 350ha, in relevant part, directs FDA to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which
PO 00000

Frm 00010

Fmt 4701

Sfmt 4702

we have determined such standards minimize the risk of serious adverse health consequences or death. Section 419a3 21 U.S.C. 350ha3 further requires that these minimum standards provide sufficient flexibility and are appropriate to the scale and diversity of the production and harvesting of raw agricultural commodities. Section 402a3 of the FD&C Act 21 U.S.C.
342a3 provides that a food is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food. Section 402a4 of the FD&C Act provides that a food is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Additionally, section 701a of the FD&C Act 21
U.S.C. 371a grants the authority to issue regulations for the efficient enforcement of the FD&C Act. This proposed rule includes requirements that are necessary to prevent food from being adulterated, and a regulation that requires measures to prevent food from being held under insanitary conditions whereby either of the proscribed results may occur allows for the efficient enforcement of the FD&C Act. The amendments we are proposing to the produce safety regulation thus would allow FDA to efficiently enforce sections 402 and 419 of the FD&C Act.
In addition to the FD&C Act, FDAs legal authority for the proposed rule derives from sections 311, 361, and 368
of the PHS Act, which provides authority for FDA to issue regulations to prevent the spread of communicable diseases from one State to another.
Specifically, the PHS Act authorizes the Secretary to make and enforce such regulations as are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States . . . or from one State . . . into any other State section 361a of the PHS Act.
See sec. 1, Reorg. Plan No. 3 of 1966 at 42 U.S.C. 202 for transfer of authority from the Surgeon General to the Secretary; see 21 CFR 5.10a4 for delegation from the Secretary to FDA.
The provisions in the proposed rule are necessary to prevent food from being contaminated with human pathogens such as Salmonella, L. monocytogenes, and E. coli O157, and therefore to prevent the introduction, transmission, or spread of communicable disease from foreign countries into the United States, or from one state in the United States to another. We expect that the proposed
E:FRFM06DEP2.SGM

06DEP2