What the FDA publishes without anyone asking

One release makes it a release to everyone

The rule underneath the whole scheme is short. Any agency record disclosed in an authorized manner to any member of the public "is available for disclosure to all members of the public".

That is why so much of this system is worth checking before writing to anyone. Once a document has gone out lawfully, it is not a favor granted to one requester.

Three exceptions are named. Trade secret and confidential commercial material, and personal privacy material, go only to the people those protections exist for.

Certain limited disclosures follow their own special rules, and records about an individual retrieved by name sit under the separate privacy regulations.

Giving a person their own record does not open it to anyone else. The rule says so directly.

Some material never needed a request at all

The agency keeps a category of material prepared for routine public distribution, such as pamphlets, speeches and educational materials.

Those "shall be furnished free of charge upon request as long as the supply lasts." The records-request machinery does not apply to them.

It applies again only in one situation. If the supply runs out and individual copies have to be reproduced on request, the ordinary rules return.

Anything else in writing is treated as a formal request whether or not the requester frames it that way. Take a written ask for existing records not prepared for routine distribution. It "shall be deemed to be a request for records pursuant to the Freedom of Information Act, whether or not the Freedom of Information Act is mentioned in the request".

There is a warning at the end of the same section. "All existing Food and Drug Administration records are subject to routine destruction according to standard record retention schedules."

Existing records only, with one discretionary exception

The request rules "apply only to existing records that are reasonably described in a request". Nobody has to build a document to answer a question.

That single sentence explains most disappointing outcomes. A request that asks for an analysis, a total or a list that the agency does not already keep is asking for a new record.

There is a discretionary door. The Commissioner may "prepare new records in order to respond adequately to a request for information" where doing so serves the public interest and the agency's objectives.

It is discretion, not a right. But it is worth knowing it exists before assuming a question is unanswerable.

The three-request rule

A separate section requires indexes to specified categories of records, and copies of the electronic records themselves where required.

"Indexes shall be maintained, and revised at least quarterly". Four categories are listed.

The first two are formal. One is final orders published in the Federal Register denying or withdrawing approval of a new drug or new animal drug application where a hearing was requested. The other is statements of policy and interpretation still in force but not published in the Federal Register.

The third is administrative staff manuals and instructions to staff that affect a member of the public.

The fourth is the practical one. Records already released in response to a request go into this set where the agency has determined they have become, or are likely to become, the subject of further requests for substantially the same material.

And a bright line sits beside that judgment call. Records that "Have been requested three or more times under the Freedom of Information Act." belong there too.

All of it is reached through the agency's own website, with a printed index available from the disclosure staff.

Where a request goes, and how long the file survives

One office is responsible for compliance, and all requests for agency records have to be sent to it in writing. The address is published on the agency site rather than in the regulation.

The file that a request creates has a stated life. Ordinary request files "may be destroyed 2 years from date of final response."

A denial lasts longer. Files created by a request that was wholly or partially denied "may be destroyed 5 years after the denial letter was issued."

An appealed denial lasts longest. Those files may be destroyed four years after the agency's final determination, or three years after final adjudication by the courts, whichever is later.

That schedule updates itself. It is revised automatically whenever the government-wide records schedule it follows changes.

Whose names stay in the document

One sentence answers a question people often ask about redactions on agency documents.

Employee names "will not be deleted from disclosable records except where such deletion is necessary to prevent disclosure of an informant or danger to the life or physical safety of the employee". Other extraordinary circumstances also qualify.

So a blacked-out name on an agency document is not routine housekeeping. The default runs the other way.

That is useful when comparing two copies of the same document. A redaction that appears in one and not the other is a fact about the release, not about the underlying record.

Format, searching, and two rules that save money

The agency "shall make reasonable efforts to provide a record in any requested form or format if the record is readily reproducible by the agency in that form or format."

Where it is not readily reproducible that way, the agency may offer alternatives. If the requester expresses no preference, "the agency may provide its response in the form and format of the agency's choice."

Response letters have to carry contact details for the public liaison and for the government information services office.

On searching, the agency "shall make reasonable efforts to search for records kept in electronic form or format", except where that would significantly interfere with its automated systems.

The regulation defines the word rather than leaving it to argument. To search means "to review, manually or by automated means, agency records for the purpose of locating those records that are responsive to the request."

Two further sections quietly reduce cost. A requester is referred to the primary source where a document sits in agency files "but which is available elsewhere at a lower cost". A set of records also goes to a national technical information service, which reproduces them at cost.

Copying can also be contracted out, and the rule is careful about the order of operations. Records go to a private contractor "after deletion of all nondisclosable data and information."

The manuals, and the numbers inside them

A separate section makes agency manuals public, and it is more useful than its title suggests.

Administrative staff "manuals and instructions that affect a member of the public are available for public disclosure." An index exists, and manuals created from late 1996 onward are online.

Manuals about internal personnel rules and practices are outside that, unless the Commissioner decides to release them under the discretionary rule.

The third paragraph is the one worth the trip. It makes public the action levels used to decide when the agency will act against a violative product.

It also makes public the "limits of sensitivity and variability of analytical methods which are used in determining whether a product violates the law". The direct reference levels above which field offices may request legal action are public too.

For anyone reading testing claims, that is a rare thing: the agency's own published statement of what its methods can and cannot resolve.

The reading rooms, and what sits in each

Two public reading rooms are named, at one address, open on weekdays during stated hours.

The disclosure staff's room holds "A guide for making requests for records or information from the Food and Drug Administration". It also holds the staff manuals that affect the public, previously released records likely to be requested again, and indexes to its own holdings.

The dockets room holds a different kind of material. "Final opinions, including concurring and dissenting opinions, as well as orders, made in the adjudication of cases", plus policy and interpretation statements still in force and not published in the Federal Register.

Both rooms may hold anything else the agency decides is appropriate.

Reading room records created from late 1996 onward are made available electronically, and the agency may post more than it has to.

How to use this, and what it does not cover

The practical sequence is to check the indexes and the already-released set first. A record requested three or more times is supposed to be posted, and popular records in this field are requested constantly.

Then read the manuals section. Action levels and method sensitivity limits are published, and they set the frame for any claim about what testing proved.

Only after that does a written request make sense, because a request buys existing records and nothing more.

One limit on this article. Only subparts B and C of part 20, plus two sections of subpart F, were read. The exemptions in subpart D, the limitations in subpart E, and the fee and appeal mechanics were not re-read for this piece.

Addresses, telephone numbers and website locations appear in these sections and change over time. Nothing here should be treated as a current contact detail.

Sources

Each document below is named as it names itself, with the date printed on that document rather than the day it was read.

1. Title 21 Code of Federal Regulations section 20.21, Uniform access to records, read in full for the release-to-one, release-to-all rule and its three exceptions — Electronic Code of Federal Regulations, Office of the Federal Register, March 1989
2. Title 21 Code of Federal Regulations section 20.23, Request for existing records, read in full for the deemed-request rule, routine distribution materials and the destruction warning — Electronic Code of Federal Regulations, Office of the Federal Register, March 1977
3. Title 21 Code of Federal Regulations section 20.24, Preparation of new records, read in full for the existing-records limit and the discretionary exception — Electronic Code of Federal Regulations, Office of the Federal Register, March 1977
4. Title 21 Code of Federal Regulations section 20.26, Electronic availability and indexes of certain records, read in full for the quarterly index, the four categories and the three-request threshold — Electronic Code of Federal Regulations, Office of the Federal Register, September 2022
5. Title 21 Code of Federal Regulations section 20.30, Food and Drug Administration Division of Freedom of Information, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, November 2014
6. Title 21 Code of Federal Regulations section 20.31, Retention schedule of requests for Food and Drug Administration records, read in full for the two, five and four year periods — Electronic Code of Federal Regulations, Office of the Federal Register, June 1982
7. Title 21 Code of Federal Regulations section 20.32, Disclosure of Food and Drug Administration employee names, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, March 1977
8. Title 21 Code of Federal Regulations section 20.33, Form or format of response, read in full for the readily-reproducible standard and the default to the agency's choice — Electronic Code of Federal Regulations, Office of the Federal Register, September 2022
9. Title 21 Code of Federal Regulations section 20.34, Search for records, read in full for the electronic search duty and the definition of a search — Electronic Code of Federal Regulations, Office of the Federal Register, May 2003
10. Title 21 Code of Federal Regulations section 20.51, Referral to primary source of records, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, May 2003
11. Title 21 Code of Federal Regulations section 20.52, Availability of records at National Technical Information Service, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, May 2003
12. Title 21 Code of Federal Regulations section 20.53, Use of private contractor for copying, read in full for the deletion-before-transfer requirement — Electronic Code of Federal Regulations, Office of the Federal Register, May 2003
13. Title 21 Code of Federal Regulations section 20.107, Food and Drug Administration manuals, read in full for the disclosable manuals, the personnel-rules exception, and the published action levels and method sensitivity limits — Electronic Code of Federal Regulations, Office of the Federal Register, November 2014
14. Title 21 Code of Federal Regulations section 20.120, Records available in Food and Drug Administration Public Reading Rooms, read in full for the contents of each room and the electronic availability provision — Electronic Code of Federal Regulations, Office of the Federal Register, July 2023